Elgar Encyclopedia of Healthcare Management 1800889445, 9781800889446

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Elgar Encyclopedia of Healthcare Management

ELGAR ENCYCLOPEDIAS IN BUSINESS AND MANAGEMENT Elgar Encyclopedias in Business and Management represent the definitive reference works in the field. The Encyclopedias present an overarching guide to a wide variety of subject areas within business and management, and form an essential resource for academics, practitioners, and students alike. Each Encyclopedia is edited by one or more leading international scholars, and contains a broad collection of entries authored by key scholars within the field that collectively aim to provide a concise and accessible coverage of the essential subjects. The Encyclopedias cover discrete subject areas across management including, but not limited to, corporate governance, strategic management, human resource management, international business, family business, social innovation, and critical management studies. Equally useful as reference tools or high-level introductions to specific topics, issues, methods, and debates, these Encyclopedias are an invaluable contribution to the field. For a full list of Edward Elgar published titles, including the titles in this series, visit our website at www​.e​-elgar​.com​.

Elgar Encyclopedia of Healthcare Management Edited by

Federico Lega Professor of Health Management and Policy, Director, Research and Training Center in Health Administration, Department of Biomedical Science, University of Milan, Italy

ELGAR ENCYCLOPEDIAS IN BUSINESS AND MANAGEMENT

Cheltenham, UK • Northampton, MA, USA

© Federico Lega 2023

With the exception of any material published open access under a Creative Commons licence (see www.elgaronline.com), all rights are reserved and no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical or photocopying, recording, or otherwise without the prior permission of the publisher.

The Preface and Chapter 1 are available for free as Open Access from the individual product page at www.elgaronline.com under a Creative Commons Attribution NonCommercialNoDerivatives 4.0 International (https://creativecommons.org/licenses/by-nc-nd/4.0/) license. Published by Edward Elgar Publishing Limited The Lypiatts 15 Lansdown Road Cheltenham Glos GL50 2JA UK Edward Elgar Publishing, Inc. William Pratt House 9 Dewey Court Northampton Massachusetts 01060 USA A catalogue record for this book is available from the British Library Library of Congress Control Number: 2023939407 This book is available electronically in the Business subject collection http://dx.doi.org/10.4337/9781800889453

ISBN 978 1 80088 944 6 (cased) ISBN 978 1 80088 945 3 (eBook)

EEP BoX

Contents

List of figuresx List of contributorsxi Prefacexiv PART I

PART III

SCENARIOS

1

Big data and artificial intelligence Martina Cappellina

2

2

Disruptive technology innovations Claudia Bianchino

6

3 Genomics Andrea Sommariva

8

EVOLUTION OF THE PHARMA AND MEDTECH INDUSTRY

11 Market access Emanuele Marsili

30

12 Digital therapeutics Elena Maggioni

33

13 Biotech Francesco Bagordo, Antonella De Donno and Tiziana Grassi

36

PART IV

FOUNDATIONS OF HEALTH ECONOMICS

4 Globalization Houseyin Akyil

11

5

Medical tourism Shir Sara Bekhor

13

14 Baumol’s cost disease David Brett Doerksen

40

6

Precision medicine Valeria Mazzola

16

15 Disease mongering Giulia Gallo

42

19

16 Moral hazard in health insurance 44 Ana Paula Fontoura Andrade Reis

7 Robotics Michele Giovanni Cusmai PART II

BASIC MODELS OF HEALTH SYSTEMS

8

Beveridge model Yagis Bey

22

9

Bismarck model Assaf Ben Haim

24

10 Market-driven model Eric Berrou

26

17 Quasi-markets Mario del Vecchio

46

18 Supplier-induced demand Ghina el Nounou

48

PART V

v

FUNDING

19 Payment mechanisms Martina Pisarra

51

20 Sources of funding Guido Noto

55

21 Tariff vs price Guido Noto

57

vi  Elgar encyclopedia of healthcare management

PART VI

HEALTH POLICY PRINCIPLES

PART IX

22 Equality and equity Silvia de Donato

60

23 Universalism Giulia de Fortunato

62

24 Well-being Valentina Lombardi

64

PART VII INVESTMENT ANALYSIS 25 Business planning of healthcare services Giovanni Aguzzi

69

26 Sources of funding for investments 71 Clara Del Prete, Marta Marsilio and Fabio Amatucci PART VIII LEVELS OF CARE 27 Acute, sub-acute and post-acute care Mehmet Can Cifci

77

28 Chronic care Ana Ciobanu

79

29 Home care and community care Claudia Bianchino, Davide Carnevali and Niccolò Principi

83

30 Hospital Clara Del Prete

86

31 Long term care Zignat Courtoux

91

32 Prevention Elisabetta Pierini

NEW PARADIGMS

36 Access to healthcare Claudia Bianchino

108

37 Co-production Marta Marsilio and Chiara Guglielmetti

110

38 Demedicalization Francesco Mazziotta

113

39 Evidence-based medicine Pietro Magnoni

115

40 From compliance to concordance Bharat Nandakumar

119

41 Gender medicine Eduardo Marra

121

42 Global health Giovanna Clerici

123

43 Health literacy Sara Garlini

125

44 Initiative medicine Preetha Karki

127

45 Integrated care Sanem Inci

130

46 Population health management Federica Michelozzi

133

47 Skill mix and task shifting in healthcare Alfredo Marchetti

136

93

48 Value-based vs volume-based healthcare Vanessa Maffi

138

33 Screenings Federica Natarelli

97

PART X

34 Primary healthcare Carolina Curti

101

35 Secondary vs tertiary vs quaternary care Magdalena Czajkowska

104

PLAYERS

49 Boundaryless hospital Benedetta Calcaterra Borri

142

50 Community and country hospital Gloria Castelletti

144

Contents  vii

147

64 Professional vs managerial culture 182 Marco Sartirana

52 Primary care center Edoardo Campioli

150

65 Professionalism Marco Sartirana

184

53 Research hospital Navpreet Tiwana

152

66 Stakeholder management Andrea Rotolo

186

54 Teaching hospital Laura Cavazzana

154

67 Teamwork Luca Solari

187

68 Turf wars Elena Maggioni

189

51 Intermediate and transitional care settings Emilie Cozzani

PART XI

TRENDS

55 Business models Federico Lega

157

69 Change management Riccardo Primavera

193

70 Disaster management Clara Del Prete

195

161

71 Leadership and leadership styles Gabriele del Castillo

199

164

PART XIV ROLES

56 Decentralization and devolution in healthcare Federico Lega

159

57 Multidisciplinarity and inter-​professionality Anna Prenestini 58 Telemedicine Claudia Bianchino

59 Vertical and horizontal integration (hub and spoke network)168 Alice Danieli PART XII BEHAVIOURS: CHALLENGES TO LEADING HEALTH ORGANIZATIONS 60 Accountability Andrea Rotolo

173

61 Accountable care plan and organization174 Steven Howard 62 Iatrocracy, professional bureaucracy and corporatization Federico Lega 63 Political arena Federico Lega

PART XIII PRACTICES

177 180

72 Case manager Annachiara Rotolo

203

73 Clinical engineer Paolo Oliva

205

74 Clinical leader Peter Lees

208

75 Controller Clara Carbone and Bernardo Provvedi

211

76 Family and community nurse Cecilia Rossi

215

77 General practitioner Antoni Peris

218

78 Hospitalist Sonia Maria Prevedello

220

79 Medical director Giuseppe De Filippis and Pietro Manzi

223

viii  Elgar encyclopedia of healthcare management

80 Operations manager 225 Marta Marsilio and Anna Prenestini 81 Pharmacist Maria Grazia Cattaneo, Sabrina Beltramini, Susanna Ciampalini, Domenica Costantino, Maria Cristina Galizia and Piera Polidori

228

82 Quality and risk manager Francesca Montesi Righetti

233

84 Guidelines and protocols in healthcare systems Alert Vukatana

ORGANIZATION

92 Clinical service lines Aswathy Varma 93 Converging trends in hospital transformation Federico Lega

PART XV TOOLS SYSTEM AND PROCESS: DISEASE MANAGEMENT 83 Clinical governance Gaia Ratti

PART XVIII

94 Divisionalization, clinical directorates and Troika model in healthcare Federico Lega 95 Organizational culture Anna Prenestini and Stefano Calciolari

237

239

267

271 273

96 Organizational design and development for healthcare organizations276 Federico Lega 97 Patient-centered hospital and health organization Gabriele Zimei

PART XVI INNOVATION MANAGEMENT

264

281

85 Clinical trial Davide Salvadori

243

PART XIX PEOPLE

86 Health technology assessment Claudia Bianchino

246

98 Clinical and professional engagement285 Martyna Emilia Pszczolka 99 Great Place to Work®288 Federica Natarelli

PART XVII OPERATIONS 87 Electronic clinical records Anushka Shankar

251

100 Magnet hospital Michele Giovanni Cusmai

88 Patient flow logistics 253 Stefano Villa and Rossella Pellegrino

PART XX PERFORMANCE

89 Patient management Lisa de Felice

256

90 Supply chain Shatakshi

258

101 Balanced scorecard in healthcare organizations Anna Prenestini

91 Techniques for process and organizations improvement: lean management in healthcare Marta Marsilio

261

291

294

102 Budgeting (financial vs operational)298 Michele Giovanni Cusmai 103 Customer satisfaction Elena Maggioni

301

Contents  ix

104 DRG and case mix index Francesca Grosso

303

PART XXII PROCUREMENT

105 Length of stay Gabriele del Castillo

305

111 Centralized procurement Marta Marsilio

324

112 Innovation procurement Marta Marsilio

327

106 Performance measurement and management systems Anna Prenestini and Guido Noto

307

107 PROMs and PREMs Fivia Stavrou

310

113 Managed entry agreements (MEA) 330 Benjamin Oskar and Francesca Randon

108 Strategic control Anna Prenestini

313

114 Value-based procurement Silvia Tarricone PART XXIII

PART XXI PLANNING

333

QUALITY

109 Strategic planning Andrea Rotolo

318

115 Accreditation in healthcare Marta Szlaszynska

337

110 Strategy making Corrado Cuccurullo

320

116 Audit Francesco Mazziotta

340

117 Quality management Francesca Montesi Righetti

343

Index346

Figures

10.1

Market-driven model

26

28.1

Innovative care for chronic conditions framework

81

29.1

Responsible providers of health and social services by country

84

29.2

Needs assessment methods by country

84

35.1

The pyramid of healthcare services

104

35.2

NHS professionals classified by level of assistance

105

37.1

A comprehensive framework of co-production

111

59.1

Scheme of hub and spoke system

168

59.2

The hub and spoke organization in airlines

169

59.3

Analogy of hub and spoke model

169

78.1

Similarities and differences between traditional internal medicine and hospital medicine

221

88.1

Patient flow logistics in a hospital

253

102.1

Management of a budget

298

110.1

Structural flow and activities that characterize strategy-making

321

113.1

Different types of MEAs

330

x

Contributors

Giovanni Aguzzi, Director of Planning & Control, Purchasing and Centralized Programming at Centro Diagnostico Italiano

Maria Grazia Cattaneo, Pharmacist and Head of Quality Control, Papa Giovanni XXIII Hospital, Bergamo

Houseyin Akyil, IMS (International Medical School) UniMi student

Laura Cavazzana, Specializing Student in Hygiene and Public Health at the State University of Milan

Fabio Amatucci, University of Sannio

Susanna Ciampalini, Chief Pharmacist, Healthcare Planning, at Ministry of Health, Rome

Francesco Bagordo, Researcher in General and Applied Hygiene at the University of Bari Aldo Moro

Ana Ciobanu, IMS (International Medical School) UniMi student

Shir Sara Bekhor, IMS (International Medical School) UniMi student

Giovanna Clerici, Specializing Student in Hygiene and Public Health at the State University of Milan

Sabrina Beltramini, Head of Pharmacy, Hospital San Martino Genoa Assaf Ben Haim, IMS (International Medical School) UniMi student

Domenica Costantino, Head of Pharmacy, Local Health Authority, Reggio Calabria

Eric Berrou, IMS (International Medical School) UniMi student

Zignat Courtoux, IMS (International Medical School) UniMi student

Yagis Bey, IMS (International Medical School) UniMi student

Emilie Cozzani, San Donato Hospital Student

Claudia Bianchino, Market Access EMEA at Boston Scientific Benedetta Calcaterra Borri, IMS (International Medical School) UniMi student

Corrado Cuccurullo, Full Professor Financial Reporting & Analysis – Corporate Governance – Performance Management at Campania University

Stefano Calciolari, University of Milan – Bicocca

Carolina Curti, IMS (International Medical School) UniMi student

Edoardo Campioli, San Donato Hospital Student

Michele Giovanni Cusmai, ASST Rhodense, public hospital

Mehmet Can Cifci, IMS (International Medical School) UniMi student

Magdalena Czajkowska, IMS (International Medical School) UniMi student

Martina Cappellina, Specializing Student in Hygiene and Public Health at the State University of Milan

Alice Danieli, IMS (International Medical School) UniMi student Silvia de Donato, IMS (International Medical School) UniMi student

Clara Carbone, Head of Planning and Control, ASST Hospital North Milan

Antonella De Donno, Full Professor Hygiene and Preventive Medicine at Salento University

Davide Carnevali, Specializing Student in Hygiene and Public Health at the State University of Milan

Lisa de Felice, San Donato Hospital Student

Gloria Castelletti, IMS (International Medical School) UniMi student xi

xii  Elgar encyclopedia of healthcare management

Giuseppe De Filippis, CEO Santa Maria della Misericordia di Perugia Hospital

Vanessa Maffi, IMS (International Medical School) UniMi student

Giulia de Fortunato, IMS (International Medical School) UniMi student

Elena Maggioni, Fellow Researcher at the State University of Milan

Gabriele del Castillo, Specializing Student in Hygiene and Public Health at the State University of Milan

Pietro Magnoni, Specializing Student in Hygiene and Public Health at the State University of Milan

Clara Del Prete, Master in Disaster Management student at Tel Aviv University

Pietro Manzi, Medical Direction Santa Maria della Misericordia di Perugia Hospital

Mario del Vecchio, Affiliate Professor of Government, Health and Not for Profit at SDA Bocconi School of Management

Alfredo Marchetti, IMS (International Medical School) UniMi student

David Brett Doerksen, IMS (International Medical School) UniMi student Ghina el Nounou, IMS (International Medical School) UniMi student Ana Paula Fontoura Andrade Reis, IMS (International Medical School) UniMi student Maria Cristina Galizia, Pharmacist at Policlinico Consorziale Teaching Hospital, Bari Giulia Gallo, Specializing Student in Hygiene and Public Health at the State University of Milan Sara Garlini, San Donato Hospital Student Tiziana Grassi, Associate Professor of General and Applied Hygiene at the University of Salento Francesca Grosso, Specializing Student in Hygiene and Public Health at the State University of Milan Chiara Guglielmetti, University of Milan Steven Howard, Associate Professor, Health Management & Policy, Saint Louis University Sanem Inci, IMS (International Medical School) UniMi student Preetha Karki, IMS (International Medical School) UniMi student Peter Lees, Former CEO, Faculty of Medical Leadership and Management, UK Federico Lega, University of Milan Valentina Lombardi, Specializing Student in Hygiene and Public Health at the State University of Milan

Eduardo Marra, IMS (International Medical School) UniMi student Emanuele Marsili, Access Strategy Lead at Galderma Marta Marsilio, University of Milan Francesco Mazziotta, Specializing Student in Hygiene and Public Health at the State University of Milan Valeria Mazzola, IMS (International Medical School) UniMi student Federica Michelozzi, IMS (International Medical School) UniMi student Francesca Montesi Righetti, Healthcare and Risk Manager Consultant Bharat Nandakumar, IMS (International Medical School) UniMi student Federica Natarelli, IMS (International Medical School) UniMi student Guido Noto, Researcher in Business Economics at the Department of Economics at the University of Messina Paolo Oliva, Head of Clinical Engineering Service at Humanitas Hospital Benjamin Oskar, Senior Global Market Access Manager at Hansa Biopharma Rossella Pellegrino, Catholic University of Milan Antoni Peris, Director-Gerent CASAP – Consorci Castelldefels Agents Salut Elisabetta Pierini, Specializing Student in Hygiene and Public Health at the State University of Milan Martina Pisarra, Fellow Researcher at the State University of Milan

Contributors  xiii

Piera Polidori, Head of the Pharmacy at Villa Sofia Hospital, Palermo Anna Prenestini, University of Milan Sonia Maria Prevedello, IMS (International Medical School) UniMi student Riccardo Primavera, IMS (International Medical School) UniMi student Niccolò Principi, Specializing Student in Hygiene and Public Health at the State University of Milan Bernardo Provvedi, ASST Hospital North Milano Martyna Emilia Pszczolka, IMS (International Medical School) UniMi student Francesca Randon, Market Access & HEOR Head Jazz Pharmaceuticals Gaia Ratti, IMS (International Medical School) UniMi student Cecilia Rossi, IMS (International Medical School) UniMi student Andrea Rotolo, Lecturer di Government, Health & Not for Profit in SDA Bocconi School of Management Annachiara Rotolo, San Donato Hospital Student Davide Salvadori, IMS (International Medical School) UniMi student Marco Sartirana, Research fellow at the

Centre for Research on Health and Social Care Management (CERGAS) of SDA Bocconi School of Management Anushka Shankar, IMS (International Medical School) UniMi student Shatakshi, IMS (International School) UniMi student

Medical

Luca Solari, Full Professor Department of Political and Social Sciences of the State University of Milan Andrea Sommariva, Specializing Student in Hygiene and Public Health at the State University of Milan Fivia Stavrou, IMS (International Medical School) UniMi student Marta Szlaszynska, IMS (International Medical School) UniMi student Silvia Tarricone, IMS (International Medical School) UniMi student Navpreet Tiwana, Specializing Student in Hygiene and Public Health at the State University of Milan Aswathy Varma, IMS (International Medical School) UniMi student Stefano Villa, Catholic University, Milan Alert Vukatana, IMS (International Medical School) UniMi student Gabriele Zimei, San Donato Hospital Student

Preface

I have to admit that I was not aware of what I was going to face when I accepted to do this work. The effort that it required has nothing to do with editing any other book, at least in my personal experience (which comprises over 20 books). Some explanations are due to the reader, with regards to the choices that I had to take in leading and supervising the whole process. As a matter of fact, editing an encyclopedia on healthcare management posed several (and very significant) challenges, from its design to the completion. First was to define the “scope” itself of the encyclopedia. More than any other sector, healthcare has social, political, institutional, technical and professional factors that all combined to contribute to shape and significantly influence management practices. Therefore, it would be nearly an impossible mission to tackle some management issues with the numerous perspectives and differences developed worldwide in health systems. Funding, accounting, human resources, accreditation are just some examples of topics that would require long in-depth descriptions (essay-like) which would not fit with the format of an encyclopedia. Second, it seems to me that it was not the case to illustrate within the encyclopedia basic topics and themes that are found in general management textbooks/encyclopedia. It would have been a waste. More interesting was to focus on a specific list of entries identified and selected to provide to the reader those topics (and food for thought) of particular interest and relevance for healthcare management. Third, the aim was not to produce just a catalogue of voices connected with healthcare management practices and theory but to provide something a bit more meaningful to the reader, organizing the topics in themes that potentially represent key points in the strategic agenda of health managers and policy makers or scholars. Fourth, there was the need to identify for specific entries an author that is not just a theory expert of the field but someone coming from a country/system where the

issue was clearly prominent in the management agenda and debate. An international team of authors made of a mix of academics and practitioners was to be engaged in the project. Hence, choices had to be made. Having said that, this is a first edition of the encyclopedia and for sure there is much space for improvement and learning. Hopefully, identification of entries, themes and authors will be found if not satisfactory at least interesting by readers. The “fil rouge” I adopted in designing the encyclopedia and identifying and selecting entries/themes is the following: Leading and effective leadership require three macro knowledges and competences: professional, managerial, context-wise. The first one refers to technical skills (i.e. what is a DRG system, legal frameworks and requirements, hospital operations, quality tools, etc.). The second refers to management skills and practices (i.e. planning and control, performance management, leadership practices and styles, etc.). The latter refers to knowledge and deep understanding of system/organizational dynamics that support the sense-making and inspirational activity of managers/leaders. Knowing and framing the current healthcare context and scenarios helps managers to increase their capability to lead and steer (that is why mastering concepts and frameworks such as the patient-centred/focused organization, value-based healthcare, population health management paradigm, etc. is so central). Therefore, entries and themes were selected to provide a meaningful and balanced list of topics on each of the three macro knowledges/competences. Finally, I want to warmly thank the team of authors, without their commitment we would not have an encyclopedia on healthcare management. And special thanks go to Claudia and Clara for the hard work they put into this project. Claudia Bianchino specifically for the support in coordinating the kick-off of the xiv

Preface  xv

project and for her stamina and continuous work through the whole journey. Clara Del Prete for the amazing dedication and problem solving ability she put in place in escorting me to the conclusion of the work. Without her contribution this encyclopedia would not be completed today. She did a great job in doing all the big and small things that lay in the foreground and background of such

demanding work involved in completing and fine-tuning this encyclopedia. Last but not least a huge thanks to Daniel Mather, my Senior Editor at Edward Elgar Publishing, for his direction, encouragement and patience. Federico Lega Milan, March 2023

PART I SCENARIOS Healthcare is facing unprecedented changes and a “new normal” is already gaining ground in the everyday life of healthcare managers. The aim of the “new healthcare” is to provide super-personalized and predictive healthcare for the most common diseases, where the citizen can quickly connect with the doctor remotely, and show and share their data on the network, wherever they are, the possibility for everyone to find the best care for themselves anywhere at any time and for any need. Here are highlighted the disruptive changes that health systems are already facing and that will revolutionize the way healthcare is delivered and the strategic development of health organizations and their management.

1

1.

Big data and artificial intelligence

Finance and insurance and government can benefit very strongly from big data as long as barriers to its use can be overcome. While all sectors will have to overcome barriers to capture value from the use of big data, barriers are structurally higher for some than for others. For example, the public sector, including education, faces higher hurdles because of a lack of data-driven mindsets and available data. Capturing value in healthcare faces challenges, given the relatively low IT investment performed so far. Sectors such as retail, manufacturing, and professional services may have relatively lower barriers to overcome for precisely the opposite reasons. Big data in healthcare refers to the abundant health data amassed from numerous sources including electronic health records (EHRs), medical imaging, genomic sequencing, payor records, pharmaceutical research, wearables, and medical devices, to name a few. Healthcare data analytics enable the measurement and tracking of population health, thereby enabling this switch. The use of big data analysis to deliver information that is evidence-based could, over time, increase efficiencies and help sharpen our understanding of the best practices associated with any disease, injury or illness. This also leads to remarkable advancements, even while reducing costs. With the wealth of information that healthcare data analytics provides, caregivers and administrators can now make better medical and financial decisions while still delivering an ever-increasing quality of patient care. Various technologies are in use for protecting the security and privacy of healthcare data. The most widely used technologies are:

In statistics and computer science, the term ‘big data’ generally refers to a collection of data extensive in terms of Volume, Velocity and Variety that requires more than the ability of commonly used software tools, but new specific methods and technologies for the extraction of values, analysis or knowledge. The term big data has been used since the 1990s and the definition has changed over time. The first definition including the three Vs was given by Douglas Laney in 2001. In a study published in 2016, De Mauro, Greco, Grimaldi proposed that the nucleus of the concept of Big Data includes the following aspects: ● ‘Volume’, ‘Velocity’ and ‘Variety’, to describe the characteristics of information; ● ‘Technology’ and ‘Analytical Methods’, to describe the requirements needed to make proper use of such information; ● ‘Value’, to describe the transformation of information into insights that may create economic value for companies and society. In 2011 a McKinsey Global Institute report characterizes the main components and ecosystem of big data as follows: ● Techniques for analyzing data, such as A/B testing, machine learning, and natural language processing; ● Big data technologies, like business intelligence, cloud computing, and databases; ● Visualization, such as charts, graphs, and other displays of the data. Big data can generate financial value across many sectors like healthcare, public administration, global personal and location data, retail and find, mainly with a growth of the specific economic value, growth in annual productivity and also with a reduction in working capital. Computer and electronic products and information sectors, traded globally, stand out as sectors that have already experienced very strong productivity growth that are poised to gain substantially from the use of big data.

● Authentication: Is the act of establishing or confirming claims made by or about the subject are true and authentic. It serves a vital function within any organization: securing access to corporate networks, protecting the identities of users, and ensuring that a user is who he claims to be. Most cryptographic protocols include some form of endpoint authentication specifically to prevent man-in-the-middle (MITM) attacks. ● Encryption: Data encryption is an efficient means of preventing unauthorized access of sensitive data. Its solutions 2

Big data and artificial intelligence  3

protect and maintain ownership of data throughout its lifecycle from the data center to the endpoint and into the cloud. Encryption is useful to avoid exposure to breaches such as packet sniffing and theft of storage devices. ● Data Masking: Replacing sensitive data elements with an unidentifiable value, but is not truly an encryption technique so the original value cannot be returned from the masked value. It uses a strategy of de-identifying the datasets or masking personal identifiers. ● Access Control: Once authenticated, the users can enter an information system but their access will still be governed by an access control policy which is typically based on the privilege and right of each practitioner authorized by the patient or a trusted third party. More than ever it is crucial that healthcare organizations manage and safeguard personal information and address their risks and legal responsibilities in relation to processing personal data, to address the growing thicket of applicable data protection legislation. Different countries have different policies and laws for data privacy (such as GDPR for the EU). As the concept of big data and data science has changed over the last few decades, the definitions of artificial intelligence (AI) have also changed over the years. Professor John McCarthy (Stanford University) in 2004 in his paper of Q&A about AI offers us the following definition in simple words: “It is the science and engineering of making intelligent machines, especially intelligent computer programs. It is related to the similar task of using computers to understand human intelligence, but AI does not have to confine itself to methods that are biologically observable.” AI is a constantly evolving field in its applications, and the most used today are: ● Logical AI – the program decides what to do by inferring that certain actions are appropriate for achieving its goals; ● Search – AI programs examine possibilities and discoveries are made about how to do this more efficiently in various domains; ● Pattern recognition – the program compares what it sees with a specific or different pattern in several observations;

● Representation – AI uses usually mathematical logic to represent facts or data in some way; ● Inference – from some facts, others can be inferred. Mathematical logical deduction is adequate for some purposes, but also non-monotonic inferences have been added for different purposes; ● Common sense knowledge and reasoning; ● Learning from experience – the approaches to AI based on connectionism and neural nets are specialized. The limitation is that not everything can be represented correctly as useful information for programs and receivers; ● Planning – this is used for making strategies for achieving specific goals; ● Epistemology – this is a study of the kinds of knowledge that are required for solving problems in the world; ● Ontology – this is the study of the kinds of things that exist; ● Heuristics – it is a way of trying to discover an idea or a fact imbedded in a certain program; ● Genetic programming – AI solve tasks by mating random LISP (list programming) programs and selecting which fit the best. There are already a number of research studies suggesting that AI can perform as well as or better than humans at key healthcare tasks, such as diagnosing disease. Today, algorithms are already outperforming radiologists at spotting malignant tumours, and guiding researchers in how to construct cohorts for costly clinical trials. Most of these technologies have immediate relevance to the healthcare field, but the specific processes and tasks they support vary widely. 1. Machine learning – neural networks and deep learning. Machine learning is a statistical technique for fitting models to data and to ‘learn’ by training models with data. The most common application of machine learning is precision medicine: predicting what treatment protocols are likely to succeed on a patient based on various patient attributes and the treatment context. 2. Natural language processing – the dominant applications of NLP involve the creation, understanding and classification of clinical documentation and pubMartina Cappellina

4  Elgar encyclopedia of healthcare management

lished research. NLP systems can analyse unstructured clinical notes on patients, prepare reports, transcribe patient interactions and conduct conversational AI. 3. Rule-based expert systems – these are based on if–then rules. Expert systems require human experts and knowledge engineers to construct a series of rules in a particular knowledge domain. However, when the number of rules is large and the rules begin to conflict with each other, they tend to break down. Moreover, if the knowledge domain changes, changing the rules can be difficult and time-consuming. 4. Physical robots – mostly for surgeries. Surgical robots, initially approved in the USA in 2000, provide ‘superpowers’ to surgeons, improving their ability to see, create precise and minimally invasive incisions, stitch wounds and so forth. 5. Robotic process automation – RPA doesn’t really involve robots but computer programs on servers. They are mostly used for administrative tasks like updating patient records or billing. When combined with other technologies they can extract data, recognize images and so on. 6. Diagnosis and treatment applications – there are also several big companies investing specifically in diagnosis and treatment recommendations for certain pathologies, with programs based on rule-based systems incorporated within national healthcare systems. 7. Patient engagement and adherence applications – providers and hospitals often use their clinical expertise to develop a plan of care that they know will improve a chronic or acute patient’s health. A growing focus in healthcare is on effectively designing the ‘choice architecture’ to nudge patient behaviour in a more anticipatory way based on real-world evidence. 8. Administrative applications – a part of the daily work schedule is spent on regulatory and administrative activities. AI can be used for a variety of applications including claims processing, clinical documentation, revenue cycle management and medical records management, spending less time on a computer and more time with patients. There is a considerable attention to the concern that AI could lead to automation of Martina Cappellina

jobs and displacement of the workforce. Of course there are factors in healthcare that could limit job losses, first of all the human touch and experience that patients, especially the elderly, value greatly. There are also ethical implications around the use of AI in healthcare. Healthcare decisions have been made almost exclusively by humans in the past, and the use of smart machines to make or assist with decisions raises issues of accountability, transparency, permission and privacy. Many AI algorithms are virtually impossible to interpret or explain. There are also likely to be incidents in which patients receive medical information from AI systems that they would prefer to receive from an empathetic clinician. Data scientists must learn multiple programming and database languages and master advanced statistical analysis. One factor affecting worker availability is that it takes many years to become a data scientist. Most US data scientists agree that it takes on average 4.9 years. Important knowledge areas include statistics, computer science, which encompasses an understanding of data structures, algorithms, and database systems (e.g., Hadoop); and problem formulation (i.e., the ability to formulate problems to bring about effective solutions). Data scientists require the strongest analytical skills as well as proficiency with specialized tools such as machine learning, Apache Hadoop, and data mining. Moreover, data scientists require generalized skills such as SQL, R, and data analysis. Machine learning skills, in particular, are becoming mandatory for data scientists for building automated decision systems that provide future predictions. The ability to mine text is also a prerequisite for working with unstructured data, particularly in healthcare, where much of the clinical data is in note format. While a data scientist’s role requires technical and statistical expertise, the importance of data communication should not be underestimated. For example, storytelling and communicating findings are required skills for many job positions. Also, soft skills such as problem solving and the ability to work effectively within a multidisciplinary team are needed. A data scientist can specialize in different sectors based on personal interests: business

Big data and artificial intelligence  5

analysis, artificial intelligence, data visualization, data mining and so on. Martina Cappellina

Bibliography

Abouelmehdi, K., Beni-Hssane, A., Khaloufi, H. and Saadi, M. (2017), Big Data Security and Privacy in Healthcare: A Review. Procedia Computer Science. doi: 10.1016/j. procs.2017.08.292 Davenport, T. and Kalakota, R. (2019), The Potential for Artificial Intelligence in Healthcare. Future Healthcare Journal. doi: 10.7861/futurehosp.6-2-94 De Mauro, A., Greco, M. and Grimaldi, M. (2016), A Formal Definition of Big Data Based on its Essential Features. Library Review, 65(3), 122–135. doi: 10.1108/LR-06-2015-0061 Dolezel, D. and McLeod, A. (2021), Big-Data Skills: Bridging the Data Science Theory-Practice

Gap in Healthcare. Perspectives in Health Information Management. PMID: 33633520 Manyika, J., Chui, M., Bughin, J., Brown, B., Dobbs, R., Roxburgh, C. and Byers, A.H. (May 2011), Big Data: The Next Frontier for Innovation, Competition, and Productivity. McKinsey report. https://​www​.mckinsey​.com/​ capabilities/​mckinsey​-digital/​our​-insights/​big​ -data​-the​-next​-frontier​-for​-innovation. McCarthy, J. (2004), What is Artificial Intelligence. http://​jmc​.stanford​.edu/​articles/​ whatisai​.html Meyer, M.A. (2019), Healthcare Data Scientist Qualifications, Skills, and Job Focus: A Content Analysis of Job Postings. Journal of the American Informatics Association. doi: 10.1093/jamia/ocy181 NEJM Catalyst (2018), Healthcare Big Data and the Promise of Value-Based Care. https://​ catalyst​.nejm​.org › doi › full › CAT.18.0290

Martina Cappellina

2.

Disruptive technology innovations

as important as rental. Unlike, for example, Uber, which can be considered an innovation in the taxi service, Netflix has changed the paradigm with regard to the consumer– service provider relationship. Previously the second, in the form of a television channel, first chose when and how the consumer could watch a film or series; now it is the consumer who makes this choice. At the same price. With the rental this possibility existed, but it had a very high cost, the Netflix revolution has allowed the birth of a new model with a low cost price. The European Commission’s Expert Panel on investing in health (EXPH) (2021) defined “disruptive innovation” in healthcare “as a type of innovation that creates new networks and new organizations based on a new set of values, involving new players, which makes it possible to health improve outcomes and other valuable goals, such as equity and efficiency”. Healthcare, and in general the health sector more than any other context, is facing the transformations driven by the so-called “fourth industrial revolution”. It is characterized by a series of disruptive innovations, which irreversibly and substantially modify the current way of working, such as artificial intelligence, the spread of robotics, the internet of things, nanotechnologies and a series of new tools and technologies capable of using “big data” effectively and connecting them with intelligent grids, also favoring new forms of cooperation between humans and between them and technologies (for example portable sensors). The main characteristics of disruptive innovation are those of:

With the term “Disruptive innovation”, today, we indicate precisely those innovations (technological, business, method, etc.) capable of changing the status quo of a market or a consolidated business model. The origin of this term is attributed to the authors of the article “Disruptive Technologies: Catching the Wave”, published in 1995 in the Harvard Business Review. If we want, the concept can be traced back to the economist Schumpeter who in his Theory of Economic Development (1934) defines “incremental innovations” as the continuous improvements of existing products and services. Unlike other types of innovation which modernize already existing sectors, the disruptive type concerns the creation of a market that is often completely new and determines the end of others that may have dominated for years. An example is that of automobiles in the early 20th century, when Henry Ford, with the creation of his Model T, a fully standardized, affordable middle-class car at the time, revolutionized mobility. Contributing more than others to putting carriages and horses out of the market. Other characteristics of disruptive innovation are the extraneousness of disruptive companies from the market that they actually destroy, and then the radical nature of the change, which goes beyond product innovation, and also concerns the birth of new business models. Another example of a non healthcare disruptive innovation is Netflix that has not simply innovated the entertainment TV market, it has revolutionized it by downsizing the traditional one, and destroying a segment Table 2.1

(a) Improve health outcomes (b) Create a new professional culture

Types of innovation

Incremental

An innovation that does not affect existing markets

Evolutionary

An innovation that improves a product in an existing market according to customer expectations

Revolutionary

An innovation that is unexpected, but does not affect existing markets

Disruptive

An innovation that creates a new market or expands an existing market by applying a different set of values, which eventually (and unexpectedly) surpasses an existing market

6

Disruptive technology innovations  7

(c) Serve new groups and/or have new products/services (“create new markets”) (d) Create new “players” (e) Subvert old patterns. Claudia Bianchino

Bibliography

Bower, J.L. and Christensen, C.M. (1995). Disruptive technologies: catching the wave. Harvard Business Review, January‒February. Clayton, M., Christensen, M., Raynor, E. and McDonald, R. (2015). What is disruptive innovation? Harvard Business Review. https://​hbr​ .org/​2015/​12/​what​-is​-disruptive​-innovation European Commission, Directorate-General for Health and Food Safety, Expert Panel on effective ways of investing in Health (EXPH): opinion on public procurement in healthcare system: the EXPH adopted this opinion at

the plenary meeting on 28 April 2021 after public hearing on 3 February 2021, Publications Office, 2021,  https://​data​.europa​.eu/​doi/​10​ .2875/​832331 Haleem, A., Javaid, M., Singh, R. and Suman, R. (2022). Medical 4.0 technologies for healthcare: features, capabilities, and applications. Internet of Things and Cyber-Physical Systems, 2. 10.1016/j.iotcps.2022.04.001. Lega, F. and Bianchino, C. (October 2021). Nulla sarà più come prima. Progettare per la sanità, 03/2021, pp. 16‒19. Ricciardi, W. (2019). Disruptive innovations: which impact on well-being and health care? GIHTAD (2019), 12:Suppl. 3 https://​ springerhealthcare​.it/​GIHTAD/​2019/​10/​07/​ innovazioni​-dirompenti​-quale​-impatto​-su​ -salute​-e​-sanita/​ Schumpeter, J.A. (1934). The Theory of Economic Development: An Inquiry into Profits, Capital, Credits, Interest, and the Business Cycle. Transaction Publishers, Piscataway.

Claudia Bianchino

3. Genomics

drug treatments, and in some cases, gene therapies. The discovery of more than 100,000 robust associations between genomic regions and common diseases has pointed to new biologic mechanisms, such as the role of microglia in Alzheimer’s disease, autophagy in inflammatory bowel disease, and synaptic pruning in schizophrenia. It has also enabled the development of polygenic risk scores to identify patients at increased risk for heart disease, breast cancer, and other conditions, although additional rigorous testing of such scores is needed, including evaluation of clinical outcomes. Studies of cancer genomes have revealed hundreds of genes in which somatic mutations propel tumor initiation and growth, information that has fueled the development of new drugs. Genomic analysis is also helping to explain why some people have responses to certain therapies or survive certain infections, whereas others do not. Studying the genome may help researchers understand how genes interact with each other and with the environment and how certain diseases, such as cancer, diabetes, and heart disease, form. Genome-based research is already enabling medical researchers to develop improved diagnostics, more effective therapeutic strategies, evidence-based approaches for demonstrating clinical efficacy, and better decision-making tools for patients and providers. Rapid progress is also being made in the emerging field of pharmacogenomics, which involves using information about a patient’s genetic make-up to better tailor drug therapy to their individual needs. A deeper understanding of genetics will shed light on more than just hereditary risks by revealing the basic components of cells and, ultimately, explaining how all the various elements work together to affect the human body in both health and disease. Studies of people of diverse ancestral backgrounds have revealed the ways in which genomic variation contributes to population-level differences in disease susceptibility, drug responses, and the diagnostic accuracy of clinical approaches guided by genomic research. One insight from such studies has been the identification of African ancestry-specific APOL1 variants that protect against African sleeping sickness but increase the risk of kidney failure; these variants account for about 70% of cases of nondiabetic kidney failure in people of African ancestry

Genomics is the study of the complete set of DNA (including all of its genes, the genome) in a person or other organism, including interactions of those genes with each other and with the environment. Almost every cell in a person’s body contains a complete copy of the genome. The genome contains all the information needed for a person to develop and grow. Studies of human genetic variation using DNA sequencing have undergone an extraordinary development from their introduction over 40 years ago up to current technologies, which allow for a human genome to be sequenced and analyzed within a matter of days at consumable costs of approximately $1000. The first widely used method was developed by the British chemist Frederick Sanger in the 1970s and he received the Nobel prize in 1980. “Sanger sequencing” relies on nucleotide-specific chain-terminating inhibitors to identify the sequence of a specific fragment of DNA. The method was continuously refined over the years and incorporated in the first generation of automated sequencers. Sanger sequences show very high accuracy but are restricted to a single DNA fragment at a time and a maximum sequence length of 1000 bp. DNA sequencing throughput increased from 1000 base pairs per day to more than 1000 base pairs per second, which opened the door for low-cost sequencing techniques that are enabling genomic advances to be incorporated into routine medical care. Genomic research has evolved from seeking to understand the fundamentals of the human genetic code to examining the ways in which this code varies among people, and then applying this knowledge to interventions that are tailored to target, with precision, the underlying causes of disease. With the completion of the first reference sequence of the human genome, attention shifted from searching for genes to discovering their functions. Systematic genetic mapping in families and populations helped scientists pinpoint the genetic variants that contribute to human disease. The discovery of genes responsible for more than 5000 rare Mendelian diseases has facilitated genetic diagnostics for many patients, pregnancy-related counseling, new 8

Genomics  9

in the United States. In addition, a risk haplotype for type 2 diabetes in SLC16A11 that is present in about half of Indigenous peoples of the Americas and rare in peoples of European or African ancestry explains about 20% of the increased type 2 diabetes prevalence among Mexican Americans as compared with European Americans. Genomic research has also shown that PCSK9 loss-of-function mutations are more common in people of African ancestry than in other populations; such mutations reduce cholesterol levels and the risk of heart disease and are providing new insights for drug development. Next generation sequencing (NGS) is a DNA sequencing technology which has revolutionized genomic research. Using NGS, an entire human genome can be sequenced within a single day. In contrast, the previous Sanger sequencing technology, used to decipher the human genome, required over a decade to deliver the final draft. All NGS platforms perform sequencing of millions of small fragments of DNA in parallel. Bioinformatics analyses are used to piece together these fragments by mapping the individual reads to the human reference genome. Each of the three billion bases in the human genome is sequenced multiple times, providing high depth to deliver accurate data and an insight into unexpected DNA variation. NGS can be used to sequence entire genomes or constrained to specific areas of interest, including all 22,000 coding genes (a whole exome) or small numbers of individual genes. Whole exome sequencing (WES) is a genomic technique for sequencing all of the protein-coding regions of genes in a genome (known as the exome). The goal of this approach is to identify genetic variants that alter protein sequences, and to do this at a much lower cost than whole genome sequencing (WGS). Since these variants can be responsible for both Mendelian and common polygenic diseases, such as Alzheimer’s disease, whole exome sequencing has been applied both in academic research and as a clinical diagnostic. Genetic diseases and congenital malformations are the leading causes of prolonged hospitalization and mortality in infants and children. In addition, patients with rare diseases commonly experience multiyear

diagnostic evaluations and receive multiple misdiagnoses during that time. Rapid whole-exome sequencing (rWES) offers the potential for early diagnosis-​ predicated precision medicine. Thus, establishing a precise molecular diagnosis can reduce costs by ending this diagnostic odyssey and, in many cases, aiding in medical management.

Examples

Patient A was a three-month-old boy with persistent jaundice and conjugated hyperbilirubinaemia and deranged liver enzymes. Ultrasound scan and hepatobiliary scintigraphy was inconclusive for biliary atresia. Despite a subsequent Kasai operation and on table cholangiogram, the child did not improve clinically and was put on a waiting list for a liver transplant. In view of the atypical course and findings, the child was offered rWES, which revealed a de novo JAG1 mutation substantiating the genetic diagnosis of Alagille syndrome. As up to 90% Alagille syndrome patients would clinically improve without the need for a transplant, a liver transplant was withheld and medical treatment was optimized, and the child responded well. By achieving the rWES diagnosis within a turnaround time of 18 days, liver transplant was avoided, saving $427,937. Patient B presented at 11 months old with recurrent episodes of hypoglycaemia, hepatomegaly, and neutropenia. The clinical picture was suspicious of glycogen storage disease (GSD) type Ib. By conventional diagnostic pathway the child would have required a liver biopsy, or sanger sequencing which has a TAT of approximately eight weeks. During this time, the child would be empirically given granulocyte-macrophage colony stimulating factor (GM-CSF) for neutropenia. With rWES, the pathogenic variant of the G6PC gene was identified within seven days, making a molecular diagnosis of GSD type Ia, and showed no mutation in the gene of GSD type Ib. The accurate diagnosis rendered GM-CSF unnecessary. Costs of the GM-CSF treatment saved could not be compared due to the lack of a control case for direct comparison. However, avoidance of a liver biopsy as an alternative diagnostic modality alone saved $22,230. The focus of genomics research has recently moved beyond analyzing DNA variAndrea Sommariva

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ation to studying patterns of gene expression in individual cells. This effort is revealing hundreds of new cell types and characterizing the ways in which cell types differ between healthy people and people with various diseases. With the cost of sequencing a complete genome having dropped from $3 billion during the Human Genome Project to $600 today, there are growing efforts to create large-scale biobanks of complete genome-sequencing and phenotype information from hundreds of thousands of people. The ultimate goal is for healthcare systems to couple genomic information with medical records. Over the past eight years, CRISPR (clustered regularly interspaced short palindromic repeats)-Cas9 (CRISPR-associated protein 9) technologies have emerged as accessible and adaptable tools for studying and altering genomes. CRISPR-Cas9 can be used to induce genome edits by creating targeted DNA breaks that trigger site-specific DNA repair. In next-generation formats, it can also control the transcriptional output of genes or alter genome sequences using a process of nucleotide base editing that does not require repair of DNA breaks. As these technologies continue to mature, it will become increasingly possible to alter cellular genomes efficiently and accurately. Coming on the heels of engineered nucleases, CRISPR-Cas9 tools have accelerated the pace of genomic research by permitting highly efficient knockouts or edits of virtually any gene in

Andrea Sommariva

cells or model organisms. Current applications largely focus on single-gene disorders for which gene editing can be carried out ex vivo on appropriate cells, such as bone marrow hematopoietic stem cells in the case of sickle cell anemia. Increasing abilities to target genetic mutations in vivo with oligonucleotides or gene editing should put many Mendelian disorders within reach for therapies and maybe cures. Andrea Sommariva

Bibliography

Behjati, S. et al. What is Next Generation Sequencing? Archives of Disease in Childhood 98(6), 236‒38 (2013). Chung, Claudia C.Y. et al. Rapid Whole-Exome Sequencing Facilitates Precision Medicine in Paediatric Rare Disease Patients and Reduces Healthcare Costs. The Lancet Regional Health ‒ Western Pacific 1, (2020). https://​doi​.org/​10​ .1016/​j​.lanwpc​.2020​.100001 Collins, F. et al. Human Molecular Genetics and Genomics – Important Advances and Exciting Possibilities. The New England Journal of Medicine, 384, 1–4 (2021). https://​doi​.org/​10​ .1056/​NEJMp2030694 National Human Genome Research Institute. A brief guide to Genomics. National Human Genome Research Institute (online). Last update August 16, 2022. https://​www​.genome​ .gov/​about​-genomics/​fact​-sheets/​A​-Brief​ -Guide​-to​-Genomics Petersen, B. et al. Opportunities and Challenges of Whole-Genome and -Exome Sequencing. BMC Genetics, 18 (2017).

4. Globalization

munities. Global epidemics include that of non-communicable diseases such as obesity, which could be linked strongly to the global food trade and aggressive marketing strategies applied by well-established fast-food chains in poorer countries. Finally, if we were to say a few more words on globalization and health, it is evident that the ongoing COVID-19 novel coronavirus pandemic is one of the most drastic examples of how globalization, by the means of extremely facilitated, accessible and relatively affordable international travelling, can be a lifechanging event in the whole world, alarming the health system. This pandemic might be used as a tool by many to protest against globalization and to even ask for an alternative. However, as Sir Richard Feachem stated in his paper, an alternative, at least a realistic one, doesn’t exist as of now. He also adds that we currently (written before the COVID-19 pandemic) have a better understanding of how these acute events could be dealt with both in terms of knowledge and tools compared to the 15th century. Dr. Jeffrey P. Koplan, an internationally well-known public health leader, and his colleagues, preferred to distinguish between global health, public health and international health. They emphasize the fact that there is an overlap between these terms and a widespread confusion is observed. For example, international health is widely used as a synonym of global health. On the other hand, public health is considered to have its focus on the health matters of a population in a specific country, and therefore at a national level. However, regardless of this distinction, he adds that the common point to all these terms is to address the underlying social, economic, environmental and political determinants of health. Defining global health perfectly, as we have cited before, proves to be very important and challenging at the same time. Therefore, different definitions indeed exist and each can be criticized when analyzed from a different perspective. Koplan and his colleagues adopted the following definition for global health: “an area for study, research and practice that puts an emphasis on improving health and providing equity in healthcare for all people around the world, regardless of their location” (in August et al., 2022).

According to WHO, globalization can be referred to as increased connectedness and interdependence of people and countries. It is composed of two inter-related elements: opening of international borders with the aim of allowing exchange of goods, services, finance, people and ideas and second, the implementations adopted at institutional and political levels to facilitate this aim at a practical level. It has to be noted that globalization is not a simple concept, and we must be ready to expect the unexpected meaning that this term encompasses a dynamic potential for both positive and negative effects on development and health. Globalization can also be defined in a more abstract, simple way as openness: can be openness to trading, new ideas, foreign investments, people, and to different cultures. We have to keep in mind that the effects of globalization on different aspects (economic, social, political etc.) are not mutually exclusive and are interlinked in a complex manner. An example provided by Sir Richard Feachem, Director of the Global Health Group at UCSF Global Health Sciences, states how globalization, openness to trade, arrival of capital and high-end technology would result in an economic growth, especially in poorer countries and he puts an emphasis on the fact that national economic growth is in direct positive correlation with the improvements in health. Although most experts agree on globalization being here to stay for a very long time even if protested against by some, they still feel the need to keep the world up to date with the health risks associated with it. Mr. Tikki Pang, Director of the Department of Research Policy & Cooperation at the World Health Organization, thinks that globalization can be defined roughly as an increasing integration of the world. Along with economics, politics, social issues and cultures, health risks are no exception to this integrative aspect. The main concerns for health matters in the context of globalization stand out as tobacco, alcohol and global epidemics. Given the fact that stricter rules are being implemented day by day in the developed nations, it makes sense that big companies in the field of alcohol and tobacco production started to increasingly target poorer and less educated com11

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On the other hand, Professor Ilona Kickbusch, who is the founder of Global Health Centre, prefers to define global health as “those health matters that go beyond the national borders and governing bodies and call for actions on the global forces that determine the outcome of people”. One proposed definition by Robert Beaglehole and Ruth Bonita, Professors of Community Health at University of Auckland, refer to global health as collaborative transnational research and action for promoting health. It must be kept in mind that, this definition still stems from the one Kaplan suggested, however it is deemed by them as being sharper and shorter yet still managing to put an emphasis on the collaborative aspect. Collective side of global health should not be undermined simply because of the multiplicity of determinants and complex variety of institutions being involved. Transnational aspect relates to the involvement of at least two countries, which would otherwise be referred to as local and not as global. Research reflects on how important it is to include evidence-based policies. Action refers to the use of the information obtained by research constructively, in all countries to strive for better in terms of health and health equity. A few words could also be said regarding the global health centres being mostly localized in wealthy and powerful countries, even though the burden of preventable disease is more prevalent in middle and especially low-income nations. One of the most plausible explanations for this “unexpected” situation could be an interest in global health stemming from strong public health institutions at a national level, which are not so commonly found in developing countries. To conclude, I would like to briefly mention the current global health policy status of the EU. Is there a presence of common vision among the EU member states? The results of an article highlight that among the participant countries in an analysis (France,

Houseyin Akyil

Germany, the United Kingdom, Belgium, and Denmark), it was seen that global health was coded differently. Referring back to fundamentals of global health, the definition, it is questionable whether the EU member states have acknowledged the importance of a common definition and therefore, if they are acting efficiently towards a common goal. Houseyin Akyil

Bibliography

August, E., Tadesse, L., O’Neill, M. S., Eisenberg, J. N. S., Wong, R., Kolars, J. C., & Bekele, A. (2022). What is global health equity? A proposed definition. Annals of Global Health, 88(1): 50. https://​doi​.org/​10​.5334/​aogh​.3754 Beaglehole, R., & Bonita, R. (2010). What is global health?. Global Health Action, 6 April. doi:10.3402/gha.v3i0.5142 Feachem, R.G. (2001). Globalisation is good for your health, mostly. BMJ (Clinical research ed.), 323(7311): 504–6. https://​doi​.org/​10​.1136/​ bmj​.323​.7311​.504 Kickbusch, I. (n.d.). Kickbusch Health Consult. https://​www​.ilonakickbusch​.com/​kickbusch/​ global​-health/​ Kickbush I. (2006). The need for a European strategy on global health. Scandinavian Journal of Public Health, 34: 561‒5. Koplan, J.P. (n.d.). About. Emory University, Emory Global Health Institute. http://​ ghi​ -ctp​ .emory​.edu/​about/​leadership/​jeff​.html Koplan, J.P., Bond, T.C., Merson, M.H., Reddy, K.S., Rodriguez, M.H., Sewankambo, N.K. et al. (2009). Towards a common definition of global health. Lancet, 373: 1993‒5. Pang, T., Guindon, G.E. (2004). Globalization and risks to health. EMBO Reports, 5: S11–S16. https://​doi​.org/​10​.1038/​sj​.embor​.7400226 Steurs, L., Van de Pas, R., Delputte, S., & Orbie, J. (2018). The global health policies of the EU and its member states: A common vision? International Journal of Health Policy and Management, 7(5): 433–42. https://​doi​.org/​10​ .15171/​ijhpm​.2017​.112 World Health Organization (WHO) (n.d.). Globalization. https://​www​.who​.int/​topics/​ globalization/​en/​

5. Medical tourism

the mapping is not geographically accurate, “North” is typically meant as “high income” countries, while “South” is considered “low or middle income” countries; South–North: This flow typically involves wealthy patients from low- or middle-income countries seeking care in high-income countries, often because they seek high-quality treatment or specialties not available at home. North–North: This form of medical tourism involves patients moving from one high-income country to another, the motive is most commonly availability. For example, crossing borders for medical treatment in the European Union to reduce the waiting period. South–South: This flow involves travel from one low-to-middle income country to another for treatment, characterized by individuals with the ability to pay to leave their home country, who leave because of concerns about the quality of healthcare, the lack of infrastructure, or the lack of specialized procedures they need. North–South: People from high-income countries traveling to low–middle income countries due to lack of universal health care or expensive treatments, for example U.S. citizens traveling to South-East Asia countries.

Medical tourism is commonly defined as “traveling abroad to obtain medical or surgical treatment”. However, this definition fails to encompass the complexity of the subject. As the market for medical tourism is growing and associated services, organizations and policies are formed, medical tourism is tied with social, economic, legal and ethical implications, both on local and global levels. To better understand the complexity of medical tourism, Cohen (2014) defines different types of classifications: ● According to legal status of the treatment, the procedure may or may not be legal in the country of origin and destination. For example, one may seek a particular treatment which is legal in both their home and destination country, like a hip replacement surgery. When a procedure is illegal in home country, but legal in the destination country, it is often a reason to travel for it, and an example can be assisted suicide. A procedure may be illegal in both origin and destination country but easier to achieve in the latter: transplant tourism is an example of such. ● According to the payer, financing the travel and procedure can be done by the patient (AKA out-of-pocket), a private insurance company or the home country government (often public insurance). Medical tourism for services illegal in the patient’s home country will almost always involve patients who are paying their own costs. Out-of-pocket payment is also used to get more affordable treatment for those uninsured, to reduce waiting time for non-emergency procedures or for reasons regarding quality of care. Recently an increasing number of private insurance companies offer medical tourism services which allow reduced expenses to both the patient and the company. The same incentive is driving public insurers, in addition to providing a solution to those on long waiting lists. ● According to the flow of patients, this suggested definition of medical tourism is divided it into four quadrants (North– North, North–South, South–South, South–North) according to the type of origin and destination countries. Although

From these definitions we can summarize the main drivers for an individual to choose traveling abroad for a medical procedure: reduced cost, increased availability (cutting waiting lists) and better quality care. Additional reasons include the opportunity to combine medical care with a vacation, a preference for care from providers who share the traveler’s culture, or to receive a procedure or therapy not available in the home country. In addition to the reasons for which an individual will independently seek medical treatment abroad, there are important economic incentives that drive a country to invest in medical tourism marketing and infrastructure. The “medical tourist” contributes to the domestic economy, both in terms of medical spending and in terms of their spending on traditional tourist activities. Although the COVID-19 pandemic caused a major setback for this segment, the global medical tourism market size was valued at USD 44.8 billion in 2019 and is expected to grow at a compound annual growth rate 13

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(CAGR) of 21.1% from 2020 to 2027, reaching USD 207.9 billion by 2027. The expected growth in countries that emerge as popular destinations for medical tourism (Thailand, India, Costa Rica, Mexico, Malaysia, Singapore, Brazil, Colombia, Turkey, Taiwan, South Korea, Spain, Czech Republic) is also highlighted by the “Medical Tourism Market Size, Share & Trends Analysis Report by Country” by Grand View Research in 2022. Among these countries, Thailand was the most popular destination for medical tourism in 2019, offering affordable quality care for elective procedures. According to the Tourism Authority of Thailand (TAT, 2022), in 2018 around 2.8 million people visited Thailand to seek medical care (not including tourists who happen to require medical assistance during their stay) thus making 7% of the 38 million tourists who visited that year, generating approximately 0.4% of Thailand’s gross domestic product (GDP). Another aspect related to medical tourism is the type of treatment that patients seek to achieve abroad. The most common are cosmetic surgery, dentistry, orthopedics and heart surgery. In Thailand, cosmetic surgeries are the most preferred type of treatment. Medical procedures such as knee replacement, hip replacement, and gastric bypass are more affordable in India as compared to other developed nations. Costa Rica is preferred by medical tourists for dental procedures. Although medical tourism has great benefits for both the patient and the host country, there are important implications that must be considered. For example, in less developed countries, medical tourism may aggravate the shortage of medical staff by attracting workers away from the public sector towards private hospitals catering to foreigners. The increase in demand for private care causes a snowball effect: increased costs in private hospitals leads to increased costs also in public hospitals and in the universal healthcare insurance, and potentially undermines future medical training. A possible solution to this problem could be taxing tourists who visit the country solely for the purpose of seeking medical

Shir Sara Bekhor

treatment. The revenue generated could then be returned to the public sector and be used to train physicians and retain medical school professors. Another issue described in the literature is the possible unintended, undesired effects of medical tourism upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if home country healthcare facilities must spend resources on treating postoperative complications. For example, traveling for cheaper cosmetic procedures was found to be associated with complications, hospital readmission, higher costs and poor results. The most common complication being infection, and the most severe death. In summary, although halted by the recent pandemic, medical tourism is a growing field propelled by globalization, bringing down barriers and increasing opportunities for individual patients. With a growing market and contribution to domestic economies, medical tourism is also associated with potential damage to healthcare systems. Therefore, regulation and international agreements are essential to make medical tourism beneficial to all parties. Shir Sara Bekhor

Bibliography

Cohen IG. Patients with Passports: Medical Tourism, Law, and Ethics. Oxford University Press; 2014. doi:10.1093/acprof: oso/9780199975099.001.0001 Finch S. Medical tourism driving health care disparity in Thailand. Can Med Assoc J. 2014, 186(1): E11 LP-E11. doi:10.1503/ cmaj.109-4658 Grand View Research. (2022). Medical tourism market size, share & trends analysis report by treatment type, by service provider, by country, and segment forecasts, 2022‒2030. Grand View Research: https://​www​.grandviewresearch​ .com/​industry​-analysis/​medical​-tourism​-market Medical Tourism: Chapter 9 of the 2020 Yellow Book | Travelers’ Health | CDC. Accessed April 13, 2021. https://​wwwnc​.cdc​.gov/​ travel/​yellowbook/​2020/​travel​-for​-work​-other​ -reasons/​medical​-tourism Medical Tourism: Getting medical care in another country | Travelers’ Health | CDC. Accessed

Medical tourism  15 April 13, 2021. https://​wwwnc​.cdc​.gov/​travel/​ page/​medical​-tourism Medical Tourism Market Size | Industry Report, 2020‒2027. Accessed April 13, 2021. https://​ www​.grandviewresearch​.com/​industry​ -analysis/​medical​-tourism​-market Naranong A, Naranong V. Les effets du tourisme médical: l’expérience thaïlandaise. Bull

World Health Organ. 2011, 89(5): 336‒344. doi:10.2471/BLT.09.072249 Venditto C, Gallagher M, Hettinger P et al. Complications of cosmetic surgery tourism: Case series and cost analysis. Aesthetic Surg J. 2021, 41(5): 627‒634. doi:10.1093/asj/sjaa092 WHO | Medical tourism in Thailand: A cross-​ sectional study. WHO. Published online 2015. Accessed April 13, 2021. http://​www​.who​.int/​ bulletin/​volumes/​94/​1/​14​-152165/​en/​

Shir Sara Bekhor

6.

Precision medicine

ties of warfarin across individuals, ultimately creating variation in individuals’ responses to warfarin. FDA has recommended that the dose must be personalized to an individual based on the specific genetic variants they possess in the VKORC1 and CYP2C9 genes. Another example is the one of imatinib that is a drug used to treat chronic myelogenous leukemia. It inhibits an enzyme called tyrosine kinase that is increased by the formation of a fusion of two genomic regions, one encompassing the abelson proto-oncogene (abl) and the other the breakpoint cluster region (bcr). This fusion event arises in many tumors contributing to the development of CML and is referred to as the “bcr-abl fusion.” However, not all individuals with CML have tumors harboring the bcr-abl fusion mutation. Therefore, imatinib is typically given only to individual CML patients with this fusion event. In more recent years they are trying to identify genetic profiles possessed by patients and then craft therapies that uniquely target those profiles. For example, the drug ivacaftor is designed to treat individuals with cystic fibrosis that have very specific pathogenic mutations in the gene CFTR that can have different mutations causing different types of dysfunction. Ivacaftor is only useful for the small subset of CF patients whose CFTR mutations lead to specific gating problem (Davis et al., 2012). Precision medicine can be used not only for the treatment of diseases, but also for the early detection and prevention of them. Regarding the early detection of diseases, we know that if an individual is susceptible to a disease, or susceptible to recurrence of it, then that individual should be monitored. It is now believed that such monitoring should be pursued with use of “personal thresholds,” as opposed to “population thresholds” that are derived from epidemiologic data and population surveys and include, for example, cholesterol levels higher than 200. Differently, personal thresholds are established from legacy values of a measure collected on an individual over time that used to gauge how deviant future values of that measure might be for that individual. Drescher et al. (2013) explored the utility of personal thresholds applied to longitudinal CA125 levels collected on a number of women, a subset of whom developed ovarian cancer. They have demonstrated that the use of personal thresh-

The increasing use of biomedical assay as DNA sequencing, proteomics, imaging protocols, and wireless monitoring devices, has revealed a great inter-individual heterogeneity of many diseases suggesting that strategy for treating a patient with a specific disease, and possibly monitoring or preventing that disease, must be tailored or “personalized” to that individual’s unique biochemical, physiological, environmental exposure, and behavioral profile. In fact, precision medicine consists in the application of patient-specific profiles, incorporating genetic and genomic data as well as clinical and environmental factors, to assess individual risks and tailor prevention and disease-management strategies. Its role is growing and is expected to grow more since the power of precision medicine lies in its ability to guide healthcare decisions toward a more effective management of a given patient, and thus, improve care quality, while reducing the need for unnecessary diagnostic testing and therapies. There is a lot of overlap between the terms “precision medicine” and “personalized medicine.” According to the National Research Council, “personalized medicine” is an older term with a meaning similar to “precision medicine.” However, there was concern that the word “personalized” could be misinterpreted to imply that treatments and preventions are being developed uniquely for each individual. The Council therefore preferred the term “precision medicine” to “personalized medicine.” Most people use the two terms interchangeably. Precision medicine has been firstly used for the treatment of patients with a specific disease: we know that pharmacokinetic and pharmacodynamics of drugs are often under the control of a unique set of genes (e.g., drug metabolizing enzymes) that could harbor naturally occurring genetic polymorphisms that influence their function and hence how the body ultimately deals with a particular drug. An example of personalized diseases treatment is the drug warfarin: it targets a particular gene, VKORC1, and is metabolized in part by the gene CYP2C9. Naturally occurring genetic variation in both the VKORC1 and CYP2C9 genes leads to variation in the pharmacodynamic and pharmacokinetic proper16

Precision medicine  17

olds could have captured the ovarian cancer almost a year earlier, on average, than the use of population thresholds. Recent research and clinical activities are opening new territories for next generation personalized medicine strategies:

his or her response to content provided in the app. In this way, the app can be personalized.

● The use of patient-derived cell and organoid “avatars” for determining the best therapies for that patient.

Analyzing data exploring patterns, patient subgroups and individual patient profiles that could shed light on variation in fertility rates, responses to interventions to enhance fertility, etc. The results of these analyses could then guide future care for patients with infertility issues since genetic variants known to influence fertility have also been identified and could be used to support diagnoses or personalized intervention plans (Jungheim & Carson, 2018). Valeria Mazzola

In fact, it is now possible to harvest cells from individuals and use pluripotency induction methods to generate additional cell types of relevance to a patient’s condition without having to directly biopsy the affected tissue. In addition, it is possible to create partial organs or “organoids” from cells obtained from an individual. Once you have these in vitro cellular “avatar” you might identify key molecular pathologies that might give an indication as to how best to treat an individual patient of interest (Beltrao-Braga et al., 2013). Or they can accommodate personalized drug screening so they test thousands of drugs and compounds against a patient’s cells to identify drugs or compounds that uniquely correct the patient’s molecular defects (Aboulkheyr et al., 2018). ● The use of intense individualized diagnostic and monitoring protocols to detect signs of disease. The availability of inexpensive genotyping and sequencing technologies is allowing individuals and their healthcare providers to assess their genetically mediated risk for disease and/ or make a genetic diagnosis if they are already diseased. Genetic assays can be used for generating a diagnosis for individuals with idiopathic conditions as well as for a continuous monitoring to identify evidences for a health status change in an individual. Such diagnoses and monitoring are highly personalized by definition (Patel et al., 2013). ● The development of personalized digital therapeutics. The content provided by a digital therapeutic app to an individual could vary depending on what is learned about that individual and

● The use of personalized medicine approaches in treating patients with infertility issues.

Bibliography

Aboulkheyr EsH, Montazeri L, Aref AR, Vosough M, Baharvand H. Personalized cancer medicine: An organoid approach. Trends Biotechnol. 2018; 36(4):358–71. doi: 10.1016/j. tibtech.2017.12.005 [PubMed: 29366522] Beltrao-Braga PC, Pignatari GC, Russo FB, Fernandes IR, Muotri AR. In-a-dish: Induced pluripotent stem cells as a novel model for human diseases. Cytometry A. 2013; 83(1):11–17. doi: 10.1002/cyto.a.22231 [PubMed: 23281003] Davis PB, Yasothan U, Kirkpatrick P. Ivacaftor. Nat Rev Drug Discov. 2012; 11(5):349–50. doi: 10.1038/nrd3723 [PubMed: 22543461] Drescher CW, Shah C, Thorpe J, O’Briant K, Anderson GL, Berg CD et al. Longitudinal screening algorithm that incorporates change over time in CA125 levels identifies ovarian cancer earlier than a single-threshold rule. J Clin Oncol. 2013; 31(3):387–92. doi: 10.1200/ JCO.2012.43.6691 [PubMed: 23248253] Ginsburg GS, Phillips KA. Precision medicine: From science to value. Health Aff (Millwood). 2018 May; 37(5):694‒701. doi: 10.1377/ hlthaff.2017.1624. PMID: 29733705; PMCID: PMC5989714. Goetz LH, Schork NJ. Personalized medicine: Motivation, challenges, and progress. Fertil Steril. 2018 Jun; 109(6):952‒963. doi: 10.1016/j.fertnstert.2018.05.006. PMID: 299​35​ 653; PMCID: PMC6366451. Jungheim ES, Carson KR. Leveraging real-world data to move toward more personalized fertility treatment. Fertil Steril. 2018; 109(4):608–9. doi: 10.1016/j.fertnstert.2018.01.036 [PubMed: 29653708] Lee MT, Klein TE. Pharmacogenetics of warfarin: Challenges and opportunities. J Hum Genet.

Valeria Mazzola

18  Elgar encyclopedia of healthcare management 2013; 58(6):334–8. doi: 10.1038/jhg.2013.40 [PubMed: 23657428] Liao X, Lochhead P, Nishihara R, Morikawa T, Kuchiba A, Yamauchi M et al. Aspirin use, tumor PIK3CA mutation, and colorectal-cancer survival. N Engl J Med. 2012; 367(17):1596–606. doi: 10.1056/NEJMoa1207756 [PubMed: 23094721] Nan H, Hutter CM, Lin Y, Jacobs EJ, Ulrich CM, White E et al. Association of aspirin and NSAID use with risk of colorectal cancer according to genetic variants. JAMA. 2015; 313(11):1133–42. doi: 10.1001/jama.2015.1815 [PubMed: 25781442] National Research Council (US) Committee on A Framework for Developing a New Taxonomy

Valeria Mazzola

of Disease. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. Washington (DC): National Academies Press (US); 2011. 1, Introduction. O’Dwyer ME, Druker BJ. Status of bcr-abl tyrosine kinase inhibitors in chronic myelogenous leukemia. Curr Opin Oncol. 2000; 12(6):594–7. [PubMed: 11085460] Patel CJ, Sivadas A, Tabassum R, Preeprem T, Zhao J, Arafat D et al. Whole genome sequencing in support of wellness and health maintenance. Genome Med. 2013; 5(6):58. doi: 10.1186/gm462 [PubMed: 23806097]

7. Robotics

Business drivers: ● Robotics is seen as a potential cost-reducing factor by allowing a shift to less expensive outpatient services (minimally invasive robotic surgery); ● Safety, appropriateness and quality of treatment; ● Workforce rationing in the health sector (inadequate generational recycling and staff cuts); ● Marketing (hospitals and health facilities advertise the offer of high-tech solutions). Robotics in healthcare, in a broader sense, can be used strategically, in light of the drivers that seem to move it, both at the micro level of the single health facility, but also at the macro level (national or regional), to support decision making and health policy definition. Moreover, the implementation of robotics in the healthcare sector guarantees a greater efficiency of the system thanks to the reduction of costs by increasing productivity (productive efficiency), accompanied by a qualitative increase of the clinical outcome in terms of improvement of the patient’s state of health (treatment effectiveness).

As reported by the Robotics Business Review (2009, p. 1): Robotics for medicine and healthcare is considered to be the domain of systems capable of performing coordinated mechatronic actions (strength or motion exercises) based on the processing of information acquired through sensor technology, with the aim of supporting the functioning of disabled individuals, medical interventions, care and rehabilitation of patients, and also to support individuals in prevention programs.

Robots must requirements:

meet

certain

essential

1. Sensors: robots use sensors in their activity to detect and acquire information; 2. Intelligence: robots must be able to process the information they capture via sensors and turn it into output to support decision-making, coordination and control; 3. Movement: robots are able to automatically follow pre-programmed instructions, or instructions generated in real time through sensor inputs, so that they can perform a deliberate, controlled and usually repeated mechatronic action; 4. Autonomy: ability of robots to move or perform tasks in response to environmental and internal stimuli, without human intervention (Sense–Think–Act).

In healthcare, robotics can be applied to different fields: ● Surgical assistance robots: assisting surgeons in performing complex procedures, using AI, surgical robots can avoid, for example, nerves, muscles and vessels during surgery. They can provide surgeons with more detailed information during an operation and improve performance. The field of surgical robotics is constantly evolving, some surgical robots may even be able to complete tasks autonomously, allowing surgeons to supervise the operation via a console; ● Diagnosis: this area covers all applications of robotics that make it possible to carry out diagnoses in parts of the body that are difficult to access, reducing the invasiveness of the diagnostic procedure and enabling the physical and psychological discomfort of the patient to be reduced; ● Rehabilitation robotics: modular, exoskeletal, therapeutic and limb robots are applicable in this field, and can provide support in rehabilitation activities fol-

Drivers and lines of development of robotics in healthcare: Social drivers: ● Ageing population; ● Increased rate of disability; ● Raising awareness of “active” ageing. Technology drivers: ● Increased functionality and computing power of microprocessors and technology; ● Increased miniaturization of robotic devices; ● New types of materials available for implementation; ● Classes of innovative and affordable advanced technologies and cameras (vision solutions and 3-D systems). 19

20  Elgar encyclopedia of healthcare management

●

●

●

●

lowing acute episodes, also in cases of chronicity. The support activity carried out by the robot in the therapeutic field can objectively measure the patient’s performance, intensify treatment and provide the possibility of tailoring treatment to the patient’s specific characteristics; Prosthetics: in this field, the use of robotics has led to significant advantages in the patient’s perception of the robotic device not as an external body, but as an integral part of himself, resulting in the development of different invasive and non-invasive interfaces in the interaction between the subject and the robotic device; Care: here robots interact directly with the care recipient, robots can be used in long-term care to fulfil monitoring and social integration tasks, helping to reduce caregiver workloads and improving the emotional well-being of the patient; Cleaning and disinfection: a notable increase in robotics in this field was noted during the COVID-19 pandemic, bringing attention to the use of robots for disinfection procedures in hospitals, but also in public places, thus avoiding exposing operators to biological risk; Service robots: alleviate the daily workload of healthcare workers by handling routine logistical tasks, offering more time for healthcare workers to devote to needs of primary importance for patients.

An interesting case study of the application of robotics in the healthcare field arises from the use of the Da Vinci robot in minimally invasive surgery, where the surgeon does not operate with his hands, but intervenes by operating a robot remotely via a console. The robot was patented by the American company Intuitive, and in 2000 the US Food and Drug Administration (FDA) approved the use of

Michele Giovanni Cusmai

this system in general surgery. The system is based on three components: (1) a control/ command console connected by a fibre optic cable to the robot; (2) a robotic trolley located close to the operating table, which has four arms: one for optics, the other three equipped with operating instruments; (3) a complementary trolley, equipped with a monitor for the surgical team and light and CO2 insufflation sources. The version marketed in 2009 (da Vinci Si system) is provided with a second console, capable of accommodating a second operating surgeon in training. The main benefits of using the robot include enhancement, improvement and optimization of the operating images, elimination of tremors and matching hand movements to instrument tips. Although the state of the art is still evolving, there are considerable benefits to be gained from its application, leading to greater safety, quality and availability of care. Robotics has the potential to become a highly transformative technology for healthcare, however, it must be kept in mind that, in their use, robots should be complementary to, and not replace, the professionals who use them. Robots must therefore be a tool to support the choices of intervention, choices that are still the responsibility of the “human” component, which the robot cannot fulfil. Michele Giovanni Cusmai

Bibliography

Bieller S., The role of robots in healthcare, in IFR Secretariat Blog, 31 May 2021 Cardillo G., Carleo M., Di Martino M., Il robot Da Vinci in chirurgia toracica, Roma, Accademia Lancisiana, 2014 RBR Staff, Healthcare robotics: Current market trends and future opportunities, Robotics Business Review, 13 April 2009 Van Boxsel J., Rensma A., Butter M., Roadmap robotics for healthcare, EFMN, n. 157, November 2008

PART II BASIC MODELS OF HEALTH SYSTEMS A health system is an organization that creates synergies between people, institutions, and resources to provide health recovery and protection services to the population. A health system has two functions: (1) Protect health (think of inspections on food production, agriculture, the animal husbandry); and (2) Produce health services (prevention, diagnostics, cures and rehabilitatition). Historically, there are three basic models of healthcare systems. This cluster provides the foundations of the main architectures and configuration of health systems, with insights into the pros and cons of each model, the diffusion and current evolutions.

21

8.

Beveridge model

ment, as the high-income countries strive to shift away from health coverage as a right of labour or wealth. However, the system does have a drawback as it may lead to long waiting-lists when the hospitals are understaffed, given that everyone is guaranteed access to health services. The system is centralized, with the government at its core, collaborating with insurers, managing hospitals and employing healthcare personnel. This arrangement presents a practical concern, especially during times of crisis, such as war or a pandemic like the one we experienced in 2020, where the funding for health services may decline, as public revenue decreases. This can cause shortages of equipment and personnel, ultimately decreasing the quality of healthcare delivered. Cuba represents an extreme approach to this model with total government control and consequently total vulnerability. However, in most developed countries following the Beveridge Model, there are still some private hospitals who have their economic flexibility, or private insurance companies that can provide alternatives to government-provided healthcare. It can also be likened to the USSR model, but one where the system allows more independence. This is why the Beveridge Model has been described as “socialized medicine” in literature. A commonly reported disadvantage of the Beveridge Model is that since it is funded by taxes, every taxpayer must pay higher taxes regardless of their utilization of healthcare services. This disadvantage, however, is outweighed by the humanitarian point of view that every individual can access all services regardless of their ability to pay. This egalitarian approach ensures the development of social security and the emergence of self-reliant classes. Additionally, the countries utilizing the Beveridge Model tend to spend a lower percentage of their GDP on healthcare compared to other nations. One reason for this is that the governments in Beveridge Model countries have a strong incentive to prioritize cost-efficient preventive care. Finland’s successful public health programs, which effectively reversed the obesity epidemic, serve as evidence for this emphasis on prevention. Furthermore, the model emphasizes primary care, evident in the fact that 70% of British doctors are primary care physicians whereas this number is only 30% in the US. Primary care leads

The Beveridge Model is a healthcare system in which the government provides healthcare coverage for the entire population using general government revenues such as tax payments. It functions as the National Health Service (NHS) in the UK since 1948, but it is utilized in other countries as well, such as Spain, Italy, Finland, New Zealand, Hong Kong and Cuba. The primary goal of this model is to establish universal healthcare coverage, ensuring that all individuals have access to necessary health services of adequate quality without facing financial hardship. The Beveridge Model, sometimes referred to as Beveridge Healthcare System, is named after Sir William Beveridge, an economist and social reformer who was appointed by the Prime Minister Winston Churchill to define a paradigm for the country after World War II. During a time where all war-torn countries were grappling with severe economic depression, Sir William Beveridge published a report titled Social Insurance and Allied Service in 1942, which later became known as the Beveridge Report, and a bestseller. In the report, he outlined the so-called “five giants” that should be tackled if a more modernized British society is to be created. These five giants were idleness, referring to unemployment; squalor, referring to poor housing; disease, referring to lack of healthcare; ignorance, referring to poor education; and want, referring to poverty and need. Each so-called giant required substantial reforms, and the reform for developing a healthcare system led to the establishment of the NHS in 1948. In the Beveridge Model, the healthcare is centralized and nationalized, and the government acts as the sole payer. This eliminates competition in the market and helps maintain low healthcare prices. Since the healthcare funding is derived from income taxes just like any other government service, patients do not have to pay any further fees after a visit or an operation. This is a representation of the core principle that health is a human right that should be available to everyone; to the CEO of a multi-million-dollar company who pays six-figure taxes; as well as to the unemployed and the poor who cannot contribute to the tax revenue of the govern22

Beveridge model  23

to reduced emergency department usage, increased utilization of preventive services, lower overall costs, fewer hospitalizations and improved outcomes. Italy provides a good example of a national health system similar to the Beveridge Model of the British NHS, but with more flexibility. Over time, the power has gradually decentralized from the Italian state to the 21 Italian regions. The state now has a limited supervisory role but ensures the equitable distribution of essential levels of health services across the country. Although the system is far from perfect, it provides consistently reproducible and high-quality outcomes, as demonstrated by its second-place ranking in the measurement of overall performance and efficiency among healthcare systems in all 191 World Health Organization member states. Yagis Bey

Bibliography

Baldwin, Sally, Social Security and Social Change: New Challenges to the Beveridge model, Harvester Wheatsheaf, 1994 Chung, Mimi, Princeton Public Health Review, Health Care Reform: Learning From Other Major Health Care Systems, 2 December 2017, https://​pphr​.princeton​.edu/​2017/​12/​02/​ unhealthy​-health​-care​-a​-cursory​-overview​-of​ -major​-health​-care​-systems/​ HealthMatters, The Beveridge Model, 26 December 2010, http://​healthmatters4​.blogspot​ .com/​2010/​12/​beveridge​-model​.html Kutzin, Joseph, World Health Organization, Bismarck vs. Beveridge, 1st annual meeting

of SBO network on health expenditure, 21‒22 November 2011, Paris, OECD Le Grand, Julian, Winter, David, The Middle Classes and the Welfare State under Conservative and Labour Governments, Journal of Public Policy, 1987, 6(4), 399‒430 Nguyen, Angeline, Morning Sign Out, International Health Care Systems, 14 August 2017, https://​morningsignout​.com/​international​ -health​-care​-systems​-part​-1​-the​-beveridge​ -model/​ Nuti, Sabina, Assessment and Improvement of the Italian Healthcare System: First Evidence from a Pilot National Performance Evaluation System, Journal of Healthcare Management, May–June, 2012 Physicians for a National Health Program, Health Care Systems – Four Basic Models, accessed 7 April 2021, https://​www​.pnhp​.org/​single​_payer​ _resources/​health​_care​_systems​_four​_basic​ _models​.php Physicians for a National Health Program, Summary of International Health Systems, April 2011, http://​caphysiciansalliance​.org/​ wp​-content/​uploads/​2011/​11/​International​ -Comparison​.pdf Tandon, Ajay, Measuring Overall Health System Performance for 191 Countries, World Health Organization, 2000 UK Parliament, 1942 Beveridge Report, accessed 7 April 2021, https://​www​.parliament​.uk/​ about/​living​-heritage/​transformingsociety/​ livinglearning/​coll​-9​-health1/​coll​-9​-health/​ World Health Organization, Universal Health Coverage, accessed 7 April 2021, https://​ www​.who​.int/​healthsystems/​universal​_health​ _coverage/​en/​

Yagis Bey

9.

Bismarck model

Newly adopted reforms and countries in which a range of systems coexist have led to many national variations to the classical models mentioned above (McPake & Normand, 2008). The Bismarck model was emulated and set the grounds for the development of many social security schemes and taxation systems in Europe. Compulsory fees made by insurees to their respective national security trusts were then utilized to fund health services, often to private medical providers, employing a fee-for-service payment method (Tulchinsky, 2018). Countries in which this model is used today, apart from Germany, are France, Belgium, Austria, the Netherlands, Switzerland, countries of Eastern Europe (CEE), and non-European countries such as Japan, Latin America, and Israel (Tulchinsky, 2018). In “Bismarck and the Long Road to Universal Health Coverage” (Tulchinsky, 2018), Tulchinski gives an overview on the implementation of the model in Germany, describing how, since its founding in 1883, many reforms to the model have gradually led to universal coverage for the German population. Nowadays, decision-making powers concerning the German health system are shared between the different states, the federal government, and civil societies. Statutory Health Insurance (SHI) became compulsory to all German citizens in 2009, and its residents have paid 15.5% of their wages as contributions. The SHI generally covers 85% of the residents, who are eligible to choose between 118 sick funds for a broad range of services. In order to enhance the quality of care to the citizens, monetary incentives were introduced in 1990 to encourage competition between these funds. The rest, 15% of the population, is covered under different schemes such as private health insurance and governmental programs (Tulchinsky, 2018). The payment method to hospitals is based on diagnostic categories rather than length of stay. Doctors, instead, are paid per capita for each patient who is registered under their care for a specific length of time (this is in contrast to a fee-for-service method used in other health systems), while a federal compulsory program provides cover for longer-term care (Tulchinsky, 2018). In 2015, its health expenditures were 11.3% of its GDP, and Germany was among the EU countries that spent most on healthcare. Of its

Otto von Bismarck, the Chancellor of the German Empire between 1871 and 1890, created the first Bismarck model in 1883. Despite having an aristocratic legacy and conservative views, he succeeded in forming the first contemporary social welfare system in Europe that provided national health insurance to its citizens, in addition to forming pension plans and accidents coverage (Tulchinsky, 2018). Based on foundations of competition, solidarity, and self-governance, the employment-based social insurance he has developed became widely known as the Bismarckian model. The model relied on “Sick Funds,” which were collected by mandatory contributions by workers and their employers, which, in turn, were used to pay for health service providers, such as doctors and health institutions (Tulchinsky, 2018). Nowadays, the German “Bismarckian system” is one of the leading models of state-operated health services, along with the “Semashko system” of the Soviet Union, Britain’s “Beveridge System” of the National Health Service, and Canada’s National Health Insurance (Tulchinsky, 2018). Unlike private health insurance, contributions to collectively financed health systems are not risk-based, meaning they do not depend on the health status of the insured. They can either be dependent on income, as seen in Germany, where contributions are proportionate to the salary up to a fixed ceiling, or be uniform, as in Switzerland, for instance (Zweifel et al., 2009). In many democratic countries, a market for private healthcare services often exists, and private insurers provide coverage for these services. Private health insurance is, in fact, a common feature in the Bismarckian system for the proportion of the population that is not covered through the public system (Zweifel et al., 2009). Many of the collectively financed healthcare systems present today have been introduced in the last 135 years (Zweifel et al., 2009). Healthcare systems worldwide are generally diverse and thought to be deeply impacted by each nation’s distinct history, tradition, local politics, culture, and social norms (Lameire et al., 1999). 24

Bismarck model  25

health expenses, 73% were on public sector, while 27% were private. By 2014, Germany notably had almost 40% more intensive-care beds per 1000 capita than all other original EU states (Tulchinsky, 2018). An international review of healthcare systems by Lameire et al. (published in 1999) (Lameire et al., 1999) compared three health-system models used by several countries, according to data collected during the 1990s. The Bismarckian model, classified as a “mixed” model applying both public and private service providers, was compared to the Beveridge model, which is predominantly based on public providers, and to the Private Insurance model in the United States of America (USA), which involves private funding and private providers. In each of the participating countries (such as Canada, UK, and Italy for the Beveridge model, and countries such as Germany, Switzerland, and France, for the Bismarckian model), the three models were evaluated based on three characteristics: Quality of care (measured by several indicators, such as the number of life-years lost in terms of premature death or unnecessary death, or life expectancy at birth), equity (percentage of the population covered through solidarity systems), and efficiency (measured by the system's cost and calculated as a percentage of the Gross National Product (GNP) spent on healthcare, and as expenditure for healthcare in “Purchasing Power Parities”). Overall, no discrepancies were observed between public and mixed (Bismarckian) provider systems regarding healthcare quality. Considering equity, or in other words, the access to the healthcare system, countries adopting the public system demonstrated practically 100% coverage, while Bismarckian countries were not far behind, with a varied range of coverages between 90% and 100% in most countries. However, the difference to 100% coverage in these countries is generally made up through additional private insurance for a typically wealthier part of the population. Conversely, the private system in the US showed 44% coverage, the lowest of all. Finally, the healthcare systems demonstrated differences also in their efficiency, as indexed by their cost. Bismarckian countries generally spent between 7.3% and 9.9% of their GNP on healthcare, more than most “public” countries, that generally spent less, between

6.7% and 8.5%. However, the US “private” system spent much more – nearly double – than the public system and reached 14.2% of its GNP. A similar pattern appeared in health expenditures, whereby “public” countries showed the lowest healthcare expenditures, followed by “mixed” Bismarckian countries. At the same time, the “private” system has spent far more, around twice the average of the former. It is important to note that Lameire et al. considered only non-medical health-related indicators in this review to serve as a background for further analysis (Lameire et al., 1999). Comparative analyses used these days to identify relative strengths and weaknesses between countries, such as those performed by the OECD (OECD, 2019), utilize many other factors to provide perspective into how well health systems perform in comparison. Established first in Germany, the Bismarck Health System is one of the most significant models of state-operated health systems, on which many countries around the world base their health systems. It also influences the design of new systems structures in developing countries and in reformulating already established ones in developed countries (Tulchinsky, 2018). As a not-for-profit social healthcare system, it provides coverage to all citizens while simultaneously allowing the co-occurrence of a private sector, making it a multi-payer system. Competition is encouraged between and within sectors, while a tight regulation controls costs. Assaf Ben Haim

References

Lameire, N., Joffe, P., & Wiedemann, M. (1999). Healthcare systems: an international review: an overview. Nephrol Dial Transplant, 14 Suppl 6, 3‒9. https://​doi​.org/​10​.1093/​ndt/​14​.suppl​_6​.3 McPake, B., & Normand, C. (2008). Health Economics: An International Perspective. Routledge. OECD. (2019). Health at a Glance 2019: OECD Indicators. Paris: OECD Publishing. Tulchinsky, T. H. (2018). Bismarck and the Long Road to Universal Health Coverage. In Case Studies in Public Health (pp.  131‒179). Elsevier. https://​doi​.org/​10​.1016/​b978​-0​-12​ -80​45​71​-8​.00031​-7 Zweifel, P., Breyer, F., & Kifmann, M. (2009). Health Economics. Springer.

Assaf Ben Haim

10. Market-driven model

relies on non-income related payments called premiums made by the patient to a private insurer. Essentially, revenue for both comes from household income but in public insurance this money is collected, pooled and distributed via the state whereas with private insurance contributors pay the money directly to the risk-pooling organization. PHI however is not only defined by how it collects its revenues, instead several variables come into play when describing its various forms around the world. In fact, when looking at private healthcare markets, it can sometimes be difficult to distinguish public from private insurance. One variable that distinguishes various forms of PHI is whether participation is mandatory or not. In most countries, PHI is voluntary and public insurance is mandatory. There are, however, exceptions. In Switzerland, residents are required to purchase basic health insurance from competing private companies that offer different insurance packages. Persons wishing to purchase insurance cannot be turned down by the insurer and the premiums each company charges are fixed (though it varies amongst regions) regardless of health status – known as community-rated premiums. Insurers may not profit from basic insurance provided but may provide additional services. Low-income individuals also receive financial support from their local government to help reduce premium costs – in 2009 one-third of Swiss residents received subsidies. Overall Switzerland’s healthcare system is viewed positively for its universal coverage and its efficiency. There are, however, important problems that remain: per capita out-of-pocket healthcare costs are significantly higher than in any other OECD country – 60% higher than in the United States for example. As explained previously, most if not all countries in the world rely on a combination of private and public insurance to finance their healthcare system and provide coverage to their citizens. This, in combination with out-of-pocket expenses, creates a wide spectrum of systems in which private insurance plays different roles. Indeed, in its 2004 study on PHI, the OECD has identified four main functions PHI provides: primary PHI; duplicate; complementary and supplementary cover. Primary PHI is when individuals rely solely on private insurance to pay for their expenses. This occurs either when PHI is

Health insurance is one way in which healthcare systems across the world collect and pool together revenue to provide services to individuals in need of medical care in what can be described as a third-party payor system. In this way, patients pool their resources together over time in an institution that is then responsible for paying part/all of their healthcare costs. This enables patients to receive medical services they normally couldn’t afford – mainly because of the variable nature and the very high prices of healthcare services. The other method of financing healthcare is the out-of-pocket model where patients pay directly for the services they require.

Figure 10.1

Market-driven model

How to classify healthcare systems has been a topic of debates over the years and the general consensus describes three overall models – private insurance being one. However it is widely accepted today that no country relies entirely on one model but instead all healthcare systems are “hybrid and composite systems that mix and combine elements inspired by different models” (Toth, 2016). As such it seems more valuable to focus this discussion on how private insurance functions alongside and supplements public health insurance around the world rather than go into a comparison of the various classifications that have appeared over the years. The OECD distinguishes public and private insurance based on the source of funding. Public health insurance (PHI) is mainly financed through direct taxes/taxation on salary via social security contributions that vary according to income. PHI instead 26

Market-driven model  27

the only available form of cost coverage for medical expenses or when individuals substitute publicly financed with private insurance. The former is common in many lower/middle-income countries where government-run insurance schemes are less available and private insurance – largely through employers – represents the only form of risk-pooling for patients. This is the case in Namibia, South Africa and Zimbabwe where PHI pays for more than 20% of total healthcare costs. The other situation where PHI plays the role of primary care is seen to varying degrees in the Netherlands, Germany and the USA. There, governments provide publicly funded healthcare to parts of the population and leave the rest responsible for buying private healthcare. In Germany, a subset of the population – higher-income and independent workers – may opt out of public healthcare to be covered exclusively by PHI. Primary PHI poses certain challenges: unregulated markets such as those seen in low- to middle-income countries tend to create inequity in access to care with people often turning away from it because they cannot afford insurance premiums. Additionally this system can often lead to adverse-selection/cream skimming on the part of insurers since they bear all the risk and will, when possible, turn away high-risk patients for lack of profit. Duplicate cover is when PHI covers the same services provided by public insurance but allows contributors access to different providers or levels of service. This is particularly common in countries where public and private medical providers – hospitals, doctors, clinics – are separated. This situation is present for example in Ireland and Australia where over 40% of the population have PHI allowing them to be covered for treatments undergone in private hospitals, as well as getting “special treatment” like private rooms in public hospitals. This system is prohibited in countries like Canada to avoid the creation of a two-tiered system where medical providers provide preferential treatment of privately insured patients, as well as differences in the quality of care between private and public hospitals. To curb this, countries like Australia opt to regulate what services duplicate insurance can cover and only reimburse part of the costs incurred in private hospitals.

Complementary cover is when individuals subscribe to PHI to complement public insurance and pay for costs that the latter does not fully cover. France’s healthcare system for example, features a universal public health insurance system that provides incomplete coverage and the vast majority of the population (92%) has private complementary insurance. Unlike in some countries where PHI serves to reduce waiting times, increase the range of services or providers available, in France this complementary insurance provides reimbursement for co-payments not covered as well as optical or dental care. These private insurers are mainly “mutuelles” which do not vary the costs of premiums based on patient risk/profile but rather on the extent to which costs are reimbursed. Supplementary cover is extremely common in any country with public health insurance and refers to PHI that covers costs for services not included in public insurance: elective, optical, dental care, pharmaceuticals, rehabilitation, complementary medicine and other expenses associated with medical care in general like hotel stays and transport. Overall it seems clear that private insurance does not refer to a single model but to a wide variety of schemes aimed at improving medical care either by expanding the available options of providers and services available, by reimbursing costs or services not covered by public schemes or simply by providing the only available form of risk-pooling available to patients. Most of these models work in collaboration with public insurance and provide their own set of advantages and disadvantages, usually but not always filling the gap between lack of coverage and public insurance. Though each country is unique in its use of private insurance, general trends can be seen particularly when you separate countries according to their wealth and income level. Indeed as Schieber explains (Gottret & Schieber, 2006), healthcare financing generally evolves as countries transition from lowto high-income, with the goal being publicly financed universal coverage. Governments in low-income countries provide basic healthcare with a limited budget. Private insurance is virtually non-existent and most spending is out-of-pocket and generally only available to a small part of the population. As countries transition to middle-income, tax revenues Eric Berrou

28  Elgar encyclopedia of healthcare management

increase and social insurance schemes can develop. The expanding formal employment sector is accompanied by a PHI market and overall out-of-pocket expenses decrease. Finally as countries move to high-income their improved institutions are able to sustain public insurance models that cover the most at-risk populations, private insurance markets make up a significant portion of healthcare spending and out-of-pocket expenses become an accessory. This is further supported by Sekhri & Savedoff (2005), who assert that no high- or middle-income country uses private coverage as the primary method for insuring populations who are poor or at high risk and that in 2001, 39 countries in the world had private insurance markets contributing to more than 5% of total health expenditure, 46% of these belonging to the low- and lower-middle-income categories. Both of these highlight the potential role of private insurance in developing a nation’s healthcare financing, at first taking over some of the out-of-pocket expenses and finally merging with public health insurance to cover an increased percentage of the population towards universal coverage. Eric Berrou

Bibliography

Ayanian, J.Z., Weissman, J.S., Schneider, E.C., Ginsburg, J.A., & Zaslavsky, A.M. (2000). Unmet health needs of uninsured adults in the United States. JAMA, 284(16), 2061–2069. https://​doi​.org/​10​.1001/​jama​.284​.16​.2061. Buchmueller, T., & Couffinhal, A. (2004). Private health insurance in France, OECD Health

Eric Berrou

Working Papers, No. 12, OECD Publishing, Paris. https://​doi​.org/​10​.1787/​555485381821. De Pietro, C., Camenzind, P., Sturny, I., Crivelli, L., Edwards-Garavoglia, S., Spranger, A., Wittenbecher, F., & Quentin, W. (2015). Switzerland: Health system review. Health Systems in Transition, 17(4), i–xix. Gottret, P., & Schieber, G. (2006). Health financing revisited: A practitioner’s guide (English). Washington, DC: World Bank Group. http://​ documents​.worldbank​.org/​curated/​en/​ 874011468313782370/​Health​-financing​ -revisited​-a​-practitioners​-guide. Hussey, P., & Anderson, G.F. (2003). A comparison of single- and multi-payer health insurance systems and options for reform. Health Policy, 66(3), 215‒28. doi: 10.1016/ s0168-8510(03)00050-2. PMID: 14637007. Jamison, D.T., Breman, J.G., Measham, A.R. et al. (eds) (2006). Disease Control Priorities in Developing Countries. Washington, DC: The International Bank for Reconstruction and Development/The World Bank; New York: Oxford University Press, Chapter 12. OECD (2004). Private health insurance in OECD countries, The OECD Health Project, OECD Publishing, Paris. https://​doi​.org/​10​.1787/​ 9789264007451​-en. OECD/WHO (2011). OECD Reviews of Health Systems – Switzerland. OECD Publishing, Paris. Sekhri, N., & Savedoff, W. (2005). Private health insurance: Implications for developing countries. Bulletin of the World Health Organization, 83(2), 127‒134. https://​apps​.who​ .int/​iris/​handle/​10665/​269347. Toth F. (2016). Classification of healthcare systems: Can we go further? Health Policy, 120(5), 535‒543. doi: 10.1016/j.healthpol. 2016.03.011. Epub 2016 Mar 28. PMID: 27041537.

PART III EVOLUTION OF THE PHARMA AND MEDTECH INDUSTRY As far as the pharmaceutical industry is concerned, the first evident fact is that it consists of large companies that, to stay competitive, need innovation as the main driver for their success. Large-scale research and innovation have been broadly recognized as the major drivers of performance. Innovation can affect both the scientific/patent and the managerial front. This cluster highlights the major transformations and new areas of research that the pharmaceutical and medtech industries are experiencing in relation to their role and recognition within health systems, with specific reference to the implications and opportunities that these changes are generating for health managers.

29

11. Market access

increasing prevalence of chronic diseases, the authorities and payers developed new criteria to evaluate the level of reimbursement of the new treatment/technologies, since it became economically unsustainable to guarantee access to the new expensive treatments to all the patients indicated. The median monthly price of new cancer treatments in the US, for instance, increased from just over $100 in the 1960s to over $10,000 in 2019 at the time of FDA approval (Memorial Sloan Kettering Cancer Center, 2022). In this period were founded the main Health Technology Assessment (HTA) agencies: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) in Spain (1991), National Institute for Health and Care Excellence (NICE) in the UK (1999), Agenzia Italiana del farmaco (AIFA) in Italy (2003), Haute Autorité de santé (HAS) in France (2004), Gemeinsamen Bundesausschusses (G-BA) and Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWIG) in Germany (2004), Institute for Clinical and Economic Review (ICER) in the United States (2005) and the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada (1989). The HTA definition is a

Market Access is the process aimed at guaranteeing that patients promptly get access (and maintain it) to the drug therapies or new technologies at the appropriate price without further burden on limited budgets. The Market Access process can be applied to various medical products, including biologic drugs, chemical entities, medical devices, digital technologies, telemedicine, and processes such as gene therapies like CAR-T or genome editing therapies. Over the past 25 years, Market Access has gained increasing importance due to the introduction of more innovative and expensive drugs to the market, coupled with significant pressures on governments and healthcare systems to avoid overspending limited budgets. Notably, the medications introduced in the market during the 1990s primarily consisted of chemical compounds with lower manufacturing costs compared to the biotechnological products launched today. During the 1990s, there was a high need for a new medication that can relieve symptoms or treat the most common diseases. The main pharmaceutical discoveries were mostly related to cardiovascular, diabetes, respiratory and infectious disease, pain, contraceptive, and psychiatric treatments. Back then, rapid access to these new treatments was ensured by obtaining Marketing Authorization. The health authorities required that the product has quality, efficacy, and safety data, as well as adherence to approved manufacturing standards. Regulators played an important role in ensuring access to the new product. The progression of the technology led science to increase the research of new chemical compounds and also monoclonal antibodies (mAbs). The evolution of the knowledge of the human body and DNA led to a focus on a new era of disease such as oncology. The first mAb with an oncologic indication, rituximab, a chimeric anti-CD20 IgG1 was approved for non-Hodgkin’s lymphoma in 1997 by the US FDA (Lu et al., 2020). This set the start of the introduction of several new molecules, with a higher economic impact on the health systems, that came in the next decade. With the increase of innovative and expensive treatments, the demographic trends, and

multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, and robust manner. HTA answers clinical questions of new, potentially innovative healthcare technologies such as: How well does a new technology work compared with existing alternative health technologies? For which population group does it work best? (Sacchini et al., 2009)

HTA bodies provide the appraisal of evidence and payers emphasize different elements in the consideration of reimbursement of the technology. 5 main Payers archetypes have to be considered: 1. Clinical differentiation archetypes. In these markets, such as Germany and France, payers compare clinical evidence for similar products to identify the additional clinical benefit of the new product. 2. Health economic archetypes. In markets such as the UK, Australia, Canada, and Sweden, payers make decisions based on 30

Market access  31

the value for money of a new intervention in terms of both their costs and clinical outcomes. Value for money is formally evaluated using health economic models. There are various types of health economic models, such as cost-effectiveness, cost minimization, or cost-utility models. 3. Budget-driven archetypes. For markets such as Spain, Italy, Turkey, and Japan, price and reimbursement are primarily determined by budget impact at either a national, regional, or local level. Budget impact analyses are used to estimate the financial consequences of a new treatment within a specific healthcare setting given inevitable resource constraints. 4. Patient out-of-pocket archetypes. In countries such as Brazil, Hong Kong, Indonesia, and Singapore, the cost of treatment is predominately paid for by the patient. In some cases, such as Brazil, there is large private and out-of-pocket (OOP) health expenditure even with universal health coverage. 5. Free-market competition. In the US, price is based on market considerations with limited regulation. Manufacturers launching products within the US must negotiate with multiple organizations including Medicare, Medicaid, and private insurers to gain access to product formularies. It should be noted that whilst the US is often characterized as a “free-market” archetype, it also has high patient out-of-pocket expenditure. The pharmaceutical companies, to address the requests and needs of regulators, developed new market access strategies to ensure the reimbursement of their treatments. These strategies involve collecting data that demonstrate the value of new technologies compared to standard care, as well as implementing pricing and payment schemes that minimize risk for the healthcare system. The key activities to ensure reimbursement and successful access to new treatments are: 1. Evidence generation: a. Clinical data b. Outcomes research data c. Health economics models d. Real-world evidence studies e. Landscape assessment

2. Evidence communication: a. Value dossier b. Value proposition c. Objection handler 3. Stakeholder engagement a. Early advisory board/ focus groups with ex-payers b. Stakeholders mapping c. HTA training, partnership, round table, multi-stakeholder workshop, position paper 4. Pricing strategy Market Access is the broad term within the pharmaceutical company that encompasses multiple stakeholders that collaborate to develop the value package: Pricing and Channel, Value and Access, Health Economics and Outcomes Research (HEOR), and Real World Evidence (RWE). A robust market access strategy is crucial not only during product launch but also throughout its lifecycle to maximize revenue potential. Payers often request additional clinical data during price re-evaluations to maintain pricing and patient access to treatment. With the introduction of immunological and rare disease treatments that offer significant benefits to specific patient populations, agencies and companies have started to place greater emphasis on patients’ needs. The shift has moved from a purely cost-focused approach to a patient-centered vision, wherein the new product must satisfy the patients’ requirements in addition to minimizing economic impact on healthcare systems. Consequently, Market Access is evolving towards Patient Access. The humanistic value of new products has gained importance, and it is increasingly common to include Patient-Reported Outcome (PRO) analyses in clinical trial protocols. Furthermore, the US FDA has developed a series of methodological guidance documents under the umbrella of Patient-Focused Drug Development (PFDD) since December 2016. PFDD is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation processes (U.S. Food and Drug Administration, 2022). Emanuele Marsili Emanuele Marsili

32  Elgar encyclopedia of healthcare management

Bibliography

.mskcc​.org/​research​-programs/​health​-policy​ -outcomes/​cost​-drugs Lu, RM., Hwang, YC., Liu, IJ. et al. Development Sacchini, D., Virdis, A., Refolo, P., Pennacchini, of therapeutic antibodies for the treatment of M., & de Paula, IC. Health technology assessdiseases. J Biomed Sci 27, 1 (2020). https://​doi​ ment (HTA): ethical aspects. Medicine, Health .org/​10​.1186/​s12929​-019​-0592​-z Care, and Philosophy 12, 4 (2009), 453–457. Memorial Sloan Kettering Cancer Center (2022). https://​doi​.org/​10​.1007/​s11019​-009​-9206​-y Price & value of cancer drug. https://​ www​ U.S. Food and Drug Administration (2022). CDER patient-focused drug development. https://​www​ .fda​.gov/​drugs/​development​-approval​-process​ -drugs/​cder​-patient​-focused​-drug​-development

Emanuele Marsili

12. Digital therapeutics

ication, thus improving their therapy adherence. The latter focuses on algorithms that extend and enhance the functions of the drug and consequently its therapeutic action, such as platforms that substitute medications with sensory stimuli, delivered via an application on a mobile device. This software aims to monitor adherence to treatment and manage undesirous effects associated with drug therapy. Moreover, DTx can optimize patient care and health outcomes regardless of being used independently or in concert with medications, devices, or other therapies. On the other hand, so far, patients’ active participation seems still too complex to be verified. Digital therapies might transform the clinical and economic management of diseases. One of the main economic implications of digital therapies is to reduce the impact of pharmaceutical spending. Leveraging technology can alleviate healthcare industry overheads by improving treatment outcomes or replacing existing treatments. In addition, by improving therapeutic adherence and facilitating follow-ups, DTx would have a favorable impact on both direct health and non-health costs, as well as indirect and social costs. It benefits the NHS, individual healthcare facilities, patients, and caregivers. However, a critical aspect of DTx’s application is represented by the initial investment as it requires expenses for both technical equipment and practitioners’ literacy. Moreover, literature documents DTx effects only in the long term. From a clinical management perspective, the digital therapeutics lifecycle can be updated quickly through regular software updates. This implies both the possibility of customizing and improving the offer of services and the reduction of the costs of switching between therapies. In addition, the use of DTx improves patients’ lives thanks to the non-toxicity and lack of side effects. Finally, they allow an increase in the direct interaction with patients by increasing their engagement and improving their adherence to therapy. Even though DTx may have favorable implications for the NHS and patients, a firm commitment from all institutional and clinical stakeholders is required to ensure the therapeutic value of this application. Moreover, the large-scale introduction of digital therapies is not without challenges. Patients and

Health and digital technology are getting closer and closer, driving the development of Digital Health, that includes Digital Therapeutic (DTx). The COVID-19 pandemic has stimulated further innovations “imposing” their fast implementation. DTx deliver evidence-based therapeutic interventions through high-quality software programs to prevent, manage, or treat a medical disorder or disease. DTx products incorporate advanced technology best practices relating to design, clinical evaluation, usability, and data security. They are developed through randomized and controlled clinical trials, being certified by regulators, as required, to support product claims regarding risk, efficacy and intended use. Even though the DTx structuring and development process is like that of drugs, their therapeutic key factor is not based on a chemical molecule but on an algorithm relating to the therapeutic element responsible for the clinical effect. From 1995 researchers started developing and applying technology to provide cures through a “one-to-many” model; nevertheless, it was only in 2015 that Sepah et al. (2015) introduced the term “digital therapies” in the literature. The concept was to expand the reach of physicians by overcoming time, place, and staff limitations that represent a constraint to healthcare delivery, while taking better care of patients with fewer resources, providing access, convenience, and efficiency. Nowadays, through the usage of mobile applications, games, and virtual reality, DTx represents an emerging and innovative area of medical therapy, already available today, albeit to a limited extent, in medical practice and with great potential not yet fully exploited in terms of health, particularly for the treatment of many chronic diseases and addictions. DTx can operate as “standalone” or “plug-in”. The former provides the patient with the tools to manage emotions and to modify negative beliefs and misperceptions of the mind through already existing therapeutic models; these models have been in use for years in the traditional relationship between therapist and patient, such as mobile applications and devices, which help patients with reminders for time and dosage of med33

34  Elgar encyclopedia of healthcare management Table 12.1

Advantages and disadvantages of digital therapeutics

Point of view Clinical

Advantages

Disadvantages

No toxicity and other associated side effects

A serious mistake while using DTx might affect

Direct access to patients and increases the ways to

thousands of patients at a time without ready

interact with and empower patients

mechanisms for detection and correction

More efficacious as ensures continuous monitoring of Some applications cannot guarantee the accuracy of the diagnosis

patient vitals and follow-ups

Encourages adherence to health lifestyle behavior and Some applications might give false claims which prescribed medications

are designed without scientific input of medical

Opportunity to pair DTx with proven medications

professionals

Multidisciplinary approach Managerial

Minimize costs associated with attending hospital or

Compromised patient privacy

doctor’s clinic

Legal liability for injuries

Minimize time in administrative tasks and routine

Cross-jurisdictional practice of medicine

communication, and more time spent on treating patients

clinics must be trained, both on the effectiveness of these new therapies and their use and access. Besides, doctors and nurses need greater digitalization, and governments must take charge for this shortage. Finally, bureaucratic and legislative aspects need to be considered both at the system and individual structure level: the reimbursement of digital therapies requires an analysis of DTAP (Diagnostic-Therapeutic Assistance Paths) as well as the understanding of how they are integrated within these paths, in terms of cost reduction that they can favor. Moreover, databases’ interoperability must guarantee the privacy and safety of patients. Nowadays, DTx cannot be prescribed to patients in Italy and most European countries. However, there are spot experiences in Germany, where Deprexis, a web application indicated for the adjunctive treatment of chronic or recurrent depression, has been reimbursed for years, in France, and in the UK where NICE has approved a conditional reimbursement in clinical trials for Deprexis and Sleepio (a digital therapeutic for insomnia). The literature on this subject also demonstrates the ability of DTx to drive large-scale behavioral change. A 2020 study (Van Rhoon et al., 2020) showed that systematic behavioral intervention aimed at diet and exercise, through face-to-face communication, substantially reduced people’s risk of developing type-2 diabetes. This discovery has led to the development of similar lifestyle change programs in the United States, and several DTx companies are developing Elena Maggioni

models to provide such behavioral programs in digital formats to reach more people. For example, an American DTx company offers, through a social network, a behavioral intervention for diabetes, including a one-year educational curriculum, personalized health coaching, and support through a small group of peers. This program also leverages on connected devices to track people’s nutrition, activity, and weight using tools like hardware, software, and human coaching for a long time. The COVID-19 pandemic has boosted the implementation of new digital tools by both healthcare professionals and patients: in this scenario DTx is able to represent a fundamental element to streamline procedures, lighten waiting lists and increase patient engagement. Moreover, DTx’s market is growing because it reduces diagnostic times and monitors the health costs related to the incidence and prevalence of chronic diseases. In fact, although the Italian Digital Biotech sector is still in its infancy, the development of its Digital Therapeutics is estimated to reach $9.4 billion in 2028. Digital Therapeutics, therefore, might transform both the clinical and economic management of addictions and chronic diseases in the Italian context where the current socio-demographic framework is characterized by an aging population and a relative increase in cases of chronicity and comorbidity. Elena Maggioni

Digital therapeutics  35

Bibliography

industry. Perspect Clin Res 2020; 11:54‒8. https://​pubmed​.ncbi​.nlm​.nih​.gov/​32670828/​ Dang A. et al. Role of digital therapeutics and the Recchia G. et al. Terapie digitali, necessità per lo changing future of healthcare. J Family Med sviluppo dell’ecosistema tecnologico ed ecoPrim Care 2020; 9:2207–13. https://​www​.ncbi​ nomico dell’Italia. Tendenze nuove ‒ Numero .nlm​.nih​.gov/​pmc/​articles/​PMC7380804/​ Speciale 1/2021. https://​www​.afiscientifica​.it/​ Fontanari A. Le Digital Therapeutics rivoluziwp​-​​content/​uploads/​2021/​01/​TerapieDigitali oneranno il modo di gestire la nostra salute. TendenzeNuove.pdf Digital Health Italia. 10 June 2021. https://​ Sepah SC, Jiang L, Peters AL. Long-term outdigitalhealthitalia​.com/​le​-digital​-therapeutics​ comes of a Web-based diabetes prevention -rivoluzioneranno​-il​-modo​-di​-gestire​-la​-nostra​ program: 2-year results of a single-arm lon-salute/​ gitudinal study. Journal of Medical Internet Hug-Sung Kim. Apprehensions about excesResearch 2015; 17(4):e92. https://​doi​.org/​10​ sive belief in digital therapeutics: Points of .2196/​jmir​.4052 concern excluding merits. J Korean Med Sci. Van Rhoon L, Byrne M, Morrissey E, Murphy 23 November 2020. https://​pubmed​.ncbi​.nlm​ J, McSharry J. A systematic review of the .nih​.gov/​33230984/​ behaviour change techniques and digital feaKhirasaria R. et al. Exploring digital therapeutures in technology-driven type 2 diabetes pretics: The next paradigm of modern health-care vention interventions. Digital Health 2020; 6. doi:10.1177/2055207620914427

Elena Maggioni

13. Biotech

numerous and each macro area has several different content areas so nowadays we are talking about medical, agricultural, food, industrial, environmental and marine biotechnology, bioinformatics, nanobiotechnology, and even legal, ethical and informative biotechnology. Medical biotechnology is a branch of medicine which, through the application of microbiology, biochemistry, molecular biology and genetic engineering, aims to produce technological products and services for the prevention, diagnosis and treatment of diseases. In the field of prevention, of both infectious and chronic-degenerative diseases, the production of vaccines is undoubtedly the sector that has benefited the most from the use of biotechnology. Historically, vaccines have been developed using methods that follow the paradigm of isolating, attenuating or inactivating, and injecting the disease-causing pathogen or pathogen component. Over time, more refined methods were introduced such as chemical treatment of a protein toxin to form a toxoid, development of a purified and inactivated virus, and so on. Some of these methods are still used today. However, in May 1986 the approval of vaccine Recombivax HB, against hepatitis B infection, marked a milestone in the development of medical biotechnology. It was the first biotechnological vaccine, produced using recombinant DNA technology, to which mRNA vaccines and viral vector vaccines were subsequently added. Today, these types of vaccines are used against SARS-CoV-2. The advantages of biotechnological vaccines include: drastic reduction of safety risks, greater efficacy against viruses with high genetic variability, feasibility even with difficult-to-cultivate pathogens, defined process components, more controlled bioprocesses and a shorter production process which is necessary for a rapid response to health emergencies such as pandemics. Moreover, the technological revolution consisting of recombinant DNA, genomics, proteomics, and progress in understanding the immune system has removed most of the technical barriers that formerly limited vaccine developers and has presented amazing new opportunities to use vaccination approaches to prevent and treat not only infectious dis-

Biotech is the common abbreviation of biotechnology, defined as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”, by the UN Convention on Biological Diversity (1992). The use of biological systems for the production or transformation of certain substances for food purposes is a practice known since ancient times. However, in the last century, due to the knowledge obtained from research on DNA and the achievements of genetic engineering, biotechnologies have been applied in various fields, including medicine, contributing to the development of highly technological products and services able to significantly improve people’s well-being. Therefore, biotechnology can be distinguished into traditional (or conventional) biotechnology and innovative (or advanced) biotechnology. Traditional biotechnology refers to the use of basic biological processes in the transformation of some natural substances. These processes are still used today, with increasingly accurate control systems, and involve the use of living organisms such as bacteria, yeasts, plant or animal cells, especially in the food, agro-zootechnical and environmental fields (production of bread, cheese, yogurt, alcoholic drinks, vinegar, etc.). The improvement of knowledge in genetics has led to the development of innovative biotechnologies. These, applying the principles of genetic engineering and molecular biology, use techniques that allow to isolate, clone and introduce specific genes into a heterologous organism, provide new characteristics to the recipient cells or alter the sequence of a gene and produce another one more suitable to meet specific needs. The biotechnologies that have developed around these processes include a very wide range of applications, which, according to the OECD (Organisation for Economic Co-operation and Development) (2022), can be traced back to four macro areas: (1) pharmacology, medicine and diagnostics; (2) agriculture, veterinary and animal husbandry; (3) bioindustry; (4) environment. However, the fields of application of biotechnology are 36

Biotech  37

eases but also cancer, allergies and many chronic diseases. In the diagnostic field, biotechnology has contributed to the development of more accurate and less invasive methods for the early and specific identification of any type of pathology, including complex ones, chronic diseases and cancer, supporting the development of predictive and personalized medicine. In particular, molecular diagnostics, through the use of specific biomarkers, has become increasingly important in defining the natural history of diseases, identifying risk conditions, carriers and susceptible individuals, as well as the most suitable therapeutic strategies. Biotechnologies also play an important role in the pharmaceutical field for the development of advanced therapies based on the use of biotechnological drugs. A “biotechnological drug” or “biological” is defined as “a pharmaceutical inherently biological in nature and manufactured using biotechnology” (Rader, 2008, p. 744). Biologicals are large and complex molecules made from living organisms and are different from the chemically synthesized “small molecule drugs”. They are generated from a non-native source (not existing as such in nature) through the engineering of a biological system consisting in the manipulation of the genome or in the generation of a hybridoma. Their mechanism of action mimics the function of endogenous biological molecules. A little over thirty years after the first biotechnological drug was placed on the market, recombinant human insulin produced using genetically modified bacteria, there is a wide variety of biologicals (i.e. monoclonal antibodies, recombinant proteins, cell and gene therapies, products derived from stem cell technology) that are used to treat a wide variety of diseases (oncological, genetic, inflammatory, autoimmune diseases, neurological and degenerative diseases). Today biotechnology represents a consolidated and constantly evolving tool that allows progress in the medical and pharmaceutical fields with the aim of improving the quality and duration of life of the entire population. It is clear that the transition from knowledge acquired through research to application in public health requires management, harmonization and sustainability tools, which guaran-

tee the improvement of health performance, in terms of effectiveness of interventions and system efficiency, and containment of the health expenditure. In particular, Public Health (in Italy guaranteed through the National Health System) is a system that guarantees the prevention, treatment and control of diseases as well as the promotion and maintenance of the health of the entire population. The management of such a complex system, together with other factors including the progressive aging of the population, the increasing use of specialist services, the evolution of biomedical technologies, the development of new diagnostic and therapeutic tools, has resulted in a continuous increase in public health expenditure, requiring the adoption of management models aimed to ensure its sustainability. Keeping this in mind, an organizational model based on the digitization of the system, able to harmonize progress in the field of biotechnologies and make them universally available, could have the following effects: ● improve the organizational appropriateness and sustainability of care; ● optimize accessibility, safety and quality of assistance; ● strengthen diagnosis and prevention, especially for diseases where early diagnosis plays a crucial role (including cancers); ● ensure therapeutic personalization and continuity; ● modify the therapeutic pathways and, in particular, decentralize the assistance to chronic patients, in a logic of proximity healthcare. Finally, an efficient digital network allows to develop and make universally available a series of tools such as the “Electronic Health Record”, as well as to define an effective “Health Data Governance” for the purposes of treatment, research and management. Francesco Bagordo, Antonella De Donno and Tiziana Grassi

Bibliography

Barcelos, M.C., Lupki, F.B., Campolina, G.A., Nelson, D.L., Molina, G. The colors of biotechnology: general overview and developments of

Francesco Bagordo, Antonella De Donno and Tiziana Grassi

38  Elgar encyclopedia of healthcare management white, green and blue areas. FEMS Microbiol. Lett., 365, fny239 (2018). Ladisch, M.R., Kohlmann, K.L. Recombinant human insulin. Biotechnology Progress, 8(6), 469‒478 (1992). OECD. (2022). Organizational Structure. Tratto da OECD – Better policies for better lives: https://​www​.oecd​.org/​about/​structure/​ Rader, R. (Re)defining biopharmaceutical. Nat Biotechnol., 26, 743–751 (2008). UNEP. Convention on Biological Diversity.

United Nations Environment Programme (1992). https://​www​.un​.org/​en/​observances/​ biological​-diversity​-day/​convention​#:​~:​text​ =​The​%20Convention​%20on​%20Biological​ %20Diversity​,been​%20ratified​%20by​%20196​ %20nations Venters, C., Graham, W., Cassidy, W. Recombivax-HB: perspectives past, present and future. Expert Review of Vaccines, 3(2), 119‒129 (2004).

Francesco Bagordo, Antonella De Donno and Tiziana Grassi

PART IV FOUNDATIONS OF HEALTH ECONOMICS One of the main problems in health management is related to spending control. It is therefore essential that healthcare organizations are structured in such a way as to follow increasingly economic and business logic so that clinical effectiveness is accompanied as well as economic efficiency. The healthcare manager must bear in mind that the clinical world is inevitably linked with the economic one and that this connection determines the emergence of certain mechanisms. This cluster groups together the economic mechanisms that are essential to managing healthcare services.

39

14. Baumol’s cost disease

the only sector in which we can see the cost disease. It tends to arise in jobs that involve non-routine human interaction, such as the arts, education and healthcare. To understand this, we should consider the five main factors that lead to an increase in productivity:

William Baumol was an American economist from New York, who passed away in 2017. During his 95 years, he had a variety of contributions to the field of research in economics, ranging from his theory of contestable markets, to entrepreneurship, to his self-titled cost disease. The latter is a very intriguing concept that focuses on the rising costs in some job sectors. Classical economics states that wage increases should be proportional to increases in productivity. However, Baumol noted that some jobs experience wage increases without a corresponding increase in productivity. This observation is explained by Baumol’s cost disease. Consider a string quartet, which is characteristically made up of four musicians; two violinists, one violist and a cellist. Our hypothetical quartet plays a two-hour show every day at a theatre, during which they play a dozen songs. Because these four musicians can’t really increase the amount of music they play in a given amount of time (without sacrificing the quality of the music, of course), they don’t really have a case for their wages to increase. Now, consider an automobile factory. For several reasons, the average time it takes to produce an automobile has dramatically decreased over the past few decades. Therefore, if more cars are produced per hour, the whole factory will be more profitable. It follows that those who produce the cars should get a commensurate increase in their salary. This creates a competition between these employers for the workers, as if the string quartet hears increased wages at the automobile factory, and don’t see their own wages increase, then it would probably make sense for them to leave the quartet and join the factory. This encapsulates the main point of Baumol’s cost disease, which is that the wage increase in jobs that don’t increase productivity is driven by the wage increase in jobs that actually do increase productivity. So ultimately, productive jobs dictate the wages in all jobs, regardless of their respective increases in productivity. The example we discussed was not chosen haphazardly, as Baumol initially based his theory on the study of the performing arts sector. However, not surprisingly, this is not

1. 2. 3. 4. 5.

Increased capital per worker Improved technology Increased labour skill Better management Economics of scale as output rises.

As you can probably guess given the technological advancements that we see all around us, productivity increases much more rapidly in jobs and sectors that use machinery or equipment of some sort. This is not to say that technology doesn’t make artistic or healthcare jobs easier. Considering the arts, production teams have benefitted enormously from the advancements in lighting and audio effects in recent years. The key point is that this increases the quality of the play, but doesn’t increase the productivity. The play will still last for two hours, and so the output per unit time doesn’t actually increase. In fact, the only way that productivity can increase in artistic jobs is through the economics of scale, by increasing the output (i.e., more shows). Healthcare has also benefitted greatly from improved technology and increased skill in recent years, but has there actually been an increase in productivity? This is a bit more difficult to discern, as it somewhat depends on the metrics that we use to gauge productivity in the medical field. As argued by Colombier (2012), healthcare is actually a necessity and not a luxury at the national level, and thus should not be considered in the same manner as the arts or education. They showed mathematically that Baumol’s cost disease impacts healthcare growth in a less than proportional manner, so the fact that inflation in healthcare exceeds macroeconomic inflation cannot be caused by Baumol’s cost disease. There are actually a number of ways to solve cost disease. Let’s return to our string quartet. The owner of the theatre in which these musicians play may opt to increase the price of a concert ticket in order to increase their wages. Increases in price may make the most sense in this scenario, but it’s not the perfect solution in every case. Returning to healthcare, it wouldn’t be feasible to continue 40

Baumol’s cost disease  41

to increase the cost of a doctor’s appointment, neither in a private nor public system, as somebody will ultimately have to front that bill. Some other possibilities include: ● Decreasing the quantity or supply ● Decreasing the quality ● Decreasing the profit margins, dividends or investments ● Increasing the non-monetary compensation ● Employing more volunteers ● Increasing the total factor productivity. When it comes to medicine, there is no perfect solution. What often happens is that hospitals turn to residents, who earn notably less than fully qualified doctors and whose salary hasn’t increased at nearly the same rate. By increasing the ratio of residents to doctors, the hospital won’t be paying nearly as much in total salary. Another option would be to increase the workload of these residents, so that you could hire even fewer total personnel. While this works well from a cost-effectiveness point of view, it’s obvious that increasing the number of employees with a lower level of qualification and then overworking them will lead to a decrease in the quality of their work. One alternative solution could be to increase the involvement of students. In some countries, students are hardly utilized in the hospitals, thus producing poorly prepared residents. It would then make more sense to give students a more prominent role early on, both so that they can be more prepared to tackle the responsibilities of a resident when the time comes, as well as decreasing the costs while they work in the hospital. It varies by country, but it’s certainly not uncommon for students to work in the hospital free of charge. Another more radical option may be the transition to more automated medical services. This is a highly controversial topic,

as right now there is a great deal of debate regarding the extent to which you can automate medical activities. Despite this, over the years we have seen many manual jobs phased out and replaced due to technological advances, so it’s certainly not unimaginable that one day doctors may be replaced as well. This sort of revolution would undoubtedly be met with strong pushback by the medical field (as is the case with all professions facing replacement), but the potential increases in productivity can’t be ignored. Ultimately, we can see that Baumol’s cost disease is a fundamental part of today’s economy and, barring a radical alteration in some sectors, is here to stay. While this is a good thing for those employed in jobs which don’t see increases in productivity, those entering into these professions should be aware that there are always those who wish to cut costs. For this reason, while we’ve dealt with this chronic disease for some time, there may one day be a cure. But for now, those employed in these professions appear to be safe. David Brett Doerksen

Bibliography

Colombier, Carsten (2012), Divers of health care expenditure: Does Baumol’s cost disease loom large?, Social Sciences Research Network, Discussion Paper 12–5, https://​ papers​ .ssrn​ .com/​sol3/​papers​.cfm​?abstract​_id​=​2341054 DeMarco, DM et al. (2017), Eliminating residents increases the cost of care, Journal of Graduate Medical Education, 9 (4), 514‒517, 10.4300/ JGME-D-16-00671.1 Maiello, Michael (2017), Diagnosing William Baumol’s cost disease, Chicago Booth Review, 18 May 2017, https://​review​.chicagobooth​.edu/​ economics/​2017/​article/​diagnosing​-william​ -baumol​-s​- cost-disease Towse, Ruth (2012), A Handbook of Cultural Economics, Chapter 11, pp. 91‒95, Cheltenham, UK and Northampton, MA, USA: Edward Elgar Publishing.

David Brett Doerksen

15. Disease mongering

● Create a debate around a disease negatively influencing the public opinion and proposing as a solution treatment of dubious effectiveness; ● Widespread misuse of statistics and clinical studies in order to enhance the benefits and deny the occurrence of relevant side effects; ● Affirm that a common symptom is a severe disease; ● Promote a disease through a public campaign financed by the same pharmaceutical company that sells the drug meant to cure it.

Our dream is to make drugs for healthy people. This would allow us to sell to everyone. (Henry Gadsen, General Director of Merck & Co. Fortune Magazine 1977)

The expression disease mongering identifies the practice of widening the diagnostic boundaries of treatable illnesses and promote their public awareness in order to profit and expand the markets for treatment. In terms of public health education, raising the awareness concerning preventable and treatable conditions can be extremely useful to boost the public understanding of a disease and the importance of the appropriate uptake of the correlated treatments. Being aware of the risks associated with certain conditions and of the treatments currently available is crucial not only for the health professional but also for the untrained population. Due to the lack of public health education funding, disease awareness campaigns are often carried out by drug companies. Occasionally, these commercially sponsored awareness campaigns meant to increase product sales, have been beneficial to the public health. It is not infrequent that a major disease is detected as a result of a patient seeking medical advice after contact with a disease awareness campaign. In addition, in some instances they helped to de-stigmatize certain conditions, leading to a better diagnosis and treatment. However, the most common result of selling risk factors as diseases is to distort the prevalence and the severity of a condition in order to legitimize large-scale medical intervention. Therefore, this approach is not only misleading and expensive but usually doesn’t take into account the patient’s best interest. The label disease mongering was first used in 1992 by Lynn Payer to describe the Johnson and Johnson’s Listerine campaign against halitosis. According to Lynn Payer various techniques are used to create false perception such as:

However, nowadays the Scientific Council of the American Dental Association recognizes halitosis as a condition requiring professional medical attention. This condition is not only correlated to social stigma, but it is also linked to many different medical conditions such as gum infections or kidney failure. According to European regulation policies, the target of prescription drugs advertisements are only physicians. In European countries the only drugs that can be advertised to the public are over-the-counter medications that are often aimed at the amelioration of the individual lifestyle. Nonetheless nowadays pharmaceutical companies are pushing towards a deregulation of advertisement policies toward an US-like system where the final target of prescription drugs advertisements are not physicians but the consumer itself. The expansion of medicalization of a certain condition can be achieved in three possible ways: qualitative (determining whether the condition taken into account is a disease or not), quantitative (lowering threshold), or temporal (antedating a diagnosis). If on one hand disease mongering is a powerful tool for the pharmaceutical companies to increase their revenues, it is also true that this term is often exploited by conspiracy theorists to deny the existence of real diseases. A striking example of disease mongering used by pharmaceutical companies in order to treat the broadest number of people is the use of the homeopathic preparation Oscillococcinum marketed by Boiron as a remedy to prevent and treat flu-like symptoms. Despite the lack of clear scientific evidence, the manufacturing company promotes the use of its preparation as a medication to take while still healthy in order to prevent the flu or to treat it after the occurrence of

● Identify normal aspects of the human life as abnormal and as such requiring medical attention; ● Define a disease in an ambiguous way in order to attribute it to the widest possible number of people; 42

Disease mongering  43

the symptoms. The only studies available that prove the efficacy of the homeopathic preparation are the one financed by Boiron itself. Moreover, it is interesting to highlight that physicians often only prescribe therapies aimed at relieving symptoms in the case of flu as there is no drug with a proven efficacy to treat the flu. Other examples of diseases that have been a cardinal feature of disease mongering include mild forms of depression and anxiety, social anxiety disorder, intermittent explosive disorder, attention deficit disorder, irritable bowel syndrome, restless legs, low bone mineral density, erectile dysfunction, premature ejaculation and female sexual dysfunction. Nevertheless, a massive coordination between professional figures and lay audiences is crucial to establish the legitimacy of an expanded definition of a certain condition in order to avoid either an overtreatment or an undertreatment. On the other hand, cases of false disease mongering are also widespread. Among the most common ones are the conspiracy theories on the inexistence of AIDS, antivaxxers, and osteoporosis. For example, in the case of osteoporosis, conspiracy theorists define the condition as a mere lack of bone density without properly taking into consideration the risk of fractures inherently correlated to the disease. While it is true that osteopenia is a condition that until a certain extent is physiologically associated to the ageing process, it is true as well that the high risk of fracture due to severe osteopenia is crucial to be addressed in order to preserve the patient’s quality of life. As it emerges, one of the consequences of disease mongering is not only an increase in awareness of certain diseases, but it is also a more widespread medicalization of different conditions. A crucial role in this context

is played by pharmaceutical companies that apply aggressive marketing strategies in order to sell their products. It is undeniable that the progress made in the pharmaceutical industry has enhanced the quality and length of life of the population. However, it is essential to find a balance between overmedicalization and denying the existence of any disease. In addition, the ever-increasing cost of medicalization to the public healthcare system is bound to draw more attention towards overmedicalization and disease mongering. One of the crucial strategies to address disease mongering may be to invest in large-scale longitudinal studies with long-term follow-up of certain conditions for which conclusive and coherent results are lacking. The usefulness of the potential role of drugs and food supplements in treating a certain condition should be documented with a robust methodology and on a large scale. Giulia Gallo

Bibliography

Dear JW, Webb DJ. Disease mongering: a challenge for everyone involved in healthcare. Br J Clin Pharmacol. 2007; 64(2):122‒4. Doran E, Henry D. Disease mongering: expanding the boundaries of treatable disease. Intern Med J. 2008; 38(11):858–61. Payer L., Disease-Mongers. How Doctors, Drug Companies and Insurers Are Making You Feel Sick, 1992, John Wiley & Sons, New York. Ranucci G, Spagnuolo MI, Iorio R, Ranucci G, Spagnuolo MI. Obese children with fatty liver: Between reality and disease mongering. World J Gastroenterol. 2017; 23(47):8277–82. Wolinsky H. Disease mongering and drug marketing: Does the pharmaceutical industry manufacture diseases as well as drugs? EMBO Reports 2005; 6(7):612–14. https://​doi​.org/​10​.1038/​sj​ .embor​.7400476

Giulia Gallo

16. Moral hazard in health insurance

of the total healthcare spending, and the remaining is paid by the insurer. Finally, once the individual has spent a maximum amount out of pocket, there is a “catastrophic coverage”, in which there is no cost-sharing and the insurance covers everything. Adverse selection and moral hazard often happen together in health insurance contracts and have a big impact on health insurance markets. In adverse selection, the asymmetric information (when one party in a contract has more information than the other, giving the margin of taking advantage) is about the type of individuals that are attracted to a certain health insurance plan, causing a bias before entering a contract. In moral hazard, the asymmetrical information is about the behavior of individuals that are entering a health insurance plan, causing a bias after entering a contract (Hodgson, 2020). Adverse selection is seen in health insurance contracts when sick people are more likely to choose low co-pay insurance and healthy people are more likely to choose high co-pay insurance (cheaper premium). The fact that healthy people choose the high co-pay implies that the health insurance provider will incur fewer expenditures, making it even cheaper than if people choose at random. The opposite is true for ill people who choose the low co-pay plan since it is more expensive to cover them because they require more healthcare. As a result, the firm must raise the insurance premium, making it even more expensive if people choose randomly between the two plans. What happens in moral hazard is that the co-pay has an incentive impact on people’s healthcare behavior, which influences the pricing of insurance plans. Individuals with high co-pay insurance plans will use healthcare more sparingly, lowering their insurance premiums. Individuals with low co-pay insurance plans will use healthcare more recklessly, impacting the price (increasing the cost of insurance premiums) or lowering the quality of care supplied (Hodgson, 2020). A solution to a moral hazard could be a decrease in the asymmetric information or to modify/decrease the incentive to exploit that asymmetric information. As an attempt to decrease the asymmetric information between health insurance companies and individuals, a health inspection on consumers will help insurers to have a better sense of the consumer’s estimated health

Moral hazard is an extremely important concept, and it is among the hot topics in the health insurance industry. Moral hazard, by definition, can happen when two parties come into agreement with one another and it is the risk that a party has not entered a contract in good faith or has provided misleading information about its assets, liabilities, or credit capacity (Kenton, 2020). It may also mean that a party has an incentive to take unusual risks in a desperate attempt to earn a profit before the contract settles (Kenton, 2020). In health insurance settings, there are two ways in which we can appreciate moral hazards. The first, called the “ex ante moral hazard”, is that individuals that have an insurance plan tend to become less careful towards their health because health insurance covers the financial costs that would be caused by poor health behaviors. This is not of such focus in literature because the increased financial cost is not the only one nor the most important one when one becomes ill (Einav & Finkelstein, 2018). The second, called “ex post moral hazard”, is the concept that people that have a generous insurance health contract have an incentive to use more resources than otherwise would have been used because the insurance company bears the cost; so, in this case, the consumer responds to the demand for healthcare depending on the amount they have to pay for it (out-of-pocket price) (Einav & Finkelstein, 2018). In addition, when individuals have different insurance plan options, those that need more care (individuals with chronic diseases, for example) will tend to choose more generous plans. In economics, the moral hazard idea is of major relevance since it poses a barrier to insurance’s consumption smoothing goal. Moral hazard is also an example of asymmetric information leading to a market failure. When talking about a typical health insurance contract, individuals initially pay a deductible, which is the amount paid for covered healthcare services before the insurance plan starts to pay. After the deductible is exhausted, the individual has the customer cost-sharing (or co-insurance/co-pay), in which the individual pays only a percentage 44

Moral hazard in health insurance  45

cost. The problem with this approach is that diagnostic tests done on inspection could expose too much information on an individual’s health, making insurance companies present a bill rather than avert an unexpected healthcare cost to the consumer, rendering health insurance no longer viable (Marginal Revolution University, 2015). Group health insurance via employers is another solution for this problem and it is widely utilized in the United States. In this case, the employer (which has the same low level of information as the insurers about its employees’ health) purchases insurance as part of a group plan for all its employees (which have various health states) decreasing the adverse selection problem. This strategy, however, has significant problems, such as a lack of health insurance for those who lose their jobs or retirees. To address this issue, various laws were introduced in the United States to make health insurance more affordable, resulting in these individuals being insured by the government, such as Medicare (for those over 65 years old or under 65 years old with a disability) or Medicaid (state and federal program that provides health coverage for very low-income individuals). The Affordable Care Act (ACA or Obamacare), is a law signed in 2010 that expanded Medicaid, created health insurance exchanges, and included health-related provisions. Under the ACA, health insurance was designed to be affordable and aimed to give those with lower incomes premium tax credits and cost-sharing reductions (Sean, 2021). In the ACA, all individuals are supposed to purchase health insurance (the ones that do not are fined by law). The idea is to force the healthy individuals into the pool of those who buy the insurance and that will moderate the cost of health insurance, avoiding the death spiral (a condition where the structure of insurance plans leads to premiums rapidly increasing because of changes in the covered population) (Marginal Revolution University, 2015). However, there are some controversial ideas that the act inflated the moral hazard

already present in the health insurance industry. Some of the basic provisions outlined in the law were: insurers can no longer deny coverage to those with pre-existing conditions, large employers are required to offer employee health coverage, all plans must cover the ten essential benefits of health insurance, banned annual and lifetime limits on employer plans, and plans are only affordable if the cost is less than 9.5% of family income (Sean, 2021). As Sean described “Restricting costs, mandating employer coverage, and requiring minimum benefits further drive a wedge between the consumer and the real cost of healthcare. Since the ACA, premiums spiked which is consistent with the economic theory about moral hazard” (Sean, 2021). This highlights that, while the adverse selection and moral hazard model is simple, there are many complex applications to health insurance problems, and alternative solutions frequently have many limitations in addressing the moral hazard that exists in the health insurance industry (Marginal Revolution University, 2015). Ana Paula Fontoura Andrade Reis

References

Einav, L., & Finkelstein, A. (2018). Moral hazard in health insurance: what we know and how we know it. Journal of the European Economic Association, 957‒982. Hodgson, A. (2020, May 2). Adverse Selection vs Moral Hazard. Retrieved from YouTube: https://​www​.youtube​.com/​watch​?v​=​ Nm0wV0CenWY​&​t​=​483s Kenton, W. (2020, July 23). Moral Hazard. Retrieved from Investopedia: https://​ www​ .investopedia​.com/​terms/​m/​moralhazard​.asp Marginal Revolution University. (2015, September 23). Asymmetric Information and Health Insurance. Retrieved from YouTube: https://​ www​.youtube​.com/​watch​?v​=​pUkRo9COd38 Sean, R. (2021, July 13). The Affordable Care Act Affects Moral Hazard in the Health Insurance Industry. Retrieved from Investopedia: https://​ www​.investopedia​.com/​ask/​answers/​043015/​ how​-does​-affordable​-care​-act​-affect​-moral​ -hazard​-health​-insurance​-industry​.asp

Ana Paula Fontoura Andrade Reis

17. Quasi-markets

and their choices. In this way an internal market is created, where “internal” refers to the circumstance that both the buyer and the seller are NHS organizations. As the reform progressed, NHS purchasers were allowed to purchase care from private providers. For this very reason some commentators preferred to use, as a label, the term quasi-markets instead of internal/planned markets. Notwithstanding the initial opposition of different actors in the system, professionals included, who feared a “marketization” and “privatization” of the NHS, by the end of the nineties a general consensus had developed that the essential features of the reform were worth keeping, notably the split between purchasing and providing. As long as the changes were implemented it had become more and more evident that the “internal market” was not a “real market” and could never be. In many geographical areas and service segments a competition between different providers did not exist and, even if it potentially existed, purchasing agencies did not exploit their market power tending to establish relationships based on collaboration more than threat. The fundamental concepts at the basis of the quasi-market approach – purchaser– provider separation, contractual relationships and promotion of competition – rapidly diffused in a large group of European countries influencing several reforms of healthcare systems. This was the case of the Italian system that in 1993 underwent a radical reform largely inspired by a quasi-market conceptual framework. Under the reform to local health units (LHUs), public entities funded by Regions on a per capita base, were given the dual function to produce and buy from independent public hospitals, private accredited providers and other LHUs all the services needed by their population. Given the freedom enjoyed by patients in choice of providers, the system was intended to enhance clinical quality and economic efficiency through competition. From a managerial point of view, contractual arrangements in terms of transaction objects and contract typologies, with subsequent nature and allocation of risks, represent a critical issue. Notwithstanding the impressive refinement over recent decades in the field of measurement tools and pricing mechanisms (e.g. prospective payments systems), health-

At the beginning of the 1980s, in many countries the main concerns about Welfare State (WS) schemes and arrangements started to change, moving from equity and social justice to efficiency and consumer choice. Quasi-markets (internal markets and planned markets are to be considered as equivalent expressions in the healthcare case) were one of the principal means used to reform the delivery of welfare in order to achieve those results. The general idea was to preserve the founding principles of WS, modifying its ways of functioning through the introduction of market stimuli. On the supply side monopolistic providers were to be replaced by competitive independent ones, even if services suppliers would have preferably been public or not-for-profit organizations as opposed to classical for-profit market actors. On the demand side the consumer purchase power would not be expressed in money terms. Consumer choices would be financially supported through earmarked funds managed by purchasing agencies or through vouchers confined to specific services directly allocated to users. In other cases the consumers would be represented in the market by agents, such as GPs or case managers, instead of operating by themselves. In the late eighties and early nineties this approach found a concrete application in the healthcare sector shaping the reform of one of the symbols of the WS itself: the British National Health Service (NHS). At the basis of the reform was the White Paper Working for Patients whose declared aims were to improve value for money, to reward efficient and higher quality providers and to encourage greater responsiveness of services to patients, while maintaining the basic principle of “equity of access for equal need”. In order to achieve the desired results the NHS was reorganized separating, inside the same system, the purchaser and provider functions. Purchasers (health authorities or HAs) would buy services from providers of acute or community health services (renamed NHS trusts) through a contract on behalf of their resident population. The HAs would receive budgets from central government on the basis of a weighted capitation formula. Under the scheme providers should compete for business since the “money follows the patients” 46

Quasi-markets  47

care remains plagued by the problems of “incomplete contracts”, that is the difficulty to fully specify contractual obligations for the provision of services. It is still relatively easy for providers to “game” the system lowering the requested quality or selecting the easiest or more lucrative cases (cream-skimming). On this basis the possibility of obtaining the desired service improvements through the private provision of public services is often questioned. Different contract typologies make technically possible diverse allocation of risks between purchasers and providers, generating different sets of incentives. Block contracts (fixed budgets), cost–volume schemes, fee for service differently allocate volume risks while tariffs or negotiated prices draw different scenarios for the allocation of cost risks. However, in the real world, the actual allocation of financial risks (incentives) is often handled differently from the stipulation of formal contractual provision. In the case of public providers, if some deficit occurs, it is almost always the purchaser, being part of the same administration, that, ex post, must cover the financial gap. In the case of private providers, especially large private hospitals, they are very often “too big to fail”, too important for the system to be left entirely exposed to market mechanisms and their incentives. Quasi-market has been an important component of a wider transformation that has changed the conceptualization and the func-

tioning of many public healthcare systems. Now most of its approaches and tools have been incorporated in the basic physiology of systems. Yet it must be underlined that market logics and mechanisms can represent only a part of the overall rationality governing public systems and organizations. In this perspective managers shouldn’t be misled by languages and concepts that when used in the domain of public systems assume a meaning different from the “private market environment” from which they have originated. Mario del Vecchio

Bibliography

Allen, P., & Petsoulas, C. (2016) Pricing in the English NHS quasi market: a national study of the allocation of financial risk through contracts, Public Money & Management, 36:5, 341‒348, DOI: 10.1080/09540962.2016.1194080 Dan, S., & Andrews, R. (2016) Market-type mechanisms and public service equity: a review of experiences in European public services. Public Organiz Rev, 16, 301–317. https://​doi​.org/​10​ .1007/​s11115​-015​-0310​-6 Le Grand, J., & Bartlett, W. (1993) The theory of quasi-markets, in J. Le Grand & Bartlett, W. (eds) Quasi-Markets and Social Policy. London: Macmillan. Pollitt, C., & Bouckaert, G. (2011) Public Management Reform: A Comparative Analysis – New Public Management, Governance, and the Neo-Weberian State. Oxford: Oxford University Press.

Mario del Vecchio

18. Supplier-induced demand

trust, knowledge, regard, and loyalty. Ideally, the doctor acts as an agent on behalf of the patient to recommend the best treatment possible. The patient considers the doctor to know best about their medical condition, and holds them in high regard, and as such, would completely trust their recommendation about any possible test or treatment suggested. The method and tone in which a doctor conveys test results or diagnoses can sway the medical decision, with little ability for patients to defy this decision considering their health situation. For this reason, if doctors were to act in a non-ethical manner, they can influence the patients into taking more tests and drugs, than might be needed, and possibly undergo a surgical procedure which is not beneficial or otherwise has a non-surgical alternative. This is especially prevalent in societies where doctors are paid in a fee-for-service manner, where doctors over-prescribe for their own financial gain. On the opposite end of the information asymmetry, there are cases in which patients are making use of the available medical information found readily on the internet in order to self-diagnose. This behavior leads them to pressurize their doctors into over-prescribing treatments that otherwise would not have been recommended. This phenomenon is referred to as patient-induced demand. Another reason for the occurrence of SID is clinical uncertainty, and the lack of proper guidelines that deal with the best practice when dealing with chronic diseases, especially in the first stages. The difference in the individual practices and professional opinions between different doctors about the reliability of available diagnostic tests and the effectiveness of various treatments leads to a lack of uniformity in care. Moreover, the guidelines do not fully cover when to admit patients in their early stages of certain chronic diseases. In these cases, doctors might admit patients too early, in a precautionary manner, and overprescribe tests and treatments to ensure the best possible outcome for their patients. For this reason, it is observed that the increase in number of available hospital beds is correlated with an increase in their utilization, especially for medical, non-surgical, patients. If this demand influence by doctors on patients is too widespread, it can have a lot of detrimental economic effects on the healthcare system. It can also cause a disruption in

In health economics, the term supplier-induced demand (SID) is defined as the demand that occurs in excess of what would have occurred if the patients were fully informed. It implies that physicians recommend tests or procedures that are not necessary for the diagnosis or treatment of the patients’ ailments. This notion is peculiar in economic terms when compared to the rules that supply and demand follow outside the health sector, where increased supply or decreased demand require a drop in prices. In healthcare, the quantity supplied is always equal to the quantity demanded at the predetermined prices. This observation was first described by what is known as Roemer’s law. Roemer’s law, simply put, states that “in an insured population, a hospital bed built is a filled bed.” Milton Roemer was an American health services researcher who made the correlation between the availability of hospital beds and their use. This law was further confirmed by Enoch Powell, a British health minister, who proposed a similar rule which he called the “Parkinson’s law” that stated that “the number of patients always tends to equality with the number of beds available for them to lie in.” This observation has long been a subject of controversy, and experts claim that it cannot be scientifically proven because it cannot be measured. Nonetheless, it has had an integral role in shaping health policies in many countries, most notable of which is the “Certificate of Need” policy in the US which states that any healthcare institution must acquire approval before expanding or building any new facility. This policy, along with others, was passed for the goal of controlling healthcare costs by avoiding SID. SID refers mainly to the idea that doctors can manipulate their patients’ demand for medical services in order to create additional demand for these services. This manipulation can be anything from over-prescribing diagnostic tests and drugs to performing unnecessary surgical procedures. This manipulation would not be possible if not for the presence of the information asymmetry between doctor and patient which is inherent in the doctor– patient relationship. The doctor–patient relationship is composed of four main elements: 48

Supplier-induced demand  49

the doctor–patient relationship, eliminating the trust between them, which could be dangerous for the health of the individuals. Another type of SID occurring in the healthcare system is the prevalence of advertisement for over-the-counter drugs and dietary supplements under false pretenses. As such, patients would self-diagnose and proceed to self-medicate using these drugs leading to ineffective treatments and delayed proper diagnoses and treatments, which eventually leads to higher healthcare costs. While SID is mostly caused by doctors acting out of self-interest in order to promote their financial income, there are cases where it occurs due to doctors’ attempts to promote the well-being of their patients. So, while it is commonly regarded negatively, it might result in positive outcomes, in cases where patients are subject to more expensive, yet vital and beneficial, treatments that they might not have opted for without their doctors’ recommendation. Even though SID doesn’t contribute to a large fraction of the increasing healthcare costs, many studies discuss the possible solutions to minimize this phenomenon. Among the most prominent solutions which was proven in a study to minimize healthcare costs and the number of radical procedures performed was the “shared decision-making” method. This method is based on giving the patient all the needed information on the possible treatment options and allowing the patient to be involved in choosing the appropriate treatment. This solution works in a two-fold manner. It allows the patient to take control of decisions concerning their health and well-being, and it decreases the information asymmetry between doctor and patient. Another solution proposed and proved to be efficient was implementing a price transparency policy within healthcare institutions. This allows patients to be more

informed of the prices and alternatives found and serves as a deterrent for doctors from over-prescribing. In conclusion, it is verifiable to note the presence of SID and implement the necessary measures to reduce it thus reducing its economic healthcare impact. Studies reveal that reducing the information asymmetry between doctors and patients is the best way to ensure best practice and that patients are receiving the best and necessary treatment. Ghina el Nounou

Bibliography

Bickerdyke, I., Dolamore, R., Monday, I., & Preston, R. (2002). Supplier-induced demand for medical services, Productivity Commission Staff Working Paper, Canberra, November. Chipidza, F.E., Wallwork, R.S., & Stern, T.A. (2015). Impact of the doctor–patient relationship. The Primary Care Companion for CNS Disorders, 17(5). Donaldson, C. & Gerard, K. (1993). Economics of Health Care Financing: The Visible Hand (pp.116‒117). New York: St. Martin’s Press. Mohamadloo, A., Zarein-Dolab, S., Ramezankhani, A., & Jamshid, J. (2019). The main factors of induced demand for medicine prescription: a qualitative study. Iranian Journal of Pharmaceutical Research, 18(1), 479–487. Powell, E. (1966). A New Look at Medicine and Politics. London: Pitman. Schommer J.C., Singh, R.L., & Hansen, R.A. Distinguishing characteristics of patients who seek more information or request a prescription in response to direct-to-consumer advertisements. Research in Social and Administrative Pharmacy, 1(2), 231‒250. Shain, M. & Roemer, M.I. (April 1959). Hospital costs relate to the supply of beds. Modern Hospital, 92(4), 71–73. Wennberg, J., Barnes, B., & Zubkoff, M. (1982). Professional uncertainty and the problem of supplier-induced demand. Social Science and Medicine, 16(7), 811–824.

Ghina el Nounou

PART V FUNDING The financing of health systems is increasingly moving towards models that, in addition to reporting individual services and financing health services based on outcomes, finance the entire patient care cycle. This cluster groups together all the general financing mechanisms that are applied in healthcare systems, both in terms of remuneration for healthcare services and in terms of financial instruments that are used to implement projects within healthcare organizations.

50

19. Payment mechanisms

1.

Per capita

2.

Adjusted per capita

It consists in a physicians’ or healthcare providers’ payment method with an amount of money fixed before service’s delivery in order to provide agreed services for each registered individual over a fixed period. Thus, capitation is paid ex ante of the coverage period to a healthcare entity in consideration of its providing or arranging to provide. Capitation is a population-based payment and is a prospective method. The actual cost may be higher or lower than the per capita rate. Capitation payments enable a stronger control on the volume and price of services, particularly on costs. However, they may encourage under-provision or poorer quality care than is optimal for patients if the rates are too low. In any form, capitation payments are characterized by the following elements: (i) payment is referred to a defined group of patients, (ii) care is paid ex ante with a predetermined rate; and (iii) the financial risk is owned by the recipient of the per capita payments. It is a mode of payment for GPs in several countries.

In the healthcare sector, discussions on accessibility, quality of care and efficiency improvement and costs reduction have been focused on providers’ payment methods for decades. Payment mechanisms represent the way a government, insurance company, or other fundholder distributes funds to a healthcare provider or physician. They can be defined as a type of contract among two or more players – providers, patients, and payers – that incentivizes healthcare services provision, minimizing the risk of opportunistic behaviors. Considering that any contact between a physician and a patient is characterized by asymmetric information, physicians are considered agents for patients, thus an important question is whether they take decisions on what the best for patients is, or whether they behave as rational economic agents trying to maximize their profit. The payment mechanism influences and impacts costs constraints, the number of patients’ accesses, hospitalizations, quality of care and consequently health outcomes. Considering that providing the most cost-effective healthcare services obtained an increasing interest during the recent years, healthcare managers should guide the transition to efficient and effective payment mechanisms. Payment mechanisms can be prospective or retrospective. In prospective payments, the provider’s budgets are determined ex ante and they are not based on the provider’s actual costs. The payment rate for a package of healthcare services is negotiated and agreed before service provision. Prospectively set payment rates include case-based and per capita-based payments and increase efficiency because of the health provider’s higher financial risk. In retrospective payments, the provider’s costs are fully or partially paid after service occurs and the payment rate is set during or after the service has been performed. It is more cost enhancing than cost reducing. Fee-for-service is an example of retrospective reimbursement. Accordingly, payment mechanisms are summarized as follows.

Per capita payments are sometimes differentiated according to age or sex of patients. For example, in preventive and primary care, different forms of capitation are applied and typically adjusted to the main socio-economic and morbidity indicators to encourage efficiency and/or promote equity. Other capitation types are based on factors such as the entity accepting the capitation payment and how the capitated entity financially relates to the entity providing care. Area Capitation. It is a fixed per capita rate for providing care to a specified geographic area patient. For example, an insurer or intermediary that pays a fixed rate per person to provide care for all the enrolled residents of a state, region, or province. Usually, it is based on the region’s specific healthcare needs and burden of disease. Direct Capitation. Healthcare providers are directly paid, and their healthcare expenditures are determined ex ante, and the per capita fee is constant with respect to disease diagnosis. For example, for renal disorders, there is a prospective flat payment per patient per month to provide services and the provider becomes responsible both for 51

52  Elgar encyclopedia of healthcare management

the patient’s direct dialysis expenses and for a prespecified set of dialysis complications requiring additional care. The “Gatekeeper” Capitation Strategy. It involves an area-wide capitation with a “gatekeeper strategy” adopting a triage role in addition to the financial role of the fund holder. The gatekeeper directs the patient to an appropriate specialist according to the patient’s needs (e.g., to oncologists for cancer cases). These specialists (direct providers) are paid on an “average case” that is like a DRG schedule. The insurer adopts a medical and fiscal role, and it is not a direct provider of healthcare, covering a smaller individual area than for area capitation (because of the triage role).

3.

Case-based payments

Providers are paid with a fixed amount of money per case for each diagnosis, admission, or discharge. In most cases it is based on a schedule of payment by diagnosis, often on so-called diagnosis related groups. It can be based on a single flat rate per case. These new payment systems are likely to favor controls, increase efficiency, and improve quality of care. Diagnosis Related Groupings (DRG). This is a case-based payment where healthcare providers are paid on the type of disease or case treated with an agreed fee that is determined ex ante regardless of the actual costs. The system of diagnosis-based payments requires some steps widely identified in literature: (i) developing a diagnosis classification system based on the homogeneity of the resource used and clinical characteristics (e.g., principal diagnosis, secondary diagnosis); (ii) determining the relative weights of the group; (iii) determining the level of payment per relative unit; and (iv) establishing adjustments to the payment rate. Besides the principal diagnosis, DRGs consider concomitant diseases and complications, the type of treatment, and the age of the patient. The diagnosis is the prospective element of payment, while the type of treatment and the actual costs constitute a retrospective component. In addition, very expensive cases (“outliers”) are reimbursed separately by the payer, which further reduces the prospective character of DRG-based payment. Many scholars claim that case-based payments need a substantial and complex IT system which Martina Pisarra

requires that insurance agencies have the capacity to exercise a strong purchaser role. DRG payments focus on a technical efficiency to make better use of available resources, but they also encourage hospitals to increase the number of patients. DRG payments are used for hospital inpatient cases in many countries.

4.

Fee for service (FFS)

5.

Per diem

It is a payment method based on an agreed fee specifying what is payable for each item of the supplied service. The FFS system requires medical (diagnostic and therapeutic) activities separately identified since the amount of money reimbursed of each item is determined ex ante. It is an activity-based payment method where providers are reimbursed for each individual service provided. Not on the list activities are not paid. Providers increase their returns by producing more services, so access of care is guaranteed as is provision of quality of care. FFS typically incentivize providers to increase their clinical activity, so possible negative consequences are connected to the over-production of care, that is, care which does not deliver any significant marginal health benefits, the “supplier induced demands” phenomenon, due to providers’ information power. Prices are prospectively determined for each service, for example diagnosis, drugs, and so on, and are paid after the service. It is a predominant mode of payment for GPs and for outpatient specialist services. They represent daily payments to hospitals for inpatients admissions. Specifically, healthcare providers are paid a fixed amount of money for given services per day. They give a strong incentive to extend the length of stay and increase the number of admissions, enhancing health expenditure (e.g., in Germany). Therefore, the OECD countries are gradually moving away from this payment method, for example Norway abandoned them in the 1980s because of the increasing length of stay.

6. Budget

Budgets are predetermined fixed amounts of money (prospective payments) allocated to

Payment mechanisms  53

providers for a certain period. The amount is usually based on previous levels and adjusted by an inflation factor. It usually determines the framework for the following introduction of other provider payment methods. Budgets are of two types: (i) budgets for the whole healthcare sector (global budget), and (ii) budgets for parts of it (line – item budget) such as for ambulatory care, hospital care, pharmaceuticals and so on. Global budgets. There is total flexibility on how and what to spend of the amount of money to deliver an agreed-upon set of services. Line – item budget. Providers receive an amount of money to spend on specific itemized services. The budget is not flexible, and the expenditure must follow line items, unless with prior authorization from the authorities. Cost containment can be achieved and depends on the type of budget and its rigidity. Providers are fully responsible for all profits and losses under hard budgets, while with soft budgets there is a fixed amount of spending without penalty in case of excess expenditure. The hard type is more effective for cost-containment but can reduce access and quality of services. The risk of excess of spending in a soft budget is large. The disadvantage of budgets is that they do not provide incentives to ensure quality of care and can encourage the under-provision of healthcare services. Consistently, they control total costs, but may lead to access problems and waiting times. They usually represent a payment for public hospitals in several countries. Healthcare organizations are moving to new payment mechanisms that already took place in few countries to ensure value-based payments.

7.

Pay for performace, pay for outcomes or pay by results

In pay for performance (P4P), healthcare providers are paid through explicit financial incentives based on specific performance indicators that may refer to resource use, clinical quality, and patient-reported outcomes. Consistently, the reimbursement of healthcare providers explicitly depends on meeting predefined quality targets based on process and structure indicators. P4P became a popular

approach to increase efficiency in healthcare. In the United States P4P has become widespread, but P4P programs are being implemented in many other countries, including in the United Kingdom, Israel, Canada, Taiwan, New Zealand, and Germany. In P4P models, “outcome indicators” typically contribute less than 10% to the performance-related incentive payments. Systematic reviews suggest positive impacts of P4P programs on healthcare organizations’ performance, however evidence on wider impacts of P4P on cost savings and health outcomes are inconclusive. Pay for outcomes. An outcome-based payment model is a payment model in which the performance-related incentive payments for the healthcare providers depend for at least 10% on outcomes of the provided care, and it is designed to ensure favorable effects in terms of quality of care or healthcare costs. Payments by results (PBR) is a form of reimbursement where payments depend on an independent verification of results. They are a new type of partnership between governments, investors, and service providers engaging them through complex outcome-based financial agreements.

8.

Bundled payments

The bundled payments are a recent payment method that covers the full cost of the entire care cycle for treating a patient for a clinical condition or over time for chronic conditions or primary care. The aim of care should be defined from the patient’s perspective, achieving the outcomes that matter to patients. Care should include all needed services, including managing comorbidities and related complications. A bundled payment method combines the payments for physicians, hospitals, and other healthcare services into a single amount. In preventive and primary care, they should include all the needed care for each defined patient segment. Important outcomes to meet include maintaining or going back to normal functions, reducing pain, and avoiding or reducing complications. The complexity, outcomes, and cost of treating a particular condition are affected by differences in patients’ age and health status, as well as their social and living conditions. These risk factors should be included in the payment and in outcomes’ expectations to reward providers for taking Martina Pisarra

54  Elgar encyclopedia of healthcare management

on hard cases. In addition to the full costs of the needed care, bundle payments should cover a margin for providers that use effective and efficient clinical and administrative processes. It should not cover unnecessary services or inefficient care. Bundle payments are one of the six pillars to implement Value Based Healthcare. Martina Pisarra

Bibliography

Barber SL, Lorenzoni L, Ong P. Price Setting and Price Regulation in Health Care: Lessons for Advancing Universal Health Coverage. Geneva: World Health Organization, Organisation for Economic Co-operation and Development. 2019. Boachie MK. Healthcare provider-payment mechanisms: a review of literature. J Behav Econ Financ Entrep Account Transp. 2014; 2(2):41–6. Kazungu JS, Barasa EW, Obadha M, Chuma J. What characteristics of provider payment mechanisms influence healthcare providers’

Martina Pisarra

behaviour? A literature review. Int J Health Plann Manage. 2018 Oct 8; 33(4):e892–905. Maceira, D. Provider payment mechanisms in healthcare: incentives, outcomes, and organizational impact in developing countries. Major Applied Research 2, Working Paper 2. Bethesda, MD: Partnerships for Health Reform Project, Abt Associates Inc. 1998. OECD. Better Ways to Pay for Healthcare. OECD Health Policy Studies. Paris: OECD Publishing. 2016. Porter ME, Kaplan RS. How to pay for healthcare. Harvard Business Review. 2016 Jul–Aug; 88‒100. Rizzello A, Caridà R, Trotta A, Ferraro G, Carè R. The use of payment by results in healthcare: a review and proposal. In: La Torre M (ed.), Social Impact Investing Beyond the SIB. Cham: Springer International Publishing. 2018; pp. 69–113. Vlaanderen FP, Tanke MA, Bloem BR, Faber MJ, Eijkenaar F, Schut FT et al. Design and effects of outcome-based payment models in healthcare: a systematic review. Eur J Heal Econ. 2019 Mar 5; 20(2):217–32. Wyszewianski L, Thomas JW, Friedman BA. Case-based payment and the control of quality and efficiency in hospitals. Inquiry. 1987; 24(1):17–25.

20. Sources of funding

ence and budget negotiation. As well as in the general taxation case, resources may be distributed to healthcare providers according to different criteria (capitation, activity-based methods, incremental criteria, budgets).

The provision of health services and products is aimed at addressing population and individual care needs. As in every economic activity, production and provision processes requires investments in assets and production factors. To do these investments, health systems need to collect an adequate level of financial resources. These resources may be coming from different sources of funding depending on the architecture and governance of the health system. The two macro-categories of sources available are public expenditure and private sources. Public sources comprise general taxation and earmarked tax and social health insurance. Private sources comprise private (compulsory and voluntary) health insurance, donations and out-of-pocket spending.

1.

Social health insurance

4.

Private health insurance

Social health insurance, also referred to as the Bismarck model, is a source of funding in which people pay a fee to a fund that in turn pays for healthcare activities delivered by a wide set of providers. Usually, in countries adopting this form of funding, working people (entrepreneurs, employees, self-employed, etc.) are obliged by law to pay contributions that cover a package of services available to the insured, their dependents and the population. It is a form of financing and managing healthcare based on risk pooling. On the one hand, social health insurance pools the health risks of the population; on other hand, it pools the contributions of individuals, households, enterprises, and the government. Thus, it protects people against financial and health burdens and is a relatively fair method of financing healthcare. In health systems based on social health insurance, healthcare providers are usually paid by the health authority through activity-based methods.

General taxation

General taxation finances health in Beveridge-like systems. In such cases, the government collects income and other taxes from individuals and organizations operating in the national territory. Then, based on the political preferences, a share of these financial resources is devoted to funding the health system and its services. These resources may be then distributed to healthcare providers or health sub-systems based on different criteria among which we may find capitation (i.e. the population living in a specific geographic area and its epidemiological characteristics), activity-based methods (e.g. tariffs, fee-for-service, per diem), incremental criteria (pay-per-performance) and budgets.

2.

3.

Private health insurance comprises two types of funding, compulsory prepayments and voluntary ones. In countries adopting this source of funding, compulsory prepayment is mandatory for citizens or specific population targets to purchase an insurance policy from a health insurance company. Voluntary prepayments are based on the choice of single individuals, families or employers to purchase health insurance. This is a solution often used so as to cover for the need for particular treatment not included in the government’s medical service baskets (e.g. dental services). Providers are paid by the insurance based on the tariffs or the prices of the goods or services delivered.

Earmarked taxation

Earmarked taxation differs from general taxation since those who contribute to public expenses (i.e. taxpayers) know the destination (in terms of public expenditure chapter) of their funding. In other words, earmarking involves separating all, or a portion, of the total revenues from taxes and setting it aside for a designated purpose – for example, health. Differently from general taxation, earmarking ensure that taxes collected will be devoted to the health system and protect these financial resources from political influ-

5. Donations

Donations include those voluntary contributions from the general public, governments (budget of the national government or foreign 55

56  Elgar encyclopedia of healthcare management

aid) or corporations which finance health programs and activities and investments.

6. Out-of-pocket

Out-of-pocket is a direct payment for healthcare goods and services from the household primary income or savings. It is a source of funding in every health system and in lower-income countries is usually the main one. The out-of-pocket payment may cover the whole value of the good/ service purchased, or it may have the form of a co-payment – that is, when the cost is shared with a government or an insurance scheme. When the cost is shared with a government scheme, out-of-pocket may be used to co-finance a specific set of health goods or services and/or to limit non-appropriate delivery of care. The above-reported taxonomy comprises the general sources of funding that are adopted by health systems and declined and implemented according to their specific characteristics (governance structure, population distribution and epidemiology, volume of activities per setting of care, etc.). As previously reported, although every system tends to adopt a model based on one main source of funding, the majority of health systems combine different sources to finance the healthcare delivery. For example, in Germany, which adopts a Bismarck-based system, social health insurance accounts for 78% of the total health expenditure, 11% is the share of out-of-pocket, and 6% comes from government schemes (collected from taxes). The United Kingdom health system, which is based on the Beveridge model, is financed by 79% through general taxation, 16% of out-of-pocket and 3% by voluntary health insurance (OECD, 2019).

Guido Noto

Decisions of which source of funding should be used (and in which percentage) is undertaken at the political level and depends on the health system model adopted. However, they have important implications for the management of health systems and healthcare providers. Each source tends indeed to determine pros and cons and the health managers’ work is to leverage on the first and limit the second. For example, the Italian National Health Service adopts a Beveridge-like model based on general taxation. This model which is acknowledged for providing a high level of access, coverage and equity usually tends to determine a long waiting time for care delivery if compared to other models (e.g. the social health insurance one). This happens also in Italy. As such, Italian managers and policy-makers are devoting much effort to reducing waiting times through the extensive use of performance targets and indicators often linked to organizational reward systems. Guido Noto

Bibliography

Cashin, C., Sparkes, S., & Bloom, D. (2017). Earmarking for health: from theory to practice. Geneva: World Health Organization. Doetinchem, O. (2010). Hypothecation of tax revenue for health. World Health Report (2010) Background Paper, No 51. Geneva: World Health Organization. OECD (2019). Health at a Glance 2019: OECD Indicators. Paris: OECD Publishing. OECD, Eurostat, & World Health Organization (2017). A System of Health Accounts 2011: Revised Edition. Paris: OECD Publishing. WHO (2003). Social health insurance. Report of a Regional Expert Group Meeting. New Delhi: World Health Organization.

21. Tariff vs price

the services they receive (excluding some co-payment cases) and tariffs are used for regulating transactions between providers and health authorities or insurance companies. In these cases, providers may seek for a margin by improving their efficiency and reducing production and provision costs. In private healthcare systems (or in private purchases of health services), providers usually apply prices that are paid directly by users or by insurance companies. In this case, providers have an additional lever to seek for profit margin which is the price setting. If prices are usually fixed with the goals of producing an adequate remuneration of the invested capital, tariff setting also considers other social factors as their levels necessarily impact on the behaviour of agents involved in the service production and on the use of the services by the population. Thus, tariff policies can be applied to promote value for health spending and to reduce non-desirable behaviours such as inappropriate care delivery or opportunistic behaviours from providers. Tariff levels may indeed disincentivize the use of a treatment or a product and promote the use of a suitable alternative leading towards increased efficiency or better outcomes at the health system level. As such, when designing a tariff system, health authorities and policy makers should take into account what effects this may have on the users’ and providers’ behaviour. The adoption of prices and/or tariffs and their levels depends on various factors, for example the financing system (Beveridge, Bismarck, etc.); the kind of service (primary care service, inpatient, outpatient, long-term care service, etc.); the kind of provider delivering the service (public, private non-profit, private for-profit, etc.). For example, in the Italian National Health Service, which is a Beveridge-like system, the DRG tariffs are used by the Local Health Authorities to remunerate both public and private health providers delivering public health services to the resident population. These tariffs are defined at the national level and then adapted by every regional health system in order to account for their peculiarities and to support their health policies. Healthcare managers at every level need to gain full awareness about the price/tariff system in use. Their choices in terms of prices/tariffs are indeed key to achieve a dual aim: (i) achieving the financial sustainability

Nowadays people know the price of everything and the value of nothing. (O. Wilde)

Price and tariff are often used as synonymous though they express conceptually different meanings. Both are used to remunerate health providers for the goods and services delivered to their users. Generally speaking, the price corresponds to the monetary value of an item. For example, in the case of the delivery of a specific treatment, a price takes into account the cost of production factors (pharmaceuticals, medical devices, cost of labour, amortization of infrastructures, etc.) and, eventually, a markup required by the provider and determined on the basis of multiple factors such as the market power of the facility, the price applied by other competitors, the desired profit margin, and so on. As such, prices are determined and strictly linked to the activities performed. The tariff is an imposed amount of money that does not necessarily represent the value of the item. While for most services and goods it is easy – and thus a common practice – to negotiate the price for every single purchase, for some healthcare services and governance settings, this would be overcomplicated or not necessary. For instance, in a regulated healthcare market, services are usually exchanged on the basis of a tariff established at a higher government level. This tariff, although taking into account the complexity of the service provided, is not necessarily accounting for all of the production factors used to deliver the service and does not (usually) include any markup based on reference market characteristics. Tariff levels can be determined based on different criteria such as activities performed, incremental basis, population served and budgets. While prices are conceptually negotiated for each transaction, tariffs are usually updated less frequently to take into account macro changes in the variables determining the cost of the service – such as the introduction of new technology for delivering a specific treatment, significant changes in the cost of certain production factors, etc. Tariffs are usually adopted in regulated healthcare systems. In these kinds of systems, users are not asked for a direct payment for 57

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of their entity, (ii) creating population value through the effects on the agents’ behaviours. Guido Noto

Bibliography

Barber, S.L., Lorenzoni, L., & Ong, P. (2019). Price setting and price regulation in health

Guido Noto

care: lessons for advancing Universal Health Coverage. Geneva: WHO. Fattore, G., & Torbica, A. (2006). Inpatient reimbursement system in Italy: how do tariffs relate to costs? Health Care Management Science, 9(3), 251‒258. Rosenberg, M.A., & Browne, M.J. (2001). The impact of the inpatient prospective payment system and diagnosis-related groups: a survey of the literature. North American Actuarial Journal, 5(4), 84‒94.

PART VI HEALTH POLICY PRINCIPLES It is important that the healthcare manager is aware of the principles that guide healthcare systems such as the fairness, ease of access, and holistic well-being of the patient. Here are clustered all the priority aspects on which health policy agendas have focused in recent years and will focus in the future.

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22. Equality and equity

of the individual differences determined by non-modifiable factors. To be considered in the context of equality and equity are the social determinants, which are the attributes defining the underlying social advantage or disadvantage. More and less advantaged social groups are determined by those differences that place people at different levels of a social hierarchy. Everyday examples of these more and less advantaged social groups include groups defined by socioeconomic status (determined by income, educational level, occupation), religious orientation, racial/ethnic origins, gender, sexual orientation, age, or disability. A health disparity, to be so defined, should be systematically associated with social advantage. True equality in the health context is difficult to reach because of the presence of some factors that determine health which are not controllable by the human influence. These include, for example, the genetics predisposing certain individuals or populations to specific diseases. Nonetheless, the concepts of equality and especially of equal rights are central and indispensable. The concept of equality is crucial for the operationalization and hence measurement of health equity. Operationalization can be defined as the process of defining the measurement of a phenomenon that is not directly measurable, though its existence can be inferred by other phenomena. For example, in medicine, the phenomenon of health could be operationalized by certain indicators such as tobacco smoking or the body mass index. A measure of some kind is necessary for equity because, while equality can be judged and assessed with respect to measurable outcomes, the equitability of a process is more open to interpretation. This stems from the fact that the definition of what is equitable or not and the consequent allocation of resources is determined by those in positions of power. Equality is an essential reference point in the pursuit of greater equity in health, especially in such contexts where disadvantaged groups are not represented equally. As long known, it is common for groups experiencing health inequities to be underrepresented and generally to lack political, social, and economic power. It logically follows that, to effectively act on inequities, the interventions should help empower the group in question through systemic changes.

Equality and equity are two words which are extremely important in the health context. They represent two of the three fundamental principles upon which the Italian national health system is built and are considered extremely relevant also from other international entities such as the World Health Organization. Even though they sound similar, their meaning is different, and their interchangeable use is conceptually wrong. It’s important to grasp the basic difference between these two terms to understand why they are both crucial in the health context, and how one concept is indispensable for the achievement of the other. According to the Cambridge dictionary, equality is the “right of different groups of people to have a similar social position and receive the same treatment” (i.e. equality between sexes, races, etc.). Equity is instead defined as the “situation in which everyone is treated fairly and equally”. The World Health Organization defines health equity as “the absence of avoidable or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically”. Therefore, health equity is used to refer to the elimination of the possible disparities in controllable or remediable aspects of health. In simple terms, equality means giving everyone the same thing, whereas equity means giving people what they need. To better grasp what they mean specifically in the health context, a metaphor can be used, where three men of different heights are trying to reach for apples on a tree. Every man is given a box of the same height to reach for the fruit, according to the principle of equality. In this way, considering the different heights of the men, only the tallest will be able to reach for the apples. If the boxes were to be distributed according to the equity principle instead, then every man would get the number of boxes which are necessary for him to reach for the fruits. In this metaphor, overly simplified, the apples represent the common goal of good health that all men aspire to, the boxes are the allocation of resources available and the different men’s heights are a symbol 60

Equality and equity  61

As previously mentioned, health is a fundamental human right and hence health equity means social justice. It is important to notice that health is not just the absence of disease: it represents both physical and mental wellbeing. For this reason, there are social determinants to health which include the household living conditions, conditions in workplaces, health care systems. One of the most important and talked about examples of how equality is fundamental for the fulfilment of good health is that of gender equality. It is well known how gender inequalities drive inequities in health. Geeta Rao Gupta said that gender is “everyone’s problem, but no one’s responsibility” (Gupta et al., 2019). The important point is that gender norms and inequalities affect health outcomes for gender minorities. These are powerful determinants of health and wellbeing, distinct from those solely caused by the biological differences based on sex. Due to the historical legacy of gender-based injustice though, the health consequences of gender inequality fall most heavily on women. The world’s community is trying to improve the situation by defining the Sustainable Development Goals (SDGs) for health and gender equality and trying to fulfil them. Unfortunately, according to the Lancet commission on gender and global health, the world is far from meeting the SDGs. According to the commission, to reach the goals of gender equality and health equity the “change needed is substantial, structural and system-wide” (Hawkes et al., 2020). In countries where women are disenfranchised, but even in more developed countries, those in power tend to argue that the conditions for women are appropriate to the different capacities and roles in the society. These beliefs have roots in a culture where male privilege has never been questioned. In those realities, equality is a crucial reference point in the attempts to achieve greater equity in health. The basis for including the definition of equity in health should be “equal opportuni-

ties to be healthy”, meaning the elimination of systemic social disparities in both health status and in its key social determinants. Silvia de Donato

Bibliography

Anand S. The concern for equity in health. J Epidemiol Community Health. 2002 Jul;56(7):485‒7. doi: 10.1136/jech.56.7.485. PMID: 12080153; PMCID: PMC1732197. Braveman P, Gruskin S. Defining equity in health. J Epidemiol Community Health. 2003 Apr;57(4):254‒8. doi: 10.1136/jech.57.4.254. PMID: 12646539; PMCID: PMC1732430. Cambridge Dictionary, Definition of equality from the Cambridge Academic Content Dictionary © Cambridge University Press, https://​dictionary​ .cambridge​.org/​dictionary/​english/​equality. Culyer AJ, Wagstaff A. Equity and equality in health and health care. J Health Econ. 1993 Dec;12(4):431‒57. doi: 10.1016/0167-6296(93)90004-x. PMID: 10131755. Fenner DE. Equality, equity, and justice. Am J Obstet Gynecol. 2020 Nov;223(5):619‒20. doi: 10.1016/j.ajog.2020.09.042. PMID: 33131651. Gupta GR, Oomman N, Grown C. Gender equality and gender norms: framing the opportunities for health. Lancet. 2019;393:2550–62. Hawkes S, Allotey P, Elhadj AS, Clark J, Horton R. The Lancet Commission on Gender and Global Health. Lancet. 2020;396(10250):521–2. https://​doi​.org/​10​.1016/​S0140​-6736(20)31547​-6 Horton R. Offline: Gender equality-the neglected SDG for health. Lancet. 2015 Nov 14;386(10007):1928. doi: 10.1016/ S0140-6736(15)00945-9. Epub 2015 Nov 13. PMID: 33721965. Whitehead M. The concepts and principles of equity and health. Int J Health Serv. 1992;22(3):429‒45. doi: 10.2190/986L-LHQ6-2VTE-YRRN. PMID: 1644507. WHO, Definition of health equity, https://​www​ .who​.int/​health​-topics/​health​-equity​#tab​=​tab​_1. Wilkinson RG. Socioeconomic determinants of health. Health inequalities: relative or absolute material standards? BMJ. 1997 Feb 22;314(7080):591‒5. doi: 10.1136/ bmj.314.7080.591. PMID: 9055723; PMCID: PMC2126067.

Silvia de Donato

23. Universalism

important dimension for coverage to be effective is service quality. The WHO consultative group proposed three strategies to address fairness and equity issues as countries move towards UHC. First, categorize services into priority classes defined by each country. Secondly, expand coverage for high-priority services to everyone. Finally, ensure that disadvantaged groups are not left behind in assessing entitlements (e.g., low-income groups, rural populations). WHO has identified several initiatives that must be introduced to improve health coverage. Individuals and communities should have more comprehensive access to high-quality health services, skilled health workers should provide quality, people-centered care, and policymakers should be committed to investing in UHC. The crucial point is having a people-centered primary healthcare, having its roots in the community, and focusing not only on preventing and treating disease and illness but also on improving well-being and quality of life. Four arguments are more commonly used in support of UHC. The first relates to ethics and morality and the notion that safeguarding everyone’s physical and mental health is fair and consistent with principles of proper conduct and distributive justice. The second concerns the acceptance of health as a fundamental human right. The third regards the observation that healthy populations tend to be more socially cohesive and politically stable. The fourth is economical, UHC corrects health-related market failures, such as those related to the social benefits of disease prevention among individuals. Furthermore, good health may promote economic well-being not just among healthy individuals but also at the macroeconomic level. Less comprehensive health service coverage reinforces poverty by failing to protect individuals from illnesses that have high treatment costs or limit their ability to work or learn. These economic arguments are supported by evidence that committing resources to healthcare is associated with an increased investment return. At the same time, the financial cost of extensively expanding access to healthcare globally is a barrier to achieving UHC. This regards especially low- and lower-middle-income countries that would need a much higher increase in their respective annal per capita health expenditures.

The World Health Organization (WHO) defines universal health coverage (UHC) as all people having access to the health services they need, when and where they need them, without financial hardship. It includes the full range of essential health services, from health promotion to prevention, treatment, rehabilitation, and palliative care. The notion of UHC dates back to Otto von Bismarck, who established the world’s first national social health insurance system in Germany in 1883. More recently, the International Conference on Primary Health Care with the declaration of Alma-Ata in September 1978 expressed the need for national and international action to protect and promote “health for all”. It recognized the economic and social development as a cause, but also a consequence, of better health. Also, it underlined the importance of primary healthcare and international cooperation to advance the protection and promotion of health in resource-constrained settings. From the 19th century, the importance of a health system allowing all people access to care was raised, but still nowadays, WHO estimates that at least half of the world population do not receive the health services they need. Moreover, about 100 million people are pushed into extreme poverty each year because of out-of-pocket spending on health. Moreover, the Sustainable Development Goals (SDG) 2030 Agenda includes UHC achievement and access to quality healthcare (Goal 3), “to ensure healthy lives and promote well-being at all ages”. Two specific indicators include this concept, target 3.8.1 evaluates the “coverage of essential health services (defined as the average coverage of essential services based on tracer interventions that include reproductive, maternal, newborn and child health, infectious diseases, non-communicable diseases and service capacity and access, among the general and the most disadvantaged population)”. In contrast, SDG indicator 3.8.2 evaluates the “proportion of the population with large household expenditures on health as a share of total household expenditure or income”. UHC has three fundamental dimensions: proportion of the population covered, the proportion of expenditures prepaid, and the ratio of health services included in UHC. A fourth 62

Universalism  63

Wealthy industrial countries are much further along the path to achieving UHC. However, they also face challenges involving rising costs of new healthcare technologies and the growing share of their populations at the older ages. Other potential pitfalls could impede UHC expansion or undermine its positive impact on health and well-being. For example, focusing too much on coverage alone, rather than ensuring the quality of health services, could undetermined UHC effectiveness. Furthermore, the path to UHC and the interventions prioritized in this process will be unique to each country pursuing universal coverage. Besides, a UHC agenda that fails to address social determinants of health could limit its impact on health outcomes. While UHC, as defined in the SDGs, overlaps with human rights standards, there are important human rights omissions, as the failure to confer priority to providing access to health services to poor and disadvantaged communities in the process of expanding health coverage and in determining which health services to offer. Measuring coverage effectiveness at the health-system level is crucial for understanding whether health services align with countries’ health profiles and are of sufficient quality to produce health gains for populations of all ages. Global Burden of Diseases (GBD) 2019 Universal Health Coverage Collaborators published in Lancet a systematic review assessing UHC effective coverage for 204 countries and territories from 1990 to 2019. Globally, performance on the UHC adequate coverage index improved from 45.8 in 1990 to 60.3 in 2019. Nevertheless, country-level UHC effective coverage in GBD 2019 still spanned from 95 or higher in Japan and Iceland to lower than 25 in Somalia and the Central African Republic. Moreover, the results of this review showed that many countries are slowing down performance on effective coverage indicators for non-communicable diseases compared to those for communicable diseases and maternal and child health, despite non-communicable diseases accounting for a more significant proportion of potential health gains in 2019. Thus, it seems global ambitions to accelerate UHC service coverage are increasingly unlikely unless combined action on non-communicable diseases occurs and countries can better translate health spending into improved performance.

In Italy, the principles of universality and equality characterize the National Health System, since its inception, in fact, they were the cornerstones of the 1978 reform. The compulsory nature of sickness insurance was sanctioned, thus overcoming the mutualistic system favoring a social security system characterized by the universality of assistance for the entire population. The new social security system was implemented no longer by the suppressed mutualistic bodies but through the NHS and financed through general taxation. The subjective meaning of universality, related to the generalized access to services, has been progressively specified by leveraging on the income situation of the beneficiaries, also through the provision of co-participation (or exemption) to the cost of services, and on the nature of the requested health service, which must be appropriate. Giulia de Fortunato

Bibliography

A global indicator framework for the Sustainable Development Goals and targets of the 2030 Agenda for Sustainable Development. https://​ unstats​.un​.org/​sdgs/​indicators/​Global​%20Indicator​ %20Framework​_A​.RES​.71​.313​%20Annex​.pdf. Assessing the universal health coverage target in the Sustainable Development Goals from a human rights perspective. Chapman AR. BMC Int Health Hum Rights 16(1):33. doi: 10.1186/ s12914-016-0106-y. PMID: 27978827; PMCID: PMC5159947, 2016 Dec 15. Measuring universal health coverage based on an index of effective coverage of health services in 204 countries and territories, 1990‒2019: a systematic analysis for the Global Burden of Disease Study 2019. Collaborators, GBD 2019 Universal Health Coverage. Lancet 396(10258):1250‒1284. doi: 10.1016/ S0140-6736(20)30750-9, s.l., 2020 Oct 17. Ministero della Salute. http://​www​.salute​.gov​.it/​ portale/​ministro/​p4​_5​_2​_4​_2​.jsp​?lingua​=​italiano​ &​menu​=​uffCentrali​&​label​=​uffCentrali​&​id​=​570. The promise and peril of universal health care. Bloom DE, Khoury A, Subbaraman R. Science 361(6404):eaat9644. doi: 10.1126/ science.aat9644. PMID: 30139847; PMCID: PMC6510304., s.l., 2018 Aug 24. WHO Health financing for universal coverage. https://www.who.int/health_financing/ topics/benefit-package/UHC-choices-facingpurchasers/en/#:~:text=The%20universal%20 health%20coverage%20(UHC,financial%20 coverage%20or%20financial%20protection. WHO Universal Health Coverage. WHO. https://www.who.int/health-topics/ universal-health-coverage#tab=tab_1.

Giulia de Fortunato

24. Well-being ●

There is no consensus around a single definition of well-being, but there is general agreement that, at minimum, well-being includes the presence of positive emotions and moods (e.g., contentment, happiness), the absence of negative emotions (e.g., depression, anxiety), satisfaction with life, fulfillment, and positive functioning. In simple terms, well-being can be described as judging life positively and feeling good. For public health purposes, physical well-being (e.g., feeling very healthy and full of energy) is also viewed as critical to overall well-being. Researchers from different disciplines have examined different aspects of well-being that include: the physical well-being, economic well-being, social well-being, development and activity, emotional well-being, psychological well-being, life satisfaction, domain specific satisfaction, engaging activities and work. Health and wellness are strongly connected to economic growth: individuals with high levels of well-being are more productive at work and have less needs in terms of healthcare. In other words, well-being and productivity are strongly connected: research by iOpener Institute of Oxford has shown that workers who live happily in the workplace are 65% more energetic and they endure their work more easily. Another research by Gallup has shown the connection between happiness, absenteeism’s reduction (happy people are 41% less absent) and productivity (less absence increases the productivity by 17%). Moreover, well-being that integrates mental health and physical health, results in more holistic approaches to disease prevention and health promotion. Well-being is associated with numerous health-, job-, family-, and economically related benefits. For example, higher levels of well-being are associated with decreased risk of disease, illness, and injury; better immune functioning; speedier recovery; and increased longevity. More specifically:

●

●

●

●

perceive their life is going from their own perspective. Well-being is an outcome that is meaningful to the public. Advances in psychology, neuroscience, and measurement theory suggest that well-being can be measured with some degree of accuracy. Results from cross-sectional, longitudinal, and experimental studies find that well-being is associated with self-perceived health, longevity, healthy behaviors, mental and physical illness, social connectedness, productivity, factors in the physical and social environment. Well-being can provide a common metric that can help policy makers shape and compare the effects of different policies (e.g., loss of greenspace might impact well-being more so than commercial development of an area). Measuring, tracking and promoting well-being can be useful for multiple stakeholders involved in disease prevention and health promotion.

Health is more than the absence of disease; it is a resource that allows people to realize their aspirations, satisfy their needs and to cope with the environment in order to live a long, productive, and fruitful life. In this sense, health enables social, economic and personal development fundamental to well-being. Health promotion is the process of enabling people to increase control over, and to improve their health. Environmental and social resources for health can include peace, economic security, a stable ecosystem, and safe housing. Individual resources for health can include physical activity, healthful diet, social ties, resiliency, positive emotions, and autonomy. Health promotion activities aimed at strengthening such individual, environmental and social resources may ultimately improve well-being. The multidimensional conception of health, described by the World Health Organization (WHO) – which already in 1946 referred to the physical, mental, and social components of the concept of health and then expanded it in 1998 – as a dynamic state of complete physical, mental, social well-being and spiritual, and not mere absence of disease. The spiritual and personal component is then highlighted to identify those variables connected to the subjective and objective con-

● Well-being is a valid population outcome measure beyond morbidity, mortality, and economic status that tells us how people 64

Well-being  65

ditions of good-being (understood as health in its positive conception) and evil-being (illness, problem, discomfort, or lack of health in its negative conception) to be considered globally in the approach to the person. It was only in the early 1980s that attention began to be paid to the concepts of Wellness and Occupational Health Promotion. Alongside the prevention of physical diseases, considered, until then, as the only fundamental protection of workers’ health, well-being interventions began to be developed that paid particular attention to psychosocial aspects. The adoption of the term “wellness” in the organizational context marked the end of a purely medical vision of the person in a state of work discomfort, made evident by a dynamic conception of the person– environment relationship. In fact, the interventions in those years were limited to acting on those working conditions that could only constitute a risk of physical damage. Considering Italy’s example, in this context an important turning point has been introduced, from the transposition of EU legislation, with the Legislative Decree n. 626/1994 which, providing for the role of the Head of the Prevention and Protection Service (RSPP), contributed to the redefinition of organizational and risk management models in the company, in support of the hypothesis that one of the determining factors in the occurrence of accidents is to be traced back to the organization of work, the culture of safety and not exclusively to structural deficiencies of machines and systems. This decree fully implemented within the Legislative Decree n. 81/2008 and subsequent amendments makes the employer participant and responsible for a process of improving safety conditions in the workplace through a periodic risk assessment that considers the organizational and subjective aspects associated with the performance of the work activity. Precisely on health conditions, through the introduction of the Occupational Health Psychology (OHP) studies, there was an important improvement in the same in favor of the health of workers. This study area intervenes on three fundamental dimensions: the work environment, the individual and the work/family balance, paying attention to primary prevention without neglecting, at the same time, the

other levels of prevention. In addition, in this period, stress studies began to incorporate the concept of safety at work into the broader concept of organizational well-being, due to the emerging importance of psychosocial factors and the changes taking place in working conditions. Only with the beginning of the 2000s, a new and original perspective considered the organization as a living organism and the person as a multidimensional individual, in which the functions of coexistence with others (control, conformity, creativity, etc.) interacted with company operations (times, spaces, climate, etc.). Personal well-being and corporate well-being are not opposed but mutually reinforce each other. Past research lends support to the view that the negative affect component of well-being is strongly associated with neuroticism and that positive affect component has a similar association with extraversion. This research also supports the view that positive emotions, central components of well-being, are not merely the opposite of negative emotions, but are independent dimensions of mental health that can and should be fostered. Although a substantial proportion of the variance in well-being can be attributed to heritable factors, environmental factors play an equally if not more important role. Exploring now the literature about this topic, obviously most results are about the effects of the pandemic on the health of common people/healthcare-workers/ students and so on in the last year. There are studies that investigate the relationship between the work context, organizational well-being, and the psychophysical health of healthcare providers, throughout a sample of healthcare providers (physicians and nurses) and healthcare students (medical students and nursing students). Overall, both the physical and mental health of the healthcare providers and students are explained by the variables of the organizational context: organizational well-being and socio-demographic/work characteristics. The results show a dependence on gender and age. Furthermore, decision latitude had a positive effect on physical health, while job demands had a negative effect, explaining 21% of the Personal Care Services (PCS) of the healthcare providers and students. Mental health improved via the Valentina Lombardi

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satisfaction and positivity of healthcare professionals and students of these disciplines. Because well-being is subjective, it is typically measured with self-reports (examples: Avallone, Karasek, Siegrist). The use of self-reported measures is fundamentally different from using objective measures (e.g., household income, unemployment levels, neighborhood crime) often used to assess well-being. The use of both objective and subjective measures, when available, are desirable for public policy purposes. There are many well-being instruments available that measure self-reported well-being in different ways, depending on whether one measures well-being as a clinical outcome, a population health outcome, for cost-effectiveness studies, or for other purposes. For example, well-being measures can be psychometrically based or utility-based. Psychometrically based measures are based on the relationship between, and strength among, multiple items that are intended to measure one or more domains of well-being. Utility-based measures are based on an individual or group’s preference for a particular state and are typically anchored between 0 (death) to 1 (optimum health). Some studies support the use of single items (e.g., global life satisfaction) to measure well-being parsimoniously. Peer reports, observational methods, physiological methods, experience sampling methods, ecological momentary assessment, and other methods are used by psychologists to measure different aspects of well-being. As an example, in Italy the Italian National Institute of Health, in collaboration with the University of Sassari, activated the Observatory on Wellbeing and the prevention of work-related stress (OSS BEN) in 2018, with the aim of promoting analyses and training courses that meet the needs of professionals working in the fields of health, university and school. The aim is to allow access to the most effective and updated theories and practices useful for promoting psychophysical well-being, reducing stress, anxiety, and depression. CDC’s (Centers for Disease Control and Prevention) Health-Related Quality of Life Program has led an effort since 2007 to examine how well-being can be integrated into health promotion and how it can be measured in public health surveillance Valentina Lombardi

systems. Several studies have examined the feasibility of existing scales for surveillance, including application of item-response theory to identify brief, psychometrically sound short-form(s) that can be used in public health surveillance systems. CDC and three states in the US (OR, WA, NH) collected data using the Satisfaction with Life Scale and other well-being measures on the 2010 Behavioral Risk Factor Surveillance System. CDC also led the development of overarching goals related to quality of life and well-being for the “Healthy People 2020External” initiative. The World Economic Forum has estimated that, between 2011 and 2030, a cumulative GDP loss of $47,000 will be recorded globally due to illness, level of spending on healthcare and social security, reduced productivity, absences from work, prolonged disability, and reduced income for the affected households. The workplace is destined to increasingly represent a lever through which to promote the physical and psychosocial well-being of workers, with a subsidiary impact and in preventive terms on the demographic trends. The empirical evidence has shown, in fact, that the work environment is the strategic and privileged place to promote an active process of empowerment of workers through so-called policies’ “change of habit”, aimed at reducing health risk factors and developing well-being. Valentina Lombardi

Bibliography

Aguzzoli C, De Santi A, Geraci A (Eds) (2021). Benessere e gestione dello stress secondo il modello biopsicosociale: focus su scuola, università e sanità. Roma: Istituto Superiore di Sanità (Rapporti ISTISAN 21/4). Health-Related Quality of Life (HRQOL) (2018). Well-Being Concepts. Centers for Disease Control and Prevention. https://​www​.cdc​.gov/​ hrqol/​wellbeing​.htm National Academies of Sciences, Engineering, and Medicine (2018). Health and Medicine Division, Board on Global Health; Global Forum on Innovation in Health Professional Education; Forstag EH, Cuff PA (Eds). A Design Thinking, Systems Approach to Well-Being Within Education and Practice: Proceedings of a Workshop. Washington (DC): National Academies Press (US); Oct 11. Appendix B, The Importance of Well-Being in the Health

Well-being  67 Care Workforce. https://​www​.ncbi​.nlm​.nih​ .gov/​books/​NBK540859/​ Rimassa, A. (2020). Wellbeing e formazione: insegna alle tue persone come auto-gestirsi e saranno più felici (e più produttive). Il Sole 24Ore. https://​www​.ilsole24ore​.com/​art/​ wellbeing​-e​-formazione​-insegna​-tue​-persone​

-come​-auto​-gestirsi​-e​-saranno​-piu​-felici​-e​-piu​ -produttive​-ADX0g57​?refresh​_ce​=​1 Zaghini, F., Vellone, E., Maurici, M., Sestili, C., Mannocci, A., Ercoli, E., Magnavita, N., La Torre, G., Alvaro, R., Sili, A. (2020). The influence of work context and organizational well-being on psychophysical health of healthcare providers. La Medicina del lavoro, 111(4), 306–320. https://​doi​.org/​10​.23749/​mdl​.v111i4​ .9075

Valentina Lombardi

PART VII INVESTMENT ANALYSIS Investment analysis involves researching and evaluating an industry to predict its future performance and determine its suitability for a specific investor. Investment analysis involves the evaluation or creation of a financial strategy, the use of relevant ratios, trend analysis, and the opinions of researchers to decide how to allocate funds to various investment vehicles. In the healthcare sector investment analysis regards decisions both for service providers (e.g. hospitals, local health authorities, ambulatory or long-term care organizations) and for public and private third-party payers (e.g. National Health Services and insurance companies).

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25. Business planning of healthcare services

A healthcare-specific phenomenon affecting revenues is called “Supplier Induced Demand” (SID). SID occurs when asymmetry of information exists between supplier and consumer, as within the doctor–patient relationship: a player of the supply-side “induces” demand (Richardson & Peacock, 2006). Business planning in healthcare requires specific attention to SID impact, as SID could represent both an opportunity (delivering high-quality care while maintaining costs, promoting the physician as a “gatekeeper”) as well as a threat (the supplier may use superior information to foster an individual to demand a greater amount of the service).

Business planning can be defined as the “systematic development of a plan for meeting a business objective” (Thomas, 2021, p. 279): the goal is to define economically sustainable objectives and set the path for where a company would like to go in the future. In the healthcare sector business planning regards decisions, both for service providers (e.g. hospitals, local health authorities, ambulatory or long-term care organizations) and for public and private third-party payers (e.g. National Health Services and insurance companies). The essence of business planning is focusing on long-term goals, usually from three to five years into the future depending on the availability of good estimates and “thinking big,” taking into consideration all possible scenarios and paying due attention to the evolving contest and related risks. Getting the right approval and commitment from management is also crucial: weak methods and processes, poor transparency in the management of these efforts can lead to erroneous assumptions and costly errors in the development of new healthcare ventures, thus hindering the achievement of financial and operating goals. According to this definition, business planning is nothing complicated as human beings have been planning in one way or another since rational thinking emerged. However, as a formalized way of organizing development in complex societies, planning is a twentieth century invention (Mintzberg, 1994) and it requires a clear and simple methodology to get robust results.

“2nd brick” – OPEX: operating expense. OPEX traditionally comprises the following costs of a service: ● Disposables costs: products designed for a single use after which it is disposed of as waste. ● Direct labor costs: wages paid to workers such as customer service, administrative staff, radiologists, professional nurses and physicians. ● Maintenance costs: cost for the care by specialized personnel for maintaining equipment in a satisfactory operating condition (systematic inspection, detection, and correction of failures before they occur). ● General and Administrative (G&A): expenses to manage the business such as salaries of executives, legal and professional fees, utilities, insurance, office rents, office supplies, cleaning, etc. “3rd brick” – CAPEX: or capital expenditure includes all fixed assets with a useful life extending beyond a year. If the useful life is longer than a year, the cost must be capitalized and the capital expenditure costs are then depreciated over the life of the asset in question, where depreciation is the charge for a year concerning fixed assets. Examples of CAPEX could be MRI (magnetic resonance imaging technology), or any other medical technology, building a new hospital, and so on.

Business planning of healthcare services in “ten bricks”

1st brick” – REVENUES: or turnover is income that a company receives from the sale of services to customers. Revenues are cash inflows from delivering or producing goods or services; every time a business sells a product or performs a service, it obtains revenue. In healthcare, these are represented by laboratory tests, imaging services, surgical interventions, bed occupation, or every type of clinical service.

“4th brick” – EBITDA AND EBIT MARGINS: Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) is 69

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an accounting measure as a proxy for a company’s profitability. EBITDA = Revenues – OPEX Earnings Before Interest and Taxes (EBIT), is a measure of a company’s profit that includes all expenses except interest and income tax expenses. EBIT = EBITDA – Depreciation & Amortization “5th brick” – PROFIT AND LOSS ACCOUNT (P&L): P&L shows revenues and expenses during a year of a business object, being it a service or a product, or the company itself. It indicates how the revenues (money received from sales) are transformed into the net income (the result after all revenues and all expenses have been accounted for). The purpose of the income statement is to show managers and stakeholders whether the company, or part of it, has made or lost money and how. “6th brick” – TIME: strategic decisions deserve a long-term timeframe, which encompass usually more than three years (mostly five years, but also ten years depending on availability of data and estimates); the longer the time into future, the harder it is to make strong assumptions. Medium-term is usually considered between one and three years, short-term usually under one year (budget). “7th brick” – FREE CASH FLOW (FCF): represents how much cash can be extracted from a company or a service without causing issues to its operations. FCF can be calculated as a proxy taking EBITDA, less tax effect and subtract any changes in CAPEX. “8th brick” – WEIGHTED AVERAGE COST OF CAPITAL (WACC): is the minimum return that a company should earn on an existing asset base to satisfy its creditors, owners, and other providers of capital, otherwise they will invest elsewhere. Usually, it is “top-down” information from the company strategic committee. “9th brick” – NET PRESENT VALUE (NPV): is defined as the sum of the FCF

Giovanni Aguzzi

discounted back to its present value; usually the rate of return used is WACC. “10th brick” – INTERNAL RATE OF RETURN (IRR): is the rate at which an investment “breaks even”. IRR is the rate of return that makes the NPV of all net cash flows from a particular investment equal to zero. The higher an investment’s IRR, the more desirable it is to undertake it: ● An investment whose IRR is greater than or equal to WACC should be accepted. ● An investment whose IRR is less than WACC should be rejected. Once all the “bricks” have been taken into account and properly analyzed, the “wall” is built behind every strong and economically sound decision. Within the context of a dynamic environment, such as healthcare, business plans should always be evolving and updated: the very act of going through the planning process forces management of a company to examine who they are, what they are doing, and why they are doing it. Often, the by-products of the planning process are more important to the organization than the plan itself (Thomas, 2021). This notion is summarized in a quote attributed to the British statesman Benjamin Disraeli who contended: “The plan is nothing; planning is everything.” Giovanni Aguzzi

Bibliography

Abrams R.M. (2003) The Successful Business Plan: Secrets & Strategies. The Planning Shop Mintzberg H. (1994) The Fall and Rise of Strategic Planning. Harvard Business Review, vol 72. Richardson J.R.J., Peacock S.J. (2006) Supplier-Induced Demand. Appl Health Econ Health Policy 5, 87–98. https://​doi​.org/​10​ .2165/​00148365​-200605020​-00003 Thomas R.K. (2021) Business Planning. In: Health Services Planning. Springer, New York, NY. https://​doi​.org/​10​.1007/​978​-1​-0716​-1076​-3​_11

26. Sources of funding for investments

two types of bonds: (1) binding (revenue bonds), tied to a specific project and to the cash flows generated by that project, and (2) unbound (general obligation bonds) tied solely to the entity, its solvency and payments are based on general revenues. The healthcare sector can also resort to the use of investment funds. This financial instrument allows it to accumulate the savings of several actors and manage them as a whole. Funds participants are paid a fee that varies according to the performance of the investment. This instrument enables the establishment of a pool of resources that can be used to finance different types of investments, including those in the healthcare sector. In the report “Financing Health for All: Increase, transform and redirect” (The WHO Council on the Economics of Health for All 2021), the WHO emphasizes the urgency of governments in taking action to improve and increase investment in healthcare. Regarding the use of debt for investment, the paper shows the need to overcome fiscal constraints on investment and improve public–private relations with the aim of incentivizing private investment.

Introduction

In the healthcare sector, investments assume significant importance. The recent global pandemic has revealed that, even in the most advanced countries, this sector needs more investments to meet the increasing needs of populations, generated by factors such as aging populations and longer life expectancy but also by the emergence of disastrous events that put under significant stress these types of systems, which are on the front line for ensuring the wellbeing of communities. To understand the relevance of investments in the healthcare sector it’s enough to consider that among the Sustainable Development Goals, goal number 3 urges global actors to significantly increase funding in the health sector by 2030. There are several sources of financing for health sector investments. The use of debt (bank debt and through investment funds), donations and fundraising, project finance, and public–private partnership will be analyzed below.

Donations

Donations in the healthcare sector are voluntary contributions that provide an essential source of funding and help finance nations’ budget priorities. Donors can come from a variety of backgrounds (i.e., international organizations, private sector, etc.). This type of financing instrument is more prevalent in low and lower-middle income countries. According to a country’s income level, in fact, the amount of the total healthcare expenditure (which increases as its wealth increases) and the size of the donations (which decreases as its wealth increases, leaving room for other types of financing) change. Specifically, in countries with a Gross National Income (GNI) per capita less than US$500 per year, donations are, on average, 45 percent of the total healthcare expenditure, while in countries with a GNI per capita higher than US$3,000 donations account for a very small share of the total healthcare expenditure.

Debt

Companies use debt both to defer their payments and to finance their investments. Financing debt instruments include bank loans, mortgages, overdrafts, and bonds. The use of bank debt to finance healthcare investments is more common in countries where the type of healthcare system in place allows states to take on debt in order to finance different types of investments (i.e., United States). On the contrary, in countries which base their healthcare system on Beveridge-type models (i.e., Italy) the use of debt is subject to strict limits for public administrations, with the aim of safeguarding public accounts and because of intergenerational transfer issues. Another debt instrument other than the use of bank debt, as mentioned, are bonds specifically intended for the healthcare sector. This instrument provides cheaper borrowing rates than mortgages and the possibility of financing more than one investment at a time. There are 71

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Fundraising and crowdfunding

Another source of funding for investments in the healthcare sector is fundraising. Fundraising refers to the set of activities that an organization puts in place to raise financial funds for achieving a public benefit purpose. Effective fundraising requires the preparation of a fundraising plan that helps to allocate resources in order to achieve the best results and the completion of the goal. Crowdfunding is a way of raising funds to finance projects and businesses that allows funds to be raised from a large number of people through online platforms. These online platforms allow interaction between fundraisers and the crowd and enable online donation collection. In exchange for this intermediary service, fundraisers pay the platforms a fee if the collection is successful. The application of these platforms to the health sector is a recent and rapidly developing phenomenon. As revealed by the study “Crowdfunding in Healthcare” (Bassani et al. 2019), up to October 2017, 76 healthcare crowdfunding platforms raised over $132 million. The United States is the country with the largest number of successfully funded projects.

Project finance Definition The expansion of public–private partnerships (hereinafter referred to as PPPs) is a global phenomenon affecting all sectors, at any governance level, which involves all types of public institutions. In their early stages, these forms were identified as project finance, an Anglo-Saxon expression that does not represent a new tool, but a cultural innovation in the financing of healthcare structures, based on the project feasibility and capability to pay off the debt through its own profits rather than on an evaluation of the borrower, on the borrower’s economic and financial position and on the (collateral, financial, and personal) securities given by the borrower. The capability to gather resources for the implementation and economic exploitation of the investment is thus linked to the project capability to repay the loan and be remunerative. The healthcare sector, however, does not use a pure project finance model as it

has recourse to hybrid forms better known, according to an Anglo-Saxon definition, as public–private partnerships (PPPs). Generally speaking, a partnership can be defined as a co-operation relationship based on the convergence of interests, aimed at achieving joint economic and social goals, and indirectly securing individual advantages to each partner. The prerequisite for the success of such a relationship is a significant involvement of the various partners through the contribution and exchange of: ● ● ● ● ● ●

capital, financial resources; scientific and management know-how; human resources; distinctive competence; organization flexibility; managerial and entrepreneurial capability.

Rationale The use of project finance is dictated by the need to bridge the gap between available financial resources and investment needs in the healthcare construction sector and by the need to convey efficiency and quality standards, typical of the private sector, in the process of modernization and requalification of the structures of healthcare system. The involvement of know-how and private capital in the healthcare construction sector is today evidenced by the considerable size reached by the market in terms of projects and investments activated. Goal The public–private partnership concept is a broad one and embodies a wide range of models of co-operation between public and private partners, aimed at involving private capital and competence in the implementation of works and in the offer of public utility services. The financial PPP types can be referred to five possible alternatives of contractual relations: concession of construction and management; concession of public works with project finance (with or without sponsor); establishment of a foundation of participation; contracts of leasing; public–private mixed-capital companies. Independently of the management formula selected, the partnerships – connected with investments – between public healthcare units and private businesses follow a common

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logic scheme, based on a different risk allocation and sharing, when compared with the traditional contract types. Actually, the model applicable to the healthcare sector provides for the distribution of responsibilities to the healthcare unit and the private party (partner, concessionaire, lessee), according to which ● the private part implements the infrastructure (modernization, revamping, expansion, new construction), thanks also to a public unsecured contribution (price) given by the healthcare unit; ● the private part is responsible for the management of all the support services, such as ordinary and extraordinary maintenance of building, facilities, and green areas; administrative services; hotel services of an industrial nature; healthcare activity support services; commercial services; immovable property management (renting of areas for commercial activities); ● the responsibility for healthcare activities generally rests with the public healthcare unit, with the exception of some cases involving private parties to various degrees (foundation of participation). Thus, with a view to securing an economic– financial balance of the operation, the partnership involves the following: ● the purchase of all the supporting activities by the healthcare unit (works directly funded by the Public Administration), through the payment of a rental to the private party; ● the payment of an initial price to the private party to support the investment; ● the direct management, by the private party, of the commercial activities, against payment by users; ● the management of immovables, through the rent of spaces (commercial, related with healthcare) to private parties. In consideration of such features, in the healthcare sector the pure project finance model (i.e., without any financial or risk involvement of the public healthcare unit) gives its place to forms of PPPs characterized by a broader involvement of the public party for investment implementation, in co-operation with the private party.

History and literature

In healthcare systems the PPP model has become basic (Hodge and Greve 2017), both for the construction and management of new infrastructures and for technological modernization. This model, used for contracting-out the timely delivery of new hard physical facilities and as a political alternative to privatization, originated in the UK in the early 1990s in the framework of the New Public Management (NPM) movement. Despite numerous authors who have underlined its benefits, such as the greater cost efficiency, the full transfer of risks, the rapid realization times (Specchia et al. 2017), others have investigated the limits and drawbacks, such as narrow remuneration margins, affordability and sustainability for public finance, excessive costs represented, especially for the case of the construction of large infrastructures (Reeves et al. 2013; Siemiatycki 2011). Therefore, over the last few years, a small amount of operations has increased, mainly concerning technologies and modernization of technological infrastructures. In this case, the advantages of the PPP are above all linked to greater risk distribution, punctuality of deliveries and compliance with budgets (Ozorhon et al. 2021).

Two examples

Among the initiatives for the construction of new hospitals, the A.O. Ospedale Civile di Vimercate used PF for the new hospital complex divided into three main buildings: Outpatients, Diagnosis and Treatment and Inpatients, plus logistics and technology blocks and an area for a hospital car park. The value of the project is about €232,600,000 (public capital contribution is €94,950,000), for 570 beds. Lifetime concession is 24 years; Services granted to the concessionaire (INSO Spa, Pessina Costruzioni Spa, Cooperativa Cellini Scarl, Gozzo Impianti Spa, STI Spa, Olicar Spa, Serist Spa) are: operation of maintenance services (buildings and plant), cleaning and sanification, laundry, patient and staff catering, waste disposal, operation of heating and computing networks. Among the initiatives for health technologies, an example is the one launched by Policlinico Ospedali Riuniti di Foggia.

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The operation involves the completion and integrated management of the operating departments of the new Emergency Urgency Department, including the maintenance of high-tech equipment, and the construction of the new sterilization center and related services. The value of the investment is approximately €27,769,142 without any public contribution and the duration of the concession is 10 years. The concessionaire (Althea Italia Spa and Steritalia Spa) has the right to manage the maintenance of new equipment and high-tech equipment, the supply of DM and surgical instruments, the latter for the entire hospital and not only for the DEU.

Future developments

What we now understand thanks to experiences so far cumulated is that full exploitation of opportunities generated by partnership requires compliance with some basic conditions. First, healthcare government must be provided with professional profiles fit for a close evaluation of the characteristics of the operations to be made, mainly profitability and sustainability in the long run. Second, it is necessary to make a pondered evaluation of governance capabilities, based on a correct balance of the parties involved, on the sharing of risks among the various parties, on the integration of often conflicting interests, on logics of exchange and co-operation between public local government and private operators. Third, successful operations show that a critical factor, common to all the operations implemented, depends on the full involvement of all parties, from the very beginning: the calling and handling of meetings, the promotion and achievement of the necessary understandings, a strong communication and negotiation activity can bring about the favorable conditions necessary for the initiative. The involvement of the private sector in the implementation of infrastructural projects according to the analyzed schemes represents a positive factor on condition that: ● greater attention be devoted to project planning and to the preparation of adequate and accurate feasibility studies;

● occasions be envisaged for an exchange of views involving both the various professional skills of people who will operate in the structure and the local components; ● private businesses and credit institutions be available to have moments of open co-operation for the construction of operations based on fair risk sharing among the parties involved, on remuneration margins consistent with the risk and the prevailing market conditions, on the full undertaking – with a professional skill not always found – of the respective implementation and management responsibilities; ● the risks connected with operations of this kind be correctly perceived, starting from a higher expense to be faced by future generations and the implications often not in line with the regional planning and, as such, difficult to be governed. Clara Del Prete, Marta Marsilio and Fabio Amatucci

Bibliography

Amatucci, F., & Vecchi, V. (2010). Il finanziamento degli investimenti in Manuale di finanza per le aziende e le amministrazioni pubbliche. Egea. pp.65‒92. Bassani, G., Marinelli, N., & Vismara, S. (2019). Crowdfunding in healthcare. The Journal of Technology Transfer, 44(4), 1290‒1310. Hodge, G. A., & Greve, C. (2017). On public– private partnership performance: A contemporary review. Public Works Management & Policy, 22(1), 55–78. https://​doi​.org/​10​.1177/​ 1087724X16657830 Notaro, S.J., & Snyder, G.L. (2006). Establishing a fundraising plan in healthcare organizations. World Development Indicators, WHO Global Health Expenditures Database. Ortiz-Ospina, E., & Roser, M. (2017). Financing healthcare. Published online at OurWorldInData.org. https://​ourworldindata​ .org/​financing​-healthcare Ozorhon, B., Ozcan-Deniz, G., & Kir, O.D. (2021). Challenges of public private partnership (PPP) healthcare projects: Case study in developing countries. EPiC Series in Built Environment, 2, 136‒145. Reeves, S., Perrier, L., Goldman, J., Freeth, D., & Zwarenstein, M. (2013). Interprofessional education: Effects on professional practice and healthcare outcomes (update). The Cochrane database of systematic reviews, 2013(3),

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Sources of funding for investments  75 CD002213. https://​doi​.org/​10​.1002/​14651858​ .CD002213​.pub3 Siemiatycki, M. (2011). Urban transportation public–private partnerships: Drivers of uneven development? Environment and Planning A: Economy and Space, 43(7), 1707–1722. https://​ doi​.org/​10​.1068/​a43572 Specchia, V., D’Attis, S., Puricella, A., & Bozzetti, M.P. (2017). dFmr1 plays roles in

small RNA pathways of drosophila melanogaster. International Journal of Molecular Sciences, 18(5), 1066. https://​doi​.org/​10​.3390/​ ijms18051066 The WHO Council on the Economics of Health for All. (2021). Financing health for all: Increase, transform and redirect. WHO. https://​www​.who​ .int/​publications/​m/​item/​council​-brief​-no​-2

Clara Del Prete, Marta Marsilio and Fabio Amatucci

PART VIII LEVELS OF CARE In this cluster, levels of care are classified according to type, setting and focus. Ranging from prevention to territorial healthcare provision, made through the development of Community Care that deals with treatments that don’t need hospitalization. This description should provide health managers with an understanding of the multifaceted context in which health organizations operate. This configuration allows health organizations to choose a specific care “environment” and to develop its management towards vertical and horizontal partnerships, alliances, integrations, and collaborations.

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27. Acute, sub-acute and post-acute care

Prehospital care refers to the assistance that is given by the community or first-contact healthcare professionals such as ambulance personnel. Critical care refers to care provided by specialised centres that are able to stabilise and continuously monitor patients in life-threatening stress. Trauma & acute care surgery refers to treatment of patients who require acute surgeries such as acute appendicitis. It can be seen that these domains encompass different specialties and require a wide range of capabilities, which cannot always be provided by a single healthcare facility. The aim in acute care is to discharge the patient or to discharge them to following steps of their treatment as soon as possible. This is to prevent saturation of acute care services, as well as for subjects to benefit the most from timely actions of treatments that follow the initial acute treatment. However, it is also important to not make frequent and abrupt changes and discharges, as these could detrimentally affect the patient who has recently undergone a critical event. Thus, transitions between different types of caring facilities and treatments should be as smooth as possible, which is especially important for frail, elderly population. Sub-acute, from an etymological point of view, signifies a tapered angle that is not sharp at the end, similar to a tip of a wooden pencil that has been smoothened out. This analogy signifies its difference from acute care, as closely resembling acute events in the suddenness of the events but not as emergent. As a term, sub-acute care was born in the 1980s in the United States out of a taxonomical dilemma. It was initially used to describe patients that did not meet the established criteria for acute care; but occupied acute care beds for their treatments nonetheless. As more hospitals started identifying patients as “sub-acute”, a need to better define this subgroup was born, mainly due to legal reimbursement necessities between hospitals and health insurance associations. Although sub-acute can be positioned in between, it is closer to acute than chronic. The main characteristics of sub-acute care when compared to acute care are that its intensity is less and its duration is typically longer. Range of duration is defined as ranging from 3 to 30 days as defined by the American Subacute Care Association, however it should be noted that there is no clear consensus on the definition of sub-acute care. Some typical examples of

Acute, from an etymological point of view, describes an angle that ends sharply, below 90°. In medical terms, it indicates a condition that develops rapidly with a sudden onset which also requires attention in a timely manner. Acute, sub-acute and post-acute care are three different care modalities regarding acute conditions, which are not necessarily mutually exclusive; but rather transitioning and overlapping notions. These types of care are most frequently provided by secondary healthcare facilities and beyond; although it is also possible to provide these in primary healthcare facilities in reserved instances. Acute care is a type of short term assistance that aims to improve the overall well being of patients in acute distress, for which the urgency of care also determines the efficacy of its outcome. The most important aspect in this care is time; both the time of development of the clinical picture, and the duration of care are fairly short; while the urgency of medical attention is immediate. It is important to note that not only curative actions but also preventive, palliative, rehabilitative actions may be considered within acute care. Several resources cite the inpatient admission duration to be less than 72 hours for acute care, although this is not a clear-cut consensus. There are six different domains of acute care that were described by the WHO in 2012. These being emergency care, urgent care, short-term stabilisation, prehospital care, critical care, and trauma care & acute care surgery. Emergency care regards life- or limb-threatening events, such as acute vascular events like myocardial infarction. Urgent care refers to assistance that is outside of hospital emergency setting that can be taken advantage of in a walk-in setting; thus can be provided by primary healthcare facilities, unlike most of the other domains which require more specialised units. An example could be a child with sudden onset fever visiting a general practitioner. Short-term stabilisation regards the stabilisation of a patient’s acutely imbalanced parameters before the start of a definitive treatment, such as administration of IV fluids to a critical patient with volemic loss before an immediate surgery. 77

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sub-acute care could be described as wound care, care for stroke patients, post-operative management, pain management, infusion treatments such as IV antibiotic therapy, and rehabilitative actions such as speech or hip rehab. Post-acute care, on the other hand, regards a short-term treatment by skilled nursing/rehabilitative facilities after the acute/sub-acute patient has been discharged. Medicare, the national health insurance program of the United States, states that post-acute care can be given by “a skilled nursing facility (SNF), a hospital-based inpatient rehabilitation facility (IRF), a long-term care hospital (LTCH), or from a home health agency” (United States of America, 2014). Many patients that have gone through an acute event may require longer-term assistance for their recovery from the acute event, as well as management of chronic outcomes and disabilities. These patients cannot keep using acute care facilities, as they need different specialists that focus on longer-term outcomes than an acute specialist. Post-acute care facilities thus provide a continuation of the treatment that was initiated by the acute care setting. Multidisciplinary teamwork, although necessary for acute and sub-acute care, is one of the core elements of post-acute settings, as patients usually have outcomes and comorbidities that affect different domains. Some examples for post-acute care settings could be post-stroke speech rehabilitation, and post knee arthroplasty physical rehabilitation. Aims of the post-acute care are to optimise the patient’s recovery and their functioning, reduce their future needs of long-term care; or concisely: to minimise their disabilities. Transition between acute/sub-acute care and post-acute care should be done carefully. The acute care team should carefully assess the patient’s individual needs and aims and determine a post-acute care-giving facility that is most likely to provide the best outcome for the patient. However, currently there are no standardised means to assess which facility would benefit a given patient the best. A common issue regarding the utilisation of

Mehmet Can Cifci

post-acute care is that in many instances these facilities are used as a “safety net” when the patients do not have a stable and safe location of discharge. This leads to unoptimised improvement for a given patient, as well as to the misuse of funds and facilities which could benefit another patient much more. In all cases, a correct post-acute care continuum is vital to optimise the patient’s well-being as well as to minimise readmissions. Mehmet Can Cifci

Bibliography

Gleckman, H. (2014). A modest step to improve Medicare post-acute care. Forbes. https://​www​ .forbes​.com/​sites/​howardgleckman/​2014/​07/​ 02/​a​-modest​-step​-to​-improve​-medicare​-post​ -acute​-care/​?sh​=​54ed87d9182f Hartley, G. W. & Camilo, S. (2012). Patient management in postacute inpatient settings. In Andrew A. Guccione, Rita A. Wong & Dale Avers (eds), Geriatric Physical Therapy (Third Edition), Mosby. Pages 482‒499. ISBN 9780323029483. https://​doi​.org/​10​ .1016/​B978​-0​-323​-02948​-3​.00035​-3. https://​ www​.sciencedirect​.com/​science/​article/​pii/​ B9780323029483000353 Mistry, P. R., Sandhu, S. & Hopkins, M. (1999). Subacute care: which patients benefit? Cleveland Clinic Journal of Medicine, 66(7), 443–446. https://​doi​.org/​10​.3949/​ccjm​.66​.7​ .443 PIH Health (2020). What is post-acute care? https://​ www​.pihhealth​.org/​wellness/​articles/​what​ -is​-post​-acute​-care/​#:​~:​text​=​Post​%2Dacute​ %20care​%20includes​%20rehabilitation​,or​ %20care​%20provided​%20at​%20home United States of America, One Hundred Thirteenth Congress, IMPACT Act of 2014, H.R. 4994, page 2, BILLS-113hr4994enr.pdf (govinfo. gov) White, H. K. (2019). Post-acute care: current state and future directions. Journal of the American Medical Directors Association, 20(4), 392–395. https://​doi​.org/​10​.1016/​j​.jamda​.2019​.02​.027 Zimmerman, S. & Sloane, P. D. (2007). Long term care. In James E. Birren (ed.), Encyclopedia of Gerontology (Second Edition). Elsevier. Pages 99‒107. ISBN 9780123708700. https://​doi​.org/​ 10​.1016/​B0​-12​-370870​-2/​00116​-5

28. Chronic care

of the expenses that hide behind the cost of treatment. ● Health care workers experience professional and work-related frustration in managing chronic conditions and healthcare administrators are dissatisfied with outcomes of care and wasted resources. ● Governments, employers, and societies suffer because of the loss of workers due to death, disability, and morbidity related to chronic conditions. Moreover, chronic conditions result in major losses of productive potential.

Chronic conditions account for more than 60% of global disease burden in developed countries and trends for developing countries forecast a similarly concerning situation. Epidemiological studies demonstrate increases in chronic conditions all over the world. The chronic conditions are the leading cause of disability and they are becoming the most expensive problems faced by our healthcare systems. In this respect, they pose a threat to all countries from a health and economic standpoint. Chronic conditions are interdependent and intertwined with poverty, and they complicate healthcare delivery in developing countries that concurrently face unfinished agendas around acute infectious diseases, malnutrition, and maternal health. This global rise in chronic conditions is happening due to public health successes, populations are ageing and increasingly patients are living with one or more chronic conditions for decades. The demographic transition, urbanization, consumption patterns, adoption of unhealthy lifestyles, and the global marketing of health risks such as tobacco are other factors contributing to an increase. This places new, long-term demands on healthcare systems. The management of all chronic conditions – noncommunicable diseases, persistent communicable diseases, long-term mental disorders and ongoing physical/structural impairments – is one of the greatest challenges facing healthcare systems throughout the world. The impact of the chronic conditions is big. Healthcare costs become excessive when chronic conditions are poorly managed. However, the impact of chronic health problems extends far beyond the obvious expenses associated with medical treatment. From an economic perspective, everyone pays a toll:

When health problems are chronic, the acute care practice model doesn’t work. Healthcare systems have evolved around the concept of acute, infectious disease, and they perform best when addressing patients’ episodic and urgent concerns. However, the acute care paradigm is no longer adequate for the changing health problems in today’s world. Unfortunately, but perhaps because of its remarkable success, the acute care model now permeates the thinking of patients, healthcare workers, organizations, and governments. It is pervasive across all levels of the healthcare system, and perpetuated by outdated healthcare training curricula. Health care systems have to evolve by moving towards a model of care that incorporates both acute problems and chronic conditions. Without advances, countries can anticipate increasingly inadequate care and waste of precious resources. In the 1990s, Wagner et al. proposed the Chronic Care Model (CCM) as a way of improving care for chronic diseases such as heart disease, hypertension, diabetes, and pulmonary disease by identifying critical components and strategies. The Chronic Care Model, one of the widely recognized disease models in the world served as a patient-centred, evidence-based, proactive framework that aims to redesign ambulatory care systems and achieve healthcare improvement for patients suffering from chronic disease. So far, CCM has been adopted and implemented in many areas of medical practice. The results have suggested that implementation of CCM could greatly improve medical outcomes and reduce unnecessary medical burden. Strategies for preventing avoidable hospitalizations suggested by articles in the literature are strongly connected with CCM

● Patients (and families) pay the measurable monetary costs, including the expense associated with medical care, reduced workdays, and lost employment. In addition, patients (and families) incur costs that defy precise monetary calculation, such as condition-related disability, shortened life span, and lowered quality of life. ● Health care organizations pay most of the cost of medical care, but also bear many 79

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components, such as self-management training for both patients and healthcare providers, identification of existing community resources, electronic systems of medical records for monitoring, as well as sharing and linking among ambulatory services, hospitals and communities, and primary care practices. Moreover, healthcare providers have shown good adherence to the medical practices which were tailored and multifaceted with CCM components. Nevertheless, no single component within CCM may achieve all these expected goals, indicating that adopting multiple components of CCMs is essential to enhancing quality health in primary care. Another strategy to organize thinking about healthcare systems is to divide these complicated networks into strata or levels. Micro-, meso-, and macro-levels provide a reasonable framework and refer to the patient interaction level, the healthcare organization and community level, and the policy level, respectively. Each of these levels interacts with the other two. For example, consider the levels as linked by interactive feedback loops in which events at one level influence actions and events at another level, and so on. Patients respond to the system in which they receive care, and healthcare organizations and communities are responsive to policies that in turn influence patients. And the feedback loops perpetuate. At the micro-level the patient interaction problems are represented by the failure to empower patients and failure to value patient interactions. “There is substantial evidence (from over 400 studies of self-management) that programmes providing counseling, education, information feedback, and other supports to patients with chronic conditions are associated with improved outcomes” (Dineen-Griffin et al., 2019). “Including patient in decision making and treatment planning makes the delivery of care for chronic conditions more effective and more efficient.” At the meso-level the problems with the healthcare organization and its links to the community are the following: failure to organize care for chronic conditions; healthcare workers lack tools and expertise (because of the training based on acute models); practice is not informed by scientific evidence; information systems are not in place; failure to address prevention and connect with community resources. Ana Ciobanu

The macro-level is facing policy issues related to the lack of a legislative framework, outmoded health policies and plans, insufficient investments, standards and monitoring, overlooked intersectoral links and misaligned provider incentives and, finally, a lack in continuing education. These levels of the healthcare system are not discrete entities, rather their boundaries blur and they dynamically interact with and influence each other. Evolution is necessary within each stratum. Increased attention to patient behaviours and healthcare worker communications is paramount for improving care for chronic conditions. Care has to be coordinated for chronic conditions using scientific evidence to guide practice. Community resources must be integrated in order to make significant gains. Healthcare organizations must streamline services, upgrade the skills of healthcare workers, focus on prevention, and establish information tracking systems to provide planned healthcare for predictable complications. Governments need to make informed decisions for their populations and set standards for quality and incentives in healthcare. Financing must be coordinated and intersectoral links must be strengthened. Without change, healthcare systems will continue to grow increasingly inefficient and ineffective as the prevalence of chronic conditions rise. Both high- and low-income countries spend billions of dollars on unnecessary hospital admissions, expensive technologies, and the collection of useless clinical information. Healthcare expenditures will continue to escalate, but improvements in populations’ health status will not. As long as the acute care model dominates healthcare systems, it will effectively undermine health outcomes that otherwise could be accomplished. Decision-makers and other leaders in healthcare are in positions to initiate changes in health systems to address care for chronic conditions. To be most effective, leaders need to consider influencing the micro-, meso-, and macro-levels of the system. In the case of chronic conditions, new, expanded models promise a brighter future for healthcare leaders and patients alike. Some of the essential elements for taking action are as follows: support a paradigm shift, manage the political environment, build integrated healthcare, align sectoral policies for health, use healthcare personnel more effectively, centre care on the patient and

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Figure 28.1

Innovative care for chronic conditions framework

family, support patients in their communities, emphasize prevention. The failure to address the economic repercussions of chronic conditions by revising health policies and health services endangers the economic prosperity of all nations. In summary, chronic conditions are no longer viewed conventionally (e.g., limited to heart disease, diabetes, cancer, and asthma), considered in isolation, or thought of as disparate disorders. The demands on patients, families, and the healthcare system are similar, and, in fact, comparable management strategies are effective across all chronic conditions, making them seem much more alike than different. Ana Ciobanu

Bibliography

Allegrante, John P., Martin T. Wells, and Janey C. Peterson. “Interventions to support behavioral

self-management of chronic diseases.” Annual review of public health 40 (2019): 127‒146. Coleman, Katie et al. “Evidence on the chronic care model in the new millennium.” Health affairs 28.1 (2009): 75‒85. Davis, Ronald M., Edward G. Wagner, and Trish Groves. “Patients as partners in managing chronic disease.” Evaluation 320 (2000): 537‒540. Davy, Carol et al. “Effectiveness of chronic care models: opportunities for improving healthcare practice and health outcomes: a systematic review.” BMC health services research 15.1 (2015): 1‒11. Davy, Carol et al. “Factors influencing the implementation of chronic care models: a systematic literature review.” BMC family practice 16.1 (2015): 1‒12. Dineen-Griffin S., V. Garcia-Cardenas, K. Williams, K., and S.I. Benrimoj “Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice.” PLoS one. 14.8 (2019, 1 August): e0220116. doi: 10.1371/ journal.pone.0220116. PMID: 31369582; PMCID: PMC6675068. Grover, Ashoo, and Ashish Joshi. “An overview of chronic disease models: a systematic literature

Ana Ciobanu

82  Elgar encyclopedia of healthcare management review.” Global journal of health science 7.2 (2015): 210. Harris, Melanie et al. “Practice change in chronic conditions care: an appraisal of theories.” BMC health services research 17.1 (2017): 1‒10. Holman, Halsted, and Kate Lorig. “Patients as partners in managing chronic disease: partnership is a prerequisite for effective and efficient health care.” BMJ (Clinical research ed.) 320.7234 (2000): 526–527. https://​doi​.org/​10​ .1136/​bmj​.320​.7234​.526 Kadu, Mudathira K., and Paul Stolee. “Facilitators and barriers of implementing the chronic care

Ana Ciobanu

model in primary care: a systematic review.” BMC family practice 16.1 (2015): 1‒14. Wagner, Edward H. “Academia, chronic care, and the future of primary care.” Journal of general internal medicine 25.4 (2010): 636‒638. Wagner, Edward H. “Chronic disease management: what will it take to improve care for chronic illness?” Effective clinical practice 1.1 (1998). Wagner, Edward H. et al. “Improving chronic illness care: translating evidence into action.” Health affairs 20.6 (2001): 64‒78. World Health Organization. Innovative care for chronic conditions: building blocks for actions: global report. No. WHO/MNC/CCH/02.01. World Health Organization, 2002.

29. Home care and community care

cancer influences the demand for home care; ● Science and technical innovation: medical advances contribute to increasing life expectancy. At the same time, the development of technology solutions applied to home care allows to deliver services directly from patients’ homes; ● Changes in attitude and expectations: the concept of individualized and tailored care are rising gradually; ● Policy priorities and choices: deinstitutionalization and home care are considered a priority by many governments not only for its health, social and emotional benefits but also for its potential in reduction in public expenditure.

Home care and Community care refers to services provided at home or in the community enabling older people or people with disability or chronic diseases to remain in their home environment, rather than in institutions (e.g. hospital or long-term facility). Several types of home care services exist, each meeting different needs: ● home medical service, e.g. management of chronic medical conditions, appropriate prescriptions of drugs, education of the patients and their caregivers on the patients’ medical conditions and the management plan; ● home nursing service, e.g. post-surgical management, wound management, stoma care, vital signs measurement (blood pressure and blood sugar checks), caregiver education provision, advice on Activities of Daily Living (ADLs), monitoring of proper taking of medication; ● home therapy service, e.g. physiotherapy, occupational therapy, speech therapy; ● home personal care, e.g. personal hygiene, support/assistance with ADLs and other personal care tasks, mind stimulating activities.

Evidence of the effectiveness of home care in improving quality of life, reducing mortality, hospitalizations, and inappropriate admission to long-term residential care and reducing healthcare costs is mixed and heterogeneous. Home care is understood, organized and practiced differently around the European region. Regarding organizational designs and structure, in many countries (e.g. Belgium, France, Italy, Portugal, Spain and the United Kingdom), the “health” component of home care is part of the healthcare system and the “social” component is part of the social system. In other countries (e.g. Denmark, Finland and Sweden) provision of home care services are under the responsibility of a single institution: the municipalities (see Figure 29.1). How home care is financed widely differs among countries. Basically, home care services are provided by two different types of providers – publicly (under the direct control of government at a national, regional or local level) and privately owned organizations. Among privately owned organizations, further distinctions must also be made between:

Home care can be formal, that is delivered by healthcare professionals, or informal provided by relatives, friends, and volunteers. During the 20th century, hospitals became the dominant form of care provision. In the last two decades, deinstitutionalization and request for home care started to increase significantly, due to: ● Demographic shifts: the rising proportion of old and very old people with increasingly complex conditions and chronic diseases; ● Social change: the conversion of the traditional large families into small family units and the female labour market participation reduces the possibility of providing informal care; ● Changes in epidemiology: the increase of non-communicable diseases such as mental illnesses, dementia, diabetes, heart diseases, respiratory diseases, stroke and

● privately owned providers who are funded publicly vs privately owned providers who are hired by the client directly, without public resources; ● non-profit-making and profit-making providers. Professionals working in home care services are heterogeneous, divided into professional 83

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Figure 29.1

Responsible providers of health and social services by country

and non-professional personnel (e.g. nurses, therapists, home care assistants, social workers, physicians, dietitians, homemakers, companions, volunteers, etc.). While in southern and some central European countries informal care remains the dominant source of home care, in northern Europe it is less common. These variations are due not only to the availability of formal services but also to the general population’s attitude towards the role of informal caregivers and to the cultural background of each country. Cash-for-care schemes (relatives to be paid for the care they provide) are blurring the boundaries between formal and informal care. An important and growing concern is the shortage in the supply of home workers because of low salary, isolated working conditions, absence of job stability and career progression. Whilst immigrants could be a possible answer to this problem, at the same time their recruitment implies a possible reduction in the quality of care because often they are not properly

Figure 29.2

trained, licensed and often work outside the oversight of regulatory bodies. In order to provide the appropriate home care services, the definition of eligibility criteria, the early detection of eligible people and proper needs assessment are crucial. These aspects may vary considerably among countries (see Figure 29.2). Since home and community services are quite fragmented and interdependent with other sectors (e.g. hospital, primary healthcare, housing and social welfare sector), integration and coordination between home care and other services and between professionals and informal caregivers is another crucial point. Actually, poor coordination and integration between home care services and the acute hospital sector care and the lack of capacity in home care services to support safe early discharge from hospital lead to increasing waiting lists, inappropriate admissions, bed-blocking, multiplication of diagnoses, tests and procedures as well as medical errors, suboptimal judgement, misunderstanding and

Needs assessment methods by country

Claudia Bianchino, Davide Carnevali and Niccolò Principi

Home care and community care  85

delay in rehabilitation. Case management (a collaborative process of assessment, planning, facilitation and advocacy for options and services to meet an individual’s health needs) has been introduced to overcome this criticism. Technology could be a facilitator in the development of home care. For instance, it could be a connector between informal and formal care, improving the quality of life both of patients and informal carers. Technology through remote systems (such as heart monitors and blood sugar monitors) may also prevent users from going to a physician’s office, clinic, or hospital to receive care, allowing at the same time more frequent patient monitoring preventing/ delaying admission to long-term care institutions. Then, the use of telecare could result in a reduction of the human resources needed in home care. In conclusion, home care is in demand, not only among citizens in Europe (who prefer to stay independent as long as possible), but also among decision-makers (who expect it to be a cheaper alternative to hospital-based and nursing home care). Future challenges are: ● facing inequalities (in quality, extent of delivery and access) to home care services. Clear eligibility criteria, proper screening, early and multidimensional needs assessment should be part of modernizing home care delivery systems in many European countries; ● improving integration of different types of home care and between social services and healthcare in order to ensure efficacy and efficiency, improving the quality and increasing the level of satisfaction of both users and providers of care; ● facing shortage of human resources. Informal carers will certainly continue to be major contributors to home care. Governments will need to achieve a balance between informal and formal carers. It will be also necessary to ensure qualified, trained and equipped staff;

● developing proper management skills which are important at all levels of the home care delivery system. Both social and healthcare staff will have to perform more managerial work in addition to direct care. The same is true for the national, regional and local governments to cope with the necessity of developing steering mechanisms for commissioning, contracting, purchasing, planning, evaluating, quality assurance mechanisms and producing policies aimed at recruiting and retaining home care workers that include appropriate levels of training and pay. Client relations management is also required (e.g. development of: easy and accessible information; communication between payers, services and clients; care management; and counselling). Claudia Bianchino, Davide Carnevali and Niccolò Principi

Bibliography

Bennett L, Honeyman M, Bottery S. New models of home care. The King’s Fund. 2018. Boland L, Légaré F, Perez MMB, Menear M, Garvelink MM, McIsaac DI, Guérard GP, Emond J, Brière N, Stacey D. Impact of home care versus alternative locations of care on elder health outcomes: an overview of systematic reviews. BMC Geriatrics. 2017, 17:20. Genet N, Boerma WG, Kringos DS, Bouman A, Francke AL, Fagerström C, Melchiorre MG, Greco C, Devillé W. Home care in Europe: a systematic literature review. BMC Health Services Research. 2011, 11:207. Kuluski K, Ho WJ, Hans PK, Nelson M. Community care for people with complex care needs: bridging the gap between health and social care. International Journal of Integrated Care. 2017, 17(4):2, 1–11. Low LF, Yap M, Brodaty H. A systematic review of different models of home and community care services for older persons. BMC Health Serv Res. 2011, 9(11):93. WHO Europe. The solid facts: home care in Europe. Copenhagen, 2008. World Health Organization – the European Observatory on Health Systems and Policies. Home care across Europe. Current structure and future challenges. Copenhagen, 2012.

Claudia Bianchino, Davide Carnevali and Niccolò Principi

30. Hospital

higher social classes, especially for imperial staff and for gladiators. It is to Christians that we owe the origin of the modern hospital, as the first hospitals were built only after the recognition of Christianity. At the beginning of the 5th century hospitals spread throughout the Christian East. The attitude of Christians towards the sick was based on Christ’s “The Good Samaritan” parable. Monasteries played a vital role in promoting care and the development of hospitals. In the following centuries, many hospitals were built near monasteries. During the Middle Ages, the construction of hospitals was widespread in both the western and eastern parts of the Roman Empire. St. Benedict of Nursia, founder of the Benedictine Order, built the monastery and hospital at Montecassino in Italy in 529 and launched one of the most influential initiatives in the field of hospitalization. In the 9th century, Charlemagne issued a decree that required, for each cathedral built in his territory, a school, a monastery, and a hospital next to it. Thus, in the 10th century monasteries became a dominant element of hospital activity. In the late Middle Ages, gradually, the driver of hospitalization in Europe shifted from being almost exclusively associated with monasteries, to having a greater involvement of civil authorities. Also, monastic institutions gradually expanded their health services to the rest of the communities. Between the 14th and the 15th centuries, great progress was made in terms of both medical research and building development. The hospital was considered a specialized structure with its own spatial, functional, and organizational characteristics. Distinctions were made between the poor and the sick, between men and women, and between the chronically ill, the acute and the infected. The hospital became a city within the city, an institution that is no longer necessarily religious but controlled by the representatives of the citizens. The Ca’ Granda dei Poveri di Dio, built in 1456 in Milan at the behest of Francesco Sforza and commissioned to Filarete, is an emblem of this period of progress. Between the 16th and the 17th centuries, the protestant areas emphasized the scientific aspects of healthcare. Instead, Catholic areas continued normally their religious hospital practice, with the belief that rich people

Definition

A hospital is an institution that is built, managed, and equipped for the diagnosis of disease, for the treatment, both medical and surgical, of the sick and injured and for accommodation during this process. The modern hospital is often also a research and teaching center. Hospitals complement the effectiveness of many other parts of the healthcare system, providing availability of services for acute and complex conditions. They concentrate scarce resources in well-organized networks to respond to the health needs of the population. They are also an essential element of the Universal Health Coverage and are a critical resource for achieving the Sustainable Development Goals.

History

The precursors of hospitals date back to ancient Greece: the temples of Asclepius. In these places, people received medical advice, prognosis, and treatment after entering a state of induced sleep (like today’s anesthesia) in which they received guidance from the healer god Asclepius. After the awakening, their dreams were interpreted by priests, who then assigned the most suitable therapy. The therapies were in most cases magical and mystical in nature and distant from the existing Hippocratic medicine, based on scientific knowledge. In ancient Rome around 100 bc, the first facilities similar to modern hospitals were buildings intended for sick slaves, soldiers, and gladiators. With the extension of the Roman Empire, sending wounded and sick soldiers home for treatment, was no longer an option. For this reason, military hospitals were established. There were two types of hospitalization: ● Permanent hospitals erected at strategic points called valetudinaria; ● Temporary field hospitals at the front during campaigns. Valetudinaria were afterward also established for the civilian population and the 86

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could obtain God’s grace through good work and that patients could obtain grace through suffering. Since the beginning of the 18th century, the progress of medical sciences, the classification of diseases, the breakdown of specialist medical functions, the greater attention paid to the patient, and the increasing control of hygiene and the environment, led to a new distribution of space. This provided medicine with the conditions necessary to innovate treatments and to increase gradually the humanization of hospitals. Hospitals’ architecture was based on the so-called “pavilion” design. The model was based on breaking down the compact building into separate parts, allowing each function to be equipped with service areas, and improving ventilation, exposure, and lighting. However, even this model had its limits, which over the years have led to it being overcome. The need to link the different areas of the hospital and more in general to overcome the limitations of the “pavilion” model, led, around the 1940s and the 1950s, to the affirmation of the “monoblock” model. It should also be noted that, in the 19th century, hospitals and the healthcare professions became more professionalized, with a reorganization of hospital management along more bureaucratic and administrative lines. The 20th century saw, as said before, the birth of the monoblock architecture model, concentrating all hospital functions in a single building, unlike the previous pavilion structure. In this new model, the reduction of distances by emphasizing vertical displacement has also resulted in lower production costs.

Recent developments

In the last years of the 20th century, due to the decline of the concept of the hospital as a mere machine for curing the sick, the introduction of new technologies, and the introduction of the idea that the hospital and healthcare were subject, like other consumer goods, to competitive pressures, hospitals took on new characteristics. These included: ● More articulated shapes at the expense of compact forms; ● A higher quality of space, both in the areas reserved for the public and in the areas dedicated to the staff;

● More attention paid to the relationship between indoor and outdoor environments. Using Italy as a case study for recent developments in terms of hospital organization, the project launched by Umberto Veronesi (Italian Ministry of Health) at the beginning of the 21st century is worth mentioning. This project was entrusted to a ministerial commission led by architect Renzo Piano to build a new model of the hospital. The guiding principles for the hospital of the future developed were: 1. Humanization; 2. Urbanity; 3. Sociality; 4. Organization; 5. Interactivity; 6. Appropriateness; 7. Reliability; 8. Innovation; 9. Research; 10. Education. The project aimed to ensure structural and functional flexibility, to facilitate timely adaptation to innovations and technological and organizational changes, which is essential to face changing needs over time. The meta-project aims to make hospitals a place: ● Open to the outside world, seeking forms and design solutions that allow a continuous and natural exchange between the internal life and the social life of the city; ● Increasingly characterized by a patient-​ centered vision, which pays attention to their needs, care, and comfort; ● Which minimizes any inconveniences, for the patient and their caregivers, which may also result from structural aspects of the hospital. Particular attention is paid to wayfinding within the facilities to facilitate patient access to the different areas; ● Inserted in contexts with green spaces and with integrated peri-sanitary activities (shop, hotels, restaurants, services, etc.); ● That encourages updating and adaptation to new developments in the clinical scientific field through continuous training and research.

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The final mission of the project can be summarized as the desire to “reinvent” the hospital, basing the design of these institutions on humanization and the centrality of the patient. Modern hospitals have been going through a period of profound change for years now. They are subject to exogenous and endogenous pressures that generate new organizational needs. Among the variables influencing hospital change: ● The socio-demographic change of the population and the increase in the complexity of patients’ health needs. These changes lead to a steadily aging population, an increase in chronic diseases, and a consequent increase in the complexity of the cases (the elderly patients often present more than one health problem, fragility and are not self-sufficient); ● The technological evolution, which changes care needs and production processes; ● The convergence of different disciplines, which produces the need for greater operational coordination in delivery processes and a governed development strategy; ● The changes in professional demographics: a higher proportion of female medical staff, a reduction in the number of doctors, and the aging medical workforce; ● The need to find organizational schemes that combine research and medical care, to exploit the opportunities for research at all hospital sites. Modern hospitals are therefore faced with the above-mentioned changes and have to focus on three main improvements: 1. Reconfiguring the organization and internal governance (re-designing), through: a. asset management; b. knowledge management; c. disease management. 2. Building vertically integrated systems between hospital and territory (bridging); 3. the engagement of Increasing professionals.

Nya Karolinska Solna – VBH and innovation

Following what has been described, it is important to introduce a real application of the Clara Del Prete

described recent trends. The Nya Karolinska (NK) University Hospital in Solna, Sweden, fully represents the changes in recent years in hospital design, management and innovation. Opened in 2018, it is associated with Karolinska Institutet, a university founded in 1810 that is, according to the QS World University Rankings 2019, among medical universities, number three in Europe and number six in the world. It is one of the most state-of-the-art healthcare facilities in the international hospital landscape. “Delivering highly specialized care together with research and training, on a large scale and at the highest level of quality according to the patient first philosophy” is the mission of the two institutions. The change in care needs in recent years has necessitated a renewal of the structure’s supply system. The innovations carried out are all based on the concept of Value-Based Healthcare, which aims to maximize value for the patient by achieving the best ratio between optimal clinical results and the expenditure incurred to obtain them. Innovations implemented to increase value for the patient include: 1. Innovations in the organizational model – NK has based the organization of all clinical activities on the fundamental unit of the “flow”, identified based on single medical conditions and created Patient Flow Management Teams, led by a Patient Flow Captain, that consists of professionals from different fields to ensure the diversity of the team. This created the basis for working with integrated care units and taking care of the patient in an all-around way. 2. ICUs – one of the major innovations in patient care processes at NK came from the new flow organizations: the organization of clinical pathways by integrated care units. This innovation represents a major paradigm shift: the focus is no longer on the individual need of the patient, but on the patient as a whole. 3. Bundle payment financing mechanism – this is an innovation based on the concept of a single price that covers the entire integrated care cycle, it is therefore linked to the organization by ICUs. 4. Lean measures – thanks to the application of Lean Thinking principles, it was possible to create single rooms for all

Hospital  89

admissions, to use a standardized design for wards and rooms, and to make use of robotic transport and electronic clinical records. This enabled the hospital to maximize efficacy and efficiency and at the same time to reduce errors of different kinds. 5. Layout – the principle that guided the organization and optimization of all spaces in the building was “proximity to everything”. Also, an outstanding feature of NK, from the architectural point of view, is the so-called “academic passage”. This passage structurally links the hospital to the university, providing a fast route for the transfer of new knowledge and research results directly to the patient’s bedside.

Future developments – foster resilience

The COVID-19 pandemic has created an unprecedented number of patients needing admission to hospitals and ICUs since its outbreak. Many hospitals have struggled to maintain standards of care under pressure, with critically ill patients being treated outside ICUs and doctors unable to keep up with patients’ needs due to an increase in the number of patients per medical professional. However, these problems were not present in all hospitals. On the contrary, some absorbed the increased demand, maintained standards of care, and delivered high-quality care even when the COVID-19 number of cases was high. Hospitals should understand why some facilities have been able to respond effectively, while others have had serious difficulties. Usually the “4S” for preparedness system (staff, stuff, space, and system) is used to understand the hospital’s response to the pandemic. Even if these factors were naturally necessary, today it can be said that they are definitely not enough. Using the lens of organizational resilience can be effective in understanding the pandemic response of hospitals. Organizational resilience characterizes those systems that can adapt quickly in response to a challenge, allowing mitigated effects and faster recovery.

What should a resilient hospital have done in the context of COVID-19? ● Respond to a surge in ways that ensure the delivery of high-quality care for infected patients; ● Respond to a surge in ways that preserve standards of care for uninfected patients; ● Preserve access to care for the entire community, maintaining elective surgical activities and mitigating worsening health disparities during the pandemic; ● Protect the welfare of the frontline staff, not only by providing personal protective equipment but also by ensuring clear communication from leaders. Other contributing factors that can increase the resilience of hospitals are scalable clinical protocols, flexible electronic medical records, a supportive, interdisciplinary, and psychologically safe work environment. Resilience must also be sought in the integration between hospitals and in effective and transparent leaders, which are essential to promote organizational alignment during rapidly changing situations, both clinically and administratively. The hallmark of organizational resilience is the flexibility to change whenever unexpected challenges arise and the ability to absorb shocks that cannot be avoided. Unfortunately, the COVID-19 pandemic will not be the last large-scale health threat of the 21st century. Hospitals can never be fully prepared for this kind of event, but if they develop sustainable resilience, they will be ready. Clara Del Prete

Bibliography

Barbash, I.J. & Kahn, J.M. (2021). Fostering hospital resilience – lessons from COVID-19. JAMA. 326(8):693–694. doi:10.1001/jama.2021.12484 Cilliers, L. & Retief, F.P. (2002). The evolution of the hospital from antiquity to the end of the middle ages. Curationis. 25(4):60–66. https://​ doi​.org/​10​.4102/​curationis​.v25i4​.806 Cope, Doris K. (2004). The history of anesthesia: Proceedings of the Fifth International Symposium on the History of Anesthesia, Santiago, Spain, 19–23 September 2001.

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90  Elgar encyclopedia of healthcare management Anesthesiology. 2004; 100:202–203 doi: https://​ doi​.org/​10​.1097/​00000542​-200401000​-00052 Giroldi, S. & Lega, F. (2018). L’ospedale moderno mette il paziente al centro dell’organizzazione, Progettare per la sanità, 18–23. Grosso, G., Contarino, F., Biondi, M. & Mistretta, A. (2009). Evoluzione del concetto di ospedale in Italia. Annali di igiene: medicina preventiva e di comunità. 21(5):479‒488. Karolinska Institutet. (2021). Environmental and Climate Action Plan 2021‒2024. From https://​

Clara Del Prete

staff​.ki​.se/​environment​-and​-climate​-action​ -plan​-2021​-2024 Lega, Federico (2020). Economia e Management Sanitario: Settore, Sistema, Aziende, Protagonisti. Manuali. 177. Porter, M.E. & Teisberg, E.O. (2006). Redefining health care: creating value-based competition on results. Harvard Business Review Press. EAN 9781591397786

31. Long term care

carrying out ADLs and IADLs, physical construction in an effort to make the home more accessible to the patient (for example, by installing wheelchair ramps and hydraulic lifts, or renovating rooms to lower risk of falls or injury), as well as actual clinical services such as nursing, physical therapy, and drug administration. It is estimated that the vast majority of long term care – by some counts up to 90% – is carried out informally in the home by family, friends, and other unpaid volunteers or members of the community. In many countries, these informal caregivers may be monetarily compensated by government funds when the care they give is deemed necessary by a physician or advanced practice provider, effectively becoming municipal employees. However, the vast majority of these caregivers are not paid for their efforts, which may be thankless, difficult for those without specific training (or difficult even with such training), and time-consuming. All of these factors combine to cause the so-called caregiver burden. There have been numerous informational, psychosocial, and emotional interventions to try to understand and ameliorate the burden on informal caregivers. One 2013 review found that care-recipient illness/deficits was an important avenue to be considered by means of stress theory, while role theory facilitated our understanding of caregiver burden as a function of role conflict and role overload, recommending a mixed approach. It also highlighted the unique roles of women (and the gendered nature of informal caregiving) and adult children caregivers (and ensuing non-normative role reversal) in the long term care field as potential areas of further specialized study. The majority of people in long term care are senior citizens; the current percentage of the population over 65 is: 23.2% in Italy, 19.2% in Europe overall, and 16.5% in the United States. With a rapidly aging population, these numbers will only continue to rise, implying a nebulous future for the burden not only on informal caregivers but licensed health aides and facilities. Although the efforts being made to overcome these issues is out of the scope of this chapter, some studies suggest that they are not enough to support federal subsidization or outright payment of many services, including

The phrase “long term care” refers to the assistance given to some people, often elderly and typically with various disabilities and/ or chronic illnesses and conditions, in order to see to not only their medical exigencies but also their day-to-day needs in a safe and assistive environment. Since the particular condition or conditions requiring long term care is naturally different from patient to patient, the specifics of long term care are personalized as much as possible to the individual person receiving it; for example, some patients may require help when they eat or use the bathroom, while others may need assistance in managing their medications, dealing with their finances, and performing various household chores. These activities can more precisely be divided into Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs). Both ADLs and IADLs are not only of the utmost necessity for independent life but are also well-recognized predictors of morbidity and mortality. ADLs are basic self-care tasks, such as those the first patient in the paragraph above needs help with – in general, personal hygiene, eating food, using the bathroom, dressing, walking, and transferring (for example, getting into and out of bed). IADLs, on the other hand, are the more complicated tasks that one must nevertheless carry out in order to successfully live independently and secure one’s quality of life. These include tasks such as those the second patient needs help with, along with others such as preparing meals, using phones and other technology, shopping and doing groceries, and handling transportation. Long term care may either occur at the home of the patient, with the assistance of a carer, or at an external location such as a nursing home or assisted living facility. These are not two words for the same thing: a nursing home is a type of medical facility while an assisted living facility is primarily a residential environment and typically costs less for the patient, although there is some overlap between the two. Long term care can also involve clinical services in the setting of the patient’s personal residence, and this is known as home health care, which may involve assistance 91

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the various options for long term care outlined above. Zignat Courtoux

Bibliography

Bastawrous M. Caregiver burden: a critical discussion. Int J Nurs Stud. 2013 Mar;50(3):431‒41. doi: 10.1016/j.ijnurstu.2012.10.005. Epub 2012 Nov 3. PMID: 23131724. Harris-Kojetin L, Sengupta M, Park-Lee E, Valverde R. Long term care services in the United States: 2013 overview. Vital Health Stat 3. 2013 Dec;(37):1‒107. PMID: 26158640. Leiyu S, Singh D (December 8, 2015). Essentials of the U.S. Health Care System. Jones & Bartlett Learning; 4 edition. p. 232. Pallin DJ, Espinola JA, Camargo CA Jr. US population aging and demand for inpatient services. J Hosp Med. 2014 Mar;9(3):193‒6. doi:

Zignat Courtoux

10.1002/jhm.2145. Epub 2014 Jan 24. PMID: 24464735. Park-Lee E, Caffrey C, Sengupta M, Moss AJ, Rosenoff E, Harris-Kojetin LD. Residential care facilities: a key sector in the spectrum of long term care providers in the United States. NCHS Data Brief. 2011 Dec;(78):1‒8. PMID: 22617275. Population ages 65 and above (% of total population). (2021). Retrieved April 9, 2021, from https://​data​.worldbank​.org/​indicator/​SP​.POP​ .65UP​.TO​.ZS Saltman RB, Dubois HFW, Chawla M. The impact of aging on long-term care in Europe and some potential policy responses. International Journal of Health Services. 2006;36(4):719‒46. Wang DXM, Yao J, Zirek Y, Reijnierse EM, Maier AB. Muscle mass, strength, and physical performance predicting activities of daily living: a meta-analysis. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):3‒25. doi: 10.1002/ jcsm.12502. Epub 2019 Dec 1. PMID: 31788969; PMCID: PMC7015244.

32. Prevention

the turning point might relay into the educational interventions associated with the test rather than the test itself. ● Tertiary prevention: tertiary prevention aims to soften the impact of an ongoing illness or injury that has lasting effects or to slow or stop disease progression in order to improve as much as possible the ability to function, the quality of life and the life expectancy. It is often based on educational interventions, mainly support groups, for example teaching a patient how to talk with their loved ones about the disease, how to explain to children the meaning of a terminal disease.

Definition

Prevention is a primary goal of public health because it consists of all of the actions taken to decrease the chance of getting a disease, to maintain the health status and to prevent diseases or detect them earlier. It acts both on the people, as general population or individuals, and on the environment. Preventive services are different than other medical interventions because they are proactively administered to healthy individuals instead of in response to a symptom, sign or diagnosis. Its feature is that it requires an extra effort because its effects will show their impact just in the future: “healthy” people and all of the stakeholders have to invest in their future. This requires a vision, a long-term project.

It also focuses on helping people manage long-term, often-complex health problems and injuries, for example cardiac or stroke rehabilitation programs, chronic disease management programs (e.g. for diabetes, arthritis, depression, etc.), vocational rehabilitation programs to retrain workers for new jobs when they have recovered as much as possible. Tertiary prevention also aims to manage disease post diagnosis through measures such as chemotherapy, rehabilitation and screening for complications.

Rationale

It is a relevant and urgent topic in public health because it has a huge impact on future sanitary costs and quality of life, also considering that life expectancy is longer and chronic diseases are increasing daily.

Objectives

Focus on the health manager

The goals of prevention can be subdivided into three classes, each one acting in different stages of life and different settings.

Prevention is an investment. It requires the ability, associated with the opportunity, to plan the future. It is useful for a health manager to plan how to administer properly today in order to save money in the future. In developed countries, therefore, it would seem that the practice of screening for disease should be widespread. That it is not so to the extent that might be expected is due to a number of factors, among them the cost of screening and the tendency in the medical profession to wait for patients rather than actively to look for disease in the population. Another factor is inadequate knowledge of the principles and practice of screening for disease.

● Primary prevention: it is focused on interventions for a healthy population in order to decrease risk factors and to provide protective factors. Primary prevention aims to prevent disease or injury before it occurs through measures such as vaccinations, altering risky behaviors and banning substances known to be associated with a disease or health condition. ● Secondary prevention: it acts on an apparently healthy population where individuals might already be in an early stage of disease and the goal is to make the diagnosis as long as there are still no symptoms. The result would be to reach the disease in a more treatable and less damaging stage in order to reduce its impact. The key strategy is screening. Sadly, despite the efficacy of these tests, many people still die of diseases that could have been detected earlier. Thus

Historical development

The topic of prevention is as ancient as Hippocrates who classified diseases depending on seasons, climates, irregular food, exercise and habits of the individual. 93

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In 1388 the first sanitary act in England, directed to the removal of nuisances, was passed; in the 15th century the plague recommended quarantine and cleansing; in the 16th century the first attempts at notification of epidemic disease and isolation of the patient were made. The study of mortality statistics was initiated in England in the 17th century. The modern era in preventive medicine opened in the mid-19th century with Louis Pasteur’s discovery of the role of living microbes as the cause of infections. Toward the end of the century the principle of insect-borne transmission of disease was established. In 1861 Dobell published a monograph advocating “periodical examinations”: the idea of the periodic health examination goes back a long way. In the mid 19th century Semmelweis realized that doctors’ labors were more fatal than midwives’ because the former didn’t wash their hands between general surgeries and labors: the introduction of washing hands with chlorinated lime solutions marked the beginning of antiseptic procedures. Tremendous progress has been made towards this topic over the last fifty years, especially for cancer prevention. In 2020‒2021 the Sars-CoV-2 pandemic caused a decrease and delay in screening and preventive programs thus determining an increase in missed cancer diagnoses (estimated increase between 8% to 16% of deaths up to five years after diagnosis of the most common cancers); at the same time new demanding needs activated new resources, for example psychological support groups for health staff. Historical events and prevention have always been closely related, influencing each other.

Settings of primary prevention: ● ● ● ●

workplaces schools local health boards canteens, cafeterias…

Roles in primary prevention: ● ● ● ● ●

doctors certified staff inspectors teachers who attended specific courses prevention technicians

Targets of primary prevention: ● ● ● ● ● ● ●

children families workers retired people employees people as communities and individuals population when it is more approachable and more willing to change ● food choices ● buildings, streets, parks, landscapes… ● any other place of interest

Secondary prevention

Tools of secondary prevention: ● regular examinations and screening tests to detect disease in its earliest stages (e.g. to detect cancer, prenatal screenings) ● daily, low-dose aspirins and/or diet and exercise programs to prevent further heart attacks or stroke ● modified work so injured or ill workers can return safely to their jobs Settings of secondary prevention:

Primary prevention

● hospitals ● laboratories ● clinics

● legislation and enforcement to ban or control the use of hazardous products (e.g. asbestos) or to mandate safe and healthy practices (e.g. use of seatbelts and bike helmets) ● education about healthy and safe habits (e.g. eating well, exercising regularly, not smoking) ● immunization against infectious diseases

Roles in secondary prevention:

Tools of primary prevention:

Elisabetta Pierini

● general practitioners and the other medical doctors ● all of sanitary workers ● psychologists and experts in advertising screening campaigns

Prevention  95

Targets of secondary prevention:

● Follow-up services

● people at the recommended age to participate in screening programs ● subgroups at higher risk (family history, exposure, current or past disease that increase other risks, past therapies that increase the risk…)

Tertiary prevention

Focus on screening: ● The decision to recommend a screening test or preventive intervention requires a particularly high bar of evidence that testing and intervention are both practical and effective. ● Some limits of screening can be early diagnosis, over-diagnosis, false sense of security, side effects on insurance coverage. ● Screening programs can save the time of highly trained professional people. Part of their work can be performed by less highly trained personnel able to carry out screening tests. ● The best studies to approve the introduction of a new screening test are randomized controlled trials. ● WHO guidelines for screening criteria were published in 1968 but they are still actual and usable: ● Important health problem ● Accepted treatment for recognized disease ● Facilities for diagnosis and treatment ● Suitable latent and symptomatic stage ● Suitable test or examination ● Test acceptable to population ● Natural history of condition understood ● Agreed on policy on whom to treat ● Cost of finding economically balanced with overall health ● Case finding should be continuous process To evaluate the appropriateness of a screening program these parameters need to be respected: ● ● ● ● ●

Validity Reliability Yield Cost Acceptance

Tools of tertiary prevention: ● ● ● ● ●

some kinds of chemotherapy rehabilitation screening for complications support groups psychological interventions

Settings of tertiary prevention: ● hospitals ● laboratories ● clinics Roles in tertiary prevention: ● medical doctors, nurses, sanitary workers ● psychologists ● physiotherapists Targets of tertiary prevention: ● patients ● patients’ relatives ● caregivers

Future development

The future of prevention relies on genetic screening as the recent years showed, but the COVID-19 pandemic reawakened the need for a strict control of viral diseases too. At the same time the spread of metabolic diseases will request attention and resources in order not to turn into the next “epidemic”. ● Infectious diseases: there are important connections between infectious and noninfectious diseases: some cases of cancer, e.g. cervical and liver cancer, can be prevented through vaccination; diabetes, obesity, and tobacco and alcohol use increase risks of both cancer and infections. Solid financial support and improved research ability, along with network communication technology, also greatly facilitate the application of epidemic prevention measures. The most recent pandemic outbreak offers some essential lessons: ● every country must have the core public health functionality to identify a threat Elisabetta Pierini

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● ●

●

●

●

when it emerges, stop it promptly, and prevent it wherever possible. This includes trained epidemiologists, high-quality laboratories, accurate disease surveillance systems and rapid response teams: full-time staff dedicated to monitoring and improving infection control and facility leadership to fully support these staff. the lack of effective infection prevention and control in hospitals and other healthcare facilities is a key vulnerability. Smoke and tobacco use: smoking-cessation counseling and treatment are effective clinical interventions, but public health interventions, including raising tobacco taxes, expanding smoke-free public places, running hard-hitting antitobacco advertising campaigns, reducing images of smoking in movies and television and increasing the purchase age to 21 years, can be more effective. Cardiovascular disease: improved cardiovascular care, particularly better blood-pressure control, could save many lives. Implementation of daily aspirin use for people at high risk, blood-pressure control, cholesterol management and smoking cessation are all effective measures. Blood pressure: standardized protocols that simplify availability, delivery and use of core blood-pressure medications and allow tasks to be delegated to nursing and nonmedical staff, could save a million or more lives worldwide each year; a reduction of sodium intake in conjunction with treatment could save even more. Physical activity: increasing physical activity and improving nutrition are key to obesity prevention and control, and policies that change the environment to make healthful eating and regular physi-

Elisabetta Pierini

cal activity easier, safer, and more attractive are likely to be most effective. ● Car accidents: in many countries, motor vehicle crashes are now the leading cause of death among people of 15 to 29 years of age. Public health interventions such as lowering allowable blood alcohol levels for drivers and implementing random traffic stops to reduce drunk driving; increasing the use of seat belts, child restraints, and helmets; promoting increased taxation of alcohol; and reducing and enforcing speed limits are effective, inexpensive, and highly cost-effective. Better-engineered roads and vehicles also increase safety and reduce crash injuries and deaths. Elisabetta Pierini

Bibliography

Armstrong, Katrina A., Gary J. Martin “Chapter 4: Screening and prevention of disease: Harrison’s principles of internal medicine, Twentieth Edition” https://​www​.britannica​.com/​science/​preventive​ -medicine https://​www​.cdc​.gov/​pictureofamerica/​pdfs/​ picture​_of​_america​_prevention​.pdf Maringe, Camille, James Spicer, Melanie Morris, Arnie Purushotham, Ellen Nolte, Richard Sullivan, Bernard Rachet, Ajay Aggarwal “The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study”; The Lancet, 21(8):Aug 2020 Pan, Xingchen, David M Ojcius , Tianyue Gao, Zhongsheng Li , Chunhua Pan , Chungen Pan “Lessons learned from the 2019-nCoV epidemic on prevention of future infectious diseases”; Microbes and Infection, 22(2):Aug 2020 Wilson, J. M. G., G. Jungner “Principles and practice of screening for disease”; World Health Organization; 1968

33. Screenings

Objective and benefits of screenings

Chronic diseases such as cancer and the cardiovascular diseases, often of insidious onset, have become more important as killers than communicable diseases in developed countries. In the developing countries, as infectious disease comes under control, however, chronic diseases are significantly increasing and screening for disease is growing in importance with time. If detected early, they stand a reasonable chance of being cured. The purpose of screening is to identify people in an apparently healthy population who are at higher risk of a health problem or a condition, so that an early treatment or intervention can be offered, reducing mortality. The objectives of screening programmes also include: to reduce the incidence of a condition by identifying and treating its precursors; to reduce the severity of a condition by identifying people with the condition and offering effective treatment and to increase the patient’s choice by identifying conditions or risk factors at an early stage in a life-course when more therapeutic options are available. An effective screening programme can deliver significant public health benefits. Examples of benefits include: reduction in the incidence and mortality of cervical cancer; early intervention for newborns with hearing loss to support speech and language development. The family and society may benefit as well: economic analysis has shown how antenatal and neonatal screening can save society the costs of lifetime support into adulthood by preventing long-term disabilities. Detecting the condition at an early stage provides other benefits, including using a less-toxic treatment or intervention, such as reducing the use of chemotherapy for people with breast cancer.

Definition

The Commission on Chronic Illness Conference on Preventive Aspects of Chronic Disease, held in 1951, defined screening as the presumptive identification of unrecognized disease or defect by the application of tests, examinations, or other procedures which can be applied rapidly. Screening tests sort out apparently well persons who probably have a disease from those who probably do not. A screening test is not intended to be diagnostic. Persons with positive or suspicious findings must be referred to their physicians for diagnosis and necessary treatment. (Goldstine, 1952)

A screening test does not provide certainty but only a probability that a person is at risk from the condition of interest. Screening is different from early diagnosis: screening invites people who do not have symptoms to undergo testing, whereas early diagnosis is intended to detect conditions as early as possible among people with symptoms.

Rationale

The aim of early disease detection, or secondary prevention, is to discover and cure conditions which have already produced pathological change but which have not so far reached a stage at which medical aid is sought spontaneously. In some cases, such as antenatal screening, the purpose of screening is to give people information about an increased risk or condition to help them make an informed decision about their care or treatment. There is also an economic aim of achieving more for unit expenditure by saving the time of highly trained professional people. Part of their work can be performed by less highly trained personnel able to carry out screening tests, whether by hand or by automated means. However, it seems likely that the total cost of screening in a community is higher, not lower, than the cost of conventional medical care since more people will be found to be in need of treatment.

Historical development of screenings

The historical development of screening can best be examined by observing the measures taken to control endemic communicable disease-measures which are still vitally important in many countries. For example, in tropical and subtropical areas of the world parasitic diseases such as malaria, schistosomiasis and ancylostomiasis have long been 97

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the subject of mass detection to attempting to stamp out the human reservoir. Only when the prevalence of endemic communicable disease has been reduced to a minimum has early detection been directed towards the secondary aim of chronic disease detection. In a smaller way the same story can be told of industrial health examinations. For example, early detection techniques, like chest X-ray, blood film and urinary lead content, were developed for silicosis and lead poisoning where the cause could not be wholly eradicated. With advancing sophistication in industry, the idea grew not only of monitoring the health of workers in relation to known environmental health risks but also of anticipating non-industrial hazards to the health of individuals by periodic health examination. The motivation for screening has been dealt with by Chapman, Mountin and Smillie, published between 1949 and 1952, at the time of maximum growth of this concept in its application to chronic diseases. Much screening practice evolved in the USA during the 1950s in the form of multiple screening programmes. In 1957 the Commission on Chronic Illness accepted the value of multiple screenings as “contributing to good medical practice” and considered that it “constitutes a practical means for early detection of a number of important chronic diseases and impairments” (Roberts, 1954). The CCI considered at that time that screening might profitably be carried out for the following conditions: pulmonary tuberculosis, visual defects (including chronic glaucoma), hearing defects, syphilis, diabetes, cancers of skin, mouth, breast, cervix and rectum, hypertensive disease, ischaemic heart disease. In 1960 the American Public Health Association strongly endorsed multiple screening in a publication entitled “Chronic disease and rehabilitation: a program guide for state and local health agencies”. With the formation, in 1961, of the Chronic Diseases Division of the United States Public Health Service came the ability to provide State services with project grants for setting up demonstration screening programmes. The era of modern screening began in 1968 when WHO commissioned a report on screening from James Maxwell Glover Wilson and Gunner Jungner. The report was Federica Natarelli

entitled: “Principles and practice of screening for disease”. This publication contains the principles of early disease detection: 1. The condition sought should be an important health problem. 2. There should be an accepted treatment for patients with recognized disease. 3. Facilities for diagnosis and treatment should be available. 4. There should be a recognizable latent or early symptomatic stage. 5. There should be a suitable test or examination. 6. The test should be acceptable to the population. 7. The natural history of the condition, including development from latent to declared disease, should be adequately understood. 8. There should be an agreed policy on whom to treat as patients. 9. The cost of case-finding (including diagnosis and treatment of patients diagnosed) should be economically balanced in relation to possible expenditure on medical care as a whole. 10. Case-finding should be a continuing process and not a “once and for all” project. With the sequencing of the entire human genome and the emergence of new genomic technologies, a growing number of diseases started to be detected in the pre-clinical stage, and even in the pre-pathological stage, using molecular and non-molecular diagnostic techniques. Genetic screening led to the revision of the screening principles by the WHO in 2008: 1. The screening programme should respond to a recognized need. 2. The objectives of screening should be defined at the outset. 3. There should be a defined target population. 4. There should be scientific evidence of screening programme effectiveness. 5. The programme should integrate education, testing, clinical services and programme management. 6. There should be quality assurance, with mechanisms to minimize potential risks of screening.

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7. The programme should ensure informed choice, confidentiality and respect for autonomy. 8. The programme should promote equity and access to screening for the entire target population. 9. Programme evaluation should be planned from the outset. 10. The overall benefits of screening should outweigh the harm.

Types of screenings

We can identify different types of screenings: ● “Mass screening” indicates the large-scale screening where no selection of population groups is made. ● “Selective screening” is used for selected high-risk groups in the population. It may still be large-scale and can be considered as one form of population. ● “Surveillance” is a term often used as a synonym for “screening”, however, while the latter tends to be thought of as a cross-sectional, short-term operation on a population at risk, “surveillance” conveys rather the sense of a long-term vigil over the health of an individuals or of a population. Furthermore, if we consider the object, we can recognize two kinds of screenings: “case-finding” is a term applied to that form of screening of which the main object is to detect disease and bring patients to treatment in contrast to “epidemiological surveys” whose principal aim is to elucidate the prevalence, incidence and natural history of the condition under study.

Screening programme

A screening programme is not just a single test but rather a pathway where all the steps are required to be effective: 1. Identify the population eligible for screening: determine the group to be screened based on best evidence. 2. Invitation and information: invite the full cohort for screening, supplying information tailored appropriately for different groups to enable informed choice to participate.

3. Testing: conduct screening test using agreed methods. 4. Referral of screen positives and reporting of screen-negative results: refer all screen-positive results to appropriate services and make sure screen-negatives are reported to individuals. 5. Diagnosis: diagnose true cases and identify false positives. 6. Intervention, treatment and follow-up: intervene or treat cases appropriately. In some conditions surveillance or follow-up will also be required. 7. Reporting of outcomes: collect, analyze and report on outcomes to identify false negatives and to improve the effectiveness and cost-effectiveness of the screening programme.

Screening test performance

Sensitivity and specificity indicate how well a test performs: sensitivity is the ability of the screening test to identify people with the condition as positive and specificity is the ability of the screening test to identify healthy people as negative. These indicators vary according to the threshold value. The threshold value of a test is the cut-off between values determined to be screen positive (with the condition) and screen negative (without the condition). When screening programmes choose a highly sensitive threshold for the screening test then specificity is affected. This results in very few false negatives but more false positives. All the positive results are then investigated with a further test with high specificity to exclude the false positives. The performance of a screening test is also measured by the positive predictive value, which is the likelihood that the screening participant has the condition that screening targets when the test is positive, and the negative predictive value, which is the likelihood that the screening participant does not have the condition under investigation when the test is negative. They both depend on the prevalence and the distribution of the severity of the condition in the screened population.

Potential harms of screenings

Screenings can also lead to unintended and inevitable harm. Screening tests cannot be Federica Natarelli

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100% sensitive or specific therefore there will always be false positives and negatives: ● People who have false-positive results are subjected to unnecessary investigations and their potential complications and can also have psychosocial problems due to the positive result. A screening programme with many false positives can strain the health system because they need to be investigated and use services such as endoscopy making people with symptoms wait longer to be treated. ● People who receive a negative test result may ignore important symptoms, resulting in delayed diagnosis. Legal claims as a result of false-negative results can be very costly for a screening programme. False-negative screening results may decrease the trust and confidence in the screening programme. Another significant problem is overdiagnosis, it is the result of the earlier detection of conditions that would never cause individual harm in lifetime. Once a screening programme starts, everyone who is found to have a condition has to be offered treatment even though some of these people would not have needed treatment. Overdiagnosis is recognized as a problem in cancer screening but quantifying its exact impact is often difficult. At the individual level, identifying who has been overdiagnosed and who was correctly diagnosed with a condition that, if untreated, would have led to a poorer outcome is not possible. The methods for calculating overdiagnosis are complex and can depend on contextual factors. In screening, overtreatment can occur alongside overdiagnosis. Overtreatment means that people receive more extensive or invasive treatment than is required to improve health outcomes. For example, in countries with prostate screening programmes, men are subject to surgery and radiotherapy for prostate cancer with concomitant problems such as impotence and urinary incontinence in circumstances in which the cancer may not have caused them any harm in their life-

Federica Natarelli

time. Overtreatment can also occur because benign conditions found as part of screening are treated unnecessarily, such as surgical removal of small benign breast lumps. Screening programmes usually require considerable investment in equipment, personnel and information technology. This can strain a health system, resulting in reallocation of resources (such as funding, time or personnel) to the screening programme and away from symptomatic care, delaying care for people with symptoms and potentially leading to greater inequalities. In some circumstances screening may be altogether uneconomical. A condition may be almost universally prevalent, and under these conditions mass treatment without screening may be the course to pursue, thus avoiding the high cost of preliminary confirmation of a virtually certain diagnosis. Federica Natarelli

Bibliography

American Public Health Association. Technical Development Board. Program Area Committee on Chronic Disease and Rehabilitation, Chronic Disease and Rehabilitation: A Program Guide for State and Local Health Agencies, Washington, 1960. Andermann, Anne, Ingeborg Blancquaert, Sylvie Beauchamp, Véronique Déry Revisiting Wilson and Jungner in the genomic age: A review of screening criteria over the past 40 years. Bulletin of the World Health Organization 2008;86(4): 241‒320. Goldstine D. Steps toward prevention of chronic disease. Summary of the National Conference on Chronic Disease: Preventive Aspects, held March 12‒14, 1951. Commission on Chronic Illness, Chicago, 1952. American Journal of Public Health and the Nation’s Health 1952;42(9): 1137–1138. Roberts DW. The Commission on Chronic Illness. Public Health Reports 1954;69(3): 295–299. Wilson J, G Jungner Principles and practice of screening for disease. Geneva: World Health Organization, 1968. World Health Organization. Regional Office for Europe, Screening programmes: a short guide. Increase effectiveness, maximize benefits and minimize harm, 2020.

34. Primary healthcare

and as close as feasible to people’s everyday environment. (Nations, 2019)

All people, everywhere, deserve the right care, right in their community. This is the fundamental premise of primary healthcare, a term used to describe the first contact a person has with the health system when having a health problem or issue that is however not an emergency. It is the most widely used portion of the health system and may be provided by several different health professionals, including general practitioners (GP), physiotherapists or pharmacists. Primary healthcare (PHC) is an underlying basis of the Global Health philosophy, and as such it addresses the majority of a person’s health needs throughout their lifetime. This includes physical, mental, and social well-being and it is people-centered rather than disease-centered. PHC is a whole-of-society approach that includes health promotion, disease prevention, treatment, rehabilitation, and palliative care. It is classified according to two broad categories, the first one focusing on wellness and prevention (investigation of patient’s health history to determine probable risk factors; providing vaccinations; performing screenings for early diagnosis; lifestyle changes coaching for prevention), while the second one is represented by acute healthcare. The first category aims at diagnosing and treating common health conditions within the area of expertise of the involved clinician. In case of urgency instead, usually the patient is directed to the best place and especially to the most specific care facility based upon the cause of the acute event. Thanks to the interconnection between primary care providers, there is also the possibility to refer to other medical specialists upon requirement. Since its introduction in 1961, the term has undergone multiple reinterpretations. A clear and simple definition has been developed to facilitate the coordination of future PHC efforts at the global, national, and local levels and to guide their implementation: PHC is a whole-of-society approach to health that aims at ensuring the highest possible level of health and well-being and their equitable distribution by focusing on people’s needs and as early as possible along the continuum from health promotion and disease prevention to treatment, rehabilitation and palliative care,

The initial definitions included the following categories to describe what primary care is or who provides it (Lee, 1992; Spitz, 1994). These include: ● The care provided by certain clinicians— some proposed legislation, for example, lists the medical specialties of primary care as family medicine, general internal medicine, general pediatrics, and obstetrics and gynecology. Some experts and groups have included nurse practitioners and physician assistants (OTA, 1986; Pew Health Professions Commission, 1994). ● A set of activities whose functions define the boundaries of primary care—such as curing or alleviating common illnesses and disabilities. ● A level of care or setting—an entry point to a system that includes secondary care (by community hospitals) and tertiary care (by medical centers and teaching hospitals) (Fry, 1980), ambulatory versus inpatient care. ● A set of attributes, as in the 1978 IOM definition—care that is accessible, comprehensive, coordinated, continuous, and accountable—or as defined by Starfield (1992)—care that is characterized by first contact, accessibility, longitudinality, and comprehensiveness. ● A strategy for organizing the healthcare system as a whole—such as community-oriented primary care, which gives priority to and allocates resources to community-based healthcare and places less emphasis on hospital-based, technology-intensive, acute-care medicine (IOM, 1984). A clue to the difficulty lies in an ambiguity of the word primary. This may in fact be understood in a sense either of first in time or in order. Hence, we have a relatively narrow concept of primary care as “first contact,” the entry point, or ground floor of healthcare delivery. This meaning of primary can connote only a triage function in which patients are then passed on to a higher level of care. If, on the other hand, primary is understood in its sense of chief, principal, or main, then primary care is better understood as a central and fundamental basis of health-

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care. The latter relies upon the idea of essential healthcare and has thus been properly defined to be made “universally accessible to individuals and families in the community … through their full participation and at a cost that the community and country can afford” (WHO, 1978, p. 3). In order to encircle and embrace both the mentioned aspects, primary care denotes the provision of integrated, accessible healthcare services by clinicians who are accountable for addressing a large majority of personal healthcare needs, developing a sustained partnership with patients, and practicing in the context of family and community (IOM, 1984). In this way both a timely and ordered definition of “primary” would be satisfied. On this basis, three fundamental characteristics of primary medicine, defined as the personal health system of individuals and families, as distinguished from public health include the clinicians providing: 1. First-contact care (as compared to that based on referral), 2. Assuming the responsibility for the patient over time regardless of the presence or absence of disease, and 3. Serving as the “integrationist” (serve a coordinating role). According to this it was moreover preferable that all family members be cared for by the same physician (Alpert and Charney, 1973). From a broader point of view, primary care also includes such public health measures as sanitation and ensuring clean water for populations apart from the delivery of personal health services. This duality aims at providing care in the community as well as care through the community. With the addition of this society-based approach, there are three main aspects that primary care has to satisfy nowadays: 1. Meeting people’s health needs throughout their lives. 2. Addressing the broader determinants of health through multisectoral policy and action; 3. Empowering individuals, families, and communities to take charge of their own health. The latter gives the term a more dynamic twist, by making it become not only the defiCarolina Curti

nition of a service provided, but also an active goal to be achieved. When we focus on the personal services provided in a community setting, we see that providers work in medical clinics, community health centers and allied health practices, such as physiotherapy and podiatry practices. Another more recently developed way of access to the service includes the health advice telephone helplines such as nurse-on-call, which make it even easier to reach the needed care, without physically moving. These services are moreover available 24 hours a day and can thus provide valuable health advice during those hours when other healthcare services are closed. Primary care is not a static service, but rather must be visualized as a constantly evolving and dynamic system that has to keep pace with the changing needs of the world’s population. The 1978 Alma-Ata declaration recognized the critical importance of high-quality primary healthcare in the creation of effective and responsive health systems. Since then, the rising costs of medical care, increased citizen expectations from health systems, population ageing, and subsequent greater prevalence of chronic diseases have only reinforced the interest in the efficiency of primary healthcare. The current situation of the COVID-19 pandemic has brought to light how primary care is still not living up to its full potential, and hence has stimulated innovative practices both at national and local level, such as expanding the roles of nurses and pharmacists, developing digital solutions to monitor health status, easing access to care and using health information infrastructures for disease surveillance. The rise in the aged population also pushes an effective Primary Care system to aim at both delaying the onset of chronic diseases and reducing the resulting mortality rates. Innovations are thus taking place with the goal of promoting greater general effectiveness of the system. They are, however, still present only at a local level or on a small scale and have not yet achieved the full potential for a system-wide transformation of care. Among the various policies applied, the most promising one relies upon the creation of new configurations of care, housing multiple professionals with advanced skills working in teams, supported by digital technology to enable seamless co-ordination of care, and that are pro-actively engaged in

Primary healthcare  103

preventive care, tailored to the needs of the population they serve. Carolina Curti

Bibliography

Alpert JJ, Charney E. The Education of Physicians for Primary Care. Publ. No. (HRA) 74-3113. Washington, D.C.: U.S. Department of Health, Education, and Welfare, 1973. Better Health Channel (n.d.). Primary healthcare explained. https://​www​.betterhealth​.vic​.gov​.au/​ health/​ServicesAndSupport/​primary​-healthcare​ -explained​#primary​-healthcare​-services Fry J. (ed.) Primary Care. London: Heineman, 1980. Institute of Medicine (US) Committee on the Future of Primary Care; Donaldson MS, Yordy KD, Lohr KN, et al., editors. Primary Care: America's Health in a New Era. Washington (DC): National Academies Press (US); 1996. 2, Defining Primary Care. https://​www​.ncbi​.nlm​ .nih​.gov/​books/​NBK232631/​ IOM. Community-Oriented Primary Care: A Practical Assessment . Volume I. The Committee Report. Washington, D.C.: National Academy Press, 1984. Lee P. The problem: Assessing the primary care paradigm. Proceedings: Volume I. The National Primary Care Conference. Washington, D.C., March 29–31, 1992. Rockville, MD: U.S. Public Health Service, Health Resources and Services Administration, 1992. Nations U. Primary Health Care towards Universal Health Coverage and the Sustainable Development Goals, September 23. From UN

Web TV: https://​media​.un​.org/​en/​asset/​k1d/​ k1dyztexgr, 2019. OTA (Office of Technology Assessment). Nurse Practitioners, Physician Assistants, and Certified Nurse-Midwives: A Policy Analysis. Health Technology Case Study 37. Publ. No. OTA-HCS-37. Washington, D.C.: U.S. Government Printing Office, 1986. Pew Health Professions Commission. Nurse Practitioners: Doubling the Graduates by the Year 2000. San Francisco: Pew Health Professions Commission, 1994. Spitz B. The architecture of reform, or how do we build our health care system around primary care when we don't know who a primary care provider is, how many we need, or what they do? Unpublished draft document, 1994. Stanborough RJ, MFA. Medically reviewed by Harshil Matta, DO (2020). What is primary care and why do you need it? Healthline. https://​ www​.healthline​.com/​find​-care/​articles/​primary​ -care​-doctors/​what​-is​-primary​-care Starfield, B. Primary Care: Concept, Evaluation, and Policy. New York: Oxford University Press, 1992. WHO (World Health Organization). Alma-Ata 1978: Primary Health Care. Report of the International Conference on Primary Health Care, Alma-Ata, Union of Soviet Socialist Republics, 6–12 September 1978. Geneva: World Health Organization, 1978. WHO. Primary Health Care. Geneva: World Health Organization, 2021. https://​ www​ .who​ .int/​news​-room/​fact​-sheets/​detail/​primary​ -health​-care​#:​~:​text​=​Primary​%20health​ %20care​%20is​%20a​,and​%20social​%20health​ %20and​%20wellbeing; https://​www​.who​.int/​ health​-topics/​primary​-health​-care​#tab​=​tab​_1

Carolina Curti

35. Secondary vs tertiary vs quaternary care As a direct result of the incredible complexity of modern medicine, healthcare in most countries is subdivided into various levels of service, with divisions such as primary, secondary, and quaternary healthcare being the most common. Primary healthcare, which includes general practice and community services, is usually patients’ first point of contact with a medical professional, while the upper tiers involve increasing degrees of specialisation. Therefore, coordination of care between the various levels of services, that is, the deliberate integration of patient care activities between two or more participants involved in a patient’s care to facilitate the appropriate delivery of healthcare services, becomes a key issue for both medical professionals and policymakers (Wadmann, Strandberg-Larsen and Vrangbæk, 2009).

Figure 35.1

The pyramid of healthcare services

The four levels of healthcare represent both increasing degrees of specialisation in medicine and decreasing numbers of patients at each tier. Secondary care, also known as referral services, is often dedicated to only patients requiring diagnosis or treatment. To access those services, patients usually require a written referral from a primary care physician. Secondary care is usually provided by local and regional hospitals and involves specialised tests and appointments with specialists (‘Medicine’, no date). As the percentage of elderly people is increasing in almost all populations, various analyses show that the burden of managing chronic conditions and advocating for active

maintenance of health should be shifted from secondary care to primary care in the future to decrease the number of admissions to secondary care facilities (Jones et al., 2013). Although, some studies show that, due to ineffective communication, ‘bottlenecks’ can form between primary and secondary care, making it increasingly difficult for some patients to consult a specialist or obtain a correct diagnosis (Lorenzini Erdmann et al., 2013). Problems could also arise if patients consult a number of different specialists for the same condition and the information is not relayed rapidly and effectively between physicians, or if the patient is simply referred to the wrong specialist (Torrey, 2020). Since primary and secondary care facilities form the backbone of healthcare in every country and deal with the largest numbers of patients, it is crucial to continue working on improving communication between the two systems to ensure the delivery of highest quality of care to the patients. In systems with a relatively high degree of decentralisation, which allow the local governments to freely develop and shape the solutions and procedures in healthcare, communication between the two tiers is often the least effective. Secondary care in such systems (e.g. Sweden) may often seem confusing to primary care providers, which leads to issues with effective referrals and fragmentation of responsibility, as well as a narrow focus on department-specific activities, while no-one takes responsibility for overseeing total patient care, as each unit protects its own interests (Wadmann, Strandberg-Larsen and Vrangbæk, 2009). Tertiary care is the third tier of healthcare and is usually exclusive to the largest hospitals in each country. It involves highly specialised services, such as neurosurgery, transplants, and renal or haemodialysis, or care devoted to specific groups of patients, such as women, children, or patients with mental disorders (‘Medicine’, no date). Tertiary care facilities require highly trained staff and equally highly specialised equipment; therefore, while the number of patients who require this level of care is significantly lower than for primary or secondary care, the cost of care per patient is exponentially higher. Access to tertiary care, similar to secondary care, usually requires a written referral from a primary care doctor or a secondary

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Secondary vs tertiary vs quaternary care  105

Source:  Multiple Sclerosis Trust (2018).

Figure 35.2

NHS professionals classified by level of assistance

care specialist. Whilst tertiary care centres provide highly specialised care, it is important to ensure that the primary care physicians are informed about patients’ course of treatment at this level, as studies show that this enhances patients’ prognosis and ensures the best long-term results (Torrey, 2020). The highest tier of medical care is known as quaternary healthcare and is usually seen as an extension of tertiary care. It is available in the same types of medical facilities that accommodate tertiary care but is often characterised by the experimental nature of the treatment, which could include new pharmacotherapy and highly uncommon surgical interventions (Torrey, 2020). A significant downside to the highly specialised nature of quaternary care is the fact that it is only provided in a few national or regional centres in each country, and these are characterised by extremely large catchment areas. For this reason, patients often have to travel long distances to receive care at those centres, and this has been shown to negatively impact the outcomes of the treatment, related to issues such as higher rates of wound infection, reoperation, and prolonged period of mechanical ventilation in the group of patients who have to travel further (Mehaffey et al., 2017). Although the four-tier structure is common and there are many similarities among different countries in terms of the division and organisation of healthcare, it must be emphasised that there are also significant differences between various national systems, depending on the degree of centralisation, means of funding, and specific procedures

adopted by the countries. Similarly, we must remember that the described levels of care are usually only available in developed and wealthy countries, and, even in those countries, some individuals with lower incomes may have limited access to highly specialised care. Unfortunately, in countries where large percentages of the population live at or below the poverty level, access to even primary healthcare could be problematic, due to financial reasons and long physical distances patients have to travel to access their closest healthcare provider, if large sections of the population live in rural rather than urban areas. Magdalena Czajkowska

Bibliography

Jones, R. et al. (2013) ‘The future of primary and secondary care’, British Journal of General Practice, 63(612), pp. 379–382. doi:10.3399/ bjgp13X669400. Lorenzini Erdmann, A. et al. (2013) ‘Secondary health care: best practices in the health services network’, Revista Latino-Americana de Enfermagem, pp.  131‒139. doi:10.1590/ S0104-11692013000700017. ‘Medicine’ (no date). https://​www​.britannica​.com/​ science/​medicine (Accessed: 14 April 2021). Mehaffey, J. H. et al. (2017) ‘Access to quaternary care surgery: implications for accountable care organizations’, Journal of the American College of Surgeons, 224(4), pp. 525–529. doi:10.1016/j.jamcollsurg.2016.12.017. Multiple Sclerosis Trust (2018). Care in the NHS. https://​mstrust​.org​.uk/​a​-z/​care​-in​-the​-nhs (Accessed: 14 April 2021). The Conversation (2018) People across Africa have to travel far to get to a hospital. We

Magdalena Czajkowska

106  Elgar encyclopedia of healthcare management primary​-secondary​-tertiary​-and​-quaternary​ worked out how far, 13 September. https://​ -care​-2615354 (Accessed: 14 April 2021). theconversation​.com/​people​-across​-africa​-have​ -to​-travel​-far​-to​-get​-to​-a​- hospital-we-worke Wadmann, S., Strandberg-Larsen, M. and Vrangbæk, K. (2009) ‘Coordination between d-out-how-far-102585 (Accessed: 14 April primary and secondary healthcare in Denmark 2021). and Sweden’, International Journal of Torrey, T. (2020) ‘Primary, secondary, tertiary, Integrated Care, 9(1). doi:10.5334/ijic.302. and quaternary care’, Very Well Health, 16 February. https://​www​.verywellhealth​.com/​

Magdalena Czajkowska

PART IX NEW PARADIGMS Having to manage a new normal, to keep the pace with the technological development and the more and more frequent innovations, but also in the light of the recent COVID-19 pandemic, the healthcare manager must be aware of the changes that healthcare organizations are undergoing in order to face internal and external challenges. Healthcare organizations, regardless of the complexity of this industry, must guarantee a higher and higher standard of quality and develop a more territorialized system that can both provide ordinary healthcare assistance and be able to deal with extraordinary events. To achieve this, healthcare organizations need to overcome today’s dominant paradigm, centred on specialist medicine and hospitals of excellence, and move towards a community-based paradigm.

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36. Access to healthcare Healthcare accessibility can be defined as the relative convenience of achieving healthcare services at a certain location. Another detailed definition was provided by Luo and Wang (2003) who developed the 2SFCA method conducted in two steps. STEP 1: Individuate a catchment area through a threshold travel cost (d0) for each service site j and search the population within the catchment. The supply to demand ratio Rj for each service site j is calculated with the following equation: Sj

​Rj  ​=  ___________ ​       ​ ​∑ k ∈​(​Dist ​(i,j)​≤​d​ ​)​ ​Pk​ 0

Dist (i,j) is the travel cost from i to j, Sj is the supply capacity of service site j, Pk is the number of people in population location k STEP 2: Individuate a catchment with d0 as threshold travel cost for each population location i and search all service sites within the catchment. ​Af​ i​   ​=  ​ 

∑ 

​ Rj​

j ∈​(​Dist ​(i,j)​≤​d0​ ​

The access to healthcare is the result of five voices: 1. ADEQUACY: Adequacy is linked to quality of care and adaptation to the need of care. It is so important that the patient is informed and involved in decisions regarding their care. 2. ACCESSIBILITY: The treatment must be accessible throughout all stages of care, from health promotion and early diagnosis through to all treatments. 3. AFFORDABILITY: Affordability means that patients have the possibility of accessing health services with the least possible financial impact. 4. AVAILABILITY: Patients need to have access to healthcare in their country. 5. APPROPRIATENESS: The care provided must be appropriate for the patient’s needs. The pursuit of equity of access to healthcare is a main goal of the healthcare systems and it is possible to classify three kind of systems: ● Tax-funded systems that provide universal population coverage based on resi-

dency. People not covered may access public health services but must pay for the healthcare out of their own pocket. ● Social Health Insurance based systems that cover people who contribute to the system. In these systems, people with a gainful employment (employees and self-employed) are therefore covered. ● Mandatory Private Health Insurance systems where premiums are directly paid by the insured members to the insurance company on an individual basis or are paid by the employer and deducted from the salary of the employee. For example, in the United States, healthcare is privatized and the government does not guarantee health coverage to citizens. More specifically the American one is an hybrid system. Americans receive medical care through a hybrid of two different healthcare delivery systems: the government-funded or “public” health system and for-profit and nonprofit private health insurers. Citizens can purchase health insurance coverage from an insurance company, or they can obtain it through their employment. On the other hand, in Italy over the years a considerable effort has been made to build a health system based on the principles of universal coverage, solidarity and human dignity. The Italian one is a tax funded system. In Italy hospitals are funded with tax revenue, and each region is responsible for fund distribution. Every citizen is guaranteed basic healthcare to cover essential levels of care. Many treatments require a small co-payment from the patient, but the cost is low. In other words health coverage in a healthcare system is made up of three voices: ● Population coverage: the part of the population entitled to publicly funded health services ● Benefit package: the health services covered ● User charges: the percentage of out of pocket that patients have to pay for these services. The overall conclusion is that, while the general direction of travel is towards improved access to healthcare, important inequalities in access to healthcare persist, both between and within countries; and large

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Access to healthcare  109

shares of the EU population, in particular vulnerable groups, face multiple hurdles and therefore do not obtain the care they need. The report “Inequalities in access to healthcare: A study of national policies 2018” (Baeten et al. 2018) identified the following main challenges regarding inequalities in access to healthcare: inadequacy of the public resources invested in the health system; fragmented population coverage; gaps in the range of benefits covered; prohibitive user charges, in particular for pharmaceutical products; lack of protection of vulnerable groups; lack of transparency on how waiting list priorities are set; inadequate availability of services, in particular in rural areas; problems with attracting and retaining health professionals; and difficulties in reaching particularly vulnerable groups. Access to healthcare is generally considered as a human right that systems must guarantee. Claudia Bianchino

Bibliography

Baeten, Rita, Spasova, Slavina, Vanhercke, Bart, & Coster, Stephanie. (2018). Inequalities in access to healthcare. A study of national policies 2018. EC Report. 10.2767/371408. Gulliford, M., Figueroa-Munoz, J., Morgan, M., Hughes, D., Gibson, B., Beech, R., & Hudson, M. (2002). What does ‘access to health care’ mean? Journal of health services research & policy, 7(3), 186–188. https://​doi​.org/​10​.1258/​ 135581902760082517 Luo, W., & Wang, F. (2003). Measures of spatial accessibility to healthcare in a GIS environment: Synthesis and a case study in Chicago region. Environment and planning. B, Planning & design, 30(6), 865–884. https://​doi​.org/​10​ .1068/​b29120 Ma, L., Luo, N., Wan, T., Hu, C., & Peng, M. (2018 Oct 31). An improved healthcare accessibility measure considering the temporal dimension and population demand of different ages. Int J Environ Res Public Health, 15(11), 2421. doi: 10.3390/ijerph15112421. PMID: 30384482; PMCID: PMC6266999.

Claudia Bianchino

37. Co-production Co-production in public services has emerged as a central theme in public policy reform. It is considered a potential solution to the current and future challenges in the public sector, given the expected benefits including improved services provided, a greater economic and financial sustainability of the system, the more efficient use of resources, and increased citizen satisfaction. The concept of service co-production has its roots in the late 1970s and early 1980s, and, in 1996, Elinor Ostrom defined it as “the processes through which inputs, used to provide a good or a service, are contributed by individuals who are not in the same organization” (Ostrom, 1996, p. 1073). After a period of declining interest, co-production regained prominence during the global financial crisis in 2008 and 2009, as pluralistic models of governance and a sense of community gained favor among scholars and policymakers. Despite this growing interest, co-production is still a nebulous concept, a woolly-word in the field of public policy, with a wide range of definitions. Theoretical and empirical contributions on the topic have increased significantly in the past decade, and co-production has been investigated in different disciplines and applied in numerous policy sectors. In public service literature, co-production is broadly understood as the active involvement of lay actors (individual users, groups of users, or communities) partnering with professionals (i.e. government agents serving in a professional capacity) in any phase of the public service cycle (i.e. commissioning, design, delivery, and assessment) (Bovaird, 2007). In service management literature, co-production is assumed to be one of the most important elements of value co-creation, and, specifically, refers to the participation, involvement, and engagement of customers in the production (i.e. co-design or shared delivery) of goods and services (McColl-Kennedy et al., 2017). Scholars agree in considering healthcare to be one of the most theoretical and empirically promising application fields for co-production. The global pressure for sustainable health systems has led to a reevaluation of healthcare service delivery models and the role of patients in many countries. Scholars, policymakers and practition-

ers increasingly acknowledge the need to move beyond the traditional dyadic (i.e. the doctor–patient relationship) medical service delivery model, characterized by the patient playing a passive role, and move towards a “patient paradigm” and a system dimension approach, that considers the managerial and organizational implications of co-production. The COVID-19 pandemic has further emphasised the urgency of adopting a co-production approach, where shared responsibility among citizens, health providers, and governments ensures higher success rates compared to traditional hospital-based care. One of the most cited definitions of co-production of health is from Batalden et al. (2016, p. 509), who describe it as: “the interdependent work of users and professionals who are creating, designing, producing, delivering, assessing, and evaluating the relationships and actions that contribute to the health of individuals and populations”. Thus, according to this definition, health co-production encompasses a wide variety of activities in which health providers (public or private) and health consumers (patients and/or carers or communities) voluntarily work together to produce some benefits in any phase of the service cycle (i.e. commissioning, design, delivery, and assessment). Co-production in healthcare is an increasingly widespread and consolidated management practice in several Anglo-Saxon and northern European countries. Considering the main themes addressed, co-production tends to refer to traditional areas of health (e.g. public health, social care), with a focus on social and health-related issues (e.g. the elderly and chronic diseases) and the use of technologies (Fusco et al., 2022). Despite the growing interest in co-production in the health sector, empirical studies investigating the managerial and organizational implications of co-production are still scarce and, sometimes, the empirical methodologies are lacking in clarity and robustness. Scholars identified four constructs that constitute co-production activation and process: (i) antecedents (i.e. factors driving customer participation); (ii) management activities (i.e. activities aiming to affect customer inputs), and (iii) outcomes (i.e. positive or negative results); (iv) the general context (i.e. the macro-environment in which co-production takes place). The evaluation of co-production

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Co-production  111

Figure 37.1

A comprehensive framework of co-production

needs to consider the complex and mutual interactions that link antecedents, management and outcomes. A recent systematic review (Fusco et al., 2022) systematizes the empirical literature on healthcare co-production, offering a detailed description of each lever. Overall, co-production initiatives seem to be studied mostly with no link with the general context (e.g. political systems, views on the role of government, financial health, legal and institutional frameworks). The most investigated antecedents of co-production can be classified related to healthcare users (e.g. health status, psychological and emotional drivers), professionals (e.g. competence and skill), providers (e.g. resource availability), and services (e.g. type and characteristic – inpatient/outpatient). Management activities can be classified into five categories: supportive leadership; institutional arrangement (e.g. formalized and ad hoc structures); planning, control and accountability (e.g. goal setting and evaluation plan); patients’ management tools (e.g. communication, training); professionals’ management tools (e.g. training). However, these activities have received less frequent attention compared to the antecedents. Finally, considering the outcomes, research reports positive impacts on users

(e.g. service satisfaction/perceived quality, health and well-being); providers (e.g. effectiveness, efficiency, innovativeness); professionals (e.g. learning and job satisfaction); community (e.g. social capital and service democratization). However, co-production is not a panacea: collaboration among actors may be partially or totally unsuccessful, producing negative or inconsistent results on the users, providers, and professionals involved. The investigation of drawbacks is still limited. This would help reduce the areas of uncertainty and identify the most effective combinations of antecedents and management tools for successful co-production. The challenge – both for academics and practitioners – lies in developing reliable (e.g. longitudinal approach), feasible (according to the specific characteristics of the co-production initiative) and sustainable approaches that consider medium and long-term outcomes. This should also include a greater focus on the dark side of co-production. Marta Marsilio and Chiara Guglielmetti

References

Batalden, M., Batalden, P., Margolis, P., Seid, M., Armstrong, G., Opipari-Arrigan, L., & Hartung,

Marta Marsilio and Chiara Guglielmetti

112  Elgar encyclopedia of healthcare management H. (2016). Coproduction of healthcare service. BMJ Quality & Safety, 25, 509–517. Bovaird T. (2007). Beyond engagement and participation: user and community coproduction of public services. Public Adm Rev., 67(5), 846–860. Fusco F., Marsilio M., & Guglielmetti C. (2022). Co-creation in healthcare: framing the outcomes and their determinants. Journal of

Marta Marsilio and Chiara Guglielmetti

Service Management, revised and resubmitted, March 2022. McColl-Kennedy, J., Snyder, H., Elg, M., Witell, L., Helkkula, A., Hogan, S., & Anderson, L. (2017). The changing role of the health care customer: review, synthesis and research agenda. Journal of Service Management, 28(1), 2‒33. Ostrom, E. (1996). Crossing the great divide: coproduction, synergy, and development. World Development, 24(6), 1073–1087.

38. Demedicalization Demedicalization is the process by which a behavior or a condition, once labeled as “sick” or as “pathological”, becomes categorized as natural or normal. For that condition there is a scaling of therapies recommended to patients on the basis of their actual needs so the reduction of the use of medical practices and drugs. The introduction of this word is important because this term indicates the importance of staying updated about the conditions considered “medicalized” in order to know what condition needs to be treated and what is the correct approach. Indeed, the knowledge of the demedicalization of a condition could be the first step to make that condition not discriminating anymore. The demedicalization of certain conditions is also a sign of technological innovation and also a sign of the growth of the scientific knowledge. For example, once, pregnancy and delivery were conditions considered “sick” because of every possible complication following these two events, while now it is known that these conditions are more rarely associated with any pathological condition that could endanger the life of the mother or the newborn. This is why today these two conditions are “demedicalized”. It is important, in the light of what has been said, to know that “medicalization” is not a synonym of “hospitalization” and “demedicalization” does not absolutely mean “recovery”. The health manager should not only know the existence of this term, but also what conditions have been “demedicalized” through the years. Furthermore, in ethical terms the presence of this new concept could help to not discriminate people once discriminated. One of the most famous conditions once considered sick and now accepted, or at least that should be accepted, is homosexuality. It is obvious that, if a word is scientifically used to identify a situation considered pathological, the person with this condition will be mainly identified by that and automatically considered sick. The direct consequence of this is that people with a demedicalized condition could be easily integrated in the work context. Clearly, it is not an easy process: the fact that a term does not indicate in this moment

a pathological condition does not mean that in the common sense this will be automatically accepted. Because once the condition considered was perceived as “sick, different, not normal”, it is also important for the health manager to consider the path to take in order to integrate a worker into a potentially hostile context. A condition could be demedicalized not only because it becomes considered normal or accepted because it is not a pathological condition, but also because there could be a technological improvement of the techniques to control that potentially dangerous condition. As mentioned above, the main example of this consideration is pregnancy and delivery. Once these two events were potentially lethal both for the mother and the newborn. The experience and the technological improvement made these events safer than in the past, so it is possible to affirm that these conditions have been demedicalized because they are more rarely really pathological because of the lower incidence of complications. Demedicalization has also been central in recent changes of the conceptualization of mental illnesses. For example, the rehabilitation has recast mental illness as having components of an impairment, a dysfunction, a disability and a disadvantage. More recently, the concept of recovery from psychiatric disability has gained momentum. This concept is likewise demedicalized in nature, in that it is comprised of the constructs of personhood, growth, resilience in the face of a trauma and human capacity. The opposite side of this concept is identified by the word “medicalization”. This term indicates the process in which a personal or a social phenomenon becomes understood and described with medical terms. By the way, unnecessary medicalization leads to huge social and financial costs as well as increased anxiety and risk of complications from further workups for incidental or clinically unimportant findings. In the future, probably more conditions will be demedicalized. The progress of science, new technological discovery and the improvement of research will be the key for this process and conditions now medicalized will be demedicalized because of new cultural approaches and because of the development of new skills of healthcare workers to

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prevent complications or certain pathological conditions. Francesco Mazziotta

Bibliography

Birrer RB, Tokuda Y. Medicalization: A historical perspective. J Gen Fam Med. 2017 Mar

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24;18(2):48‒51. doi: 10.1002/jgf2.22. PMID: 29263990; PMCID: PMC5689393. Di Segni Obiols S. Sodomitas, homosexuales, gay: de la persecución a la desmedicalización [Sodomites, homosexuals, gay: from persecution to demedicalization]. Vertex. 2006 Mar– Apr;17(66):99‒104. Spanish. PMID: 16645673.

39. Evidence-based medicine Evidence-based medicine (EBM) is a method for transferring research-derived knowledge into clinical practice. Adapting its definition by David L. Sackett et al. in 1996, it is “the conscientious, explicit, and judicious use of current best available evidence to guide clinical decision-making for the care of individual patients”. EBM relies on the integration of three key components: 1. Knowledge of the best available evidence coming from systematic research about the accuracy of diagnostic tests, the impact of prognostic factors, the effectiveness and safety of preventive, curative or rehabilitative interventions; 2. Clinical skills and expertise of the health professional; 3. Consideration of the patient’s values and expectations. Developed as a reaction against poorly designed observational research and clinical decisions based solely on physicians’ personal experience, consolidated habits or experts’ dogmas, EBM represents a formalized methodology yielding a more rigorous approach to care. As a cultural movement, EBM has progressively spread worldwide, favored by some factors that put a strain on traditional models of medicine: ● The limited transfer of research results into healthcare, as made apparent by the wide variability in clinical practice and results, the inappropriate use and/ or overuse of some treatments and the persistent use of ineffective treatments; ● The economic crisis of health systems, coming with demand growth and increasing costs of healthcare (especially “low-value healthcare”); ● The increasing awareness of citizens about health and healthcare services; ● Groundbreaking innovations in information and communication technology and the exponential growth in volume and complexity of biomedical information, making continuing professional updating harder for the individual clinician.

In most cases, diagnosis, prognosis and results of a treatment are uncertain for individual patients, and must therefore be expressed as probabilities. The probability for a single patient can be estimated using past experience with groups of similar patients. However, as clinical observations apply to different individuals and are performed by different clinicians, they can be easily affected by systematic errors (biases). Also, all clinical observations may be influenced by chance. In order to avoid mistaken conclusions, clinicians must rely on observations based on solid scientific principles, including methods to reduce bias and estimate the role of chance. In the logic of EBM, the use of a treatment cannot be supported just by its plausibility. It requires evidence that the treatment is effective and modifies patient-relevant outcomes. Improvements in research design, clinical measurements, and methods for analyzing data have led to a better understanding of how to produce valid clinical research. Building on this, EBM presents itself as a self-learning process for clinicians, who should be eager to search the literature for valid, relevant and updated information, in order to fill their own knowledge gaps and provide the best care to their patients. Explicit aims of EBM are: ● to provide a reference of excellence to guide clinical decisions; ● to give a valid approach for medical interventions; ● to favor integration of one’s own experience with peers’ expertise and patient preferences; ● to identify gold standards and differentiate among different alternatives; ● to improve medical practice and limit the variability and errors produced by lack of evidence. The following key milestones in the development of EBM can be identified: ● 1830: Pierre Charles Alexandre Louis, in Paris, strived to promote a “Médecine d’Observation”, claiming that physicians should not rely on their individual experiences or speculations about causes of disease but rather decide based on systematic observation of patients and quantitative estimates of therapeutic effects;

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● 1972: in his book Effectiveness & Efficiency: Random Reflections on Health Services, Archibald Cochrane lamented the lack of available and updated critical reviews of the effects of healthcare; ● 1981: a group of clinical epidemiologists at McMaster University (Hamilton, Ontario, Canada), led by David Sackett, published the first of a series of articles (“How to read clinical journals”) in the Canadian Medical Association Journal about critical appraisal of medical literature ● 1991: the actual term “evidence-based medicine” made its first appearance in an article of the American College of Physicians Journal Club by Gordon Guyatt; ● 1993: the Cochrane Collaboration was founded by Ian Chalmers and a group of 70 other international colleagues, with the goal to create and disseminate up-to-date reviews of randomized controlled trials of healthcare interventions and help healthcare professionals make informed decisions; ● 1997: Muir Gray introduced evidence-​ based healthcare (EBHC), an extension of EBM into prevention and healthcare management, shifting from individual care to population health. EBHC applies the best available evidence about the effectiveness of healthcare interventions for informed health planning while considering sociocultural values and economic resources; ● 2005: EBM had widely extended across all health professions and was therefore replaced by evidence-based practice (EBP). In the Sicily statement on evidence-based practice (Dawes et al., 2005), the core-curriculum of EBP was defined as including: understanding the principles of EBP, recognizing it in action, implementing evidence-based policies, and having a critical attitude to one’s own practice and to evidence. The practice of EBM involves five essential steps: 1. Formulating answerable questions embodying patient’s needs and information gaps. If assessing clinical interventions, these should be structured following the “PICO” model and include: Patient characteristics, Intervention under Pietro Magnoni

consideration, Comparison with other possible options, and expected Outcomes. 2. Getting evidence from the published literature. Health professionals can refer to biomedical information databases such as MEDLINE, Embase, CINAHL, Cochrane Library, Clinical Evidence, TRIP Database. 3. Critically appraising evidence for its internal and external validity, clinical relevance, and consistency across studies. As the number of published papers in electronic databases grows exponentially, being aware of scientific methodology can help interpret and select high quality studies that are applicable to the situation at hand. Clinicians may exploit systematic reviews and guidelines made by others, while checking that they have been produced with explicit and rigorous methods. 4. Applying the results of the appraisal into clinical practice, integrating them with one’s own professional experience and the patient’s specifics. EBM cannot be separated from patient-based medicine: once the most appropriate treatment has been identified, it must be evaluated for suitability for the individual patient, considering their comorbidities, social conditions, preferences, and ability and willingness to undergo treatment. 5. Evaluating performance by assessing the outcome of the chosen intervention. EBM has been advocated as the key to the success of modern healthcare. It has created enormous benefits for population health. By separating useful from useless interventions and therapies, EBM has allowed to achieve extraordinary improvements in life expectancy and quality of life, including, but not limited to: ● providing the evidential basis for effective population-level control of risk factors for myocardial infarction and stroke; ● the administration of antenatal steroids to mothers in premature labor, that allowed to halve risk of respiratory distress syndrome in premature babies and to improve their long-term health; ● the introduction of laparoscopic surgery for bowel cancer patients as a technique that offered quicker recovery times, less

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pain and smaller scars compared to open surgery; ● the transformation of HIV from fatal infection to chronic disease; ● rigorous verification of cancer therapies and their substantial effects on outcomes. EBM must strive to overcome its limitations. At present, most clinicians and all scientific societies acknowledge that clinical practice should be informed by the best available evidence. In medical education, students and trainees are being increasingly educated on critical thinking, methods for literature research and critical appraisal of the published literature. Nonetheless, actual application of the EBM method is hampered by: ● intrinsic difficulties in gathering and evaluating scientific studies and transferring their results to a clinical case; ● persistent professional habits consolidated by routine; ● limited evidence in niche areas not much covered by research; ● limitations in transferability of results to population minorities, or to elderly patients who may be affected by multiple conditions with disease and drug interactions; ● risks associated with the production, dissemination and interpretation of scientific literature, such as: selective reporting and publication bias; misquotations or taking conclusions out of context; mistaking “no evidence of effect” for “evidence of no effect”; using observational studies for more than they were originally intended for; guidelines biased by institutional support, financial or material conflicts of interest. The greatest limit to application of EBM is resistance to change. Health professionals may perceive EBM-derived guidelines as “cookbook medicine” mining their professional authority. However, EBM emphasizes clinical judgment above blind following of rules, templates or guidelines. Another criticism pertains to the strict consideration of what constitutes good evidence, with patient narratives being usually excluded. This loss of the “patient’s voice” has led some clinicians to argue for a “narrative-based medicine”. Therefore, EBM might also be improved by broadening the

types of research conducted within its scope, and should include knowledge and expertise from diverse fields including cognitive psychology, sociology and economics. EBM, which is informed by meta-analyses or group-centered studies from which mean values or figures are derived to infer recommendations, also needs to be contrasted with precision medicine, a data-driven approach focusing on the individual. It is possible and desirable to bridge between the two, as they should be viewed as mutually complementary. This era of groundbreaking scientific developments in high-resolution, high-throughput technologies is allowing the cost-effective collection and analysis of huge, disparate datasets on individual health. Aggregation and meta-analyses of big data from cross-institutional and transnational large-scale registers and cohorts will allow to perform detailed analyses of very large population samples and draw robust inferences for stratified subgroups. Through collection, analyses and worldwide sharing of standardized medically relevant data, evidence-based precision medicine will shift progressively from therapy to prevention and lead to improved citizen-centered healthcare and sustained well-being. EBM integrates with evidence-based management to maximize quality in healthcare. Healthcare systems operate as complex adaptive systems. Although it may be difficult to isolate general phenomena and processes that can reasonably be claimed to underlie managerial practices, and there are limitations to how far findings can be generalized or transferred between different situations, adapting the principles of EBM to health management will help to apply innovation in a systematic way and improve the provision of care. As EBM reinforces clinicians’ skills and identifies clinical actions leading to better medical services, evidence-based health management recognizes hospital strategies, organization, and management practices to provide evidence-based medical services. It emphasizes the role of management and care leadership commitment, clinical staff engagement, organizational culture, knowledge of care processes, and continuous monitoring of indicators. Health management involves a variety of activities that include daily decision-making, such as prioritizing a specific direction in Pietro Magnoni

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relation to other possibilities. Here modern concepts of health economics may help in choosing the best option that is both clinicallyand cost-effective. EBM offers a scientific background and points out the most effective practices. It also helps healthcare providers to assess the strengths and limitations of cost-effectiveness studies and apply their results to real-world health services. Decision-making also includes correcting existing pathways or processes in order to guarantee their uniformity and high performance and improve quality of care. EBM merges with clinical quality improvement tools to create the concept of evidence-based quality improvement (“doing the right things right”). Finally, continuous performance measurement allows to adjust actions according to the best evidence available at a given time. Four strategies have been identified to foster evidence-based health management: ● focusing evidence-based decision-making on strategically important issues; ● developing committees and other structures to diffuse management research throughout organizations; ● building a management culture that values research; ● training managers in the competencies required to apply research evidence to decision-making in health management. Pietro Magnoni

Bibliography

Accad M, Francis D. Does evidence based medicine adversely affect clinical judgment? BMJ 2018; 362: k2799. Beckmann JS, Lew D. Reconciling evidence-based medicine and precision medicine in the era of

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big data: challenges and opportunities. Genome Med 2016; 8 (1): 134. Cartabellotta A. Gli sprechi della ricerca biomedica e la crisi dell’Evidence-based Medicine. Evidence 2014; 6 (9): e1000088. Cochrane A. Effectiveness & Efficiency: Random Reflections on Health Services. The Nuffield Trust, 1972. Dawes M, Summerskill W, Glasziou P, Cartabellotta A, Martin J, Hopayian K, Porzsolt F, Burls A, Osborne, J & Second International Conference of Evidence-Based Health Care Teachers and Developers. Sicily statement on evidence-based practice. BMC Medical Education 2005; 5 (1): 1. https://​ doi​ .org/​ 10​ .1186/​1472​-6920​-5​-1 Freddi G, Romàn-Pumar JL. Evidence-based medicine: what it can and cannot do. Ann Ist Super Sanita 2011; 47 (1): 22–25. Guyatt GH. Evidence-based medicine. ACP J Club. 1991; 114:A–16. Hasanpoor E, Janati A, Arab-Zozani M, Haghgoshayie E. Using the evidence-based medicine and evidence-based management to minimise overuse and maximise quality in healthcare: a hybrid perspective. BMJ Evid Based Med 2020; 25 (1): 3–5. Iovine R, Morosini P. Guida alla medicina basata sulle evidenze. Salute territ 2005; 152 (11): 264–284. Kovner AR, Rundall TG. Evidence-based management reconsidered. Front Health Serv Manage 2006; 22 (3): 3–22. Makdisse M, Katz M. Health management and evidence-based medicine. Einstein (Sao Paulo) 2013; 11 (3): IX–X. Sackett DL. How to read clinical journals: I. why to read them and how to start reading them critically. Canadian Medical Association Journal. 1981; 124 (5): 555–558. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312 (7023): 71–72. Sense About Science, Academy of Medical Royal Colleges. Evidence Based Medicine Matters: Examples of where EBM has benefitted patients. Sense About Science, London (2013). Stevens H. Evidence-based medicine from a social science perspective. Aust J Gen Pract 2018; 47 (12): 889–892.

40. From compliance to concordance The patient experience is a collection of broad interactions between many factors. Out of these factors, three definitions that make up patient experience tend to be the most prominent. These are: 1. ‘The delivery’ of the whole organisation: a factor which is linked to the interaction between the frontline workers and the patient; 2. The rational and/or emotional experience of the patient: which includes subcategories such as competence of staff and healthcare workers, the facilities they are surrounded by, and finally bedside etiquette; 3. The dealing with the ‘intuitive perception’ of the patients: which for example contains the ‘gut feelings’ drawn from quality of the accessories, visible cleanliness of bedding and seating, name tags oriented in the right way around’ etc. If we look further within the first two definitions, we can appreciate how compliance and competence may be relevant. These factors, compliance and concordance, not only affect the formation of patient experience itself but can also have an effect vice versa (being the result of patient experience). Compliance and concordance are factors which are not within the same spectrum of definitions. It becomes clearer when we look at the exact definitions of the two. Compliance refers to the ‘extent to which the patient’s behaviour matches the prescriber’s recommendations’ (Chakrabarti, 2014). It’s also important to distinguish compliance with adherence; a term differing due to the involvement of the patient in an active role as opposed to the passive role (seen in compliance). In the case of compliance, the beliefs of the patient are not contributed and may in fact be an obstacle to it. A patient’s compliance (and adherence) can be measured in a number of ways such as with prescription records, pharmacy dispensing data, validated surveys, electric pill counters, and serum drug levels. In addition, a systematic review analysed 13 research articles and concluded that factors such as patients’ ‘past experience’ with illness and therapy, ‘vicarious

experiences, beliefs, attitudes, and the treatment experience itself’ can all have an effect on compliance (and adherence) to therapy (Johnston, 2013). Concordance, on the other hand, being a relatively recent term, does not refer to a patient’s ability or behaviour when taking prescribed medicine, but rather the ‘nature of the interaction between clinician and patient’ (Chakrabarti, 2014). In other words, concordance focuses on the relationship between the patient and prescriber, which involves the degree to which the prescription represents a shared decision. A concordant process takes into account the whole beliefs, preferences, likes and dislikes of both parties, eventually reaching a shared and mutual decision but keeping the patient’s needs above all in this ‘therapeutic alliance’. There are still no accepted, valid and reliable tools to measure concordance, however it is now understood that concordance is meant to make compliance as a general interaction between physicians and patient ‘obsolete’. With emerging research within compliance, it is clear a target focused more on concordance rather than compliance leads to a healthier patient experience. Keeping these definitions in mind, a concordant interaction between patient and prescriber leads to a productive and positive patient experience. A positive patient experience in turn, is pivotal when it comes to adherence (seen specifically in patients with chronic conditions, in which a strong commitment from patients to work with their providers is essential for achieving positive results), compliance and significant clinical results. These clinical results refer to a positive correlation to processes of care for both disease prevention and management. As an example, a paper published on PubMed was able to support the hypothesis that a positive patient experience was correlated with an increased level of ‘self-management skills and quality of life’ in patients with diabetes (Adu et al., 2019). Another positive result seen in patients with well received patient experience is an overall improvement in health outcome. An article studying the effect of patient-centred care (a feature critical in concordance) on HIV infected patients published in 2006 reported that patient-centred care is significantly and independently associated with receiving antiretroviral therapy along with

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adherence (to ART), and presenting with low HIV RNA levels; thus, concluding that the ‘quality of patient-physician relationship is directly related to the health of patients’ (Beach et al., 2006). Furthermore to drive home this point another study published in 2001 was able to conclude that a positive patient experience within healthcare, in patients with acute myocardial infarction, was associated with ‘better health outcomes a year after discharge’ (Fremont et al., 2001). The effects of a superior patient experience is not only limited with a positive outcome in patients but also towards financial indicators within the healthcare sector. Examples of such financial indicators are fewer malpractice claims for primary care physicians, lesser numbers of employees leaving jobs (turnover) and less likelihood of disenrollment from a primary physician’s practice. To conclude, it is clear that our healthcare policies must be managed in a complex and intricate manner in order to lead to a positive clinical experience for patients, which in turn will lead to a beneficial impact not only to the patients and their health (and wellbeing) but to staff, employers and the healthcare sector as a whole. Compliance and concordance are key components that need to be addressed, which if done so correctly, can facilitate this interaction making the most use of its impact on healthcare and all parties involved. Bharat Nandakumar

Bibliography

Adu MD, Malabu UH, Malau-Aduli AEO, Malau-Aduli BS. Enablers and barriers to effective diabetes self-management: A multi-national investigation. PLoS One. 2019 Jun 5;14(6):e0217771. doi: 10.1371/journal. pone.0217771. PMID: 31166971; PMCID: PMC6550406. Beach MC, Keruly J, Moore RD. Is the quality of the patient–provider relationship associated with better adherence and health outcomes for patients with HIV? J Gen Intern Med. 2006 Jun;21(6):661‒5. doi: 10.1111/j.1525-1 497.2006.00399.x. PMID: 16808754; PMCID: PMC1924639. Bell JS, Airaksinen MS, Lyles A, Chen TF, Aslani P. Concordance is not synonymous with compliance or adherence. Br J Clin Pharmacol. 2007 Nov;64(5):710‒1; author reply 711‒3.

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doi: 10.1111/j.1365-2125.2007.02971_1.x. Epub 2007 Sep 13. PMID: 17875196; PMCID: PMC2203263. Chakrabarti S. What’s in a name? Compliance, adherence and concordance in chronic psychiatric disorders. World Journal of Psychiatry. 2014;4(2): 30–36. https://​doi​.org/​10​.5498/​wjp​ .v4​.i2​.30 European Patient Forum (2015). Adherence and Concordance – EPF Position Paper. https://​ www​.eu​-patient​.eu/​globalassets/​policy/​ adherence​-compliance​-concordance/​adherence​ -paper​-final​-rev​_external​.pdf Fremont AM, Cleary PD, Hargraves JL. et al. Patient-centered processes of care and long-term outcomes of myocardial infarction. J Gen Intern Med. 2001;16:800–8. https://​doi​ .org/​10​.1046/​j​.1525​-1497​.2001​.10102​.x Greenfield S, Kaplan HS, Ware JE Jr et al. Patients’ participation in medical care: Effects on blood sugar control and quality of life in diabetes. J Gen Intern Med. 1988;3:448‒57. Johnston BJ. The role of patient experience and its influence on adherence to antidepressant treatment. Journal of Psychosocial Nursing and Mental Health Services. 2013;51(12):29–37. https://​doi​.org/​10​.3928/​02793695​-20130930​ -04 Levinson W, Roter DL, Mullooly JP, Dull VT, Frankel RM. Physician-patient communication. The relationship with malpractice claims among primary care physicians and surgeons. JAMA. 1997;277(7):553–9. https://​doi​.org/​10​ .1001/​jama​.277​.7​.553 Osterberg L, Blaschke, T. Adherence to medication. The New England Journal of Medicine. 2005;353:487‒97 DOI: 10.1056/ NEJMra050100 Rave N, Geyer M, Reeder B, Ernst J, Goldberg L, Barnard C. Radical systems change. Innovative strategies to improve patient satisfaction. The Journal of Ambulatory Care Management. 2003;26(2):159–74. https://​doi​.org/​10​.1097/​ 00004479​-200304000​-00008 Safran DG, Montgomery JE, Chang H et al. Switching doctors: predictors of voluntary disenrollment from a primary physician’s practice. J Fam Pract. 2001;50(2):130‒6. Segal JZ. ‘Compliance’ to ‘concordance’: a critical view. The Journal of Medical Humanities. 2007;28(2):81–96. https://​doi​.org/​10​.1007/​ s10912​-007​-9030​-4 Sequist TD, Schneider EC, Anastario M et al. Quality monitoring of physicians: linking patients' experiences of care to clinical quality and outcomes. J Gen Intern Med. 2008;23(11):1784–90.

41. Gender medicine Gender medicine is the area of medicine involved in understanding the differences and the similarities between male and females of all ages from the physiological point of view, in the area of prevention, in clinical signs, in therapy, in responses to drugs, in the social, psychological and prognostic impact. It also means to arrive at a more appropriate and greater efficiency and equity in health. Gender medicine has not to be considered as a single specialty but as an extensive approach of every single specialty. Its original name was “sex and gender medicine” evidencing the difference that there is between the two terms; the term “sex” refers to the genetic and biological features, it’s possible to define the difference between males and females but also to get the biological difference between cells, tissues and animals. On the other side “gender” refers to something that is unique to humans, and involves the economic, social role and cultural vision of individuals; so it’s not possible to say that genders are two but they are the sum of the many different conditions that defines a person such as sex, age, ethnic, social, economic and life conditions. It’s fundamental to get this difference when dealing with gender medicine and generally many misunderstandings between “sex and gender” words arise in people that are not deeply involved in the field. To make a more concrete example sex can refer to the biological markers while gender can reflect in the psychological and cultural behavior. The field is very young and only at the beginning of the 1990s can be identified the increased interest in the topic that then led to an effective production of papers and creation of organizations all around the world. At the moment it still meets difficulties in acquiring the importance that it deserves but the correct path has been taken in many different countries. Also of note is the huge difference in number of publications and interest between the medical specialties. Only in 2006 was the International Society of Gender Medicine (IGM) founded, now counting more than 1000 members all around the world. Apart from international congresses the society is sponsoring many workshops and scientific meetings.

Looking at literature, the number of Italian physicians involved in the field is impressive, publishing papers and organizing international meetings. Analyzing the situation, it’s interesting and motivating seeing the primary role that the country has in gender medicine. Indeed, Italy was the first country in the world to have a healthcare plan and a law for the development of specificity and gender equity in health; the major people responsible have been the two senators Lorenzin and Boldrini; they were at the base of the law regulating the implementation of gender-specific medicine, definitively approved at the beginning of 2018. The plan that follows from it has a holistic approach and doesn’t want to have an exclusive medical field but it has to involve also biologists, psychologists, healthcare managers, not forgetting the private companies, such as the pharmaceutical ones. The regional authorities, that in Italy are responsible for the health system, must coordinate the development of networks between universities, agencies and professionals. Still focusing on Italy, 2009 has to be indicated as the date in which thanks to the cooperation between experts, the university hospital of Padua and the Giovanni Lorenzin medical science foundation, was born the national research center for gender health and medicine; its role is to increase the speed with which health professionals accept and incorporate in their way of thinking the gender medicine in everyday working life. The center is also part of the international society of gender medicine and the president of the association sits on the board of that organization. The Italian national institute of health (ISS) got into action even before with the creation of a specific structure in 2007 that deals with gender differences and the “Women health specific project” that focused on 25 operational units all around Italy in five different areas: metabolic and cardiovascular diseases, immunity and endocrinology, work environment, iatrogenic diseases and adverse reactions and determinants of women’s health. The goal of these was to develop healthcare that takes account of gender differences, gender-targeted prevention protocols, specific guidelines and environmental influences on health. Personalized medicine is the goal of modern medicine and the first step of it is gender medicine; but still there are many dif-

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ficulties when trying to render gender medicine a part of the normal clinical life. First, there is still a lack of knowledge regarding all the similarities or the differences between men and women; second, there is a gender bias that, even if it’s decreasing year by year, remains a big social obstacle. An example of a method to overcome difficulties is the one adopted by the US national institute of health (NIH) in 2014; they specified that researchers in all the NIH funded preclinical research should account for sex and have to consider sex as a biological variable. If on one side there are still many obstacles to overcome, on the other side it’s possible to see the path to follow to defeat them; according to Marianne J. Legato (2017), one of the principal experts worldwide in gender medicine, the most effective way to make people be aware, interested, passionate and use daily gender medicine is to expose them to data and try to find sponsorships to increase the production of data, because the astonishing results that are now available totally change the way people think and interpret the approach to the patient. The first area in which gender medicine focused was cardiovascular diseases. Taking into consideration Acute Myocardial Infraction (AMI), as expected by what has been said above, pathophysiology, clinical presentation and clinical outcome are all influenced by sex differences. To be more concrete, females continue to experience higher post-AMI mortality and globally poorer outcomes despite the improvements in treatment due to the fact that most cardiovascular studies have been primarily based on males. Regarding ST Elevation Myocardial Infarction (STEMI), for example, the in-hospital death is 3.2% for males and 8.4% for females. Coronary heart disease is under-recognized in women, in particular in younger age and diabetes groups of patients; due to the fact that women are less likely than men to have typical angina and more likely to have atypical or non-anginal pain. The ones above are just some of the many examples in cardiovascular diseases; the same can be done in many other specialties and in future it’s desirable that all the specialties will be full of studies regarding these differences and will align their approach to the patient based on these. Eduardo Marra

There are also differences in the way drugs act, involving the pharmacodynamic and the pharmacokinetics aspect. The efficacy and the safety profile are totally different. The final goal would be to have drug leaflets that differ for males and females in the dosage to take. To cite one of the many different studies, von Moltke and Greenblatt (2003) focused on drugs metabolized only by CYP3A4 and found out a remarkable influence that gender has on CYP3A4, with the mean for female/male ration of clearance difference that was significantly divergent and 20‒30% higher in women than men (von Moltke, Greenblatt. 2003). To conclude, in a world in which the differences of sex and gender are at the base of many discussions and are one of the main aspects of the political discussion, it’s a big opportunity for medicine to give the example and train this epochal change. Increase the interest, the studies and the financing to go in depth into this topic must be the goal of medicine to guarantee a better and safer future for all the patients in all specialties. Eduardo Marra

Bibliography

Baggio G, Corsini A, Floreani A, Giannini S, Zagonel V. Gender medicine: a task for the third millennium. Clinical Chemistry and Laboratory Medicine 2013;51(4): 713‒727. Baggio G, Malorni W. The Italian law on gender medicine: a reality and a hopeInizio modulo. Ital J Gender-Specific Med 2019;5(3):105‒107. Gemmati D, Varani K, Bramanti B et al. “Bridging the gap”: everything that could have been avoided if we had applied gender medicine, pharmacogenetics and personalized medicine in the gender-omics and sex-omics era. Int J Mol Sci 2019;21(1):296. doi:10.3390/ijms21010296Fine modulo Grego S, Pasotti E, Moccetti T, Maggioni AP. “Sex and gender medicine”: il principio della medicina di genere [Sex and gender medicine: the foundation of gender medicine]. G Ital Cardiol (Rome) 2020 Aug;21(8):602‒606. doi: 10.1714/3405.33894 Legato M. (2017). Principles of Gender-Specific Medicine. Academic Press. ISBN: 9780128035061 Lippi D, Bianucci R, Donell S. Gender medicine: its historical roots. Postgraduate Medical Journal 2020;96:480‒486. von Moltke LL, Greenblatt DJ. Medication dependence and anxiety. Dialogues in Clinical Neuroscience 2003;5(3):237–245. https://​doi​ .org/​10​.31887/​DCNS​.2003​.5​.3/​lvonmoltke

42. Global health Global Health concerns the health needs of the entire population of the world. In 2009, a possible definition of Global Health was given in the Lancet as: an area for study, research, and practice that places a priority on improving health and achieving equity in health for all people worldwide. Global Health emphasizes transnational health issues, determinants, and solutions; involves many disciplines within and beyond the health sciences and promotes interdisciplinary collaboration; and is a synthesis of population-based prevention with individual-level clinical care. (Koplan et al., 2009, p. 1995) In 2010 in the international journal Global Health Action (Beaglehole and Bonita, 2010) introduced a definition that uses key concepts such as those of collaboration, research, action, promotion and finally that of Health for all with the aim of emphasizing these concepts to underline their importance. A further contribution to the definition of Global Health was made in 2016 by Wernli et al. who rethought the concept of Global Health, defining it as: “a system–based, ecological and transdisciplinary approach to research, education, and practice which seeks to provide innovative, integrated, and sustainable solutions to address complex health problems across national boundaries and improve health for all” with the aim of reducing the age-old gap between medicine and public health. In this context, health is understood as a state of bio-psycho-social well-being and as a fundamental human right, the result of processes that are not only biological but also economic, social, political, cultural and environmental. Global Health aims to seek multidisciplinary and multi-sector solutions ranging from prevention, health promotion, treatment, and rehabilitation. The approach is based on knowledge of the various factors that influence the health status of an individual or a community (determinants of health as behavioral, socioeconomic, cultural, environmental, living and working conditions). Global Health puts particular attention on the analysis of health inequalities, which are present in terms of life expectancy, disease, and disability both within and between countries. The Global Health approach promotes

the strengthening of health systems from a universalistic perspective with reforms geared toward equity, solidarity, sustainability and social inclusion. Despite continued increases in average health levels, there are important differences in life expectancy, disease and disability both within and between countries. These differences, if not justified by a biological basis, can be avoided and contrasted through an approach of collaboration and integration between different health and non-health policies, promoting the strengthening of health systems from a global perspective with the objective of equity, solidarity, sustainability and social inclusion. Global Health is not only linked to geographic location but embraces health issues that affect many countries such as climate change, urbanization, and migration. It can address global solutions such as vaccinations, polio eradication, epidemic infectious diseases such as Dengue, Influenza A (H5N1) or HIV. But it should also address global problems such as tobacco control, micronutrient deficiencies, obesity, injury prevention and the health of migrant workers. The concept of Global Health was preceded by those of public health and then of international health. More than a century ago, from the second half of the 1800s to the 1950s/60s was introduced the concept of “public health” which on a clinical level corresponded to tropical medicine. This was because it was during the colonization phase and as far as public health was concerned it was in the post industrialization age, in the period that saw how the health of populations was equally as important as individual health. From the post-war period we move to the concept of international health that focuses on international aid, cooperation between one country and another and lasts until the end of the Cold War, then we enter the era of globalization, and we start talking about the concept of “Global Health”. Global Health is the science that deals with issues of equity, and access and inequality in access to health. It focuses on issues that directly or indirectly affect health but can transcend national boundaries so finding solutions often involves global cooperation. The main goal is health equity for all people. An important point in the history of Global Health occurred with the creation of the

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WHO. The WHO was established in 1948, a foundation on the constitution of 1946, as a United Nations agency specializing in health issues that includes 149 Member States. Its role is one of leadership and partnership with other agencies that promote health. It formulates health policies of even very technical guidelines. It performs monitoring, future assessments and statistics, and research on major diseases and conditions worldwide. Finally, it gives technical support to countries. The WHO works on the Sustainable Development Goals formulated in 2015 valid until 2030, which are 17 essential elements that represent common goals on important issues for global development. Among the various goals, the third, “good health”, directly concerns health and specifies the targets to be achieved. Its aim is to “ensure healthy lives and promote well-being for all at all ages”. This goal contributes to all the other goals that represent different areas of development but are all related to health. One of the great functions of WHO is to protect the world’s health through the “International Health Regulations” formulated in 2005 that indicate the importance of identifying risk, assessing it, notifying it, and addressing it. They are a tool of international legislation with the purpose of protecting health globally. They require each country to make an annual self-assessment report of its own conditions with respect to pandemics or health emergencies. It is not limited to specific diseases but applies to new and evolving public health risks and implies an

Giovanna Clerici

international response to the emergency and spread of the disease. The new era of the Global Health will be linked to all the important and rapid transitions: demographic, economic and consequently epidemiological, with the need to become increasingly precise in addressing the issues and on the question of investments within their own countries. To face the new problems linked to Global Health, the WHO will have to increase its capacity to declare health emergencies and ensure that there is an adequate response to pandemics. It will need to rethink and modernize its surveillance systems, and lead countries in achieving universal health coverage and better strategic communication. Giovanna Clerici

Bibliography

Beaglehole, Robert, and Ruth Bonita. “What is Global Health?” Global health action 3.1 (2010): 5142. Brown, Theodore M, Marcos Cueto, and Elizabeth Fee. “The World Health Organization and the Transition From ‘International’ to ‘Global’ Public Health.” American journal of public health 96.1 (2006): 62–72. Koplan, Jeffrey P et al. “Towards a Common Definition of Global Health.” The Lancet (British edition) 373.9679 (2009): 1993–1995. Wernli, Didier et al. “Moving Global Health Forward in Academic Institutions.” Journal of global health 6.1 (2016): 010409. WHO (2016). International Health Regulations (2005) Third Edition. ISBN: 9789241580496 Yach, D. “The Globalization of Public Health, I: Threats and Opportunities.” American journal of public health 88.5 (1998): 735–8; discussion 742.

43. Health literacy The concept of health literacy was born in the seventies to indicate the ability of individuals to read often and understand written health material and at the beginning it spread mainly in the clinical setting in the USA, given that the coexistence between numerous ethnic groups was the cause of misunderstandings between healthcare personnel and patients. In 1998 the WHO framed health literacy in the dimension of “life skills” and defined it in general as the achievement of a level of knowledge, skills and superiority useful for undertaking actions aimed at improving personal and community health, also promoting modification conditions and lifestyles. Over the past two decades this concept has further expanded and has become increasingly important due to its implications in terms of individual health, public health, sustainability of health systems and global health, so much so that the WHO itself considers it a key tool for the achievement of various objectives in the current era of the SDGs. Despite the awareness of the importance of the topic, still today there is a lack of consensus regarding its definition (there are over 250 different definitions in the academic literature) and it can already be anticipated that unfortunately this extreme flexibility of meaning limits the development and the implementation of adequate measurement systems and interventions aimed at improving it. The authors of a systematic review in 2020 (Liu et al., 2020) proposed to define health literacy as “the ability of an individual to obtain and translate knowledge and information, in order to maintain and improve health in an appropriate way to individual and system contexts”. This definition includes the three key issues of health literacy: 1. Knowledge of health, healthcare and health systems; 2. Processing and use of information in various formats relating to health and healthcare; 3. Ability to maintain health both through self-management and in collaboration with health professionals. Health literacy requires both a complex group of skills (listening, reading, calculating, ana-

lyzing, decision-making,…), and the ability to apply these skills to health situations. In an age in which the patient interfaces with complex health information and even more difficult therapeutic choices, appropriate health literacy allows you to correctly access health services, correctly analyze the risks and benefits, calculate dosages, communicate accurately with professionals, interpret test results and evaluate health information for quality/credibility in a critical and informed manner. The most vulnerable categories are therefore represented for different reasons by the elderly, migrants, ethnic minorities and the lower income segment of the population. The level of individual and community health literacy is therefore influenced by multiple factors. Among these we find: age, gender, literacy, knowledge and command of the language, level of education, job occupation, socio-economic level, cultural background, previous illness experiences, presence of physical disabilities/cognitive deficits. The family, social and environmental context in which one lives is also an important determinant, in fact it can have a negative impact on the level of health literacy or vice versa allow for improvement, especially if it guarantees good communication and usability of information relevant to the health context. A low level of health literacy is closely linked to worse clinical outcomes and increased healthcare costs, both for the individual and for society. Patients with poor health literacy have greater difficulties in understanding health information, greater exposure to risk factors, poor adherence to vaccination/screening campaigns, limited knowledge about diseases, less adherence to prescribed drugs, insufficient and ineffective use of healthcare, inability to self-manage and greater errors, worse health conditions and higher risk of access to the emergency room, hospitalization and death. Poor health literacy has been associated with reduced capacity for self-management and self-efficacy especially in cardiovascular, respiratory, musculoskeletal diseases and diabetes; therefore, in recent decades, health literacy appears to be one of the most promising and economic approaches to overcome the challenges in the management of Non Communicable Diseases (NCDs), which are

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increasingly growing due to the global demographic and epidemiological transition. However, the rapid development of the SARS-CoV-2 pandemic has shown that health literacy is as important in the prevention and management of communicable diseases as it is for noncommunicable diseases. Health literacy is a highly underestimated public health problem globally. Only with its improvement is it possible to help the citizen to grasp the reasons behind the recommendations, to discriminate reliable information from wrong and contradictory information and to reflect on the results of their actions. The consequences of poor health literacy make it clear how important it is for the future to take into consideration the ways in which health information is offered; it is necessary to generate an adequate environment (systems, organizations, procedures, local/​ regional/​national protocols) and to develop adequate campaigns to simplify the research, understanding, evaluation and application of health information for all citizens. It is equally essential to raise awareness among professionals on the issue of health literacy, so that they develop skills to correctly identify the patient’s or caregiver’s level of health literacy and actively act to adopt appropriate communication strategies. The specific empowerment of the individual/caregiver, in the perspective of Patient Centered Care, makes it possible to increase the appropriateness of interventions, increase the resilience of home care and make users able to face the health demands and challenges of daily life. The improvement of knowledge, skills and motivations underlying health literacy leads to an increase in levels of autonomy and a mature empowerment, based on direct knowledge of the phenomena to implement self-management of one’s health and active

Sara Garlini

participation in the path of care. In this vision, therefore, health literacy must be seen as an important determinant of health, which has a strong impact on the equity and sustainability of health systems and, more broadly, on the opportunities for improving the quality of life of populations and individuals. The increase in health literacy levels should be, from my point of view, one of the priority challenges for the future. Sara Garlini

Bibliography

Berkman ND., Sheridan SL, Donahue KE et al. Low Health Literacy and Health Outcomes: An Updated Systematic Review. Ann Intern Med. 2011;155:97‒107 https://​www​.researchgate​ .net/​profile/​Katrina​-Donahue/​publication/​ 51501673​_Low​_Health​_Literacy​_and​_Health​ _Outcomes​_An​_Updated​_Systematic​_Review/​ links/​0912f​50c75cf069​c70000000/​Low​-Health​ -Literacy​-and​-Health​-Outcomes​-An​-Updated​ -Systematic​-Review​.pdf http://​careonline​.it/​wp​-content/​uploads/​2017/​12/​ Health​_Literacy​_Care​_6​_2017​.pdf https://​nnlm​.gov/​initiatives/​topics/​health​-literacy​ #toc​-2 https://​www​.nursetimes​.org/​health​-literacy​ -metodo​-e​-strumento​-per​-la​-promozione​-della​ -salute/​75749 Liu C, Wang D, Liu C, et al. What is the Meaning of Health Literacy? A Systematic Review and Qualitative Synthesis. Fam Med Community Health. 2020;8(2):e000351 https://​www​.ncbi​ .nlm​.nih​.gov/​pmc/​articles/​PMC7239702/​ Mackey LM, Doody C, Werner EL, Fullen B. Self-Management Skills in Chronic Disease Management: What Role Does Health Literacy Have? Med Decis Making. 2016 Aug;36(6):741‒59. https://​pubmed​.ncbi​.nlm​ .nih​.gov/​27053527/​ Paakkari, L et al. COVID-19: Health Literacy is an Underestimated Problem. The Lancet Public Health. 2020;5(5):e249‒e250 https://​ www​.thelancet​.com/​journals/​lanpub/​article/​ PIIS2468​-2667(20)30086​-4/​fulltext

44. Initiative medicine Today, our world of healthcare is quickly transforming from a reactive to a proactive system. Proactive medicine aims to keep people healthy, and reactive medicine aims to cure people after they become ill. Initiative medicine is another word for describing the proactive system approach, where it is the health system that takes the initiative step to improve the quality of the health service provided to an individual and the population in general. Globally, most health systems are designed as a “sick care” system. This system, for the most part, was not designed to help prevent the onset of disease but rather to diagnose and treat the illness. So, the health system plays a big role only when the person comes in already sick. This reactive approach to healthcare is both expensive, and, to some degree, ineffective in meeting the needs of today’s population. Proactive medicine invests more time and resources up front, to prevent illness if possible, to detect and treat it early when it is cheaper and more effective, and to manage chronic disease before it progresses and causes complications which can be irreversible. It helps patients holistically by addressing their social and physical environment and mental as well as physical health. Healthcare is undergoing a profound revolution as a consequence of three contemporary thrusts: systems medicine, big data, and patient involvement in their own health through social networks. Systems medicine is focused on developing biological, technical, and computational tools to decipher the complexities of disease. It integrates multiscale biological information into predictive and actionable models. It provides key strategies and technologies for deciphering the complexities of disease. Big Data refers to new technologies providing management and processing capabilities, targeting massive and disparate data sets. It offers the promise of large-scale analysis of outcomes, patterns, temporal trends, and correlations. The evolution of Big Data analytics moves us from description and reporting to forecasting, predictive modelling, and decision optimization. This convergence is leading to the healthcare landscape to experience a tremendous

paradigm shift to a new framework defined by the P4 of medicine: Predictive Medicine, Preventive Medicine, Personalized Medicine and Participatory Medicine. These categories are set to modify the existing healthcare paradigm, elevate healthcare competency, reduce costs, and help move our healthcare system from reactive to preventive and proactive. Predictive Medicine – It is a branch of medicine that aims to identify patients at risk of developing a disease, thereby enabling either prevention or early treatment of that disease. The goal of predictive medicine is obtaining and cataloguing characteristics about individual patients, analysing the data to predict the patient’s individual risk for an outcome of interest, predicting which treatment in which individual will be most effective, and then intervening before the outcome occurs. It entails predicting the probability of disease and instituting preventive measures to either prevent the disease altogether or significantly decrease its impact upon the patient. It is a relatively new subspecialty in healthcare, yet the concept itself is not novel. In the most basic terms, predictive medicine utilizes specific laboratory and genetic tests to determine an individual’s probability of developing a disease. We can be the present day witness of the leaps medical science has taken with the help of genetics. It has revolutionized medicine and has not only improved our predicting ability, for example the BRCA gene and breast cancer, but has also opened up a world of targeted therapy against specific molecular factors. However, the major barriers of genetics-based prediction medicine is the high cost and the multifactorial etiology of most of the diseases that are prevalent in the population. Preventive Medicine – They are medical practices that are designed to avert and avoid a disease. It takes a proactive approach to patient care. The aim of preventive medicine is the absence of disease, either by preventing the occurrence of a disease or by halting a disease and averting resulting complications after its onset. Disease and disability are affected by environmental factors, genetic predisposition, disease agents, and lifestyle choices and are dynamic processes which begin before individuals realize they are affected. Disease prevention relies on anticipatory actions that can be categorized as primal, primary, sec-

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ondary, and tertiary prevention. Each level of prevention is summarized as: Primal and Primordial Prevention: Primordial prevention refers to measures designed to avoid the development of risk factors in the first place, early in life. Primary Prevention: Methods to avoid occurrence of disease either through eliminating disease agents or increasing resistance to disease. Examples include immunization against disease, maintaining a healthy diet and exercise regimen, and avoiding smoking. Secondary Prevention: Methods to detect and address an existing disease prior to the appearance of symptoms. Examples include treatment of hypertension (a risk factor for many cardiovascular diseases) and cancer screenings. Tertiary Prevention: Methods to reduce the harm of symptomatic disease, such as disability or death, through rehabilitation and treatment. Examples include surgical procedures that halt the spread or progression of disease. Quaternary Prevention: Methods to mitigate or avoid results of unnecessary or excessive interventions in the health system, including potential violations of rights. The modern preventive medicine and the promotion and protection of health require an understanding of the interactions between host, agent, and environment which can be called the ecology of health-related human behaviour. The avoidable health problems that are prevalent in the general population can be due to individual bad behaviour like smoking, unhealthy diet, sedentary lifestyle, alcohol consumption, overweight or obesity, drug abuse, or it can be due to environmental factors like infectious pathogens, air pollution, unsafe water, poor sanitation, malnourishment and so on. The goal of preventive medicine is to work on the avoidable aspect of the disease. One of the best ways to do that is to increase awareness in the general population about the impact of the choices they make, on their health. Awareness motivates individuals to practise their own prevention by taking measures to protect their own health, and “motivation” is the key word in modern day preventive medicine. Personalized Medicine – Personalized medicine is rooted in the belief that since individuals possess nuanced and unique characteristics at the molecular, physiological, environmental exposure, and behavioural Preetha Karki

levels, they may need to have interventions provided to them for diseases they possess that are tailored to these nuanced and unique characteristics. This belief has been verified to some degree through the application of emerging technologies such as DNA sequencing, proteomics, imaging protocols, and wireless health monitoring devices, which have revealed great inter-individual variation in disease processes. The medicine forefront nowadays has been to tailor the needs of individual patients and cater to them to have an overall better healthcare system. An example is dosing of some drugs on an individualized basis based on age, body-mass index, comorbidities, and other clinical parameters. However, overall, medicine has largely followed the “one-size-fits-all” paradigm until now. Precision medicine can be defined as personalized medicine enhanced by technology. We have leaps in technology that can assess a multitude of complex measurements on clinical samples and when aided by analytics, have motivated a more personalized or “precision” approach to medicine, in which molecular and cellular markers help tailor patient management to each individual. Participatory Medicine – Participatory medicine is about patient empowerment. It entails a genuine shift of power from traditional experts to patients and their families and friends. It increases the space within which patients and their families and friends can make decisions that are meaningful to them, embedded in infrastructures that are socially just and represent the broadest of interests. They do this by improving medical literacy, by enabling patients to engage with data and information that are relevant to them, to connect with others who may have relevant experience or expertise, or by facilitating mutual support. A better picture of “genuine” participatory medicine is when a patient can make choices about their healthcare from unlimited sources of possibilities while respecting their autonomy and choices. However, people’s freedoms are inevitably limited by the means and resources available to them. Implementation of the P4 system is not possible until individuals are actively aware about their health and participate to better it. P4 medicine, the clinical face of initiative/ proactive medicine, has two major objectives: to quantify wellness and to demys-

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tify disease. Patients and consumers will be a major driver in the realization of P4 medicine through their participation in medically oriented social networks, directed at improving their own healthcare. Taking a more active role in one’s own health and making healthy lifestyle changes that support the wellness of our whole being is at the basis of Initiative Medicine. Preetha Karki

healthcare. Genome med, 5, 110. https://​ doi​ .org/​10​.1186/​gm514 Hood, L., & Flores, M. (2012). A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. New biotechnology, 29(6), 613‒624. ISSN 1871-6784. https://​ doi​.org/​10​.1016/​j​.nbt​.2012​.03​.004. Jen, M. Y., Shahrokhi, M., & Varacallo, M. (2021). Predictive Medicine. StatPearls Publishing. Murdoch, T. B., & Detsky, A. S. (2013). The inevitable application of big data to health care. JAMA, 309(13), 1351–1352. https://​doi​.org/​10​ .1001/​jama​.2013​.393 Bibliography Auffray, C., Charron, D., & Hood, L. (2010). OH Blog (2020). The shift from reactive to proactive care. Orion Health. https://​blog​.orionhealth​ Predictive, preventive, personalized and partic.com/​the​-shift​-from​-reactive​-to​-proactive​-care/​ ipatory medicine: back to the future. Genome Peters, S. G., & Buntrock, J. D. (2014). Big med, 2, 57. https://​doi​.org/​10​.1186/​gm178 data and the electronic health record. The Beim, P. Y., Elashoff, M., & Hu-Seliger, T. T. journal of ambulatory care management, (2013). Personalized reproductive medicine on 37(3), 206–210. https://​doi​.org/​10​.1097/​JAC​ the brink: progress, opportunities and chal.0000000000000037 lenges ahead. Reproductive biomedicine online, 27(6), 611–623. https://​doi​.org/​10​.1016/​j​.rbmo​ Prainsack, B. (2014). The powers of participatory medicine. PLoS biol, 12(4), e1001837. https://​ .2013​.09​.010 doi​.org/​10​.1371/​journal​.pbio​.1001837 Clarke, E. A. (1974). What is preventive medicine?. Canadian family physician/​Medecin de Schork, N. J. (2019). Artificial intelligence and personalized medicine. Cancer treatment and famille canadien, 20(11), 65–68. research, 178, 265–283. https://​doi​.org/​10​ Colburn, H. N., & Baker, P. M. (1973). Health .1007/​978​-3​-030​-16391​-4​_11 hazard appraisal: a possible tool in health protection and promotion. Canadian journal of Sigman, M. (2018). Introduction: Personalized medicine: what is it and what are the chalpublic health/​ Revue Canadienne de Sante’e lenges? Fertility and sterility, 109(6), 944–945. Publique, 64(5), 490–492. http://​ www​ .jstor​ https://​doi​.org/​10​.1016/​j​.fertnstert​.2018​.04​.027 .org/​stable/​41987201 Elemento, O. (2020). The future of precision Stöppler, M. C. (2021). Medical definition of preventive medicine. Medicine Net. https://​ medicine: towards a more predictive personalwww​.medicinenet​.com/​preventive​_medicine/​ ized medicine. Emerging topics in life sciences, definition​.htm 4(2), 175–177. https://​doi​.org/​10​.1042/​ET​LS​ Terzi, O. O. (2019). The genese of 20190197 predictive-personified medicine and the Goetz, L. H., & Schork, N. J. (2018). Personalized problems of its implementation in Ukraine. medicine: motivation, challenges, and progress. Wiadomosci lekarskie (Warsaw, Poland: 1960), Fertility and sterility, 109(6), 952–963. https://​ 72(1), 99–102. doi​.org/​10​.1016/​j​.fertnstert​.2018​.05​.006 Hood, L., & Auffray, C. (2013). Participatory Warren, M. (2018). The approach to predictive medicine that is taking genomics research by medicine: a driving force for revolutionizing storm. Nature, 562(7726), 181–183. https://​doi​ .org/​10​.1038/​d41586​-018​-06956​-3

Preetha Karki

45. Integrated care Integrated care is a concept bringing together different health and social care services that patients may receive to ensure they experience it as one harmonious service, with their needs placed at the center. Most commonly used definitions of integrated care demonstrate two principle characteristics: First, it involves joining key aspects in the delivery of care systems that are fragmented. Second, that the concept must deliver ‘care’ (refers to providing assistance or treatment to people in need). The definitions are the following; 1. A health system-based definition: Health services that are managed and delivered so that people receive a continuum of diagnosis, treatment, disease management and rehabilitation etc. coordinated across the different levels and areas of care within and beyond the health sector. 2. A manager’s definition: The process that involves creating and maintaining a common structure between independent stakeholders. Coordinating their interdependence in order to enable them to work together on a collective project. 3. A social science-based definition: Integration is a coherent set of methods and models on the funding, administrative, organizational, service delivery and clinical levels designed to create collaboration within and between the cure and care sectors. 4. A definition based on the perspective of the patient (person-centered, coordinated care): I can plan my care with people who work together to understand me and my carer(s), allow me to control and join up services to achieve the outcomes important to me. We can distinguish four types of integration: organizational, functional, service and clinical. 1. Organizational integration, can be described as joining up several establishments through coordinated provider networks and mergers. 2. Functional integration, means integration of non-clinical and back-office functions

through, for example, shared electronic patient records. 3. Service integration, refers to integration of different clinical services by, for example, establishing multidisciplinary teams. 4. Clinical integration, is integration of care into a single and coherent process within/ or across professions by means of using shared guidelines and protocols. These integration types can be further characterized by the mechanism of integration. When integration is based on mutual values for collaboration that is seen as normative integration; whereas integration characterized by the unity of policies and directives at various levels of the organization is systemic integration. Integration can also be described as horizontal or vertical; Horizontal integration occurs when activities across operating organizations that are at the same stage in the process of delivering services come together (ex. mergers of social and healthcare organizations). Vertical integration implies coordination of services among operating parts that are at different stages in the process of delivering services. Organizations at different levels of the hierarchical structure are joined up under one management authority by, for example, integrating primary and secondary care. There are different levels of integration: 1. Integration at the micro-level aims to achieve a harmonious care experience for the individual (ex. personalized care plans). 2. Integration at the meso-level aims to provide integrated care for a particular care group or populations with the same disease or conditions. 3. Integration at the macro-level can be described as provision of integrated care to an entire population (ex. through categorization of needs and adapting services according to these needs). The timespan also differs as integrated care can be focused on a specific episode of care, for example hospitalization and follow-up, or it can have a life-long approach, for example for chronic conditions.

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The intensity with which organizations and services need to integrate with each other depends on the needs of the patient. There are different levels; full integration involves combining health and social sectors into a new organizational model and works best when aimed at people with severe and long-term needs, while partial integration creates links between two sectors to improve their coordination and works with situations of less severity and duration. Social care is about providing social, emotional and physical support to help people live their lives. It is a comprehensive term for a wide-range of non-medical services from child protection to end-of-life care provided by local authorities, voluntary help, and independent bodies to support the social needs of individuals especially the elderly, vulnerable or with special needs, to improve their quality of life. Social care is provided by a variety of people: social care workers, occupational therapists, nurses, registered managers and supervisors. But the vast majority is care workers in residential and nursing homes. In fact, most people that provide care are not paid, such as people who look after an older, ill or disabled family member, friend or partner and they are called carers. Some types of social care are the following: adult, children’s, mental health and substance abuse, gerontological, psychiatric, medical, criminal justice, military and veterans. Adult social care provides help, care and protection from harm for adults with physical disabilities, learning disabilities, or physical and mental illnesses. This could include help with dressing, washing, getting out of the bed in the morning, help taking medicine, and help with the housework. Adult social care is part of a complex system of related services including health, housing, welfare, benefits and leisure. As a result, people can often experience services that aren’t coordinated, are difficult to access and that aren’t focused on their individual needs, meaning they don’t get the help they need until they reach an emergency point. This is where integration comes into play with attempts to get this complex system to work in a joined-up way. Children’s social care services support children in need – children who must be pro-

tected from harm, who need to be placed in residential or foster care, or disabled children. In general, these services are provided by local authorities in a demand-led manner and lately the demand has been rising, creating difficulties. Social workers carry out both office and home visits to ensure the well-being of the children and families. They must identify any academic, behavioral, and social problems, and take steps to correct them. Furthermore, they can work in school settings where at-risk children are identified and supported. Nowadays, an increasing number of people have long-term and medically complex conditions which require regular support and treatment. It is important for these people to have services that are coordinated, easy to access, and professionals that help them to better manage their conditions themselves. Integrated care is best suited for this matter as it can reduce confusion, repetition, delay and gaps in service delivery and people getting lost in the system. An example is diabetes care in Bolton, where a community-based diabetes network supports the management of diabetic patients with severe and complex needs. Care is based within a Diabetes Centre that hosts a multi-disciplinary specialist care team, but this team also reaches into the local hospital for inpatient care, and out into general practices to support consultations. Patients and staff have reported high satisfaction with the community-based service and, in 2005/6, Bolton achieved the lowest number of hospital bed days per person with diabetes in the Greater Manchester area. Sanem Inci

Bibliography

Adult social care. (2017, April 7). Retrieved April 10, 2021, from https://​www​.kingsfund​.org​.uk/​ topics/​adult​-social​-care Children’s social care. (n.d.). Retrieved April 10, 2021, from https://​www​.in​stitutefor​government​ .org​.uk/​publication/​performa nce-tracker-2019/ children-social-care Delivering better integrated care. (n.d.). Retrieved April 9, 2021, from https://​ www​ .gov​ .uk/​ guidance/​enabling​-integrated​- care-in-the-nhs Goodwin, N. (2016, October 28). Understanding integrated care. International Journal of

Sanem Inci

132  Elgar encyclopedia of healthcare management Integrated Care. Retrieved April 09, 2021, from https://​www​.ijic​.org/​articles/​10​.5334/​ijic​ .2530/​ Integrated care models: an overview. (n.d.). Retrieved from https://​www​.euro​.who​.int/​ _​_data/​assets/​pdf​_file/​0005/​322475/​In tegrated-care-models-overview.pdf The evidence base for integrated care. (n.d.). Retrieved from https://​www​.kingsfund​.org​.uk/

Sanem Inci

​sites/​default/​files/​Evidence​-base​-integrated -care2.pdf Writers, S. (2019, July 1). Child and family social worker: Comprehensive career guide. Retrieved April 11, 2021, from https://​www​.socialwork​ .org/​careers/​child​-and​-family​-social​- worker/

46. Population health management Population health is a relatively new concept that has not yet been precisely defined; Kindig and Stoddart (2003, pp. 380‒381) provide the most commonly used definition, describing population health as “the health outcomes of a group of individuals, including the distribution of such outcomes within the group”; its field includes not only health outcomes, but also the patterns of health determinants, and the policies and interventions linking these two. It is an approach to health aimed at improving the health of the entire human population. The populations or groups taken into consideration are often geographic regions, including nations or communities; however, they can also be other subgroups, such as employees, ethnic groups, disabled persons, or prisoners. Another important aspect is that population health considers health inequality and inequity and the distribution of health across these subpopulations. One of the most comprehensive definition was that formulated by Dunn and Hayes (1999, p. 57), who stated that: population health refers to the health of a population as measured by health status indicators and as influenced by social, economic and physical environments, personal health practices, individual capacity and coping skills, human biology, early childhood development, and health services. As an approach, population health focuses on interrelated conditions and factors that influence the health of populations over the life course, identifies systematic variations in their patterns of occurrence, and applies the resulting knowledge to develop and implement policies and actions to improve the health and well-being of those populations.

T.K. Young, author of the book Population Health (2004, p. 4) describes the term as a “conceptual framework for thinking about why some populations are healthier than others as well as the policy development, research agenda, and resource allocation that flow from this framework”. Ensuring population health goes well beyond the clinical care, support and services provided by the healthcare system. The overall goal of a population health approach is that of maintaining and improving the

health of the entire population, but also reducing inequalities in health between population groups, which can be based on race, ethnicity, language, income, gender, sexual orientation, disability and other factors. This is because good health belongs to the whole, not just to an individual. In order to do so, population health, rather than focusing only on ill or high-risk individuals, deals with the full range of health determinants affecting the entire population, thereby integrating biological, social, economic, cultural, environmental, quantitative and qualitative factors. More specifically, these determinants include medical care, public health interventions, aspects of the social environment such as income, education, employment, social support or culture, and aspects of the physical environment, like urban design, clean air or water, but also genetics and individual behaviors. Moreover, it is important to underline the fact that population health research does not deal with these factors individually, but instead it is concerned about the interaction between them. This is why the term “patterns” of determinants is used. There is much research that needs to be done today from a population health perspective. Research in this field is performed through the examination of systematic differences in outcomes across populations, the complexity of interactions among the previously cited determinants, the biological pathways linking determinants to population health outcomes, and the influence of different determinants over time and throughout the life cycle. Moreover, population health requires attention to the resource allocation issues and involves the estimation of the cross-sectoral cost-effectiveness of different types and combinations of investments for producing health. Therefore, the active involvement of a wide range of stakeholders is needed to improve population health, including government, providers, insurers, academia, employers and unions, the media, philanthropy, political leaders, community organizations and others, which all have a role in making population health a priority, in focusing on health disparities, and in adopting a “health-in-all policies” mindset to inform all decision-making. Working together, it is possible to transform the environment we live and work in, and to make the healthiest choices possible as our default ones.

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Since we have said that health risk is related to a complexity of social, economic and political factors that both surpass and powerfully interact with “downstream” elements such as individual behaviors, biological traits, and access to healthcare services, taking into account the environmental and social determinants of health is essential to create effective population-level interventions for health improvement. Population-level health interventions are policies or programs that shift the distribution of health risk by addressing the underlying social, economic and environmental conditions. Policies and interventions define therefore the methods in which health outcomes and the patterns of health determinants are implemented. These interventions might be programs or policies designed and developed in the health sector, but they are more likely to be in sectors elsewhere, such as education, housing or employment. Furthermore, population health is one of the cornerstones of the Triple Aim. The so-called IHI Triple Aim, developed by the Institute for Healthcare Improvement, is a framework that describes an approach aimed at optimizing health system performance by pursuing simultaneously three dimensions, which are the improvement of the patient experience of care, including quality and satisfaction, the improvement of the health of populations, and the reduction of the per capita cost of healthcare. One way to improve population health is population health management, which has been defined as the technical field of endeavor which utilizes a variety of individual, organizational and cultural interventions to help improve the morbidity patterns and the healthcare use behavior of defined populations. In order to be successful, population health management should simultaneously improve the health of the population and the quality of care, while reducing cost growth, according to the principles of the Triple Aim. Various measures, both objective and subjective, have been developed to assess health; objective measures include for example mortality and disease-specific prevalence statistics. However, there has been an increased focus on including experienced health: for experienced health, the number and quality of survey instruments varies greatly per construct, ranging from general quality of Federica Michelozzi

life, which has many instruments available (for example, Short Form 12, or SF12), to self-management (for example, Patient Activation Measure 13, or PAM13). SF12 and PAM13, combined with lifestyle characteristics such as exercise and alcohol use, can be used by population health management and other regional initiatives to measure the physical, mental, lifestyle and health involvement constructs of population health. To sum up, health is a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity. While access to traditional health services is important, many factors affect health and well-being, including our individual actions and social connections, the places and communities that we are part of, the services that are delivered in our neighborhood, and the decisions made by local and national government. Healthy communities are defined not only by our individual actions or access to traditional healthcare, but green spaces, social activities, education and employment opportunities, healthy food, good housing and transport all play a hugely important role. To prevent illness and improve the health and well-being of local communities, all these aspects and more must be considered: this is what a population health approach really is. Federica Michelozzi

Bibliography

Dunn, J. R., & Hayes, M. V. (1999). Toward a lexicon of population health. Canadian journal of public health = Revue canadienne de sante publique, 90 (Suppl 1), S7–S10. https://​ doi​.org/​10​.1007/​BF03403570 Hawe, P., & Potvin, L. (2009). What is population health intervention research? Canadian journal of public health = Revue canadienne de sante publique, 100(1), I8–I14. https://​doi​.org/​10​ .1007/​BF03405503 Hendrikx, R. J. P., Spreeuwenberg, M. D., Drewes, H. W., Ruwaard, D., & Baan, C. A. (2018). How to measure population health: an exploration toward an integration of valid and reliable instruments. Population health management, 21(4), 323–330. https://​doi​.org/​10​.1089/​pop​ .2017​.0097 Institute of Medicine (US) Committee on Assuring the Health of the Public in the 21st Century. The Future of the Public’s Health in the 21st Century. Washington (DC): National Academies Press (US); 2002. 2, Understanding

Population health management  135 population health and its determinants. https://​ 93(3), 421‒31. doi: 10.2105/ajph.93.3.421. www​.ncbi​.nlm​.nih​.gov/​books/​NBK221225/​ PMID: 12604486; PMCID: PMC1449802. Kindig, D. A., & Stoddart, G. (2003). What is World Health Organization; The constitupopulation health? American Journal of Public tion; Paper presented at International Health Health, 93, 366‒369. Conference, New York, June 19‒July 22, 1948. Reidpath, D. D. (2007). Population health: con- Young, T. Kue (2009). Population Health: cepts and methods, second edition. J Epidemiol Concepts and Methods, 2nd edn (New York, Community Health, 61(2), 175. doi: 10.1136/ 2004; online edn, Oxford Academic, September jech.2006.049627. PMCID: PMC2465647. 1, 2009), 4 https://​doi​.org/​10​.1093/​acprof:​oso/​ Szreter, S. (2003). The population health approach 9780195158540​.001​.0001 in historical perspective. Am J Public Health,

Federica Michelozzi

47. Skill mix and task shifting in healthcare The term skill mix is used to describe the mix of posts, grades or occupations in an organization (more properly grade mix) but can also refer to the combinations of activities or skills needed for each job within the organization. Task shifting, instead, can be thought as the redistribution of selected tasks among the different healthcare providers. This often consists in shifting tasks from one cadre of healthcare workers to an existing, lower-level cadre. This can be made possible either by promoting retraining of health professionals to cover for additional and new tasks or by redesigning the function of different health facilities. However, skill mix and task shifting are often used interchangeably. Task shifting and the design of a more strategic skill mix have been motivated by the shortage of available skills and professionals, increasing maintenance costs of healthcare and by changing health priorities (globally and nationally). Albeit to different extents, these issues afflict both low/medium and high-income countries and are taking a high toll on the performance of healthcare systems. Common drivers of skill mixing in most countries are the shortage of physicians, nurses and poor coverage of certain essential services. Physician shortage is an issue shared by the UK, Germany, Russia and many other countries. Each health system has its peculiar liabilities that often cause inadequate service to its clients. For example, Russia has a very low number of general practitioners making primary care particularly deficient. Albeit to different extents, many other countries are struggling with geographical uneven distributions of health coverage, with urban centers being more equipped and staffed than rural areas. Lack of an adequate number of physicians has promoted the substitution of many of the activities that were once exclusively of physicians by nurses. With adequate retraining and education, the role of advanced practice nurses is now gaining more momentum. There are different possible skill mix initiatives to increase coverage and outcomes in the healthcare domain. Some involve role changes while others change the interface between services.

When it comes to role switching, possibilities include enhancement, substitution, delegation and innovation. Currently, the most employed are substitution, enhancement and delegation. Substitution implies working across professional divides or by exchanging one type of worker for another. Similarly, enhancement is achieved by increasing the depth and range of a job by extending the role or skills of a particular group of workers. Delegation simply refers to moving a task up or down a traditional uni-disciplinary ladder and overlaps with the previous solutions. Skill mixing might also imply the creation of new professional figures or the integration and education of non-registered care providers that represent an important component of healthcare. These are represented mostly by women in most countries of the world. Although not registered nor extensively educated, these workers represent the backbone of primary healthcare in low to middle income countries as well as in the developed world. Other common examples of innovation include the physician assistant (imported from the US model) but also general practitioners with special interests, nurse practitioners, clinical nurse specialists and advanced practice nurses. While being more evident in some instances, innovation often overlaps with substitution or enhancement (e.g. in the advanced practice nurses case). Change to the interface between services is another possible strategy that can improve healthcare functioning. It can be done either by transfer, relocation or liaison. Transfer consists in changing the settings of healthcare provision, for example by substituting community care to hospital care. Relocation can be exemplified by hospital clinics run in primary care facilities, found outside of the hospital and rooted in the territory. Similarly, liaison is the use of specialists in one healthcare sector to educate and support staff working in another. An example of liaison would be the cooperation of hospital specialists with primary care providers. All of these solutions promote a more integrated model of healthcare, where hospitals and external facilities are tightly interconnected. As an example of successful skill mixing we now consider the case of advanced practice nurses in the UK. Advanced practice nurses are defined as registered nurses who

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have acquired the expert knowledge base, complex decision-making skills and clinical competence for expanded practice. By fostering the education and specialization of nurses, it is possible to increase coverage of the healthcare service in various sectors, from primary care to emergency medicine. Common shifted tasks include preventive care and long-term follow-ups for certain chronic diseases (type 2 diabetes, obesity, high blood pressure, asthma) diagnosis and care of certain mild, acute infectious diseases (respiratory and/or urinary tract infections) as well as drawing up certain health certificates. This implementation has the double effect of relieving stress from overwhelmed physicians and increasing coverage. In this way, healthcare becomes more sensitive to the actual needs of its clients. Moreover, it seems that nurse-driven primary healthcare has higher results in term of patient’s satisfaction compared to care provided by physicians. Skill mixing is an important intervention aimed at improving coverage and efficacy of healthcare systems. It should be planned thoroughly by assessing the needs of the target population, as often different nations have different health needs. There is no “One size fits all” when it comes to task shifting and every restructuring plan should take into account the professional and personal instances of the workforce. Substantial financing is required to institute change and to support sustainable development in time. Effective transitions often require full support and guarantees from national institutions and healthcare workers’ associations. The process of task shifting should be not mandated by cost-cutting intentions. Although the acquisition of a more strategic skill mix will eventually lead to higher efficiency, these are long term benefits. The promotion of task shifting is often more expensive in the short term, as it requires retraining of the targeted caregiver population.

Skill mixing initiatives can encounter significant resistance from caregivers. An example would be the reluctancy of physicians when it comes to substituting or delegating symbolic medical duties such as diagnosis or medication prescriptions. Doubts are often dissipated by presenting the issues and care gaps that are driving these changes in a transparent way. Active engagement of the involved parties goes a long way as it fosters change from within the workforce. Moreover, retraining and task shifting should be supported by certifying at a curriculum level the acquisition of new skills and by promoting individual professional development. Financial incentives and the creation of positive working environments are of extreme value for a successful transition. Lack of proper retribution to new classes of workers (e.g. advanced care nurses) could easily create a barrier to effective skill-mixing. The final aim of task shifting is the establishment of a dynamic workforce that values teamwork and cooperation as the most effective tools to provide optimal healthcare. The leading motto is to get the right workers with the right skills in the right places doing the right things. Alfredo Marchetti

Bibliography

Bluestone J Why task shifting? CapacityProject, June 2006. https://​pdf​.usaid​.gov/​pdf​_docs/​Pn​a​ dg831​.pdf Buchan J, Dal Poz MR. Skill mix in the health care workforce: reviewing the evidence. Bulletin of the World Health Organization. 2002;80(7):575‒580. Chen L, Evans T, Anand S et al. Human resources for health: overcoming the crisis. Lancet. 2004;364(9449):1984‒1990. doi:10.1016/ S0​14​0-6736(04)17482-5 How can optimal skill mix be effectively implemented and why? Accessed April 7, 2021. https://​e​urohealtho​bservatory​.who​.int/​publi​ cations/​i/​how​-can​-optimal​-skill​-mix​-be​ -effectively​-implemented​-and​-why

Alfredo Marchetti

48. Value-based vs volume-based healthcare Unlike other industries, healthcare delivery cannot be based merely on profit, but it has to guarantee safety, efficiency, equity, patient centeredness and effectiveness. This tradeoff condition between costs and patients’ benefits needs at its core a system that is able to gain the best possible results with the resources available. The management of health has to face the increasing pressure of costs due to different issues such as new technological developments, increased expectations, necessity of improving clinical practice, the burden of aging and chronic complex patients. Other than that, the development of preventive interventions has shown to be effective and cost effective, but this requires additional resources (both time and money) to put them in places and also the gradual shift from the current low value interventions to the new preventive approaches. Despite these current issues, no increase in the investments has been promoted during the years and for this reason, resources are finite and never enough. Healthcare has been generally volume-based so the system is organized around what physicians do, it is fragmented in single providers offering a full range of services and it is focused on the amount of services provided and their profitability. One of the most common volume-based reimbursement methods is the fee-for service care that is defined by healthcare.gov as “method in which doctors and other health care providers are paid for each service performed as tests and office visits”. This approach is rewarding providers for how many services they perform and not for patient outcomes. It is an incentive to provide more services than the one really needed or the most expensive, but it obliges some practitioners to increase the number of patients seen each day, shortening the visit time. The quality of services provided is not the best possible as “quantity” and time are the main elements considered. It is a big issue in different countries, especially the US where the payment system is a continuous matter of debate.

The volume-based administration of health expenditures has been largely criticized due to the inappropriate care and wasted resources. For this reason, nowadays more and more countries are trying to overcome this paradigm, moving toward the so-called “value-based healthcare”. What is searched in these years is the achievement of better health outcomes at lower cost that means a payment system that encourages and rewards providers to give the best to patients. A single definition of value-based healthcare is not present, but for example healthcare.gov defines Value-based Purchasing as “Linking provider payments to improved performance by health care providers. This form of payment holds health care providers accountable for both the cost and quality of care they provide.” It is possible to describe it as the condition when providers are rewarded when they are able to help patients in ameliorating their health, reduce the effects and incidence of chronic diseases and live healthier. The benefits of this system should be many including better efficiency and higher patient satisfaction, lower cost and better outcomes, healthier society, reduced and controlled costs that are aligned with patients’ outcomes, reduced risks and improved management timing. A big contribution for the development of this new concept was given by Michael E. Porter, an academic at the Harvard Business School, who was one of the first suggesting the need of a new strategy of healthcare management. He stated that this change should come from physicians and provider organizations themselves, firstly identifying the goal that should not be profit but good results. He defined value as “health outcomes achieved that matters to patients relative to the cost of achieving those outcomes” or shortly as “health outcome achieved per dollar spent”. Its improvement requires “improving one or more outcomes without raising costs or lowering costs without compromising outcomes, or both” (Porter, 2010, pp. 2477‒2488). For the purpose of the transition, it has been theorized as a strategic agenda called “The Value Agenda”, made up of six components that are independent and mutually reinforcing. The first one is the organization into an Integrated Practice Unit. It means shifting from the verticalized organization by specialties into a multidisciplinary team made up of clinical and non-clinical

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figures, focused on patients’ needs. The second one is the measurement of outcome and costs for each patient. Evaluation of the results is fundamental for team improvement that is based on progress assessment and comparison with others. This should take into account the specific medical condition, not the specialty or intervention and it should cover all the care process. Outcomes and costs should be evaluated separately, in fact health outcomes should be measured and then compared to the total cost of their achievement; this will determine value. Nowadays, this measurement is still not well defined, in fact not outcomes but processes are used as adherence to best practice, protocols or guidelines. The third is evaluating a new payment approach. Two payment methods have been considered: capitation and bundle. In capitation, the payer makes a periodic payment for each subscriber (generally payment per patient per month) to a single provider. It is made to reward providers for decreasing the overall cost of treatment at population level, but it is difficult to adjust the payments for the individual risk of each patient. In bundle payments, the patient pays a single price for a whole package of products and services that meet their need. In this way, a single price covers the overall care required, that is associated with the achievement of good outcomes and it takes risks into account. This is only related to that specific condition and not to emergency situations. Capitation, despite that it seems better than the fee for service model, rewards providers for spending less but not achieving a better outcome. On the contrary, bundle payment is designed around patient’s needs and this permits on one side the continuity of care and on the other side the improvement of multi-disciplinarity. In fact, teams have the possibility to decide how to spend that money and a better integrated and coordinated care can be achieved. At the moment, it seems the best aligned approach with the concept of value. The fourth point is an integrated care delivery system that is based on defining the role of each service, and concentrating them in few locations and integrating different ones. The fifth is the expansion of the geographic reach to increase not only the volume but also the value. This can be achieved either via a hub and spoke model with IPU and

satellite facilities or through clinical affiliations in which providers share facilities with partners. The last point is building an information technology platform that should be patient centered with all types of data, it needs to be accessible to all parties involved and be easily interpreted with common data definitions. Following these ideas, in 2019 the European Commission set up an Expert Panel with the aim to pursue a modern, responsive and sustainable health system. The background is the Charter of Fundamental Rights of the EU saying that “everyone has the right to timely access to affordable, preventive and curative healthcare of good quality”. So healthcare is one of the priorities that is taken into account to reach an inclusive distribution of resources and the core principles are access, equity, quality and performance. On top of this, the importance of value in this setting is elucidated, from its definition to the subsequent implementation of the concept “value-based healthcare”. In the report, the term value is broadened with respect to the core ideas of M. Porter. They stated that this word doesn’t have a single definition, generally speaking it is related to what is considered to be good, referring to people, things, actions. Something can be good by itself or in relation to something else; health per se is a value and it is associated with the subjective experience of an individual but always considering the population. It is described in the so-called triple value model (used in Italy and the UK) that is composed of: personal value that is related to the good and bad outcomes associated with the individual’s goals; the allocative value, that is, how resources are allocated in the different population subgroups and the equity with which this is done; and the technical value that is associated with the correct distribution of the available resources based on the necessities of the population. Another value is added, and this is the societal value that is the relationship between the actions performed and the outcomes in terms of participation, solidarity, equity and recognition of diversities. It is stated that the implementation of value-based healthcare should be performed via a long-term strategy made through reallocating resources from low to high value care to reach financial sustainability, making Vanessa Maffi

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the population aware of health sustainability, supporting the methods of appropriate care, creating learning communities to bring together the best expertise, encouraging health professionals to take responsibility for increasing value and supporting shared decision making with patients. Vanessa Maffi

.eu/​health/​sites/​health/​files/​expert​_panel/​docs/​ 024​_defining​-value​-vbhc​_en​.pdf Porter, Michael E. Defining and introducing value in health care. Evidence-based medicine and the changing nature of health care: 2007 IOM annual meeting summary. National Academies Press, 2008. Porter, Michael E. What is value in health care? New England Journal of Medicine 363.26 (2010), 2477–2481. doi:10.1056/nejmp1011024 Porter, Michael E. and Robert S. Kaplan. How Bibliography to pay for health care: bundled payments will finally unleash the competition that patients Berenson, Robert A., and Eugene C. Rich. US want. Harvard Business Review (July–August approaches to physician payment: the decon2016) https://​hbr​.org/​2016/​07/​how​-to​-pay​-for​ struction of primary care. Journal of General -health​-care Internal Medicine 25.6 (2010): 613‒618. Defining value in “value-based healthcare”. Report Porter, Michael E. and Thomas H. Lee. The strategy that will fix health care. Harvard Business of the Expert Panel on effective ways of investReview (October 2013) https://​hbr​.org/​2013/​10/​ ing in health (EXPH). 2019. https://​ec​.europa​ the​-strategy​-that​-will​-fix​-health​-care What is value-based healthcare?. NEJM Catalyst 3.1 (2017). https://​catalyst​.nejm​.org/​doi/​full/​10​ .1056/​CAT​.17​.0558

Vanessa Maffi

PART X PLAYERS Health organizations are under deep transformations. In this cluster are highlighted those organizations that are emerging as “new players” within health systems, with a discussion on their roles, characteristics and challenges posed by their management. It presents the idea of a conceptual model of a patient-centric, value-based hospital that overcomes typical sectorial, organizational, and geographical boundaries and offers greater efficiency and better quality outcomes for patients, of a highly specialized, research centre and teaching hospital, of hospitals sat between primary care and secondary care which are traditionally defined as local hospitals that are staffed mainly by GPs and nurses to provide care in a hospital setting, predominantly for rural populations and others.

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commentary, we will focus on the burden of diseases classified by cause. At a global level, 60% of the total burden of diseases is given by non-communicable diseases, with 28% for The boundaryless hospital is defined as communicable diseases and the remaining is “digitalized, orchestrates medical services in related to injuries. A notable shift has been networks and ensures a safe and efficient noted from the 1990s where non-communicasteering of the patient through the continuum ble diseases started their growth. In 2017 it has been stated that the two major causes of care” (Eiff & Eiff, 2021, p. 388). It is a conceptual model of a patient-centric, of disease burden worldwide are cardiovasvalue-based health network that overcomes cular diseases and cancer. These growing typical sectorial, organizational, and geo- trends are at the basis of a demanding and graphical boundaries and offers greater qualified healthcare system. Additionally to efficiency and better quality outcomes for this, more patients are multi-morbid and considered as polypharmacy (assuming multiple patients. The boundaryless hospital is patient-​ different drugs). Based on these concepts, oriented, provides a safe environment, the two main ethical points are to be analyzed. medical knowledge is state-of-the-art and Our main interest as doctors is to provide limited resources are used in a goal-oriented evidence-based medicine, integrating new (effective) manner and without waste (effi- and innovative treatments conforming to the cient). Furthermore, the boundaryless hospi- patient expectations, but at the same time the tal overcomes typical negative characteristics economic component plays a very important of hospitals: multi-bed rooms, lack of privacy role in the whole setting. It is here that the boundaryless hospital has a pivotal role in and lack of patient autonomy. In the western world we have a quite clear providing a patient-oriented management, idea on how a hospital is structured, filled limiting the resources used without wasting with highly specialized staff and providing any. To master the “not so more future chalsophisticated services with high quality techlenges”, the provision of healthcare has to nology. It is quite evident how small cities have developed around large multi-branched be organized in networks. To deal with these hospitals sustaining the growth and finance of problems, a triangle of targets or “triple aim these areas. Let’s just think of how Cleveland, approach” has ben developed. The three difOhio has largely developed and entrusted ferent aims are: improving the experience its economic growth and stability on the of care (quality and satisfaction), improving Cleveland hospital, now ranked second best population health and reducing per-capita worldwide. But will hospitals continue in this cost (societies need to go beyond healthcare). direction? With this commentary I would like The benefits of the triple aim approach are to reason on how hospitals are now at an evo- devoted to have a healthier population and lutionary standpoint and how the fundamental new designs to better identify the problems. nature of these structures is going to change. In order to achieve these goals, hospitals must To understand this, it’s important to analyze undertake a new role in the continuum of care which are the problems that the society faces, offering integrated services and providing the how do we deal with these problems (with best possible care. Hospitals need to become a specific focus on the triple aim approach) boundaryless. The boundaryless hospital has the main and how boundaryless hospitals have gained aim to overcome the negative aspects of their trust in the recent years. The discussion on boundaryless hospitals hospitalization such as: lack of privacy or has to start by focusing on why these “new autonomy, crowded environments and concept hospitals” have to be largely imple- multi-bedrooms. The solution is to introduce mented. The society is ageing and dealing the medical service portfolio which enables with this changing population needs a whole a multi-modality patient assessment and is new structure. Global burden of disease can always available to be retrieved. Technology be assessed by means of different parameters helps this process with telemedicine, digital such as: cause, morbidity, mortality or disa- health and other applications. Two main bility adjusted life years. For the sake of this chains must be considered when evaluating how to create the medical portfolio. First, 142

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the medical value chain which includes the sequence of treatments needed by the patient. Second, the hospital value chain aimed at allocating internal and external resources necessary to treat a disease. The boundaryless hospital will act as a network coordinator with the main aim of organizing healthcare. The advantages of working as a network with respect to a centralized individual hospital are the following: a virtual access to medical information which includes expert knowledge, provides a continuum of care and allows resource sharing with better money allocation (saving costs). As mentioned above, to allow this we need a medical portfolio providing the medical services and storing documents electronically which can be easily retrieved at need. The ideas outlined which would be necessary for the creation of a boundaryless hospital must be included in what is known as integrated care models. As evaluated above, an ageing population is multi-morbid and many different conditions have to be considered. Diagnosis, treatment, rehabilitation and follow-up are each provided by single specialists, but the entire case is given to a manager which shortens the stay in the different sectors. The integrated care approach saves 10% of the total costs of a procedure in every sector. On top of this, the integrated care model not only saves time, but it allows to connect different medical service providers at different supply chains. The medical service portfolio is also at the basis of insurances which can develop treatment programs, discount agreements with pharmaceutical companies and discount agreements with fitness centers. The commentary has focused on the importance of creating a boundaryless hospital which tends to solve the challenges posed

by the ageing population through medical and technological progress. The first aspect we analyzed was the triple aim approach to understand how healthcare can be improved both for patients and for hospitals. The main point was then to assess the boundaryless hospital starting from the medical service portfolio up to the integrated care model which seems the most solid idea to face the upcoming problems. Networks are fundamental in order to provide a continuum of care and simultaneously contains the costs of healthcare. The boundaryless hospital “plays a pivotal role in network medicine and drives the cross-sectoral digitalization of medicine along the continuum of care” (Eiff & Eiff, 2021, p. 390). Benedetta Calcaterra Borri

Bibliography

Braithwaite, J. (1994, October 1). The boundaryless hospital. Wiley Online Library. https://​ onlinelibrary​.wiley​.com/​doi/​epdf/​10​.1111/​j​ .1445​-5994​.1994​.tb01759​.x Eiff, M. C., & Eiff, W. (2021, April 6). The boundaryless hospital. HealthManagement. Eiff, W. von (2016). Network management as a strategic option for the “boundaryless hospital“. In: Albach, H. et al. (eds.) The boundaryless hospital. Rethinking and redefining healthcare. Berlin & Heidelberg: Springer. Institute for Healthcare Improvement (IHI). (2021). The IHI triple aim. Lapão, L. V. (2016). The Importance of time in developing a boundaryless hospital: an example. SpringerLink. https://​link​.springer​ .com/​chapter/​10​.1007/​978​-3​-662​-49012​ -9​_5​?error​=​cookies​_not​_supported​&​code​=​ fe3700c2​-b794​-4f18​-ab4f​-f771a413bfbf Roser, M. (2016, January 25). Burden of disease. Our World in Data. https://​ourworldindata​.org/​ burden​-of​-disease

Benedetta Calcaterra Borri

50. Community and country hospital Despite the established existence of community hospitals as healthcare facilities, a unique and comprehensive definition of a community hospital is not available. Nonetheless some defining features can be identified being it an integral component of local healthcare delivery systems in a variety of countries in the world. Community hospitals represent institutions which cover an array of different services according to the local needs of the community where they are placed, adapting to the context and being flexible to respond to local necessities. They are found to be predominantly located in rural areas, allowing delivery of care to places where otherwise it would be not available. The variety of services delivered allows a local integrated primary, secondary, social and community care, ranging from prevention to diagnostic (with the possible presence of laboratories and imaging techniques), minor injury, emergency and palliative care, inpatient and outpatient services. This allows these structures to offer inpatient care for low level patients as an alternative to acute hospitals as well as stepdown services for patients from acute care together with post-acute or rehabilitation care, in particular for elderly and patients affected by chronic conditions. Studies in different countries highlighted the involvement of community hospitals for instance also in gynecology, maternity, mental health and surgery. The community hospital staff is constituted mainly by General Practitioners (GPs) and nurses together with other health professionals such as physiotherapists, occupational therapists, speech therapists and dieticians together with further healthcare assistants. There is in addition a pivotal collaboration among local GPs and specialists of acute hospitals, that consists of specialists’ intermittent (for instance by means of weekly visits) or remote supervision. Advances in technologies, as represented by telemedicine and videoconferencing, are at the basis of this collaboration which maximizes the variety of services delivered by community hospitals, under the remote advice and support of acute hospital specialists. An example

of technological enhancement is represented by shared electronic health records for the interplay among the different levels of care. Furthermore telemedicine can be adopted not just aiming at health professionals’ collaboration, but also for patient–specialist direct interaction as demonstrated by some services of mental health or teleophthalmology. In this way community hospitals allow an integration between different levels of care. This is also supported for instance by the connection between the community hospital and primary care due to the involvement of GPs, with the continuity of care a benefit supporting this system where local GPs are already known by patients and their families. The limited specialists’ involvement raises the need for GPs and nurses working in community hospitals to master a variety of skills, being flexible in their roles. For instance GPs should be able to perform minor surgeries or caesarian sections, while nurses are required to acquire a broad variety of skills covering also extended managerial responsibilities. Another distinguishing feature of this healthcare institution is the focus on an approach of care being patient-centered. Gathering information about various inpatient community hospitals, it was possible for researchers to identify some common features. In particular they are usually found to be small, with less than 30 beds, offering multidisciplinary integrated approaches, with an average length of stay of less than 30 days and with medical personnel not being present constantly for all the hours of the day every day of the week, because they mainly rely on the activity of nurses and on-call doctors. Patients and their families have been investigated and a shared positive evaluation of these structures has emerged. Specific aspects which allow community hospitals to stand out were identified and in particular one of their main points of strength is the closeness to home, as well as the familiar, relaxed and quiet atmosphere present in the environment together with the possibility of having relationships both with professionals and with family and friends while being hospitalized by receiving their visits, actively involving patients, their relatives and caregivers in the recovery process. Another recognized strength is the method this institution follows in approaching patients based on a personalized, holistic and multidisciplinary care, taking into consideration all the needs

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of the single subject, supporting also the psychological transition which often patients experience, above all elderly, as the cause of hospitalization can represent a major life event for instance in the case of admissions occurring following an accident or an illness. Nevertheless, further attention on psychological, emotional and mental health is recognized to be needed in these structures. Studies have been performed about the benefits that community hospitals provide to the local communities and among these have been found that advantages arise from the fact that they bring an intermediate level of health and social care together with economic consequences, for instance offering a variety of jobs to local people and supporting the local economy, adding also a social and human value such as allowing volunteering. They cover also a cultural role giving a sense of community, identity and belonging, but also of security and autonomy to the community members. At the same time further studies have been led about the inverse relationship in order to show what the community brings to its community hospital and it has been identified that locals help and support this type of infrastructure by volunteering, allowing financial support for example through fundraising, offering services and activities. This is what is shown by currently available studies, however it is important to take into consideration that situations are not identical everywhere but vary according to the different realities and contexts. Studying literature about community hospitals raises the awareness that available evidence at present is lacking about some aspects and limited about others, not allowing a full generalization of possible conclusions. For this reason further research would be needed, especially about the efficiency and cost-effectiveness of this institution, in particular focusing on non-post-acute care, about which knowledge is notably scarce. Current research about cost analysis is indeed limited and what has emerged until now is that community hospitals tend to have equivalent or improved outcomes compared to acute hospitals in a variety of services and when costs resulted to be lower, it was mainly due to the fewer and shorter admissions, the lower average daily costs, the fewer and less expensive drugs and performed interventions.

In addition, further studies should be aimed at understanding how community hospitals could contribute to new models of care and some research should also deal with topics such as the training for health professionals in this setting. It would also be useful to further investigate at what level and in which way community hospital services are based on community needs, answering open questions such as regarding the possible role of this healthcare delivery system in urban settings, being it mainly rurally located at the moment. In the future, technological development could further enhance the role of community hospitals, leading to an increased integration among the different levels of care. The flexibility intrinsic to this institution could allow adaptations to possible changes in the healthcare system as those which are already occurring due to the rising of chronic conditions and the progressive aging of the population in a context of increasingly constrained resources. Currently some challenges are arising from the increasing shortage of GPs, thus showing a need for innovation in education systems. In addition, the ongoing delivery of services to wider geographical areas and the increasing acuity of inpatients could clash with the principles of community hospitals, together with the possible rise of other locally delivered services that could overlap with those offered by community hospitals, weakening their value. In particular, a main challenge arises from the lack of a national strategy and policies regarding this care delivery system being not fully defined on the role these structures should cover, which adds to the increasing financial pressure. About this, the observation of the service decentralization and local health authorities’ fragmentation together with the difficulty of coordinating local care has suggested the importance of some central planning in supporting the development of competences and responsibilities at the local level. In conclusion, despite further research being needed, community hospitals, if correctly managed, may cover a pivotal local role in new healthcare delivery models as “community hubs”, being strong in their variety of patient-centered services, of their integrated intermediate level of care, of their collaborative nature and of their link with the Gloria Castelletti

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local communities, possibly further limiting the inequalities of access to the healthcare system. Gloria Castelletti

developments – scoping review, systematic review, country reports and case studies. Southampton (UK): NIHR Journals Library; 2017 Jun (Health Services and Delivery Research, No. 5.19.) Chapter 3, Community hospitals in high-income countries: a systematic review of the evidence on effectiveness and Bibliography cost-effectiveness. https://​www​.ncbi​.nlm​.nih​ Community Hospitals Association: http://​ www​ .gov/​books/​NBK436708/​ .communityhospitals​.org​.uk/​pdf/​CHA/​CHA​ Pitchforth E, Nolte E, Corbett J et al. Community _Definitions​_CH2016​.pdf hospitals and their services in the NHS: idenDavidson D, Ellis Paine A, Glasby J et al. Analysis tifying transferable learning from international of the profile, characteristics, patient experience developments – scoping review, systematic and community value of community hospitals: review, country reports and case studies. a multimethod study. Southampton (UK): NIHR Southampton (UK): NIHR Journals Library; Journals Library; 2019 Jan (Health Services 2017 Jun (Health Services and Delivery and Delivery Research, No. 7.1.) Chapter 8, Research, No. 5.19.) Chapter 7, Conclusions Discussion and conclusions: the meaning of and recommendations. https://​www​.ncbi​.nlm​ community hospitals. https://​www​.ncbi​.nlm​ .nih​.gov/​books/​NBK436689/​ .nih​.gov/​books/​NBK536256/​ Winpenny EM, Corbett J, Miani C, King S, McCormack B. The developing role of community Pitchforth E, Ling T, van Teijlingen E, Nolte E. hospitals: an essential part of a quality service. Community hospitals in selected high income Qual Health Care. 1993 Dec;2(4):253‒8. countries: a scoping review of approaches doi: 10.1136/qshc.2.4.253. PMID: 10132461; and models. Int J Integr Care. 2016 Nov PMCID: PMC1055156. 24;16(4):13. doi: 10.5334/ijic.2463. PMID: Pitchforth E, Nolte E, Corbett J et al. Community 28316553; PMCID: PMC5354221. hospitals and their services in the NHS: identifying transferable learning from international

Gloria Castelletti

51. Intermediate and transitional care settings Intermediate care, including transitional care services, is not a new idea. It emerged in the mid-1990s: it is a model of care that supports the integration and continuity of care as well as prevention of avoidable admissions to hospital. These services are time-limited: they are mainly employed at times of a deterioration in health or at times of transition, such as when moving from one’s home to hospital, assisted living or long-term care. They have a particular importance in preventing the onset and progression of frailty and functional decline in adults, particularly older adults. The task of the intermediate care units (IMCUs) is to care for patients whose treatment is complex and therefore require constant or close monitoring. These are patients whose conditions suggest possible failure of one or more organs, or whose conditions are too serious or unstable for a return to standard care units (SCUs), however the severity of these diseases or the treatment requirements for these specific clinical pictures, do not always justify admission to an intensive care unit (ICU). For this reason, an increasing number of special units (IMCUs) are being set up to offer highly specialised treatment and close monitoring, in order to fulfil an intermediate role between SCU and the ICU. Four broad service models of intermediate care have evolved: Bed-based intermediate care services are provided within an acute hospital, community hospital, residential care home, nursing home, or other bed-based setting with the aim of preventing unnecessary acute hospital admissions and premature admissions to long-term care and/or to receive patients from acute hospital settings for rehabilitation and to support timely discharge from hospital. Services are usually delivered by the multi-disciplinary team, but predominantly by health professionals and carers (in care homes). Community-based services provided to service users in their own home/care home. These services will usually offer assessment and interventions supporting admission avoidance, faster recovery from illness,

timely discharge from hospital and maximising independent living. Services are usually delivered by the multi-disciplinary team, but predominantly by health professionals and carers (in care homes). Community-based services provided to service users in their own home/care home, with an expected standard response time of less than four hours. Crisis response services will typically provide an assessment and some may provide short-term interventions (usually up to 48 hours) with the aim of avoiding hospital admission. Services are usually delivered by the multi-disciplinary team, but predominantly by health professionals. Community-based services provided to service users in their own home/care home. These services help people recover skills and confidence to live at home and maximise their independence. Services are usually delivered by the multi-disciplinary team, but predominantly by social care professionals. Promoting independence and shifting care away from hospitals and residential homes has been a policy objective for over 30 years.

Evidence of effectiveness and costs

A scoping review of the literature, including studies published between 2002 and 2019 about transitional care and/or intermediate care intervention for adults aged ≥ 50, concluded that intermediate and transitional care models provide positive outcomes for middle-aged and older adults and give an important contribution to healthcare systems, in particular evidence shows that well-designed intermediate care can: ● improve people’s outcomes and levels of satisfaction; ● reduce admissions to hospital and long-term social care services; ● reduce delayed discharges. Despite general positive outcomes, some authors have a negative opinion of this system due to the risk of omission of care and malpractice for the elderly as a consequence of early discharge from the hospital. Anyway, more often positive results were achieved despite the challenges of delivering such complex services in different settings due to a high volume of interventions and costs.

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Concerning economics, some authors concluded the cost of staffing, which is the most relevant part of total costs, is lower in intermediate care units (ICMUs) than in intensive care units (ICUs). Moreover, bed capacity and length of stay are the major determinants of unit throughput, so predictions made before any change in bed availability should be compared with occupancy rate and length of stay observed after the change. In fact, healthcare systems are flexible and can adapt to multiple external constraints, maintaining a natural disposition to growth. However, other authors concluded that acute hospitals may not be cost effective settings for nurse-led intermediate care. Both inpatient and total costs were significantly higher for nurse-led care than for standard care of post-acute medical patients. These data suggest that this model of care should not be pursued unless clinical or organisational benefits justify the increased investment. Despite the unclear economic situation there are two other good reasons to pursue the intermediated care growth: the first one is that there are wide variations in the performance of local heath and care systems, in offering care closer to home. Intermediate care could make a much bigger difference to people’s experience, outcomes and use of resources. The second is that demand for intermediate care is increasing and investment in intermediate care is not keeping pace with rising need. Expenditure in recent years has remained static and capacity is around a half of what is required. Reablement capacity is actually falling, despite increasing evidence of its effectiveness, and waiting times for intermediate care are rising. As a result, the potential of intermediate care to reduce the pressure on hospitals and social care is under-utilised.

Intermediate care units during the COVID-19 pandemic

Gonzalez et al. (2019) refer that during the COVID-19 pandemic in Spain the intensive care units (ICUs) occupation increased up to 163% and to deal with this shortness of ICU capacity effectively, some regional healthcare systems put in place COVID-19 intermediate care units (IMCUs), infrastructures consisting of a 24-hour healthcare multidisciplinary Emilie Cozzani

team with capacity to perform non-invasive mechanical ventilation in monitored beds. The COVID-19 IMCUs were implemented with two major objectives: ● avoiding the ICUs becoming overwhelmed, concentrating and taking care of candidate patients to ICU; ● favouring and incrementing a “step-down” from the ICUs for patients who have been recently discharged from ICUs who, in all cases, still need close monitoring. In the authors’ experience, these COVID-19 IMCUs can significantly reduce mortality when perfectly coordinated with the ICU team. In fact usually at the early stages of the disease, with apparent clinical stability, but with signs of potential severe disease at admission, these cases can rapidly progress and might worsen within hours. In these cases, close monitoring helped in the early identification of patients who needed to be transferred to the ICU for mechanical ventilation. In the authors’ opinion, COVID-19 IMCUs’ organisation should be encouraged in all hospitals as a response to the emerging challenges of this pandemic. It is clear that an intermediate model of care, if appropriately built as organisational care, can become a positive chance for patients’ health. The key for success could be to operate in a patient-centred mode, by accurately defining the individual plan of care. Emilie Cozzani

Bibliography

Capuzzo M. Costs of intermediate care and intensive care. ICU Management & Practice. 2007;7(2). González-Calle D, Villacorta E, Sánchez-Serrano A, León M, Sanchez PL. Coronavirus disease 2019 intermediate care units: containing escalation of ICUs. Crit Care Med. 2020;48(12):e1372‒e1374. NHS Benchmarking. National Audit of Intermediate Care Network Report 2015. Salsi A, Calogero P. Intermediate care. Italian Journal of Medicine. 2010;4:57‒62. Sezgin D, O’Caoimh R, Liew A, O’Donovan MR, Illario M, Salem MA, Kennelly S, Carriazo AM, Lopez-Samaniego L, Carda CA, Rodriguez-Acuña R, Inzitari M, Hammar T, Hendry A; all EU ADVANTAGE Joint Action Work Package 7 partners. The effectiveness of intermediate care including transitional care

Intermediate and transitional care settings  149 interventions on function, healthcare utilisation and costs: a scoping review. Eur Geriatr Med. 2020 Dec;11(6):961‒974. doi: 10.1007/ s41999-020-00365-4. Epub 2020 Aug 4. PMID: 32754841; PMCID: PMC7402396. Walsh B, Steiner A, Pickering RM, Ward-Basu J. Economic evaluation of nurse led intermediate care versus standard care for post-acute medical patients: cost minimisation analysis of

data from a randomised controlled trial. BMJ. 2005 Mar 26;330(7493):699. doi: 10.1136/ bmj.38397.633588.8F. Epub 2005 Mar 9. PMID: 15757959; PMCID: PMC555630. Waydhas C, Herting E, Kluge S. et al. Intermediate care units. Med Klin Intensivmed Notfmed. 2018;113:33–44. https://​doi​.org/​10​.1007/​ s00063​-017​-0369​-7

Emilie Cozzani

52. Primary care center Primary care center is a model of public health facility developed all over the world as a result of the principles of Primary Health Care which were first outlined in the Declaration of Alma-Ata in 1978. All people, everywhere, deserve the right care, right in their community. This is the fundamental premise of primary health care. Primary health care (PHC) addresses the majority of a person’s health needs throughout their lifetime. This includes physical, mental and social well-being and it is people-centered rather than disease-centered. PHC is a whole-of-society approach that includes health promotion, disease prevention, treatment, rehabilitation and palliative care. A primary health care approach includes three components: ● meeting people’s health needs throughout their lives; ● addressing the broader determinants of health through multisectoral policy and action; ● empowering individuals, families and communities to take charge of their own health. The rationale for the benefits for primary care for health has been found in: greater access to needed services; better quality of care; a greater focus on prevention; early management of health problems; organizing and delivering high quality care for chronic non-communicable diseases. Nowadays the ageing population has an increasing incidence of chronic diseases and multi-morbidities and requires a simultaneous mix of social and health care services from different providers and professionals. Decision makers have invested in primary care reforms by integrating services and promoting the co-location of general practitioners and other health and social professionals in one single point of access: primary care centers (PCCs). This strategy is applied in the public and private sector to facilitate the access of services for users and to reduce costs for both the provider (fixed and running costs) and the client (travel, time and emotional costs).

The co-location of services and professionals, includes family physicians, nurses and social workers, as well as specialists from secondary care services, therefore it guarantees a single point of access for care, which may also reduce duplication and ensure that service users receive responsive services. Some studies highlight the usefulness of this model in many ways: ● health professionals who are co-located in the same environment may have more opportunities to organize inter-​ professional meetings, to share information concerning common patients and their expertise, to increase interaction, collaboration and cohesion in order to achieve a personal and professional growth; ● cost savings related to the decrease in hospital admissions and readmissions, avoidable emergency department visits and length of stay; ● general practitioners and staff who work in a proactive, bundled and shared way in their clinics were more likely to have higher morale and a lower level of burnout. The limit of the application of this strategy is that the co-location of services in the same facility does not by itself guarantee the fulfilment of integrated care, because it does not automatically lead to collaborative working arrangements between professionals and services located in the same facility. However, Sara Barsanti and Manila Bonciani’s study (2019) conducted on Tuscan general practitioners highlights the positive impact of this form of co-location on perceived professional collaboration and clinical governance tools at the primary care level.

Worldwide situation

Primary Care Centers have been set up in Belgium with Community Health Centers, France with Maisons de Santé, the Netherlands with Primary Health Centers, Spain with Centros de salud, England with GP-led Health Centers or Polyclinics, and in Italy with Case della Salute. In the USA this concept was first introduced by the American Academy of Pediatrics in 1967 with the Patient Centered

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Medical Home (PCMH), which has also been established in Canada.

The Italian model

The Italian PCC model (Case della Salute) was first implemented in 2007 (Italian National Law 27 December 2006 No. 296). The model involves the co-location of general practitioners, who traditionally work alone in single practices, within the same building with other professionals, such as nurses, specialists, social workers and administrative staff, as well as with other services (blood testing, maternal care, vaccinations, diagnostic imaging). It shares many key principles with the PCMH such as team-based care; patient-​ centered orientation; enhanced access to care; care coordination and integration across all elements of the health and welfare system; quality and safety benchmarking through evidence-based medicine, clinical decision support tools, audit and systematic discussion among professionals. Italian primary care centers are also based on a framework of integrated care on many levels: ● clinical (even between different levels of care); ● professional integration (among general practitioners, nurses, social workers, specialists, administrative professionals); ● organizational (considering the coordination of services and the efforts towards quality improvements among the team); ● system;

● logistical; ● institutional (between health care and social welfare system). In Italy the realization of this strategy and the development of an efficient territorial medicine network is still far from the accomplishment. The difficult management of the COVID-19 pandemic is clear evidence of the situation, and 2020 data shows that in most Italian regions none or just a few Case della Salute were set up. Interaction between regions, investments in primary care centers and renewal of the general practitioner position could be the key points in order to overtake the hospital-centered vision of public health and to improve the territorial assistance. Edoardo Campioli

Bibliography

Barsanti S, Bonciani M. General practitioners: between integration and co-location. The case of primary care centers in Tuscany, Italy. Health Serv Manage Res. 2019 Feb;32(1):2‒15. Brambilla A, Maciocco G. Le Case della salute. Recenti Prog Med. 2016; 105:147–150. Fassari L. Assistenza territoriale al palo. La storia incompiuta delle Case della Salute: a 14 anni dalla legge in oltre il 30% delle Regioni non ci sono. Pochi anche gli ospedali di Comunità. Quotidianosanità.it (2022). http://​ www​ .quotidianosanita​.it/​studi​-e​-analisi/​articolo​.php​ ?articolo​_id​=​93087 Valentijn P, Schepman S, Opheij W. Understanding integrated care: a comprehensive conceptual framework based on the integrative functions of primary care. Int J Integr Care. 2013;13:e010.

Edoardo Campioli

53. Research hospital Definition

A Research Hospital is a healthcare organization within which clinical activities go hand in hand with biomedical research and higher education activities. The term Research Hospital refers to a series of organizational structures known worldwide with different names such as Research Hospitals, University Hospital or Research Medical Centers. These facilities are characterized by being excellent care facilities equipped with particularly advanced diagnostic, therapeutic and rehabilitative technologies. In each institute, a process of integration between scientific research and clinical activities is in progress with the aim of creating new knowledge for the whole health system and the medical community.

Role and goals

Research Hospitals therefore represent fundamental interconnection nodes between the academic world and healthcare networks. The three main objectives pursued by the Research Hospitals, which also represent its mission, are: ● Clinical activity; ● Research activity; ● Education of health professionals. In a holistic view, these three objectives are interconnected with each other, acting as a support, a starting point and a goal for each other. It should not be forgotten that the activity of a Research Hospital must represent a resource not only for the single structure or the single community but must generate added value for the whole health system. Regarding research activities, Research Hospitals are catalysts for experimentations in the biomedical field. These structures often make use of academic professional contributions, in a strong integration with the university network, as well as the advantage of being able to draw on specific public and private funding given the recognition of their fundamental role. The line of activity involves both basic research and clinical application through clinical trials. It is clear that Research Hospitals represent the funda-

mental node for translational research, that is, the transformation of the results obtained from basic research into clinical applications (from bench to bedside), in order to improve and implement methods of prevention, diagnosis and therapy of human diseases. Clinical activity in Research Hospitals aims to be a point of excellence within the healthcare network. The provision of highly trained professional profiles, the availability of advanced technologies and state-of-the-art facilities represent the fundamental prerequisites. The influence of the academic environment also represents an effective push for the adoption of care and therapeutic protocols that are strongly evidence-based, hand in hand with above average levels of training for health professionals. The last feature of Research Hospitals is represented by their strong educational vocation. These institutions often represent the training center of various health professionals (doctors, nurses, technicians) in their university and post-graduate careers. The possibility of attending a dynamic, cutting-edge environment, with complex clinical cases is an important resource for the training of future professionals.

Organizational structure

Organizational structures of Research Hospitals are heterogeneous with different models adopted internationally. Regarding the governance, we can distinguish hospitals belonging to university institutes, hospitals affiliated with university institutes and hospitals completely independent from the academic world. The prevailing model envisages a separation of scientific and clinical governance, although characterized by a physiological and inevitable dialogue between the two. The separation of governances has a dual goal: as for scientific activity, the trend is to channel ad hoc resources engaged in the development and promotion of scientific activity through the development of organizational models, research protocols and fund-raising strategies (e.g. establishment of grant offices); from a clinical point of view, governance must first and foremost guarantee the functioning of the healthcare pathways and the best possible outcomes for patients. The most recent organizational models arise precisely from the need to merge these

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two souls of Research Hospitals. Among the solutions adopted, the so-called clinical service lines and centers take on particular importance. Clinical service lines represent process lines that are transversal to the various specialist divisions of a hospital. They represent a multi-professional organizational solution that aims to generate the best possible outcome for a specific clinical target. The centers, on the other hand, represent multidisciplinary organizational structures dedicated to the diagnosis, treatment, and research of specific pathologies.

Critical issues and future developments

Research Hospitals were created to be centers of excellence in order to combine high standards of healthcare with stimulating and fertile work environments for professional growth within an academic philosophy. Nevertheless, the reality of the facts paints scenarios that are often not so idyllic. Returning to the three souls of a Research Hospital, it is possible to make some reflections: from a clinical point of view, the data show that while the health outcomes for rare and complex diseases are higher in Research Hospitals than in canonical hospitals, they do not show great differences for the treatment of generalist pathologies, characterized by a higher prevalence within the general population; from the scientific point of view, in recent years there has been a proliferation of academic publications often not followed either by a corresponding increase in financial investments or by a similar application of new knowledge, resulting in a decrease in the quality of scientific publications; from the training point of view, moreover, some examples have shown how the degree of satisfac-

tion of health professionals with their training path is higher in non-university health structures than in university health structures. In conclusion, Research Hospitals represent a reality that aims for excellence with all the pressure points to succeed. The challenge for healthcare management is to adopt organizational solutions that facilitate the expression of their potential, removing the hindering factors and promoting practices that facilitate the integration of different needs with the aim of creating added value. Navpreet Tiwana

Bibliography

García-Romerom A, Escribano A, Tribó JA. The impact of health research on length of stay in Spanish public hospitals. Research Policy. 2017;46(3):591‒604, ISSN 0048-7333. https://​ doi​.org/​10​.1016/​j​.respol​.2017​.01​.006. Goodwin JS, Lin YL, Singh S, Kuo YF. Variation in length of stay and outcomes among hospitalized patients attributable to hospitals and hospitalists. J Gen Intern Med. 2013 Mar;28(3):370‒6. doi: 10.1007/s11606-012-2255-6. Epub 2012 Nov 6. PMID: 23129162; PMCID: PMC3579964. Nachev P, Herron D, McNally N et al. Redefining the research hospital. NPJ Digit. Med. 2019;2:119. https://​doi​.org/​10​.1038/​s41746​ -019​-0201​-2 Pons J, Sais C, Illa C, Méndez R, Suñen E, Casas M, Camí J. Is there an association between the quality of hospitals’ research and their quality of care? J Health Serv Res Policy. 2010 Oct;15(4):204‒9. doi: 10.1258/ jhsrp.2010.009125. Epub 2010 May 13. PMID: 20466753. Yano E, Yamaoka K, Sugita S, Kobayashi Y, Niino N, Fukui T, Yamakado M, Nishizaki O, Ogata T, Segami K. Comparing postgraduate medical education at university and non-university hospitals in Japan. Acad Med. 1992 Jan;67(1):54‒8. doi: 10.1097/00001888-199201000-00011. PMID: 1729996.

Navpreet Tiwana

54. Teaching hospital A teaching hospital is an institution that provides clinical training to future health professionals while delivering medical care to patients and carrying out medical research. It is generally identified as a center of secondary or tertiary care, highly specialized, in a major city, and is affiliated with a medical school, often with a large academic department and a reputation for excellence in research. In these hospitals, several members of the treatment team are trained: medical students, resident physicians, nurses, midwives, physiotherapists, and other professionals. Generally, teaching hospitals treat a greater variety of illnesses, including complex and rare conditions, manage a wider case mix of patients and work in larger teams than non-teaching hospitals. They promote an environment of discovery and the latest advances in medicine. Teaching hospitals, indeed, tend to incorporate the most advanced techniques and the latest medical protocol into their treatment also because they are the environment in which the future doctors are trained. Not including those treatments and techniques, indeed, could be detrimental not only to the patients today but also for the patients in the next years and the future health professionals. The concept of the university hospital dates back to the fourth century ad when in the Persian Empire the academy of Gondi-Shapur was established, comprising a university, a library, and a teaching hospital. During the nineteenth century, in European universities, a modern concept of hospital-based clinical medicine developed: new healthcare institutions were founded in large cities, where students could find a large variety of patients. Hospitals were no longer just places that provided medical assistance for patients: they were places of learning and knowledge as centers of medical training and practice. Emphasis was placed on learning from practical experience rather than theory lectures, laying the foundations for what is still the education method today, particularly in English-speaking countries. Many elements developed in those years are still used in hospitals like the hospital ward round, in which a senior doctor, accompanied by junior doctors and medical students, discuss a case

at the patient’s bedside, or holding regular case reviews in which medical staff present interesting case histories.

Managing a teaching hospital

The missions of a teaching hospital are to provide health, educational, and research services. In administering such institutions, it’s necessary to consider that an unbalanced budget allocation to each of these sectors may hamper teaching hospitals from achieving all their organizational missions. Teaching hospitals, as one of the principal institutions in the health system of the countries, play a prominent role in the provision of health services, education and in performing research; but in each of these sectors they can find different challenges including low attention to education, not enough qualified therapeutic services and also less suitable research activities. Practitioners, policymakers, and health system planners need to be focused to create a good balance between those three goals, improving their potential to achieve all of them in order to provide high-quality healthcare services to patients. Moreover, the different systems do not only interact but are also integrated into each other: post-graduate medical education and clinical service are thus far so intricately embedded that it is impossible to provide medical training without delivering clinical service. If one of the integrated systems changes, this simultaneously affects the other systems and vice versa. This process can lead to frictions and tensions between these systems. So, due to the complex setting of teaching hospitals, organizational change can only be initiated by medical education stakeholders as well as care and research stakeholders’ involvement in organizational systems. Practically, that means having a great awareness of the organizational systems and of the stakeholders involved and a way of dealing with this complexity is to make an accurate stakeholder analysis. According to literature, deans and senior hospital executives (CEOs) generally agree on the necessary skills, values, and responsibilities for a successful clinical department chair. Hospital leaders place more emphasis on the clinical mission, but they recognize the importance of scholarship and teaching. Moreover, deans’ responsibilities include

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a primary emphasis on ensuring that the clinical chairs are active and accountable players in leading a high-performing clinical enterprise. Positive and continuous collaboration between deans, CEOs, chairs, and other leaders should guarantee an optimal integration and cohesion of the clinical, teaching, and research missions, which will ensure the ability to improve people’s lives, meeting the needs of patients, investors, donors, and legislators at the same time.

Teaching vs non-teaching hospitals

Compared to non-teaching hospitals, governance and control issues that impact decision support are somewhat different in teaching hospitals. This implies the need, in those settings, for even greater attention to the organizational issues involved in planning, and awareness in implementation and maintenance. The staff is indeed generally larger in number, more diverse, and subject to frequent changes over time. Literature indicates that the quality of the care provided by teaching hospitals is generally superior to other institutions, on the basis of process of care and mortality studies, especially in the oncology field. A study published in JAMA in 2017 showed lower mortality rates among teaching hospitals at both 7 days and 90 days (Burke et al., 2017). The paper describes that this difference in outcomes by teaching status may be related to greater experience treating particular conditions, but, accounting for hospital volume, this doesn’t substantially explain the differences. Teaching hospitals, as previously reported, also tend to be early adopters of the most up-to-date technologies, which could lead to better outcomes for conditions that are more technologically intensive or require specialized knowledge. However, the results of the study suggest better outcomes for a broad range of conditions, including also pneumonia and heart failure, for which advanced technologies are helpful for only a minority of patients. Additionally, better performance on process measures for several conditions seems to be associated with teaching activity, suggesting that superior processes may explain the lower average mortality reported for teaching hospitals. According to other studies, major teaching hospitals were more likely to have performed

diagnostic and therapeutic services appropriate to the patient’s underlying conditions, and to have a medical staff or clinical faculty more able in diagnostics, more up to date in new clinical research findings, and more adherent to practice guidelines. Empirical evidence from the process of care implies that the quality of care is higher at major teaching hospitals. Under some circumstances, such as for cancer, outcomes are better at such institutions. Nevertheless, they are more costly, especially those affiliated with academic health centers. The major investment is justified in the middle term by the general improvement of healthcare and medical knowledge because teaching in a healthcare setting does not affect exclusively patients in the immediate term. It is an intrinsic part of medicine that benefits patients in the long term as well. As such, teaching should be promoted in order to train better healthcare professionals in the future for both teaching and non-teaching hospitals. Laura Cavazzana

Bibliography

Burke L, Frakt A, Khullar D, Orav EJ, Jha A. Association between teaching status and mortality in US hospitals. JAMA. 2017;317(20):2105‒2113. doi:10.1001/ jama.2017.5702. Modanlou H. Historical evidence for the origin of teaching hospital, medical school and the rise of academic medicine. J Perinatol. 2011;31:236–239. doi:10.1038/jp.2010.162. Safarani S, Ravaghi H, Raeissi P, Maleki M. Challenges and opportunities faced by teaching hospitals in the perception of stakeholders and hospital system managers. Education in Medicine Journal. 2018;10(4):9–21. doi:10.21315/eimj2018.10.4.2. Sloan F. Quality and cost of care by hospital teaching status: what are the differences? Milbank Q. 2021;99(1):273‒327. doi: 10.1111/1468-0009.12502. Souba W, Notestine M, Way D, Lucey C, Yu L, Sedmak D. Do deans and teaching hospital CEOs agree on what it takes to be a successful clinical department chair? Acad Med. 2011;86(8):974‒981. doi: 10.1097/ ACM.0b013e31822223b2. Van Rossum T, Scheele F, Scherpbier A, Sluiter H, Heyligers I. Dealing with the complex dynamics of teaching hospitals. BMC Med Educ. 2016;16:104. doi: 10.1186/s12909-016-0623-3.

Laura Cavazzana

PART XI TRENDS The challenges that the healthcare system is facing and will face in the coming years go hand in hand with a necessary review of the organizational and business models adopted. In this cluster are grouped all the new approaches that have become established in recent years and that are and will influence the configuration of the healthcare industry. Among these, decentralization, multidisciplinarity and multiprofessionality, new business and integration models, are the most relevant from a managerial standpoint.

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55. Business models New business models are emerging and spreading in healthcare. In the last 20 years there’s been a major evolution in health services delivery with the emergence of very distinctive competitive positioning such as the low cost or low-price healthcare on one side and the concierge medicine on the other. Further, medical tourism has increased significantly, determining the designing of new business models that integrate service, logistics and experience. A business model can be defined as the design or architecture of the “system” through which the organization generates value, manages the delivery, and targets the expected customers. The essence of a business model is therefore traceable by the manner through which the organization delivers value to customers, entices customers to pay for value, and generates profit. It thus reflects management’s ideas, perspectives and analysis about what customers want, how they want it, and how the organization can organize to best meet those needs, get paid for doing so, and make a profit. Business modeling can be divided into three major steps: identifying the target and its needs, building the portfolio of services that match those needs, developing the mechanisms and actions required to support the expected delivery processes (primarily human resources, marketing, pricing, logistics, and all other elements that make distinctive the business model). The final aim of a business model is to help the organization to build a competitive advantage on competitors with reference to a target of customers, through a specific and distinctive positioning on the market. Here below are some examples (not comprehensive or exhaustive, the market is today very much diversified) of business models that emerged recently in the healthcare field, especially in those health sectors that do not have a public dominant system/National Health Service. Direct Primary Care (DPC). In DPC the patient/customer pays directly to the physician a standard monthly fee that covers most primary care needs. Not having to deal with an insurance overhead is significantly

decreased and patients should refer to insurance (lowering the annual cost) only for ancillary services (lab, imaging, drugs) and secondary care. House Call Practice. Rather than having a physical place, physicians offering “House Call practice” use healthcare apps, remote diagnostics and self-scheduling to manage their patients and do only home consultation. It applies well to geriatric service, pediatrics, occupational health, and it works well both for the rural and urban setting. Membership Practice. Patients that become members are entitled to premium services, such as an annual check-up, enhanced patient access (emails, telephone calls, attendance at hospital admissions), educational programmes, telemedicine, and so on. Concierge Practice. As for the membership model an annual fee is required of the patient. Concierge programs could include top levels of personalized services such as: 24/7 direct access to the physician via email, text or cell phone, appointments on demand, personalized referral management, unlimited office visits of unlimited length, house calls, telemedicine, and so on. Traveling Practice or Pendulum. This is a business model interesting for specialists. They travel from one primary care office to another, where based on their schedule they do consultations and provide on-site care to referred patients. This is something also developed by hospital systems that have outreach specialty clinics, and certainly has great potential in underserved and rural communities. The pendulum practice may utilize innovative hand-held technology to evaluate, monitor and control adherence/compliance of patients or to identify the need for further testing, procedures or surgery. Telemedicine Practice. Two-way video consultation, very useful for rural and underserved communities, but increasingly interesting also for urban areas. Friendly technology has become widely available, allowing physicians to cost-effectively provide remote services, in some cases also becoming an out-of-pocket substitute of insurance or NHS services, due to the convenience and zero waiting lists that often can be offered. Federico Lega

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Bibliography

Elton, Jeff, and Anne O’Riordan. Healthcare Disrupted: Next Generation Business Models and Strategies. John Wiley & Sons, 2016. Fredriksson, Jens Jacob et al. Business model framework applications in health care: A sys-

Federico Lega

tematic review. Health services management research 30.4 (2017): 219‒226. Hwang, Jason, and Clayton M. Christensen. Disruptive innovation in health care delivery: a framework for business-model innovation. Health affairs 27.5 (2008): 1329‒1335. Pfannstiel, Mario A., and Christoph Rasche. Service Business Model Innovation in Healthcare and Hospital Management. Springer, 2017.

56. Decentralization and devolution in healthcare Decentralization has won a high reputation in the political debate about health services planning and delivery in the last thirty years (Mwinkaara Sumah et al. 2016). Especially in public health systems where bureaucratic organization and logics have been under attack for many years, given their consequences in terms lack of efficiency, red tape and much more. Decentralization and devolution appeared to be a good answer to the problems shown by the bureaucratic model as it promises modern, flexible, efficient, customer-focused, entrepreneurial, and community-accountable public systems. Decentralized settings are expected to “listen” better to the local contexts and their needs and should be able to offer customized services. Further, decentralization and devolution should increase economic responsibility and accountability as economic/fiscal constraints are better linked to level of services delivered and their costs, and when necessary it is the local level that should intervene on taxes or co-payments. The concepts of decentralization and devolution can be defined using the classical typology proposed by Rondinelli et al. (1989) where four archetypes of decentralization are identified: deconcentration, delegation, devolution, and privatization (Rondinelli et al. 1989, pp 70‒74): ● Deconcentration: Handing over of some amount of administrative authority or responsibility to lower levels within central government ministries and agencies. Shifting of the workload from centrally located officials to staff or offices outside of the national capital. When it is more than mere reorganization, it gives some discretion to field agents to plan and implement programs and projects, or to adjust central directives to local conditions, within guidelines set by central ministry or agency headquarters. ● Delegation: Transfers managerial responsibility for specifically defined functions to organizations that are outside the regular bureaucratic structure and that are only indirectly controlled by the central

government. It has long been used in administrative law. A sovereign authority creates or transfers to an agent specified functions and duties, which the agent has broad discretion to carry out. Ultimate responsibility remains with the sovereign authority. ● Devolution: Creation or strengthening – financially or legally – of subnational units of government, the activities of which are substantially outside the direct control of the central government. Local units of government are autonomous and independent, and their legal status makes them separate or distinct from the central government. Central authorities frequently exercise only indirect, supervisory control over such units. Normally, local governments have clear and legally recognized geographical boundaries within which they exercise an exclusive authority to perform explicitly granted or reserved functions. They have corporate or statutory authority to raise revenues and make expenditures. They should be perceived by local citizens as organizations providing services that satisfy their needs, and as governmental units over which they have some influence. It establishes reciprocal and mutually beneficial relationships between central and local governments. Local governments are not merely subordinate administrative units, but they have the ability to interact reciprocally with other units of government in the political system of which they are a part. ● Privatization. Governments divest themselves of responsibility for functions and either transfer them to voluntary organizations or allow them to be performed by private enterprises. In some cases, governments transfer responsibility to “parallel organizations” such as national industrial and trade associations, professional groups, religious organizations, political parties, or cooperatives. These parallel organizations are given the responsibility to license, regulate, or supervise their members in performing functions previously performed or regulated by the government. Therefore, there is not a single concept of decentralization valid for the healthcare sector. In some countries decentralization

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has meant devolution, in a few countries it has meant privatization, in many countries those trends have been accompanied with stronger degrees of autonomy and managerial responsibility for single organizations, coherent with the “delegation” concept. Federico Lega

Bibliography

Cuccurullo, C., F. Ferre, F. Lega. The challenge and the future of health care turnaround plans: evidence from the Italian experience, Health Policy, 2012;106(1):3‒9. Mwinkaara Sumah, Anthony, Leonard Baatiema, Seye Abimbola. The impacts of decentrali-

Federico Lega

sation on health-related equity: a systematic review of the evidence, Health Policy, 2016;120(10):1183‒1192. Rondinelli, D.A. Government decentralization in comparative perspective: theory and practice in developing countries, International Review of Administrative Science, 2016;47(2):133‒145. Rondinelli, D.A., J.S. McCullough, R.W Johnson. Analysing decentralization policies in developing countries: a political-economy framework, Development and Change, 1989;20(1):57–87. Rondinelli, D.A., J.R. Nellis, S. Cheema. Decentralisation in developing countries: a review of recent experiences, World Bank Staff w.p. n. 581, World Bank, Washington DC, 2012.

57. Multidisciplinarity and inter-​professionality Multidisciplinarity and inter-professionality are usually considered among the most effective means to introduce innovations (i.e. technologies, processes, products, and services) and to face rapidly environmental changes. The multidisciplinary and inter-professional work in healthcare organizations is usually delivered by teams, whose members work together for delivering health services, research, and education. A team can be described as follows (Kozlowski & Ilgen, 2006): (a) two or more individuals who (b) socially interact (face to face or, increasingly, virtually); (c) possess one or more common goals; (d) are brought together to perform organizationally relevant tasks; (e) exhibit interdependencies with respect to workflow, goals, and outcomes; (f) have different roles and responsibilities; and (g) are embedded in an encompassing organizational system with boundaries and linkages. Traditionally, healthcare teams were uni-disciplinary (e.g., a team of paediatric nurses or paediatricians working on a hospital ward), meaning that team members held very similar functional knowledge and conducted similar clinical or care tasks (West & Lyubovnikova, 2013). More recently, teams started to comprise members (a) from different functional and clinical backgrounds (multidisciplinary teams) and/or (b) from other allied health staffs (inter-professional teams), working together towards shared goals to fulfil complex and interdependent tasks that require varying degrees of specialist skills, along with different clinical and care knowledge. Multidisciplinary teams are oftentimes inter-professional, but inter-professional teams may also be uni-disciplinary when they work on the same specialty unit. In the healthcare systems, multidisciplinary and inter-professional teams are crucial in responding effectively and efficiently to the current patient needs but also as vehicles for healthcare delivery changes. In the past, healthcare organizations were characterized by professional autonomy among the different medical specialties (usually linked to a specialty unit in the

organizational chart) and by the dominance of the medical profession against the other health staff. During the twentieth century, the rise of professional bureaucracies and the powerful medical knowledge domains were mainly due to: (a) the fast progress of medicine, requiring a continuous specialization of the clinical knowledge in different branches and fields; (b) the major occurrence of acute illnesses in a population with a minimal prevalence of chronic diseases (because of the younger average age), requiring the intervention of a specific clinical knowledge. There are several reasons behind the rising relevance of multidisciplinary and inter-professional work in healthcare organizations. First, in a context of growing complexity of the patient due to aging and to the increasing number of diseases (especially in the case of seniors and chronic patients), it is necessary to integrate the specialistic and professional efforts to have a more holistic and comprehensive view of the care and cure needs. Second, Evidence Based Medicine and other sources of clinical standards (i.e. guidelines, protocols, and clinical paths) foster the cooperation in the response to the diseases and the distribution of the tasks and responsibilities among doctors of different specialties and the health staffs, also overcoming the traditional dominance of chiefs of specialty over the other professionals. The presence of multidisciplinary and inter-professional teams in healthcare organizations is growing in different medical fields and for several pathologies. The most structured and diffused multidisciplinary and inter-professional teams are those dedicated to cancer patients, and they are considered the gold standard in oncology care (Prades et al., 2015), but cooperation between disciplines and different professionals are increasingly required for different healthcare settings and pathologies, such as critical care and trauma setting, operating rooms, mental health, primary care, long-term (elderly) care, and so on. Moreover, a growing part of the healthcare entities are introducing matrix-like organizational models in which clinical centres (also called clinical service lines) intersected the hierarchical line of clinical directorates. The aim of clinical centres is to coordinate care delivery for specific health problems and/ or patient flows (e.g., frail patients, cardiovascular, oncological, neuroscience diseases, etc.) and transversal multidisciplinary and

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inter-professional teams may also be integrated within. The healthcare literature shows several beneficial outcomes of multidisciplinary and inter-professional work in teams (West et al., 2001; West & Lyubovnikova, 2013; Prades et al., 2015): (1) increased patient safety and reduced medical errors; (2) reduced patient mortality in hospitals; (3) better clinical and process outcomes for cancer patients, with evidence of improved survival among colorectal, head and neck, breast, oesophageal and lung cancer patients; (4) increased patient satisfaction; (5) an increasing contribution in changing clinical diagnostic and treatment decision-making with respect to urological, pancreatic, gastro-oesophageal, breast, melanoma, bladder, colorectal, prostate, head and neck, and gynaecological cancer patients; (6) lower time to treatment; (7) improved worker outcomes, such as increased job satisfaction and intent to stay at work, reduced stress and burnout, and a lower staff absenteeism and turnover; (8) more effective use of resources, more streamlined and cost-effective patient care, along with reduced physician visits and hospitalization rates; (9) improved recruitment in clinical trials. However, to achieve these beneficial outcomes it is necessary to improve the effectiveness of multidisciplinary and inter-professional teamwork. In this perspective, Buljac-Samardzic et al. (2010) – based on a literature review of the existing empirical research – show different types of interventions and investments, identifying three categories: training, tools, and organizational interventions. Training involves a systematic process through which a team is trained (often by facilitators) to master and improve different aspects of team functioning. Different types of training tools are identified: simulations, training based on Crew Resource Management (CRM), team-based intervention training; articles with high or moderate quality of evidence found positive associations with team behaviour, attitudes (towards teamwork), self-efficacy, individual effectiveness, emotional exhaustion, de-personalization and perception of care (Buljac-Samardzic et al., 2010). Tools can be divided into checklists, goal sheets, and case analysis; unfortunately, all studies had a low quality of evidence but showed positive results, especially on comAnna Prenestini

munication and team unity (Buljac-Samardzic et al., 2010). Organizational interventions are actions or changes that focus on the organizational context but are expected to have an impact on team functioning (i.e. decision-making, continuous quality improvement, and redesign of care processes); only one study reported that continuous quality improvement interventions resulted in a higher number of quality improvement projects, a higher quality of these projects, and improved achievement of self-defined objectives (Buljac-Samardzic et al., 2010). The introduction of care pathways is a specific intervention useful for improving interdisciplinary teamwork, promoting team coordination, communication, and relations, inter-professional documentation, and staff knowledge (West & Lyubovnikova, 2013). Moreover, the use of information technology (IT) is commonly described as a useful way of sharing patient situation, details and providing documentation (Prades et al., 2015): while some teams favour physical meetings, others show a rapid adoption of IT for data-management and communication, especially to overcome logistics-related barriers by means of online video-conferences and to share radiology and histopathology images in the context of networks. Finally, team member attitudes are considered among the most important requirements to improve effectiveness, particularly in case of renewal of processes and innovation in a changing environment (Fitzgerald & Davison, 2008). In fact, the multidisciplinary and inter-professional teams require team members to develop and maintain high levels of interdependency to enable communication, generate and share information and knowledge. The fostering of collaborative efforts in and by these teams involves the management of multiple factors (Reese & Sontag, 2001): knowledge held by team members about other members’ disciplines; overlap of the roles of individual members; different theoretical perspectives and values of individual members; different perceptions of occupational esteem; and workload equity. Thus, team development activities should ensure that team members value the importance of shared responsibility, communication, and collective decision-making, and have a good understanding of the roles of team members (Courtenay et al., 2013).

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According to Fitzgerald and Davison (2008), there is a strong need in the healthcare organizations to better understand and overcome barriers to a multidisciplinary and inter-professional approach, such as medical dominance, hierarchical division of labour, a high complexity of the organizational environment, and disparity of goal congruence between and within healthcare teams. Therefore, to sustain the effectiveness of multidisciplinary and inter-professional teams it is necessary: (a) to implement organizational strategies that foster clinical service lines and teams beyond traditional hierarchical schemes; (b) to define clear organizational models and routines, such as the superordinate goals that distribute accountability across all team members, the roles and responsibilities in each phase, the membership requirements (for core, allied, and support members), the procedures for the meetings and the discussion of the cases, the patient engagement approaches; (c) to support the team with data management, IT, and clerical and administrative activity; (d) to train each team member to work jointly, especially improving soft skills such as leadership for the team coordinator and adaptive capacity for all the members. Thus, to implement a multidisciplinary and inter-professional approach cannot be only a matter of health policies, but the managers of healthcare organizations must guarantee guidance on the superordinate mission and goal of each team, control on the accountability, investment of resources in the development of a favourable organizational context

and adequate means for achieving the results, along with team training. Anna Prenestini

Bibliography

Buljac-Samardzic, M., Dekker-Van Doorn, C. M., Van Wijngaarden, J. D., & Van Wijk, K. P. (2010) Interventions to improve team effectiveness: a systematic review. Health Policy, 94(3), 183‒195. Courtenay, M., Nancarrow, S., & Dawson, D. (2013) Interprofessional teamwork in the trauma setting: a scoping review. Human Resources for Health, 11, 57. Fitzgerald, A., & Davison, G. (2008) Innovative health care delivery teams: learning to be a team player is as important as learning other specialised skills. Journal of Health Organization and Management, 22(2), 129‒146. Kozlowski, S. W., & Ilgen, D. R. (2006) Enhancing the effectiveness of work groups and teams. Psychological Science in Public Interest, 7, 77‒124. Prades, J., Remue, E., Van Hoof, E., & Borras, J. M. (2015) Is it worth reorganising cancer services on the basis of multidisciplinary teams (MDTs)? A systematic review of the objectives and organisation of MDTs and their impact on patient outcomes. Health Policy, 119(4), 464‒474. Reese, D. J., & Sontag, M. A. (2001) Successful interprofessional collaboration on the hospice team. Health & Social Work, 26(3), 167‒175. West, M. A., & Lyubovnikova, J. (2013) Illusions of team working in health care. Journal of Health Organization and Management, 27(1), 134‒142. West, M. A., Borrill, C., Dawson, J., Scully, J., Carter, M., Anelay, S., Patterson, M., & Waring, J. (2001) The link between the management of employees and patient mortality in acute hospitals. The International Journal of Human Resource Management, 13(8), 1299‒1310.

Anna Prenestini

58. Telemedicine For more than 30 years, clinicians, health services researchers, and others have been investigating the use of advanced telecommunications and computer technologies applied to healthcare. Telemedicine is the main result of these efforts (Institute of Medicine, 1996). The definition places the accent on the concept of distance, the real key word that together represents the essence of telemedicine and prefigures its merits and advantages: the possibility of making visits remotely with great benefit for all the people who live in isolated places, have transport or walking problems or, simply, prefer not to waste time in queues or in traffic. The continuous evolution of demographic trends and the health and assistance needs of the population, in which an ever-increasing percentage suffer from chronic disorders, requires a structural and organizational redesign of the service network, above all in order to allow for a rationalization and integration of local services. Advantages of telemedicine include: ● improving the level of interaction between the territory and operators reducing the need for travel, often problematic in the case of fragile users consequently guaranteeing cost management ● ensuring greater equity of access to care ● ensuring better management of chronic cases thanks to continuous and multidisciplinary management and, in some specific cases, timely intervention. A visit provided in telemedicine therefore allows a better approach by the user who can video-consult with the doctor while remaining within the home (or work) environment in which they live every day. The first example of telemedicine dates to 1906, when the Dutch Einthoven carried out tests of remote electrocardiographic consultation through the telephone, creating the electrocardiograph (Institute of Medicine, 2012): the telephone had been invented and the physiologist used it to transmit sounds of a patient’s heart and lungs from one place to another; a scientifically innovative idea, however scarcely effective, due to the inadequacy of the communication systems of

the time. In 1959, the first transmissions of images and X-rays spread, and therefore the first applications of telemedicine. The real debut of telemedicine was recorded in the 1960s, in the United States, thanks to the use of communication systems aimed at monitoring vital parameters (heartbeat, respiratory rate) of astronauts in space, ensuring them the most effective healthcare possible. Telemedicine services can be traced back to four major macro-areas: 1. Continuity area; 2. Multidisciplinary area; area and access 3. Gatekeeping appropriateness; 4. Prevention/health education area.

Continuity area

● Televisita: act in which the professional interacts remotely in real time with the patient even with the support of a caregiver. It cannot be considered the means to conduct the doctor–patient relationship exclusively at a distance nor can it replace the first medical examination in person. The television is to be understood limited to the control activities of patients whose diagnosis has been formulated during a visit in person. The visit must always be reported. The patient or family member must first authorize this type of contact, also for reasons of privacy and security; ● Telerefertation: it is a report issued by the doctor who has subjected a patient to a clinical or instrumental examination whose content is typical of reports performed in person and which is written and transmitted by means of digital and telecommunication systems.

Multidisciplinary area

● Medical teleconsultation: act in which the professional interacts remotely with one or more doctors in a synchronous manner in order to discuss the clinical situation of a patient by sharing clinical data, reports, images, audio-video relating to the specific case. If the patient is present then we speak of multidisciplinary television (which falls into the category seen above).

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Gatekeeping area and access appropriateness

● Telephone triage: consultation carried out by doctors or health professionals towards patients in order to indicate the most appropriate diagnostic/therapeutic path to follow and if it is necessary to perform the visit straight away in person or remotely or it can wait for a later date.

Prevention/health education area

● Teleprevention: remote monitoring system that allows you to obtain patient data to prevent or stop pathologies, provide more personalized care, train and educate patients on lifestyles. The workshop will be an opportunity to present some of the many interesting projects for the application of telemedicine in hospital–territory integration that are developing in the national territory as well as to deal with what is happening internationally. There are different experiences of telemedicine at an international level both in developed and developing countries. In Finland there are currently two active projects: 1. The e-Archive project, the aim of which is to digitize all hospital documents, creating a single format, and facilitating access to patient registers, who will be able to decide which information to make public; 2. Fundus screening project, which provides for continuous monitoring of patients with type 2 diabetes, in order to prevent diabetes (Khatri et al., 2011). In the UK, the “Whole System Demonstrator (WSD) Program”, aimed at the elderly, the differently able and chronically ill patients, which involved over 6,000 patients and over 200 doctors in two years. The results of the study were very significant, to the point of drawing up new programs, in collaboration with clinical companies, professional and socio-health associations, involving about three million candidates, including doctors and patients (Quotidianosanità, 2011; see also Department of Health, 2011). One of the first major telemedicine programs in Norway is the teleECG initiative that started in 1995 after initial pilot projects

and is a telemedicine service used in order to facilitate early diagnosis and treatment of suspected myocardial infarction in patients not hospitalized. The initiative started in northern Norway as a way to reduce time from acute cardiac illness to treatment and now is available in over 100 ambulances. This teleECG system, in fact, can either be used inside of the patient’s home or in the ambulance en route to the hospital. Ambulances send ECG images to the hospitals that are fitted with equipment to read and store the images sent. Once received, the images are analysed by a cardiologist at hospital who is able to make a diagnosis and recommend an immediate course of action. This initiative has spurred radical changes. The teleECG system has helped decrease call time to treatment time, resulting in faster treatment and better patient outcomes. Cardio patients’ outcomes have improved 15–20%. Having the ability to connect and consult with a cardiologist remotely has improved the quality of service and care from ambulances and paramedics (Ryu, 2012). In France the Ministry of health published in the Journal Officiel del la République Francaise a decree that defines the telemedicine services, the conditions of implementation and organizational aspects in order to set up the telemedicine in the healthcare system. In China the rural population, which represents about 70% of the entire Chinese population has access to only 20% of healthcare resources. Most digital projects involve a rural hospital, where signals, diagnostic images, and videos are acquired and sent to a main hospital. One of the most relevant projects covered the Sichuan area in West China and was carried on from 2002 to 2013: the telemedicine network connected 249 spoke hospitals in 112 rural cities with some highly specialized urban hospitals, focusing on 40 medical expertise areas. The authors, in addition to clinical improvements, also sum up the net saving of some US$ 2.3 million for patients (diagnosed in the rural hospital, patients did not need to move to the main hospital) and of some US$ 3.7 million for specialists (specialists did not need to move to the rural hospital to complete the diagnosis or to validate the treatment) (Combi et al., 2016). Claudia Bianchino

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Italy

The acceleration brought about by the pandemic and the legislation has led to an increase in the use of telemedicine applications by doctors, which before the emergency was just over 10%: the most used telemedicine service is teleconsultation with medical specialists, used during the last year by 47% of specialists and by 39% of General Practitioners (GPs) and which collects the interest for the future, overall, of 8 out of 10 (Osservatori.net, 2021). Compared to the past, we have three advantages that will foster change: an unprecedented awareness of the importance of digital, the resources of the National Recovery and Resilience Program (NRRP) and the related reforms. Now all the players in the Italian health ecosystem, from doctors to patients, from institutions to health facilities, are called upon to collaborate to build a “connected” healthcare modeled on the needs of the citizen/patient. One of the key barriers to the wider use of remote consultations was the need to change existing restrictions to allow such services to expand. Restrictions had to be relaxed rapidly with the demands of providing care during the COVID-19 crisis. In France, teleconsultations have been reimbursed since September 2018, but were restricted to physicians only and only with established patients (i.e., had at least one face-to-face consultation before a teleconsultation). Remote consultations also had to be by video link not over the telephone and use professional software to ensure data protection and privacy. The restrictions were dramatically simplified at the beginning of March 2020. In Germany, the Federal Association of Statutory Health Insurance Physicians (KVB) reported on first quarter (Q1) of 2020 and about 19,500 teleconsultations were performed in March 2020, compared to 1,700 teleconsultations in January and February 2020 (Richardson et al., 2020). Many countries have also relaxed regulations around the use of e-prescriptions (e.g. Austria, Greece, Ireland), or allowed remote certification of sickness absence from work. In some systems, changes to the way services are paid for needed to be made before remote consultations could be reimbursed (Waitzberg et al., 2022). In December 2020, during the State-Regions Conference, the new national Claudia Bianchino

guidelines for telemedicine were approved, with the aim of giving uniform indications throughout the entire territory for the provision of remote services, in particular specialist ones. The new guidelines were born in an exceptionally difficult historical moment, presenting themselves as an opportunity for an organizational and cultural renewal of the health system. The guidelines define the remuneration and tariff system to which the national/ regional regulatory framework that regulates access to the various LEA levels (Essential Assistance Levels) is applied. The guidelines also include the procedures relating to prescription, booking and reporting. The document then defines professional responsibility in the exercise of telemedicine, equating it to any health act conducted in the exercise of the health profession, providing further information in relation to the operational solutions to be chosen, to provide the best guarantees to users and the types of outcome of the service and the methods of making the reports available, as well as the possibility of sharing documents with other healthcare professionals, with the patient’s consent, also through the electronic health record. As regards the technologies, the minimum and sufficient elements are established to provide the service remotely, such as a connection network between doctors and patients, web portal for access by doctors and patients, access from computer, tablet or smartphone for healthcare professionals, login, GDPR compliance management, patient connection tools. Hardware and/or software certification as a medical device, suitable for the type of service to be provided, is then included among the basic characteristics. These pandemic years have contributed to substantially convincing most doctors of the usefulness that these tools can have in daily practice. The use of telemedicine, or remote clinical consultations, was limited in most OECD countries before the COVID‑19 pandemic, held back by regulatory barriers and hesitancy from patients and providers. From March 2020 onwards, given the impossibility of visiting in person, they took steps to facilitate and promote the use of telemedicine. Prior to the COVID‑19 pandemic, Estonia, Hungary, Iceland, Ireland, Korea, Luxembourg, Mexico, Turkey and the United

Telemedicine  167

States) allowed medical consultations to be performed only in the physical presence of the patient. While it was possible to use telemedicine services in other countries, many governments had requirements specific to telemedicine that discouraged its use. Twenty-three out of 31 countries are currently allowing teleconsultations to be performed by health workers that are not doctors, six more than before the COVID‑19 pandemic (Estonia, Germany, Iceland, Luxembourg, Portugal and the United States). However, only 17 countries state that rules and regulations governing the provision of telemedicine services are well established and clear. Many of the changes that have enabled greater use of teleconsultations during the pandemic are still temporary and have not been made permanent (Conferenza Stato Regioni, 2020). Claudia Bianchino

Environment: Workshop Summary. Washington, DC: The National Academies Press. https://​doi​.org/​10​.17226/​13466. Khatri, V., Peterson, C. B., Kyriazokos, S., & Prasad, N. R. (2011). A Review of Telemedicine Services in Finland. In: Dremstrup, K., Rees, S., & Jensen, M. Ø. (eds) 15th Nordic-Baltic Conference on Biomedical Engineering and Medical Physics (NBC 2011). IFMBE Proceedings, vol 34. Springer, Berlin, Heidelberg. https://​doi​.org/​10​.1007/​978​-3​-642​ -21683​-1​_1 Osservatori.net (2021). Sanità digitale oltre l’emergenza verso un modello di connected care. Osservatori.net – Digital Innovation. https://​www​.osservatori​.net/​it/​prodotti/​ formato/​report/​sanita​-digitale​-oltre​-emergenza​ -modello​-connected​-care​-report Quotidianosanità. (2011, December 19). Cure domiciliari. UK: con telemedicina calano spesa sanitaria (-8%) e mortalità (-45%). https://​www​ .quotidianosanita​.it/​studi​-e​-analisi/​articolo​.php​ ?articolo​_id​=​6631 Richardson, E., Aissat, D., Williams, G. A., & Fahy, N. (2020). Keeping What Works: Remote Consultations During the COVID-19 Pandemic. References Eurohealth, 26(2), 73‒76. Combi, C., Pozzani, G., & Pozzi, G. (2016). Ryu, S. (2012). Telemedicine: Opportunities and Telemedicine for Developing Countries. Developments in Member States: Report on the A Survey and Some Design Issues. Applied Second Global Survey on eHealth 2009 (Global Clinical Informatics, 7(4), 1025–1050. https://​ Observatory for eHealth Series, Volume 2). doi​.org/​10​.4338/​ACI​-2016​-06​-R​-0089 Healthcare Informatics Research, 18(2), Conferenza Stato Regioni. (2020). Indicazioni 153–155. https://​doi​.org/​10​.4258/​hir​.2012​.18​.2​ nazionali per l’erogazione di prestazioni .153 di telemedicina, Repertorio atti n.215/CSR Waitzberg, R., Gerkens, S., Dimova, A., Bryndová, (Conferenza Stato Regioni Dicembre 17, 2020). L., Vrangbæk, K., Jervelund, S. S., Birk, H. https://​www​.statoregioni​.it/​media/​3221/​p​-3​-csr​ O., Rajan, S., Habicht, T., Tynkkynen, L. K., -rep​-n​-215​-17dic2020​.pdf Keskimäki, I., Or, Z., Gandré, C., Winkelmann, Department of Health. (2011). Whole System J., Ricciardi, W., de Belvis, A. G., Poscia, A., Demonstrator Programme. https://​www​.gov​ Morsella, A., Slapšinskaitė, A., Miščikienė, L., .uk/​government/​publications/​whole​-system​ … Quentin, W. (2022). Balancing Financial -demonstrator​-programme​-headline​-findings​ Incentives During COVID-19: A Comparison -december​-2011 of Provider Payment Adjustments Across Institute of Medicine (US) Committee on Evaluating 20 Countries. Health Policy (Amsterdam, Clinical Applications of Telemedicine, & Field, Netherlands), 126(5), 398–407. https://​doi​.org/​ M. J. (Eds.) (1996). Telemedicine: A Guide to 10​.1016/​j​.healthpol​.2021​.09​.015 Assessing Telecommunications in Health Care. Washington, DC: National Academies Press. Institute of Medicine. (2012). The Role of Telehealth in an Evolving Health Care

Claudia Bianchino

59. Vertical and horizontal integration (hub and spoke network) The hub and spoke organization design is a model that arranges service delivery assets into a network consisting of an anchor establishment (hub) complemented by secondary establishments (spokes). The hub or main campus offers a full array of services, while the spoke or satellite campus offers a limited array of services (Elrod and Fortenberry, 2017). The hub and spoke network is highly scalable. It means that both spokes and hub can be added as needed. Usually, hubs are added in case of impracticable geographical distance between the existing hub and spokes. In case of two or more hubs, a multi-hub network is created. Figure 59.1 is an example of a hub

and spoke network for STEMI treatment in India (Alexander, n.d.). The organization of hub and spokes varies depending on the institution, services, and size of the market addressed. In healthcare, advanced medical services and services supporting care delivery are located in the hub. Basic healthcare services are broadly distributed across the spokes, so that they are available for the local population. To conclude, the satellite campus assists patients routinely and only in case they require complex services, not available in spokes, they are routed to the central campus or hub.

History of hub and spoke model

The hub and spoke model can be seen as a wheel. Figure 59.2 shows the hub as the central part of the wheel, while the spokes of the wheel are the satellite campus. The hub and spoke model was originally designed for the transport industry. In fact, Delta Airlines applied it for the first time in

Source:  Alexander (n.d.).

Figure 59.1

Scheme of hub and spoke system

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Vertical and horizontal integration (hub and spoke network)  169

1950 to optimize the connections of the airplanes. The idea was to connect several spokes to the main hub, as shown in Figure 59.3. In the late 1970s, this system was exported to other sectors, such as telecommunications, information technology, and healthcare (Wikipedia, 2021).

Source:  Wikipedia (2021).

Figure 59.2

The hub and spoke organization in airlines

Hub and spoke history in healthcare

The first application of this model in the healthcare sector was done in Shreveport, Louisiana by Wills-Knighton health system

(W.K. health system). In 1924, W.K. health system was created to fulfill the healthcare needs of the population in west Shreveport. Until 1970, the W.K. health system played a small role in the healthcare delivery. Then, due to the growth of the population and economic prosperity, the company decided to open a new hospital in the downtown area of the city. In 1983, to coordinate the two hospitals the hub and spoke model was used. The south hospital was the first satellite hospital, while the west hospital was the hub. Currently, the W.K. health system has 1290 beds across five hospitals and one retirement community. The WK medical center is the hub (est. 1924) and five spokes (hospitals) are present (Elrod and Fortenberry, 2017): ● WK South (spoke, est. 1983); ● WK Bossier Health Center (spoke, est. 1996); ● WK Pierremont Health Center (spoke, est. 1999); ● WK Rehabilitation Institute (spoke, est. 2017); ● The Oaks of Louisiana (spoke, est. 2007).

Benefits of hub and spoke models

Several benefits were identified by the transport industry. These benefits were confirmed by the experience of the W.K. health system (Elrod and Fortenberry, 2017).

Source:  Wikipedia (2021).

Figure 59.3

Analogy of hub and spoke model

Alice Danieli

170  Elgar encyclopedia of healthcare management

Consistency across operations The hub and spoke model can be compared to a hierarchical organization. The hub is considered the chief of all the satellite hospitals. It emanates the technical directives and the directives for the management of the patient for the whole organization. In the spokes, administrators should check that these directives are followed. The goal is that the patients are equally treated in every facility. Increases efficiencies The most advanced technology and the most skilled staff are located in the main campus. The satellite hospitals send the patients who require these services to the hub. This management eliminates cost duplication, increases return of investments and boosts economies of scale. In addition, the costs of care for patients, hospitals and insurances are reduced. Obviously, the allocation of complex services in the hub is not a strict rule. In fact, if a technology is required in one satellite center, due to high demand, the company can decide to implement these technologies also in one or more spokes. Furthermore, the non-directly related healthcare services, such as human resources, marketing, material management and finance operations are located in the main campus. To conclude, the central based organization affects positively the financial performances and it provides the possibility to reinvest money. Savings can be also used for charity purposes, such as providing healthcare to the uninsured population. Enhanced quality The hub and spoke model allows improving quality of care, achieving better outcomes for the patients. In particular, the system can concentrate resources on a single site, obtaining the formation of highly specialized centers. For example, in the case of the W.K. health system, inside the central campus there is the Heart and Vasculature Institute that is excellent in its field. Enhanced market coverage The expansion of care facilities has a high amount of cost. The hub and spoke model reduces these costs because new satellite campuses have limited services and their Alice Danieli

goal is to provide basic healthcare (Elrod and Fortenberry, 2017). In conclusion, the reduction of cost will enhance the interest of the company to open other satellite campuses. Improved agility The hub and spoke model provides the possibility to follow the evolving markets. The company decides the investment and which satellite will take advantage of this investment. In this way the investment is limited and focused on the area where it is required. It means that the expansion risks are under control. In addition, if the market changes, the acquired technology and skills can be moved to another satellite. Risks In the transport sector, this model usually does not have important drawbacks. In contrast, in the healthcare sector, some risks are present (Elrod and Fortenberry, 2017).

Congestion at hubs

The most important concept in this model is that patients are redirected from spokes to a hub. In some cases, it may create congestion at the main campus. The congestion can be easily avoided working on several points, such as parking spots, scheduling appointments, space requirements, technology available and staff coverage. An important aspect to consider is that all these points should be discussed and implemented every time new satellites are added to the network.

Overextension of spokes

The satellites should be located at adequate distance from the hub, otherwise, there are service failures. In fact, before building up a new satellite it is important to analyze the scenario and try to compare the project of the institution and the population’s needs.

Staff dissatisfaction at spokes

The spokes operate under the directives of the hub. This type of organization can cause some discontent in the staff of the spokes. In fact, they could complain about lack of autonomy to operate. The topics of discontent usually regard the schedule of the work, offered services, advertising campaigns and the development of site-specific personnel

Vertical and horizontal integration (hub and spoke network)  171

policies. However, the autonomy of the staff is not compatible with the hub and spoke model that aims for equal patient experiences across the system. To overcome this problem, a good administrator is fundamental. In addition, informative employee orientation and periodic training opportunities can be helpful.

Transport disruption

The hub and spoke model is based on the connection between facilities. To connect hub and spokes, different means of transport can be used, such as personal transportation, patient transportation vans, emergency vehicles and aircraft (Elrod and Fortenberry, 2017). However, unexpected events can hinder the transportation process, for example traffic accidents, vehicle breakdowns and so on. For this reason, a patient transportation division should be created to overcome possible adverse events.

Hub and spoke in Italy

In Italy, the hub and spoke model has been used for several years. The most important healthcare service that is based on hub and spoke in Italy is the emergency service. On 2 April 2015, a ministerial decree was released to regulate the emergency service (Salute.gov, 2019). The emergency service is organized in this way: ● Hospital with ER: it is a hospital where patients should be managed, treated and may be transferred to the first level D.E.A. hospital. ● First level D.E.A. hospital: its functions are the same of a hospital with ER. In

addition, it is able to manage complex pathologies and it has intensive care units for short stays. This is considered a spoke. ● Second level D.E.A. hospital: All the lower hospital level functions are performed. Then, it has some highly specialized centers, such as a burns center, transplant center, cardiac surgery and neurosurgery. This is the hub center. In the end, there is also the possibility of having an additional hospital for disadvantaged areas. It is possible when the time between a particular area and the spoke is more than 90 minutes or more than 60 minutes from a hospital with ER. The hub and spoke model is applied also in other medical sectors, such as oncology, rare diseases, emergency surgery (cardiovascular and neurological). Alice Danieli

Bibliography

Alexander, Thomas. STEMI India’s successful hub and spoke model: a blueprint for others? The Stent – Save a Life. n.d. www​.stentsavealife​ .com/​news​-articles/​stemi​-india​-s​-successful​ -hub​-and​-spoke​-model/​. Elrod, J.K. and Fortenberry Jr, J.L. The hub and spoke organization design: an avenue for serving patients well. BMC Health Serv Res. 2017;17(Suppl 1):457. Salute.gov. Servizio Sanitario Nazionale: i LEA. Salute.Gov. January 30, 2019. http://​ www​ .salute​.gov​.it/​portale/​lea/​d​ettaglioCo​ntenutiLea​ .jsp​?lingua​=​italiano​&​id​=​4716​&​area​=​Lea​&​ menu​=​ospedaliera. Wikipedia. Hub and spoke. January 2021. https://​it​ .wikipedia​.org/​wiki/​Hub​_and​_spoke.

Alice Danieli

PART XII BEHAVIOURS: CHALLENGES TO LEADING HEALTH ORGANIZATIONS One of the most important abilities for a manager is the ability to lead, in other words, to know how to manage the internal relational dynamics and the vulnerabilities that are closely connected to them. These kinds of dynamics are even more acute in healthcare organizations, because of the complexity that is intrinsic in their nature. This cluster groups these dynamics within healthcare organizations and gives a perspective on how to deal with them.

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60. Accountability

Goals

Definition

Accountability is defined as the quality or state of being accountable, which means having the obligation or willingness to accept responsibility or to account for one’s actions. The concept of accountability can be applied to healthcare systems by entailing all the procedures and processes by which different actors of the healthcare sector justify and take responsibility for their activities. Accountability contains three essential components: (1) the role that health sector actors play (who is/should be accountable? To whom they should be accountable?); (2) the domains of accountability (e.g., professional competence, legal and ethical conduct, financial performance, adequacy of access, public health promotion, and community benefit); (3) the procedures of accountability, including formal and informal procedures for evaluating compliance with domains and for disseminating the evaluation and responses by the accountable parties.

Rationale

Accountability has become increasingly important especially because governments are nowadays required to provide health services effectively, efficiently, and equitably at the same time. These challenging goals have been pursued in many countries also by privatizations and partnerships with private healthcare providers, or by fostering competition in service delivery, by using performance management systems, and by directly involving citizens and patients in evaluating healthcare services. Furthermore, expenditure of public resources for healthcare has a relevant impact on budgets of all countries, thus requiring particular attention on how public funds are being used. These converging factors have pushed towards the adoption of accountability as a fundamental pillar of modern healthcare systems. The underlying idea is that healthcare systems have an unexploited margin for improvement if they better align the utilization of resources with what is known about the appropriateness and effectiveness of care.

According to WHO, there are three main goals of accountability in the healthcare sector. The first is to control the utilization of public resources (financial accountability); the second is related to compliance to legal procedures, professional standards and protocols; the third is linked with the idea that feedback can support policymaking and management to improve the quality and standards of healthcare services. The focus of accountability may vary between industrialized countries (where it is centered around cost issues, quality assurance, and access) and developing or transitioning countries (where there could be additional concerns about availability and equitable distribution of basic services, abuses of power, financial mismanagement and corruption, and lack of responsiveness of healthcare services).

Future development

Achieving higher and satisfying levels of accountability is not always easy. Some distinctive features of healthcare services have an impact on the ability of stakeholders to be accountable. To improve accountability, healthcare systems must work on overcoming or compensating the consequences of asymmetries among providers, users, and oversight bodies in terms of information, expertise, and access; another area of future development is the alignment of diverging interests and incentives of public and private actors; finally, institutional capacity building is still required in many countries to create the conditions for the systems to be accountable. Andrea Rotolo

Bibliography

Emanuel EJ, Emanuel LL. What is accountability in health care? Ann Intern Med. 1996 Jan 15;124(2):229‒39. doi: 10.7326/0003-4819-124-2-199601150-00007. PMID: 8533999. Maynard, A. Health care rationing: doing it better in public and private health care systems. Journal of Health Politics, Policy and Law. 2013;38(6):1103–27.

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potentially harmful to patients (Johnson, 2014).

Goals

Every system is perfectly designed to get the results it gets. (W. Edwards Deming, potentially further attributed to Arthur Jones, Paul Batalden, and/or Donald Berwick)

Definition

Accountable Care (sometimes referred to as Accountable Care Organization or Accountable Care Plan) is defined as the collaboration of a group of healthcare providers (including hospitals, physicians, and other clinicians) who agree to share responsibility for quality, cost and coordination/integration of healthcare services with aligned incentives for a defined population of patients. The goals of ACOs are to improve quality of care, limit unnecessary health service utilization, and to restrain or reduce spending (AAFP, 2022; AHA, 2022; CMS, 2022; KHN, 2022; Kingsfund, 2018; Italian Health Ministry, 2022). Some definitions also specify the need to address social determinants of health, as well as the importance of patient collaboration in decision-making, cultural sensitivity and equity, and emphasizing health over illness by focusing on well-care over sick-care and providing the right care at the right place and time (Zorg Instituut, 2022).

Rationale

For many years, healthcare spending in nearly all countries has been steadily rising as a percentage of gross domestic product (GDP). From 2010 to 2020, health spending as a percentage of GDP in OECD countries increased from 8.6% to 9.9% (OECD, 2022a). Italy experienced approximately the average, with healthcare spending rising from 8.9% in 2010 to 9.7% of GDP in 2020. Reducing the rate of healthcare spending growth is becoming a priority globally. Many believe a major contributor to this spending problem is the traditional or “legacy model” of payment: fee-for-service (FFS). In FFS, providers (hospitals, physicians, and others) earn more revenue by providing greater volumes of services. This “provider-induced demand” has been criticized as unnecessary and even

The goal of an Accountable Care model is to change the incentive structure of the legacy payment model (fee-for-service or FFS in most countries) to provide more financial reward for improving health, reducing spending, improving health equity, and disincentivizing the provision of excessive and/or unnecessary volumes of healthcare services. Goals may also include patient co-creation of prevention-focused health goals.

What the healthcare manager needs to know

With ACO-like arrangements becoming more and more common around the world, healthcare managers need to be well-educated on this new model which has significant implications for healthcare providers’ delivery models and organizations’ financial sustainability. Healthcare managers must be equipped to negotiate ACO arrangements with payers and other providers, implement the operational changes necessary to thrive under the new arrangements, and then collect and analyse data to evaluate performance of each entity partnering in the ACO model (DeVore & Champion, 2011).

History

Some of the earliest ACO models were in Massachusetts, U.S.A, chiefly as a part of the Massachusetts health reform efforts of 2006, as well as other pioneering efforts in other U.S. states like Colorado (Davis & Schoen, 2007; KFF brief, 2013; Howard et al., 2014a). Those experiments in turn inspired the “Coordinated Care Organization” health reform model in Oregon, U.S.A in 2007‒2011 (Howard et al., 2015; Howard et al., 2014a; Howard et al., 2014b), the ACO model component of the U.S.A.’s Affordable Care Act of 2009, and some early private insurer ACO efforts (Howard et al., 2014a). Similar ACO-like models have since been adopted by multiple U.S. states’ Medicaid programs, large employers and private insurers in the U.S., multiple provider–payer arrangements in the Netherlands, and multiple demonstration projects in Germany (Zorg

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Accountable care plan and organization  175

Instituut, 2022; Cattel & Eijkenaar, 2020; Howard et al., 2022).

able hospitalizations, or prescription opioid use.

Description

Examples

While ACOs can be structured in many ways, an integrated network of providers must be formed that can provide all, or nearly all, the services in the healthcare continuum. This can be done in many ways. For example, all could be owned by the same company, as with Kaiser Permanente or Geisinger in the U.S.A. Or, the ACO organization could simply be assembled by a confederation of independent providers, as with most of the other Medicare ACOs in the U.S., or some of the alternative payment arrangement experiments in the Netherlands. While risk and reward could be shared in multiple ways between payers and providers, the most common ACO financial models (including first 10-years of U.S. Medicare ACOs) were “shared savings models.” The payer attributes/assigns a particular patient population to a provider ACO entity (the entities were often newly formed join ventures of hospital, primary care, specialty care, and other provider organizations). In the American Medicare example, this could be all Medicare enrollees (predominantly patients age 65 or older) within a hospital or ACO’s metropolitan area or geographic service area. An historical spending benchmark is computed (often a three-year rolling average of total cost of care, or a specific subset of the total cost of care). A future spending target (per patient) is based on that historical benchmark. If the providers involved in the ACO are able to provide all the types of healthcare specified in the contract (for example, everything except long-term care, dental or optical services) within the target cost levels (lower than the benchmark), then the payer and provider/ ACO will share the difference (the “savings”) in a predetermined ratio (perhaps 50/50, or 60/40, for example). However, to help ensure quality and avoid denial of important healthcare services, specific quality goals must be achieved, in addition to the cost savings. Such metrics could include improving vaccination rates and rate of annual preventive exams in the population, or reductions of low-value or potentially harmful services, like caesarean section births, lower-back surgeries, avoid-

The U.S. Medicare program’s ACO models have been some of the leading, most recognized ACOs globally. For more information about the current and earlier generations of the Medicare ACO program, as well as other payment and delivery model reforms being considered, see the Centers for Medicare and Medicaid Services website.1 The Zorg Instituut of the Netherlands is also a leader in the transition to value-based care, including accountable care organization-like structures (“Appropriate Care”) (Zorg Instituut, 2022).2

Future developments

The trend among ACO initiatives is for providers to undertake increasing levels of risk, providing greater financial opportunities for gain if cost, utilization, and quality targets are achieved, and the risk for losses if they are not (Baker & Singer, 2022; Howard et al., 2022). Steven Howard

Notes

1. See https://​innovation​.cms​.gov/​innovation​-models/ ​aco​-reach; https://​www​.cms​.gov/​Medicare/​Medi care​-Fee​-for​-Service​-Payment/​sharedsavingspro gram. 2. See https://​www​.zo​rginstituu​tnederland​.nl/​werk agenda/​passende​-zorg.

Bibliography

AAFP (American Academy of Family Physicians) (2022). definition: https://​www​.aafp​.org/​ family​-physician/​practice​-and​-career/​delivery​ -payment​-models/​acos​.html AHA (American Hospital Association) (2022). definition: https://​www​.aha​.org/​accountable​ -care​-organizations​-acos/​accountable​-care​ -organizations Baker, N., & Singer, P. M. (2022). Accountable care organization reform: past challenges and future opportunities for public health. Public Health, 205, 99‒101. https://​doi​.org/​10​.1016/​j​ .puhe​.2022​.01​.012 Cattel, D., & Eijkenaar, F. (2020). Value-based provider payment initiatives combining global payments with explicit quality incentives: a sys-

Steven Howard

176  Elgar encyclopedia of healthcare management tematic review. Medical Care Research and Review, 77(6), 511‒537. CMS (Centers for Medicare & Medicaid Services) (2022). https://​innovation​.cms​.gov/​innovation​ -models/​aco Davis, K., & Schoen, C. (2007). State health system performance and state health reform: variations in state performance signal opportunities for all states to improve the way they deliver health care. Health Affairs, 26(Suppl2), w664‒w666. DeVore, S., & Champion, R. W. (2011). Driving population health through accountable care organizations. Health Affairs, 30(1), 41‒50. https://​doi​.org/​10​.1377/​hlthaff​.2010​.0935 Howard, S. W., BeLue, R., & van de Klundert, J. (2022). Editorial: The role of healthcare delivery, payment and policy innovations in decreasing the global burden of chronic disease. Frontiers in Public Health, 10, 972064. https://​ doi​.org/​10​.3389/​fpubh​.2022​.972064 Howard, S. W., Bernell, S. L., Yoon, J., & Luck, J. (2014a). Oregon’s coordinated care organizations: a promising and practical reform model. Journal of Health Politics, Policy and Law, 39(4), 933‒940. Howard, S. W., Bernell, S. L., Yoon, J., Luck, J., & Ranit, C. M. (2014b). Oregon’s coordinated care organizations: unique healthcare delivery model or just managed care by another name? ACA Implementation Research. Howard, S. W., Bernell, S. L., Yoon, J., Luck, J., & Ranit, C. M. (2015). Oregon’s experiment in

Steven Howard

health care delivery and payment reform: coordinated care organizations replacing managed care. Journal of Health Politics, Policy and Law, 40(1), 245‒255. Italian Health Ministry 2022 (ASLs): https://​www​ .pnrr​.salute​.gov​.it/​portale/​documentazione/​ usldb/​glossdett​.jsp Johnson, E. M. (2014). Physician-induced demand. Encyclopedia of Health Economics, 3(77), 77‒83. https://​web​.archive​.org/​web/​ 20150724175807id​_/​http://​www​.mit​.edu:​80/​ ~erinmj/​files/​PID​.pdf KFF brief (2013). Focus on health reform brief #8311: Massachusetts health care reform: six years later. https://​www​.kff​.org/​wp​-content/​ uploads/​2013/​01/​8311​.pdf khn​ KHN (Kaiser Health News) (2022). https://​ .org/​news/​aco​-accountable​-care​-organization​ -faq/​ Kingsfund Org. (2018). https://​ www​ .kingsfund​ .org​.uk/​publications/​accountable​-care​ -explained​#:​~:​text​=​Accountable​%20care​ %20partnerships​%20(ACPs)​%20are​,mental​ %20health​%20services​%20and​%20GPs. OECD (2022a). https://​www​.oecd​.org/​els/​health​ -systems/​health​-expenditure​.htm OECD (2022b). https://​www​.oecd​-ilibrary​ .org/​sites/​ae3016b9​-en/​1/​3/​7/​1/​index​.html​ ?itemId​=/​content/​publication/​ae3016b9​-en​&​ _csp​_​=​ca​413da5d445​87bc564463​41952c275e​ &​itemIGO​=​oecd​&​itemContentType​=​book Zorg Instituut (2022). Passende zorg (appropriate care). https://​www​.zo​rginstituu​tnederland​.nl/​ werkagenda/​passende​-zorg

62. Iatrocracy, professional bureaucracy and corporatization The issue of securing health system and health organization sustainability has become very popular, dominating public debate over the last 30 years. The “new public management” approach implemented in the 1990s by many European countries contributed to the great emphasis put on the financial management of health organizations. Consequently, health systems and health organizations were often reconfigured, transformed, downsized, merged, redesigned, streamlined, etc. for the purpose of improving their cost management capacity: to reduce costs. It was in this environment that what can be labeled “corporatization” emerged in the 1990s in many health systems and health organizations. Before that period, the model of “professional bureaucracy” (Mintzberg 1983), described health organizations well, as they were characterized by a specialties-based internal design. Such design was fit to accommodate specific needs driven mostly by the interests of the medical class, such as: ● The need to develop a specific expertise and skill set, from the allocation and ownership of resources and logistics (beds, operating theaters, outpatient clinics, nurses, health staff etc.) to clinicians. ● The need to clearly separate (and position) the “turf” governed by different physicians in the same hospitals or across different hospitals, a common path in professional contexts. ● Staff self-interest, whereby the distribution of doctors and medical work was more influenced by professional interest, financial inducements, rivalries and career aspirations than by patients’ needs. In general, the influence of power and politics on organizational design choices is well-documented (Pfeffer, 1992). In this light, the professional bureaucracy can be understood as the evolution of the iatrocracy, the health organization (mainly the hospital) run by doctors with no other external or internal supervision. The organization of

healthcare systems in most Western countries has traditionally been governed by the medical profession (Berg, 2008). Berg (2008) has used the terms “medicracy” and “iatrocracy” interchangeably to describe these traditional forms of medical governance. A key characteristic has been the implementation of doctors in central positions, in order to emphasize professional practice and prevent interferences from outside influence. When in the 1960s different countries introduced management ranks within hospitals and health organizations, to support and to some extent to control the full discretion experienced by medical professionals till that point, the professional bureaucracy emerged. An organization with two souls: one professional, the other bureaucratic. Yet, as we already stated, the professional side remained dominant and modeled the internal design according to its will. The common root and progress of medical knowledge and specialties led to striking similarities in the organization of hospitals located in different countries, such as the USA and Latin-American market-oriented countries as opposed to NHS and public system-based countries. Healthcare management tended to be characterized as passive and custodial in deference to professional groups – especially physicians – who exerted considerable control over healthcare demand in all contexts. The professional bureaucracy relies on standardization of skills and indoctrination. It hires duly trained and indoctrinated specialists – professionals – and then gives them considerable control over their work. Control over their own work means also that the professionals work relatively independently from their colleagues, but closely with the clients (patients) they serve. Most necessary coordination between the operating professionals is handled by the standardization of skills and knowledge – in effect, by what they have learned to expect from their colleagues. Whereas business generates its own standards – its internal technostructure (quality, operations) designs the work standards for its operators and its line managers enforce them – the standards of the professional bureaucracy originate largely outside its own structure, in the self-governing association its operators join with their colleagues from other professional bureaucracies. The profes-

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sional bureaucracy emphasizes authority of a professional nature – the power of expertise. The strategies of the professional bureaucracy are largely ones of the individual professionals within the organization as well as of the professional associations on the outside. The professional bureaucracy’s own strategies represent the cumulative effect over time of the projects, or strategic initiatives, that its members are able to convince it to undertake. The technical system cannot be highly regulating, certainly not highly automated. The professional resists the rationalization of their skills – their division into simply executed steps – because that makes them programmable by the technostructure, destroys their basis of autonomy, and drives the structure to the machine bureaucratic form. Therefore, professional bureaucracy is an inflexible structure well-suited to produce its standard outputs but ill-suited to adapt to the production of new ones. Change in the professional bureaucracy does not sweep in from new administrators taking office to announce major reforms. Rather, change seeps in by the slow process of changing the professionals – changing who can enter the profession, what they learn in its professional schools (norms as well as skills and knowledge), and thereafter how willing they are to upgrade their skills. Examples of professional bureaucracies other than hospitals and health organizations are organizations such as universities and large consultancy firms. In the 1990s, this “model” was revisited with two major paths of change: a. The introduction of a layer of top management (CEO, COO, CMO, etc.), apt to guarantee better unitary management and strategic development of the health organization; b. The development of a stronger “technostructure” to serve the needs of management. Planning, budgeting, management control, quality, strategic human resource management are some examples of the functions that quickly emerged within health organizations and were responsible for developing and running operational mechanisms that supported clinicians’ decision-making and accountability.

Federico Lega

This marked what can be considered “corporatization”. Health organizations started to practice more structured decision-making processes concerning planning, investments, budgeting and performance appraisal. By corporatization we mean reforms of governance of public and private health organizations that have included: (a) increasing the management autonomy of the organization (autonomization); (b) exposing health organizations to market-like pressures; and (c) divestiture of the organizations from the pure public sector regulations (semi-privatization). The whole process started with the advent of “New Public Management”. Changes (a) and (c) referred mainly to the public domain, while (b) affected all kinds of health organizations that increasingly are facing market-like contexts, greater expectations in terms of outcomes, transparency and accountability to the system, challenging financial pressures. In response, a new “entrepreneurial” and business-like mindset seemed to be necessary to survive the evolving environment. Both at top level and middle level. From CEOs, to clinical leaders, from board to bed side. In this light, corporatization of health organizations drew more attention toward benefits of competition. But even more interesting is the shift that corporatization determined in the internal design and dynamics of health organizations, especially in hospitals. Clinical directorates have been created, and benchmarking of departmental performance has been introduced. Many of these efforts are part of the growing trend toward applying “best-practice” management techniques from private companies to reform governance of the hospitals. Frequently, attempts are made to introduce business-process reengineering, patient-focused care, or quality-improvement techniques. As noted by Bury et al. (2008): Departments (divisions, CDs, clinical service lines) can be regarded as equivalent to the business units, or service lines, in a commercial organization. Each department functions as a service line responsible for the quality of the product delivered, the customer’s satisfaction with that product, the productivity of the people who work in the department, and the department’s economic performance. For hospitals, the product is patient care, and economic performance is the degree to which a department provides that care within the limits set by a country’s reimbursement system. Clinical

Iatrocracy, professional bureaucracy and corporatization  179 departments can function as service lines only if they have the power to make decisions. Thus, Service Line Management (SLM) allocates autonomy to the front line: the clinicians in each department, particularly the clinical directors, have greater control over its activities and greater input into its long-term goals. Of course, this autonomy must be earned. Clinicians must accept greater accountability for the functioning of their departments, and all departments must be monitored regularly to ensure that performance problems are corrected… We strongly believe that each service line should have a single point of accountability, so we recommend that each be headed by one clinical leader. If a hospital wants a clinical leader and a general manager to share service line leadership, it must make sure that both parties understand who is responsible for making final decisions…These clinicians will need to understand the broader challenges their hospitals face, to accept ownership of their service lines, and to be capable of making decisions that take into account many financial, operational, clinical, and human factors.

The introduction of the CDs/SLM/business units model generated a shift in focus: the source of legitimacy for the hospital increasingly became its performance, and the board of directors became the source of authority. This corporatization also led to “managerial-market orientation” (Scott et al., 2000) or “efficiency logic” (Arndt & Bigelow, 2006). Business units are hence expected to facilitate the development of “business modeling” within health organizations. Modern healthcare needs a new approach in designing and reconfiguring care provision. Business modeling can be a driver and a solution for this challenge. Federico Lega

Bibliography

Arndt M., Bigelow B. (2006), Toward the creation of an institutional logic for the management of hospitals: Efficiency in the early nineteen hundreds, Medical Care Research and Review, 63(3): 369‒394. Berg O. (2008), The demise of the “iatrocracy”, Journal of Management & Marketing in Healthcare, 1(2): 117‒119. Bury E., Carter K. S., Feigelman M., Grant J. M. (2008), How service-line management can improve hospital performance, Health International, 54–65. Kirkpatrick I., Bullinger B., Dent M., Lega F. (2013), The translation of hospital management models in European health systems: a framework for comparison, British Journal of Management, 24(S1): 48‒61. Lega F., DePietro C. (2005), Converging patterns in hospital organization: beyond the professional bureaucracy, Health Policy, n. 74. Lega F., Prenestini A., Rosso M. (2017), Leadership research in healthcare: a realist review, Health Service Management Research, 30(2): 94‒104. Lega F., Spurgeon P., Prenestini, A. (2013), Is management essential to improving the performance and sustainability of healthcare systems and organizations? A systematic review, Value in Health, 16(1 suppl): S46‒S51. Mintzberg H. (1983), Structuring in Fives: Designing Effective Organization, Englewood Cliffs, Prentice Hall. Pfeffer J. (1992), Managing with Power: Politics and Influence in Organizations, Boston, Harvard Business Review Press. Scott W. R. (1982), Managing professional work: three modes of control for health organizations, Health Service Research, 17: 213‒240. Scott W. R., Ruef M., Mendel P. J., Caronna C. (2000), Institutional Change and Healthcare Organizations, Chicago, IL: Chicago University Press.

Federico Lega

63. Political arena It is not unusual in any organization, and specifically in a professional organization like healthcare, to hear of the senior management group as “the barons”. In expressing the governance of the business in this way, one gets the sense of competition for resources, the competition for attention in terms of career progression within the organization, and something of the pattern of patronage within the different units. Moreover, professionals, like physicians, nurses, therapists, social workers, and many others, frequently clash as they rely on culture and identity founded on different values. The resulting “tribal warfare” transforms the organization into a playing field where each individual performs his art, both professional and political. The organization is pulled apart by the pushes coming from different internal parties and its strategic development is influenced by the dominant ones. The organization becomes then a context for power games. As Pettigrew et al. (1992) suggests, power is central to the strategy process in organizations because decisions about what strategy to maintain or innovate will always be political. Such decisions threaten the existing distribution of organizational resources as represented in salaries, in promotion opportunities, and in control of tasks, people, information, and new areas of business. Power and organizational politics are central in professional organizations where different professional groups share the “scene”. They all seek to legitimate the ideas, values, and demands while simultaneously denying or decrying those proposed by others. Hence, power dynamics generate “games” rich in organizational symbolism, wrapped up in myths, beliefs, language, and legend – all contributing to define an organizational culture. In professional organizations, especially in healthcare, there are several sub-organizational cultures and lots of politics often generated by the following: ● Turf wars in the organization between different groups with different values, identities, aims; ● The complexity and the degree of uncertainty attached to issues to be addressed; ● The salience of the issues for different actors and identities in the organization;

● The external pressure coming from stakeholders or other actors or organizations in the environment; ● The history of past politics in the organizations in question. According to Mintzberg’s (1983) studies, this situation defines the organization as a political arena, one in which the system of politics comes into play whenever the systems of authority, ideology, or expertise may be contested in various political games. Mintzberg identifies various commonly occurring political games, including the following: ● Insurgency games: Played by lower-status participants against the dominant elites. ● Counter-insurgency games: Played by the dominant elites against the insurgents. ● Sponsorship games: Played by patrons and clients. ● Alliance-building games: Played among peers who implicitly seek reciprocal support. ● Empire-building games: A political actor or subsystem seeks to capture others and enroll them as subordinate to its interests. ● Budgeting games: The objective is to secure resources. ● Expertise games: The games of strategic contingency. ● Lording games: Relatively powerless players seek to “lord it” through using their legitimate power over those supplicant or lower in status. ● Line vs. staff games: Each side uses legitimate power in illegitimate ways in games of rivalry. ● Rival camps games: Alliance or empire-building games develop into rival blocks that face each other in zero-sum games. ● Strategic candidate games: Those in power seek to ensure the succession of preferred candidates as vacancies arise. ● Whistle-blowing games: Participants, usually lower-status ones, seek to expose malfeasance or illegitimacy outside the organization to effect internal policy or strategy changes. ● Young Turks games: Organizational authority is preserved, but a coup unseats its present incumbents to institute a regime change In organizations, politics are normal and serve many orderly functions.

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Political games are a natural or physiological condition of professional context, and they are to be expected in healthcare. The dynamics that Mintzberg identified are not mutually exclusive and often overlap and interact. Healthcare management have to face them regularly, and specifically have to cope with four major forms in the political arena, defined as follows: ● Confrontation context, characterized by intense, confined, and unstable conflict, as in a takeover or merger; ● Shaky alliances, where conflict is moderate, confined, and relatively stable, as in professional organizations subject to public accountability, such as public hospital or education systems; ● Politicized organizations, with conflict that is moderate, pervasive, and relatively stable, such as large public sector bodies or regulatory agencies; ● Complex political arenas, subject to intense, pervasive, and brief unstable conflict, such as organizations riven by major fault lines of factional and doctrinal

division, both internally and in terms of external alliances and relations. Healthcare organizations tend to belong to the “shaky alliances” archetype, but especially large teaching hospitals or academic medical centers can be represented by complex political arenas. Federico Lega

Bibliography

Abernethy M, Vagnoni E. (2004), Power, organization design and managerial behaviour. Accounting, Organizations and Society, 29:207‒225. Allen B, Currie G. (2011), Shaping strategic change: making change in large organizations. Journal of Health Services Research & Policy, 16(3):184–186. Hofstede G. (1997), Cultures and Organizations: Software of the Mind, New York, McGraw-Hill USA. Mintzberg H. (1983), Power In and Around Organizations, Englewood Cliffs, Prentice Hall. Pfeffer J. (1992), Managing with Power: Politics and Influence in Organizations, Boston, Harvard Business Press.

Federico Lega

64. Professional vs managerial culture Due to the evolution of society and organizations, in the last 40 years traditional professional worlds have been exposed to management. Liberal professionals such as lawyers are increasingly working in large organizations, with forms of hierarchy, structured procedures and management control systems. In the welfare sector, professionals in hospitals, tribunals, schools and universities are required to take efficiency into account alongside effectiveness, and to openly report performances and be accountable to the public rather than (only) to the profession (Kirkpatrick et al., 2005). This process of managerialization has involved also public sector organizations, especially after the New Public Management reforms introduced in the 1980s and 1990s in most western countries (Ferlie et al., 1996). And these trends deeply impacted healthcare services and healthcare professionals. Historically, professionalism and managerialism have been considered two alternative cultures or logics. While professionals are concerned with quality and effectiveness, managers are mostly concerned with efficiency; while professionals claim discretion and autonomy, managers wish to introduce standardization and procedures. Professional culture does not accept other forms of regulation than informal peer-control and confidential performance appraisal, whereas managerial culture wishes clear hierarchy and explicit performance management systems. If professionals focus their activity on treating individual cases, managers look at the collective and at the overall organizational interest. These dichotomies can be found in healthcare, as shown by the divergencies between professionals (first and foremost doctors) and administrators. The spread of management led to alternative responses from professionals, which have been interpreted, by sociologists and management scholars, from different angles. Initially, the view of the clash between cultures prevailed. Professionals’ resistance to management has been studied, which could be either open – fighting to protect themselves from managerial “intrusions” – or subtle – drawing management into profes-

sional practice to gain a new source of power and pursue self-interest. Subsequently the academic debate, in line with practical evidence, has progressively moved beyond this dichotomic view by stressing new intertwined combinations of management and professionalism, where neat boundaries are blurred and negotiations take place between different identities and practices. Noordegraaf (2015) describes the earlier evolution as a transition from pure (traditional) professionalism to a model of controlled professionalism in which managerial culture is juxtaposed to professional one and aims at controlling it, often generating professional resistance, as coordination mechanisms, sources of authority and values are clearly in contrast. The third phase of managed or hybrid professionalism, instead, has features in which managerial and professional elements coexist. In healthcare, hybridization has taken various forms, from hybrid organizational practices, such as quality management or care pathways; to hybrid structures, such as clinical networks; to hybrid roles, such as clinical directors. In particular, hybrid roles, that is, professionals engaged in managing professional work, colleagues, and other organizational resources, have been seen as a way to reduce the frictions between traditional professional values and new organizational paradigms. Accordingly, they have diffused among health systems of the Western world, first in the US (Montgomery, 2001) and then in the UK, Canada, New Zealand and Australia, and other countries in Scandinavia and Continental Europe. They were found capable to reconcile the two apparently conflicting worlds, to bridge the gap between colleagues and administrators, being “loyal” and committed towards both the organization and the profession. They facilitated the introduction of managerial practices like financial management, reporting, human resource management, process reengineering, etc. in healthcare organizations. This trend has been common in most advanced countries, although the speed of change varied according to the different health systems, the nature and process of public management reforms and the nature of organizational settlements with the healthcare professions. At the same time, individual responses to hybrid practices and roles can

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change according to a number of personal and contextual factors. For instance, while some doctors were willing and motivated to take up the managerial roles, others performed managerial tasks with reluctancy. In order to support the effectiveness of these hybrid roles, it is first of all necessary to select them wisely, and the best doctor-in-management is not necessarily the most prestigious specialist or the best researcher. At the same time, organizations should provide them with adequate support for understanding management tools and vocabularies, for example thanks to prepared managerial staff, for assimilating the new identity, for example through adequate training and mentoring, and for legitimizing the new role before peers, for example through adequate delegation of strategic responsibilities. Recently, observing what is happening in professional organizations, various authors have suggested moving beyond the very notion of hybridity. The concept of hybridity implies that managerial and professional cultures remain two logics apart, although tied together, while “we can redefine the meaning of ‘professional’ and ‘organizational’ and trace new service logics in which organizing becomes part of professional work (beyond hybridity). Whereas hybrid professionalism is ‘meaningfully managed professional work’, the move beyond hybridity implies new forms of professionalism in which organizing becomes part of professional work and repertoires” (Noordegraaf, 2015, p. 199). The very nature of professionalism needs to evolve due to the evolution of societal demands, with patients calling for

more transparent, flexible and interconnected services, and citizens claiming transparency and stakeholder involvement in decision making: “in order to become effective and legitimate, present-day professionalism will need to become much more open and connective” (Noordegraaf, 2015). In this new and reconfigured professionalism, elements like quality improvement, accountability to patients, integrated care pathways, become genuinely professional features. Accordingly, this evolution affects not only professionals in managerial roles, such as clinical directors or medical directors, but professionals at all levels, including the frontline. Marco Sartirana

Bibliography

Davies, H. T., Nutley, S. M., Mannion, R. (2000). Organisational culture and quality of health care. Quality in Health Care: QHC, 9(2), 111–119. Ferlie, E., Ashburner, L., Fitzgerald, L., Pettigrew, A. (1996). The New Public Management in Action. Oxford: Oxford University Press. Kirkpatrick, I., Ackroyd, S., Walker, R.M. (2005). The New Managerialism and Public Service Professions: Change in Health, Social Services, and Housing. Basingstoke: Palgrave Macmillan. Montgomery K. (2001). Physician executives: The evolution and impact of a hybrid profession, in: Blair J., Fottler M., Savage G., (Eds.) Advances in Health Care Management Volume 2. London: Emerald Group Publishing. Noordegraaf, M. (2015). Hybrid professionalism and beyond. (New) forms of public professionalism in changing organizational and societal contexts. Journal of Professions and Organization, 2(2), 187‒206.

Marco Sartirana

65. Professionalism Professionalism refers to the values, conduct and qualities of professions and professionals. Professionals first and foremost can be found in the world of liberal professions, such as doctors and lawyers, but also in fields that are more connected to private or public organizations, such as accounting, engineering, education, social work, police, and so on. Different definitions exist of what is a profession, which identify some recurring features. A profession can be defined as a group of individuals who render a service in the interest of others, who possess an expert knowledge acquired through a long education and training, who are characterized by a rigorous ethical code demanding high standards of behavior, and in which the access to and practice of the profession is self regulated by professionals and their associations in a way that is accepted by the community. First of all, professionalism has a service element, as professionals always render a service to individuals and/or the community. The service element is present in many other types of occupations, however, professional service has a vocational dimension as it is also connected to a transcendent value, such as justice, truth, health, and so on, which may reach beyond those who are benefiting from the service. Serving this ideal is one of the reasons why professionals claim independence of judgment and freedom of action rather than mere faithful devotion to the client. This element grounds the strong intrinsic work motivation of professionals, and explains the greater commitment to doing good work than to economic gain, as well as to the quality rather than the economic efficiency of work. Second, knowledge. The word profession comes from the Latin word profiteri (to declare publicly, to confess openly, to teach) therefore profession is an art that can be publicly taught, and professionals acquire their knowledge through long educational pathways, usually in higher education. They are experts, who use this knowledge and skills to perform a specialized work. In treating complex cases they exercise autonomy, as they are free to decide how to treat every single case they are faced with in their professional practice. But knowledge is a source of power, as there is an information asymmetry between the professional and his

client. For this reason, a third element is that professionals are committed to act ethically, and in particular to avoid dishonestly profiting from their position violating the client’s trust, to respect confidentiality over personal information, but also, for instance, to declare if they are not competent to solve specific problems. In many cases these norms are condensed in codes of conduct, an historical example being the Hippocratic Oath. Finally, professionals are self-regulated, as they have an independent jurisdiction over professional practice. They are grouped in associations which define the knowledge that characterizes their professional work, and which distinguishes it from other professions, as well as the qualification that should be met to enter the profession. Professional groups formally authorize new members to the profession, define the codes of conduct, control professional practice and give sanctions. Freidson (2001) calls this a “third logic” other than the market and the bureaucracy of organizations, a logic in which work is self-controlled and the professional groups regulate the profession. For these reasons, our societies have granted autonomy to individual professionals and professional groups. Sociologists of professions, in studying the development and institutionalization of different professions over time, have underlined the presence of competition within the system of professions (Abbott, 1988). Different professions compete among each other for expanding the respective jurisdictions over areas of specialization in terms of services/needs. This competition can be found not only between different professions, but also within professions which are internally fragmented on the basis of specific bodies of knowledge. Both cases are very common in medicine. Contrasts can arise between professions regarding who is entitled to perform a specific activity, for example, drug prescription between doctors and nurses. But contrasts can be found also between medical disciplines with regard to alternative approaches to similar health problems, for example, cardiothoracic surgery or an interventional cardiologist for coronary interventions; borderline domains, for example dermatologists or plastic surgeons in skin surgery; or who is the main player in the care pathway of a patient, for example

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surgeons and/or oncologists in cancer care, and so on. Professionals can perform their activity individually or in small groups, like General Practitioners or lawyers working in private practices, but in many cases, they work within professional organizations, such as hospitals, tribunals, universities, or large professional service firms (PSF) in the fields of legal services, engineering, consulting, and so on. Mintzberg (1979) identifies the professional bureaucracies as one of the five main configurations of organizational structures. According to his view, unlike machine bureaucracies, which are the typical configuration of large firms in both the public and private sector, professional bureaucracies are characterized by a large operating core made up of professionals who work autonomously of the administrative hierarchy and their colleagues. The necessary coordination is achieved through the standardization of skills and peer control. Furthermore, professionals are not only in control of their work, but tend to maintain the collective control of the professional bureaucracy, as middle managers are often professionals themselves. Virtually all large healthcare organizations are examples of professional bureaucracies, in which doctors and other professionals are granted a relevant autonomy over decision making, middle managers (e.g., heads of specialty units, nurse managers and clinical directors) are professionals themselves, and participatory bodies are often in charge of electing executives or cooperating with them. Due to this professional entrepreneurialism, intrusions of business-like management are hardly accepted, as well as the formulation of top down strategies and the set-up of management control mechanisms. Of course, this is a general archetype, and many elements can vary according to institutional, cultural and organizational contexts. However, large healthcare organizations can be ascribed as professional bureaucracies across different countries, especially in the western world, and sectors (private, public and not-for-profit). The traditional model of professionalism described above has a number of potential drawbacks, in particular that professional autonomy becomes professional isolation (De Bruijn, 2010). For instance, specialization and competition among professions and specialties often leads to organizational

fragmentation, lack of coordination and turf wars. The presence of a protected jurisdiction can generate insensitivity to demands coming from clients and taxpayers and to social or technological evolutions, producing self-referentiality. The idealistic vocational dimension of professionalism may turn out into paternalistic approaches, that are increasingly unacceptable by educated and liberal citizens of the twenty-first century. And peer control, with its tacit and informal performance appraisal systems, can degenerate into laissez-faire, at the expense of clients. In healthcare these risks are clear, as the increase in chronic diseases and evolutions in treatments and procedures require that different professions and disciplines work in coordination to provide patients with effective and timely care pathways. At the same time, society calls for cost control alongside quality, as well as transparency in performance reporting. For these reasons, studying the evolution of professionalism in different countries, many scholars have studied the development of a new or “reconfigured” professionalism, characterized by the engagement of clinicians and a focus on coordination, quality improvement and accountability to patients, which has the potential to “rehabilitate professionalism as a force for good, and thus rescue it from the persistent and damaging accusation that it is primarily a self-interested claim aimed at obtaining monopoly rents and other privileges” (Martin et al., 2015: 378). Marco Sartirana

References

Abbott, A. (1988). The System of Professions: An Essay on the Division of Expert Labor. Chicago, IL: University of Chicago Press. De Bruijn, J. A. (2010). Managing Professionals. London: Routledge. Freidson, E. (2001). Professionalism: The Third Logic. Chicago, IL: University of Chicago Press. Martin, G. P., Armstrong, N., Aveling, E. L., Herbert, G., Dixon-Woods, M. (2015). Professionalism redundant, reshaped, or reinvigorated? Realizing the “third logic” in contemporary health care. Journal of Health and Social Behavior, 56(3), 378‒97. Mintzberg, H. (1979). The Structuring of Organizations. Englewood Cliffs, NJ: Prentice Hall.

Marco Sartirana

66. Stakeholder management

● acting alone/in alliance with other stakeholders; etc.

Definition

Stakeholder management is defined by the processes and the tools used to identify, categorize, and engage with different stakeholders. A “Stakeholder” is any group or individual who can affect or be affected by the achievement of a healthcare organization’s objectives. In the healthcare sector, examples of stakeholders could be patients, citizens, employees, suppliers, patients’ associations, local governments, central government, regulating agencies, and so on. The idea at the basis of stakeholder management implies a bi-directional relationship between a healthcare organization (and its management) and its stakeholders. From a managerial perspective, this concept implies that management in healthcare organizations should focus on value creation by fostering and empowering relations with their more relevant stakeholders.

Rationale

Stakeholder theory is based on principles such as: building positive relationships, promoting fairness and integrity, adopting long-term thinking and vision, and creating win–win solutions focused on reciprocity. This approach appears consistent with a sector characterized by uncertainty, rapid changes, high levels of interdependence and, in general, a complex environment. Managerial tools which can be used in the healthcare sector to support managers in engaging with stakeholders derive from strategic management literature and suggest that there are two steps: 1. Stakeholder analysis 2. Stakeholder management Stakeholder analysis is focused on creating an assessment of stakeholders in terms of such criteria as: ● ● ● ● ●

power; interest; predictability; impact; direct or indirect exercise of power;

Usually, stakeholder analyses are carried out by using a 2x2 matrix, representing two variables at a time. Once stakeholders have been assessed, stakeholder management consists of evaluating how the relationship with every single stakeholder can be modified to better support the healthcare organization’s goals.

Goals

Systematic application of stakeholder management principles can lead organizations to achieve various types of goals: ● Improved relationships with their major stakeholders; ● Promote cooperation and trust between the organizations and their stakeholders; ● Higher rates of innovation; ● Higher efficiency; ● Value creation and co-creation. Stakeholder analysis and mapping techniques could also support a better policy-making action: it helps the identification of affected parties and provides knowledge of their interests and their likely reaction to policy changes. Different studies have shown that relationships with stakeholders have a direct impact on financial performance. Moreover, stakeholder relationships and resource allocation decisions are inseparable, especially in the healthcare sector, where managers need to make decisions on how to distribute resources (often public resources) and how the allocation of resources will impact different parts of the communities involved. Andrea Rotolo

Bibliography

Berman, S. L., Wicks, A. C., Kotha, S., & Jones, T. M. (1999). Does stakeholder orientation matter? The relationship between stakeholder management models and firm financial performance. Academy of Management Journal, 42(5), 488‒506. Harrison, J., & Thompson, S. (2015). Strategic Management of Healthcare Organizations: A Stakeholder Management Approach. Business Expert Press. Jones, T. M., & Wicks, A. C. (1999). Convergent stakeholder theory. Academy of Management Review, 24(2), 206‒221.

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67. Teamwork Introduction

Effective teamwork within healthcare management

Teamwork refers to the collaborative way of working of a team committed to the same goal within an organization. A work team has several defining characteristics. First, its members strive for a common objective and share the responsibility to achieve it. Second, the composition of the team is defined by the organization which results in the team being endowed with the power to achieve its goals. Last, teamwork implies interdependency and accountability: anyone’s actions are likely to have an impact on other members of the group (Mosser and Begun, 2014). The specific relevance of teamwork in health management derives from the growing complexity of tasks in healthcare as a consequence of different challenges related to the pressure towards more efficiency, the introduction of new technologies, and the evolution of professional competencies (Weller et al., 2014). These factors point to the need to increase collaboration and coordination among practitioners, and between them and managers. For instance, professional organizations in the United States (US) and Canada are developing competency models for interprofessional and collaborative healthcare practice (Mosser and Begun, 2014). Recent developments also aim to overcome the traditional divide between administrative and clinical staff within healthcare organizations. For an effective collaboration in modern healthcare, managers and administrators are now required to be acquainted with clinical processes and engage with clinicians and patients for quality service, and vice versa clinicians need to be more actively involved in administrative processes (Mosser and Begun, 2014). So, the main objective of teamwork in health management is to improve health-related outcomes and the general welfare of patients. The literature has shown that effective teams in the health sector deliver better patient care, reduce unintended harm events, and improve overall operating efficiency (Baker et al., 2006; Rydenfält et al., 2017). Based on this background scenario that illustrates the importance of teamwork in healthcare, we now look deeper at the tools and the case studies of teamwork in the healthcare sector.

Teams are effective when they achieve their goals. For clinical teams, the goals concern different aspects of healthcare provision (safety, equity, timeliness, etc.), whereas they may vary for management teams depending on the business unit or specific functions within the organization. Nonetheless, several sources within the literature identify a common set of values, characteristics, and hazards that lead to or hinder effective teamwork. Five values related to respect for team members were found to be conducive to teamwork by Hammick and colleagues (2009). They argue that respect for everyone in the team, honesty about one’s and others’ epistemic limits, willingness to engage with others, and a caring and approachable attitude towards your colleagues are essential values to hold for effective teamwork within and among interprofessional teams. Other studies have looked at individual competencies – as the sum of individuals’ skills, knowledge, traits, and motives – as indicators of teamwork success within the healthcare sector. A survey of healthcare executives, managers, and clinicians found that leadership, negotiation, knowledge of organizational goals and strategies, respect for others, and commitment to a quality outcome to be the most widely recognized set of competencies for successful teamwork. A case study conducted within Polish public hospitals revealed that professional education and expertise determined healthcare workers’ preferences for selected co-workers. This underlines the importance of professional training and opportunities for lifelong learning for healthcare professionals to be effective team members within their organization by leveraging their technical skills (Mijal and Winter, 2017). However, researchers in the United Kingdom (UK), found that perceptions and social relations were more important in determining the effectiveness of teams collaborating within the National Health Service (NHS). Notably, the study reveals how the language of teamwork may sometimes be used to mask the tension created by coercion and power relations within a hierarchical structure (Finn et al., 2010). This suggests that both individual technical expertise and

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social relations within the team matter for effective teamwork in health organizations.

Role of leaders and senior healthcare managers

A context conducive to teamwork where interprofessional collaboration is promoted and rewarded is a key pre-condition for teamwork to be effective within healthcare services. Leaders play a pivotal role in creating the right conditions for collaboration. Senior figures within the team should be responsible for creating the (1) team-based organizational culture and (2) structure while providing (3) resources and expertise to achieve this (Mosser and Begun, 2014). Organizational cultures create values and beliefs that encourage teamwork: we mentioned collaboration, respect, and patient focus. Healthcare managers should develop a good understanding of their organization’s existing values and use hiring and promotion techniques to bring people to adhere to this vision. Some scholars have suggested that to promote teamwork, organizational structures should be designed as a cluster of interacting teams hierarchically accountable. Finally, senior managers should provide team members with high-quality organizational resources (information and communication flow) for training and education about teamwork within the organization (Mosser and Begun, 2014).

Barriers to effective teamwork in healthcare management

Constraints to effective teamwork can be of a structural and/or operational nature. In the first category, the literature highlights that virtual teams will face higher barriers to collaboration than teams that meet frequently in person. Professional hierarchies and silos also hinder communication and effective sharing of information (Weller et al., 2014). It has been suggested that occasional in-person meetings boost engagement of mostly virtual management – and now with the advent of telemedicine – clinical teams. Finally, regardless of personal attributes and competencies, healthcare teams need a regular stream of resources – financial and otherwise – to work effectively. One operational issue highlighted is the danger of marginalizing junior staff and Luca Solari

not questioning more senior members with a longer tenure within the organization. Neglecting junior resources and not giving them the space to contribute creatively to the team can have severe consequences on engagement and staff turnover (Mosser and Begun, 2014). Especially for clinical teams, special attention has been paid to efficient communication among interprofessional team members.

Future trends

As specialization and complexity increase in healthcare service provision, research on teamwork will continue to be relevant and needed. Future avenues of research include paying more attention to organizational networks and their impact on teamwork; integration of clinical and management teams; fully integrating teamwork within higher education and training programs, which at the moment take an overly individualistic approach when training future clinicians and health managers. Luca Solari

References

Baker, D., Day, R. & Salas, E., 2006. Teamwork as an essential component of high-reliability organizations. Health Services Research, 41(4p2), pp.1576‒1598. Finn, R., Learmonth, M. & Reedy, P., 2010. Some unintended effects of teamwork in healthcare. Social Science & Medicine, 70(8), pp.1148‒1154. Hammick, M., Olckers, L. & Campion-Smith, C., 2009. Learning in interprofessional teams: AMEE Guide no 38. Medical teacher. 31. 1‒12. 10.1080/01421590802585561. Mijal, M. & Winter, M., 2017. Factors influencing teamwork in health care. Engineering Management in Production and Services, 9(2). Mosser, G. & Begun, J.W. (Eds.), 2014. Understanding Teamwork in Health Care. McGraw Hill, esp. Chapter 7: Competencies for healthcare team members and Chapter 19: The future of teamwork in health care. Rydenfält, C., Odenrick, P. & Larsson, P.A., 2017. Organizing for teamwork in healthcare: an alternative to team training? Journal of Health Organization and Management, 31(3), pp.347‒362. Weller, J., Boyd, M. & Cumin, D., 2014. Teams, tribes and patient safety: overcoming barriers to effective teamwork in healthcare. Postgraduate Medical Journal, 90, pp.149‒154.

68. Turf wars “Turf war” can be defined as a situation in which two or more people or organizations compete in an area of business or other activities. In recent years, this phenomenon has become a prominent topic of discussion among healthcare professionals due to the technological boom, recent innovations, and new frontiers of medicine. Tense situations have increased from doctors’ tendency to use new technologies in ways never used before. Hence, new paradigms of health service delivery have blurred the limits of the previously well-defined specialties and sub-specialties, eliminating their exclusive rights on processes and procedures.

Turf wars’ causes and consequences

The literature highlights how the university environment could represent a first critical factor: faculties train students to be members of a discipline rather than a profession, sowing from the beginning a silos culture and attitude. Outside the university context, as already mentioned above, the extensive use of new technologies leads to greater transversality and multidisciplinary therapies; this, in turn, may generate struggles for the territory. These critical issues are found both among clinicians of different departments and between doctors and nurses. In a health system based on private healthcare, as the American one, the professional license can represent a significant barrier for professionals in different sectors. A study for George Mason University’s Mercatus Center shows that many Americans prefer to see a nurse or medical assistant rather than wait for an available doctor. This preference can profoundly change the demand in the healthcare market, the supply models and generate skepticism and friction between professionals. Finally, the evolution towards the increasing specialization of clinicians, combined with the enrichment of therapeutic options and a rising number of patients who are indeed more complex and fragile, pose a growing need for multidisciplinary work and regulation of the risks of “land wars” in specialized areas characterized by such

plurality of options, like oncology, cardiovascular, neuroscience, osteoarticular. Turf wars, therefore, may cause situations of tension that can have several negative ramifications on the proper functioning of the medical staff and the quality of care provided to patients. Some of the managerial criticism most noted by the literature are: ● lack of coordination or collaboration between doctors; ● loss of revenue or lower strategic expansion opportunities in healthcare organizations; ● potential negative influence on hiring decisions; ● distrust between medical staff and the organization’s top management; ● rivalry between specialties or medical personnel who compete for procedures or services leading to the so-called “Silo Effect”.

How to prevent and manage turf wars: from university to top management

Universities should represent the first change factor, providing extensive training in the medical profession and paying greater attention to ethics and communication skills that transcend the departments to which they belong. Moreover, top management should consider turf wars’ clinical and managerial implications. Hospital leadership may also apply strategies to stem the effects of turf wars on services delivery: ● Establish a system of core/non-core priorities for introducing new technologies. To set up threshold criteria defining both education and training required for each specialty or procedure, and minimum competencies mandatory for the initial granting of investments, defining the competence’s expectations. This approach could significantly reduce misperceptions of favoritism between departments. In the same way, the definition of a clear procedure to introduce new technologies or services in the health organization will help reduce the battles on the turf by formalizing a coherent and simplified process throughout the health organization.

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● Create centers of excellence or service lines. The foundation of centers of excellence for disease groups would encourage medical staff from different specialties to collaborate to provide high-level assistance. Multidisciplinary teams allow doctors to work with each other and not against each other, thus avoiding internal disagreements and improving patient outcomes and satisfaction through the provided care. At the same time, multidisciplinarity leads to a change in the conviction that each department is the “owner” of the space and services provided. This concept leads specialized staff to be jealous of the equipment used in their department without expanding the overall view of these technologies’ usage. This belief’s shift could significantly reduce or avoid turf battles. ● Involve specialties in educational and didactic activities. During conferences, medical staff might learn from each other to improve the standards of provided care. ● Define codes of conduct. When behavioral standards are clearly defined, medical personnel can be kept accountable for positive attitudes or unprofessional behavior. In addition to the purely managerial problems, corporate leadership might face ethical dilemmas caused by turf wars: benefiting a department is sometimes inevitable. Indeed, multidisciplinary teams and paths cannot always be set up due to the required investments in structures and technologies. Therefore, in watertight silos kind of health organizations, the management should require the opinion of the most competent collaborators, in the different areas, reserving, however, the right of final decision in the best interest of the whole organization.

A possible organizational solution from the literature

The literature shows that the turf wars phenomenon involves numerous areas of the health world, but the hospital radiology department shows up as the most frequent conflict zone. Historically, radiology, focused on diagnostic imaging, was a physically separate

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department from the rest of the hospital. As technology has advanced, radiology has evolved beyond diagnostic to include a variety of therapeutic and invasive procedures. Due to this change, radiologists enter direct competition with cardiologists for procedures such as coronary angiograms, stent placement, and balloon angioplasty. At the same time, several other specialties have developed procedures based on the use of technologies available only in the radiology department: gastroenterology, neurosurgery, cardiothoracic surgery, orthopedics, and cardiology. Radiologists considered the intrusion of other specialists into their traditional territory both a professional and economic threat, especially in the growing market for outpatients. The solution, therefore, requires multidisciplinary intervention suites. Radiologists, cardiologists, vascular surgeons, and neurosurgeons not only increasingly overlap in the types of diagnostic and interventional procedures they perform, but they share the same operating room, support space, and equipment when performing a procedure to assess heart function, brain function, or other vascular problems. Because duplicated interventional procedure suites would require increasing space and investments, that is why the current trend is creating centralized suites, shared by different departments. Their co-location will provide optimal future flexibility as specific procedures and techniques evolve. Sharing space for patient hiring, preparation, and recovery saves capital and operating costs. Therefore, facilities planners must create flexible and generic spaces to prevent patients from getting involved in the crossfire between competing specialists. Turf wars have existed in the past and will continue in the future with the continuous advances we see in medicine and technology. Moreover, the “democracy” of internal dissent by clinicians to the leadership makes more difficult the elimination of turf wars. Therefore, the key is to recognize and stem wars’ repercussions to improve customer satisfaction. A better working environment will make it easier for medical staff to be collegial and collaborative and focus on providing excellent patient care instead of worrying about a potential threat to their livelihoods. Elena Maggioni

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Bibliography

El Banna D. 7 ways to mitigate and resolve turf battles in healthcare organizations. 18.11.2018 https://​www​.linkedin​.com/​pulse/​7​-ways​ -mitigate​-resolve​-turf​-battles​-healthcare​-diana​ -el​-banna/​ Hayward C. Physician turf wars complicare la pianificazione delle strutture. SpaceMed

Essentials. 15.10.2018 https://​blog​.spacemed​ .com/​understanding​-physician​-turf​-wars/​ Lega F. Management e leadership dell’azienda sanitaria. Egea. Milano. 2016. pp.  21‒26, 138‒143. Michener L. From turf wars to common ground: the shifting dynamics of medical student education. Ann Fam Med. 2003; 1(4):245‒246 https://​www​.ncbi​.nlm​.nih​.gov/​pmc/​articles/​ PMC1466610/​

Elena Maggioni

PART XIII PRACTICES Being a leader in the healthcare industry takes effective communication, continued education, decision-making, workforce organization, networking, the ability to anticipate challenges, and the use of technology to your advantage. There is a direct connection between quality and quantifiable healthcare practices and effective leadership. The approaches and practices implemented at the strategic and operational level, are one of the most important components of organizational success. A good manager needs some secret weapons to fulfill his job. Listed below are some essential good practices that should be implemented and/or taken into account in every healthcare organization.

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69. Change management By definition, change management is a structured approach to transitioning individuals, teams, and organizations from a current state to a desired future state. Change management is a framework that provides strategies to change-leaders about how to prepare and support those impacted by the change, so that the change will be effective. Change management is not a process improvement method, rather it is a method for reducing and managing resistance to change when implementing process, technology or organizational change. This is not just a matter of technical aspects related to the change, but involves also managing the feelings, perceptions, and reactions of the people that may impact, or are impacted by the change. Most change management frameworks, involve processes for creating an environment for change, facilitating the transition, and reinforcing or sustaining the change. Change is unavoidable in many fields, but a specific problem to healthcare is that many change projects fail for many reasons: poor planning, unmotivated staff, lack of communication or excessively frequent changes. Therefore, using best practices derived from change theories can help improve the odds of success. Most changes in public health are guided by the will to become more effective and efficient or to decrease costs and improve profits. Change translates not only into broad terms, such as a hospital that wants to become a more performance-based organization to increase quality and meet accreditation standards, but also into smaller realities, for example, a department that wants to change its shift protocol to reduce the number of unwitnessed patient falls. Despite being a small reality and therefore apparently easier to manage, if the change management is not properly set, it is likely that the staff will continue to revert to previous shift protocols to save time or just because they are used to it. Therefore, the change will fail to occur. That’s why change theories and frameworks are needed for an effective change. Many change theories have been postulated, each is different with unique strengths and weaknesses. Among those, a well-known

one is Rogers’ Diffusion of Innovation Theory developed in 1962, introducing these five change phases: ● Knowledge (education and communication to expose staff to the change); ● Persuasion (use of strategies to get staff interest; peers persuading peers); ● Decision (staff decide whether to accept or reject the change); ● Implementation (putting new processes into practice); ● Confirmation (staff recognize the value and benefits of the change and continue to use changed processes). Later, Kotter’s Eight-Step Change Model, created in 1995, includes the following change management steps: ● ● ● ● ● ● ● ●

Create a sense of urgency for change; Form a guiding change team; Create a vision and plan for change; Communicate the change vision and plan with stakeholders; Remove change barriers; Provide short-term wins; Build on the change; Make the change stick in the culture.

All change initiatives consist of three main stages: pre-change, change, and post-change.

Pre-change: preparing for the change

Define change management strategy; prepare a change management team. A critical aspect of pre-change planning is to involve stakeholders in problem identification, goal setting and action planning. This will increase the participation of more staff. The first step in managing change is building awareness around the need for change and creating a desire among employees. Therefore, initial communications are designed to create awareness around the reasons for change and the risk of not changing. Communications should be designed to share the right messages at the right time. This begins with a careful analysis of the audiences, key messages and the timing for those messages. Each audience has particular needs for information based on their role in the implementation of the change.

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Part of Rogers’ change theory is interested in identifying how the staff members would accept changes through the process. It describes different categories which change leaders should assess among their staff to plan their first moves. ● Innovator: passionate about change and technology; frequently suggest new ideas for departmental change ● Early adopter: high levels of opinion leadership in the department; well-respected by peers ● Early majority: prefer the status quo; willing to follow early adopters when notified of upcoming changes ● Late majority: skeptical of change but will eventually accept the change once the majority has accepted; susceptible to increased departmental social pressure ● Laggard: high levels of skepticism; openly resists change. Most staff will likely belong to the early or late majority. Change leaders should focus their initial education efforts on Innovator and Early Adopter staff. In particular, early adopters are often essential to persuade early and late majority staff to accept the change. Then change leaders should also incorporate a Force Field Analysis. This involves establishing which factors are influencing the situation: facilitators and barriers to change. In this way change leaders should work on reducing barriers through communication and education, and promote facilitators through staff recognition and various incentives.

Mid-change: managing change. Take actions and implement plans

During the change process, change leaders must verify that all members are performing new processes as planned. Another Force Field Analysis may be helpful during this period to ensure no new barriers have emerged. Further strengthening of change facilitators through staff engagement, recognition, and sharing of short-term wins will help maintain the impulse toward change.

Riccardo Primavera

As the process continues, staff should be provided with additional training to overcome any deficit if needed. Finally, leaders must continue to monitor progress toward goals.

Post-change: reinforcing change. Collect and analyse feedback, implement corrective actions, celebrate successes

Once the change has become the new routine, change leaders should still periodically verify the processes. In this phase, change leaders can take a less active role in the change maintenance process, however, once they release control, the staff may slowly revert to the old behaviors. Therefore, periodic checking and continued data monitoring can solidify the change. Lastly, change managers should celebrate with the staff the results obtained thanks to the change, repeatedly sharing evidence of the success. In summary, since health departments work to best serve the communities, respond to dramatic changes in budgets, staffing and policy, change management techniques are useful tools to create the proper environment in which practitioners understand why change is happening, adopt changes faster, become an active part of the process and therefore, move toward innovations to improve outcomes. The practitioners themselves can become leaders to accelerate change initiatives and drive organizational success within their health departments. Riccardo Primavera

Bibliography

Barrow JM, Annamaraju P, Toney-Butler TJ. (2022). Change Management. [Updated 2022 Sep 18]. StatPearls Publishing. https://​ www​ .ncbi​.nlm​.nih​.gov/​books/​NBK459380/​ Villaria A. (2012). Change Management for a New Clinical Future. Healthcare Innovation. https://​www​.hcinnovationgroup​.com/​home/​ blog/​13017495/​change​-management​-for​-a​-new​ - clinical-future

70. Disaster management The events that have marked the past two years may be a first clue to understand the reasons that make disaster management a relevant topic. The relevance is even greater when looking at these issues by taking the perspective of the healthcare sector, which plays a key role in overcoming disasters and saving lives. Health systems are under great stress in responding to these events, facing peaks of additional demand while at the same time maintaining their ordinary operations.

Definition

In both everyday life and the literature, the terms “disaster”, “crisis” and “emergency” are often used interchangeably, and similarly the term “disaster management” is often referred to as “crisis” or “emergency management”. In the article “Understanding the Terminologies: Disaster, Crisis and Emergency” (Al-Dahash et al., 2016), the authors sought to shed light on the issue by providing definitions of each term. A disaster is defined as the result of a combination of hazards, vulnerability, and lack of response measures. These are unexpected events that require the implementation of special planning, coordination, and appropriate resource measures to minimize the consequences that result in destruction, loss, damage, and that overwhelm the ability to manage and restore. A crisis is defined as a disruptive event that physically affects a system as a whole and presents an economic risk and could cause rapid changes in public order. The significance of these events comes from the unpredictability and uncontrollability that disrupts and/or prevents normal operations. An emergency is defined as any imminent or ongoing event that threatens people, property and the environment and requires a rapid and coordinated response. These are situations in which ordinary procedures are suspended and require the implementation of extraordinary measures to save lives, protect individuals, limit damage, and return to normal conditions. It is a broader term that includes disasters, catastrophes, and lower-order disruptive events. These three terms are united by their sudden nature and the damages they cause,

but disasters and crises are more closely intertwined than emergencies. UNDRR (United Nations Office for Disaster Risk Reduction, 2022) defines disaster management as “the organization, planning and implementation of measures to prepare for, respond to and recover from disasters”. The primary purpose of disaster management is to reduce risks from actual and potential disasters. Secondary purposes include reducing damage from disasters, ensuring public safety, and providing assistance to survivors and the disadvantaged (Coppola, 2021). Given that disasters tend to be repetitive events, their occurrence forms a cycle that can be divided into four main phases. There are different representations of the cyclical nature of disasters, all of which share the presence of the four phases: mitigation, preparedness, response, recovery. Generally, the first two phases are implemented before the event occurs and the last two after the impact, but all components of this cycle are interconnected and implemented at different levels, before, after and during the occurrence of the disaster event (Coppola, 2021). The characteristics of the four phases that make up the cycle are briefly described below: 1. Mitigation: actions or efforts taken to reduce the likelihood and/or consequences of disasters; 2. Preparedness: actions taken prior to the occurrence of a disaster to ensure adequate response and recovery; 3. Response: actions taken immediately before, during, or immediately after a disaster with the goal of saving lives, reducing health impacts, ensuring public safety, and meeting the needs of those affected; 4. Recovery: actions aimed at restoring or improving livelihoods and health, as well as economic, physical, social, cultural, and environmental activities, assets, and systems.

Goals

The application of disaster management in these facilities thus becomes an indispensable aspect of good disaster management, but more importantly, of increasing the resilience of hospitals and communities them-

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selves. The article “Rethinking Resilience: Definition, Context and Measure” (Phillips & Chao, 2021) includes the words of a journalist from The Guardian who refers to the term resilience as a “buzzword” (Hussain, 2013). In literature, there are not only numerous studies that define the concept of resilience in different ways, but also studies that, through a systematic review, try to “make order” among this multitude of meanings. Definitions vary depending on the object of analysis (e.g., resilience of organizations, systems, communities, etc.), but there is variation even among definitions focused on the same object of analysis (Carlson et al., 2012). UNDRR (2022) defines resilience as “the ability of a system, community, or society, exposed to hazards, to withstand, absorb, accommodate, adapt, transform, and recover from the effects of a hazard in a timely and efficient manner, including by preserving and restoring its basic essential structures and functions through risk management”. It’s important to add to this definition the perspective analyzed by Phillips and Chao, about learning and growth. The authors report the thinking of Hoegle and Hartmann (Hoegle & Hartmann, 2021, pp.  456‒464): some organizations “bounce back”, returning to their status quo; others “bounce beyond” and become stronger than before the shock. “Resilience is not just bouncing back, it means changing the way you respond, shifting perceptions, and growing from that. […] Resilience must be transformative. […] It involves learning.”

Elements for implementation in hospitals

The international literature to date (Castoldi et al., 2022; Chand & Loosemore, 2016; Dichter et al., 2022; Donelli et al., 2022; El Sayed et al., 2018; Farley et al., 2017; Gao et al., 2018; Ghanaatpisheh et al., 2019; Goralnick et al., 2015; Kajihara et al., 2016; Lim et al., 2020; Rodrìguez & Aguirre, 2006; Schreiber et al., 2004; Stenberg, 2003; Toner et al., 2017; Ybarra, 2019; Zhong et al., 2014) highlights four essential elements for the application of disaster management in hospitals.

Clara Del Prete

Structural critical factors These include infrastructure and geographic location. Hospital infrastructure must be designed with the goal of increasing its structural resilience, both from a mitigation and preparedness perspective. Elements to consider include vertical access, emergency exits and lights, wayfinding, alerting and surveillance systems, and the presence of power generators. Similarly, it is important to consider aspects relating to geographic location so as to derive valuable insights regarding patient influx and possible strategies for collaboration with nearby points of care. Organizational critical factors Organizational factors include human resources, governance, and leadership. Indeed, there is a need to assess the number of human resources available and possible ways to train lower-level staff and volunteers, as well as the need to pay attention to the psychological well-being of staff. Governance and leadership are two elements that ensure good response and restoration through clear definition of roles and relationships, creation of a cohesive climate, decentralization of decision making to increase organizational flexibility, and identification of critical functions. Operational critical factors Operational critical factors include the management of material resources, production capacity and production areas, information systems, communication and information management, and movements and networking. From the perspective of material resources, adequate stockpiling in the preparedness and response phases is essential. It is equally important to be able to increase production capacity to handle sudden peaks in demand and to manage production areas so that patient flow is smooth. Regarding information management, back-up information systems and alternative means of communication must be provided to ensure efficient processing and efficient exchange of information. Consideration should also be given to how to evacuate and transfer patients, as well as how to coordinate with other facilities for resource and information sharing and patient load balancing.

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Implementation facilitators Implementation facilitators include the provision of continually updated contingency plans that are the result of experience and feedbacks, but also training, a process that must involve the entire organization and external stakeholders through tools such as exercises and simulations. Ultimately, learning is the most important challenge for an effective application of disaster management, inherent in transforming individual learning into organizational learning that can fuel the preparedness.

Future developments

For a better application of disaster management in hospitals, the following should be explored in the future: (1) the need for innovation of critical factors and implementation facilitators with the goal of extending the elements of routine management to emergency management and meeting the growing needs of these complex facilities; (2) the need for a cyclical approach to disaster management that encompasses the full range of mitigation, preparedness, response, and recovery phases in order to implement “strategic” disaster management and establish a virtuous cycle toward improving resilience; (3) the need for greater government commitment and advocacy and a declination of national interventions and policies to the local level. Clara Del Prete

References

Al-Dahash, H., Thayaparan, M., & Kulatunga, U. (2016). Understanding the terminologies: disaster, crisis and emergency. In Proceedings of the 32nd annual ARCOM conference (pp. 1191‒1200). ARCOM 2016. Alexander, D. (2002). Priciples of Emergency Planning and Management. Edinburgh: Terra Publishing. Carlson, L., Bassett, G., Buehring, W., Collins, S., Folga, S., Haffenden, B., … Whitfield, R. (2012). Resilience: theory and applications. Decision and Information Sciences Division – Argonne National Laboratory. Castoldi, L., Greco, M., Carlucci, M., Lennquist Montàn, K., & Faccincani, R. (2022). Mass Casualty Incident (MCI) training in a metropolitan university hospital: short-term experience with MAss Casualty SIMulation system

MACSIM®. Eur J Trauma Emerg Surg, 283–291. Chand, A. M., & Loosemore, M. (2016). Hospital learning from extreme weather events: using causal loop diagrams. Building Research & Information, 44(8). Coppola, D. P. (2021). Introduction to International Disaster Management. Butterworth-Heinemann. Dichter, J. R., Devereaux, A. V., Sprung, C. L., Mukherjee, V., Persoff, J., Baum, K. D., … Hick, J. L. (2022). Task Force for Mass Critical Care writing group – mass critical care surge response during COVID-19: implementation of contingency strategies – a preliminary report of findings from the Task Force for Mass Critical Care. Chest, 429‒447. Donelli, C. C., Fanelli, S., Zangrandi, A., & Elefanti, M. (2022). Disruptive crisis management: lessons from managing a hospital during the COVID-19 pandemic. Management Decisions, 66‒91. El Sayed, M., Chami, A. F., & Hitti, E. (2018). Developing a hospital disaster preparedness plan for mass casualty incidents: lessons learned from the downtown Beirut bombing. Disaster Med Public Health Prep, 379‒385. Farley, J. M., Suraweera, I., Perera, W., Hess, J., & Ebi, K. L. (2017). Evaluation of flood preparedness in government healthcare facilities in Eastern Province, Sri Lanka. Glob Health Action, 10(1). Gao, L., Wu, Q., Li, Y., Ding, D., Hao, Y., Cui, Y., … Sun, H. (2018). How prepared are hospitals’ emergency management capacity? Factors influencing efficiency of disaster rescue. Disaster Med Public Health Prep, 176‒183. Ghanaatpisheh, E., Khankeh, H. R., & Masoumi, G. (2019). Challenges for hospital resilience in emergencies and disasters: a qualitative study in Iran. Journal of Clinical and Diagnostic Research, 1‒8. Goralnick, E., Halpern, P., Loo, S., Gates, J., Biddinger, P., Fisher, J., … Peleg, K. (2015). Leadership during the Boston marathon bombings: a qualitative after-action review. Disaster Medicine and Public Health Preparedness, 489‒495. Hoegle, M., & Hartmann, S. (2021). Bouncing back, if not beyond: challenges for research on resilience. Asian Bus Manage, 456‒464. Hussain, M. (2013). Resilience: meaningless jargon or development solution? The Guardian. https://​www​.theguardian​.com/​global​ -development​-professionals​-network/​2013/​ mar/​05/​resilience​-development​-buzzwords Kajihara, C., Munechika, M., Kaneko, M., Sano, M., & Jin, H. (2016). A matrix of the functions and organizations that ensure continued health-

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198  Elgar encyclopedia of healthcare management care services in a disaster. Quality Innovation Prosperity, 145‒156. Lim, H. W., Zaishang, L., & Dongping, F. (2020). Impact of management, leadership, and group integration on the hospital response readiness for earthquakes. International Journal of Disaster Risk Reduction, 48, 101586. Phillips, F. Y., & Chao, A. (2021). Rethinking resilience: definition, context, and measure. IEE Transactions on Engineering Management (early access). Rodrìguez, H., & Aguirre, B. E. (2006). Hurricane Katrina and the healthcare infrastructure: a focus on disaster preparedness, response, and resiliency. Front Health Serv Manage, 13‒23. Schreiber, S., Yoeli, N., Paz, G., Barbash, G., Varssan, D., Fertel, N., … Halpern, P. (2004). Hospital preparedness for possible nonconven-

Clara Del Prete

tional casualties: an Israeli experience. General Hospital Psychiatry, 359–366. Stenberg, E. (2003). Planning for resilience in hospital internal disaster. Prehosp Disast Med, 291‒300. Toner, E. S., McGinty, M., Schoch-Spana, M., Rose, D. A., Watson, M., Echols, E., & Carbone, E. G. (2017). A community checklist for health sector resilience informed by Hurricane Sandy. Health Secur, 53‒69. United Nations Office for Disaster Risk Reduction. (2022). Sendai framework terminology on disaster risk reduction. https://​www​.undrr​.org/​ terminology/​disaster​-management Ybarra, N. (2019). Hurricane Harvey: one hospital’s journey toward organizational resilience. J Perinat Neonatal Nurs, 246‒252. Zhong, S., Clark, M., Hou, X. Y., Zang, Y. L., & Fitzgerald, G. (2014). Development of hospital disaster resilience: conceptual framework and potential measurement. Emerg Med J., 31(11).

71. Leadership and leadership styles

Definition of leadership

The concept of leadership and its declination in the health sector are subjects of increasing attention both from a scientific-theoretical point of view and in the practical repercussions in the various organizational realities. ● Leadership is “the behavior of an individual … directing the activities of a group toward a shared goal” (Hemphill & Coons, 1957); ● Leadership is “the influential increment over and above mechanical compliance with the routine directives of the organization” (Katz & Kahn, 1978); ● “Leadership is exercised when persons … mobilize … institutional, political, psychological, and other resources so as to arouse, engage, and satisfy the motives of followers” (Burns, 1978); ● “Leadership is realized in the process whereby one or more individuals succeed in attempting to frame and define the reality of others” (Smircich & Morgan, 1982); ● Leadership is “the process of influencing the activities of an organized group toward goal achievement” (Rauch & Behling, 1984); ● “Leadership is about articulating visions, embodying values, and creating the environment within which things can be accomplished” (Richards & Engle, 1986); ● “Leadership is a process of giving purpose (meaningful direction) to collective effort and causing willing effort to be expended to achieve purpose” (Jacobs & Jaques, 1990); ● Leadership “is the ability to step outside the culture ... to start evolutionary change processes that are more adaptive” (Schein, 1992); ● “Leadership IS the process of making sense of what people are doing together so that people will understand and be committed” (Drath & Palus, 1994); ● Leadership is “the ability of an individual to influence, motivate, and enable others to contribute toward the effectiveness and success of the organization…” (House et al., 1999).

There are almost as many different definitions of leadership as there are persons who have attempted to define the concept. (Stogdill 1974, Bass 1998). There is no single definition of leadership and most of them imply that it accounts for a process whereby a person’s influence is used purposely over other people to guide, structure, and facilitate activities and relationships in a group of people or organization. According to recent leadership theory research, leadership itself funds its basis upon a tripod of outcomes: direction, alignment and commitment. Therefore, leadership task is to produce these three outcomes within its setting of action. The way leaders can exert their leadership varies with the leadership styles they develop, hence, how they approach others, how they provide guidance, how they implement and monitor plans, and how they motivate their group and organization. Leadership styles have been widely investigated. Academic literature and research historically evolved, developing many different leadership models, and identifying several leadership styles. Three of them are constant throughout the models: ● Transformation leadership, based on principles of mutual admiration, continuous and creative exchange of ideas and on sharing a common vision. ● Transactional leadership, where compliance is achieved through a reward and punishment mechanism with respect to the objectives achieved. The leader constantly monitors the work of collaborators/followers and ensures that they follow the instructions received. ● Laissez-faire or passive/avoidant leadership, explained as “abdicates responsibilities and avoids making decisions” (Luthans, 2005) or a “failure of taking a managing responsibility” (Avolio, 1999; Bass, 1998). These styles can be considered three broad metacategories, as they include many different approaches to achieve their goals. In “Leadership that gets results”, David Goleman explored leadership styles and defined six major categories (Goleman, 2000). In healthcare settings, transformational and transactional leadership theories represent the

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most investigated theories in academic leadership research. In this context, in the last few years a new paradigma of leadership has been emerging, laying its foundations in the concept of collective efficacy, defined as “a group’s shared belief in its conjoint capabilities to organize and execute the courses of action required to produce given levels of attainments” (Bandura, 1997). “Collective Leadership”, as it is called, represents the new concept of sharing power to ensure that leadership and skills are correlated at every level of the organization, relative to the different tasks. Furthermore, it is understood as the strategy aimed at integrating leadership within the entire organization. In this perspective of collective leadership, responsibility, and reliability act simultaneously on an individual and collective level. This type of leadership therefore derives both from the individual leaders identified and from the relationships between the leaders themselves. In fact, the performance of the organization lies not only in the number and quality of the identified leaders, but mainly in the extent to which the leaders, both formally and informally, directly and indirectly, work collectively in support of the organization’s objectives, embodying the founding values of the chosen organizational culture. What leadership style to choose? Every healthcare manager has to deal with the opportunity to become a leader while becoming an efficient manager. The leadership style to choose is largely influenced by the type of organization and by the type of personal attitudes and specific skills, both technical and relational/emotional, that the leader recognizes to have. Gabriele del Castillo

Gabriele del Castillo

Bibliography

Avolio, B. J. (1999). Full Leadership Development: Building the Vital Forces in Organizations. Thousand Oaks, CA: Sage. Bandura, A. (1997). Self-efficacy: The Exercise of Control. W. H. Freeman/Times Books/ Henry Holt & Co. Bass, B. M. (1998). Transformational Leadership: Industrial, Military, and Educational Impact. Mahwah, NJ: Lawrence Erlbaum Associates. Burns, J. M. (1978). Leadership. New York: Harper & Row. Drath, W., & Palus, C. (1994). Making Common Sense: Leadership as Meaning-Making in a Community of Practice. Greensboro, NC: Center for Creative Leadership. Drath, W. H., McCauley, C. D., Palus, C. J., Van Velsor, E., O’Connor, P. M. G., & McGuire, J. B. (2008). Direction, alignment, commitment: Toward a more integrative ontology of leadership. The Leadership Quarterly, 19 (6), 635–653. Goleman, D. (2000). Leadership that gets results. Harvard Business Review, 78, 78‒90. Hemphill, J. K., & Coons, A. E. (1957). Development of the leader behaviour description questionnaire, in Stodgill, R. M., & Coons, A. E. (eds.) Leader Behaviour: Its Description and Measurement. Columbus, Ohio: Bureau of Business Research, Ohio State University. House, R., Hanges, P., Ruiz-Quintanilla, S., Dorfman, P., Falkus, S., & Ashkanasy, N. (1999). Cultural influences on leadership and organizations: Project Globe, in Mobley, W. H., Gessner, J., & Arnold, V. (eds.) Advances in Global Leadership. Bingley, UK: Emerald Group Publishing, pp. 171‒233. Jacobs, T. O., & Jaques, E. (1990). Military executive leadership, in Clark, K. E., & Clark, M. B. (eds.) Measures of Leadership. Leadership Library of America, pp. 281‒295. Katz, D., & Kahn, R. L. (1978). The Social Psychology of Organizations. New York: Wiley. Luthans, F. (2005). Organizational Behavior. New York: McGraw Hill. Rauch, C. F., & Behling, O. (1984) Functionalism: Basis for an alternate approach to the study of leadership, in Hunt, J. G., Hosking, D. M., Schriesheim, C. A., & Stewart, R. (eds.) Leaders and Managers: International Perspectives on Managerial Behavior and Leadership, pp.  45‒62. http://​dx​.doi​.org/​10​.1016/​B978​-0​ -08​-030943​-9​.50012​-7 Richards, D., & Engle, S. (1986). After the vision: Suggestions to corporate visionaries and vision champions, in Adams , J. D. (ed.) Transforming

Leadership and leadership styles  201 468‒469 Leadership. Alexandria, VA: Miles River Press, pp. 199‒214. Schein, E. H. (1992). Organizational Culture and Leadership (2nd ed). San Francisco: Jossey-Bass. Smircich, L., & Morgan, G. (1982). Leadership: The management of meaning. The Journal of Applied Behavioral Science, 18, 257‒273. http://​ dx​.doi​.org/​10​.1177/​002188638201800303 Stogdill, R. M. (1974). Handbook of Leadership. New York: The Free Press. Sudha, K. et al. (2016). Leadership styles, leader’s effectiveness and well-being: Exploring collec-

tive efficacy as a mediator. Vision: The Journal of Business Perspective, 20, 111‒120. The Kings Fund (2014). Developing collective leadership for health care. http://​www​ .kingsfund​.org​.uk/​sites/​files/​kf/​field/​field​ _publication​_file/​developing​-collective​ -leadership​-kingsfund​-may14​.pdf. The Kings Fund (2015). Leadership and Leadership Development in Health Care: The Evidence Base, 1st ed. http://​www​.kingsfund​ .org​.uk/​sites/​files/​kf/​field/​field​_publication​ _file/​leadership​-leadership​-development​-health​ -care​-feb​-2015​.pdf. Yukl, Gary A. (2013). Leadership in Organizations. Boston: Pearson.

Gabriele del Castillo

PART XIV ROLES The healthcare manager needs to consider the dynamics among different professionals and be aware of the main characteristics of the essential roles that contribute to the provision of healthcare. One of the most important managerial roles is to balance the different professionals in the smoothest way and at the same time maximize their potential in the most efficient way. Existing or emerging professionals who play a key role in accessing innovation, hospital-territory integration, the quality of services provided, and the management of chronicity belong to this class. This cluster takes also into account the increase in importance of the middle management, as intermediate roles that link the top management with physicians.

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72. Case manager The word “case” derives from the medical tradition and has as its purpose the need to identify the appropriate care to be given to the single suffering person. The word “management” is associated with the modern concept of organizing and managing any program or business. In the medical/clinical field, case management is the methodology that defines new professional skills, no longer aimed at the mere provision of individual services, but at the facilitation, activation and coordination of the entire complex of the needs of the assisted person. A fragmentary, ineffective and uneconomic taking care is therefore avoided. The case manager is the coordinator/ manager of the clinical case; more specifically, the professional who acts as the “reference person” of the case, and coordinates, organizes and manages all the activities and complex situations that affect the specific care of a sick or disabled person. The case manager takes care not only of a patient’s individual path but also of his or her nucleus. This professional figure intervenes and mediates relations with medical personnel, the family and institutions and plays a fundamental role in the communication between the patient and the health personnel. The delicate and difficult task of this manager focuses on building and managing relationships, including the bureaucratic aspects and interaction with local health services. The case manager does not enter into the merits of the therapies set by the doctors; however, the role requires medical knowledge to support the team of specialists from whom the patient is being treated. The role lasts for as long as necessary for the management of all ongoing care and assistance processes. The case manager, summarizing, finalizing and realizing two main objectives: optimization and continuity of the assistance provided, maintenance of the patient’s quality of life. The case manager collaborates with hospitals and local health authorities, with the social services of the municipalities and in all social and health initiatives that involve interaction between the various forces of the territory. It is therefore possible to identify three different models of Case Manager: Hospital, Hospital/Community, Community.

In the hospital context, it coordinates activities for high-risk patients and facilitates the transition between services and departments. In the hospital/community area, the case manager deals with high-risk patients, following the transition between acute care and long-term care environments. In the context of the community, the case manager works in patient’s homes and interfaces with community services. The role of the case manager, of American origin, was born from the beginning with a managerial character, during the 1970s; over time it has undergone several “adjustments”, following changes in national and international social and health regulations, which are constantly evolving. Today, the role of the case manager takes place between the health and social sectors. The case manager also requires economic knowledge: he must know how to rationalize costs and times in the best possible way. Resources, whatever they are, should never be wasted; therefore, it anticipates expenses and shares with the patient and optimizes the various procedures to be performed, in the most useful and functional chronological order possible; all for the maximum well-being of the patient. In Italy, the case manager still has a marginal presence, but is becoming an increasingly popular figure. In France, England and Germany it is already quite a widespread profession. In these countries, public and private social welfare structures themselves adopt this operating model, which has proved increasingly necessary in order to offer an advanced and adequate service to society. Among these managers we count those who have obtained degrees in medicine and to a greater extent the graduates in nursing who have followed specific professional training courses. There are also trade associations. The Italian Case Manager Association (AICM) was born in Bologna in 2006. A Commission for Case Manager Certification (CCMC) has been active in the USA since 1990, responsible for supervising and validating Case Management processes, providing the relevant Certifications to professionals who adhere to this program. At the international level, the Case Management Society of America (CMSA) plays an important role, publishing a scientific journal dedicated spe-

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cifically to the topic of Case Management: the Professional Case Management Journal. The response that the global community has been called upon to provide to address COVID-19 encompasses the entire continuum of health and human services, including acute and subacute care, treatment for complications, examinations and home therapies. The case managers played a fundamental role in planning and promptly implementing personalized assistance plans mostly by observing the medical and psychological needs of people belonging, for various reasons, to the categories more fragile and at risk, such as the elderly, physically and mentally disabled, and people belonging to ethnic minorities. Annachiara Rotolo

Annachiara Rotolo

Bibliography

#machelavoroè: il Case Manager (cliclavoro.gov. it) Associazione Italiana Case Manager (AICM) (https://​a​ssociazion​eitalianac​asemanager​.it/​) Case Management – Cliccascienze, 26 Marzo 2019 (Case Management – Cliccascienze) Case Management on the Front Lines of COVID-19 (M. Baker, S. Nelson, J. Krsnak), Professional Case Management Journal, March/April 2021 Vol. 26/No. 2 (lww.com) Case Management Society of America (CMSA) (https://​cmsa​.org/​) Chi è il Case manager, ovvero il gestore della complessità (Chi è il Case manager, ovvero il gestore della complessità – Morning Future) MASTER in Case Management (https://​ www​ .unimib​.it/​didattica/​master​-universitari/​ area​-medico​-sanitaria​-aa​-202021/​case​ -manag​ementinfermieristico; https://​www​ .unipd​.it/​corsi​-master/​infermiere​-case​ -manager; https://​www​.unibo​.it/​it/​didattica/​ master/​2020​-2021/​case​-management; https://​ www​.medicina​.univr​.it/​main​?ent​=​cs​&​id​=​785​&​ tcs​=​M​&​lang​=​it) The Commission for Case Manager Certification (CCMC) (https://​ccmcertification​.org/​)

73. Clinical engineer

as high as possible, and always to put the patient’s interest first:

The American College of Clinical Engineering (ACCE), founded in 1990, provided the definition of a Clinical Engineer (CE), as “A Professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology.” This definition is supplemented by the indication that “CE is a Biomedical Engineering applied to the healthcare industry. Therefore, the core activity of a clinical engineer is the Health Technology Management (HTM) with the main purpose to achieve the highest quality of care at the best cost.” In 2018, WHO highlighted the importance of the existence of this figure, stating that “trained and qualified clinical engineering professionals are required to design, evaluate, regulate, maintain and manage Medical Devices (MD), and train on their safe use in health systems.” Lately, the Technological Development is passing through a vertical growth phase thanks to the great possibility of data generation, acquisition and processing. This kind of revolution affected the whole Health Tech Industry (miniaturization of components and dimensions of technologies; creation of even smaller and more sophisticated “biosensors”; availability of Telemedicine Application; introduction of Artificial Intelligence to support the process of clinical decision making). Consequently, the diffusion in hospitals of an increasing number of Medical Technologies (MT) for diagnosis and therapy has radically changed the approach to healthcare; a modern hospital appears, in fact, as a container of technologies whose rationalization, maintenance and safety are increasingly pressing needs. For these reasons healthcare facilities must be able to choose and use MT correctly, to guarantee the safety of patients and operators, as well as the quality of the service provided, to reduce and optimize purchase and management costs. For all the above mentioned, the CE become a crucial manager to whom is entrusted one of the most important technological assets of the hospital. The main goal of the CE is to ensure that the quality standard of care provided is

● To manage the machinery inventory and the life cycle of each MT in safety; ● To ensure that each MT is available where needed, when needed, in order to provide the continuity of service; ● To plan all the maintenance activities (operative and expenditure) in order to optimize the performance of MTs and have the full cost control; ● To lead the investments for the innovation and obsolescence referring to the MTs. Therefore, the CE has the role of a “bridge” between the medical and the technical environments, and thus between the user and the supplier of the MT: in one expression, the CE’s aim is to guarantee the right intervention, to the right patient, at the right time. Considering that the MTs are strategic assets for the hospital, it became crucial to be managed by a competent professional, that is, someone able to support on the one hand all the key health care stakeholders managing the tech related issues allowing them to focus on the patient, and on the other hand the implementation of the hospital strategies. The broader field of biomedical engineering has a relatively recent history. The first modern meeting about the application of engineering in medicine was probably held in 1948, according to the Alliance for Engineering in Medicine and Biology. The first explicit published reference to the term clinical engineer appears in a paper published in 1969 by Landoll and Caceres, credited with coining it. The history of the formal accreditation procedures of this sub-discipline has been unstable. The International Certification Commission for Clinical Engineers (ICC) was formed under the sponsorship of the Association for the Advancement of Medical Instrumentation (AAMI) in the early 1970s, to provide a formal certification process for clinical engineers. A similar certification program was formed by other academic institutions such as the American Board of Clinical Engineering (ABCE). By 1985, only 350 clinical engineers had become certified. In 1999, the AAMI established that there was not a viable market for its certification program and decided to suspend that program, no longer accepting any new appli-

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cants. The new, current clinical engineering certification (CCE) program was started in 2002 under the sponsorship of the ACCE and is administered by the ACCE Healthcare Technology Foundation. In 2004, the certification program was actually put in place. These professional figures have to manage each medical device’s life cycle, considering: ● Preliminary assessment: he has to be able to determine a trade-off between the performance assurance and all the economic aspects related, through an action of Health Technology Assessment (HTA), with the purpose of determining whether a medical device is cost-effective. ● Purchase: after a comparison between different available technologies, he performs all the steps aimed at the purchase process, starting from getting in contact with the supplier, continuing with the negotiation and concluding with the issuance of a purchase order. ● Acceptance and testing of the new device. ● Installation: this step is performed considering all the technical requirements of the technology medical environment and the requests of physicians and other key health leaders. ● User’s education: training in the proper and safe use of medical technology. ● Maintenance: it is possible to distinguish two types of maintenance, preventive (that are periodic and mandatory, to check the correct functionality of the devices) and corrective (in case of failure or an unexpected event). While the devices are in the hospital, he has to organize and provide these activities. ● Obsolescence evaluation and dismission: the last step is the assessment of a technology as obsolete. Using specific algorithms (for example some implemented business intelligence software), he has to identify whether a technology has to be dismissed and replaced. In addition to these “hard skills”, the CE has to possess “soft skills” (i.e., he must be able to implement measures whose results are not measurable, but still aimed at achieving the highest possible quality standard). These consist in the re-engineering of hospital processes through the introduction of innovative solutions, both of organizational and technological nature (for example, the implementaPaolo Oliva

tion of a new approach in the management of traceability of surgical instruments). The management activities performed by the clinical engineer could be correlated to the Deming cycle (Plan-Do-Check-Act), whose phases could be associated with a specific tool: ● “Plan”: it consists in planning, establishing objectives to be achieved and processes to obtain results to be compared with the expected results. A possible tool that supports them could be the Replacement Priority Index (RPI), computed through specific algorithms. It highlights the level of priority with which the technologies within the machinery inventory should be replaced. ● “Do”: execution of the planned program, with data collection for the next two phases and targeted investments aimed at guaranteeing equipment renewal and consequent performance improvement. The Hospital-Based HTA (HBHTA) could be part of this perspective; it consists of the mutual support between various internal bodies in the company context to extract as much information as possible about the quality and the service to enhance them. ● “Check”: test phase, with the control of the responses collected in the “Do” phase, which are compared with the expected results. The implementation of the planning should be effectively supported by Key Performance Indexes (KPI), used for an accurate analysis of the state of the inventory machinery, also with the implementation of dashboards. They allow the clinical engineer to further take advantage of the decision-making process, by exploiting the retroactive effect with respect to planning. Moreover, all the information collected is useful for the last step. ● “Act”: actions to finalize and/or improve the process. Corrective actions on the significant differences between expected and obtained results are performed, to identify possible errors or mistakes and to increase the quality of the process. To carry out these activities, it is important for a clinical engineer to have a software tool at his disposal, to manage the inventory of the machines, the requests for intervention

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by the hospital departments, the creation and conclusion of work orders and so on. There are three different types of CE Services: internal, external, or “mixed”. In the first case, the CEs are employees of the hospital and all the actions mentioned above are carried out internally. In the second case the professional figures carrying out these activities are employed by external agencies, the so-called global services; this configuration is the most diffused in public healthcare. There is also the mixed model mostly used when there is a vast installation of High Medical Technology where the management maintenance is entrusted directly to the manufacturer. Up to now, many of the CEs have degrees in electronic, mechanical or other engineering, and have acquired specific skills mainly in the field. Perhaps the reason for the low consideration for CEs in public organization charts is to be found here. Until a few years ago, even doctors’ esteem for these figures was very low, even though they perform a fundamental function for them; they preferred to interface directly with MT suppliers, and this still happens in smaller or more backward contexts: to ensure that the quality of the service is maximum, it is essential to enhance a competent figure. This development is mainly limited by the fact that knowledge of the subject is limited and that many structures, especially public ones, stipulate GS contracts. GS companies are private and external, so it could be instilled the doubt that they put their own interests before that of the

user, in a perspective of value-based healthcare that is to the detriment of the patient. Finally, it would be desirable for the CE to get involved in complex processes as a competent professional about some issues. Examples are: the re-engineering of hospital processes, quality control and management in the health sector (even at a higher level than the hospital one), management consultancy for certification and accreditation of the structures. Paolo Oliva

Bibliography

ACCE (1992), Definition of a clinical engineer. https://​accenet​.org/​about/​Pages/​Clinical Engineer​.aspx Dyro Joseph (2004), The Clinical Engineering Handbook, Elsevier. Landoll J.R. and Caceres C.A. (November 1969), “Automation of data acquisition in patient testing”, in Proceedings of the IEEE, 57(11), 1941‒1953. doi: 10.1109/PROC.1969.7440 Mazzotta, Gian Marco (2017‒2018), “Evidence-based health technology management: case study presso l’Humanitas Research Hospital”, MSc Thesis for Politecnico di Milano, AA 2017–18 Scilleri S. (December 2019), “Ingegneria clinica e Ingegneria per la sanità. Metodologie di ingegneria biomedica per la realizzazione e la manutenzione delle tecnologie sanitarie: strutture, impianti, apparecchi e loro sistemi di gestione”, Dario Flaccovio Editore. WHO (2018), Health products policy and standards. Human resources for medical devices. https://​www​.who​.int/​teams/​health​-product​ -policy​-and​-standards/​assistive​-and​-medical​ -technology/​medical​-devices/​human​-resources

Paolo Oliva

74. Clinical leader Clinical leadership is a powerful concept of crucial importance to the quality of care for patients. Research evidence shows positive links between clinical outcomes, leadership and team working, emphasising the need for excellence in clinical leadership and suggesting the need for greater understanding and investment in the development of clinical leaders. Clinical leadership is not a simple or single entity and takes place in many contexts: it happens at the interface between clinician and patient; within and between clinicians in clinical teams; and in the leading of healthcare systems and organisations. In some countries, clinical leaders even hold government office. As the complexity of clinical care increases, clinical leaders are increasingly in demand in all these settings, often with little systematic preparation and little recognition of the differing needs at different levels. There is frequently an assumption that clinical excellence translates easily into leadership excellence but there is evidence from action logics to suggest it does not. Rooke (2018) points out that the focus on gaining clinical expertise with increasing specialisation makes it difficult, but not impossible, to master the necessary skills and mindset to lead an organisation or a healthcare system. Historically the leader has often been regarded as a single person, usually male, leading from the front. This has its roots in centuries of military leadership which provided much of the early theory. Autocratic leadership is still the image of many and yet the prevailing view suggests it is unfit for the 21st century, and certainly unfit for healthcare. Goleman (2000) helpfully defined six leadership styles and showed that successful leaders must be able to function in four of the six and be able to flex their style appropriately to context. Autocratic leadership was shown to correlate negatively with performance; Goleman argued that it has a value but, unsurprisingly, an over-reliance is unhelpful. Healthcare is no exception; autocratic clinical leadership may sometimes have a place in the management of emergencies but rarely beyond. The delivery of health services across the globe is becoming increasingly complex due to demographic changes, improving tech-

nology, increasing costs, and rising public expectations. This has significant implications for leadership at all levels and the theory is clear, leadership in complex situations cannot be resolved by one person and needs a coalition of expertise. Therefore, the simple concept of one leader and a number of followers is increasingly being replaced by teams of leaders with the ‘baton’ of leadership being passed to the most appropriate expert (of whatever clinical professional background) at the most appropriate time even though accountability may still rest with one person. This is as true in front-line clinical teams as it is in more senior roles. Encouragingly, the concept of the clinical multi-disciplinary team is gaining popularity globally and clinical leadership is beginning to mean more than medical leadership. The need for clinical leadership is widely accepted without a good understanding of its qualitative and quantitative value, despite a growing body of research evidence showing links to clinical outcomes. Again, this effect applies both at the front-line and in the board room. For example, it has been shown that having four clinicians (as opposed to one doctor and one nurse) on UK hospital boards significantly improves organisational outcomes as measured by patient experience. Goodall, Associate Professor in Leadership at Bayes Business School, explored the US News and World Report quality ranking of hospitals and showed that 51% of the top 100 hospitals were led by medical chief executives. Interestingly, only 5% of US hospitals have medical chief executives. Goodall concluded that hospital quality scores are approximately 25% higher in physician-run hospitals than in the average hospital (Goodall, 2011). West et al. (2002) showed that good team working in UK hospitals is associated with lower mortality. This suggests that health systems should act to ensure that clinicians are actively involved in leading services, systems and organisations and that the appropriate career development support is in place. Clinical professions should act to embrace leadership and management in their well-constructed clinical training systems. If clinical leadership were considered a clinical intervention there would be a public and professional outcry at failing to capitalise on its benefits. The research evidence to date is important and interesting but it raises more questions

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than it answers, especially in the area of training and development. We do not know how clinical leaders exert their positive benefits. Is it all clinicians or just some professions – much of the evidence points to doctors but few studies have looked at other professions? How do we best prepare the most appropriate clinicians and where and when does this fit in an already busy clinical training? International comparisons should be studied. For example, Australasia has a well-developed approach where doctors elect to leave clinical practice shortly (a minimum of three years) after graduating, for a career in ‘medical administration’. The Royal Australasian College of Medical Administrators (RACMA) has a well developed, competitive fellowship training programme for potential medical leaders. By contrast, in many other countries, entry into formal leadership and management roles comes much later in a clinical career and there are few structured development programmes and most adopt hybrid (clinical and managerial) roles. Recent years have seen a rise in clinical leadership master’s degrees. These are often popular with a profession used to gaining career progression through academic qualifications but they need to be cognisant of the way individuals learn to lead and overcome the criticism in the wonderfully named Harvard Business School article, ‘The Great Training Robbery’(2016). This suggests a very poor return on an annual $160bn investment in training and education in US corporations, the issue being the inability to transfer employee learning into changes in behaviour both at an individual and an organisational level. The US Center for Creative Leadership has been arguing their 70‒20‒10 rule for some time which suggests that experiences which lead to leadership learning follow a ratio of: ● 70% from challenging experiences and assignments; ● 20% from developmental relationships; ● 10% from coursework and training. Classroom learning would appear to be the least effective way to enhance leadership skills and takes doctors away from the ‘clinical coal-face’. Learning ‘on the job’ is the most effective but, research suggests that it

must be accompanied by active support. This is helpful in overcoming the need for space in already crowded curricula but will require a major shift towards leadership development facilitated by clinical ‘trainers’ and the support to equip them in the art. Modern healthcare is increasingly complex and requires high quality clinical leadership. A growing body of evidence supports the practice in many countries of doctors holding the most senior organisational leadership positions. However, this model is not universal and the percentage of medical chief executives varies from 100% in Singapore to 5% in the US. Research evidence suggests the higher number will produce better quality healthcare but the evidence does not answer what positive attributes cause that association with senior medical leaders, how to identify them and how to develop them. More research is needed and much more attention needs to be given to encouraging and supporting doctors to progress a career in leadership and management. This should begin in the training grades despite the challenges to already full curricula. The greater effectiveness of learning as part of everyday work offers a solution if investment is made in helping trainers to facilitate leadership learning in parallel with clinical training. A comprehensive approach to encouraging clinical leaders and a systematic approach to clinical leadership development will enhance organisational performance and improve patient outcomes. In short, leadership saves lives! Peter Lees

Bibliography

Goleman D. (2000). Leadership that gets results. Harvard Business Review https://​hbr​.org/​2000/​ 03/​leadership​-that​-gets​-results Goodall AH. (2011). Physician-leaders and hospital performance: is there an association? Soc Sci Med., 73(4): 535‒539. https://​doi​.org/​10​.1016/​j Gupta AK. (2019). Physician versus non-physician CEOs: the effect of a leader’s professional background on the quality of hospital management and health care. Journal of Hospital Administration, 8(5). Johnson SJ, Blackman DA, Buick F. (2018). The 70:20:10 framework and the transfer of

Peter Lees

210  Elgar encyclopedia of healthcare management learning. https://​doi​.org/​10​.1002/​hrdq​.21330 (accessed 7 September 2021). Mayo Clinic Model of Care: https://​ history​ .mayoclinic​.org/​toolkit/​mayo​-clinic​-model​-of​ -care​.php Multidisciplinary Team Care: https://​www​.health​ .nsw​.gov​.au/​healthone/​Pages/​multidisciplinary​ -team​-care​.aspx No more heroes: https://​www​.kingsfund​.org​ .uk/​publications/​future​-leadership​-and​ -management​-nhs Perry J, Mobley F, Brubaker M. (2017). Most doctors have little or no management training and that’s a problem. https://​hbr​.org/​2017/​12/​ most​-doctors​-have​-little​-or​-no​-management​ -training​-and​-thats​-a​-problem Rooke D. (2018). Transformational leadership capabilities for medical leaders. BMJ Leader, 2: 3‒6. Rooke D., and Torbert W. (2005). Seven transformations of leadership. Harvard Business Review, April. Snowden DJ, Boone ME (2007). A leader's framework for decision making. Harvard Business Review, 85(11): 68‒76, 149. Taberna M, Moncayo FG, Enric Jané-Salas E et al. (2020). The multidisciplinary team (MDT)

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approach and quality of care. Front Oncol., 10: 85. https://​www​.ncbi​.nlm​.nih​.gov/​pmc/​articles/​ PMC7100151/​ The 70-20-10 Rule For Leadership Development: https://​www​.ccl​.org/​articles/​leading​-effectively​ -articles/​70​-20​-10​-rule/​ (accessed 7 Sep 2021). The Great Training Robbery Michael Beer, Magnus Finnstrom, Derek Schrader: https://​ www​ .hbs​ .edu/​ris/​Publication​%20Files/​16​-121​_bc0f03ce​ -27de​-4479​-a90e​-9d78b8da7b67​.pdf Veronesi G, Kirkpatrick I, Altanlar A. (2015). Clinical leadership and the changing governance of public hospitals: implications for patient experience. Public Administration, 93(4): 1031–1048. West MA, Borrill C, Dawson J, Scully J, Carter M, Anelay S, Patterson M, Waring J. (2002). The link between the management of employees and patient mortality in acute hospitals. The International Journal of Human Resource Management, 13(8): 1299‒1310.

75. Controller

History

Definition

The management of programming and control systems, whose goal is to seek a balance between resources and results through a process of widespread accountability that guides behavior towards strategic objectives, is a profession requiring specific skills and tools that has been developed over the last century. The role of “Controller” arose in private enterprises in the early 20th century, mainly with a finance and accounting connotation, and has grown and evolved in the private sector during the past decades. Over time, Controllers acquired more and more relevance also in the public organizations, such as Hospitals or public enterprises. This was done in response to the necessity of cost control and the development of new managerial theories for the public sector, see New Public Management (Hood 1991). Numerous definitions of “Controller” can be found in the literature because of a process of stratification, evolution and hybridization of the role. In general terms, Controllers, or management accountants, are responsible for operating the performance control system of an organization and for supporting and advising the management in his choices with reports and analysis (Verstegen et al. 2007; Bogt et al. 2016). According to Anthony et al. (2014), the Controller usually carries out the following activities: ● Designing and operating information and control systems; ● Preparing financial, costs and performance reports for management and other corporate functions; ● Interpreting these reports to support the management in operational and strategic choices; ● Analysing budget proposals to assist the management in the overall budgeting process; ● Supervising internal audit and accounting control procedures.

As mentioned above, the role of Controller evolved during the past two centuries. See Mariani et al. (2020) to have further insight into the evolution of the management accounting. The first seminal experiences of management accounting can be found in North America in the first half of the 19th century. In this period, different sectors, such as railway or textile, developed rudimental systems of cost accounting that laid the foundations for the modern management accounting. It was, however, during the second industrial revolution that management accounting became a function with well-developed tools and a broad legitimacy. In this phase, Controllers were more involved in the production of reliable financial records (about production, distribution, personnel and costs) than in the interpretation of this information or the activity of management support. For these reasons, Controllers were originally associated with the diminishing word bookkeepers. In the second half of the 20th century, the role of Controller needed to adapt to several changes in the business environment, such as: market conditions (i.e. decline of mass production), organizational aspects (i.e. multi-divisional companies) and new management approaches (i.e. management by objectives). This second generation of Controllers broadened their role becoming more and more involved in the analysis and explanation of the financial figures to support the management in making decisions and decentralize responsibilities. In this phase, using a well-known metaphor, Controllers became the ship’s navigator helping the commander (i.e. the management) in maintaining the course. Moreover, Controllers became something more than simple bookkeepers only providing financial figures; they added personal interpretation and analysis for possible solutions to support management decisions. This change put Controllers in a privileged position to define “how” to meet the strategic target set by the management and which actions and operational choices should be implemented. In other words, they assumed a pivotal role in the management control. Another cornerstone in the evolution of Controllers can be found in the late 1980s. This was a vibrant period in which both

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academia and practitioners started to re-think how to define and measure performance in complex organizations. This phase of conceptual revolution led to the development of new operational tools (such as the balanced scorecard, the activity-based costing, or the rolling forecast) whose influence is still underway in modern management accounting. In this context, Controllers acquired more responsibilities and started to participate in the strategy formulation process as a full member of the decision-making team. To some extent, Controllers shifted their role from “ship’s navigators” to actual “Business Partner” of the management (Mariani et al. 2020), with less time spent in producing reports and financial figures and more time dedicated to analysing and solving operational issues, side by side with executives and top management. Therefore, Controllers needed to acquire more problem-solving skills and change management techniques to interpret this new role. Since this conceptual revolution, Controllers have started to expand their range of activities inside organizations making their role more blurred depending on the specific context of each organization and management.

Controller in healthcare

The introduction of management and control systems in healthcare is usually more recent if compared with other sectors. The diffusion of Controllership in public organizations is mostly due to the rising costs of treatments and care activities. Moreover, during the last decades, the development of new theories on public management (such as New Public Management) and the introduction of budget constraints on public expenditure, have quickened the introduction of Controllers and management control systems in the public health sector of many countries. Nonetheless, it is impossible to draw a single picture that captures the role of Controllers in healthcare. There is a wide variety of management accounting and control systems in healthcare, and, therefore, there are many possible ways to perform Controllership. This variability depends on several structural aspects that define each healthcare system such as: payment systems (flat fee vs DRGs), market structures, healthcare regulations and ownership forms (public, private for profit or private non-profit) (see Mariani et al. 2020). Clara Carbone and Bernardo Provvedi

Each combination of these factors contributes to shape management accounting and control systems and, therefore, Controller’s role at national and regional level. Therefore, in some contexts healthcare organizations’ management control systems are designed to serve mostly financial accounting and administrative purposes, whereas in other contexts it is more process-oriented, with the Controller being an active part of the decision-making team. Nonetheless, we can proceed with some general considerations dealing with the peculiarity of Controllers in healthcare. First, Controllers in healthcare have to achieve their traditional tasks (such as cost accounting, report production and budgeting) adopting a multidimensional approach in performance evaluation. It is undeniable that the respect of economic and financial targets is crucial in hospitals and healthcare organizations, like elsewhere, to ensure their sustainability. However, Controllers must take into account many other elements (such as outcome results, quality of care or clinical process) to have a complete picture of the actual performance of healthcare organizations. Second, broadening the concept of performance in healthcare organizations, Controllers are forced through a process of hybridization of their role that makes them work side by side with other professionals such as physicians, nurses, pharmacists, or clinical engineers. This approach has often generated tensions, being perceived as a trespassing of administrative and economic aspects in other professional domains that used to be the prerogative of clinical and health professions. The actual role of Controllers depends on how each organization has managed these tensions. Third, Controllers must deal with the complexity of healthcare processes. Hospitals are, indeed, sites with a great number of different and interconnected production lines, with few possible automations and high variability. These aspects represent an additional challenge for Controllers, who have to adapt their tools to a very complex environment. These adaptations involve every phase of management accounting such as: the design of reliable information systems, the collection of cost accounting data, the production of reports, the analysis and development of new operational solutions, the assignment of

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budget objectives and relative resources to each unit.

Main activities and skills

For their pivotal role, Controllers work side by side with several other functions such as, HR, financial accounting, IT system or Operations. The core activities of a Controller in a healthcare organization are summarized hereunder: ● Cost accounting: this activity is performed in close connection with the office responsible for financial accounting and financial statements. This is the original task of Controllers and requires strong technical skills. When Controllers are mainly cost accounting oriented, they usually work in line departments with less involvement in the decisional process; ● Budgeting: Controllers support the top management in setting and monitoring general and specific targets for all units and departments. These objectives are usually the result of a negotiation with the middle management which includes: the distribution and availability of resources to fulfil those targets, the definition of performance indicators, the relevance of each objective for the final performance evaluation. Targets can be collective (i.e. assigned to a variety of units) or specific (i.e. assigned to a single unit), and they are usually defined according to the indications of national or regional health authorities; ● Workload analysis and individual performance evaluations: these activities are performed with the close support of the Human Resources department (HR). The former requires that the Controller acquires a deep understanding of production processes and operations. Workload analysis has become a crucial activity in the last years for both cost reduction requirements and shortage of professionals in several disciplines. Controllers work side by side with HR departments to define and implement systems for individual performance evaluation. This activity relates to budgeting but is defined at the individual level and is usually connected to economic incentive schemes;

● Information system design and report production: Controllers are asked, usually with short notice, to provide reliable and detailed information to top management or other stakeholders. For this reason, Controllers need to work side by side with IT departments or external providers to design the information flow and to collect reliable data. This aspect is extremely important to fulfil both internal and external requests. Indeed, in countries with national health services, healthcare organizations are periodically asked to provide information (such as outcome results, production activity, financial sheets etc.) to national and regional health authorities. Finally, Controllers are asked to analyse and interpret the available information, to select what is most relevant for the decision-making process and to provide a synthetic representation for the top management. From a theoretical perspective, Controllers should find a balance among the activities listed above. In the reality of each healthcare organization, the Controllership function would be compressed and oriented to one, or more, of the previous dimensions. This depends on several factors embedded in each organization and each national/ regional healthcare environment. A not comprehensive list of these factors includes: the top management approach, the presence of charismatic professionals in other units, the leadership skills of the Controller, the development and dimension of the organization, the nature of the organization (for profit or not for profit), the development of other functions such as Operations Management, the strength of medical professions inside the organization, the number of staff. All these factors, and many more, determine the actual role of Controllers in healthcare organizations.

Hard and soft skills

Controllers have traditionally a solid background in accounting and financial statement. Nonetheless, the process of hybridization of Controllership broadens the skills required from a Controller. In complex organizations, such as those in the healthcare sector, Controllers must develop their soft skills. Clara Carbone and Bernardo Provvedi

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A list of essential skills for a Controller in healthcare is reported hereunder: ● Relational skills are crucial to interact with many different professional perspectives (such as physicians) and to avoid possible conflicts; ● Change management skills are important to achieve results in very complex environments such as hospitals or healthcare organizations; ● Analytical skills are essential for a Controller that wants to be something more than a simple “bookkeeper”; ● Flexibility and readiness are mandatory to fulfil top management requests of information; ● The ability to select priorities and organize the work accordingly is another crucial aspect of a Controller’s work; ● The ability to adopt multidimensional approaches is what distinguishes a Controller working in the healthcare sector from one working in another sector. Indeed, in healthcare organizations, ethical and clinical aspects must be taken into account. Clara Carbone and Bernardo Provvedi

Clara Carbone and Bernardo Provvedi

Bibliography

Anthony, R., Govindarajan, V., Hartmann, F., Kraus, K., & Nilsson, G. (2014). Management Control Systems: European Edition. McGraw Hill. Bogt, H. T., van Helden, J., & van der Kolk, B. (2016). New development: Public sector controllership—reinventing the financial specialist as a countervailing power. Public Money & Management, 36(5), 379‒384. Eldenburg, L. G., Krishnan, H. A., & Krishnan, R. (2017). Management accounting and control in the hospital industry: A review. Journal of Governmental & Nonprofit Accounting, 6(1), 52‒91. Hood, C. (1991). A public management for all seasons? Public Administration, 69(1), 3‒19. Mariani, A., Baraldi, S., Monolo, G., & Sacco, P. (2020). Il ruolo del controller nelle aziende sanitarie: evoluzione e tendenze. McGraw Hill Education. Verstegen, B. H., De Loo, I., Mol, P., Slagter, K., & Geerkens, H. (2007). Classifying controllers by activities: An exploratory study. Journal of Applied Management Accounting Research, 5(2), 9‒32.

76. Family and community nurse The Family and Community nurse (FCN) is a professional responsible for the nursing processes offering care to individuals, families, and groups usually outside the hospital. This figure possesses specialistic knowledge and skills in the nursing area of primary care and public health along with abilities in critical thinking, advocacy and analysis. FCN’s competence consist in the delivery of complex nursing interventions and cures, in the promotion of health, in the prevention and in the participative management of the processes of individual, family and community health, always working within the Primary Health Care (PHC) system. The object of the FCN is health, and they work to fulfill the health needs of both adult and pediatric populations, acting within a specific territory and community environment favoring the integration between medical and social services. The FCN works as an autonomous professional by referring to the nursing service of the territory, and in close connection with health and social services and other professionals of the National Health System. Since different territories have different characteristics and present different problematics, the FCN can act within them using different care models. Indeed, high-intensity urban areas, peripheral urban areas, isolated towns, mountain areas require different and specific types of interventions and management. The figure of Family and Community nurse developed from the World Health Organization (WHO) definition of “new nurse”, who is the person that helps individuals in adapting to their diseases and chronic disabilities by spending most of their time working at the home of the assisted person and their family. This figure must be framed inside the idea of a health system which takes into account the increasing of chronicity and frailty, mainly due to the increasing age of the population and coexistence of multiple pathologies, and the increasing necessity of both individual and community empowerment, resulting in a population that has the basic competences and knowledge to actively participate in their health decision (self-care). It has been demonstrated by many studies, including the one done by

the National Institute for Health and Care Research (NIHR), that interventions aimed at the improvement of individual and community abilities in actively participating in the decisional processes regarding health itself facilitates both the sustainability of the health systems and the reduction of health discrepancies. Another key point of this improved health system is to move, when it is possible, part of the Primary Health Care (PHC) outside the hospital by promoting the early discharge of patients. This can be done by providing a continuity in care and assistance at a territory and local level through the integration of services between hospitals and territories in synergies with local organizations, general practitioners (GPs) and other professionals. The FCN will be part of a multi-professional team composed of the GP and pediatrician and they will promote an action aimed at the transversal integration between health and social workers and the possible formal and informal resources present in the territory useful to solve problems concerning health needs. This will result in the creation of a collaborative and coordinated health network inside the community providing community’s welfare and individual wellbeing. In the 2000s, starting from this idea of a social health system and social innovations promoted by the Health 21 policy of the WHO, in Europe and Italy training courses for professional nursing figures, including the one for the FCN, have been developed. Facing the difficulties in creating a unitarian operative European definition of FCN, in 2018, the ENhANCE European project was started with the aim of creating a curriculum useful in implementing the core competences expected for the FCN. Based on this, in the last decades in different regions of Italy different experiences of family and community nurse have been developed in Tuscany, Friuli Venezia Giulia, Piedmont and Liguria with the CoNSENSo project. Only in 2020 the figure of FCN has been promoted at a national level thanks to the approval and conversion of the Decreto Rilancio into the law 77/2020. In Italy, the competences of the FCN, according to the FNOPI, are defined in specific post-graduate training courses including master’s degrees and PhD. The core competences promoted by the ENhANCE project which is based on the

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WHO framework for the Family Health Nurse and the WHO framework for Community Nursing Education and needed by a FCN are in: ● Needs assessment: identification and assessment of the health status and health needs of individuals and families within the context of their cultures and communities. ● Decision-making process: development of nurse leadership and decision-making skills to ensure clinical and healthcare effectiveness and appropriateness paying attention in involving individuals and families in decisions concerning their health and wellbeing. ● Health promotion and education: enhancement and promotion of health and prevention of disease and injuries in individuals, families and communities focusing on inequities and unique needs of subpopulations. maintenance of ● Communication: intra-professional and inter-professional relationships and a supportive role with colleagues to ensure that professional standards are met. ● Navigation as care coordinator and patient advocate: work together with the multidisciplinary team to prevent disease and promote and maintain health. ● Evidence-based approach: use of the best scientific evidence available, set of standards and evaluation of outcomes related to nursing activities in people’s homes and in the community. ● Enhance and promote individual and family health including e-health to support the quality of nursing care: monitoring of people affected by chronic and rare illnesses in the community in collaboration with other members of the multidisciplinary team and health promotion, education, treatment and monitoring supported by telemedicine. The interventions of FCNs extend at three levels: ● Ambulatory level: at this level the nurse gives assistance to all the users able to walk by themselves that need a low–medium complexity level of care assistance and/or health education and promotion interventions. Cecilia Rossi

The ambulatory activity is carried out in structures inside the community and preferably close to the social workers’ activity to have an integration between these two areas and provide a socio-sanitary service. The ambulatory activities includes: delivery of the main medical care requested by the users (blood draws, medications, injections, vital signs monitoring…); delivery of information regarding the health offer ameliorating the users’ access and use of the public health services; and promotion of health-education interventions. ● Household level: at this level the nurse gives assistance to the users that cannot reach the ambulatory level due to severe pathologic conditions or to deambulatory difficulties, who need continuous medium–high complexity care assistance and have low levels of autonomy requiring periodic healthcare. At this level the activities are carried out in individuals’ houses and include all the interventions mentioned for the ambulatory level plus the promotion of the continuity of cares between hospitals and the territory through the activation of a territory healthcare network; the promotion of health through the integration of nursing care with all medical, social and educative needs of all the family directing them toward health awareness, self-care and self-management; and the prevention of already potentially present needs before it is asked for. ● Social level: at this level the nurse plays transversal activities sustaining activation and integration between health and social workers and the possible formal and informal resources present in the territory to solve problems regarding health needs and care issues. The nurse acts to create a network of professionals and services aimed at ensuring the community’s welfare. In conclusion, the Family and Community nurse has been considered strategic and essential to potentiate the territorial health offer and services. Promotion of healthy lifestyle, early recognition of frailty and chronic states before the development of irreversible states of disability, improvement of the access to health services, integrated with the social and hospital services, potentiation of the offer of territorial and household services, reinforce-

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ment of local communities’ empowerment, development of therapeutic and health education to improve patient self-care and disease self-management, integrated management of chronic conditions in collaboration with the general practitioner and other professionals and a correct and helpful use of telemedicine interactive audiovisual equipment to assist and monitor home healthcare clients from a distance are the future outcomes for FCNs. These are expected to be elements of social innovation for the development of a new welfare system. Cecilia Rossi

Bibliography

Federazione Nazionale Ordini delle Professioni Infermieristiche (FNOPI), 2020. Position Statement Infermiere di Famiglia e Comunità. Gerber, L. Community health nursing: A partnership of care, American Journal of Nursing, 2012;42(suppl career):19‒20. Marcadelli, S., A. Steviano, G. Rocco. Policy proposals for a new welfare: The development of the family and community nurse in Italy as the key to promote social capital and social innovation, Prim Health Care Research and Development, 2019;28(20):e109.

Cecilia Rossi

77. General practitioner General practitioner, also known as GP or Family doctor is (or should be) the first contact between patients and health services. Its training, professional role and service basket varies from one country to another country. A GP may either work as a solo practice or be integrated in primary care teams, depending on each country or county health services organization. These may be called Primary Care Teams (PCT), Polyclinics or, such as in Italy, Casa della Salute. Family and community medicine specialty is increasingly developed in many countries and is a compulsory requirement to work at in some public health services. Specialty usually lasts three to four years and includes training in both primary care, hospital, mental health, women’s care and emergency services. Beyond clinical training, family doctors are familiar with public health and epidemiology. Specialty has been everywhere a powerful booster for GP and primary care development. It not only promotes doctors’ technical abilities and the use of evidence-based guidelines but also favors a doctor–patient relationship that goes beyond the illness. GPs are expected to deal with patients suffering from organic and psychological disorders. The scope of activity goes from diagnostic and cure to health promotion and prevention. In countries where primary care is more advanced, GPs are responsible for diagnosis of cardiovascular, lung, gastrointestinal or endocrine disease, osteoarticular health problems or mental health situations purchasing diagnostic tests, being those blood analysis, imaging or other tests (endoscopies, treadmill test, holter…). Thus the patient is only referred to hospital when needed, in case recommended treatment may not be provided by the family doctor. In any case, the follow-up may be related to primary care. Depending on the country, some activities are developed by doctors themselves or by nurses. GPs usually care for children and adults, covering the whole life span. Very few countries substitute the GP’s role by a pediatrician who cares for children up to seven or fourteen years of age. A shortage of professionals is a common situation around the world and sets a diffi-

culty for health systems. The presence of GPs and Primary Care Teams may help to solve most of the situations out of hospital. The most specific characteristic of family doctors is longitudinality, meaning the possibility for patients to be cared for by the same professional all along his or her life. Because of this, by knowing the situation at home, intrafamilial relations, possible couple conflicts, suffering for deceased elders and so on, family doctors may understand why a patient is sad, why they do not take the prescribed pills, why the recommended diet is not followed or many other situations not explained by a proper anamnesis and physical exploration. Besides, longitudinality is not only crucial for doctors to identify context, familial and social, that are health determinants for each patient but it is essential for primary care. Many decades ago, Barbara Starfield numbered some essential characteristics of primary care, longitudinality being one of them, close to gate-keeping, coordination of care and comprehensiveness. Gate-keeping depends mainly on health services organization. When the rules do not allow the population to have direct contact with the hospital or other levels of care (women’s care, mental health care, emergencies may be exceptions to the rule) primary care and GPs are even more relevant. It depends also on a doctor’s ability to deal with and solve situations by themselves, avoiding or delaying referrals. Gate-keeping is possible also because of good professional training, being a specialty linked to health systems where primary care is stronger and the amount of referrals is lower. Thus, comprehensiveness, the capacity to solve situations through technical skills, patient-centered strategies and access to diagnostic tests is also linked to specialty and determinants for gate-keeping. Doctors may work together with other professionals in primary care teams. This teamwork allows a distribution of workload among the workforce and specifically allows activities to be solved by the best-trained professionals for each goal. Thus health assistants, allowing doctors to care for specific clinical needs, may assume many administrative activities. Simultaneously, nurses, beyond technical responsibilities, may be responsible for chronic patients’ follow up, management of patients with complex situations and care for some urgent needs. Even

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a well-trained nurse aid may be responsible for techniques such as biological sampling or non-mydriatic retinography. In this specific context, GP activity may include not only care in health centers or home, but also may include care for people living in nursing homes or developing health promotion activities in the community. Team structure and its development asks for more training for GPs. Leadership is a basic requirement to move the team forward. Those professionals who have previously developed strategies to deal with patients’ worries are in the best situation to manage a team or a primary care organization, combining it with their knowledge of the context. Antoni Peris

Bibliography

OECD Policy brief (2019). Realising the full potential of primary health care. OECD. Rosen R (2018). Divided we fall: getting the best out of general practice. Research report, Nuffield Trust. Schäfer WLA, Boerma WGW, van den Berg MJ, De Maeseneer J, De Rosis S, Detollenaere J, Greß S, Heinemann S, van Loenen T, Murante AM, Pavlič DR, Seghieri C, Vainieri M, Willems S, Groenewegen PP. Are people's health care needs better met when primary care is strong? A synthesis of the results of the QUALICOPC study in 34 countries. Prim Health Care Res Dev. 2019 Jul 1;20:e104. doi: 10.1017/S1463423619000434. PMID: 32800009; PMCID: PMC6609545.

Antoni Peris

78. Hospitalist Hospitalists are clinical doctors whose responsibilities are centered upon the care of hospitalized patients. Unlike cardiologists whose focus is on a particular organ, oncologists whose focus is on a specific disease or pediatricians whose focus is on a selected patient age group, hospitalists are focused around a place of care, the hospital. The individual duties of a hospitalist may then vary within this setting and may include patient care, research, teaching and optimization of hospital performance and resources. In terms of patient care, hospitalists may oversee a patient’s entire hospital stay. They may examine the patient upon admission, order and interpret diagnostic tests, directly prescribe medications and treatments and assess the need for patient referral to other specialists within the hospital. Many patients admitted to the hospital indeed represent complex medical cases, with multiple health issues, which must be addressed by the relevant medical specialists. In that case, it is usually the hospitalist’s duty to set up, guide and coordinate a patient-specific medical team within the hospital. Leadership of such a team requires strong communication with everyone involved and adequate integration of all indicated treatment plans. Communication is key also when it comes to patient interactions: a hospitalist should serve as a patient’s advocate and go-to figure, listening to their needs and explaining everything in a clear and easy to understand fashion. Hospitalists may also be concerned with aspects of patient discharge, to ensure a smooth transition from hospital to home or other care setting. This might mean completing documentation, communicating a summary of the hospitalization to the patient’s primary care provider and sometimes even working with social workers or case managers to ascertain adequate post-discharge care. However, hospitalists are usually not responsible for patient management after discharge and will typically not provide care in the outpatient setting. The model described above is one of several possible hospitalist-based organizational models. Each hospital might indeed adopt a different model, or a slightly different version of an existing model, depending on its

individual needs and ideas. Not only are there different models for the exact role of a hospitalist, but there are also several possible models for their work schedule. A commonly adopted model involves working for about seven days followed by a similar amount of days off. This is usually unlike traditional internists who tend to work for approximately 4.5 days a week. The term ‘hospitalist’ was first introduced in 1996, in a New England Journal of Medicine article, written by MD Robert Wachter (Wachter & Goldman, 1996). Since then, several studies have been conducted to assess the changes brought about by the introduction of this new clinical role. Positive differences were identified, such as improved quality of patient care, increased patient satisfaction, reduced length of hospital stays and a general reduction in costs. For example, a January 2002 study from The Journal of the American Medical Association revealed that hospitalists allowed for a decrease in hospital expenses by 13.4%, a reduction in duration of hospital stays by 16.6% and a general amelioration of patient satisfaction and standard of care (Wachter & Goldman, 2002). Another study from the Archives of Internal Medicine, published in September 2007, showed that hospitalists were able to decrease acute length of stays by about half a day (Southern et al., 2007). In 2009, a Loyola University Health System Study, further evidenced that hospitalists can reduce the duration of patient hospital stays. They indeed revealed that patients co-managed by a hospitalist had a length of stay of approximately 3.8 days, while patients who were not overseen by a hospitalist had a length of stay of approximately 5 days. The study also showed that such decrease exhibited no negative impact on the quality of patient care. Finally, a September 2009 (Bakitas et al., 2009) study demonstrated that hospitalists allowed for more effective teamwork between hospital specialists. This, in turn, allowed for an easier transition from hospital to home, less return visits to the hospital, decreased morbidity rates, lowered hospital costs and improved patient satisfaction, both upon discharge and thereafter. Aside from their role in the clinical setting, hospitalists have also emerged as an asset in the field of quality improvement for hospitals.

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Figure 78.1

Similarities and differences between traditional internal medicine and hospital medicine

Given the nature of their work, hospitalists are indeed in a position to comprehensively evaluate key factors such as efficacy of resource allocation, general productivity and standard of hospital measures, thus ideally being able to point out what might require change, and how this change might be delivered. Moreover, when new quality improvement initiatives are suggested, hospitalists may offer prompt feedback on how these initiatives might impact the hospital. All in all, it appears that hospitalists may be well-suited to develop and evaluate, but also implement and maintain, new quality initiatives. Examples of quality improvement programs led by hospitalists, that have proven to be successful, include ameliorations in venous thromboembolism prevention, transitions of care and glycemic control. Hospitalists are usually medical doctors that specialize in general internal medicine, to later care for adults, or in general pediatrics, to later care for pediatric patients. Nevertheless, hospitalists may also receive training in other fields of medicine. In addition, it is worth noting that, although many hospitalists specialize in general internal medicine, their role is distinct from traditional internists, as summarized in Figure 78.1. In conclusion, it is becoming increasingly clear that hiring hospitalists translates into numerous advantages for hospitals, such as decreased costs, increased efficiency, greater patient satisfaction and optimized patient care. Not surprisingly, the role of the hospitalist was born to address the increasing complexity of hospitalized patients, who often display multiple health issues.

These complicated cases indeed benefit from dedicated physicians overseeing their care during hospital stays. Nevertheless, hospitalists still represent a relatively new figure, that has not yet been universally adopted. A possible reason for this might be that employing hospitalists essentially means having to alter a hospital’s existing organizational system. For example, it might be necessary to re-examine how patients are divided within a hospital, replacing the traditional system of speciality-based ward partitioning and replacing it with a system based on multidisciplinary medical teams providing high-quality care to pluripathological patients. However, redesigning a hospital’s organizational system might be costly, time-consuming and possibly meet with resistance from different parties…possible hurdles that hospitals would need to overcome before reaping the full benefits of a hospitalist’s work. Sonia Maria Prevedello

Bibliography

Bakitas, M., Lyons, K. D., Hegel, M. T., Balan, S., Barnett, K. N., Brokaw, F. C. et al. (2009). The project ENABLE II randomised controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions. Palliative & Supportive Care, 7(1): 75‒86. Fondahn, E., & Bardowell, R. (2015). Hospitalists and quality improvement: a natural pairing. SGIM Forum, 38(3): 7, 10. Loyola University Health System (2009, October 6). How to reduce hospital stays and increase patient satisfaction. ScienceDaily. Retrieved

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222  Elgar encyclopedia of healthcare management March 31, 2023 from www​.sciencedaily​.com/​ Medicine, 167(17): 1869–1874. https://​doi​.org/​ releases/​2009/​10/​091006093439​.htm 10​.1001/​archinte​.167​.17​.1869 Orlandini, G. E. F., La Regina, M., Fontanella, A., Wachter, R. M., & Goldman, L. (1996). The Campanini, M., & Gnerre, P. (2018). La figura emerging role of “hospitalists” in the American dell’Hospitalist in Italia. Italian Journal of health care system. The New England Journal Medicine, 6(1): 1–57. https://​doi​.org/​10​.4081/​ of Medicine, 335(7): 514–517. https://​doi​.org/​ itjm​.q​.2018​.3 10​.1056/​NEJM199608153350713 Southern, W. N., Berger, M. A., Bellin, E. Y., Wachter, R., & Goldman, L. (2002). The hospiHailpern, S. M., & Arnsten, J. H. (2007). talist movement five years later. JAMA: The Hospitalist care and length of stay in patients Journal of the American Medical Association, requiring complex discharge planning and 287: 487‒494. 10.1001/jama.287.4.487. close clinical monitoring. Archives of Internal

Sonia Maria Prevedello

79. Medical director Definition

Medical executive that assures guidance, supervision, quality and economic balance for a healthcare facility (public or private).

Rationale

The role of Medical Director is constantly evolving. It is well established that management and medical practice can require different expertise. In a medical field that is struggling to balance costs and quality of healthcare, medical executives can provide major contributions to the strategic decisions concerning healthcare, having both clinical and management expertise. In fact, Medical Directors have experience in everyday medical practice and they know what it means to be on the “frontline”; at the same time, they possess good knowledge of healthcare marketing strategies, health economics and resources allocation (both human and financial). In the future, the role of Medical Director will be increasingly more important in combining medicine and business in a variety of settings: hospitals, outpatients care, healthcare industries.

Goals

Medical Director’s goals can vary, depending on the type of healthcare setting they manage. Generally, there are two types of objectives: (a) quali-quantitative objectives and (b) managerial objectives. The management board or the executive board of the healthcare facility will set these goals. The quali-quantitative objectives are based on the productivity and the socio-medical level of the setting. The managerial objectives are linked to specific competences of the Medical Director and to their ability to create network and encourage teamwork within the different components of the healthcare facility.

Why is it useful

The Medical Director’s added value lies in its ability to bring together different clinical

cultures, facilitate communications between highly specialized workers and mediate between healthcare and administrative personnel. The management skills required from a Medical Director are: ● leadership and ability to delegate; ● a result-oriented and user-oriented approach; ● planning and organizing skills; ● ability to encourage teamwork; ● ability to negotiate and influence decisions; ● initiative and ability to innovate; ● management skills and interest in people’s professional growth; ● economic sensitivity, meaning the ability to maximize an effective and efficient use of the financial resources available. The Medical Director must always adopt behaviors appropriate to his role.

History

In Italy, the role of Medical Director was instituted in 1938, with the R.D. n. 1631 of the 30th of September (“Norme generali per l’ordinamento dei servizi sanitari e del personale sanitario degli ospedali”, G.U. 25, October 1938, n. 245). Since the process of corporatization of the National Healthcare Service started, this role has gone through several changes. In 1974, the USA federal regulations stated that a doctor could be recruited as director (full time or part time) in a nursing home. In January 1988, a consensus conference identified the roles and responsibilities of the hospital management staff: afterwards, new educational opportunities were introduced that focused on developing the skills needed to fulfill these functions. The literature that defines the role and the responsibilities of the Medical Director is produced by experts in the management field. In spite of the rich legislative body on this topic, the role of Medical Director is not very well known, and its function and competences are often ignored.

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A more detailed description

The Medical Director performs the following activities, in collaboration with their staff: ● analysis of the health level of the population and its impact on healthcare determinants; ● development of healthcare information systems; ● development of clinical governance and quality assurance of health services through: ● implementation of more effective and more appropriate clinical pathways; ● implementation of evidence-based clinical guidelines, procedures and protocols; ● development of management methods aimed at patient care, healthcare continuity and appropriateness of healthcare; ● continuing professional development and lifelong learning; ● valorization of other healthcare professions; ● monitoring, prevention and management of adverse events; ● protection against ionizing and non-​ ionizing radiation; ● Health Technology Assessment (HTA); ● accreditation of healthcare facilities; ● coordination of different activities; ● coordination of the hospitalization practices; ● coherence between pharmaceutical supply and clinical casuistry; ● forensic medicine applied to healthcare costs; ● programming and monitoring of the waiting lists; ● prevention and screening programs; ● local coordination of transplants.

Giuseppe De Filippis and Pietro Manzi

The Medical Director chairs many Technical Commissions and working groups, and they express their opinion about the main architectural transformations of the healthcare facilities that they manage. The Medical Director conducts external affairs with Local Authorities, with the University, with Volunteer Associations, with Trade Unions and with Professional Associations; they conduct internal affairs with the Directors of Healthcare Departments, with the Amministrative Offices, with the Prevention and Epidemiology Department, with the Clinical Risk Manager. The Medical Director usually chairs the Hospital Infection Control Committee and the Blood Management Committee: their competence can be very helpful in managing the surgical activity and assuring the good functioning of the operating block.

Future developments

The role of Medical Director is crucial for managing healthcare activities. In the future, their role in managing the healthcare budget could be enhanced in order to properly administrate Sars-CoV-2 funds and for the quali-quantitative management of other healthcare activities. Giuseppe De Filippis and Pietro Manzi

Bibliography

Merrill DG. Anesthesiol Clin. 2014 Jun;32(2):529‒40. Practice management/ role of the medical director. doi: 10.1016/j. anclin.2014.02.021. PMID: 24882136 Review Pattee JJ. Clin Geriatr Med. 1995 Aug;11(3):331‒41. History and evolution of the role of the medical director. Permut R. Group Pract J. 1989 Jan–Feb;38(1):52, 54, 59‒60. Medical director, an evolving and expanding role of the physician-executive.

80. Operations manager Operations management is the design, operation, and improvement of the processes and systems that create and deliver the organization’s products and services (McLaughlin & Hays, 2008). The goal of operations management is to plan, produce and deliver the organization’s products and services more efficiently (without waste of resources, time, and people efforts) and more effectively (consistently with customers’ needs and experience). The theories, tools, and techniques of operations management, if properly applied, can enable healthcare organizations to become more efficient and effective in response to the current patients’ needs; moreover, operations management fosters the continuous improvement of these systems and services to meet the future needs in a quickly changing environment (McLaughlin & Hays, 2008). Healthcare operations management is defined as (Langabeer, 2008) the quantitative management of the supporting business systems and processes that transform resources (or inputs, i.e. resources and assets such as labor and capital, including financial resources, technology, space, equipment, and information) into healthcare services (outputs, i.e. production and delivery of healthcare services). Logistics is one of the key perspectives of healthcare operations management and it is defined as the efficient coordination and control of the flow of all resources in the operations, including patients, personnel, and other resources. Healthcare operations management includes all functions related to the management system and business processes underlying clinical care (Langabeer, 2008) and, basically, operations managers plan and control delivery processes and systems within the healthcare organization (McLaughlin & Hays, 2008). The three main areas of application of operations management theories and tools in healthcare are (Bensa et al., 2008): (1) asset management, that is planning and controlling the productive resources involved in the delivery of healthcare services (e.g., beds, operating rooms, outpatients department slots, etc.); (2) patient flow logistics, that is planning and controlling the patient paths from a logistical point of view; (3) the man-

agement of supplies, that is planning and controlling the logistics at “right time and right place” of medical supplies (such as drugs, devices, etc.) and non-medical supplies (such as food, hotel services, cleaning, etc.). Health operations management activities are strictly related to other areas of management activity that focus on the core processes of the organization, including (Vissers & Beech, 2004): (a)  quality management, which aims to improve and maintain the quality of services delivered by processes; (b) performance management, which concentrates on measuring and monitoring the performance of the organization in terms of the outcomes of processes; (c) information management, which focuses on the design of appropriate and timely information flows and on the development of tools for providing and handling information about processes; and (d) operational research, which offers analytical techniques and approaches that can be used to investigate and improve processes. Therefore, different professional roles work as operations figures in healthcare organizations, such as operations analyst, quality manager, controller, procurement manager, facilities manager, supply chain manager, and so on. Moreover, clinicians, nurses, technicians, and other health professionals also play a key role in managing service operations (for example, bed managers, discharge managers, operating room coordinators, etc.). Nevertheless, the specific label “operations manager” (or COO, chief operating officer) is mostly used for the professional position that works on asset management and patient flow logistics, coordinating the efforts of the different administrative and health professional roles involved in managing and delivering health services both in the primary clinical processes and in the support processes (for example, director of patient transportation, procurement manager, operating room managers, bed managers, discharge managers, etc.). Thus, the operations manager is not characterized by a specific background (administrative or clinical/nursing) but by the ability to master knowledge on the analysis and design of effective and efficient systems and processes or improve existing processes. As such, the handling of operations inside a healthcare organization may benefit from a multidisciplinary and inter-professional team – coordinated by a chief operating officer – that blends different backgrounds,

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views, skills, and tools to manage and optimize the processes and the logistics flow. According to Langabeer (2008), the operations managers have multiple broad goals and functions in the healthcare organizations, including all of the following: (1) reduce costs, (2) reduce variability and improve logistics flow, (3) improve productivity, (4) improve quality of customer service, and (5) continuously improve business processes. The first goal is to reduce costs. Thus, operations managers’ primary role is to find waste in the use of the inputs (personnel, materials, technologies, etc.), improve their utilization, and generally stabilize and reduce the overall cost of delivering healthcare services. The second goal is to reduce variability and improve logistics flow. Operations managers should continuously focus the attention on the most efficient and optimal paths for movement of resources – whether those resources are physical or information flows – especially with the goal of reducing variability (i.e. the inconsistency or dispersion of inputs and outputs). Variability threatens processes because it results in uncertainty in the planning of the resources: staffing and resource consumption should link directly with patient volumes and workload, but they may change from hour to hour and day to day (Langabeer, 2008). In particular, healthcare operations management theories distinguish between artificial variability and natural variability (Litvak et al., 2005): the former is due to incorrect behaviors of professionals, farraginous internal procedures, inefficiencies in service scheduling, and bottlenecks that are potentially controllable through managerial interventions; the latter is due to exogenous factors (epidemiology, innovations, etc.) and to patient flows that are uncontrollable by the organization (e.g., the emergency department demand) but operations managers can at least forecast these flows through the analysis of historical series of data. According to Langabeer (2008), managing the variability allows an optimization in staffing mix and scheduling to accommodate the changes, without staffing at the peaks (which causes excessive costs), staffing for the valleys or low points (which will cause long lines periodically due to limited resources and therefore service quality issues), or staffing for the average (which is the most common suboptimal approach). Moreover, improving flows means seeking higher throughput (i.e. the rate Marta Marsilio and Anna Prenestini

or velocity at which services are performed or goods are delivered) or yields for the same level of inputs. The role of operations managers is to facilitate improved logistics and throughput by using streamlined process and facility designs to increase capacity, workflow, and throughput (Langabeer, 2008). The third goal is to improve productivity because it is vital for the sustainability of the healthcare organization. This is due to both the reimbursement methods (for example, using DRG systems and fee for service) and, more recently, to the need to retrieve the health services in post-Covid period. Productivity is defined as the ratio of outputs to inputs. One of the most important roles of an operations manager is to improve productivity thanks to an optimization of the healthcare inputs and processes, searching for higher levels of output from all professionals and other assets. The fourth goal is to improve quality for the patients. Healthcare cannot become so focused on cost and efficiency without an adequate attention on quality. Improved quality implies reduced medical errors, improved patient safety, and also higher levels of patient satisfaction. Ensuring that services continue to improve patient satisfaction levels, and simultaneously reduce response and waiting times, are key deliverables to providing higher quality services (Langabeer, 2008). Therefore, maintenance and improvement of high quality and service levels are expected from an operations manager, who has the aim of balancing the trade-offs between quality and costs. The fifth goal is to improve continuously business processes. In healthcare organizations processes tend to be not highly cross-functional or integrated, creating multiple efficiency problems. The role of an operations manager is to find ways to carry out processes, on the one hand, improving efficiency and effectiveness, on the other, introducing innovations. Different approaches and tools can sustain the operations managers’ role and goals. Quantitative management implies a heavy use of analytical and optimization tools such as (McLaughlin & Hays, 2008): data collection, presentation, and analysis; probability and probability distributions; and mathematical tools for data analysis including hypothesis testing, analysis of variance and variability, and regression; analytical tools such as

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optimization using linear programming and decision analysis. Some qualitative methods considered are (McLaughlin & Hays, 2008): mapping techniques, including mind mapping, process mapping, activity mapping, and service blueprinting; problem identification tools, including root-cause analysis (RCA), failure mode and effects analysis (FMEA), and the theory of constraints (TOC); force field analysis to address implementation issues. Moreover, operations managers’ techniques require an extensive use of process and quality improvement techniques to drive the most efficient and optimal methods to support patient care delivery, including basic process improvement tools, quality programs (e.g., total quality management), and those derived from Lean Management philosophy (e.g., six sigma, waste analysis, value stream mapping). The advance of operations management and patient flow logistics in healthcare organizations will continue following the need to tackle the issues of continuous improvement of the processes, increase in efficiency and productivity, and the other challenges posed by the reshaping of healthcare systems due to COVID-19 pandemic. Therefore, in the next few years there will be a continuous rise of

the healthcare organizations’ demand of new operations manager positions at every level (COO, but also bed and discharge managers, waiting lists managers, operating rooms managers, etc.). Marta Marsilio and Anna Prenestini

References

Bensa, G., Prenestini, A., & Villa, S. (2008) La logistica del paziente in ospedale: aspetti concettuali, strumenti di analisi e leve di cambiamento, in Anessi Pessina E., Cantù E. (Eds), L’aziendalizzazione della sanità in Italia. Rapporto OASI 2008. Milano: Egea, 327‒364. Langabeer, J. R. (2008) Health care operations management: a quantitative approach to business and logistics. Sudbury, (MA): Jones & Bartlett Learning. Litvak, E., Buerhaus, P. I., Davidoff, F., Long, M. C., McManus, M. L., & Berwick, D. M. (2005) Managing unnecessary variability in patient demand to reduce nursing stress and improve patient safety. The Joint Commission Journal on Quality and Patient Safety, 31(6), 330‒338. McLaughlin, D. B., & Hays, J. M. (2008) Healthcare operations management. Chicago (IL): Health Administration Press. Vissers, J., & Beech, R. (2004) Health operations management. London: Routledge.

Marta Marsilio and Anna Prenestini

81. Pharmacist Definition

The Pharmacist is the health professional expert in drugs, who can work in hospital and local healthcare facilities, community pharmacies, industries, intermediate distribution, university schools, and institutions. The pharmacist has a master’s degree in pharmacy and is registered with the competent authority of each country. The National Health Service (NHS) pharmacist works in health facilities, after having obtained post-graduate specialization in hospital pharmacy or an equivalent discipline (mandatory in some countries). In order to assist patients increasingly subject to complex advanced therapeutic regimens, it is necessary for the pharmacist to be constantly updated, after their university specialization, through continuous training. It is necessary for all pharmacists to undertake constant professional development, through continuous training.

Rationale

The pharmacist works in compliance with the expectations of the various stakeholders involved in the care pathways, first of all the patient, in an essential pharmacist–drug combination. Pharmacists at the Departments of Ministry of Health work in the areas of planning, prevention, food management, international relations, research, epidemiology, in the technical area of placing health products on the market and post-marketing surveillance. The NHS pharmacist is responsible for managing the quality and safety of drugs and for providing the best treatment for each patient who passes through the different care settings within the health system. The attention of the NHS pharmacist and the consequent interventions are increasingly oriented to the problems that affect the specific individual patient and specific individual drug therapy (appropriateness, compatibility, interaction, off-label use, pharmacovigilance, medical device supervision, etc.), with attention for the sustainability of the economic budget of each context. In some countries (e.g. Italy), the NHS pharmacist is also responsible for the correct management of medical devices and this

is of paramount importance today because the research acknowledges pharmacists have an increasingly important role in the treatment path for diagnosis, prevention, control, therapy or alleviation of a disease. Furthermore, the Italian NHS pharmacist also operates in the Territorial Pharmaceutical Services of the Local/Provincial Health Authorities (so-called “territorial pharmacist”, a role that, to our knowledge, is exclusive to the Italian NHS), carrying out these activities in the territorial assistance setting with the dispensing of specialist drugs prescribed by hospital doctors but not refundable to community pharmacies (“H drugs”) both by monitoring the appropriateness of drug prescriptions that are taken at the patient’s home, and also by inspecting and supervising the disengagement of pharmaceutical services by community pharmacies and intermediate distribution. The community pharmacist supports the general practitioner from therapeutic recognition to control over adherence, to galenic activity, to counseling, to pharmacovigilance aspects, to the promotion of screening.

Goals

The main purpose of the pharmacist is to ensure that the quality standards of the provided care are as high as possible with the resources available for the NHS, through: ● Organizational and logistic activity. ● Sterile and non-sterile galenic production and unit dose preparation. ● Clinical activity (Commissions, Reconciliation, Stewardship). ● Quality and risk management. ● Supervision of other departments and services. ● Training and research. The NHS pharmacist is placed as a strategic function between the clinical needs and opportunities of healthcare professionals in patient care and the constraints of contextual resources, regulatory and legal practitioners, priorities of top management. This entails the need for an ever-greater knowledge of the pathologies, clinical protocols and care pathways and processes and the need for continuous updating on new technologies, in relation to the standard operating conditions of specific context and the knowl-

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edge of the principles of correct resources management. The NHS pharmacist is confirmed as a key function of top management in supporting economic governance through: ● Management of support logistics; ● Collaboration in planning and control through the analysis and monitoring of pharmaceutical data; ● Collaboration in the acquisition and use of newly introduced healthcare assets, according to the Health Technology Assessment methodology and cost effectiveness profiles.

History

There are two disciplines in the history of pharmacy: one linked to the history of science and the other linked to economic-social history (Gli albori delle arti sanitarie, 2018). The first acts of a medical and pharmaceutical nature date back to 100 bc. The year 5000 bc is a historical moment in which civilization takes shape, a protohistoric period that gives attention to social organization, a fundamental intent in human progress. The health practices of this period, as regards the clinic and diagnosis, are essentially theurgic because the conviction of the direct relationship between disease and the will of the gods is strengthening, a concept that in popular culture will remain intact until the 18th century, when the Enlightenment proposes a new analysis all over the world and demanded rigor, method, and reproducibility of the experiment in science. The Egyptian civilization (3500 bc) was decisive in the history of pharmacy and pharmaceutical science. In 1873, the German Giorgio Ebers bought a papyrus (1550 bc) from an antiquarian in Thebes that today bears his name, it was immediately considered an admirable document for its historical and scientific content and is rightly called the first Pharmacopoeia. Later, with Aesculapius, a divinity (third century bc), the art of health is transformed from an elitist discipline, source of power, into a social service, which society can access: Greco-Roman medicine was born. In the temple-hospital of Aesculapius, real hospital pharmacies worked with the first pharmacists: the Rhizotomoi. Over the centuries, the symbol of the sanitary arts is the staff

of Aesculapius, the emblem of command with the snake, the symbol of the Pharmacon. Hippocrates, considered the father of scientific medicine, revisited the medical and pharmaceutical art by introducing the Hippocratic method: anamnesis, diagnosis, therapy, prognosis, which has remained unchanged since then. Pharmaceutical science became a specialty. Almost contemporary with Hippocrates, it was Theophrastus, philosopher, botanist and pharmacist, moral heir of Aristotle, who wrote a treatise in ten books on 500 plants, the ninth one entirely dedicated to medicinal drugs. With the foundation of Alexandria, medicine and pharmacy had a particular increase in attention. Famous were the philosophical and specialist medical schools in which Galen was also trained. A cultural movement was established which was given the term Hellenism, and from this great “School”, Hippocratic medicine and pharmacy grew and spread, merging pharmaceutical and philosophical knowledge into Alchemy, which while failing in some of its ambitions, greatly contributed to the progress of science and morality. After the third century bc, Rome looked at Greek culture and Alexandria with admiration. Although the two professions: medicine and pharmaceuticals, in fact operated with distinct activities, we must admit that the entire “health” sector was made disordered: by self-styled doctors, by doctors who prepared the medicines themselves to be dispensed to their own patients, from barbers, mothers, herbalists, magicians. Although many “authorities” had been legislating for a long time for a reorganization of the sector, in order to have true recognition and protection de jure, we had to wait until 1231 with Federico Imperatore and the Liber Augustalis which imposed rules of conduct for doctors and pharmacists. In the Middle Ages the aromatic monks treated the sick in hospitable convents, and in the Renaissance the apothecaries of the hospitals prepared the medicines prescribed by the doctor to administer them personally to the sick. The Hippocratic medical thought and its “Cookbook” (which was later called Pharmacopoeia) in fact remained unchanged.

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It began to crack when Galileo Galilei with his “Method” imposed the repeatability of the reaction or of any other scientific assertion; Descartes’ rationalism echoed him. After the Enlightenment, in the 19th century modern science moved towards the future; in the very first years of the century the pharmacist Sertuner discovered Morphine: divinum est sedare painm!

Main activities, tools Clinical activity ● Ward Pharmacist – prescription support, drug interaction control, potential toxicity, legislative aspects, appropriateness and sustainability of treatment. In some countries prescription of therapies. ● Pharmacological recognition for the purposes of therapeutic reconciliation in entry/transfer/exit from the different care settings. ● Antimicrobial stewardship. ● Direct distribution of drugs and medical devices to the patient. ● Patient counseling by verifying the patient’s adherence to the therapeutic plan. Education in the use of medical devices and drugs and training on the communication of adverse events associated with drugs. ● Vigilance drug and surveillance device according to legislation. Quality and risk management ● Pharmacoepidemiological and pharmaco-economic analyses of prescriptions. ● Monitoring of prescriptions (analysis of adherence to guidelines or pathways, appropriateness and feedback to clinicians). ● Monitoring of compliance with procedures related to the use of drugs and medical devices (Audit). ● Training on the issues of quality and safety in the use of the drug (and in Italy also of DMs). ● Assessment and monitoring of the risk associated with the use of the drug and medical devices. ● Training on quality and safety issues in pharmacy internal processes.

● Risk assessment and monitoring of internal pharmacy processes. Supervisory functions (Italy) ● Investigation and authorization of community pharmacies opening, drug and medical gas deposits. ● Management of the register of pharmacists operating in community pharmacies, issuing of certificates. ● Fulfillments relating to the destruction of drugs. ● Inspection activities at community pharmacies, depositories and wholesalers, the operating units of the healthcare company, accredited healthcare facilities, hospital pharmacies. Production ● Preparation and dispensing of sterile and non-sterile galenics: traditional galenics, oncology, radiopharmacy, parenteral nutrition, pain therapy, antibiotics, preparation of operating room kits, unit dose. Organizational-logistic function ● Organization of the warehouse cycle. ● Preparation and implementation of procedures for the management of health products. ● Procurement of drugs and medical devices. ● Drafting of the technical specifications for the purchase of drugs and DM. Training ● University training, pre- and post-graduate according to welfare requirements and training objectives. ● Training and information for health personnel. Clinical trial ● Collaboration in national and international clinical trials. ● In compliance with good clinical trial practices (GCP), logistics and/or preparation of the drugs used in the trial, blind management.

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● Support activities for the clinical trial process, from the authorization phase to the conclusion of the trial. Management ● Monitoring and analysis of pharmaceutical data for business planning purposes. ● Support to the budget process. Clinical/organizational multidisciplinary activities Participation in multidisciplinary commissions for example: ● ● ● ● ● ● ● ● ● ● ●

Prescriptive Appropriateness Commission Supervisory Commission Commission For The Handbook HTA Commission Rare Diseases Commission Hospital Infection Fees Commission Good Use Of Blood Ethics Committee Clinical Risk Management Committee Budget Commission Management Board.

Examples of the pharmacist’s innovative activity and clinical risk management are: ● bedside prescribing systems and unit dose distribution and controlled administration; ● monitoring systems such as pathology records; ● IT systems for the direct distribution of drugs and adherence monitoring; ● IT system for prescribing oncological therapies and robotic activities for preparing therapies in biological safety cabinets, and enclosed laboratory workspaces. No less important is the evaluation of the use of the medical device with the intended use and traceability of the device up to the patient, in particular those with high costs and high technology.

Future developments

In view of the challenges posed by an aging population, increased chronic conditions and increased volumes of healthcare expenditure, it is of the utmost importance that pharma-

cists continue to work towards appropriateness of care with optimization of resources, throughout the care pathway. Over the years and especially in this period of pandemic, the pharmacist has been able to adapt to new contexts, to work in interdisciplinary collaboration, thanks to its specific skills and competences in new scientific management and technical fields. Pharmacist is confirmed today as a profession with significant added value, in the scientific and management fields. It is also essential to consolidate the multidisciplinary collaboration (Institutional Pharmacist, Hospital and Territorial NHS Pharmacist, Community Pharmacist) for the management of patient care, without interruption between the different care settings. International studies have observed that the time of discharge is critical with regard to the availability of care, with the possible risk of harm to the patient and readmission to hospital. The internationally tested model of care for the delivery of drugs at hospital discharge has shown all the added value to be enhanced with adequate resources in all contexts. Furthermore, it is mandatory to introduce and consolidate in NHS, the figure of the Clinical Pharmacist of the Department and of the single Operational Unit, following the example of many other countries. The Pharmacist training and professional skills is necessary, to guarantee the quality and sustainability of therapies. For the community pharmacist, it is necessary to consolidate counseling and pharmacy services like home assistance, health education and prevention campaigns, carrying out first-instance analyses and instrumental self-monitoring into the pharmacy (ECG, etc.), towards implementation with Telemedicine. Maria Grazia Cattaneo, Sabrina Beltramini, Susanna Ciampalini, Domenica Costantino, Maria Cristina Galizia and Piera Polidori

Bibliography

EAHP Position Paper on hospital pharmacy specialization making a difference in medication

Maria Grazia Cattaneo, Sabrina Beltramini, Susanna Ciampalini et al.

232  Elgar encyclopedia of healthcare management by advancing the hospital pharmacy profession, 2021. European Statement on Hospital Pharmacy, European Association of Hospital Pharmacists (EAHP), 2014. FarmaPer Project https://​www​.sdabocconi​.it/​ en/​sda​-bocconi​-insight/​research​-updates/​

healthcare/​new​-challenges​-for​-pharmacists​-in​ -the​-italian​-nhs, 2021. Gli albori delle arti sanitarie, Gabriele Rampino and Gian Carlo Signore, 2018. Rapporto di ricerca – Osservatorio le nuove frontiere della professione del farmacista. La figura del farmacista: prospettive, Bocconi-FOFI, 2010.

Maria Grazia Cattaneo, Sabrina Beltramini, Susanna Ciampalini et al.

82. Quality and risk manager Human error is inevitable. We can never eliminate it. We can eliminate problems in the system that make it more likely to happen. (Liam Donaldson, World Health Organization)

Background

Risk management in organizations and enterprises originates in the United States between 1955 and 1960, having the main purpose of reducing insurance costs. Risk management can be defined as the process aimed to safeguard the enterprises’ assets against any losses occurring during the completion of their main activities, by the forecasting and evaluation of risks and the identification of procedures to avoid or minimize their impact, in the best cost–benefit scenario. The objectives of risk management can be summarized as follows: ● To create value within the organization; ● To promote the image and safety of the organization; ● To manage processes undergoing services and/or produce supply; ● To ensure business continuity; ● To contain costs related to risks and their impact on the organization (both insurance and recovery related).

Clinical risk management

Risk in healthcare organizations such as hospitals, private clinics and residential care structures is defined as the probability of a patient being victim of an adverse event, undergoing any “damage or discomfort attributable to medical practice, whether or not it is accidentally provoked, which causes a hospitalization prolongation, a worsening in health condition or even death” (Khon, Institute of Medicine, 2000). Healthcare risk management is therefore aimed to enhance patient safety, improve quality care and promote trust towards the healthcare system, besides ensuring all the previously listed objectives. Clinical Risk Management culture must be shared within the organization through the presence of a structured monitoring and train-

ing system involving all the interested healthcare operators. The role of a hospital Risk Manager is therefore to periodically evaluate risks, actuate mitigation processes and ensure a widespread knowledge of instructions and procedures aimed to reduce the happening and effects of adverse events. An effective Clinical Risk Management system should include the monitoring of claims, incidents (including near-misses) and any other event that could cause losses during the healthcare processes due to medical malpractice or organizational failures. Through the identification of risk areas (such as hospital departments, activities or procedures), Risk Managers are able to define and implement corrective proceedings and evaluate their effects in risk reduction. Considering the main objectives of the Risk Management process, the knowledge, evaluation and mitigation of risks are useful for: ● The healthcare system, increasing trust among the citizens and promoting welfare; ● The healthcare organizations, positively affecting hospitals’ reputations, promoting safety within the facilities and creating networks between them in order to spread risk management culture and share the best practices; ● The Risk Management, providing safeguard for itself, the human resources and the organization’s assets; ● The operators, promoting a safe workplace; ● The patients, enhancing quality and safety of care.

Main theories about risk management The black swan – Nassim Nicholas Taleb, 2007 The black swan is an unpredictable event that differs from what can be normally expected out of a situation and has potentially severe consequences. The human mind tends to expect from the future a repetition of usual events, excluding the possibility of something unexpected to happen. So how can an enterprise be prepared for the black swan and avoid collapsing afore the occurring of adverse events?

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The black swan theory applies to healthcare organizations through the need of: ● Monitoring their processes in a coherent, integrated and continuative risk management system; ● Improving the knowledge of the main risk-exposed areas, setting in the most suitable actions to reduce the identified risks and evaluating their effects during time; ● Proactively operating on the evaluation, prevention and mitigation of risks. We cannot truly plan, because we do not understand the future – but this is not necessarily bad news. We could plan while bearing in mind such limitations. (Taleb, 2007)

System failure approach – James T. Reason, 1990 Adverse and even catastrophic events can occur in complex organizations due to system failures. The most widespread representation of this theory is the “Swiss cheese” model by James T. Reason, who hypothesizes that most accidents are caused by either active failures (such as human error) or latent conditions. The layers represent the protections of the system, while the holes are lack of controls in the organization and/or human errors. For healthcare organizations, this theory means the need of: ● Systematically monitoring the processes; ● Identifying the generating factors of adverse events by including them in an integrated system of interconnected elements; ● Verifying the effectiveness of mitigation, prevention and control procedures; ● Adopting a system-centered approach, avoiding the single one’s behaviors. It is simply not possible to order in a package of Error Management measures, implement them and then expect them to work without further attention. You cannot put them in place and then tick them off as another job completed. In an important sense, the process – the continuous striving toward system reform – is the product. (Reason, 1990, chapter 8)

Risk management process

As previously stated, Risk Management in healthcare organizations is a complex unit Francesca Montesi Righetti

of actions and processes aimed to identify risks, improve mitigation procedures and evaluate their effectiveness, besides spreading risk management culture throughout the organization. This process can be divided into five main phases: ● Context analysis: the recognition of governmental and local regulations, recommendations, best practices, and guidelines that either regulate general practices in the healthcare system or are referred to specific areas (e.g. oncological, maternal and infant care, …), activities (e.g. surgery, medical practice, …) or topics (e.g. prevention of healthcare associated infections, surgical safety checklists, …). Context analysis should also consider any contingent situation that may imply the development of new regulations and/ or guidelines or provoke changes in the healthcare system (e.g. the sanitary emergency by COVID-19); ● Identification of risks: the classification of adverse events and the identification of any possible source of risk that can be controlled by the risk management system; ● Evaluation of risks: the estimation of frequency and impact of any identified risk, aimed to prioritize the interventions; ● Risk mitigation: the implementation of prevention and control measures, which variates depending on the main risk that needs to be treated and can be carried out by specific risk analysis (claims analysis, economical risk analysis, incident reporting system analysis, …), targeted training for healthcare operators, audits on procedures and clinical documentation; ● Monitoring and evaluation: the recurrent verification of efficacy on the implemented measures.

Future scenarios

In order to be effective, the process of Risk Management must be carried out through an integrated system involving the whole organization. Even in the healthcare sector it is important to observe the organization as a unit, so to consider not only the clinical risk – which remains central with the main objectives of guaranteeing patient safety and quality care – but also any other risk concern-

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ing the hospitals and healthcare facilities, like structural and organizational risks. An integrated approach to Risk Management, as shown by the Enterprise Risk Management method, allows to enhance patients’ and operators’ safety and also ensure business continuity, which is primary in the healthcare system. Also, emerging risks like pandemics and cyber risks must be contemplated inside the Healthcare Risk Management System, promoting a 360° approach to safety. Francesca Montesi Righetti

Bibliography

Institute of Medicine (US) Committee on Quality of Health Care in America, Kohn, L. T., Corrigan, J. M., & Donaldson, M. S. (Eds.) (2000). To Err is Human: Building a Safer Health System. National Academies Press (US). Reason, J. (1990) Human Error. Cambridge University Press, Cambridge. https://​doi​.org/​10​ .1017/​CBO9781139062367 Taleb, Nassim Nicholas (2007). The Black Swan: The Impact of the Highly Improbable. Chapter 1. The New York Times. https://​www​.nytimes​ .com/​2007/​04/​22/​books/​chapters/​0422​-1st​-tale​ .html Urciuoli, V., & Crenca, G. (1989). Risk Management: Strategie E Processi Decisionali Nella Gestione Dei Rischi Puri D’impresa. Rovereto. ISBA.

Francesca Montesi Righetti

PART XV TOOLS SYSTEM AND PROCESS: DISEASE MANAGEMENT Integrated management is defined, in the clinical context, as the organizational, proactive and multifactorial approach to healthcare provided to all members of a population affected by a specific pathology. The assistance is focused and integrated on the various aspects of the disease and related complications, the prevention of co-morbid conditions and relevant aspects of the delivery system. Disease management allows to reduce healthcare costs and improve the quality of life for individuals with chronic conditions by preventing or minimizing the effects of the disease through integrated care. Disease management programmes are designed to improve the health of patients with chronic conditions and reduce associated costs from avoidable complications by identifying and treating chronic conditions more quickly and more effectively, thus slowing the progression of those diseases.

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83. Clinical governance Clinical governance is a systematic approach to maintain and improve the quality of clinical patient care at all levels of healthcare provision within the National Health Service (NHS). Although clinical governance can be viewed generally as positive and developmental, it will also be seen as a way of addressing concerns about the quality of healthcare. Some changes in healthcare organizations have been prompted by failings of such seriousness that they have resulted in major inquiries. In fact, clinical governance became significant after the Bristol heart scandal occurred in England in 1995, during which an anesthetist, Dr Stephen Bolsin, exposed the high mortality rate for pediatric cardiac surgery at the Bristol Royal Infirmary. An inquiry found out that pediatric cardiac surgery services at Bristol were not up to the task, because of shortages of key surgeons and nurses, and a lack of leadership, accountability, and teamwork. After this dramatic event, the concept of clinical governance was elaborated and was first introduced to the UK National Health Service in the White Paper published in 1997 (Department of Health). Clinical governance has been described as the “linchpin” of the quality reforms and, since 1999 it is one of the statutory duties placed on NHS Trust Boards. Its most widely cited formal definition describes clinical governance as “a framework through which NHS organizations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish” (Scally and Donaldson, 1998). This definition highlights the need for an integrated approach, and it implies not only quality assurance but also a more dynamic aspect of quality continuous improvement. Beside the above-mentioned accredited definition, some writers have offered alternative interpretations and additional elucidations of the concept, describing clinical governance as “a systematic approach to assure the delivery of high-quality health services with the active participation of clinicians and patients supported by managers” (Winter, 1999), or “the action, the system or the manner of governing clinical affairs” (Garside, 1999), and also adding that

“a proper level of clinical governance in an organization requires that substantially the whole of clinical activity meets commonly accepted standards, where these exist, and can be shown as meeting them” (Scotland, 1998). Clinical governance applies to all areas of the NHS and, as part of an overall governance framework, it is explicitly linked to the concept of corporate governance, since it addresses those structures, systems and processes that assure the quality, accountability and proper management of an organization’s operation and delivery of service. However clinical governance applies only to health and social care organizations, and only those aspects of such organizations that relate to the delivery of care to patients and their carers; it is not concerned with the other business processes of the organization except insofar as they affect the delivery of care. So, even though the concept of clinical governance is closely linked to that of corporate governance, it also incorporates a number of quality-specific components. The development of clinical governance is designed to consolidate, codify, and universalize often fragmented and far from clear policies and approaches, to create organizations in which the final accountability for clinical governance rests with the chief executive of the health organization – with regular reports to board meetings (equally as important as monthly financial reports) – and daily responsibility rests with a senior clinician. Clinical governance requires staff to work in partnerships, breaking down boundaries by providing integrated care within health and social care teams, and between practitioners and managers and between the NHS, patients and the public. The World Health Organization is helpful in exploring the idea of clinical governance. It divides quality into four aspects: professional performance (technical quality), resource use (efficiency), risk management (the risk of injury or illness associated with the service provided), and patients’ satisfaction with the service provided. All these aspects are strictly related to the constituent elements of which clinical governance is made of. These components are sometimes referred to as the “seven pillars of clinical governance”, namely clinical effectiveness and research, education and training, clinical audit, risk management, staff management,

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patient and public experience and involvement, and information and IT. One of the most important elements is clinical effectiveness, which is a measure of the extent to which a particular intervention works. Clinical effectiveness can be followed by adopting only evidence-based approaches while treating patients, adhering to national standards and guidelines, conducting research to develop a body of evidence, and if current practice is inadequate, developing new protocols or guidelines based on experience and evidence for upgrading the level of care provided to patients in future. Education and training entails providing an appropriate support to enable staff to be competent and to develop their skills, in order to continuously remain up to date. Different systems have emerged to support continuing professional development and some practitioners can become trained educators to support such approaches. In addition, some specialties have a requirement for considerable periods of postgraduate study before accreditation. Clinical audit is the review of clinical performance and the measurement of performance against agreed standards. It is a cyclical process of improving the quality of clinical care. Carrying out an audit involves identifying a particular area of interest or concern, researching a standard to compare it to, collecting and analyzing data, identifying shortcomings, implementing methods of change and, finally, re-auditing after a time period to close the loop and assess improvements. Risk management is another fundamental component of clinical governance, since providing healthcare implies many risks that need to be minimized as part of any quality assurance program. Risk management includes, for example, reporting of incidents, following protocols, and conducting risk assessments to identify and mitigate risks where possible. Staff management relates to the need for appropriate recruitment and management of staff, ensuring that underperformance is

Gaia Ratti

identified and addressed, encouraging staff retention by motivating and developing staff, and providing good working conditions. Patient and public experience and involvement allows us to assess the quality of services from a patient’s point of view and address any issues. Methods through which this is implemented include patient feedback questions, questionnaires, patient representatives on practice and hospital boards, and patient forums to discuss healthcare matters. Finally, information and IT ensure that patient data is accurate and up to date, that protection and confidentiality of patient data is respected, and that full and appropriate use of data is made to measure quality of outcomes and to develop services tailored to local needs. Gaia Ratti

Bibliography

Garside P. (1999). Clinical governance: making it happen. BMJ (Clinical research ed.), 318(7187):881A. https://​doi​.org/​10​.1136/​bmj​ .318​.7187​.881a Gray C. (2005). What is clinical governance? BMJ, 330:s254 doi:10.1136/bmj.330.7506.s254-b Latham LA. (2003). Clinical governance: a study of implementation; a study of change. Health Services Management Centre. University of Birmingham. Mangham G (2022). How to improve the 7 pillars of clinical governance. Convene. https://​www​ .azeusconvene​.co​.uk/​blog/​how​-to​-improve​-the​ -7​-pillars​-of​-clinical​-governance Scally G, Donaldson LJ. (1998). The NHS’s 50 anniversary. Clinical governance and the drive for quality improvement in the new NHS in England. BMJ, Jul 4;317(7150):61‒5. doi: 10.1136/bmj.317.7150.61. PMID: 9651278; PMCID: PMC1113460. Scotland A. (1998). Clinical governance in the new NHS: an agenda for personal and organisational development. Clinicians in Management, 7:138‒141. Wilson J. (1998). Clinical governance. British Journal of Nursing, 7(16):987–988. https://​doi​ .org/​10​.12968/​bjon​.1998​.7​.16​.5615 Winter M. (1999). Clinical governance – getting beyond a new management mantra? Healthcare Quality, 26‒29.

84. Guidelines and protocols in healthcare systems Clinical practice guidelines are defined as “statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options”, by the Institute of Medicine (IOM, 2011). They are produced by medical associations or governmental bodies, such as the United States Agency for Healthcare Research and Quality or local healthcare which either make their own or update and fix current guidelines to provide better medical advice. Insurers practicing utilization management also publish guidelines to avoid overprescription of examinations and tests, thus reducing costs and making these tests more available for the other patients. Clinical guidelines are developed through a specific procedure, following different steps. As an example, the NICE (National Institute for Health and Care Excellence) guideline-making process starts with creating a committee, made up of experts from the field of medicine the guideline is being made for. The topics are referred from organizations such as the National Health Service or Health and Social Care department. A draft scope is provided to organizations with an interest in the topic (known as stakeholders) to comment on, outlining the need for this guideline, areas covered or not and its intentions once published. Once the guideline is made, the evidence gets reviewed again by field experts and afterwards is sent as a draft for consultation to stakeholders, that assess equality issues. The results get sent back to the committee and once a consensus is reached, the guideline is signed off and published. Special computer software packages known as guideline execution engines have been developed to facilitate the use of medical guidelines in concert with an electronic medical record system. The Guideline Interchange Format (GLIF) is a computer representation format for clinical guidelines that can be used with such engines.

A useful clinical guideline has three key elements that are always present. The first is the explicit identification of the major decisions, relevant to patients, which need to be made, and the conceivable results of these decisions. Numerous experiences with patients involve multiple choices, so the key to creating usable guidelines is to distinguish the foremost critical ones. These choices and their results may regularly be troublesome to outline, and surprisingly little is known on how specialists really make choices. The second component of successful guidelines involves bringing together the significant, substantial proof that clinicians ought to make educated choices at each of the key decision points. This remains the foremost troublesome step as, in many, if not most clinical zones, the essential research evidence is insufficient, and methodologists proceed to battle with these problems. The increasing interest in evidence-based practice and guidelines has highlighted the huge gaps within the evidence, in spite of the fact that the potential to make evidence-based decisions may be greater than generally believed. The third basic component of a successful guideline is the introduction of evidence and proposals in a brief, open format. Doctors must be able to recover and assimilate data rapidly. In addition, data must be displayed in a flexible format that’s appropriate to patients or circumstances. As clinicians move into the computer age, the possibilities of more immediate access to the relevant evidence will increase. International uniform standards are now used worldwide for the assessment of clinical guidelines. Guideline recommendations are categorized by the Class of Recommendation (COR) and Level of Evidence (LOE). The COR reflects the magnitude of benefit over risk and corresponds to the strength of the recommendation. ● Class I recommendations are strong and indicate that the treatment, procedure, or intervention is useful and effective and should be performed or administered for most patients under most circumstances. ● Class II recommendations are weaker, denoting a lower degree of benefit in proportion to risk. Benefit is generally greater for Class IIa (moderate) recommendations and smaller for Class IIb (weak)

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recommendations, for which benefit only marginally exceeds risk. A COR of IIb suggests that implementation should be selective and based on careful consideration of individual patient factors and, for invasive procedures, available expertise. ● Class III is assigned when actions are specifically not recommended, either because studies have found no evidence of benefit or because the intervention causes harm. The LOE signifies the certainty in or certainty of the evidence supporting the proposal based on the type, size, quality, and consistency of pertinent research findings. Information from randomized controlled trials give a better LOE than do observational or other studies, but other contemplations apply to recommendations involving diagnostic testing, population-based interventions, or lifestyle modifications. ● High-quality, concordant evidence from more than one adequately powered randomized controlled trial, meta-analyses of high-quality trials, or randomized controlled trial data corroborated by high-quality registry or practice-based studies qualifies as LOE A. ● Moderate-quality or less convincing evidence based on one or more trials, meta-analyses of moderate-quality studies, or data derived exclusively from registries or other sources that have not been externally validated are assigned LOE B and are now further delineated according to whether the evidence derives from randomized (B-R) or nonrandomized studies (B-NR). ● LOE C – When firm scientific support for a recommendation is not available. ● C-LD – There is now a new subcategorization of lower-quality evidence, assigned either because data are limited (i.e., based on physiological preclinical studies, case reports, or studies with methodological deficiencies in design or execution) or because the recommendation is based on clinical experience and a consensus of expert opinion (C-EO). Guidelines as every other system, have benefits and limitations. The main goal of guidelines is to ameliorate the quality of care delivered to patients. They Alert Vukatana

have the potential to diminish side effects and mortality, improve quality of life and most importantly progress the consistency of care, making it more likely that patients will be cared for in the same way despite where or by whom they are being treated. Guidelines moreover take into consideration underrecognized health issues, clinical services, and preventive interventions. On healthcare professionals’ point of view, clinical guidelines can move forward the quality of clinical choices. They alarm clinicians to interventions unsupported by great science, strengthen the significance and strategies of basic examination, and call consideration to incapable, perilous, and inefficient practices. As for the healthcare system, clinical guidelines may be effective in improving efficiency (often by standardizing care) and optimizing value for money. Implementation of certain guidelines reduces outlays for hospitalization, prescription drugs, surgery, and other procedures. The most important limitation of guidelines is that the recommendations may be wrong (at least for individual patients). First, scientific evidence about what to recommend is often lacking, misleading, or misinterpreted. Only a small subset of what is done in medicine has been tested in appropriate, well-designed studies. Indeed, when the information is certain, suggestions for or against intercessions will include subjective judgments when the benefits are weighed against the harms. Second, proposals are impacted by the suppositions, clinical experience and composition of the guideline improvement committee. Tests and medications that specialists agree are great for patients may in practice be inferior to other alternatives, incapable, or indeed harmful. Third, patients’ needs may not be the only priority in making recommendations. Practices that are problematic from the patient’s point of view may be suggested to assist control costs, serve societal needs, or protect special interests (those of specialists, risk managers, or politicians, for example). The most noteworthy threat of flawed clinical guidelines is to patients. What is best for patients generally, as suggested in guidelines, may be inappropriate for individuals. Blanket recommendations, instead of a menu

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of choices or suggestions for shared decision making, disregard patients’ preferences. Every day, clinical decisions at the bedside, rules of operation at hospitals and clinics, and health spending by governments and insurers are being influenced by guidelines. Clinicians, policy makers, and payers see guidelines as a tool for making care more consistent and efficient and for closing the gap between what clinicians do and what scientific evidence supports. Alert Vukatana

Bibliography

Halperin JL. Further evolution of the ACC/ AHA clinical practice guideline recommen-

dation classification system. Circulation. 2015;3(14):1426–1428. InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006. What are clinical practice guidelines? 2016 Jun 15 [Updated 2016 Sep 8]. https://​www​.ncbi​.nlm​.nih​.gov/​books/​NBK​ 39​0308/​ Institute of Medicine (IOM). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. https://​doi​ .org/​10​.17226/​13058. Jackson R, Feder G. Guidelines for clinical guidelines. BMJ. 1998 Aug 15;317(7156):427‒8. doi: 10.1136/bmj.317.7156.427. PMID: 9703522; PMCID: PMC1113710. Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines. BMJ. 1999 Feb 20;318(7182):527‒30. doi: 10.1136/bmj.318.7182.527. PMID: 1002​ 4268; PMCID: PMC1114973.

Alert Vukatana

PART XVI INNOVATION MANAGEMENT Innovation management helps organizations grasp an opportunity and use it to create and introduce new ideas, processes, or products. Innovation is also a significant factor in the economic growth of an organization. One of the main issues regarding innovation management is the ability to govern the access to innovations and select what truly creates added value for the organization. Some of the most common and impactful processes and players are listed below, to help the healthcare manager to embrace innovation and let it become one of the main drivers of the organization’s development.

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85. Clinical trial Clinical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health. A protocol is outlined for each clinical trial; this is best defined as a “plan” for how the trial itself will be carried out. It lays out information concerning both the volunteer subjects and the researchers: ● what is the aim of the trial, i.e. what do researchers hope to discover through the course of the trial; ● which kind of patients should be selected to enter the study in the first place; ● which kind of procedures and/or tests will be performed; ● detailed schedules for each patient and their assigned tests/procedures; ● which drugs are to be administered, including information on intended drug dosage; ● for how long the study ought to be carried out. The protocol, once outlined, is made available to the volunteer hopefuls, who must agree to a series of terms and regulations before being allowed to participate in the trial. The health professionals, be they doctors, nurses, researchers, and other associated staff involved in the trial, sign similar documentation binding them to strict rules during the course of research. These rules exist based on the concept of informed consent of all participants, and are in place so as to guarantee a high standard of safety. The health authority overseeing these rules changes depending on country: in the US it’s the FDA, the MHRA in the UK, NMPA in China and so on. The aims of clinical trials are varied, with some examples being: ● evaluation of a given drug, procedure, or medical device’s safety and effectiveness, before its larger employment in the general population; ● refinement of standard current, already approved, treatment, so as to improve

the success rate and decrease potentially harmful side effects; ● testing pre-existing treatment in a previously untested population, such as pregnant people, children, or the elderly; this aims to ascertain safety and potentially expand coverage.

Who should consider clinical trials and why?

Participation in a clinical trial is sometimes offered as an option in patients for whom pre-existing approved treatment has proven either ineffective or for whom side-effects are intolerable. This compassionate participation has often proven of key importance in the study of cancer drugs. Within the protocol will be outlined what are termed eligibility criteria, which is information on who may be selected to enter the trial. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions. Eligibility criteria are not fixed, but rather are custom suited to the trial in question, and exist in direct relation to a trial’s stated aim. Therefore, not everyone who applies for a clinical trial will be accepted. It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. When performing a trial, it is of paramount importance to consider testing on the people most likely to benefit from a medical product’s use. Still, considerations should be taken towards ensuring that a trial is sufficiently diverse, to guarantee that the validity of the results extends beyond just the selected participants. Age, ethnicity, sex, level of fitness will show far greater variability in a real-world scenario, and trials are constructed to reflect that.

Phases of a clinical trial Phase 0 trials A phase 0 trial aims to find out if a drug behaves the way researchers expect it to from laboratory studies.

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Phase 0 studies usually only involve a small number of participants and utilize a very small dose of a drug. The dose of the drug is too small to treat, but also less likely to have side effects. Phase 0 trial aims may be: ● whether the drug reaches its target; ● a drug’s pharmacokinetics and pharmacodynamics. Phase 1 trials These are usually small trials, recruiting only a few patients. The trial may be open to patients on whom standard treatment has largely failed. Phase 1 aims: ● ● ● ●

quantify safe dosage of a drug; detail potential side effects; obtain drug’s metabolism data; assess efficacy (e.g. if treatment helps shrink the cancer).

These are often dose escalation studies. This means that the first cohort is given a very small dose of the drug. If all goes well, the next is given a slightly higher dose, and dosage is gradually increased with each group. Researchers monitor the side effects people have and how they feel, until they find optimal dosage. Phase 1 trials aim to find out about dosage and side effects, as such data is critical before testing the drug’s efficacy at large. Phase 2 trials It should be noted that many drugs do not make it to phase 2. Phase 2 aims: ● whether a drug’s efficacy deserves to be tested in a larger phase 3 trial; ● which conditions (e.g. cancers) the drug proves useful in treating; ● additional data on dosage and side-effects. Phase 2 trials are usually larger than phase 1. Sometimes in a phase 2 trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo).

Davide Salvadori

Phase 3 trials These trials compare new treatments with the best currently available treatment (the standard treatment). Phase 3 aims: ● which treatment is better in treating a given condition; ● how the treatment affects people’s quality of life. Standard treatment may be compared with: ● a completely new treatment; ● different doses of the same treatment; ● having the same treatment more, or less, often; ● a new way of administering a known treatment (radiotherapy for example). Phase 3 trials usually involve many more patients than phase 1 or 2. This is because differences in success rates may be small, thus, the trial needs many patients to be able to show the difference. Sometimes phase 3 trials involve thousands of people in many different hospitals and even different countries. Phase 4 trials These trials are done after a drug has been shown to work and has been licenced. Phase 4 aims: ● more about the side effects and safety of the drug; ● highlight long term risks and benefits; ● how well the drug works when it’s used more widely.

Randomization and blinding

Randomized controlled trials are widely recognized as the standard for unbiased assessment of the effects of different medical interventions. Randomization is the process by which units, which in healthcare are the patients in a clinical trial, are “randomly” assigned to receive one of the treatments under evaluation. Randomization is a key tool in an effectively run trial and is mainly used to reduce the bias in assigning patients to study treatment groups. Blinding is used in combination with randomization to control for expectation effects

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in clinical trials. It is a normal feature of most controlled clinical trials intended to be reported in a peer-reviewed journal. Blinding or masking is intended to limit the occurrence of conscious and unconscious bias in the conduct and interpretation of outcomes in a clinical trial. Such bias would arise from the influence of a knowledge of the treatment allocation of a subject and can have an effect on recruitment, allocation of subjects, their subsequent care, the attitudes of subjects to the treatments, the assessment of outcome measures, the handling of withdrawals, and the exclusion of data from analysis. The essential aim is to prevent identification of the treatments until all such opportunities for bias have passed.

Where can I find clinical trials?

● FDA Clinical Trials Search is a database of Federally and privately supported studies available through clinicaltrials.gov. Information about each trial’s purpose, who can participate, locations, and who to contact for more information (Clinicaltrials.gov). ● National Cancer Institute about clinical trials for people with cancer. ● https://​www​.ncbi​.nlm​.nih​.gov/​ and its library, PubMed, for studies of all kinds.

Bibliography

Bridgman, Stephen, Engebretsen, Lars, Dainty, Katie, Kirkley, Alexandra, Maffulli, Nicola. (2003). Practical aspects of randomization and blinding in randomized clinical trials. Arthroscopy: the journal of arthroscopic & related surgery: official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 19. 1000-6. 10.1016/j.arthro.2003.09.023. Chen, R., Desai, N. R., Ross, J. S., Zhang, W., Chau, K. H., Wayda, B. et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ 2016; 352 :i637 doi:10.1136/bmj.i637 Diversity in clinical trial participation. (2018). U.S. Food and Drugs Administration. https://​ www​.fda​.gov/​patients/​clinical​-trials​-what​ -patients​-need​-know/​diversity​-clinical​-trial​ -participation Phases of clinical trials. (2022). Cancer Research UK. https://​www​.cancerresearchuk​.org/​about​ -cancer/​find​-a​-clinical​-trial/​what​-clinical​-trials​ -are/​phases​-of​-clinical​-trials What are clinical trials and studies? (2020). www​ .nia​ National Institute of Aging. https://​ .nih​.gov/​health/​what​-are​-clinical​-trials​-and​ -studies What are clinical trials? (2014). U.S. Food and Drugs Administration. https://​www​.fda​.gov/​ patients/​clinical​-trials​-what​-patients​-need​ -know/​basics​-about​-clinical​-trials

Davide Salvadori

Davide Salvadori

86. Health technology assessment Healthcare spending around the world is growing, but so is the number of innovative drugs and therapies. Therefore, there is a need to guarantee high standards of care as well as access to innovation while maintaining the sustainability of the system. For this reason, health technology assessment (HTA) methodology was introduced, which can be defined as a multidisciplinary approach for the assessment of health technologies to support political decisions in health systems. The HTA analyzes the actual and/or potential effects of health technology a priori and during the entire life cycle, as well as the consequences that the introduction or exclusion of an intervention has for the health system, the economy and society. The scientific and political worlds are two very different worlds. HTA is a bridge between the scientific world and that of political decisions. HTA applies to all types of health technologies, where health technology is meant: ● ● ● ● ● ●

Medicines; Vaccines; Medical devices; Surgical interventions; Public health interventions; Clinical interventions.

One of the fundamental aspects of health technology assessment is networking and sharing information. For this reason, there are several networks of international HTA agencies. INAHTA (International Network of Agencies for Health Technology Assessment) is a non-profit organization founded in 1993, with the aim of providing a link to all national agencies that deal with HTA. The Emilia-Romagna Regional Health and Social Agency is among the members of the network which in 2016 had over 50 affiliates from over 30 countries in North America and Latin America, Europe, Africa, Asia, Australia and New Zealand. All associates are non-profit agencies and are linked to a regional or national government. INAHTA members feed a database maintained by the York Center for Review Dissemination, which contains records of completed or ongoing HTA reports. All the

publications of the regional health and social agency produced in recent years as part of the evaluation of medical devices can be found in this database. INAHTA includes organizations that provide HTA advice to governments and receive most of their funding from public sources. In early 2009, there were forty-six members from twenty-seven countries, including both national and regional agencies. Interaction with other organizations includes links to Health Technology Assessment International (HTAi), the European Union Network for Health Technology Assessment (EUnetHTA), PAHO (the Pan American Health Organization, and the World Health Organization (WHO). An important feature of INAHTA is the routine interaction of its members with public sector decision makers. Output from the network has included guidelines and frameworks on HTA, reports of surveys, and joint projects (Hailey, 2009). Founded in 1978, the Italian National Health Service (NHS) has been strongly regionalized mainly after a constitutional reform, which started a devolution process. HTA started in the 1980s at the National Institute of Health and in a few University Hospitals, with a focus on big ticket technology: that process was driven by clinical engineers. In recent years, HTA has become an important tool for decision-making processes at central, regional, and local levels. In particular, the National Agency for Regional Health Services (AGENAS) and five regions (of twenty-one) are strongly committed to develop HTA initiatives connected with the planning process. At the local level, the hospital-based HTA activity is probably the most important peculiarity of the country and the real driver of the HTA movement (Favaretti et al., 2009). The European network of Health Technology Assessment Agencies (EUnetHTA) was established in 2006 in response to the call from the European Commission and the Council of Europe which defined health technology assessment as a “political priority” and recognized the need to establish a European collaborative network. Since then, the activities of the network, which today brings together 81 Agencies from 29 Member States, have developed and consolidated through three Joint Actions:

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Joint Action 1 (2010‒2012) aimed at establishing and consolidating the HTA network, overcoming the barriers to cooperation through the definition of shared methodologies and the development of tools for the collaborative production of comparative evaluations of the efficacy and safety of health technologies. Joint Action 2 (2012‒2015) aimed at implementing the tools and methodologies developed in the Joint Action, through pilot projects for the evaluation of innovative drugs and medical devices and for sharing the information bases necessary for the evaluation with health technology developers. Joint Action 3 (2016‒2020) aimed at defining a permanent and sustainable model of technical and scientific collaboration about HTA, by increasing the production of evaluations, their re-use in national and regional evaluations and their use of the information produced within the decision-making processes. EUnetHTA has released the core model, which is a guideline for the drafting of the HTA report: ● ● ● ● ● ● ● ● ● ●

Current use of technology; Description and technical characteristics; Safety; Effectiveness; Accuracy; Economic evaluation; Ethical aspects; Organizational aspects; Social aspects; Legal aspects.

There are important differences regarding the health technology assessment for drugs and that for devices: ● The field of drugs is more ancient so more regulated, while the medical devices sector is more recent and still developing so less regulated; ● The stakeholder for the drug is the pharmacist who manages pharmaceutical expenditure, while the stakeholder for the medical device is the clinician who uses the device; ● The drug doesn’t require a learning curve while the medical device does and the experience in uses affects clinical efficacy;

● The device wears out and requires maintenance while the drug is always the same; ● The drug to be reimbursed by the healthcare system requires inclusion in the handbook while the device is reimbursed by the healthcare system through Diagnosis Related Group (DRG). Health technology assessment (HTA) has become the key health policy instrument for managing the introduction and use of new oncology drugs in Europe. While the methodology of technology assessment, including calculations of cost-effectiveness, is applicable in principle also to oncology, the implementation in practice has its specific problems and consequences. Most of them are linked to the specific need to do the assessment early in the development, with limited data on outcome in clinical practice. Technology assessments ask for estimates of gains in mean survival, whereas trials are powered to study differences in progression-free or overall median survival. The development of targeted therapies and personalized cancer medicine offers opportunities but also increases the complexity of the assessment. Joint assessment of a diagnostic and a new treatment increases the number of intervention strategies that must be considered, and thus the need for data. The translation from efficacy in trials to relative effectiveness in clinical practice must also be considered. The close link between pricing of new oncology drugs and their cost-effectiveness makes the use of technology assessment for policy decisions complicated for all stakeholders involved. But without an obvious alternative that is better, the likely future is that HTA will play an increasing role in informing policy decisions aimed at evidence-based cancer care (Jönsson, 2013). The diffusion of medical devices is expanding at an astonishing rate. The increasing number of novel patents per year suggests this growth will continue. In contrast to drugs, medical devices are intrinsically dependent on the environment in which they are used and how they are maintained. This created an unprecedented global need for well-trained biomedical engineers who can help healthcare systems to assess them. The International Federation for Medical and Biological Engineering (IFMBE) is the Claudia Bianchino

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global scientific society of biomedical engineers in official relations with the United Nations World Health Organization (WHO) and has been very active in promoting the role of the biomedical engineer in HTA. The IFMBE Health Technology Assessment Division (HTAD) is the IFMBE operative branch in this field, promoting studies, projects and activities to foster the growth of this specific and very important science sector, including summer schools, training material, an HTA eLearning platform, HTA guidelines, awards and more. Pecchia et al. (2019) describes the vision, the mission and the strategy of the HTAD, with a focus on the results achieved and the impact this is having on global policymaking. In order to accomplish this mission, the IFMBE HTAD defined an articulated plan, made of five strategic goals further structured in eleven priority projects, aiming to overcome fragmentation and avoiding working “in silos”: ● Establishing periodical training events on HTA for biomedical engineers; ● Developing and sharing free high-quality training material on HTA for biomedical engineers; ● Reinforcing collaboration on HTA among biomedical engineers and other HTA experts; ● Creating new spaces to facilitate BME publications on HTA; ● Preparing IFMBE recommendations and guidelines for HTA. The evaluation of a drug’s HTA is divided into the following phases: ● formulation of the clinical question and definition of the PICO; ● collection of evidence; ● conducting the evaluation of HTA; ● drafting of the HTA report; ● formulation of recommendations for the final decision maker. The term PICO is an acronym that stands for Population/Patient, Intervention, Comparison and Outcome. When it is further detailed, specifying the type of Studies that are considered, it is called the PICOS model. The PICO model immediately highlights the comparative approach typical of an HTA evaluation. In fact, a drug must be evaluated Claudia Bianchino

with reference to the therapeutic alternatives already available, in order to define the “place in therapy”. Attention must also be paid to the choice of outcomes; very often the decision is forced by the endpoints used in the pivotal studies of the drug. The evaluator, however, can always highlight and critically analyze any limitations of the outcomes (for example, surrogate and/or non-validated outcomes). It is also useful to immediately clarify the perspective of the analysis (national, local, structural) in order to define, for example, the costs to be taken into consideration (direct, indirect, social, only the costs for the structure). There are three kind of health technology assessment. The highest level, national and/ or regional (macro level), with the responsibility of defining health policies and the programming and planning acts to implement these policies; the intermediate company level (meso) with the responsibility of implementing the defined health policy objectives with managerial logic, criteria of appropriateness and in compliance with expenditure constraints; the micro (professional) level, on the other hand, with the responsibility of implementing the most effective and appropriate interventions to guarantee all citizens the right to health defined in health policies. The HTA, therefore, is not simply a set of methods and framework for the assessment of technology but it is true to a philosophy of government for their own healthcare system that aims to tie the decisions, which are systematically taken in a health system, the available scientific evidence or otherwise to “transparent” mechanisms in which all stakeholders can participate by making their own perspective. The experience of the last forty years in the application of HTA methods has not only allowed the improvement of techniques and assessment practices, but has gradually clarified the way to go so that science and politics can interact clearly, and are transparent and mutually respectful. Claudia Bianchino

Bibliography

Favaretti, C., Cicchetti, A., Guarrera, G., Marchetti, M., & Ricciardi, W. (2009). Health technology assessment in Italy. International journal of technology assessment in health

Health technology assessment  249 an official journal of the American Association care, 25 Suppl 1, 127–133. https://​doi​.org/​10​ for Cancer Research, 19(1), 6–11. https://​doi​ .1017/​S0266462309090539 .org/​10​.1158/​1078​-0432​.CCR​-12​-1819 Hailey D., (2009). Development of the International Network of Agencies for Health Pecchia, L., Pallikarakis, N., Magjarevic, R., & Iadanza, E. (2019). Health Technology Technology Assessment. International journal Assessment and Biomedical Engineering: of technology assessment in health care, 25 Global trends, gaps and opportunities. Medical Suppl 1, 24–27. https://​doi​.org/​10​.1017/​ engineering & physics, 72, 19–26. https://​doi​ S0266462309090370 .org/​10​.1016/​j​.medengphy​.2019​.08​.008 Jönsson B., (2013). Technology assessment for new oncology drugs. Clinical cancer research:

Claudia Bianchino

PART XVII OPERATIONS Operations management is the administration of business practices to create the highest level of efficiency possible within an organization. Operations management in healthcare includes the planning, management and control of the production areas where diagnosis, treatment and assistance are carried out with the aim of ensuring a safe, appropriate, timely and efficient flow of production factors (goods and patients). A good healthcare manager must implement operation management principles in their organization and use the tools listed below to optimize the patient and goods pathway.

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87. Electronic clinical records

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An electronic clinical record (or electronic health record, EHR) is the electronic collection of health-related information regarding a patient, authorized by clinicians and staff within a healthcare organization/network. These records are essentially an electronic version of a patient’s medical history which can be shared with other physicians within the EHR network. One of the key features of an EHR is that health information can be created and managed by authorized providers in a digital format capable of being shared with all clinicians involved in the patient’s care – such as laboratories, specialists, medical imaging facilities, pharmacies, and so on. So EHRs contain information from all clinicians involved in a patient’s care. EHRs can include a variety of administrative and clinical data, including demographics, medical history, diagnoses, medication and allergies, immunization status, laboratory test results, radiology reports, vital signs, personal statistics like age and weight, and billing information. An EHR also has the ability to support other care-related activities, including evidence-based decision support. Furthermore, these electronic records help track patient progress because it is easier to add on patient data over time. An EHR improves patient care and safety: ● There is a reduction in the incidence of medical error thanks to an improvement in the accuracy, clarity, and legibility of medical records. ● An electronic platform makes patient data readily available and accessible, more so than paper records. The time it takes to access information is quicker in an electronic system versus cumbersome paper records. Concrete examples of benefits include reduction in duplication of tests, administration of treatment regimens on time, etc. ● The clinician is able to work more efficiently and in an organized manner. Moreover, the EHR system allows coordination amongst different physicians the patient might be seeing. The effect of this

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eventually spills down to better provision of healthcare to the patient. EHRs allow for orderly follow-up thanks to the possibility of accessing and adding to patient data over his or her entire medical timeline at the clinic. Additionally, the EHR system can alert the clinician about any pending preventive health screenings, drug-drug interactions, drug contraindications, etc. EHRs can also support the clinician in making decisions, diagnoses, and deciding treatment plans through evidence-based guidelines. Therefore, an EHR is more than just a tool for recording medical data. Although there is an initial start-up cost of implementing an EHR system of storing data, the costs over time are relatively low. Paper records, on the other hand, require more personnel to manage and organize paper files. Comparatively, an electronic system requires less effort, manpower, and physical storage space. Storage of paper medical records requires plenty of physical space. Furthermore, paper records are less environmentally friendly and can also decay with time. Electronic records are comparatively easier to preserve and maintain. Many EHR systems include a patient portal that allows patients to view their medical history and information whenever they wish. A feature like this improves patient involvement and awareness. Additionally, it increases clinician transparency. EHRs may also allow electronic communication with the patient, other involved clinicians, etc.

EHRs can alert the clinician about pending preventive health screenings and tests. For example, if a patient is due for a mammogram, HbA1C test, and so on, the EHR system can alert the doctor. Furthermore, EHRs help in data mining (the process of analysing or extracting data from a database to identify patterns or relationships; a database is a collection of information organized in such a way that a computer program can quickly select desired pieces of data). Data mining an EHR database can be illustrated using the following example – looking up all diabetic patients who haven’t done an HbA1C test within the past year. The concept

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of data mining can also help in the field of population-based studies and research. ● The information in an EHR can be linked to public health systems such as registries and communicable disease databases. ● Regulated access to medical records improves patient confidentiality. Having mentioned the many positives, one must also keep in mind the possible negatives: ● The start-up cost of an EHR system might be quite high, especially for a small clinical establishment. ● There may be difficulty in reforming clinical processes, technical infrastructure, and human skills. ● There may be inefficiency due to lack of proper training, incorporation, and implementation. ● There may be data entry errors. ● There may be resistance to change. ● There may be a potential lack of data security and breach of privacy. ● It could create an overdependence on technology. Switching from paper records to EHRs will naturally cause a disruption and initial decrease in productivity, but it is important to encourage clinicians to embrace the new format and be less apprehensive. A secure and experienced hosting provider along with the proper security systems, hardware, and training can make the switch easier and improve workflow. Having said this, there will be some hurdles to a smooth transition, such as the need to convert several paper records into electronic ones, providing training to all staff, and so on. Both paper and electronic storage systems are susceptible to security concerns. With electronic records, there is the possibility of breach of safety. Data security is an issue because the records are vulnerable to access by unauthorized individuals. To combat this, strong security systems should be set up. Having said this, paper records can potentially be accessed via a break in. Furthermore, it is possible to lose records due to human error or natural disasters (fires, floods). Because many facilities keep just one copy of a paper record, the loss of a single record could mean that it’s gone for good. The cost of storing and maintaining paper records can itself be a financial burden. Anushka Shankar

What makes EHRs particularly useful is the easy accessibility. Often, for paper medical records to be shared with those who need them, they must be recovered from storage, then mailed or scanned and sent via email. This is evidently a time-consuming process. However, electronic medical records allow healthcare professionals to access information almost instantaneously. Therefore, thanks to EHRs, healthcare professionals receive the information they need rapidly, and patients are treated in a timelier manner. This eventually translates into a better and more efficient healthcare system where patients are taken care of without delay. Doing away with paper records also helps save space in the office for essentials like medical supplies and equipment. Paper medical records could be difficult to read if legibility (i.e., handwriting) is compromised, leading to medical errors. Legibility can be further affected by the fact that paper records often have insufficient space for healthcare professionals to write all the necessary information. Electronic records, on the other hand, reduce the error of hand-written notes since they are written with a standardized typeface. This leaves less room for confusion, misinterpretation, and compromise in the quality of patient care. Since it is quicker to fill in information electronically as opposed to writing, it might even mean that a clinician is able to see more patients in a day. An improved patient‒clinician relationship is an aim of public health that EHRs help achieve. Anushka Shankar

Bibliography

Flenady, Vicki (2021). Elements of professional care and support before, during and after pregnancy. The Continuous Textbook of Women’s Medicine Series – Obstetrics Module, Volume 3. London: Global Women’s Medicine. Gallagher Healthcare (2018). Advantages and disadvantages of electronic health records. Gallagher. https://​www​.​gallagherm​alpractice​ .com/​blog/​post/​advantages​-and​-disadvantages​ -of​-electronic​-health​-records Gunter, T.D., Terry, N.P. (2005). The emergence of national electronic health record architectures in the United States and Australia: models, costs, and questions. J Med Internet Res. 2005 Mar 14;7(1):e3. doi: 10.2196/jmir.7.1.e3. PMID: 15829475; PMCID: PMC1550638.

88. Patient flow logistics Patient flow logistics has to do with the management of patient physical paths/ routes within a healthcare delivery organization from the very first access, to the triage towards the most appropriate setting, until the very end phase of discharge and integration with post-acute care. The focus is the optimization of patient flows throughout all the different production units along the entire healthcare chain. In the case of a hospital, we can identify, at least, five different categories of production units: ● ● ● ● ●

operating rooms (ORs); emergency department (ED); ambulatories; wards; imaging departments.

A lack of control of patient flows leads to a negative impact on the hospital performance. The literature has identified three different factors that cause patient flow problems: 1. Capacity shortage when the resources available are not in balance with the demand for these resources; 2. Patient flow variability because the timing of allocation of resources may lead to peaks and troughs; 3. Lack of coordination that results in bottlenecks or under/over utilization.

Figure 88.1

In the case of healthcare production, it is important to make a distinction between: (i) natural variability linked to the nature of healthcare processes and (ii) artificial variability caused by dysfunctional processes and misbehaviors. These two types of variability require different strategies: the first cannot be eliminated but analyzed and optimally managed coherently with organizational mission and goals, on the contrary, the second should be identified and eliminated. As outlined in Figure 88.1, patient flow logistics needs to support the execution of primary clinical processes; in this sense clinical governance sets the demand of care – that should be appropriate and coherent with international guidelines – while patient flow logistics transforms this demand into efficient, timely and effective production processes. It is important to outline that, optimizing patient flow logistics makes sense as far as clinical decisions are appropriate and evidence based.

Logistical drivers and performance dimensions

To better manage patient flow, it is possible to act on four different drivers: 1. Capacity planning; 2. Lay-out and organization of spaces; 3. Design and organization of processes and activities; 4. Information and technological innovation.

Patient flow logistics in a hospital

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The first driver (capacity planning) refers both to strategic decisions about the capacity to set up (number of beds, operating rooms, etc.) and to tactical decisions on how to use this capacity. Since patient flow logistics means, in the end, moving patients across different spaces and settings the way physical space is structured and organized does matter. Literature (Villa 2012, 2021) provides different examples of structural changes in the organization of spaces that have helped to smooth patient flows, likewise:

of all hospital beds. Finally, big data and artificial intelligence might provide a valuable contribution in different areas such as (i) forecasting; (ii) strategical management of waiting lists and (iii) redesign of production processes around patients’ needs and characteristics. Finally, to support the development of clear and structured responsibilities around patient flow logistics, it is important to set up a standardized set of measures. In this regard it is important to focus on two broad categories of indicators:

● A centralized OR block helps efficiency (thanks to economies of scale) and productivity (thanks to a better scheduling process); ● The presence of a Recovery Room increases productivity and eases the pressure on the ICU (Intensive Care Unit), a typical bottleneck of the entire surgical process; ● A discharge room – a space where patients are moved after the discharge – eases patient flow management at ED that typically fights for lack of beds in the central hours of the day.

1. Efficiency and Productivity such as: ● Cancelled cases; ● Utilization rates of single production units (e.g., operating rooms); ● Average length of stay; ● Throughput time (overall time necessary to get a certain process done); ● Turn-over time at the OR. 2. Process Indicators such as: ● Waiting times; ● Delays; ● OR over-time; ● Variability of caseload; ● Inappropriate setting (due to shortage of beds); ● Flexibility (interpreted as the capacity of the system to react to unexpected changes in demand); ● Capability of dealing with emergency.

In the last years the third driver (organization of processes and activities) has been used as a way to move towards horizontal process-based organizations, with the final goal of going beyond the vertical specialty-based organization, which turned out to be inefficient and also less effective and patient-centered, due to a lack of coordination between the different organizational units involved along the full cycle of care. Innovations in this area have followed three main trends: 1. The patient-centered model; 2. The focused hospital model; 3. The lean thinking approach. The last and crucial driver (information and technological innovation) could offer interesting opportunities to improve the performance of patient flow logistics. One of the most relevant needs is to have real-time information about the status of every patient. Second, to better manage patient flow logistics, it is also important to control the status of every production unit. For example, modern hospitals have a real-time map of the status Stefano Villa and Rossella Pellegrino

Healthcare operations and production models

When we discuss the scope of activities of patient flow logistics, and more generally healthcare operations, it is important to avoid two errors: (i) confusing Operations Management (OM) with operations research which is a discipline that develops and tests mathematical and statistical models to support operational decisions and (ii) to confuse the OM function with the production model most popular in a specific historical period. We have seen, over the years, different production models which have influenced and, somehow, shaped the OM function for example the Ford model in the 19th century, later at the beginning of this century the Total Quality Management model and, nowadays the lean model or the focused factory system.

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The lean approach provides a series of effective and user friendly tools and models to optimize the healthcare operations. This strategy focuses on meeting customer needs and improving process by optimizing flows, reducing waste and creating values. The focused factory model is one of the elements of the broader value-based healthcare models (Porter, 2008) that sustains the necessity to redesign assets and operational models around clinical conditions such as diabetes or hip replacements. However, as far as it regards patient flow logistics, there is not a one-size-fits-all model better than others, but any operational model needs to be crafted around the specificities of each organization’s mission and structure that vary deeply according to the setting, context and type of hospital.

Conclusions

We conclude emphasizing that the importance of a better patient flow management is justified by several aspects. In particular: (i)

the need of improving quality and efficiency of care to keep up with a growing demand; (ii) the change in epidemiology with a growing share of elderly patients, with chronic conditions and co-morbidities that need, by definition, a more holistic and integrated approach.

Furthermore, the recent COVID 19 pandemic has dramatically outlined the drawbacks of the current fragmented and vertical organization of healthcare delivery organizations and calls for the immediate implementation of concepts and models inspired by Operations Management science such as (i) timelines and flexibility; (ii) multidisciplinary approach; (iii) capacity planning of hospital production units (e.g., Intensive Care Units); (iv) flow separation and (v) focused hospital. Stefano Villa and Rossella Pellegrino

Bibliography

Airoldi, G. (2020). Principles of management. EGEA. Bowersox, Donald J., and David J. Closs (1996). Logistical management: the integrated supply chain process. McGraw Hill. Porter, M. (2008). Value-based health care delivery. Annals of Surgery, 248(4). Villa, S. (2012). L’operations management a supporto del Sistema di operazioni aziendali. Modelli di analisi e soluzioni progettuali per il settore sanitario, Padova, Cedam. Villa, S. (2021). Operations management for healthcare organizations: theory, models and tools. Taylor & Francis. Villa, Stefano, Anna Prenestini, and Isabella Giusepi (2014). A framework to analyze hospital-wide patient flow logistics: evidence from an Italian comparative study. Health Policy, 115 (2): 196–205. Vissers, Beech, Jan Vissers, and Roger Beech (2005). Health operations management patient flow logistics in health care. Routledge.

Stefano Villa and Rossella Pellegrino

89. Patient management Patient treatment, or patient management, is a care approach that aims to shift the focus from the disease to the patient, that is, the sick person; for this to be possible, a good doctor–patient relationship is necessary. Some studies have shown that a good interaction between doctor and patient may be necessary through the outcome of a very long treatment, like a drug; moreover, patient-focused medical treatment is associated with greater efficiency of care, with a consequent reduction in the number of diagnostic tests performed and hospital admissions. The first step to be implemented in patient management is to establish a relationship with the patient; to do this, the doctor, in particular the general practitioner, must put themself in a position to apply active listening, encourage the patient to talk about themself and their problems, reassuring them in their concerns and providing explanations that are fully understandable by the patient. To put the patient at ease, for example, open-ended questions could be used, in which the patient feels free to talk and explain their problems to the doctor, in such a way that they have the feeling of being listened to and that they are therefore more inclined to be open. Precisely for these reasons, the patient management process begins with a series of consultations: these are the center of primary care, as they allow you to know the patient and their history and allow you to build a basis for follow-up; moreover, the counseling sessions can also be used to educate the patient about their own pathology and active participation, so that a shared decision-making process can be established. This first step becomes important especially in chronic patients, where it will be possible, from time to time, to set up an individual care plan (this type of approach is also the one used in Lombardy). Furthermore, during this phase, the doctor’s task is to obtain as much information as possible about the patient’s lifestyle, their pathologies, and their perception of disease. Once you have collected what, in medical jargon, is called the anamnesis, you can move on to formulating a diagnosis. The doctor can reach the diagnosis through various diagnostic procedures, which include, for example,

clinical examinations and laboratory tests, all correlated with the interpretation of the results. In the diagnosis process it is important that the patient is informed, and it is essential that there is always effective communication, so that both parties (doctor and patient) can fully understand the medical problem; only through good communication, the patient can no longer be “labeled” as a pathology or feel helpless in the face of complicated terms regarding their state of health. In patient management it is essential to provide the patient with complete and understandable information, so that the latter can contribute to their diagnostic and therapeutic path in an informed and conscious way. In the diagnostic process and in evaluating one treatment plan over another, in addition to the patient’s preferences, it is also important to consider their social resources: these provide additional clues for planning further treatments. The third step is the development of a therapeutic plan that is valid for both the doctor and the patient. As we know, for each disease we have different treatments; the purpose of the consultations is to put the patient in front of a conscious choice, considering the pros and cons of any treatments; furthermore, should the treatment options require the help of other experts, check if their support is truly available. Talking with the patient about the therapeutic path should include different dimensions of therapy, ranging from patient self-management to the choice of appropriate drugs and treatments; in many conditions of general medicine, for example, the patient’s self-management is required, such as changing a behavior or lifestyle. The client should see these changes not as a doctor’s advice, but as a goal that they really want to achieve; for this reason, it is important that the doctor helps the patient to create action plans for changing lifestyles that are as realistic as possible (for that particular patient), in order to avoid failure. Doctors, therefore, can help patients self-manage their (generally chronic) condition through effective communication and information during consultations. The fourth step consists in administering the therapies to the patient, but gradually, through what is called “individualized stepped care”. With this mechanism of action

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for patient care, simple, minimally invasive and inexpensive interventions are initially attempted; for patients who do not respond, subsequently, more intensive treatments will be made, based on the guidelines for the disease. This method of action is an advantage both for the patient, as no annoying or invasive interventions are made immediately, and for the system, as it allows better management of the limited professional resources. It is also important to remember that some patients may need the intervention of some specialists; consequently, another task of the general practitioner is to coordinate the patient’s specialized and preventive care, in such a way that the entire therapeutic and control process becomes simpler and more organized for the patient (especially in elderly subjects, who with the advent of technology often struggle even just to make an appointment for a visit).

This type of patient management should ensure continuous monitoring of the patient’s progress by the doctor (or manager) and greater compliance with the treatments and follow-ups of the patients who take part in them, as well as better patient satisfaction, with patients not only feeling listened to and assisted in the best way, but also participating in the therapeutic choices and being more aware of their own clinical condition. Lisa de Felice

Bibliography

Aderire al percorso di presa in carico dei pazienti cronici: cosa è utile sapere. (2022). Information sheet for citizens and families Regione Lombardia. https://​www​.regione​.lombardia​ .it/​wps/​portal/​istituzionale/​HP/​D​ettaglioRe​ dazionale/​servizi​-e​-informazioni/​cittadini/​ salute​-e​-prevenzione/​presa​-in​-carico​-delle​ -patologie​-croniche/​cosa​-e​-utile​-sapere/​cosa​-e​ -utile​-sapere

Lisa de Felice

90. Supply chain Definition and purpose

Supply chain is method of strategically managing flows of goods, services, finance, and knowledge from their origin as raw materials to the final consumer. It includes all activities related to manufacturing, the extraction of raw materials, processing, storing, and warehousing, and transportation. In case of healthcare, supply chain is series of processes, workforce involved across different teams and movement of medicines, surgical equipment, and other products as needed by healthcare professionals to perform their respective jobs. The aim of supply chain in healthcare is to find the vulnerabilities or weak areas among departments and propose measures to reduce them to achieve targeted health outcomes and increase investments in global health.

Benefits

The advantages of efficient supply chain in healthcare are improved processes, efficient utilization of resources, satisfied employees, effective treatment and happy patients. The supply chain ensures proper linkage of a hospital’s departments, operations and revenue cycle. It can be visualized as a back-end program, which is necessary to integrate all the different processes together. An implemented supply chain ensures availability of medicine/products at the right time, minimizing inventory wastage, maximizing patient care, coordination in all departments and minimizing human error/medication errors. This can be accomplished by using possible measures, that is, integrating subsystems streamlining workflows and use of RFID technologies, standard product codes and Global Identification Numbers (GIN). 1. What is RFID technology? Radiofrequency refers to a wireless system comprising of a tag and a reader. The tag stores information ranging from a serial number of a product to pages of information, and it uses radio-waves to communicate information to the reader. RFIDs can be used for inventory control, equipment tracking, out-of-bed detection and fall detection, personnel tracking, ensuring that patients receive the correct

medications and medical devices, preventing the distribution of counterfeit drugs and medical devices, monitoring patients and providing data for electronic medical records systems. 2. What is a Global Identification Number (GIN)? A Global Identification Number is a sub-​ category of GS-1 identification keys (others being global location number, global shipment number etc.). The GS1 standards provide a globally harmonized and integrated framework to manage supply chain information, making the healthcare value chain more efficient. This means all stakeholders can efficiently and effectively comply with various local and global requirements and achieve interoperability and compatibility within their organization, between organizations and across borders.

Unit processes to supply chain

If we examine how industrial operations, particularly manufacturing operations, have evolved, we can see that many efforts were motivated by a desire to understand and optimize individual unit processes. These efforts led to many innovations, among them the development of improved machine tools and fixtures and the optimization of interactions between workers and their environment. As the understanding of unit processes developed, larger and larger groupings of unit processes were considered. Understanding the interactions between these groups of unit processes helped in improving the performance of entire systems. Hence, from considering individual unit processes, we progressed to considering departments of factories that perform similar operations, entire manufacturing processes from raw materials to finished products, and eventually, the operations of entire firms, as well as their suppliers and customers. Understanding these vast systems help largely in cost reduction. Steadily extending the knowledge from unit processes to interactions among larger and larger groupings of these elements is directly applicable to healthcare delivery systems. The individual unit processes in this case include the processing of a patient in an emergency room, the process by which a medical insurance claim is approved, and the scheduling of hospital operating rooms to optimize

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their performance. The need for a better understanding of how the operations of individual elements affect each other is apparent; these interactions can be quite complex because of long time lags between cause and effect. For example, the decision by a regulatory agency to disallow a certain kind of preventive procedure for infants may result in the emergence of an unexpectedly large number of children with special needs in the elementary school system several years later. Thus, propositions can be taken from industrial supply chains to enhance the healthcare supply chain functioning.

Limitations of healthcare supply chain management and how to overcome them 1. Limitations: healthcare supply chain management is complex because each stakeholder has their own interests to protect. Different stages in the supply chain flow may be focused on their own goal. Providers may want to use a specific product because they were trained with it or a specific brand or type whereas hospital executives aim to purchase the most affordable quality items. Providers may prioritize their own preferences for certain products, while financial managers attempt to cut healthcare costs and reduce out-of-date products. Oftentimes, hospitals face hoarding or squirreling away of certain products by providers. Since supply chain goals are not always aligned within an organization, the healthcare supply chain management process can be inefficient and fragmented. Patients also have a voice in the healthcare supply chain management process. Healthcare organizations may be able to regularly order the correct size of gloves and keep them stocked but some patients may need more customized medical products such as latex-free options, depending on their healthcare status. Solutions: Some healthcare organizations have found success with supply chain management through cost transparency. By harnessing price and utilization data, healthcare organizations can track and manage inventories more efficiently and construct more informed purchasing contracts with manufacturers. Different

automated tools can help organizations increase price transparency, such as computerized provider order entry systems, which can streamline and standardize physicians’ orders, or radio frequency identification technology that can capture volumes of data from a product’s barcode. Getting all hospital departments on the same page is also a key strategy for optimizing supply chains. In the era of value-based care, healthcare organizations are focused on reducing redundancies and eliminating waste, but providers also need to work together to effectively reduce costs and boost performance. Engaging clinical staff can also help to establish cost-saving habits, discourage hoarding and empower providers to keep cost concerns in mind while delivering care. 2. Limitations: Healthcare delivery system is so large and complex that it has become impossible for any individual, or even any single organization, to understand all of the details of its operations. It consists of multiple independent agents, such as insurance companies, hospitals, doctors, employers, and regulatory agencies, whose economic structures, and hence objectives, differ and in many cases conflict with each other. Both supply and demand for services are uncertain in different ways, making it very difficult to match supply to demand. This task is complicated because demand for services is determined by both available technology (i.e., available treatments) and financial considerations, such as whether or not certain treatments are covered by insurance. Decisions made by one party often affect the options available to other parties, as well as the costs of these options, in ways that are not well understood. Solutions: Even though healthcare management is very complicated, the progress made in understanding and studying the progress made by industrial systems in the last several decades in optimizing their supply and demand can give some insights, and modeling tools developed in the industrial domain can be applied to at least some aspects of healthcare delivery systems. Shatakshi

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3. Limitations: As supplies move downstream towards hospitals and clinics, the quality and robustness of accompanying management and information systems used to manage these products deteriorates significantly. Technology that provides advanced planning, synchronization, and collaboration upstream at the large supply manufacturers and distributors is rarely used at even the world’s larger and more sophisticated hospitals. Solutions: Introducing the hospitals to new technology and advancements and explaining to them the importance of efficient healthcare supply chains and why they should invest in healthcare supply chain management and technology.

Why should hospitals invest in healthcare supply chain management?

Hospital supply chain leaders: nearly half of respondents still use a somewhat manual process such as Excel spreadsheets and other less sophisticated/outdated tools to manage inventories, supply expenses and other supply chain activities. It’s no wonder supply chain costs consistently rank near the top for hospitals and healthcare systems. Surveys show there is a potential for significant SCM cost savings for hospitals. An analysis by Navigant Consulting, for example (Boldt, 2020), estimates that hospitals could save an average of 17.7 percent or $11 million per hospital annually by streamlining and standardizing their supply chain processes. All of this means that investing in supply chain technology and managing supply chain costs should be a number one priority for healthcare and supply chain leaders, especially as they position themselves for the shift to value-based care and look for ways to further deliver top quality care for less. When selecting a supply chain automation system, hospitals must include the following: ● Communication: Integrates systems and manages hospital workflows and processes by sending and receiving files for both clinical and financial systems.

Shatakshi

● Ease-of-use: Enables managers, operators, and care providers to achieve efficient system operations and maintain the standardization of processes. ● Scalability: Includes consolidated management tools for both single and multiple site locations. ● Open, flexible design: Helps users achieve data integrity for the devices in use. ● Reporting and analytics: Generates accurate, real-time inventory reporting information from receiving to patient care. ● Supply chain methodologies: Includes PAR, Kanban, ROP/ROQ, EOQ/ROP, Min/Max and Consignment capabilities; utilizes sound processes and practices for specific department requirements related to supply chain demands. ● Superior service: Creates effective clinical and financial workflow design, defines implementation requirements, and provides support before, during, and after implementation. Shatakshi

Bibliography

Arora M., & Gigras Y. (2018). Importance of supply chain management in healthcare of Third World countries. International Journal of Supply and Operations Management, 5(1), 101‒106. doi: 10.22034/2018.1.7 Boldt K. (2020, February 5). Healthcare supply chain management technology: Why hospitals should invest. https://​www​.medsphere​.com/​ blog/​why​-invest​-in​-healthcare​-inventory​-and​ -scm/​ Langabeer J. (2005). The evolving role of supply chain management technology in healthcare. Journal of Healthcare Information Management, 19(2), 27–33. National Academy of Engineering (US) and Institute of Medicine (US) Committee on Engineering and the Health Care System (2005). Reid PP, Compton WD, Grossman JH, et al., editors. Building a Better Delivery System: A New Engineering/Health Care Partnership. Washington (DC): National Academies Press (US); Supply-Chain Management and Health Care Delivery: Pursuing a System-Level Understanding. https://​www​.ncbi​.nlm​.nih​.gov/​ books/​NBK22867/​

91. Techniques for process and organizations improvement: lean management in healthcare Public and private organizations have to continuously improve the way they manage their processes in order to increase the value generated. Specifically, “Business Process Innovation” (BPI) is the approach that identifies methods and techniques enabling to increase the effectiveness and efficiency of business processes, both providing service/ output to internal (another organizational unit) and external customers (intermediate or final users) (Harrington, 1991). Since its first definition, many other terms have been used to address process improvement, such as business process re-engineering (BPR) – often addressed as synonymous with radical improvement, as opposed to the “incremental improvement” of BPI; “business process redesign”; “core process redesign”; “business restructuring”; “continuous improvement process”; and so on. All these approaches have in common the idea that the improvement of a process aims to increase the ability to achieve the set objectives by defining higher performance standards. The goal of process improvement is essentially to produce new reference standards for those activities that underpin the processes through which value is created for customers and all stakeholders. These standards have the main aim of increasing the effectiveness of the processes, improving their capability to reach the objectives, but also their efficiency by introducing a more rational use of the planned resources. Literature and management practices identify several different process improvement methodologies such as: six sigma methodology, Total Quality Management (TQM), lean management, continuous improvement (kaizen), Plan Do Check Act (PDCA), 5 Whys analysis. Even healthcare has seen the rise and fall of a number of concepts, ideas or methods for process and organization improvement, moving progressively from more traditional

approaches (medical audit, clinical audit, to clinical governance) to total quality management, continuous quality improvement, business process re-engineering, statistical process control (six sigma), and lean management (Walshe, 2009). These approaches have been adopted with the aim of improving efficiency, quality, clinical outcomes, and the satisfaction and safety of both staff and patients, and reducing medical errors. Among these practices, lean management stands out in terms of diffusion in many hospitals (D’Andreamatteo et al., 2015). Since its first adoption into healthcare in the early 1990s, lean has become one of the most frequently reported improvement approaches in the healthcare management literature (Mazzocato et al., 2010). The term “Lean production”, first coined by Womack in 1990, was used to describe manufacturing techniques developed by the founders of Toyota Motor Company, the Toyota Production System (TPS) and it became well known in the manufacturing community worldwide with the publication of the book The Machine That Changed the World (Womack et al., 2007). Lean focused on elimination of waste (“muda” in Japanese), unevenness (“mura” in Japanese), and overburden (“muri” in Japanese). Considering waste, seven categories are usually identified: 1. Defects. Includes time spent doing something incorrectly, then fixing errors. Example: time spent looking for an item missing from the supply room; 2. Overproduction. Doing more than what is needed or doing it sooner than needed. Example: unnecessary diagnostic procedures or too many laboratory tests; 3. Transportation. Needless moving of patients or goods, often resulting from a poor layout. Example: an ICU located a distance from the radiology department; 4. Waiting time for anything is waste; 5. Inventory. Excess inventory, storage, movement, spoilage, or waste all bear a cost. Example: letting supplies expire, necessitating disposal; 6. Motion. Example: employees move from room to room, floor to floor, or building to building more than necessary; 7. Overprocessing. Describes work not valued by patients or caused by rules that are not aligned with patients’ needs. Example: filling out multiple forms at every clinic visit. In healthcare, lean can be defined as a managerial approach that uses specific

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methods, procedures and tools aimed on the one hand at understanding the expectations of the patient (in terms of perceived quality of care and satisfaction with care experience), on the other hand to the optimization of production resources through a review and reorganization of organizational processes, both primary (clinical activities) and support activities (e.g., procurement, human resource management, etc.), aimed at achieving better performance. Lean management is therefore a managerial approach based on the process improvements aimed at creating value for the patient and for the health organization. Lean initiatives can affect four main dimensions: (1) the patient, where lean can ensure valuable provision of services (e.g., increased quality of care, improved clinical/ health outcomes, increased patient satisfaction, increased patient safety/security, effectiveness of care, improved appropriateness, accessibility); (2) internal processes, where lean approach can improve the quality of the service delivered through enhanced process management (e.g., time reduction – length of stay, turnaround times, waiting times – reduction of errors/adverse event/risks, waste elimination, optimization of flows, optimization of processes, reduced inventory, reduced time to solve/transmit errors, efficient layout, reduced variability, Improved resources allocation); (3) learning and growth, where lean can enable organizational well-being and enhance the contribution of healthcare staff, strengthened through training (e.g., increasing staff satisfaction, staff safety, organization and staff well-being; staff involvement and empowerment, improving teamwork and communication) and (4) financial results, focused on the economic results of lean in creating and recovering value (e.g., costs reduction; improved efficiency and productivity, increased revenue). While the value of the patient is seen as the main strategic goal, the corporate staff is considered the main resource for achieving operational objectives and at the same time the recipient of the improvement. Considering that processes are transversal to several organizational units, the involvement must cover all staff of healthcare organization, through a creation and development of multidisciplinary and multi-professional groups. Although

Marta Marsilio

the introduction and implementation of the methodology at the micro level (or of a single organizational unit) is simple and intuitive, the dissemination and adoption of the same at the meso level (the whole company) is not at all self-evident. Without a focused and continuous effort from top management and the active involvement based on the consent and trust of doctors and structure management, the organization would jeopardize the results obtained in the early stages of adoption at the level of individual processes. These criticalities are well highlighted both by the literature and by the evidence of a survey recently conducted in the American and Italian NHS (Marsilio et al., 2022). The literature on the organizational elements that determine successful implementation of Lean Management highlights how effective adoption of the method requires a coordinated strategy at company level; that strategy implies investments and effort on different dimensions – social (strategic management, organizational structure and organizational culture), technical (techniques, tools and lay-out) and external factors – that support organization-wide quality improvement practices and the lean implementation process in healthcare. Marta Marsilio

References

D’Andreamatteo, A., Ianni, L., Lega, F. and Sargiacomo, M. (2015), Lean in health care: a comprehensive review, Health Policy, Vol. 119 No. 9, pp. 1197–1209. Harrington, H.J. (1991), Business Process Improvement. The Breakthrough Strategy for Total Quality, Productivity, and Competitiveness, McGraw Hill, California. Marsilio, M., Pisarra, M., Rubio, K. and Shortell, S. (2022), Lean adoption, implementation, and outcomes in public hospitals: benchmarking the US and Italy health systems, BMC Health Serv Res, Vol. 22, pp. 122. Mazzocato, P., Savage, C., Brommels, M., Aronsson, H. and Thor, J. (2010), Lean thinking in health care: a realist review of the literature, BMJ Quality & Safety, Vol. 19 No. 5, pp. 376–382. Walshe, K. (2009), Pseudoinnovation: the development and spread of health care quality improvement methodologies, International Journal for Quality in Health Care, Vol. 21 No.3, pp. 153–159.

PART XVIII ORGANIZATION As well as any other organization, healthcare institutions have different configurations. There’s not a better or a worse organization model, it all depends on which configuration is the most suitable for the organization at issue. The main organizational models within a healthcare company are grouped below based on vertical integration (old models) or horizontal nature (new models), as well as the most important tool used by companies to represent their organizational structure: the organization chart.

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92. Clinical service lines Clinical service lines are becoming more important in hospitals over time. It is a management model which organizes and markets healthcare services based on care outputs, which are patient-centered services, as opposed to its inputs which are centered on providers of the same department (Clinical Service Line Management in Health Care Systems, n.d.). It is an approach that uses a wide range of data from different departments that a patient would encounter during their hospital visits, allowing for the analysis of how these service lines affect overall hospital efficiency, financial sustainability, and the institution’s position in the community. For example, an oncology patient is not only treated by the oncology department, but also by nursing, radiology, pathology, registration, and others. Thus, service lines group these disciplines who share a common purpose of producing a comprehensive set of clinical services to achieve a clinical output. Through the service line management model, physicians can understand the efficacy of a multidisciplinary approach and tackle current and future reforms that could cause hospital debts to rise. There have been four key pillars reported for the success of clinical service lines: governance and leadership, clinical integration, clinical transformation and analytics and innovation (Malone, 2021, part 1).

Key defining characteristics of clinical service lines 1. A clear clinical care mission: the goals of clinical service lines should have an identifiable market based on the region and a diagnostic category. 2. They follow a multidisciplinary approach. 3. They provide a way to integrate personnel and services across various disciplines. 4. They are administratively manageable and quantifiable.

Examples of care outputs that can form a clinical service line 1. Disease management: for example, a comprehensive care for cancer patient

involving many disciplines necessary or for heart disease. 2. Care of identifiable subsets of the population such as elderly population. 3. A service line for specific procedures or interventions such as organ transplantation or knee replacements.

Four key pillars for success of clinical service lines 1. Governance and leadership It is important to define the service line and decide which disciplines should and should not be included in a particular service line. This would vary between organizations, but an example is that a cardiac service line would most definitely have to include cardiac imaging, heart failure, coronary artery disease, arrythmias, valvular problems and treatment of heart attacks. The administrative model needs effective communication between the two top leaders, the physician and the administrator. These service line leaders need to establish trust and a good relationship amongst their members to accomplish goals of alignment, improved quality, and reduced costs (Malone, 2021, part 1). Service lines also give physicians leadership opportunities to develop centers of excellence as without strong physician leadership, an institution can fail to reach their goals for improving quality and cost, risking scrutiny from payer partners. Lastly, once leadership is established, it is important to have structure by identifying the appropriate providers for participation based on the goals and values the organization has defined. 2. Clinical integration Clinical integration services is defined as “health services that are managed and delivered so that people receive a continuum of health promotion, disease prevention, diagnosis, treatment, disease-​ management, rehabilitation and palliative care services within and beyond the health sector, and according to their needs throughout the life course” (Contandriapoulos et al., 2003).   Factors important for clinical integration includes patient access, as ease of access to patient services helps with early diagnosis and intervention, as well as

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reducing unnecessary procedures. It is also important to manage leakage, so patient services can be accessed in one organized system to avoid the need for patients to go to different institutions and repeat lab tests.   Clinical service lines must prioritize clinical integration as the second pillar of success while also considering value-based contracts, which is an agreement between healthcare payers and pharmaceutical manufacturers in which the amount of reimbursement is tied to value-based outcomes (Kannarkat et al., 2020). 3. Clinical transformation Clinical service lines consider various factors to understand clinical transformation, including evidence-based medicine, care model redesign, cost and quality management (Malone, 2021, part 3). Evidence-based medicine and proper clinical guidelines must be used effectively to develop methods to improve patients’ quality of care, to use resources effectively and achieve the best outcomes.   Care model redesign involves making changes to primary care practices to improve quality, efficiency and effectiveness of patient care. It involves adopting strategies and policies to manage physician performance, precise clinical documentation, clinical resource utilization and better satisfy the needs of patients and families (Health Care/System Redesign, 2020). Cost and quality management is then understood by using key performance indicators (KPIs) to monitor progress. 4. Analytics and innovation Analytics and innovation are considered the fourth pillar of success in clinical service lines. This includes key performance indicators (KPIs) and risk analysis, performance-driven care, disease and condition registries and predictive modeling. Key performance indicators include revenue, costs, margin, volume by service, service level by the staff available and most importantly, patient satisfaction. The margin is important because not all service lines may be profitable, so we must have the ability to partner with physicians to control costs and decide which service lines are most effective. All

the factors involved in the four pillars to optimize clinical service lines represent performance-driven care, where there is a financial and intrinsic incentive for physicians and healthcare workers for meeting certain performance measures. This is necessary to facilitate behavioral change and instill motivation.   Lastly, disease registries and the use of digitized care plans will allow for more research into clinical outcomes this resulting in improved and more efficient care.

What is the relevance of service lines?

The clinical service line model has been proven to facilitate the shift of health cases towards value-based services, which is characterized by coordinated, multidisciplinary, high-quality, and cost-effective care (Longshore, 1998). Not only does the model provide a better outcome at a lower cost, but it also creates new opportunities for physician collaboration and openings for physician leadership. How can we make sure that post-acute care and outpatient care is optimized to prevent bounce-backs, complications, and no-show follow-ups? Through transparency and accountability of service lines, physicians must instill the importance of follow-ups for a patient’s future as well as providing easier access to care. Considering the regional demographics and needs, leaders must choose a few focus areas from the range of services that a hospital provides. Hospitals must take into account their mission, market growth, margin and likelihood of success because there is financial pressure on hospitals and service lines can facilitate in addressing those challenges (Phillips et al., 2015). Patients usually go the hospital at a stage where they are most vulnerable and in need of help and guidance. A well-built and efficient service line structures and organizes the care for patients, so they are not required to organize it for themselves. Aswathy Varma

References

Clinical Service Line Management in Health Care Systems; The National Institute for Health

Aswathy Varma

266  Elgar encyclopedia of healthcare management Innovation, The University of Auckland. Finance. 1998 Summer;24(4):72‒79. PMID: Retrieved 10 April 2021, from https://​ i3​ 9612739. .waitematadhb​.govt​.nz/​assets/​documents/​our​ Malone J. (2021). The 4 Pillars of Clinical -work/​research​-innovation/​innovation​-library/​ Service Line Success: Part 1 – Governance Clinical​-Service​-Line​-Management​.pdf and Leadership. Retrieved 9 April 2021, Contandriapoulos AP, Denis JL, Touati N, from https://​blog​.luminahp​.com/​the​-4​-pillars​ Rodriguez C. Montréal: Université de Montréal; -of​-clinical​-service​-line​-success​-part​-1​ 2003. June, Groupe de recherche interdisci-governance​-and​-leadership plinaire en santé. Working Paper N04–01. Malone J. (2021). The 4 Pillars of Clinical Service The integration of health care: dimensions and Line Success: Part 3 – Clinical Transformation. implementation. Retrieved 9 April 2021, from https://​ blog​ Health Care/System Redesign. Content last .luminahp​.com/​the​-4​-pillars​-of​-clinical​-service​ reviewed December 2020. Agency for -line​-success​-part​-3​-clinical​-transformation​ Healthcare Research and Quality, Rockville, #:​~:​text​=​Clinical​%20resource​%20utilization​ MD. https://​www​.ahrq​.gov/​ncepcr/​tools/​ ,Precise​%20clinical​%20docu mentation redesign/​index​.html Phillips RA, Cyr J, Keaney JF Jr, Messina LM, Kannarkat JT, Good CB, Parekh N. Value-Based Meyer TE, Tam SKC, Korenda K, Darrigo Pharmaceutical Contracts: Value for Whom? M, Kumar P, Challapalli S. Creating and Value Health. 2020 Feb;23(2):154‒156. doi: Maintaining a Successful Service Line in 10.1016/j.jval.2019.10.009. Epub 2019 Dec 5. an Academic Medical Center at the Dawn PMID: 32113619. of Value-Based Care. Academic Medicine. Longshore GF. Service-line Management/ 2015 Oct;90(10):1340‒1346. doi: 10.1097/ Bottom-line Management. J Health Care ACM.0000000000000839.

Aswathy Varma

93. Converging trends in hospital transformation

Unit groupings are a change in the direction of devolved responsibility, with greater emphasis on the role of Clinical Leaders/ Chiefs of departments/division/clinical services lines.

Multi-specialty general large hospitals seem to adopt worldwide common “principles” for reorganization. Having to cope with similar environmental pressures, their trends of change seem to converge toward a process-based organization (focused on needs of patients) and away from the traditional physicians-centred view (Buchan et al., 1997; Lega & DePietro, 2005). The main features of reorganization processes in action are:

● Resources pooling. Beds, operating rooms, equipments, nursing staff, and other staff allocated to the department are shared by all specialties regrouped. Beds and operating rooms are scheduled for use by single specialties and specialists, but in cases of under-utilization, the Clinical Leader/​Chief (or any other manager delegated) may reassign them to other specialties with waiting lists. Also, different utilization on any single day due to unexpected events (patient not discharged for infection post-intervention, emergency due to aggravation of patient, etc.) is usually decided by the nursing manager or any other manager appointed to that task). This organizational design should allow for maximizing flexibility and productivity of fixed resources; ● Patients grouping. Pooled wards are reshaped according either to length of stay of patients or by patients’ needs. In the first case, multi-specialty wards are created to identify patients with similar lengths of stay, such as: day-surgery/ day-hospital, week hospital (for patients admitted on Mondays and discharged before Saturdays), long stay-low care, sub-intensive care (high care), intensive care, emergency. The benefits would be better staffing of nurses according to severity of cases admitted (length of stay is used as proxy for severity). In the second case, wards could be organized on the basis of patient needs, as: ● patients in “mental states”, such as kidney failures, alzheimer’s and any other diseases or illness in which the patient has lost their faculty to reason, and need to be watched all the time; ● patients that were not breathing, due to asthma, hearth attack, etc., typically on respirators; ● patients with complicated IV’s, such as oncology and dialysis patients, since the key factor in caring for these patients is to manage the IV systems that they are being treated with;

● Units grouping. Units (specialties) should be aggregated in accordance with care requirements. These groups may differ from the traditional specialty-based categorization of care, since the objective is to regroup units: ● horizontally overlapping, through the creation of departments based on macro-areas of specialties (general medicine, general surgery, laboratories, imaging) and grouping similar units. This type of redesign applies best in large hospitals either with a limited number of specialties or looking at rationalization of duplicated units; ● vertically integrated along the same care process, through the grouping of units based on similar products, such as body organs/parts (heart, head-neck, liver, etc. – grouping units co-operating at different stages of the same care/cure processes), on homogeneous medical areas (oncology, digestive apparatus, muscle-skeleton – grouping units co-operating either at the same time or at different stages on the same care/cure processes) or on the age of patients (elderly, maternal, pediatric departments). This type of redesign fits well in large multi-specialty hospitals, especially in the teaching ones, since it generates more focus on innovation and research along specialization paths.

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● patients needing more tests and who are frequently “off the floor”, since the department of medicine is the typical destination for the emergency room patients who have not yet been diagnosed specifically; these patients typically miss meals, wait endlessly for transportation to other centres, etc…

competences, linking them with incentives schemes apt to stimulate the professionals’ behaviours and be consistent with organizational goals; ● New managerial roles and changes in traditional ones. Hospital internal redesign creates new roles and modifies the contents of traditional ones, asking for multiskilling and cross-training to prepare people to play such positions. The idea was that this formula could Specifically, five roles are greatly influimprove nurses’ and physicians’ relations enced by the redesign: with patients through better assessment of ● Chief of Department/Division/ patients’ needs and execute specific training Clinical service line. In hospitals of nurses (Henningsen & Stein, 1997): where disciplines-based units are grouped for the first time in depart● Multidisciplinary care teams. Patient-​ ments (or division/clinical service focused care requires integrated cure and lines), a new managerial position care delivered by multidisciplinary and emerges. In fact, a “strong” managemultiprofessional teams. These teams are ment role must be played by the dein charge of studying and implementing partment’s clinical leader (Willcocks clinical protocols (also labeled clinical or & Conway, 1998; Willcocks, 1998). care pathways). Consequently, the workAs hospital organizational design groups should be formed by physicians and evolves, a more managerial role is other professionals (nurses, technicians, required. Burgoyne and Lorbiecki etc.) belonging to the specialties-based (1993) point out that the “clinician’s units where the pathology’s object of role had indeed moved away from study were usually treated. This means conventional management tasks blurring out the traditional boundaries which looks inward at the needs of between specialties and professionals. a clinical specialty, to one which ● Redesign of the physical environment. steps outside and incorporates Unit and patient grouping and resource the need for a sense of vision and pooling may require a redesign of the leadership for the direction of the physical environment. Newly built hosunit as a whole”. Nevertheless, it pitals are designed to maximize from the is possible that while some clinical beginning resource pooling and patient directors were initially supportive grouping, while old hospitals, built of clinical management (radiology, around highly fragmented and focused pathology, psychiatry, etc.) because spaces, often need to restructure; of their traditional involvement ● Redesign of organizational mechanisms. in the managerial process of their Hospitals strive to find effective ways own work, others, and in particular of managing performances on different the more glamorous and powerful grounds: health (outcomes), productivity surgical, medical, paediatrics and (outputs), financial, and people developobstetrics-gynaecology specialties, ment. The quest for effective solutions were more likely to emphasize the involves two main areas: the measureclinical and professional aspects of ment system and the human resource their role (Willcocks, 1998). It is also management system. The first has to intetrue that a variety of aspects might grate financial measures with a range influence the way the introduction of other measures, such as productivity, of clinical management of a deoutcomes, people satisfaction and propartment/division takes place, such fessional development, and they have to as historical background, cultural integrate its focus both at the departheritage, nature of work, technology ment and patient level. The second must and organization, power differentials develop tools to assess and manage the between specialties and individual development of professional skills and factors, for example motivation, Federico Lega

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training, awareness, attitudes to management, and so on (Pettigrew et al., 1992; Willcocks, 1998). In any case, organizational development in hospitals promoted through divisionalization requires a new class of managers, able to integrate the clinical competencies needed for driving strategic repositioning and for the development of the department, with managerial skills needed to re-organize and improve resource utilization in the department. ● Head of Nurses. The Department Head of Nurses (or nursing manager) has a critical role, being the managerial right arm of the Department Chief. They usually manage operations, which means beds allocation, or waiting lists, technology use, spaces distribution, nursing and support staff deployment. The aim is to bring utilization of pooled resources to the maximum productivity level (i.e. bed occupation rate, working hours/shifts, OR working time, etc.) exploiting all possible scale and scope economies. Beds are allocated either to single different specialties or to different multispecialty workgroups/teams. ● Chief of Specialty. This is the traditional role most affected by the redesign. Chiefs of Specialties, in many cases, were the real holders of organizational power, being in charge of managing, guiding, organizing their own unit with significant – if not complete ‒ autonomy. After the redesign, the heads of the specialties grouped in the department are expected to set and negotiate their goals, resources innovation and priorities with the Chief of Department. ● Manager of ward. They are in charge of daily operations. Two managers can be appointed for each multi-specialty ward: a nurse and a physician. The first manages the patient’s admission and discharges, coordinates the utilization of operating theatres and their admission list with the appointed manager, directs the work of nurses and support staff,

and assumes responsibility for the quality of the whole care process. The physician is accountable for medical assistance and for coordinating the work of their colleagues. This configures a matrix model in which each physician is asked to coordinate on one side operationally with the ward’s manager where they work, on the other side professionally with the Chief of Specialty and with the team leader. ● Team Leader. Multispecialty workgroups/team leaders should concentrate on developing and delivering cost-effective care pathways, facilitating and fostering the interprofessional cooperation, optimizing – in agreement with the head of nurses – the utilization of pooled resources. The team leader is also the typical collector and enabler of proposals for technology upgrading and investments. Such proposals are then discussed and eventually approved with the Chiefs of Specialties and the Chief of Department. Federico Lega

Bibliography

Buchan J., Seccombe I., Thomas S. Overseas mobility of U.K. based nurses, International Journal of Nursing Studies, 34(1), 54‒62, 1997. ISSN 0020-7489, https://​doi​.org/​10​.1016/​S0020​ -7489(96)00015​-6. https://​www​.sciencedirect​ .com/​science/​article/​pii/​S0020748996000156 Burgoyne J., Lorbiecki A. Clinicians into management: The experience in context, Health Services Management Research, 6(4), 248–259, 1993. https://​doi​.org/​10​.1177/​095148489300600404 Henningsen M., Stein M.K. Mathematical tasks and student cognition: Classroom-based factors that support and inhibit high-level mathematical thinking and reasoning, Journal for Research in Mathematics Education, 28(5), 524–549, 1997. https://​doi​.org/​10​.2307/​749690 Lega F. Reorganising healthcare delivering in hospital: structure and processes to serve quality, in Davies H., Tavakoli M. [eds] Strategic Issues in Health Care Management: Health Care Policy, Performance and Finance, Aldershot, Ashgate, 2004. Lega F., Calciolari S. Coevolution of hospitals and patients: how changing epidemiology and technology advances drive organisational inno-

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270  Elgar encyclopedia of healthcare management vations and lay new challenges, Journal of Healthcare Management, 57(1), 17‒33, 2012. Lega F., DePietro C. Converging patterns in hospital organization: beyond the professional bureaucracy, Health Policy, 74, 2005. Lega F., Kirkpatrick I., Kuhlmann E., Hartley K., Dent M. Medicine and management in European hospitals: a comparative overview. BMC Health Services Research, 16, 171, 2016. McKee M., Healy J., Edwards N., Harrison A. Pressures for change, in Helay J., McKee M. [eds] Hospitals in a Changing Europe, Buckingham, European Observatory on Health Care Systems Series, Open University Press, 2002. Mintzberg H. Toward healthier hospitals, Health Care Management Review, 22(4), 9‒18, 1997. Pettigrew A.M. The character and significance of strategy process research, Strategic

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Management Journal, 13, 5–16, 1992. http://​ www​.jstor​.org/​stable/​2486363 Pettigrew A., Ferlie E., McKee L. (1992). Shaping strategic change: The case of the NHS in the 1980s, Public Money & Management, 12, 27‒31, 1992. 10.1080/09540969209387719. Willcocks S (1998). The development of clinical management at an NHS Trust hospital. A case study example, Journal of Management in Medicine, 12(2‒3), 168–138. https://​doi​.org/​ 10​.1108/​02689239810231998 Willcocks S., Conway T. Strategic marketing and clinical management in health care: a possible way forward, Journal of Management in Medicine, 12(2‒3), 120–180, 1998. https://​doi​ .org/​10​.1108/​02689239810227146

94. Divisionalization, clinical directorates and Troika model in healthcare

● respiratory rehabilitation, where the patient completes their recovery before being discharged if everything has gone well.

Traditionally, most hospitals in developed countries have adopted an organizational structure built around a discipline-based specialization. As Mintzberg (1983) pointed out, they assumed the form of professional bureaucracies, characterized by an internal organization structured around skills and specific competences (cardiology, neurology, ophthalmology general surgery, vascular surgery etc.). Until the 1980s, the extraordinary progress in the medical sciences was made possible also thanks to this hospital’s focus and organization on the development of specializations and relative know-how skills. Further, this design responded to the need to clearly separate (and position) the “turf” governed by different physicians in the same hospitals or across different hospitals, a common path in professional contexts. Last but not least it served the need of keeping a “feasible” span of control, since it was clear that managing, organizing and supervising large units (in terms of beds and personnel) was a difficult task. Yet, the same design is now struggling to respond to emerging organizational needs in the medical field. In fact, it generates major issues in coordination, in standardization, in providing timely and integrated care. For instance, the treatment of a lung cancer patient in a general hospital, organized with a discipline-based structure, requires the intervention of different units: ● pneumology, where the diagnosis might take place; ● oncology, whose consultancy might be required by the pneumology unit or where the patient might be transferred to complete the diagnosis process; ● dietary, in charge of giving advice along the entire treatment pathway on patient diet prescription; ● laboratory and imaging unit, where the exams take place, thoracic surgery and radiotherapy, where the patient might go on to complete the treatment (with different patterns);

This complex scheme is further complicated by the fact that the same clinical problem (lung cancer) in a similar patient might be tackled with a (even radically) different approach by different physicians of the same unit or by different units where the patient is admitted (diagnosis/treatment process might differ consistently between the pneumology and the oncology unit). Therefore, a shift in the organizational design was necessary, which consisted in new organizational forms that grouped together specialties into larger units, often referred to as Service Lines, Divisions, Departments or Clinical Directorates (CDs) according to the specific context. They are intermediate organizational arrangements through which defined parts of larger hospitals’ health services are managed. This model was originally pioneered in the USA in the 1970s at the Johns Hopkins Hospital (JHH) in Baltimore and then served as a template for most hospitals willing to enhance their performance. The model was based on strengthening the corporate governance of hospitals and sub-divide them into business units (or “clinical directorates”) to maximize efficiency and competitiveness. Running the business units is usually a “troika”. The idea is to put a team of a general manager, a doctor and a nurse at the top of the unit management. Specifically, the unit is primarily run by a Clinical Chair (or Director), supported by a Nursing Manager and a General Manager (or Administrator). Implementing this transformation is challenging because it requires a number of important changes to the way a hospital works; the key elements include its organizational model, culture and capabilities, and its approach to strategic planning. Implementation also requires robust systems for managing performance and information. Even if the introduction of CDs and other forms of grouping clinicians suggests a convergence of hospital management around the world, it is clear that there has also been much scope for variation and translation of the CD concept both within and between health systems. The overall characteristics of health systems could also impact on the speed of

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change. In “command and control” NHS, like Italy and France, the CD model was prescribed centrally through legislation, and adopted quickly and in a relatively standardized fashion, partly as a result of coercive isomorphism (Lega, 2008). In decentralized systems, such as Germany or the Netherlands, adoption occurred more by mimetic isomorphism, with replica of “best practice” imported from high-profile institutions from abroad, like USA (Kirkpatrick et al., 2013). Notwithstanding these differences in timing, it is well recognized that the establishing of CDs gave to hospitals the grounds to pursue their own corporatization process. The intention of the clinical directorate model was to create a single line of command, with all clinical staff reporting through to directors and ultimately the CEO. Federico Lega

Bibliography

Braithwaite, J. Identifying the elements in the health service management revolution. Australian Journal of Public Administration, 1993, 52(4): 417–30. Dunnion, M., Dunne, E. Clinical directorates: stakeholders’ knowledge and expectations. British Journal of Health Care Management, 2004, 10(1): 10‒17. Kilpatrick, D. G., Resnick, H. S., Milanak, M. E., Miller, M. W., Keyes, K. M., Friedman, M. J. National estimates of exposure to traumatic events and PTSD prevalence using DSM-IV and DSM-5 criteria. Journal of Traumatic

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Stress, 2013, 26(5): 537–547. https://​doi​.org/​10​ .1002/​jts​.21848 Kirkpatrick, A. W., Roberts, D. J., De Waele, J., Jaeschke, R., Malbrain, M. L., De Keulenaer, B., Duchesne, J., Bjorck, M., Leppaniemi, A., Ejike, J. C., Sugrue, M., Cheatham, M., Ivatury, R., Ball, C. G., Reintam Blaser, A., Regli, A., Balogh, Z. J., D’Amours, S., Debergh, D., Kaplan, M., … Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Medicine, 2013, 39(7): 1190–1206. https://​doi​ .org/​10​.1007/​s00134​-013​-2906​-z Lega, F. Reorganising healthcare delivering in hospital: structure and processes to serve quality, in Davies H, Tavakoli M. [eds] Strategic Issues in Health Care Management: Health Care Policy, Performance and Finance, Aldershot, Ashgate, 2004. Lega, F. The rise and fall(acy) of clinical directorates in Italy. Health Policy, 2008 Feb, 85: 252–262. Lega, F., DePietro, C. Converging patterns in hospital organisation: beyond the professional bureaucracy. Health Policy, 2005, n. 74. Lega, F., Kirkpatrick, I., Kuhlmann, E., Hartley, K., Dent, M. Medicine and management in European hospitals: a comparative overview. BMC Health Services Research, 2016, 16: 171. Mintzberg, H. Structuring in Fives: Designing Effective Organization, Englewood Cliffs, Prentice Hall, 1983.

95. Organizational culture The concept of organizational culture is frequently used in the organizational and management literature, but it remains an elusive concept with no single consensus definition. There is general agreement on the idea that organizational culture concerns values, attitudes and beliefs shared by the members of an organization (Pettigrew 1979, Schein 1985). In this respect, Schein (1985, p. 38) provided one of the most comprehensive definitions identifying organizational culture as the pattern of shared basic assumptions that the group learned as it solved its problems of external adaptation and internal integration, that has worked well enough to be considered valid and, therefore, to be taught to new members as the correct way to perceive, think and feel in relation to those problems.

One brief but effective definition identifies culture with “the way things are done around here” (Deal and Kennedy 1982, Davies et al. 2000) as a result of shared beliefs, values, and assumptions. Organizational culture is an intangible aspect, but it can be analyzed at three different levels (Schein 1985): artifacts, values, and assumptions. They are listed in order of resilience, with assumptions being the most resistant to change and the least likely to be even discussed. “Artifacts” concern the visible (but hard to decipher) signs of an organizational culture which are usually related to the physical and social environment of the organization; typical examples are (Davies et al. 2000): buildings architecture and furnishings, ward layouts, medical technologies, clinical and organizational procedures (e.g., surgeon’s list, patients’ assessment rounds along with junior doctors), dress codes that distinguish the different professional categories, methods used to evaluate professional performances, specialist languages, mission statements and credos, and so on. “Espoused Values” regard the fundamental principles according to which organizational members distinguish “right” from “wrong” behaviors, thus orienting daily practices; examples are punctuality, loyalty, human

touch, and so on. The medical profession conduct has traditionally been based on the Hippocratic principle of placing the needs of individual patients above broader economic and corporate objectives (Davies et al. 2000). Therefore, professional autonomy is generally considered one of the most important values in healthcare organizations. “Basic Underlying Assumptions” represent the basic values and beliefs taken for granted, as they are socially accepted and unconsciously enacted or used to interpret/evaluate phenomena by all members; they may regard the human nature, society, the environment, and any other aspect of reality. Davies et al. (2000) include among these the concepts regarding the measurability, aggregation, and transferability of medical knowledge: traditionally medical research has been based on the use of rational scientific methods (e.g., controlled or randomized trials rather than qualitative and interpretative methods) to generate and accumulate knowledge. Today it is considered the only scientific method to generate new theories on the causes of diseases and new therapies responses. The elements at each level aim to foster specific expected behaviors, but they are not rigidly categorized in a specific level without any mutual relationship. For instance, if the new behaviors promoted by a value succeed to solve organizational troubles, such value gradually begins a process of cognitive transformation into a belief and, ultimately, into an assumption. On the contrary, the introduction of control tools (e.g., through artifacts such as budgets or Balanced Scorecards) aimed to foster managerial values – such as the importance of monitoring the use of the resources to implement efficient responses to target patient groups and to respond to accountability needs – may only superficially scratch the organizational culture imbued of the value of professional autonomy. In other situations, such as the core values and elements of the corporate identity, the values are likely to remain explicitly represented in artifacts (e.g., the mission statement or the company’s motto) because they specify the perspective of the top and senior management and define the acceptable values that should inform the behavior of the individuals. In any organization, the coherent pattern of assumptions determines its “cultural paradigm”. Identifying the cultural paradigm of social groups is challenging, and the task

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is even harder when considering healthcare organizations, because medicine is inherently rooted in matters involving ethics and, also due to the progressive technologic advances, may clash with religious or political beliefs (e.g., medicalization of the beginning and end of life, acceptability of clinical trials on vulnerable target patients) (Prenestini 2011). In addition, professional categories (e.g., physicians vs. nurses, medical specialties) or sub-groups tend to differentiate their identities around specific artifacts and values, generating the so called “sub-cultures”. Some sub-cultures may be associated with specific power levels within organizations. This determines a competitive configuration influencing the opportunity space of decision-making. Martin (2002) analyzed such aspects and defined three main configurations: ● Integrated cultures, where a broad consensus exists on the basic values and behavioral expectations deemed acceptable/positive in the whole organization (theoretically the ideal situation, with the highest level of stability). ● Differentiated cultures, where multiple groups have different, though not incompatible, beliefs and values (misunderstandings and conflicts are expected over time, requiring agreements to restore productive coexistence). ● Fragmented cultures, where many sub-cultures emerge and diverge radically, so that agreements between groups are only temporarily possible to meet specific common goals (changing alliances between sub-groups develop over time, with consequent diffused uncertainty and ambiguity). According to the different configuration, a different level of stability is fostered by the organizational culture. However, there is another source of dynamism because the relationship between sub-cultures and power is not constant over time: for example, gained influential role of the nursing profession due to the increasing level of qualification/specialization, rise of the managerial profession. Such dynamics are very important, because they modify the pattern of inter-professional competition characterizing healthcare (also called “turf wars” in the literature), thus influencing the equilibrium of power on which decision-making processes rely, especially Anna Prenestini and Stefano Calciolari

in multi-professional organizational settings such as clinical directorates. The concept of organizational culture differs from the one of organizational climate. The latter refers to rather temporary attitudes, feelings, perceptions of individuals; it concerns more overt, observable attributes of organizations and includes individualistic perspectives changing frequently according to situational contingencies. On the contrary, organizational culture refers to implicit, often indiscernible aspects that are enduring, core characteristic of an organization. It is hard to underestimate the implications of the cultural phenomena on organizational performance. Over the past thirty years, an important part of the academic and managerial debate has focused on “whether” and “how” organizational culture influences the achievement of the objectives and performance of an organization. Interest in organizational cultures and their relationship to organizational performance has grown considerably among researchers, resulting in several important empirical studies focused on public and healthcare organizations (Davies et al. 2007, Calciolari et al. 2018). The recent literature review by Lee et al. (2021) reported 24 empirical healthcare studies investigating the link between organizational culture (assessed with a specific questionnaire) and performance. The starting point of these studies is the belief that healthcare reforms inspired by the New Public Management were focusing excessively on structural change (e.g., introduction of managerial principles and tools, quasi markets, fostering mergers to gain economies of scale, etc.) rather than cultural change. However, it is increasingly recognized that structural change alone will unlikely secure adequate responses to improve healthcare performances (Scott et al. 2003a). In this respect, the literature provides several approaches aimed to analyze the organizational culture and identify predefined paradigms/types, with a fundamental methodological distinction between qualitative and quantitative approaches. The first type of approaches is followed by scholars/ professionals who embrace the complexity of the phenomenon more directly and reject any attempt to measure culture. They may want to explore, for instance, underlying collective assumptions through in-depth interviews or

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projective metaphors, or describe in detail the organizational life and the underlying values affecting its ‘modus operandi’ utilizing ethnographic research (Ouchi & Wilkins 1985). Quantitative methods rely on structured instruments administered through surveys to the personnel or selected (key) members of an organization. Typically, they ask questions on individuals’ perceptions about observable (e.g., practices, symbols) or unobservable (e.g., values, norms) collective patterns within their organizations. Each instrument is based on an underlying theoretical framework or conceptual logic organizing values and associating them with specific meanings, sometimes allowing to triangulate complex aspects such as collective assumptions. Quantitative methods, generally based on self-reported questionnaires, have several strengths compared with qualitative methods (Calciolari & Prenestini 2022): (a) they can be administered more quickly and cost-effectively; (b) they allow to manage larger samples; (c) the collected data can be used for comparisons between groups, organizations, and across industries; (d) they allow repeatability, and consequently, longitudinal studies. A more in-depth knowledge of the cultural characteristics of the healthcare organization – through the use of quantitative or qualitative instruments – allows to effectively promote organizational development processes and to improve specific dimensions of performance, trying to overcome the resistance to change. Anna Prenestini and Stefano Calciolari

Bibliography

Calciolari, S., & Prenestini, A. (2022) “Values-based methods for measuring organizational culture: logic, evidence and critique” in C. Newton, R. Knight (eds.), Handbook of Research Methods for Organisational Culture,

Cheltenham, UK and Northampton, MA, USA: Edward Elgar Publishing. Calciolari, S., Prenestini, A., & Lega, F. (2018) “An organizational culture for all seasons? How cultural type dominance and strength influence different performance goals”, Public Management Review, 20(9), 1400‒1422. Davies, H.T.O., Mannion, R., Jacobs, A., Powell, A.E., & Marshall, M.N. (2007) “Exploring the relationship between senior management team culture and hospital performance”, Medical Care Research and Review, 1(64), 46‒65. Davies, H.T.O., Nutley, S.M., & Mannion R. (2000) “Organisational culture and quality of health care”, Quality in Health Care, 9, 111‒119. Deal, T.E., & Kennedy A.A. (1982) Corporate Cultures, Reading, MA: Addison-Wesley. Lee, J.Y., McFadden, K.L., Lee, M.K., & Gowen C.R. III (2021) “U.S. hospital culture profiles for better performance in patient safety, patient satisfaction, Six Sigma, and lean implementation”, International Journal of Production Economics, 234. Martin, J. (2002) Organizational Culture: Mapping the Terrain, Thousand Oaks, CA: Sage. Ouchi, W.G., & Wilkins, A.L. (1985) “Organizational culture”, Annual Review of Sociology, 11, 457‒483. Pettigrew, A.M. (1979) “On studying organizational cultures”, Administrative Science Quarterly, 24, 570‒581. Prenestini, A. (2011) “Cultura organizzativa e cambiamento nelle aziende sanitarie pubbliche”, Mecosan, 19(80), 27‒46. Schein, E.H. (1985) Organizational Culture and Leadership, San Francisco, CA: Jossey-Bass., Scott, T., Mannion, R., Davies, H., & Marshall, M. (2003b) “The quantitative measurement of organizational culture in health care: a review of the available instruments”, Health Services Research, 38(3), 923‒945. Scott, T., Mannion, R., Marshall, M.N., & Davies, H.T.O. (2003a) “Does organisational culture influence health care performance? A review on the evidence”, Journal of Health Services Research and Policy, 8(2), 105‒117.

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96. Organizational design and development for healthcare organizations Organizational design is the process of defining the internal structure and dynamics of the organization. By “structure” we mean the division of labor through which is defined the hierarchy of the organization, who reports to who, which area of responsibility must be supervised. In order to identify the “right” organizational design, the “technical” starting point is the recognition of the organizational needs that should be satisfied. We introduced the technical as opposed to it there is also a “social” perspective according to which the design is built to satisfy and accommodate the will of the people belonging to the organization. Main organizational needs can be identified and discussed as dichotomies that require a prevalent choice of positioning of the organization or of any of its subunits. These dichotomies are represented by: ● Integration vs. differentiation: differentiation is the way in which the organization allocates people and resources to organizational tasks (Child, 1977). Horizontal differentiation refers then to the issue of defining how to divide labor in the organization, according to different criteria such as functions performed, clients served, markets covered, and so on. Vertical differentiation refers to the issue of specifying the reporting relationships that link differentiated organizational units designed at different hierarchical levels. A large vertical differentiation leads to tall structure, with many levels eventually organized accordingly to different criteria, while a limited vertical differentiation will lead to a flat structure, with few hierarchical levels. This means that an organization at any of its hierarchical levels might pursue a horizontal differentiation based on a different criterion. The first level might be organized by function (e.g. production and sales), the second level by market (production for Europe

and production for South America), and the third level by product (production for Europe of product A). Integration is the means by which an organization seeks to cope with internal interdependencies and to coordinate people and functions to accomplish organizational tasks (Galbraith, 1973). These means include the use of integrating mechanisms and the whole apparatus of organizational control. Therefore, differentiation choices regard the way the organization divides itself into parts, integrating the way in which the parts are combined. Obviously, organizations that are more differentiated require a greater degree of integration. But, at the same time it is natural that the best way to obtain integrated organizations is to reduce their differentiation. In this sense these two variables can be interpreted as a dichotomy. Two final points. First, as Lawrence and Lorsch (1967) note, in a contingency perspective the overall managerial challenge is to appropriately match the levels of differentiation and integration to the demands of the external environment. Second, integration might refer not only to an organization’s choices on work and structure design, but also to the need of coordinating activities across organizational boundaries, through strategic alliances, networking or group-consolidation. This has been particularly true in the healthcare sector with the growth of health networks and systems, many of which develop complex relationships involving hospitals, physician groups, long-term or home-care facilities and insurances or health plans (Shortell and Kaluzny, 2000); ● Centralization vs. decentralization: another important set of alternatives is represented by the extent to which authority, decision making and selected functions are centralized or decentralized. Centralization of authority exists when managers at the upper levels of the organizational hierarchy retain the authority to make the most important decisions, both operational and strategic. On the contrary, when authority is decentralized, it means it is delegated to managers at lower levels in the hierarchy, such as managers of organizational subunits (departments, divisions, services, etc.). The way the authority is distrib-

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uted along the hierarchy thus defines the organization’s decision-making system. Decentralization has some advantages (Hill and Jones, 1992): ● It limits communication problems between the top and the bottom of the hierarchy, thus avoiding misunderstandings, untimely decisions, loss of valuable time, and sense of irresponsibility by the lower managers; ● It promotes flexibility and responsiveness since lower managers can make on-the-spot decisions more adapted to local situations; ● It permits top management to spend more time on effective strategic decision-making and long-term planning, leaving the day-by-day and short-term operational decision-making issues to lower managers. On the other side, it is true that centralization also has its advantages. Centralized decision-making allows easier coordination of the organizational activities needed to pursue an organization’s strategy. Too much decentralization not sufficiently supervised and coordinated might lead to the loss of control of an organization’s development and functioning (sort of organizational anarchy). Furthermore, in times of crisis, centralization of authority permits strong leadership and the speedy decision-making and concerted response by the whole organization needed to cope with its problems. ● Identity/belonging vs. openness to exterior: every organization needs to find its identity to cope cohesively with the environmental threats and opportunities. This identity leads to the development of a sense of belonging by its participants and to a common organizational culture. Identity and belonging depend on the robustness of an organization’s ideology. Ideology is important in that it provides the set of ideas that decision-makers take with them to guide decision-making and to interpret their context (Brunsson, 2007). A robust ideology is one that contains a rich body of ideas on the basis of which the organization is able to face effectively external pressures. With reference

to a healthcare organization, its ideology must be sufficiently robust to face disaggregating and conflicting pressure posed by local communities and different political authorities, each interested prevalently in its own peculiar interests. A weak ideology leads to organizational anarchy, where each subunit copes freely with its environment determining organizational undesired results. A weak ideology is also very focused, which has a highly specific set of ideas not effectively applicable to many different decisions (Butler, 1991). Thus, a robust ideology is plural, as it contains a broad range of norms; as it is tolerant, it accepts new and unusual ideas, is moral, in the sense that although it contains a broad range of norms, the moral norm predominates in order to give a strong sense of the rightness of what the organization as a whole is doing. On the other side, a weak ideology is singular, since one norm dominates; it is particular, since it tends to concentrate on particular ideas known and accepted, is efficiency-oriented, since it emphasizes the instrumentality of what the participants are doing independently by any moral conviction on the usefulness of the organization’s final scopes. Along with a robust ideology, the organization needs to pay the right amount of attention to the environment’s expectations: this means sometimes acting as an open system willing to recognize and accept external pressures even if in contrast with its own ideology. When for different reasons the organization’s survival depends on the meeting of conflicting external demands, identity may be temporarily constrained in favor of a multi-faceted adaptation to stakeholders’ pressures. Where is the dichotomy? The fact is that creating a robust ideology and a defined identity requires for a certain time the stability and the closure of the organization to the external pressures, in order to consolidate and spread its body of leading ideas. On the contrary, openness might lead to the need for continuous reorganizations and reconsideration of the ideology. ● Change/innovation vs. stability/standardization: very much connected to the previous point is the alternative between the need for change and the need for Federico Lega

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stability. As political, economic, social and regulatory environmental forces exert influence on the organization, it is necessary for the organization to reshape its design to adapt or even anticipate the environment dynamics. On the other hand, an organization needs to seal off from external pressure its production processes in order to achieve maximum degrees of efficiency. The standardization of procedures represents a way through which this is accomplished. Thus, a hospital looks for clinical pathways as a way to standardize routine treatments, and tries to apply them to the majority of the patients that require that treatment. In this case, a trade-off between efficiency and effectiveness is operated by the hospital, who believes that its clinical pathways guarantee acceptable effectiveness with good efficiency. Alternatively, the hospital might be on the continuous search for new ways of treatment (drugs, diagnostics, surgical procedures, etc), looking for greater effectiveness, but sacrificing consequently the efficiency permitted by the procedure standardization. It is with this dilemma that organizations move to address their needs for change and innovation or for stability and standardization: there will be periods of stability necessary to achieve acceptable levels of efficiency followed by period of change necessary when internal production conditions do not satisfy stakeholders’ and clients’ expectations. Whether the organization adopts a reactive or proactive behavior with regards to change and innovation will depend on its role and nature: some organizations, like university hospitals, should be the place where innovation is created, while others like the community hospital should guarantee efficiency and the largest coverage of people’s healthcare needs. Conversely, any organizational change modifying existing power and authority equilibriums will be more difficult in university hospitals, where the professional community (physicians) is stronger than in the community hospital. Key organizational needs usually emerge in the process of strategy-making. The organizational design should serve the strategy, and it should support the execution of the strategy. Federico Lega

Strategy and organizational design and development are in a close relationship, as the latter is a key factor for pursuing the former, and the former influences the choices regarding the latter. Chandler (1962) noted that: ● in principle, organizational structure follows the growth strategy of an organization, or, in other words, the range and variety of tasks it chooses to accomplish; ● as they evolve, diversify and grow in size, organizations go through stages of strategy and structure, adopting in each stage an organizational design matching the variety of its strategic goals. Therefore, strategy is what guides organizational design efforts with regard to key organizational needs and pressures of environmental forces. Design involves actions on the following variables: ● Structure: operating on horizontal or vertical differentiation; system: operating ● Decision-making on centralization or decentralization of authority; ● Co-ordination forms: redefining dominant means of coordination between programming approaches (standardization of processes (clinical pathways), outputs/ outcomes, knowledge), norms (guidelines, rules and procedures) and feedback approaches (direct supervision, mutual adaptation, group coordination, project management, etc.); ● Organizational mechanisms: designing and fine-tuning planning, budgeting and controlling systems, reward systems, information systems, human resource management systems, etc.; ● Organizational culture and groups and individuals attitudes: acting on people’s motivations, beliefs, ideas, and on the organization’s ideology; ● Governance model: redefining the way and to whom the organization’s management is accountable for its actions. This is something particularly critical in the healthcare sectors because of the important public trust and social accountability responsibilities of health services organizations (Shortell and Kaluzny, 2000). The contemporary pressure for greater accountability in regard to patient outcomes, treatment effectiveness, patient

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satisfaction, cost containment and ethical use of resources is posing significant challenges to the governance structures of healthcare organizations. While organizational design is an activity developed in a specific time, organizational development is a continuous process that refers to the effort of adapting the design to the changing needs and new challenges that affect organizations in the health sector. In fast-paced turbulent environments characterized by considerable change, organizations must monitor and rethink continually their functioning and strategies. This means: (a) Re-setting an organization’s goals and design to meet organizational needs and governing over a desired time-span the changes necessary for the gradual achievement of the new state. For instance, moving from a highly centralized decision-making system towards a decentralized one might require a three year span over which lower level managers are trained to assume their new roles and responsibilities. Before delegating completely the decisions, during the two or three transition years lower managers are encouraged to assume the decision cooperatively with the upper level managers. In other words they are prepared and escorted towards the new organizational design. The implication is that in the organization someone must assume the “technical” responsibility of supervising organizational development policy implementations. Once the new design is planned, the process to reach it must be managed, and it is a task that cannot be singularly played by the top management already busy with the organization’s present and future problems. Specifically in complex organizations a specific full-time role and function must be identified; (b) Recognizing the fact that new strategies can emerge from within the organization without any formal plan. Management needs then to recognize the process of emergence and to intervene when appropriate, killing off bad

emergent strategies but nurturing potentially good ones (Hill and Jones, 1992). We refer to the work of Mintzberg (1978, 1987), that has defined strategy as “a pattern in a stream of decisions or actions”. The pattern, which represents the realized strategy, is given by the combination of the realized part of the intended strategy with eventual emergent unplanned strategies. Therefore, some intended strategies, as they are realized, change form and become, in part at least, emergent, while some emergent strategies are formalized as deliberate ones. The objective is to assess whether the emergent strategy fits the organization’s needs and capabilities. This is what is called strategic management. Finally, organizational development must also be intended as the process of creating the internal conditions to facilitate the adoption and consolidation of a new design. That involves re-training people, monitoring execution, adaptation, and a specific roadmap to reach the expected and desired new dynamics (decision-making, hierarchy, planning etc.). Federico Lega

Bibliography

Brunsson N. (2007), The irrationality of action and action rationality: decisions, ideologies and organizational actions, Journal of Management Studies, 19, 29‒44. 10.1111/j.1467-6486.1982. tb00058.x. Butler R. (1991), Designing Organizations: A Decision-Making Perspective, London, Routledge. Chandler A.D. (1962), Strategy and Structure: Chapters in the History of American Enterprise, Boston, MIT Press. Child J. (1977), Organization: A Guide for Managers and Administrators, New York, Harper & Row. Galbraith J.R. (1973), Designing Complex Organizations, Reading, MA, Addison-Wesley. Hill C.W.L., Jones T.M. (1992), Stakeholder-agency theory, Journal of Management Studies, 29, 131‒154. http://​dx​ .doi​.org/​10​.1111/​j​.1467​-6486​.1992​.tb00657​.x Lawrence P.R., Lorsch J.W, (1967), Differentiation and integration in complex organizations,

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280  Elgar encyclopedia of healthcare management Administrative Science Quarterly, 12 (1), 1–47. https://​doi​.org/​10​.2307/​2391211 Lega F. (2007), Organizational design for health integrated delivery systems: theory and practice, Health Policy, 81 (2), 258‒279. Mintzberg H. (1978), Patterns in strategy formation, Management Science, 24, 934‒948. http://​ dx​.doi​.org/​10​.1287/​mnsc​.24​.9​.934 Mintzberg H. (1983), Structuring in Fives:

Federico Lega

Designing Effective Organization, Englewood Cliffs, Prentice Hall. Mintzberg H. (1987), The strategy concept 1: 5 Ps for strategy, California Management Review, 30, 11‒21. http://​dx​.doi​.org/​10​.2307/​41165263 Shortell S.M., Kaluzny D.A. (2000), Health Care Management: Organization Design and Behaviour (4th ed.), Delmar, Albany.

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healthcare expenditure. This waste is caused by a strong inefficiency in the care process. Patient-centered health systems therefore want to adapt services to the patient’s needs in order to build, together with them, a partnership (between doctor and patient) that is The concept of “patient-centered hospital” fits not synthesized in the simple provision of into the broader context of “patient-centered a service. This way of doing medicine also care”. The concept of patient-centered care shows benefits and an improvement in the is actually of recent application, first intro- satisfaction of health professionals as well duced in 2001 by the IOM (Institute of as in the quality and efficiency of health Medicine, now called the National Academy systems. The main focus of the work refers to of Medicine). Patient-centered care does not involve politics, which with its tools should implegiving the patient what they want, when they ment a series of strategies that aim to put want it or how they want it, regardless of the the patient at the center of the care process. cost of the service. The fundamental center, The how, therefore, summarizes a series of indeed, is to allow healing by referring to strategies whose main objective is to cena profound relationship based on communica- tralize the patient in the different areas. The tion and trust: on the one hand, a bidirectional concept of the patient-centered hospital and relationship of knowledge of the patient’s the patient-centered organization are intervalues is created and, on the other hand, one spersed as operational tools with which to wants to create a strong sharing and elucida- build the health system around the needs of tion of the treatment path and clinical deci- the patient as a single individual. In reality, in addition to these two sions in such a way that the person becomes approaches, there are also other tools that an active part of his treatment process. According to the definition of the IOM pursue this objective from different points of (2011), patient-centered care represents: view, such as the IT one (with the so-called “a respectful and sensitive approach to the patient-centered information systems). Due to recent demographic changes in preferences, needs and values of individual patients while ensuring that the patient’s the population, epidemiologically charactervalues guide all clinical decisions.” This ized by an increasing prevalence of chronic concept fits closely with the definition of diseases, a large number of hospitals have clinical appropriateness, that is, caring for the reacted to reform their system towards right patient, in the right place, in the right a patient-centered hospital organizational model. way. The hospital has always been conceived The scientific evidence supporting this treatment modality testifies that patient-​ as a structure in which the patient is grouped centered care improves the quality of care, on the basis of the area of competence most the outcomes of diseases as well as increases compatible with him. From the point of view the patient’s adherence to treatments and of medical evolution, this was certainly an allows better control of their chronic diseases. interesting organizational method; however, The reason why a patient-centered it exposes, at the same time, serious shortapproach is needed is based on the strong comings, mainly of an economic and organimodification of our population. In fact, the zational nature. Often, in fact, there is a lack population has an ever-increasing life expec- of a well-defined patient care trajectory that tancy, but at the same time it suffers much continually bounces from one department to more than in the past from chronic diseases another, just as there is no capacity for intethat require continuous investigations, medi- gration between the different departments. Therefore, the need was felt to move towards calizations, and therapies. Suffice it to say that in some countries innovative and alternative organizational around the world around 1 out of 5 healthcare forms. In a 2017 systematic review (Gabutti et al., services are useless, which is followed by a quantity of wasted healthcare resources that 2017), three main trajectories for changing can cover up to 40% of the country’s total the organizational approach of hospitals were identified: 281

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(1) “Progressive patient care model”: it is an approach that aims to build organizations and models that are horizontal and transversal, thus overcoming the normal organizational structure based on specialized clinical directions. The basic idea is to organize the flow of patients according to the clinical acuity and not according to the specialist branch of the primary disease. The conventional approach, divided into different departments and specialists, in fact has a high rate of waste of resources. This new organizational system, on the contrary, provides for a strong sharing of equipment, operating theaters, health workers and materials with the ultimate aim of minimizing the waste of resources. The ways in which the patient’s path is defined can be mainly two: one based on the estimated time of hospitalization and one based on the intensity of care that the patient will prospectively need at the time of hospitalization. (2) “Patient-centered approach”: this approach is also closely connected to the “progressive” model. By imagining the progressive model as a horizontal platform, we can think that the “patient-centered approach” model wants to define the flows within this platform. From the practical side, the management of patient transport, the management of logistics, pharmaceuticals, imaging or laboratory activities that revolve around the needs of different patients are being considered. This model therefore wants to tailor hospital care around the needs of patients and away from the doctor-centered vision. (3) “Lean approach”: it is strictly connected to the “progressive” model and to the “patient-centered approach” model. Within this model we include the kit of tools necessary for the second model to outline and define the patient’s flows and trajectories within the horizontal platform. This approach, therefore, has the main objective of streamlining the processes limiting efficiency: we want a smooth running of the activities, reducing the so-called bottlenecks and also waste of resources.

Gabriele Zimei

Patient-centered healthcare organizations are organizations that can be defined as “highly reliable”: similar organizations are for example aircraft carriers or operating theaters. They are organizations that base their safety, efficiency and quality on relationships with other team members. Effective communication, at the basis of the patient-centered health concept, allows adapting to unexpected requirements instead of relying only on fixed protocols. The WHO gives us an indication of how to achieve a patient-centered healthcare organization. They report the fact that there is a series of empirical evidence that testifies that accreditation, the use of report cards and guidelines work as effective strategies in making healthcare organizations more favorable to patient-centered care (WHO, 2008). Accreditation is a process that allows you to define specific quality and performance standards. The centrality of the patient in the context of a patient-centered healthcare organization, therefore, can only be promoted by including indicators relevant to patient centralization within the accreditation process. Some countries, such as Great Britain and the USA (with its mainly private health services) have introduced P4P (Pay for Performance) systems for centralization. This system involves the use of payment methods and other incentives aimed at encouraging quality improvement and patient-focused high-value care. In other countries, particularly those that have public sector dominated health systems, it seems that much more activities promoted by the government through legislation, organization and regulation focus the patient within the health system. The interventions, in the public system, therefore, must be predominantly of a political nature much more than an economic-financial one. The patient-centered approach is increasingly proving to be a need rather than an additional resource from which to draw. In fact, from the epidemiological situation of the population of our country it is clear that in the immediate future it will be necessary to implement alternative hospital models that integrate prospectively with the increasingly current, but also future, transition needs from hospital-centric care to territorial care. The construction of new hospitals and the management of organizational systems must

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therefore not be influenced by the cultural heritage of the specialist department but must be part of the broader process that sees a progressive management of the chronic patient in the area. This change of perspective will in fact require the construction of hospitals graduated on the basis of the intensity of care with the aim of defining a path for the acute patient, who will in fact remain the real and ultimate protagonist of care within the hospital. Gabriele Zimei

Bibliography

Epstein, R. M., Fiscella, K., Lesser, C. Stange, K. C. (2010). Why the nation a policy push on patient-centered care. Health affairs (Project Hope),

S., & needs health 29(8),

1489–1495. https://​doi​.org/​10​.1377/​hlthaff​ .2009​.0888 Fiorio, C. V., Gorli, M., & Verzillo, S. (2018). Evaluating organizational change in health care: the patient-centered hospital model. BMC health services research, 18(1), 95. https://​doi​ .org/​10​.1186/​s12913​-018​-2877​-4 Gabutti, I., Mascia, D., & Cicchetti, A. (2017). Exploring “patient-centered” hospitals: a systematic review to understand change. BMC health services research, 17, 364. https://​doi​ .org/​10​.1186/​s12913​-017​-2306​-0 Institute of Medicine. (2011). Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. https://​doi​.org/​ 10​.17226/​13058. World Health Organization. (2008). People-​ centred health care: technical papers: International Symposium on People-Centred Health Care: Reorienting Health Systems in the 21st Century, The Tokyo International Forum, 25 November 2007.

Gabriele Zimei

PART XIX PEOPLE A healthcare company is primarily made up of people and professionals. Creating the best working conditions and enhancing the various roles with constant evaluation and rewarding mechanisms to motivate people, allows not only more collaboration and cooperation between professionals but also an overall more efficient organization. In this cluster are grouped all the tools necessary to manage medical and non-medical human capital and to improve organizational well-being in order to attract resources and avoid dropouts.

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98. Clinical and professional engagement Clinical engagement, also referred to as medical engagement or doctor engagement, is described by Thallon (2008, p. 5) as “the degree to which clinicians are integral to the delivery of this purpose, beyond their responsibilities as contractors or employees”. The concept is not a new one – it was described as early as in 1994 as a key feature for the implementation of quality improvement activities. Employee engagement is defined as the active and positive contribution of an individual within their normal working roles to maintain and enhance the performance of the organization which recognizes this commitment in supporting high-quality care. In healthcare this concept is based on maintaining ongoing conversations between the clinical staff (that is anyone providing hands-on care) and the managers. The way in which the sides try to achieve engagement is of great importance. For instance, when managers use the “we will continue to communicate until you agree” policy, they are less likely to succeed, because this form of engagement may not meet acceptance from the independent-minded medical staff. Therefore, to reach the best outcome, the process of engagement should be based on the active and positive contribution of healthcare workers and recognition of this commitment by the leaders. Medical staff’s propensity to engage should meet the organizational responsibility to create an appropriate environment and workplace culture for this engagement. Based on the premise that engagement comes not only from the individual employee, but also the encouraging environment and cultural components created by the managers, the Medical Engagement Scale (MES) was developed. It is a useful tool to show the correlation between the level of engagement and organizational performance. Benefits of clinical engagement measured by MES that have already been shown are decreased mortality of patients, higher safety of care and its better quality. There are also studies that have managed to show the benefits of clinical engagement, in which MES was not used. For example,

in a study of 2000 Dutch doctors, Prins et al. (2010), who assessed the level of engagement with a self-report questionnaire, found that the more engaged were significantly less likely to make mistakes. This is one of the factors that explain the correlation between medical engagement and higher patient satisfaction, as well as better clinical outcomes. Other advantages include higher satisfaction levels and better motivation of the staff. That could be due to the fact that employees feel valued when they are asked for an opinion. A stronger commitment to work has also been observed, most probably because healthcare professionals find it easier to engage in projects if they played a role in the developmental process. The long list of benefits proves that medical leaders would do well to view the establishment of a medical engagement culture as a key goal. This can be achieved by various strategies. In fact, many high-performing health organizations have created their own frameworks. The US model, prepared by the Institute of Health Improvement, consists of a range of methods for engaging physicians. First of all, a common purpose, such as improvement of patient outcomes or reduction of wasted time, needs to be discovered. Values and beliefs must be reframed to make employees feel like partners and to show them that the quality of provided services depends on both the system and the individuals. “Engaging” improvement methods should be used, for instance, the right things need to be made easy to try and easy to do. The physicians have to be engaged from the beginning and feel supported during the whole process of implementing changes. Trust within initiatives, candid communication, and appreciation of physicians’ time are also important. Lastly, the engagement plan has to consist of the identification of leaders and their education. As seen above, one of the strategies is allowing healthcare professionals to lead. This is achieved by granting them managing positions. Such doctor-leaders, thanks to their clinical experience, are more credible to their colleagues, which gives them stronger support in changes they want to implement. Moreover, they have a greater chance of successful communication with hands-on workers. Nevertheless, there is a potential downside. Doctor- leaders could involve in a way that is based only on their medical

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knowledge while forgetting about wider corporate interests. Studies that have been conducted on the topic of medical leadership are conflicting, but the pros, for example, improved clinical outcomes, seem to outweigh the cons, such as diminished social and financial performance. However, medical engagement can be undermined in various ways, not only the aforementioned narrow-mindedness of doctor-leaders. For instance, if management consults the medical staff only when critical decisions are to be made – instead of keeping an ongoing dialogue – it poses an obstacle to building mutual trust and respect. Furthermore, doctors are less likely to get involved if they know the company is focused solely on the efficiency of resource allocation and not on clinical outcomes. A systematic examination of the links between medical engagement and performance showed statistically significant associations between levels of medical engagement and performance. Healthcare systems need to put emphasis on clinical engagement if they want to improve. In 2012 (p. 23) Grimes and Swettenham conducted a worldwide review of engagement in health organizations and came to the following conclusion: “A world-class high-performing health system can be realized only when physicians are more engaged”. Nevertheless, the role of physicians is not only useful for management in healthcare systems. Their specialized knowledge is also required by business entities. Healthcare professional engagement is a concept based on increasing the involvement of medical workers in the process of developing new drugs and technologies. This process is essential since it is important for the pharmaceutical companies to know the demand and for the healthcare workers to know what to offer to their patients to provide high-quality care. Doctors require data that can back up their position as authorities. On the other hand, only good communication can guide pharmaceutical companies toward the development of products in demand. For instance, the needs of healthcare professionals have changed due to the pandemic. Nowadays, self-administered drugs and tools for remote monitoring are more valued than ever before. The cooperation between pharmaceuticals and physicians used to rely on sales field reps. However, the landscape is changing towards Martyna Emilia Pszczolka

direct contact. In one survey almost 50% of healthcare professionals declared that they could imagine a world without reps (Kotcher et al., 2021). This means that pharmaceuticals need to find new channels to communicate with doctors and indeed they have been doing so, for example by creating apps containing details about drugs and their interactions or even ones allowing the physicians to send their remarks or report adverse effects. The COVID-19 pandemic led to an even higher demand for new methods of communication by causing a disruption of traditional channels. We can already see that the “new normal” has accelerated the introduction of changes. Nowadays, most of the sales reps organize virtual meetings with healthcare professionals (a shift from 36% before the COVID-19 pandemic to 65% in May‒June 2020). This channel is here to stay – 87% of healthcare workers want either all virtual or a mix of virtual and in-person meetings after the pandemic (Charm et al., 2020). Use of a combination of face-to-face and digital engagement has also been proven to lower the cost of interactions, which led to improvement of cost efficiency. Nevertheless, healthcare professionals’ engagement may also bring a certain risk. A study has shown that industry-sponsored continuing medical education leads to less rational prescribing habits. Gift acceptance and the belief that one is receiving adequate data from the reps also cause changes in prescribing habits. As proven above, the physician’s role does not end by the patient’s bed. Healthcare professionals’ engagement is important both for the healthcare organizations and the pharmaceutical industry. Nonetheless, as shown in many studies, the cooperation methods must be chosen carefully to lead to the best outcome. Martyna Emilia Pszczolka

Bibliography

Berwick D. M. Eleven worthy aims for clinical leadership of health care reform, Journal of the American Medical Association, 1994;272:797‒802. Bonias D., Bartram T., Leggat S. (2011) Benefits and barriers of clinical engagement: A qualitative study of perceptions of medical practitioners and human resource managers in three

Clinical and professional engagement  287 Victorian public hospitals. https://​www​.anzam​ .org/​wp​-content/​uploads/​pdf​-manager/​459​ _ANZAM2011​-118​.PDF (accessed: 28.3.2023) Charm T., Coggins B., Robinson K., Wilkie J. (2020, August 4) The great consumer shift: Ten charts that show how US shopping behavior is changing. McKinsey&Company – Growth, Marketing and Sales. https://​ www​ .mckinsey​ .com/​capabilities/​growth​-marketing​-and​-sales/​ our​-insights/​the​-great​-consumer​-shift​-ten​ -charts​-that​-show​-how​-us​-shopping​-behavior​ -is​-changing​#/​ Clark J. (2012) Medical engagement: too important to be left to chance. London: The King’s Fund. Grimes K., Swettenham J. (2012) Compass for transformation: Barriers and facilitators to physician engagement, Research paper prepared for the Regina Qu’Appelle Health Region. https://​www​.rqhealth​.ca/​service​-lines/​ master/​files/​compass​.pdf Gruner L. (2008) Doctor engagement workshop: supporting doctors in enhancing clinical performance: benefits and strategies. Quality Directons Australia. Guide to Digital HCP Engagement (2021) Veeva, https://​www​.veeva​.com/​eu/​wp​-content/​ uploads/​2019/​04/​Guide​-to​-Digital​-HCP​ -Engagement​.pdf (accessed: 6.4.2021) HealthCasts. (2016) 5 key physician insights pharma needs to know. https://​www​.slideshare​ .net/​DebraHarris9/​he​althcastsw​hitepaper5​key​ phys​icianinsig​htspharman​eedstoknow Increase market performance with healthcare professionals engagement, Atrivity, https://​ blog​.atrivity​.com/​better​-market​-performance​ -with​-healthcare​-professional​-engagement (accessed: 6.4.2021) Kirkpatrick I., Kuhlmann E., Hartley K. et al. Medicine and management in European hospitals: a comparative overview. BMC Health Serv Res, 2016;16: 171. https://​doi​.org/​10​.1186/​ s12913​-016​-1388​-4 Kotcher J., Maibach E., Miller J., Campbell E., Alqodmani L., Maiero M., Wyns A. Views of health professionals on climate change and health: a multinational survey study. The Lancet. Planetary Health, 2021;5(5):e316–e323. https://​doi​.org/​10​.1016/​S2542​-5196(21)00053​ -X Lieb K., Scheurich A. Contact between doctors and the pharmaceutical industry, their perceptions,

and the effects on prescribing habits. PLoS One, 2014;9(10): e110130. Published online 2014 Oct 16. doi: 10.1371/journal.pone.0110130 McCarthy S. (2013) Medical engagement and the NSW Whole of Hospital Program: A summary of existing literature discussing medical engagement. https://​www​.health​.nsw​.gov​.au/​wohp/​ Documents/​medical​-engagement​-summary​.pdf (accessed: 28.3.23) Parvin S. (2009) The Medical Engagement scale survey. Bournemouth, The Royal Bournemouth and Christchurch hospitals NHS foundation trusts. Prins J. T., Hoekstra-Weebers J. E. Burnout and engagement among resident doctors on the Netherlands: a national study. Med Educ., 2010;44:236–247. Reinertsen J. L., Gosfield A. G., Rupp W., Whittington J. W. (2007) Engaging physicians in a shared quality agenda. IHI Innovation Series White Paper. Cambridge, MA: Institute for Healthcare Improvement; 2007. Reinventing Relevance New Models for Pharma Engagement with Healthcare Providers in a COVID-19 World (2020) Accenture Healthcare Provider Survey, May 2020. Sarto F., Veronesi G. Clinical leadership and hospital performance: assessing the evidence base. BMC Health Serv Res., 2016;16(Suppl 2): 169. doi: 10.1186/s12913-016-1395-5 Spurgeon P., Clark J., Wathes R. Medical engagement and improving quality of care. Future Hosp J., 2015;2(3):199‒202. Spurgeon P., Mazelan P. M., Barwell F. Medical engagement: a crucial underpinning to organizational performance. Health Services Management Research, 2011;24(3): 114‒120. Subramaniam H. (July 16, 2020) Healthcare professional engagement in and beyond the “New Normal”. https://​www​.iqvia​.com/​locations/​asia​ -pacific/​blogs/​2020/​07/​healthcare​-professional​ -engagement​-in​-and​-beyond​-the​-new​-normal (accessed: 6.4.2021) Thallon J. (2008) Clinical Engagement Strategy, Action Plan, National Health Service. West Kent, Primary Care Trust, United Kingdom. https://​www​.anzam​.org/​wp​-content/​uploads/​ 2018/​02/​ANZAM​-2017​-133​.pdf The Health Foundation (2013) Getting clinical leaders on board. health.org.uk

Martyna Emilia Pszczolka

99. Great Place to Work® Great Place to Work is an international brand founded in San Francisco in 1992 dedicated to the analysis of the culture of the working environment and support to management and the human resources in the creation and definition of a great place to work. The aim of the company, from research to training, is to support managers and the human resources sector in creating and maintaining an excellent working environment offering a path that starts from the Great Place to Work® certification®, which allows to be recognized as a quality working environment, to arrive at the publication of the organizations in the rankings of the best jobs in nearly 60 countries around the world. These services’ cost is based on the total employee headcount within the organization and the package chosen. ®

For All™ Methodology

The For All™ Methodology aims to put the person at the centre of every process, trying to ensure that every single employee, regardless of personal characteristics, role in the company and tasks performed, is having a consistently positive experience at work. According to this practice, a great workplace is an environment where employees trust the people they work for, have pride in what they do and enjoy the people they work with. This description underlines that what distinguishes excellent work environments is the quality of the relationships that are lived in them and identifies three fundamental relationships: between employees and managers, towards their work and the company, between colleagues. Good working environments are therefore the result of these daily relationships experienced by people in the company and trust is the key factor common to these relationships. For this method the companies that nurture the culture of trust, in which everyone is motivated to give their best because they feel important, will have superior financial performances.

Great Place to Work certification®

The Great Place to Work certification® represents the opportunity for a company to be recognized as a quality working environment, a “great place to work”. Valid for one year, it requires a minimum of 10 employees, and it is handed over as the procedure closes. The analyses use the “Trust Index” method which explore the employee perception about the working environment. The opinions of company collaborators are collected through standard surveys, anonymous questionnaires that consist of about 60 questions, based on five components of trust identified by Great Place to Work: ● Pride: individual work, working group, business image; ● Cohesion: confidence, reception, cooperation; ● Fairness: fair treatment, impartiality, justice; ● Respect: professional development, involvement, care; ● Credibility: two-way communication, competence, integrity. All employees are invited to respond, above 1000 employees a random and representative sample can be calculated. To be considered valid, a minimum participation rate is required depending on the number of employees in the organization. To be certified, an organization must achieve a minimum score of 65% positive responses to the Trust Index© survey. Results, analyses and reports return to management and may become useful tools for the identification of gaps, improvement of the workplace culture and growth of the company. When working in an environment where there is respect and trust in relationships between people, healthy processes are in fact fed that lead to a natural increase in motivation, participation and pride in being part of the company. Becoming a great place to work, means to be recognized by everyone as an excellent working environment attentive to people’s well-being, that cares about the quality of organizational culture and work environment

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and that has a relational model based on mutual trust. It attracts talent, increases the motivation of its employees and employer branding.

Best Workplaces Award®

Every year among all certified organizations, those that have achieved the best results are selected and included in the Best Workplaces Ranking® of the best companies for which to work. To be included, organizations must obtain: 65% positive responses to the Trust Index© and a minimum score of 30/60 in the Culture Audit©. The Culture Audit© is a document with 15 open questions about the corporate human resources policies compiled by the company management. It is used to analyse the company and HR management procedures and it consists of two parts that are written by the organization itself (mostly by a Great Place to Work project group consisting of employees with different roles). Culture Audit part 1 consists of factual data such as training hours, demographic characteristics, and absenteeism rate. Culture Audit part 2 consists of open questions about the nine themes: 1. Recruiting & Welcoming: “How do you recruit people who fit within the organizational culture? And how do you welcome new employees?” 2. Inspire: “How do you inspire employees that their work has more meaning than just a job?” 3. Speaking: “How do you regularly and transparently share important information?” 4. Listening: “How can employees give feedback about their work (environment), are they involved and can they indicate undesirable situations?” 5. Thank you: “How do you show appreciation for extra commitment, good results or other employee successes?” 6. Worries: “How do you help employees find a work–life balance? And how do you support the employees during and after important events?” 7. Developing: “How do you let employees develop their talents and increase their personal growth?”

8. Celebrating: “How do you celebrate successes and stimulate a team feeling?” 9. Sharing: “How do you promote a sense of honesty and transparency about pay? And how can employees participate and contribute to Corporate Social Responsibility policy?” This file is evaluated by Great Place to Work on the basis of the international rating grid VOAHIQ. The criteria measures Variety, Originality, All-Inclusiveness, Human Touch and Integration. The label of Best Workplaces Award® requires a minimum of 20 employees for the application, it is valid for one year and the winners receive media coverage from Great Place to Work partners which guarantees companies an important visibility. Getting recognized also means joining the community of companies that employees want to work for, building companionship and employee pride, reaching more job seekers, recruiting the best talent and retaining the top employees.

Great Place to Work® origins

In 1981 two journalists, Robert Levering and Milton Moskowitz, were asked by a New York publishing house to write a book entitled The 100 Best Companies to Work for in America. The publication of their book in 1984 laid the first bricks of the Great Place to Work® project. In 1988, they published A Great Place to Work: What Makes Some Employers So Good – And Most So Bad? and founded Great Place to Work® in 1992. Since 1992 the company surveyed about 100 million employees around the world and discovered that an environment where it is good to work depends on the quality of relationships, at the heart of which we find confidence, pride and conviviality. Great Place to Work® defined what makes a great workplace: trust. In 1997, in partnership with Fortune and Exame, Great Place to Work® produced the world’s first top 100 companies in the United States. In 2001, the European Commission launched a call for tender and Great Place to Work® published the first European Prize.

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Today, Great Place to Work® is present in nearly 60 countries. Based in San Francisco, the headquarters is headed by Michael Bush. Federica Natarelli

Federica Natarelli

Bibliography

Great Place to Work, https://​www​.greatplacetowork​ .com and https://​www​.greatplacetowork​.it. Levering, R. (1988). A Great Place to Work: What Makes Some Employers So Good – And Most So Bad? Random House. Levering, R. & Moskowitz, M. (1984). The 100 Best Companies to Work for in America. Plume Books.

100. Magnet hospital A Magnet Hospital (MH) is a healthcare facility characterized by high nursing standards and a good working environment for nurses. To obtain this status, hospitals and healthcare facilities must meet the criteria of the Magnet Recognition Program (MRP) of the American Nurses Credentialing Center (ANCC). If the criteria are met, a four-year certification is issued following a visit to the facility. The concept of MH originated in the USA during the 1980s (so called because of their ability to attract healthcare staff at a time of acute shortage of nurses). Following a survey by the American Academy of Nursing (AAN) it emerged that the model led to an increase in job satisfaction and autonomy, a reduction in burnout and turnover rates and an increase of staff retention. The first hospital was accredited in 1994, currently there are 549 accredited facilities in the United States (about 10% of US hospitals), the model has also been recognized in other countries, including, England, Australia, New Zealand, Singapore and Lebanon.

Magnet Hospital status and benefits

In order to obtain the MH status, facilities must demonstrate a high standard of excellence measured in five areas: 1. Transformational leadership; 2. Structural empowerment; 3. Exemplary professional practice; 4. New knowledge, innovations improvements; 5. Empirical results.

and

With the evolution of technology, healthcare and nursing are involved in significant changes. Patient management has evolved, relying on data and on the availability of new drugs, organizations must therefore undergo a process of transformation in order to grasp and meet the challenges that the future poses. In the process of organizational transformation attention must be paid to innovation and structural enhancement, through the dissemination of good practice and professional development. The model identifies the nurse as a key actor with regard

to institutional updating and policy development aimed at improving patient-relevant outcomes and practices. Practices therefore play an important role in the recognition of certification, they should be understood as staff competencies, autonomy and relationships and communication between nurses and other medical teams. Numerous studies have shown that there is a correlation between MH status and better clinical outcomes for patients through a high standard of care. From the point of view of the facility, obtaining MRP certification sends a strong signal to patients of the organization’s focus on excellence and innovation in patient and nursing care. According to a study conducted by the Robert Wood Johnson Foundation, becoming an MH leads to an increase in net patient revenue by an average of 3.89% against a cost increase of 2.46% (Jayawardhana et al., 2014). This is mainly due to the money and time saved through strong staff retention, but also from producing better outcomes leading to timely patient discharges. On the patient side, the main benefits lie in the low mortality rates that accredited facilities have and better health outcomes. A study carried out in 2015 on the outcomes of surgical patients in Magnet and non-Magnet hospitals showed that patients in Magnet hospitals were 7.7% less likely to die 30 days after surgery and 8.6% less likely to die as a result of postoperative complications (Friese et al., 2015). As for nurses, working in a MH can mean working in a place that values high quality care and encourages innovation. According to a study by American Nurse Today, staff at Magnet hospitals are more committed to their work, leading to better patient outcomes. The study found lower rates of occupational accidents and injuries and lower rates of biohazard exposure, making nurses more likely to stay at the facility, with turnover rates 1.7% lower than the industry average.

Photograph of the current situation and lines of future development

At present, the model certainly remains very widespread and developed in the American context, although internationally, a number of health systems are looking at the model

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as a key to improving the quality of care provided and at the same time the working environment. The first hospital outside of the American context to be recognized as MH by the ANCC was Nottingham City Hospital (UK), which saw significant improvements in the quality of care and working environment. The model, irrespective of the context in which it is adopted, succeeds in counteracting the disempowerment of the nursing profession within healthcare facilities by ensuring a satisfactory quality of working life through management autonomy, shared communication and control and staff empowerment. The strengths of the model were identified in 2001 by Schmalenberg and Kramer (see Kramer et al., 2008) using the Nursing Word Index (NWI) as a tool. The points recognized by nurses are: a more productive working environment; active staff training; greater expertise of nursing skills to support inexperienced staff; a greater degree of autonomy; healthier working environments; adequate staffing levels both in terms of quantity and quality of the care team; a patient-centered care culture. MH can therefore be implemented to realize a paradigm shift from a disease-centered care model to a patient-centered care model. An Italian case study of the application of the model is the one carried out by the university hospital Santa Maria della Misericordia in Udine, which has implemented a process of transfer and adaptation of the U.S. model. Unlike other international contexts, the hospital has not requested ANCC accreditation, but has decided to undertake a process of improvement by adapting the model to its organizational context by developing its own lines of action. From this, it can be seen that the transfer of the model to other contexts does not necessarily mean that accreditation is the only course of action. The model can also be adapted to one’s own reality, considering the differences that may lie in different regulations, different values, objectives, logics or a different structure of the national health service, while maintaining an

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adherence to the founding principles of the MH model. An interesting line of development of the MH model could be to be able to systemize the model, in healthcare systems the valorization of professionals and their retention does not only concern the nursing professions, but also the world of other professions that gravitate within a healthcare company, such as researchers and clinicians. A future development could be to overcome a critical point of the model, that is, the univocality of the perspective considered, within the healthcare companies one has to look at it from a systemic perspective, involving all professions. Michele Giovanni Cusmai

Bibliography

Friese C.R., Xia R., Ghaferi A., Birkmeyer J.D., Banerjee, M., Hospitals in ‘Magnet’ program show better patient outcomes on mortality measures compared to non-‘Magnet’ hospitals, Health affairs (Project Hope), 2015;34(6):986–992. https://​doi​.org/​10​.1377/​ hlthaff​.2014​.0793 Gagnon D., What is a Magnet Hospital?, Manchester, SNHU, 2021. Guarinoni G.M., Allovisio M., Salute e proffessione infermieristica, Riflessioni sistemiche, 2016;n. 15, Dec. Jayawardhana J., Welton J.M., Lindrooth R.C., Is there a business case for Magnet hospitals? Estimates of the cost and revenue implications of becoming a Magnet, Medical care, 2014;52(5):400–406. https://​doi​.org/​10​.1097/​ MLR​.0000000000000092 Kramer M., Schmalenberg C., Maguire P., Brewer B., Burke R., Chmielewski L., Cox K., Kishner J., Krugman M., Meeks D., Waldo M., Structures and practices enabling staff nurses to control their practice, Western journal of nursing research, 2008;30:539‒559. 10.1177/0193945907310559. Lesly A.K. et al., Nurse outcomes in Magnet and non-Magnet hospitals, Journal of nursing administration, 2012;42:S44‒49. DOI: 10.1097/01 Palese A. et al., Un’esperienza di trasferimento e adattamento del modello magnet hopital nel contesto italiano, Mecosan, 2010;XIX, n. 74.

PART XX PERFORMANCE The term performance has undergone a profound evolution over the years. From the prevailing self-referential conception of public administrations with an orientation to tasks and a consideration of the citizen in a “subject” position for which all attention is focused on the adequate use of resources, we have moved on to the progressive centrality of the citizen, seen as a customer of the administration and not just as a simple recipient of services, shifts the focus on the quality of services provided and production efficiency: result orientation as task orientation has been progressively replaced. Measuring and interpreting performance is a key process in every business and healthcare organizations don’t make an exception. Performance management allows to see the “bigger picture” and provides early warnings for potential problems, giving the top management the chance to make adjustments and to keep the organization on track. Performance management is also an important element to determine how to allocate resources and efforts and it now measures not only clinical outcomes but the patients’ entire experience.

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101. Balanced scorecard in healthcare organizations Performance measurement and management systems and tools traditionally focused on financial accounting indicators. At the end of the 1980s it was clear that the reliance on financial measures alone was insufficient for managing complex and everchanging organizations in every kind of industry. The traditional control tools had to expand to incorporate the evaluation of the organizations’ intangible assets, including distinctive internal capabilities, brand image, satisfied and loyal customers, motivated and skilled employees, and so on. In fact, these specific intangible resources cannot appear on a balance sheet – and consequently in the financial measures – although they are crucial for success in the competitive environment (Kaplan & Norton, 2004). Moreover, the financial measures are backward-looking and show the effectiveness of past decisions, but to survive in a dynamic environment it is necessary to introduce forward-looking indicators that determine the expected trajectory of the future performances (Kaplan & Norton, 2001). In the context of healthcare organizations, it is essential to find a balance between the response to the patient needs – achieving high levels of quality, safety, and clinical outcomes – and the economic and financial success, that is a fundamental condition for the sustainability and feasibility in the long-run of the organization. Additionally, healthcare entities are brain-intensive organizations in which intellectual capital and knowledge-based assets are crucial for the delivering of health services and the achievement of their specific mission. The healthcare sector is also characterized by an extremely dynamic environment, where technology, medicine, demographic and social conditions, direct competitors or substitute services, policies and regulatory framework, may change very fast; so, it is necessary to use metrics and evaluation tools that help healthcare managers to communicate and execute strategy, monitor both the validity of the strategic objectives and their effective implementation, and eventually adapt the strategy to changing conditions.

To face these management challenges, in 1992 Kaplan and Norton created the Balanced Scorecard (BSC). It is a multidimensional framework that allows the translation of corporate strategy through a coherent set of measurements defining long-term objectives and mechanisms to achieve them. The BSC provides a balance between financial and non-financial measures, short- and long-term objectives, and retrospective and forecast indicators. A multidimensional framework is also useful to respond to the different accountability needs of the several constituents of an organization, each with its specific interest. Since 1992, the BSC was implemented in several different industries and organizations, starting from the private sector companies to non-profit and public entities. The BSC has been developed for the implementation in healthcare organizations since the mid-1990s. According to recent reviews on the BSC in healthcare (Gonzalez-Sanchez et al., 2018; Bohm et al., 2021), the contributions of the first years focused on the applicability of this framework on healthcare organizations; since 2000 there was an increase of the interest of scholars and practitioners in the theoretical and empirical implementation of this tool in the healthcare field. To achieve a successful implementation of the BSC, Kaplan and Norton (2001) suggest five core principles that may also apply to healthcare organizations: (1) translate strategy into operational terms; (2) align the organization to the strategy; (3) make strategy everyone’s job; (4) make strategy making and execution a continual process; (5) mobilize change through executive leadership. The first condition is met when the framework is driven by and aligned with the organizational mission, vision, and strategy. In fact, the motto of the BSC is “translating strategy into action” through a set of measures and strategically aligned objectives. These measures are built around (at least four) different perspectives corresponding to the dimensions of performance that give top managers a comprehensive view of the organization. The traditional four dimensions of performance of the BSC are: (1) Financial perspective, that explains the generated economic value for the shareholders in the case of private healthcare organizations and the finan-

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cial health (finding a balance between revenues and costs, through an increase of revenues and maintaining budgetary control on costs) for non-profit and public entities. In this case, indicators come mainly from financial accounting systems; (2) Customer perspective, that focuses the attention of managers on how the final customer (mainly the patient) perceives the value proposition and the brand image of the organization, through different indicators such as market share, customer satisfaction, customer retention and acquisition, account share and revenues per customer; (3) Internal business process perspective, that includes the main relevant practices for improving the production and value chain of the healthcare organization: (a) innovation process, that concerns the ability to introduce new services, techniques, and products to existing and new potential targets of patients; (b) operations management, that aims to improve efficiency and effectiveness in patient flow logistics and supply chain management; (c) customer relationship management, with an improvement of the process for follow up services; (4) Learning and growth perspective, in which are considered the main intangible assets of a healthcare organization required to support the strategy: (a) human capital, such as people, knowledge, skills, talent and know-how; (b) information capital, that includes the availability of information systems and digital technologies, databases and network; (c) organization capital, that is the capacity of the organization as a whole to be aligned with the strategy. It includes the organizational culture (the internalization of mission, vision, and core values), the leadership (the availability of leaders to reach predetermined goals), the alignment of goals and incentives with the strategy, and the effectiveness of teamwork (the ability of sharing knowledge and skills between professionals). The perspectives are linked together by a series of cause-and-effect relationships

through the development of a strategy map. According to Kaplan and Norton (2004), managers cannot consider the importance of an intangible resource separately from other assets of the company, because the value does not reside in any individual intangible asset, but it arises from the entire set of assets and the strategy that links them together. For this reason, the BSC strategy map provides a framework to specify in visual terms how strategy links intangible assets to value-creating processes. In the traditional model, the strategy map illustrates the cause-and-effect logic by which intangible resources and employee efforts (learning and growth perspective) will generate first improvements of the internal processes, secondly more satisfied customers, and – at the end – the achievement of economic value (financial perspective). Moreover, it gives a way to analyse and show how the goals of different functions are interrelated to support the overall business strategy. For public and non-profit healthcare organizations, some scholars offered a rearranged causal order of the BSC perspectives (Niven, 2008; Lilian Chan, 2009; Trotta et al., 2013) in which the financial perspective appears as a causal antecedent of internal business process perspective, since not only the learning and growth perspective contributes to efficient and effective internal processes, but also financial health. The financial perspective, in the case of healthcare organizations, cannot be considered the end result, but the organizational strategy may also be directed towards increased revenues and budgetary control, as financial resources are required to develop the intangible assets of the organizations. Furthermore, the BSC implementation practices in healthcare show many times a complete reworking of the original framework in both the number and the types of perspectives, usually by adding other dimensions (for example, teaching and research perspective in the case of academic medical centers, environmental relations perspective, clinical perspective, etc.) or by changing the labels of the four traditional ones. Following the decision on the perspectives and the building of the strategy map, it is necessary to identify the most important areas (Key Performance Areas – KPAs) on which to measure performance within the perspectives. The final step in the logical Anna Prenestini

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process of the BSC development focuses on the identification of Key Performance Indicators (KPIs) that monitor the level of achievement of the defined performance for each predefined KPA. Managers must set measures (i.e., quantitative values that can be scaled and used for purposes of comparison) in a proper way to ensure that people understand the intended strategy and achieve performance goals. While organizations in their day-by-day operations often analyse a huge quantity of data through hundreds of indicators, the BSC forces managers to adopt a limited number of measures aligned with the strategy. The measures included in the BSC are designed to complement, not replace, the diagnostic measures used in daily operations. Kaplan and Norton (1992) claim that the BSC minimizes information overload by limiting the number of measures to the few that are organically related in a cause-and-effect relationship. Moreover, a good BSC should have a mix of core outcomes measures (lagging indicators) and performance drivers (leading indicators). Lagging indicators are correlated with economic value and reflect the goals of many strategies but they do not communicate how the outcomes are to be achieved. Leading indicators inform the managers of how to produce the desired results and are usually input and process measures; they represent the short-term mechanisms to achieve the outcome measures. The second principle (align the organization to the strategy) focuses on the communication of the BSC to ensure that every part of the organization is aligned. The time sequence requires first to transfer the BSC corporate scorecard, then to develop the BSC and measures for each function (represented by the clinical and administrative directorates, or the specialty or work units). The third principle (make strategy everyone’s job) is an essential part of the BSC model, because reaching the goal to create “strategic awareness” and to spread it throughout the entire organization is one of the conditions for the success of the BSC project. In this case, it is crucial to assign accountability to the different functions and leaders, to align the personal objectives with the organizational ones, also through the incentive system. The fourth principle (make strategy making and execution a continual process) explains one of the basic characteristics and purposes Anna Prenestini

of BSC, which should not be understood as a single project in itself but as the creation of a system of continuous learning. This can be done through integration with other business operational mechanisms and through systematic review of the process involved in implementing the BSC. This is not a static document: Performance targets should also be tested and revised according to environmental changes. The fifth principle (mobilize change through executive leadership) ensures the necessary legitimization of the methodology through the involvement of the leadership. The BSC is a cultural model of strategy orientation and accountability and therefore it needs to be strongly legitimized and used in the first instance by top management and, then, middle management. In the implementation of the BSC, the healthcare organizations may use the tool with different aims and scope at different levels of sophistication (Lawrie & Cobbold, 2004; Gonzalez-Sanchez et al., 2018): (1) at the bottom level, the organization can only integrate financial with non-financial indicators in the four traditional or different perspectives; in this case, one of the issues is that healthcare organizations may simply rearrange previous measures into the new perspectives without any cause-and-effect link between indicators and the strategy; (2) the middle level focuses on the cause-and-effect relationships between measures and the strategic objectives; at this stage the BSC uses the strategy maps to illustrate these links; (3) the third level is characterized by the development of the BSC that includes plans of action, targets, and incentives to align the individual and organizational goals. The risk of not obtaining an adequate sophistication is that BSC can be used just as a framework for integrating indicators and not as a real strategic control tool. Finally, Kaplan and Norton (2001) highlighted some factors that may cause the failure of the BSC, mainly categorized in transition, design, and/or process issues. In the case of healthcare organizations, the transition of the people who are the main sponsors of the BSC may determine the dismissal of the tool. Transition occurs also in the case of mergers and acquisitions. Second, the inability of the organization to design and align their measures to the strategic plans can invalidate the efforts in the administration of the data and

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indicators for an effective implementation of the strategies. Third, staff groups or functional officers may introduce the BSC but the lack of commitment and the personal involvement of the CEO and senior management in the process of development can cause its failure. Moreover, the BSC cannot be introduced only for tactical reasons, such as to change compensation system, to reinforce a quality management system, or to change a reporting system, because none of these purposes is so strong to transform and align an organization for effective strategy execution. Concluding, the BSC can be considered an important tool for strategic control due to its main characteristics of multidimensionality, flexibility in the design of the different perspectives, and alignment of the organization to strategy execution. Today the emerging technologies and performance management tools such as system dynamics techniques, machine learning, and others, may help in the design and maintenance of the BSC, its indicators and the forecast of cause-and-effects relationships. The main key to successfully introduce the BSC in healthcare organizations and overcome the hindering factors remains leadership, because it is required to translate the strategy into objectives and measures, and then accompanying interactively the process of performance management and control through the BSC. Anna Prenestini

Bibliography

Bohm, V., Lacaille, D., Spencer, N., & Barber, C. EH. (2021). Scoping review of balanced scorecards for use in healthcare settings: develop-

ment and implementation. BMJ Open Quality, 10:e001293. Gonzalez-Sanchez, M. B., Broccardo, L., & Martin Pires, A.M. (2018). The use and design of the BSC in the health care sector: a systematic literature review for Italy, Spain, and Portugal. International Journal of Health Planning and Management, 33:6‒30. Kaplan, R. S., & Norton, D. P. (1992). The Balanced Scorecard. Measures that drive performance. Harvard Business Review, 70(1):71‒79. Kaplan, R. S., & Norton, D. P. (1996). The Balanced Scorecard: Translating Strategy into Action. MA: Boston, Harvard Business School Press. Kaplan, R. S., & Norton, D. P. (2001). The Strategy-Focused Organization: How Balanced Scorecard Companies Thrive in the New Business Environment. MA: Boston, Harvard Business School Press. Kaplan, R. S., and Norton, D. P. (2004). Strategy Maps: Converting In-tangible Assets into Tangible Outcomes. MA: Boston, Harvard Business School Press. Lawrie, G., & Cobbold, I. (2004). Third-generation balanced scorecard: evolution of an effective strategic control tool. International Journal of Productivity and Performance Management, 53(7):611‒623. Lilian Chan, Y. (2009). How strategy map works for Ontario’s health system. International Journal of Public Sector Management, 22(4):349‒363. Niven, P. R. (2008). Balanced Scorecard Step-By-Step for Government and Nonprofit Agencies. NJ: Hoboken, John Wiley & Sons. Trotta, A., Cardamone, E., Cavallaro, G., & Mauro, M. (2013). Applying the Balanced Scorecard approach in teaching hospitals: a literature review and conceptual framework. International Journal of Health Planning and Management, 28:181‒201.

Anna Prenestini

102. Budgeting (financial vs operational) The budget is a fundamental tool for planning activities that healthcare companies (like all companies in general) use in order to carry out planning and control activities aimed at achieving efficient and effective management. The budget is the means by which the healthcare company forecasts economic/ financial trends. The purpose of the budget is to establish the objectives to be achieved within a given time frame (usually annual, but sometimes also multi-year), indicating the resources to be employed and the actions to be taken to achieve them. The management of the budget (Figure 102.1) makes it possible to periodically compare the intermediate results achieved with the final objectives and to take corrective action in the event of major deviations.

Figure 102.1

Management of a budget

The budget sheet is the operational tool in which the objectives to be pursued are explained. Budget sheets must also highlight: ● The expected qualitative and quantitative levels of activity; ● The indicators by which the achievement of objectives is measured; ● The organizational modalities by which the objectives should be realized; ● The actors involved and their level of responsibility. Proper budget management requires that the responsibility centers for management control be defined in advance. The budget in

this perspective often becomes an excellent accountability and motivation tool for the managers and operators involved, who must monitor the development of activities and the resources invested to support them.

The budget process in healthcare companies

The first stage of the process is to establish the decision-making space entrusted to the various actors involved, that is, to clarify how the budget system fits into the relationship between strategic management and responsibility centers and how budget objectives are to be managed (flexible or rigid). Having completed this first phase, it is necessary to define how the budget process is to be conducted. In this sense, there are two reference models: ● Top-down (corporate strategic management defines the objectives of the responsibility centers); ● Bottom-up (responsibility centers participate in target setting). Recent evolutions inherent in the budget formulation process see bottom-up planning implemented in most cases, as opposed to “waterfall” budgets dropped from the top through top-down systems. This is implemented to encourage the participation of individual units in the discussion of objectives, which will then be transformed into budget sheets for the performance monitoring of each unit. In the case of bottom-up configurations, the budget sheets are sent directly to the centers of responsibility, the heads of the centers formulate budget proposals, which are then verified on the basis of their economic-financial accounts and the consistency of the proposed objectives with the corporate planning. This is followed by the negotiation of the budget proposals and ultimately the implementation of the overall budget through approval by the Executive Board.

The budgeting and planning system

The budget within healthcare companies performs a planning function by means of a process of forecasting the resources required

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to achieve certain objectives according to the established order of priority. Budgeting therefore constitutes the core of the planning and control process in hospital companies, this process involves the entire organizational structure, in this sense we speak of a budgeting system. Budgeting and budget have two different definitions that are closely interconnected: ● Budgeting is the formal process by which the various organs of a company periodically reach an agreement on the use and allocation of available resources, define objectives and results, in order both to evaluate the performance of each organ and to improve the decision-making process (Amigoni, 1979); ● The budget is the document in which these objectives are made explicit, just as the periodic reports in which the deviations between objectives and results are analysed are formal communication tools at certain stages of the process that constitutes the control instrument (Amigoni, 1979). It can therefore be asserted that the budget is the company management programme expressed in economic-financial terms, aimed at guiding and directing the activities of the managers and making them responsible for short-term objectives declined in a long-term strategic plan. In turn, in healthcare companies, it constitutes the set of factors that, for each individual center of responsibility, define the objectives in terms of results to be achieved and resources related to them.

Operational budget

The operational budget concerns the consolidation of the costs and revenues envisaged in the various departmental (sectoral) budgets, thus providing an overall picture of the company’s performance in such a way as to enable the assessment and monitoring of each individual center of responsibility as regards the achievement of the general objectives, also enabling a check on the economic feasibility of the planned action programmes. The budget therefore represents the available capital with respect to the expenditure forecast for the entire realization of the

objectives, and therefore concerns the items strictly linked to the profit and loss account. The operational budget is therefore the operating planning and control tool for the responsibility centers to which the expected qualitative/quantitative objectives and the related investment and current resources are assigned. It is the company’s operational mechanism for guiding behavior towards the assigned objectives, seeking to pursue a balance between the results obtained and the (limited) resources allocated. The operational budget is fully represented in the budget sheet for each corporate center of responsibility; this sheet is made up of a direct health costs and revenues sheet and an objectives sheet (classified by performance area).

Financial budget

The financial budget, unlike the operational budget, makes it possible to verify the financial (rather than economic) feasibility by contrasting cash inflows and cash outflows, quantifying the impact of corporate choices on the financial and asset structure of the healthcare company (cash inflows/outflows, payables and receivables). The financial budget thus constitutes a document that reports the values of a financial nature expected for the following financial year. The financial flows reported in this budget can in turn be distinguished in: ● Cash flow statement: reconstructs monetary flows, resulting from the difference between all monetary income and expenditure of a company over the period under analysis; ● Cash budget: forecasts cash needs or surpluses, thus allowing appropriate actions to be planned in advance.

The role of management control in healthcare companies

With a view to the budget, Management Control has gone beyond the mere accounting framework, becoming within the decision-making process a tool for guiding the organization, thus becoming a set of rules, principles and tools available to the management in order to make correct decisions in relation to the set objectives. Management Control therefore has the function of guiding the organization, the Michele Giovanni Cusmai

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budget allows it to guide the remuneration of results, in turn, these objectives (included in the budget sheet) must be assigned to the correct operational units/professional figures. In this sense, it is necessary to specify what the criteria are for evaluating the objectives, also indicating the source of the information and data. This fosters a process of accountability involving the Directors of an operational unit or a responsibility/expense/cost center. This process, as indicated above, should develop in a bottom-up logic, through the presentation of the budget by each unit to the superior hierarchical unit that approves or modifies the proposal. This allows the involvement and negotiation between operational units placed on different hierarchical levels. Management Control thus has the key role of “facilitator” of the processes of assigning responsibilities and of the interaction

Michele Giovanni Cusmai

between different hierarchical units in the phase of budget formulation and objective assignment, playing a key role in the monitoring activity. Michele Giovanni Cusmai

Bibliography

Amigoni F. (1979). I sistemi di controllo direzionale, Giuffré, Milano. Clark, J. J. (2005, July). Improving hospital budgeting and accountability: a best practice approach: if your organization is struggling to achieve its budget targets, your budget process itself may be the culprit. It may also hold the solution. Healthcare Financial Management, 59(7), 78+. Ferejohn, J., & Krehbiel, K. (1987). The budget process and the size of the budget. American Journal of Political Science, 31(2), 296–320. Flamholtz, E.G. (1979). Organizational control system as a managerial tool. California Management Review, Winter, n. 2.

103. Customer satisfaction The expression customer satisfaction (CS) indicates an articulated process aimed at detecting the level of customer/user’s satisfaction to improve the product/service offered; the public sector defines it as citizen satisfaction and the healthcare one as patient satisfaction. The satisfaction concept is closely linked to explicit and latent expectations, to people’s perceptions, and its complex detection process; for this reason, it is better to speak about customer or citizen satisfaction management.

Measurement and dimensions of patient satisfaction in healthcare companies

Although all actors in the healthcare sector agree that the concept of satisfaction is a multidimensional construct, the literature shows that there is no gold standard tool for evaluating this concept. This lack is due to multidimensionality and the presence of both “tangible” elements, through experience, and “intangible” factors, such as reliability, responsiveness, security, and empathy. The measurement process can generate complexity too. Indeed, it includes several phases that must be analytically structured and systematically controlled. These phases are (i) development of the survey, (ii) CS survey carrying out, (iii) analysis of the data, (iv) implementation of the improvement plan, and (v) related communication actions. The process methodological approach quality is critical to successfully improve the provided services. To date, although several tools to measure satisfaction have been implemented all over the world since the 1990s, the most used evaluation method is the survey administered directly to patients. Furthermore, even if no neat model is defining which essential dimensions (factors) should be included to measure the satisfaction level, both doctors and patients agree that clinical skills, relationships, and health-related communicative behavior between patients and healthcare professionals are crucial elements for the quality of provided services and perceived satisfaction. Additional dimensions to be considered are

the physical environment (physical facilities), access opportunity, cost and duration of treatments, and the internal management process (e.g., control over doctors, interdisciplinary collaboration in the same structure). In addition, specific dimensions are triggered by services with very characteristic profiles: home care, psychiatric and pediatric services, multidisciplinary services. Finally, the most comprehensive tools also include the socio-demographic variables of patients, such as age, gender, family income, and education.

Role of citizen and patient satisfaction for healthcare management

Healthcare organizations face substantial pressure to maintain high-quality medical care while increasing safety and reducing costs. Empirical evidence shows that patient engagement leads to better health outcomes in terms of quality, cost, and performance. Therefore, providing patient-centered care is a central goal in the modern healthcare system. Despite this goal, hospital case managers and the services they provide are usually routinely evaluated, without including patients’ perspectives. Listening to users and detecting satisfaction should become a permanent and constant activity, planned, and integrated within the public strategies. When the comparison amongst the users of a given service/product is activated, it is also necessary to be able to manage the outcome of such a questionnaire: listening, providing feedback, and handling potential conflicts are critical. Raising expectations in users can be a boomerang that backfires on service providers if they are not able to fulfill the expectations coming from the surveys. A further managerial implication of patient satisfaction is to enable the sustainability of the company and the entire healthcare system. Given the limited resources, sustainability is a fundamental pillar for the health system, that needs to balance three main dimensions: social, economic, and environmental. Patient satisfaction is a crucial element for all three dimensions: in fact, patient perceptions allow the system to know which are their preferences and needs; this allows achieving more

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targeted services, reducing overall costs, and avoiding waste production. Top management must encourage and facilitate the continuous collection of data concerning patients’ opinions also through collaborators’ involvement: doctors, nursing staff, and administrative staff. In fact, if patient engagement is meaningful for healthcare, doctors and nurses must even feel involved in the improvement process. In addition, for CS management to be complete, patients’ perceptions must also be detected during the follow-up phase, when necessary. This allows verifying the quality levels of the facilities and their ability to maintain contact with patients in the area. Finally, a broad action strategy must include CS management both at the company and local health policies level. CS survey can represent a tool through which public administrations and health companies redesign their operational action plan and improvement strategies by initiating change processes and remodeling of services based on collected feedback.

An alternative approach and future development in the healthcare sector customer satisfaction

Given the multidimensionality of the satisfaction concept and the difficulty in choosing the appropriate tool to measure a patient-related outcome, one of the most popular approaches to increase patient satisfaction is based on customer relationship management (CRM). CRM is an innovative technology that aims to develop and maintain constant relationships and interactions with patients to improve their satisfaction. Greater patient involvement makes it possible to provide timely information to management which, in turn, will be

Elena Maggioni

able to provide quicker answers making the necessary changes to the service provided. Thus, CRM takes the form of a managerial approach supported by the application of technology for the exchange of information (e-health or HIT). New technologies allow healthcare players to increase their focus on patients, meet their needs and expectations, build a long-term relationship with them, improve loyalty and adherence to therapies, and enhance the quality of service. In addition, the HIT is a suitable and effective tool to achieve cost savings, increase efficiency, quality, and safety, improve data collection and workflows, provide decision support and information usability, prevent medical errors, and reduce paperwork. In conclusion, hence, patient satisfaction can be viewed as a very effective proxy to measure physicians’ and hospitals’ success. Its proper measurement can lead to the definition of business and territorial strategies to guarantee long-term sustainability to the system and improved standards of care. Elena Maggioni

Bibliography

Santos de Almeida R. et al. Satisfaction measurement instruments for healthcare service users: a systematic review. Cad. Saúde Pública, 2015, 31(1):11‒25 https://​www​.scielo​.br/​j/​csp/​a/​QL​J​ 33​sn​JPtMh6qVvfzK868q/​?lang​=​en Baashar Y. et al. Customer relationship management systems (CRMS) in the healthcare environment: a systematic literature review. Computer Standards & Interfaces, 2020, 71:103442 https://​www​.sciencedirect​.com/​sd​f​ e/​reader/​pii/​S0920548919304593/​pdf Faezipour M. and Ferreira S. A system dynamics perspective of patient satisfaction in healthcare. Procedia Computer Science, 2013, 16, 148‒156 https://​doi​.org/​10​.1016/​j​.procs​.2013​.01​.016

104. DRG and case mix index Definitions

The Diagnosis Related Groups (DRG) is a classification scheme that allows optimal inpatient case-type classification. It is an “iso-resources” system as it groups together resource-intensive homogeneous case-types, that are patients who medically would be expected to consistently use a similar amount of hospital resources. This system exploits routine information available upon hospital discharge (main diagnosis, surgery, therapy, age, comorbidities and state of discharge) to code each patient into a DRG class. Each DRG is mutually exclusive, and their number (579) extensively comprises the whole possible case-type history. DRG are further grouped into 25 Major Diagnostic Categories (MCD) which gather every organ-related pathology into one class, following the International Classification of Diseases (ICD) scheme. Case mix index is a measure of hospital performance and output: it quantifies what is the DRG average weight of a given hospital’s discharge activity in a given interval. It is calculated by summing up the DRG weight for each discharge and dividing that by the national standard DRG weight in a given month and year. Bottomline, the case mix index mirrors the diversity, complexity, and severity of patient illnesses treated at a given hospital, and therefore estimates the reimbursement rate for that hospital. Higher case mix index values indicate that a hospital has treated a greater number of complex, resource-intensive patients, and the hospital will need to be reimbursed at a higher rate.

Formula of case mix index ​CMIxy  ​=  AWxy / AWx​

​ Wxy =​average weight for department ​x​ of A the facility y​ ​at a given point in time ​AWx =​average weight for standard department x​ ​at a given point in time

History

The origin of DRG and CMI can be traced back to 1983 by R.B. Fetter who was working

at the implementation of Medicare in the USA. The initial motivation for developing the DRGs was to create an effective framework for monitoring the quality of care and the utilization of services in a hospital setting. The first large-scale application of the DRGs was in the late 1970s in the State of New Jersey. The New Jersey State Department of Health used DRGs as the basis of a prospective payment system in which hospitals were reimbursed a fixed DRG specific amount for each patient treated. In 1982, the Tax Equity and Fiscal Responsibility Act modified the Section 223 Medicare hospital reimbursement limits to include a case mix adjustment based on DRGs. In 1983 Congress amended the Social Security Act to include a national DRG-based hospital prospective payment system for all Medicare patients. In Italy it was only adopted as reimbursement system in 1992 thanks to the Decrees 502/92 and 517/93. Before then, the hospital productivity was mostly measured with the number of discharges, eventually classified into the ICD according to the pathology. The average hospital stay was the only proxy for assistential complexity.

Rationale

The necessity for hospital’s output measures stems from the heterogeneous nature of illnesses affecting a heterogeneous parterre of patients that can be cured with heterogeneous treatments. If every hospital produces the same treatment for the same patient having the same illness, then there would be no problem of output measurement as one could just count the number of treated patients for each hospital, and hospitals could be compared just as easily. On the other hand, considering each case type as a single entity would be impractical. Therefore, the DRG classification has a use in this, as it groups items together, according to similarities on one or more dimension, and delimiting groups according to specific criteria of differentiation. The DRG system indeed groups together cases that are homogeneous with respect to the level and mix of resources used in their treatment (iso-resources) “weighting” the impact of each case on the facility, resulting in a per-case reimbursement mechanism allowing the healthcare management to keep track of the hospital performances with measures of output, such as the CMI.

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Purposes

Having measures for hospital’s output as the CMI is paramount to the following: Policy applications Reimbursement: it is a widely known implication of CMI, as it allows per-case reimbursement where a flat rate is paid for each inpatient hospital claim in hopes of promoting efficiency and thereby keeping healthcare costs down. Each DRG rate is different according to the type of inpatient stay (ordinary, day hospital) and type of care (acute disease, long term disease, rehabilitation). Planning: areawide planning benefits from CMI measures as information on the expected demand for specialized facilities can directly come from it. For example, there will be regions that have higher proportions of heart strokes and will benefit from more cardiac unit beds and vice versa. Program evaluation: public healthcare programs may have an impact on the CMI, as an increase in out-of-pocket costs would be mirrored by a different composition of patients accessing the hospital (e.g. less severe cases would restrain themselves from going to the hospital) and the CMI would increase. Administrative applications Quality control: administration should supervise the quality of coding and data feeding the measures of output, in this case the CMI. Moreover, a record screening with quality criteria could be also useful to assess quality of care, so as to determine where and how the failures in the diagnostic and treatment process may occur. Planning and budgeting: any shift in CMI may indicate to the management department that a reallocation of resources is necessary, for example if there is an influx of aged people to the region, that hospital will need to equip with more intensive care beds.

Francesca Grosso

Research applications CMI can be used by researchers in order to explore hospital utilization patterns and to estimate cost and production function.

Limitations

There are several factors that can affect CMI: patient population, types of procedures performed, and the specialties cared for in a specific facility can influence CMI, as well as miscoding and bad quality data. Volumes matters and it’s important to take into account the impact of surgical vs medical procedures as a high volume of surgical procedures will increase the CMI while a high volume of short stays can negatively impact CMI. Another thing to keep in mind are the annual updates to the DRG relative weights and changes in coding guidelines that could also influence CMI. In fact, the Italian Ministry of Health periodically updates the rate table for each DRG. Francesca Grosso

Bibliography

Buttigieg S. C., Lorraine Abela, Adriana Pace (2018) Variables affecting hospital length of stay: a scoping review. Journal of Health Organization and Management, https://​doi​.org/​ 10​.1108/​JHOM​-10​-2017​-0275 Hornbrook M. C. (1982) Hospital case mix: its definition, measurement and use: Part I. The conceptual framework. Medical Care Review, 39(1), 1–43. https://​doi​.org/​10​.1177/​ 107755878203900101 OECD (2022) Length of hospital stay (indicator). doi: 10.1787/8dda6b7a-en. https://​data​.oecd​ .org/​healthcare/​length​-of​-hospital​-stay​.htm Tipton K., Leas B. F., Mull N. K. et al. Interventions to decrease hospital length of stay. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 Sep. (Technical Brief, No. 40.) https://​www​.ncbi​.nlm​.nih​.gov/​books/​ NBK574435/​

105. Length of stay Length of stay (LOS) is a measure that gives the exact time spent by the single patient occupying a bed in a specific hospital or ward. It is calculated as the difference between the date of discharge and the date of admission in the hospital. LOS is a clinical metric that can give important information on the outcomes of a specific hospital, ward or even illness or procedure. Average Length of Stay (ALOS) is another metric that is often used as an indicator of efficiency of healthcare organizations or system. It is calculated as total number of occupied hospital bed-days divided by the total number of admissions or discharges. Therefore, the ALOS refers to the average number of days spent in hospital by all patients. Data on ALOS are collected by local and international authorities that contribute to the creation of indicators available worldwide: for example, WHO European Indicator code: E992901.T, OECD Length of hospital stay (indicator) (WHO, n.d.; OECD, 2022). LOS in hospitals has been debated and researched for many decades, since it has been recognized as a way to enhance quality and performance. Hospitalization data and those referring to the duration of patients’ stay give important information on healthcare efficiency and insights on correlation with hospital acquired conditions. In fact, LOS is one of the key performance indicators used to assess hospital efficiency and control healthcare costs maintaining high standards and the best outcomes for patients. LOS is a complex and multidimensional variable, since it is associated both to factors related directly to patients’ characteristics, disease characteristics and institutional and organizational factors, such as number of beds, level of specialization, personnel resources and so on (Buttigieg et al., 2018). The actual and past research have suggested that a vast proportion of occupied hospital bed-days is inappropriate and the cost of providing hospital services is significantly affected by this variable, therefore reducing the number of inappropriate patient days in hospitals will impact hospitalization costs. As amply demonstrated, prolonged LOS is also associated with higher rates of complications, which inevitably further delay discharge, creating a vicious cycle and

increasing costs. It is evident that a prolonged LOS affects the availability of beds, in fact the two variables are inversely proportional: as the LOS increases, the availability of acute beds decreases, consequently the capability of hospitals to meet the health needs of the population decreases. A prolonged LOS, resulting in the reduction of available beds, creates a bottleneck within the hospital, reduces patient turnover and causes a lengthening of patient waiting times with an increase in waiting lists and potentially dangerous delays in hospitalization. A reduction of patients’ LOS can improve the system’s ability to respond to the health needs of the population, increasing the availability of acute care beds, as well as positively impacting hospitalization’s costs and personnel and reducing waiting lists. Healthcare systems across the world have tried a large variety of interventions to reduce hospital LOS. The different strategies differ in design, intent, and focal point. A report by the Agency for Healthcare Research and Quality (2021) investigated the main interventions included in multiple systematic reviews available in literature. They found three different groups of interventions, targeting different areas that could impact LOS: ● Clinical care quality and efficacy (enhanced recovery programs, clinical pathways, and early patient mobility programs); ● Logistical and organizational factors (care coordination, transition and discharge planning, case management, medication management, or specialized units for high-risk populations); ● Workforce (multidisciplinary care teams, redesigned staffing models). All these interventions can pose a potential risk in creating trade-offs between outcomes. In fact, reduction in LOS can determine an increased rate of readmission or a shift of costs between inpatient and outpatient settings. There is a need for research evaluating system-level interventions focused on medically complex, high-risk, or vulnerable patient populations, including frail elderly patients and those with complex chronic illness. Gabriele del Castillo

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References

Agency for Healthcare Research and Quality (2021) Interventions to decrease hospital length of stay. Technical Brief, number 40. Agency for Healthcare Research and Quality Publication No. 21-EHC015, September 2021. Buttigieg, Sandra C., Lorraine Abela, Adriana Pace (2018) Variables affecting hospital length of stay: a scoping review, Journal of Health

Gabriele del Castillo

Organization and Management, https://​doi​.org/​ 10​.1108/​JHOM​-10​-2017​-0275 OECD (2022) Length of hospital stay (indicator). doi: 10.1787/8dda6b7a-en. https://​data​.oecd​ .org/​healthcare/​length​-of​-hospital​-stay​.htm (Accessed on 23 January 2022) WHO (n.d.) Average length of stay (all hospitals). WHO Regional Office for Europe. https://​ gateway​.euro​.who​.int/​en/​indicators/​hfa​_540​ -6100​-average​-length​-of​-stay​-all​-hospitals/​ (Accessed on 23 January 2021)

106. Performance measurement and management systems Performance measurement and management (PMM) systems are defined as the formal information-based routines and procedures that guide an organization, or a social system, towards the achievement of objectives and targets in order to deliver its mission and strategy (Ouchi, 1979). Performance measurement can be defined as the process of defining, monitoring, and using indicators of the performance of organizations and programs on regular basis (Poister, 2003); in practical terms the activity of collecting data, defining measures, and computing them. Performance management uses performance measurement data in order to give a direction and affect practices and actions within an organization to achieve pre-set goals and targets (Schwartz & Deber, 2016). In this sense, performance management could be defined as the process of creating the context for performance, using the information from measurement in decision-making processes. Performance measurement and performance management cannot be separated, they are closely intertwined because the success of any organization is based on the ability to master the process of creating performance using measures that explain the consequences of the managerial decision-making. Therefore, PMM comprehends the whole process (i.e. the PMM cycle) starting from the definition of performance, the identification of related targets and the evaluation ex post of the results obtained (Lebas, 1995), providing information to define and achieve future performance. PMM is crucial for any organization or system because it allows evidence-based management: managers need hard data and facts to make decisions, not only intuition and hunches. Moreover, it creates important means for monitoring and controlling resources and it is ultimately responsible for maintaining alignment and coordination of the whole organization. PMM systems have been firstly adopted following the rise of the modern private corporations in several industries. Since the implementation of New Public Management

(NPM) reforms in the 1980s, PMM has been also extensively applied in the public sector, including the healthcare sector. PMM systems in the health sector have been studied and implemented at the health system level, at the inter-organizational level, and at the organizational level (McCracken et al., 2001; Noto et al., 2019; Vainieri et al., 2020). Performance represents the ability of an entity to achieve its desired results. Hence, an enlargement of the visions and the definitions of performance in healthcare requires that the measurement and control mechanisms of the activities and resources employed to achieve those results (i.e. PMM systems) must adapt. The concept of performance in the healthcare sector has evolved over time due to changes in the last few decades on the following elements: (a) the role of professionals, until the 1990s considered the only individuals that may evaluate their clinical work, at most among peers; (b) the role of stakeholders, whose needs of accountability had increasingly emerged; (c) the technical chances to measure and monitor different variables, such as clinical outcomes and patient experience. The evolution of PMM systems is closely related to this development. In fact, when PMM was introduced across Western Countries, the performance was mainly conceived as financial sustainability and efficiency of health systems and organizations. This produced a first generation of PMM systems mainly focussed on costs and management accounting. Later on, thanks to the introduction of clinical governance tools, the evaluation and management of clinical performance was based on indications coming from Evidence Based Medicine (EBM) and other sources of behavioural standards (such as guidelines, protocols of scientific societies, clinical paths drawn up at corporate level, etc.). So, performance started including also other dimensions such as quality of care, process measures, equity, accessibility, etc. Moreover, the introduction of the Information Technologies (IT) and computer-based software for PMM gave a significant boost to develop new tools and frameworks for evaluating the performance, to increase the timeliness and accuracy of measurement and reporting, and to forecast the impacts of actions on desired performance (cause-and-effect relationships). Consequently, PMM introduced the key features of multidimensionality,

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evidence-based data collection, and timeliness. Multidimensionality refers to the need of providing key performance indicators encompassing the different dimensions of health performance (e.g., quality of care, financial sustainability, equity, process, etc.). Evidence-based data collection refers to the need to inform decision makers through data and information based on real clinical and managerial evidence. Timeliness refers to the need for making PMM results available to inform decision makers as soon as possible. In the more recent years, the rise of value-based perspective (Porter, 2010) - and the need to evaluate not only the resources but also their relationship with the outcomes (objective and perceived by the patients and the other stakeholders) - has fostered those three key features, also adding the importance of systematic benchmarking of results, shared design, and transparent disclosure (Noto et al., 2019). Systematic benchmarking is the activity of comparing results between health systems, geographical areas, and the organization to support performance evaluation. Shared design requires the involvement of the wide set of key stakeholders of the health system (or the organization) when designing PMM systems. Transparent disclosure is related to the decision to make PMM results available to an external audience for accountability purposes. PMM are built around the selection, computation, and evaluation of measures. A measure is a quantitative value that can be scaled and used for purposes of comparison (Simons, 2000); usually, financial measures are stated in monetary terms and nonfinancial measures are quantitative data not expressed in monetary terms. A first classification of measures in healthcare services refers to the seminal work of Donabedian (1966) who identified three domains of quality of care: structure, process, and outcome indicators. Although he was referring to the evaluation of clinical and psychosocial aspects of clinical care, these same categories are useful for evaluating nonclinical performance as well. Structure indicators aim at measuring the adequacy and quality of resources (financial, human, and equipment) employed to pursue desired performance results. As for example, the ratio between medical doctors and the population to serve is a typical structure indicator used at the health system level. Anna Prenestini and Guido Noto

Process indicators refer to the measurement of care delivery processes and their outputs. These may belong to a set of sub-domains ranging from efficiency, effectiveness, productivity, and so on. One example could be the average hospital length of stay, or the bed occupancy rate. Last, outcome indicators concern the impact that healthcare has on the health status of patients. Even in this case, a set of sub-dimensions may be identified such as quality, safety, equity, appropriateness etc. Examples may be measures on 30-day mortality after treatments, or re-admissions. Moreover, the satisfaction of the patients may also be assessed in the outcome dimension. Although Donabedian classification is one of the most known taxonomies of health and healthcare indicators, multiple other studies and frameworks have been developed to assess the performance of health organization and systems (e.g., WHO and OECD). Moreover, in the last years other sources of data have been used in addition to the administrative ones coming from clinical and other records; among these patient-reported measures are those that more than others impacted on PMM practices. In management theories, the dimension of structure is known as inputs. Moreover, processes are usually measured separately from their outputs (i.e. those intermediate results that consider the quantity and the characteristics of the services produced by healthcare organizations and systems). Measures should be (Simons, 2000): (1) objective (independently measured and verified by independent auditors); (2) complete (they capture all the relevant attributes of achievement); (3) responsive (they reflect actions that individuals can directly influence). Of course, the more we will consider the outcomes dimension, the more the measure is less responsive since outcomes are influenced by several other factors out of individuals’ control. A powerful PMM system is built on – and supports – measures that (Lebas, 1995): (1) give autonomy to individuals to achieve the results within their span of control; (2) reflect cause-and-effect relationships; (3) empower and involve individuals; (4) create a basis for discussion and support the continuous improvement of the organization; (5) support decision-making.

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When related to the strategy execution, measures may be conceived as Key Performance Indicators (KPIs). PMM practices are usually carried out through the use of multidimensional accountability frameworks for healthcare organizations and systems, also with the scope of benchmarking of results, comparing systems and organizations to gain information which will help the system or the organization to improve its performance (Noto et al., 2019). Anna Prenestini and Guido Noto

References

Donabedian, A. (1966). Evaluating the quality of medical care. The Milbank Memorial Fund Quarterly, 44(3), 166‒206. Lebas, M. J. (1995). Performance measurement and performance management. International Journal of Production Economics, 41(1–3), 23‒35. McCracken, M. J., McIlwain, T. F., & Fottler, M. D. (2001). Measuring organizational performance in the hospital industry: an exploratory comparison of objective and sub-

jective methods. Health Services Management Research, 14(4), 211‒219. Noto, G., Corazza, I., Kļaviņa, K., Lepiksone, J., & Nuti, S. (2019). Health system performance assessment in small countries: The case study of Latvia. The International Journal of Health Planning and Management, 34(4), 1408‒1422. Ouchi, W. G. (1979). A conceptual framework for the design of organizational control mechanisms. Management Science, 25(9), 833‒848. Poister, T. H. (2003). Measuring performance in public and nonprofit organizations, New York: Wiley. Porter, M. (2010). What is value in health care? New England Journal of Medicine, 363, 2477‒2481. Schwartz, R., & Deber, R. (2016). The performance measurement–management divide in public health. Health Policy, 120, 273–280. Simons, R. (2000). Performance measurement & control systems for implementing strategy, NJ: Englewood Cliffs, Prentice Hall. Vainieri, M., Noto, G., Ferre, F., & Rosella, L. C. (2020). A performance management system in healthcare for all seasons? International Journal of Environmental Research and Public Health, 17(15), 5590.

Anna Prenestini and Guido Noto

107. PROMs and PREMs The quality of service and patient outcomes is extremely important for healthcare providers. Therefore, they have developed the patient-reported outcome measures and patient-reported experience measures. These tools help them measure the quality of care in terms of clinical effectiveness, safety, and patient experience.

PROMs

Patient-reported outcome measures are also abbreviated as PROMs. These are tools such as standardized, validated questionnaires given to patients in the perioperative period. They explore the perceptions of the patients’ health status, perceived level of impairment, disability, and quality of life. They measure the efficacy of a clinical intervention from the patients’ point of view. Questionnaires are completed by the patients both pre and post operatively so that we can compare the outcomes of pre and post procedure. In addition, PROMs measure patients’ perceptions of their health related to a specific disease as well as clinical effectiveness and safety. PROMs are classified as either generic or disease specific. The generic PROMS measure aspects of a broad range of medical conditions, in order to evaluate care, quality of life, and cost effectiveness of interventions. The disease specific PROMs provide an insight to individual’s aspects of a condition and their impact on outcome. These two types of PROMs are often used together.

PREMs

Patient-reported experience measures are also abbreviated as PREMs. These are tools which gather information on patients’ views of their experience whilst receiving care. They are used to indicate the quality of patient care, although do not measure it directly. PREMs are most commonly found in the form of questionnaires. They look at the impact of the process of the care on the patients’ experience, for example communication and timeliness of assistance. There is a difference between PREMS and satisfaction surveys since PREMS report the objective patient experiences, eliminating the ability to report subjective views.

PREMs are classified into relational or functional measures. The relational ones identify the patients’ experience of their relationships during treatment, for example: ‘If they feel like the health professionals were paying attention to what they said’. An example of a relational questionnaire is the CARE measure. Functional PREMs are more focused on practical issues, such as the availability of certain facilities. The data gathered can help in improving and focusing on patient-centered clinical management. They further provide vital feedback to medical professionals. PROMs show the impact of intervention/therapy, whilst PREMs look at the quality of care during the intervention. The two are used in parallel to represent the patients’ thoughts of both the process and outcome of their care. Black et al. (2014) have reported that: ‘Patient outcomes can increase patients experience ratings up to 10%, similarly improving patient experience ratings causes a 3% improvement on outcome scores’. This proves that PROMs and PREMs are strongly linked together and they significantly contribute to a superior quality of care.

Uses

They are used to determine the cost effectiveness of clinical interventions. Furthermore, they can identify triggers for surgery and potentially reduce the burden on clinical services by limiting the numbers of unnecessary or ineffectual procedures. They are useful in providing clinicians specific data on their performance. This could also support the revalidation process. They make comparisons of performance of trusts, and thus allow rewards for positive outcomes and quality care. There are a number of specialties that employ the use of both PROMs and PREMs to evaluate their patient management such as rheumatology, pediatrics, respiratory medicine, and cardiology. In addition, these instruments provide data for clinical audit between three months for ‘hernia and varicose vein surgeries’ post-procedure and between six months for ‘hip and knee replacements’ post procedure. Therefore, this allows any effects of the operation to be identified. If the patients do not reply within six months after the medical procedure, reminders and repeat questionnaires are sent to them.

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When the data supply contractors receive them back, they match the post-procedure questionnaires to the individuals’ pre-procedure questionnaires in the database in order to make comparisons.

or Aberdeen Varicose Vein Questionnaire (AVVQ). In the postoperative data collection, patients report their perceptions of the outcome of the procedure and if there were any complications.

Appropriate selection

The OHS and the OKS

PROMs and PREMs tools should be selected appropriately for the target patient group, content and reliability. The validity of the questionnaire is important. A pilot of the questionnaire prior to the initiation of data collection is vital to identify inappropriate questions for the population.

Data collection

The majority of PROMs and PREMs questionnaires are given to patients in preoperative clinics at the initial contact with health provider. The patients’ consent to participate in the PROMs questionnaire is necessary before the questionnaire is given to them. Also, the postoperative form should be completed by each person who participates in the data collection. The target data should be independent patient perceptions of their health status and care. Therefore, questionnaires should be completed away from healthcare professionals. They can only use the help of a friend or relative if required. PROMs and PREMs can also be distributed via email, telephone calls, as well as text messages. This allows the possibility of instant feedback on patient care. Online surveys and face-to-face interviews may be an alternative method for data collection.

Examples

Some examples of generic PROMS measures are the: EQ-5D and the EQ-VAS, in which the patient is asked to complete a generic set of questions regarding their health status. The EQ-5D is a standardized measure of health status and it is made up of a five-stemmed description. The EQ-VAS is a visual analogue scale in which the patient has to score their general health on a thermometer-like scale. The descriptive system covers mobility, self-care, daily activities, pain, and anxiety. Some examples of condition-specific PROMS questionnaires are: The Oxford Hip Score (OHS), the Oxford Knee Score (OKS)

They assess the outcomes of knee and hip replacements in randomized control trials. Their validity and reliability are extensively tested over prospective studies. They are internationally used and their application spans to cohort studies, audit, and use in national registries. It is the most widely used PROM in orthopaedics.

The AVVQ

The AVVQ was developed by a research which took place at Aberdeen Hospital, in collaboration with the vascular surgeons. This tool allows patient self-assessment of varicose vein severity. You can find it in both national and international guidelines for case-by-case evaluation. The ‘Elective surgery PROMS measures’ are used for procedures like ‘Unilateral hip replacements’ and ‘Unilateral knee replacements’ as well as for ‘Varicose vein surgery’ and ‘Groin hernia surgery’. They are used to provide feedback to medical professionals on quality of care and effectiveness of patients’ care. This helps in improving the current quality of service and offering patient-centered care. In addition, it provides some knowledge of patient expectations of management and hence health professionals can redesign the pathways accordingly. An example of a relational PREM tool is the CARE Measure which was developed by Dr Stewart Mercer in the context of a Health Service Research Fellowship in 2000‒2003. This is a questionnaire where the patients have to answer: ‘How good was the practitioner at...’: ● ● ● ● ● ● ● ●

Making you feel at ease Letting you tell your ‘story’ Really listening Being interested in you as a whole person Fully understanding your concerns Showing care and compassion Being positive Explaining things clearly Fivia Stavrou

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● Helping you to take control ● Making a plan of action with you.

Limitations

● Some PROMs have been originally developed for research methodology. Therefore, if they are used in clinical practice they might make the interpretation of data inaccurate. ● On site feedback collection, the patients may not be in a physical or psychological state to answer. Furthermore, patients may be concerned about the negative impact of their answers on the care given by healthcare providers and respond accordingly. Post-contact feedback relies upon an adequate sample size of patients’ response. ● Time constraints may cause disruptions to outpatient and inpatient clinical encounters in order to distribute the questionnaires. ● Translation of the questionnaires may cause the loss of meaning of the questions by literal translations. Due to the cost of translation, usually most questionnaires are translated by a relative/friend. ● Education programs may be necessary to allow clinicians to utilize these instruments correctly. This further increases the cost. Funding is usually required for the development and implementation of these tools as well as for training programs and data analysis. ● Disparities in patient experience data compared to clinical effectiveness and safety can occur. This emphasizes that patient experience is an indicator of quality, not a direct measure for it. Health professionals should always keep this in mind.

Conclusion

PROMs and PREMs are useful tools which are increasingly being used to explore

Fivia Stavrou

patients’ perceptions of their health and experiences while receiving care. The correct choice of a measuring tool is crucial in order to ensure reliable, validated data for the population. The limitations must be considered before the implementation of PROMS and PREMS. Fivia Stavrou

Bibliography

Barnett SF, Alagar RK, Grocott MP, Giannaris S, Dick JR, Moonesinghe SR. Patient-satisfaction measures in anesthesia: qualitative systematic review. Anesthesiology 2013; 119: 452–78 Black N, Varaganum M, Hutchings A. Relationship between patient reported experience (PREMs) and patient reported outcomes (PROMs) in elective surgery. BMJ Qual Saf 2014; 23: 534–42 Dawson J, Doll H, Fitzpatrick R, Jenkinson C, Carr AJ. The routine use of patient reported outcome measures in healthcare settings. BMJ 2010; 340: c186 Equity and Excellence: Liberating the NHS. https://​www​.gov​.uk/​government/​publications/​ liberating​-the​-nhs​-white​-paper (accessed 20 December 2015) Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess 1998; 2: 1–74 Fung CH, Hays RD. Prospects and challenges in using patient-reported outcomes in clinical practice. Qual Life Res 2008; 17: 1297–302 Health and Social Care Information Centre: Monthly Patient Reported Outcomes (PROMs) in England. http://​www​.hscic​.gov​.uk/​media/​ 1537/​A​-Guide​-to​-PROMsMethodology/​ pdf/​PROMs​_Guide​_V8​.pdf (accessed 10 November 2015) NHS Outcomes Framework. https://www.eng land.nhs.uk/resources/resources-for-ccgs/ out-frwrk/2. (accessed 10 November 2015) Weldring T, Smith SM. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs). Health Serv Insights 2013; 6: 61

108. Strategic control The successful realization of corporate strategies in a dynamic environment requires to overcome the traditional managerial control systems, which have their roots in the clear separation between strategic planning and strategy implementation. The primacy of planning reveals its fallacy due to the impossibility to make accurate forecasting and to understand well situations of the environment (uncertainty); moreover, the large number of internal elements (people, specialties, technologies, etc.) of healthcare organizations and the interrelationships they establish with the external environment produce complexity. Therefore, in strategic planning managers must filter information and set assumptions to reduce complexity, but this process is intrinsically selective. The characteristics of uncertainty and complexity together create the phenomenon of ambiguity that managers must be able to counterbalance with strategic control systems that compensate the risk of selectivity (Schreyogg & Steinmann, 1987). The strategic control cannot only be considered as an activity of monitoring the achievement of the objectives defined in the planning phase, but it has to capture the validity of the strategy at every stage. A deeper study of the literature reveals that there is no univocal definition of strategic control. However, there is a certain convergence in considering strategic control as a management control system with the objective of guiding corporate activity towards the execution of a specific strategy and, if necessary, modifying it to better achieve corporate objectives. The strategic control provides top management with all the information necessary to decide “whether” a change in the strategy is needed and “how” to modify it (Bergamin Barbato, 1991). Strategic control has two different meanings: the first one explains strategic control in an extremely narrow way, the second one in a broader way. In the first meaning, the objective attributed to strategic control is only to monitor the execution of the intended strategy with the use of diagnostic control systems consisting of qualitative and quantitative performance measures. The broader meaning of strategic control not only focuses on the mere evaluation of the achievement of strategic objectives, but also includes a more

in-depth analysis of the persistence of the validity of the strategy. In doing so, strategic control performs anticipatory control on the dynamics of the internal and external environment that allows to identify “weak” signals that significantly enrich the available information. According to this broader meaning, strategic control uses two different mechanisms for monitoring the strategy: feedback and feedforward. The feedback control verifies whether the strategy has achieved the intended results at the end of the implementation or not. Its aim is to support managers in the process of adopting corrective actions when the analysis of variance shows that the results achieved are different from those initially desired (Horovitz, 1979). However, feedback mechanism is a post-action control, so it may come too late for corrective actions. Moreover, the focus of the feedback mechanism is the pre-set standards and the comparison with actual results, which brings to take for granted the standards and to associate a negative judgment to any deviation, regardless of the actual effectiveness of the results obtained (Schreyogg & Steinmann, 1987). Notwithstanding that, feedback mechanisms are essential for organizational learning and the next planning cycles, for aligning incentives and evaluating the achievement of the goals. The ex post feedback mechanisms must be enriched by milestones and short-term indicators since they can give warnings for an eventual reassessment of the strategy. The feedforward mechanism monitors the strategy during implementation, allowing managers to make changes before it is too late. This mechanism enables, on the one hand, an interactive control of the premises and hypotheses of the intended strategy, and on the other hand, a constant system of surveillance that aims to identify environmental issues not recognized in the initial planning because unpredictable, but representing potential threats to the success of the plans or opportunities to consider in the strategic process. Consequently, both the mechanisms are crucial in strategy making and execution. Goold and Quinn (1990) identified the three main objectives of a strategic control system. First, strategic control makes possible to coordinate the efforts of the people involved to achieve the strategic objectives. Second, strategic control motivates individ-

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uals towards the achievement of goals, especially when aligned with incentives. Third, strategic control supports managers in the process of strategic change, reporting the need to modify the strategy or the pattern of actions. Healthcare organizations must provide managers with the appropriate strategic control tools to successfully achieve the strategic plan and be accountable to institutional and social constituents, but also to modify the strategy due to the changes of the dynamic internal and external environment. One of the most useful and comprehensive strategic control systems to apply to the healthcare organizations is the Simons’ framework on the levers of control (1995, 2000). The primary goal of the Simons’ model is to encourage innovation and organizational learning, enabling a more effective response to the strategic uncertainties that characterize the context in which the healthcare organizations work. Inspired by Mintzberg’s studies (1987), which support the existence of a spontaneous component in strategy formation that emerges from everyday activity and interaction with the external environment, Simons demonstrates how these levers of control can actively influence strategy. The four key levers of strategic control by Simons (1995) are the following: 1. Beliefs systems, used to stimulate the contribution of the people to the achievement of the desired direction and the search for new opportunities. 2. Boundary systems, used to restrict opportunity-seeking behaviour to avoid unnecessary risks. 3. Diagnostic control systems, used to motivate, control, and guide managers towards the achievement of specific objectives, rewarding them if the intended results are achieved. 4. Interactive control systems, used to encourage organizational learning and the development of new ideas and strategies. These four control levers are interdependent and operate simultaneously but with different purposes. Beliefs systems support strategic control in their function of coordination and motivation through the development and communication of mission statements, credos, and core values, which enable the individuals’ actions Anna Prenestini

to be directed towards the desired results of the healthcare organization. In addition, these systems encourage people to contribute to the strategy success, by searching also for new opportunities and giving them a sense of pride and purpose. In healthcare organizations, beliefs systems can be identified in two types of tools which inspire professionals and must never collide: corporate credos and professional credos. From the point of view of the healthcare organization, the strategic process involves the definition of the mission and vision statements, and the core values that should inspire the behaviours, which are generally reported in the strategic plan. On the other hand, healthcare entities are complex brain-intensive organizations with highly specialized professionals guided by a set of principles and values closely linked to their profession. In general terms, doctors’ credo can be found first in their professional oath (the so called “modern Hippocratic oath”), which also defines some limits in prescriptive terms. Belief systems, by encouraging people to contribute, may lead to organizational chaos if not properly addressed. Therefore, Boundary systems are created to prevent managerial attentions and financial resources from being dissipated to achieve objectives that are not consistent with the mission or strategic plans of the organization. In healthcare organizations, the boundary systems are consisting of different tools: the strategic boundaries, the codes of business conduct, and the codes of professional ethics. At corporate level, boundary systems are represented, on the one hand, by the strategic plans which constitute the reference for medium and long-term decisions for the whole organization, thus limiting the search for opportunities that are not consistent with the strategies of health organizations; on the other hand, by the “strategic frame” that the top management outlines for clinical directorates and on the basis of which the clinical middle management is required to build their own business unit’s strategic plan. The code of business conduct defines and communicates standards of behaviour for each employee and these standards are stated in negative terms; this tool eliminates ambiguity about how employees are expected to face pressure and temptation and is critical in any company whose strategy is built upon trust and a reputation for quality and

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integrity, such as healthcare organizations. Moreover, professions that depend on public trust always insist upon compliance with a code of professional conduct as a condition of membership, such as physicians. The code of medical ethics is a body of rules of self-discipline predetermined by the doctors and the physicians must adapt their professional conduct. Diagnostic control systems use the traditional feedback mechanism and aim to control the implementation of the strategy towards the desired direction. Diagnostic control systems require (1) to set a strategic goal in advance and to pre-establish the standard, (2) to measure the actual performance comparing it to the pre-set target, and (3) to use the eventual variance information as a feedback to bring strategy back on track. Any control system in the healthcare organization can be used diagnostically under the previous three conditions, for example budgeting system, Balanced Scorecard, project management, standard cost-accounting systems, human resource management, and so on. Thus, the primary objective of this lever of control is to support managers in the strategy execution and to motivate people, especially when aligned with incentives, to enhance their performance and achieve the established targets. They may be related to the classical performance measurement and management. Much of the work of the diagnostic control systems can be delegated to the management control staff. Interactive control systems assume that the environment is constantly changing and therefore the organization must be ready to face strategic uncertainties, that is, emerging threats and opportunities that could invalidate the assumptions upon which the strategy is built. Strategic uncertainties are related to changes in competitive dynamics and/or internal competencies: they are unknowable in advance and may emerge unexpectedly over time (Simons, 2000). In the event of new scenarios that invalidate the intended strategy, the organization must search for new ideas and innovations using the creativity of the personnel. Interactive control systems focus on feedforward mechanisms and healthcare managers should select only a few control tools to be used in a highly interactive way, due to the nature of “attention enhancer” of these systems. In fact,

interactive control systems demand frequent attention throughout the organization, huge amount of information, and consequently high opportunity-costs. Any control system can be used interactively by senior managers if it meets certain requirements: (1) the information must be simple to understand and everyone must think that the figures and numbers are accurate and valid; (2) the information must be used at multiple levels of the organization (from the top management to the individuals); (3) the predictions must generate new action plans with the suggestions and ideas that come from any level of the organization (emergent strategies), allowing adjustments of the strategy on a real-time basis. In this case, the interpretation of data and suggestions is not delegable to the staff, but it is an important function of top management. Nevertheless, in healthcare organizations specialized staff in strategic planning and control may be created in order to: (1) gather and collect data and information; (2) facilitate the interactive process throughout the organization by stimulating dialogue and discussion on strategic uncertainties and new emergent solutions. There are two main categories of tools of interactive control systems: the first one (“premise control”) is necessary for checking the validity of the assumptions of the intended strategy and the second one (“strategic surveillance”) for a wide-range monitoring of environmental changes. The first category considers (Prenestini, 2008): on the one hand, the constant verification of the economic, legislative, competitive, social, and so on, assumptions (e.g., the healthcare organization has estimated an increase in funding from the Regional Healthcare System that is subsequently not confirmed, or a legislative change that prevents the provision of a certain healthcare service on which the company’s competitive advantage was previously based, requiring a complete revision of the underlying strategic positioning); on the other hand, the management of specific projects that constitute the prerequisite of other strategic objectives (e.g., the opening of a new hospital is the prerequisite from which further strategic objectives descend in cascade, and a delay in the completion of work may make it necessary to identify alternative solutions). In the second category, the strategic surveillance may also be supported by the use of the traditional analysis for strateAnna Prenestini

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gic planning (e.g., trends analysis, five forces model, scenario building, etc.) or specific diagnostic tools (e.g., Balanced Scorecard, human resource management for succession planning, etc.) but used interactively. The rationale for adopting a broad meaning of strategic control, that is, a system based on both feedback and feedforward mechanisms, lies in the characteristics of high uncertainty, complexity and dynamism that characterize the healthcare environment; which therefore requires a control system that is not limited to assess whether results are in accordance with the plans or not, but that verifies if the strategic plans, in progress, maintain their validity. In summary, the healthcare sector is characterized by a critical shortage of resources, high social relevance and significant technological and clinical dynamism, resulting in an urgent need to adequately manage internal and external turbulence, overcoming the dichotomy between strategic planning and control (Prenestini, 2008). Anna Prenestini

Anna Prenestini

References

Bergamin Barbato, M. (1991) Programmazione e controllo in un’ottica strategica, Torino: Utet. Goold, M., & Quinn, J. J. (1990) The paradox of strategic controls. Strategic Management Journal, 11(1), 43‒57. Horovitz, J. (1979) Strategic control: a new task for top management. Long Range Planning, 12, 2‒7. Mintzberg, H. (1987) The strategy concept I: Five Ps for strategy. California Management Review, 30(1), 11‒24. Prenestini, A. (2008) Il controllo strategico nelle aziende sanitarie pubbliche. Mecosan, 17(68), 65‒82. Schreyogg, G., & Steinmann, H. (1987) Strategic control: a new perspective. Academy of Management Review, 12(1), 91‒103. Simons, R. (1995) Levers of control. How managers use innovative control system to drive strategic renewal. MA: Boston, Harvard Business School Press. Simons, R. (2000), Performance measurement & control systems for implementing strategy. NJ: Englewood Cliffs, Prentice Hall.

PART XXI PLANNING In this cluster are listed the tools at the managers’ disposal to plan the organization’s strategy and to check the feasibility of purchases, investments, reorganizations and daily actions and their alignment with the strategy and the vision. Strategic planning in healthcare organizations involves outlining actionable steps needed to reach specific goals. While there are different strategy types and levels, the purpose of all strategies is to bring an organization’s action into alignment with its stated mission or values. Being able to plan the direction that the organization wants to reach allows to consolidate legitimacy and leadership and achieve the great goals that the manager has set for the company. Today, healthcare providers require more patient-centric, value-based approaches, whereas many of their current systems follow older, more traditional strategy models.

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109. Strategic planning Definition

A strategic plan is one of the possible outputs of a strategic planning process, through which an organization defines its strategies (and the consequent allocation of its resources to pursue this strategy). It represents a document where strategic choices of a healthcare organization (or part of them) are formalized and where a reader should find the pattern or plan that integrates an organization’s major goals, policies, and actions sequences into a cohesive whole.

History

In other sectors, strategic planning became widespread during the 1960s, while in the healthcare sector the relevance of such processes (and strategic documents) started to be perceived by managers and policymakers after the adoption in many countries of the New Public Management (NPM) paradigm (during late 1980s and early 1990s). With NPM, it is stressed, especially for public sector organizations, that strategic planning practices must be adopted to improve their management in the long-term, to guide such institutions, and to improve their performance in an increasingly turbulent context. Strategic plans are still today a relevant part of the strategy-making process in all healthcare organizations, both public and private.

Rationale

The structure of a strategic plan can include the following items (or part of them, also depending on its purposes): 1. Executive summary 2. Context 3. Current situation analysis (internal and external environment) 4. Strategies for the future 5. Implementation plan 6. Resources allocation 7. Appendix/Enclosures A strategic plan can be used for internal purposes (steer the organization) or external purposes (meet stakeholders’ expectations or create a dialogue with them). Strategic

planning documents can also have a bureaucratic origin, especially for public healthcare organizations, since they can represent an administrative constraint imposed by law or by a higher level of government. The role of strategic plans differs from other sectors because healthcare organizations are embedded in a more complex environment, where strategy and decision-making are defined by the intersection of different cultures (professional, bureaucratic, and managerial), values (political, social, entrepreneurial, individual) and interests (different professional families, groups and individuals, firms and the public sector, different levels of government).

Goals

Strategic planning and the use of strategic plans have been proved to enhance an organization’s effectiveness (measured as the capacity to achieve its goals). However, having a plan is not enough, but it should be always accompanied by other strategic management practices, such as strategic control processes and careful stakeholder management.

Future developments

Strategic planning processes in the healthcare field often lack behind more advanced levels of planning adopted in other sectors. This could be an issue for firms confronting a volatile healthcare market, that demands that providers should adopt state-of-the-art planning processes and tools (including strategic plans) that drive growth and organizational effectiveness. A shift in the approach of strategic planning and the use of strategic plans could be achieved through: ● Knowledge Management systems (use of systematic data analysis and information to drive strategic planning); ● Innovation and creativity in strategic approaches; ● More bottom-up strategic planning (rather than top-down); ● Evolving, flexible, and continuously improving processes; ● A shift from static to dynamic strategic planning.

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Bibliography

George, B., Walker, R., & Monster, J. (2019). Does strategic planning improve organizational performance? A meta-analysis. Public Administration Review, 15 October. Lega, F., Longo, F., & Rotolo, A. (2013). Decoupling the use and meaning of strate-

gic plans in public healthcare. BMC Health Services Research, 13(1), 1‒11. Mintzberg, H., & Quinn, J. B. (1996). The Strategy Process: Concepts, Contexts, Cases. Prentice Hall. Zuckerman, A. M. (2006). Advancing the state of the art in healthcare strategic planning. Frontiers of Health Services Management, 23(2), 3.

Andrea Rotolo

110. Strategy making In a broader and more contemporary sense, strategy-making coincides with the activity of environmental analysis, strategy formulation, implementation, and strategic control. It has also been considered as a strategic process and more recently as strategizing, that is the activity of designing strategy systematically. Although there are still few and limited studies applied to healthcare, general strategy is a vast field and its concepts are defined variously (Ramos-Rodríguez, Ruíz-Navarro, 2004, Koseoglu et al., 2015; Nag et al., 2007). Uncertainties and radical change in healthcare due to socio-economic pressures, regulation, rigid costs, and innovation makes the exploitation of strategic skills increasingly necessary. Healthcare management makes decisions continuously in increasingly complex and uncertain scenarios, but it doesn’t always have training in strategy. Moreover, healthcare organizations are pluralistic ones. So, strategy-making must be participatory, aimed at achieving intermediate outcomes, strongly contextualized. The latest evidence on strategy-making can broaden the knowledge and experience of healthcare management to establish and implement strategies effectively. Historically, between 1980 and the mid-1990s, strategy-making was considered positively correlated to final financial performance outcomes, although internal and external context variables mediated the relationship. External variables – such as (i) industry, (ii) uncertainty and turbulence, (iii) complexity and stability, (iv) ambiguity, (v) hostility and munificence, (vi) life-cycle stage – as well as internal context variables – such as (vii) size, (viii) organizational complexity, (viv) levels of professionalism – explained the reasons for success or failure. In those years, the dominant belief was that a more sophisticated strategy-making process should have corresponded to a greater complexity of context. It consisted of a process articulated in phases, in a rigid sequence – starting from the context analysis, going through the formulation of the strategy, strict in its implementation, up to the control – and highly quantitative. It was a very formal process as evidenced by substantial documents containing management strategies (mission and vision), quantitative analyses of the opera-

tional scenario, goals articulated over different time horizons (short and medium terms), detailed operational plans, written procedures. The formulation processes were concentrated at the top of the company and were not very participatory. The top management, if anything, were assisted by specialized analysts who prepared analytical contributions useful for decisions, but they were the only exclusive actor entitled to decide and talk about strategy. In the mid-1990s, since the publication of a seminal monograph, The Rise and Fall of Strategic Planning by Henry Mintzberg, one of the most authoritative scholars of strategy, strategy-making ceases to be a rational, sophisticated, formal, and top-down process and it is observed and described in more realistic terms. This trend compared to the previous period is apparent in two main aspects: (1) the recognition that not only the top management, but also other actors participate actively to strategy, (2) the recognition of the importance of intermediate outcomes. The middle management – for example the heads of departments and complex organizational units or the leader of special projects – have a critical role in the success of the strategic process. They play a bridging role by having access to top management and an in-depth knowledge of operations. They can introduce important information – on resources, technologies, competitors, trends specialties – from their operational level and can directly influence their collaborators in the pursuit of organizational goals. Over time, strategy-making has become a participatory activity, described by two dimensions: the extent of practitioners’ involvement (quantitative dimension), and their effective influence on strategic decisions (qualitative dimension). Participation seems crucial for generating strategic consensus among a wide variety of stakeholders involved in the strategy process. For example, (i) the involvement of middle management and the communication of the strategy reduces prejudices on the strategic design and favors the convergence of intentions; (ii) different actors’ power-games, interests, objectives, and perceptions can prevent this convergence, if they are not settled by regular renegotiations and compromises. Developing a strategic plan, therefore, becomes a crucial opportunity to activate a communication process among multiple actors.

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Strategy-making is not immediately associated with an improvement in the organizational performance, but allows to achieve multiple intermediate results, such as: ● Integration, coordination, and communication. Strategy-making is a communication tool and a key coordination mechanism for decision-making. It is the result of social processes and is understood through the underlying micro-activities and interactions of practitioners. In other words, strategy is the result of what the actors involved in strategy-making do. The central question is no longer whether to implement an efficient or effective formal strategic strategy-making system, but rather how the actors do strategy, actually and on an ongoing basis, not in analysis and formulation sessions, but every day – even in single episodes that allow to integrate the strategic decision-making process and coordinate different actors. ● Strategic change and adaptation as final outcomes. Strategy-making can induce a significant reinterpretation of strategic circumstances, activating change, or prolonging strategic stability.

Figure 110.1

Since 2000, we have had a more realistic picture of strategy-making. Some sociological theories (i.e., strategy-as-pratice) have revealed the human side of strategy-making, which distinguishes praxis, practices, and practitioners (Whittington, 2006: 619). ●

“Practice” refers to shared routines of behavior, including tradition, norms, and procedures for thinking, acting, and using “strategy things”. ● “Praxis” refers to actual activity, what people do in practice. ● Practitioners are strategy’s actors, the strategists who both perform this activity and carry out its practices. Strategy-making activities carried out by practitioners are not uniform among organizations even in the same industry. The reality of strategic activity is always unique. However, an element that characterizes health organizations is the higher pluralism of its context. Indeed, the external context is populated by various and influential stakeholders, starting with the regulators, while in the internal context there are several families and professional subgroups, all entitled to have a fundamental role in strategic decisions and in their implementation. The diversity of this

Structural flow and activities that characterize strategy-making

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plethora of actors entails a profound diversity of expectations, objectives, mental schemes and even languages which complicates the sharing of a unique strategy. In other words, the presence of plural and diverse influential internal actors, along with the simultaneous presence of various and different influential external subjects, creates strategic ambiguity (i.e., the impossibility or inability to fully share common strategic objectives for long periods). This ambiguity is partly inherent – when internal and external pluralism are high and/or when moments occur such as turnaround, but it is also deliberately sought, in order to achieve a powerful convergence, at least temporarily, among internal and external stakeholders on the same strategic decision. Quite often, the high pluralism of the context creates strategic frictions among the stakeholders. Often, these tensions turn to organizational choices and practices that are inconsistent with strategic designs. Further tensions ignite an endless vicious circle, unless top management continually tries to accommodate the interests of powerful internal and external stakeholders. In healthcare organizations, the combined use of three different strategy-tools – such as sophisticated quantitative analyses presented in strategic workshops through intuitive graphic representations – is a “praxis” that ensures efficiency and effectiveness in strategizing (Cuccurullo 2013). These tools overcome all the main social, cognitive, and emotional risks associated with highly pluralistic contexts. Indeed, together they constitute (i) a syntactic platform – useful for using common syntaxes between different actors; (ii) a semantic platform – useful for homogenizing the “meanings” about problems and solutions; (iii) a pragmatic platform, that is,

Corrado Cuccurullo

they constitute tools that facilitate not only decisions but also collective action. Which combinations of praxis, practitioners, and practices most influence the intermediate and final outcomes, is a field yet to be explored. For example, how strategic workshops can favor the legitimation of strategy-making (intermediate outcome) and, therefore, of the overall strategy (final outcome)? Otherwise, how a large participation in strategy-making influences integration and coordination (intermediate outcome) and therefore strategic change (final outcome). Another research field is identifying under what contextual conditions bundles of praxis, practitioners, and practices allow the achievement of certain levels of performance. Corrado Cuccurullo

References

Cuccurullo, C., Lega, F. (2013). Effective strategizing practices in pluralistic settings: the case of Academic Medical Centers. Journal of Management & Governance, 17(3), 609‒629. Koseoglu, M. A., Akdeve, E., Gedik, İ., & Bertsch, A. (2015). A bibliometric analysis of strategic management articles in healthcare management literature: Past, present, and future. International Journal of Healthcare Management, 8 (1), 27‒33. Nag, R., Hambrick, D. C., & Chen, M. J. (2007). What is strategic management, really? Inductive derivation of a consensus definition of the field. Strategic Management Journal, 28 (9), 935‒955. Ramos-Rodríguez, A. R., & Ruíz-Navarro, J. (2004). Changes in the intellectual structure of strategic management research: A bibliometric study of the Strategic Management Journal, 1980–2000. Strategic Management Journal, 25 (10), 981‒1004. Whittington R. (2006). Completing the practice turn in strategy research. Organization Studies, 27, 613‒634.

PART XXII PROCUREMENT The essential tools for innovative, effective, and efficient procurement in healthcare organizations are listed below. Procurement is an access filter to innovation, and it is gaining increasing strategic importance in healthcare organizations. The purchase of the right technologies and the introduction of the right innovations can add value to the clinical quality and increase the competitiveness of the organization. Value-based procurement is an approach that delivers, not only tangible, measurable, financial benefits to healthcare organizations, but also tangible and measurable improved patient outcomes.

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111. Centralized procurement The global crisis that has affected developed countries since 2007 has created a significant amount of strain on the budgets of public administrations, prompting them to look for solutions to contain their spending. The mounting trend to curb public spending has given rise to the tendency, at the international level, to set up new independent legal bodies, whose purpose is to integrate the activities performed by various public administrations, with the ultimate goal of finding solutions to streamline and curb mounting public spending. In particular, solutions that have become widespread in the majority of EU countries are based on the centralization of technical and administrative activities at an upper-level, marked by considerable diversity in terms of institutional and organizational structures. Procurement was the first area to be the focus of experimentation into forms of upper-level cooperation. The sheer magnitude of sources managed through public procurement compels attention. Public procurement (the purchase by governments and state-owned enterprises of goods, services and works) accounts for a significant percentage of GDP and has a direct impact on the economy. Purchasing’s strategic contribution to organizations’ performance is increasingly being recognized, also in the public sector as elsewhere (Hesping & Schiele 2015). Nowadays, there is a strong effort to restructuring purchasing functions in order to find out the optimal purchasing process in different product and services categories in different contexts. In the public sector, the pressure to improve the performance of public services and public budgets constraints have recently increased the attention to public procurement and to the necessity to achieve value for money through procurement processes. Furthermore, public organizations often use public procurement as a tool to promote important economic, social and environmental policy. These policy objectives include economic goals (e.g., giving preference to domestic sources of supply), social goals (e.g., giving preference to historically disadvantaged groups such as women and minori-

ties), and environmental goals (e.g., “green” procurement). Among other procurement strategies, there is an increasing interest on the benefits derived from cooperative purchasing. Numerous researchers have discussed the subject of purchasing groups since the 1930s. Thomas Hendrick (1997) defined purchasing consortiums as: … two or more independent organizations that join together, either formally or informally, or through an independent third party, for the purpose of combining their individual requirements for purchased materials, services, and capital goods to leverage more value-added pricing, service, and technology from their external suppliers than could be obtained if each firm purchased goods and services alone.

There are different ways of describing purchasing consortia depending on the reference context. The term “consortium purchasing” denotes cooperation between industrial firms – the term used for businesses that are not independent (divisions of a large group, for example) is “group purchasing”. All of these terms refer to an agreement between two or more parties often motivated by the expectations of improved efficiency and better effectiveness due to economies of scale and economies of scope. In public and healthcare sector the purchasing centralization appears as a clear trend, with a number of countries experiencing different levels of cooperation in the procurement process. According to Schotanus and Telgen (2007), public organizations present specificities (i.e., almost no mutual competition, a common external environment, mutual trust, mutual interests, similar organizational structures, similar networks, and similar purchasing needs) that can enhance and facilitate the development of cooperative purchasing. The first example of the centralization of procurement in the public sector was E&I Cooperative Service in America, which includes different public agencies (counting around 200 to date) including universities, high schools and hospitals. The healthcare sector, in particular, represents the environment with the highest number of initiatives, both in the United States in 2006 and in Europe, where several countries have established central procurement agencies with the aim of stipulating

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framework agreements available to all public administrations, including health, which are recommended to use these contracts. Here some examples of cooperative purchasing initiatives in the healthcare sector:

provide the personnel needed to carry out its operations; ● the for-profit enterprise, consisting of an entirely separate business that sells its services.

● NHS Supply Chain, that manages the sourcing, delivery and supply of healthcare products, services and food for NHS trusts and healthcare organizations across England and Wales https://​www​ .supplychain​.nhs​.uk ● Healthcare Supply Chain Association (HSCA) – that represents the American’s leading healthcare group purchasing organizations (GPOs) https://​www​.su​ pplychaina​ssociation​.org ● ESTAR, that carries out several functions technical-administrative (including purchase of goods and services, warehouses and distribution logistics) for all the public healthcare organizations of Tuscany Region https://​ www​.estar​.toscana​.it/​ ● RESAH, a public Central Purchasing Body that leverages the purchasing power of hospitals and nursing homes in France https://​www​.resah​.fr

Schotanus and Telgen (2007) classified purchasing groups into five categories based on the influence of the group’s members and the extent of the operations executed on a joint basis:

Cooperative purchasing: approaches, benefits and drawbacks

The forms of cooperative purchasing can assume different approaches. In particular, five types of purchasing groups can be observed: ● the local network, consisting of a network of two or more organizations whose operations are based on informal mechanisms designed for the sharing of information and, in some cases, resources; ● the voluntary cooperative, consisting of an informal or organized network based on the sharing of work among the various members, with one of the members chosen to be the “lead agent” in charge of handling procedures and contracts; ● the regional purchasing agency, consisting of a central agency that offers its services to various government agencies; ● the member-owned service bureau, consisting of a third party with respect to the members of the consortium, but in which all the members are represented and who

1. Piggybacking group: informal purchasing groups based on simple mechanisms, often forming relatively large organizations, which stipulate contracts that smaller organizations can adhere to in order to benefit from the same contractual terms; the main aims of this form of organization are cutting transaction costs and reducing purchase prices; 2. Third-party group: a third-party organization that handles operations associated with the collection of information and management of contracts independently; 3. Lead buying group: a form of purchasing group based on activities being assigned to one of the members of the group, according to the criteria of specialization and taking into account the experience, resources or purchase volume; 4. Project group: a very strong form of cooperation, but which refers to a single project; for this reason, the group’s structure is relatively simple; 5. Program group: a form of cooperation based on the involvement of group members in a committee that meets regularly to assess the possibility of working together on projects. Alongside studies on the possible classifications of the types of purchasing groups, cooperative purchasing can pursue significant benefits that can be classified among these main pillars (Dimitri et al. 2006): ● the impact on strategy, namely how relationships changed with the target market and the categories of suppliers; how and if relationships developed between the different public organizations, in terms of agreements, exchanges, and forms of inter-institutional collaboration; what the consortium’s management models are (regardless of its institutional nature) and Marta Marsilio

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what level of involvement and sharing it is able to create; ● the impact in terms of control of public spending, namely if centralization enables and facilitates forms of cost–benefit analysis for the choice of categories of goods and services, what impact it has on the degree of standardization and on the unification of product lists among the various public administrations in the consortium; what impact it has in terms of improvement and innovation for the professions involved; ● the impact on organizational processes, namely in terms of the rationalization of the human resources involved in managing the procurement process, greater specialization of the administrative staff involved in procurement (as regards both the tasks and the links to individual markets or product categories), standardization, and greater efficiency in the different phases and procedures that make up the procurement process; ● the monetary-financial impact, namely any savings achieved as a result of the economy of scale (reduction in the single purchase price) as well as the reduction in costs for administration and tender management (such as costs for its publication or costs for tender committees). Actually, the centralization could also imply some drawbacks that need to be accurately managed by healthcare managers, such as: ● costs for coordination arising from the need to exchange information and for members of the consortium to spend time together, for example by founding inter-agency work groups; ● the possible loss of control suffered by consortium members with regard to certain business processes, resulting from the transfer of prerogatives to the central procurement agency, prerogatives on the one hand, and the attempt to share decisions and the most appropriate consortium governance structure on the other; ● the gradual reduction in the savings that can be achieved via collective demand, driving the search towards additional areas for improvement in the medium to

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long term with respect to possible areas for collaboration for the consortium; ● the burden put on the suppliers of goods and services because of excessive purchase volumes, making it impossible for them to cope with demand, unless they are prepared to join temporary business associations. This problem points to the need to debate the best size for consortia, in order to avoid the social costs generated by the closure of numerous supplying companies. Finally, it is necessary to highlight the possible critical factors that may determine the success of purchasing-group management. The main elements may be ascribable to the following: ● the provision of instruments for the exchange of information between the consortium’s members, with the focus on information systems and mechanisms for ongoing interaction; ● the commitment and internal support, demonstrating the sharing of objectives by all the consortium members; ● equal power and influence enjoyed by all members, as an indicator of equal representation of all interests; ● The willingness to take part, deriving from the group members’ perception of the potential benefits offered by a purchasing group. Marta Marsilio

References

Dimitri, N., Dini, F. and Piga, G., “When should procurement be centralized?” in Dimitri N., Piga G. and Spagnolo G. (eds.), Handbook of Procurement. Cambridge: University Press, 2006: 47–81. Hendrick, T.E., Purchasing consortiums: horizontal alliances among firms buying common goods and services: What? Who? Why? How? Tempe: Center for Advanced Purchasing Studies, 1997. Hesping, F.H. and Schiele, H., “Purchasing strategy development: A multi-level review”, Journal of Purchasing and Supply Management, 2015: 21(2), 138‒150. Schotanus, F. and Telgen, J., “Developing a typology of organizational forms of cooperative purchasing”, Journal of Purchasing and Supply Management, 2017: 13(1), 53–68.

112. Innovation procurement Over the last few years, the processes of purchasing goods and services in healthcare organizations have been characterized by profound changes and innovations, which have modified the inner nature of the “purchasing function”. Some new trends – such as the regulatory evolution; the greater transversality of the processes and the relevant implications at all levels; the tendency to centralize purchasing processes; the growing interaction with users, in search of increasingly more qualitative higher standards; greater collaboration with suppliers – require greater flexibility and professionalization of the structures dedicated to the purchase of goods and services, particularly in healthcare organizations. “Innovation procurement” refers to any procurement that has one or more of the following aspects: ● innovations in purchasing procedures (framework agreement, innovation partnership, competitive dialogue, competitive procedure with negotiation; etc.); ● innovations in purchasing methods (dynamic purchasing systems, electronic auctions; electronic catalogues; electronic market); ● different organizational and management solutions for centralized procurement models (centralized purchasing activities and central purchasing entities); ● innovation in evaluation and selection methods (health technology assessment, cost-effectiveness analysis, and cost– benefit analysis); ● buying the process of innovation – research and development services – with (partial) outcomes. Such innovation, bringing better performance and added value for various stakeholders, sometimes fits the traditional setting (incremental innovation), but often disorders the old system by creating different actors, flows, values (disruptive innovation) or even requires a more comprehensive transformation, as it addresses unmet needs and calls for structural or organizational reforms (transformative innovation).

Public procurement of innovative solutions allows public administrations to acquire goods, services and works characterized by a high degree of innovation, which have not undergone a standardization and industrialization process. In this context, therefore, the Administration acts as an early adopter of innovative solutions not yet marketed on a large scale, helping to determine a stabilization of their quality standards and an improvement in the prices offered. The European Community regulatory framework makes significant changes to the previous system, both in terms of introducing innovative systems and modifying existing procedures. The application of some institutes favors the purchase of innovation (Demircioglu and Vivona, 2021): ● competitive procedure with negotiation and competitive dialogue for procurement requiring immediately available solutions of a particularly complex nature or whose technical specifications cannot be established with sufficient precision; ● pre-commercial procurement: aimed at ensuring sustainable and high-quality public services, provides for a multiple reliance of research and development services to more economic operators than through a competition looking for radically new solutions to technologically complex needs. The European directive is not applied in the event that the public purchaser does not reserve to its exclusive use all the benefits deriving but shares them with the economic operators to market conditions; ● the partnership for the innovation is a procedure of purchase linked to a need of the procuring station that cannot be satisfied by acquiring a product or service already on the market; this procedure allows different stages of exchange with the market, setting intermediate objectives that the parties must achieve. Innovation procurement requires undertaking a number of specific activities that cannot be improvised. Regardless of the level of ambition, they will require some time, money and expertise. Specialized training, cooperative procurement and fostering a generally entrepreneurial culture can help to build the necessary capacity for innovation procurement at a manageable cost.

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The objectives of innovation procurement are (Miller and Lehoux, 2020; Lehoux et al., 2019): ● addressing an arising need: in some cases, innovation procurement is necessary to respond to unmet needs or new expectations, which are not adequately addressed through the existing solutions on the market; ● modernizing public services: innovation procurement can match the way public services are provided to the expectations of the increasingly technophile, environmentally responsible and socially conscious citizen and to improve the public service experience; ● delivering higher quality public service on an optimal budget: an innovative solution is rarely procured for its innovative character alone. In most cases, an innovative solution becomes interesting for public buyers when it enables similar or even better results at optimized costs; ● helping start-ups and innovative SMEs launch and grow: public buyers, whose purchasing power represents a good percentage of GDP, can not only stimulate innovation among already established market operators, but also offer concrete opportunities for SMEs and newly established innovative companies which, despite having developed solutions capable of responding to unmet needs, find it difficult to place their products on the market; ● moving markets towards innovation: when a product is not readily available on the market or when only poor-quality products are on offer, the public buyers’ purchasing power can spur the market towards innovation. The strategic potential of innovation procurement is immense, especially in supporting technological development in and by the public sector. Industries that depend on sales to the public sector can be motivated to innovate and adopt new technologies through public demand (Uyarra et al., 2020). Social sectors such as healthcare, water treatment, district heating, roads and railways almost exclusively depend on expressions of public demand. In these cases, public procurement is a clear vehicle for voicing Marta Marsilio

that demand and for driving technological progress.

The application to healthcare: some examples

From 2013 to 2019, at European Union (EU) level, the Public Administration has launched 80 innovative tender procedures for a total value of over 470 million euros (European Union, 2022). Over the years, a ranking of supply policies in innovation across Europe has been established. The healthcare sector is ideal for public procurement of innovation for two reasons: ● it is a high-spending sector in public procurement; ● it is an intensive user of technology. Innovation procurement enables the use of more quality and efficient solutions in favor of environmental and social benefits, better cost-effectiveness and new business opportunities for companies. There are several examples of innovative procurement at the European level. In the Netherlands, to ensure healthier care for hospital patients, the city of Örebro has launched a call for tenders to purchase PVC-free catheters. At the time of the tender, only one supplier was able to participate but, eight years later, all suppliers had similar products. In Poland, the Sucha Beskidzka hospital has called for a tender to deal with the negative effect of heat waves on patients and users. Instead of prescribing a specific solution, the competition specified functional criteria (lowering the temperature by 2 degrees centigrade) that would also take into account environmental and economic sustainability, as well as respect for the health of patients. The solution adopted consisted in equipping the facade of the building with solar panels that do not obscure the rooms. The panels allowed not only to reduce the temperature, but also to ensure part of the hospital’s energy needs. Belgium, Germany, France and the UK developed innovative solutions for the purpose of improving fire brigade tracking systems to increase their safety when dealing with fires that develop indoors. In Italy, the Lombardy Region’s calls for tenders were preceded by a survey of health

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needs through the publication of an invitation to the social-health companies (public and private) operating in the region. The facilities and medical staff indicated the needs of patients who, in the light of existing technologies, were dissatisfied. After verifying the unavailability on the market of the necessary goods/services, the Region has prepared three tenders for pre-commercial public contracts, all concerning the health sector and financed through the POR FESR 2014‒2020 funds. The first call requires an innovative solution related to bronco-safe aspiration; the second a mechatronic system for the administration of rehabilitation motor therapy to neurological patients with motor disabilities of the upper limb, the third is related to the implementation of a technological innovation to assess the fragility of the plaque atherosclerotic coronary artery disease.

Future developments

In spite of the increasing interest that the topic of the innovative procurement is gaining in the European political agenda, the picture that emerges is of a market with an enormous potential that still remains unexpressed both in terms of expenditure targets and complementary policies. In this regard, it is important to recognize that innovation procurement addresses high risk and cost situations. We

need to help officials overcome risk aversion and fear of the possible additional costs of stopping innovation. For this reason, a cultural change is needed not only among public buyers, but also within the entire ecosystem: between political authorities, appeal bodies, auditors and even the press. Marta Marsilio

Bibliography

Demircioglu M.A. and Vivona R., 2021, Positioning public procurement as a procedural tool for innovation: an empirical study, Policy and Society, 40(3), 379–396 European Union. (2022). eTendering Home: Search a document. Tratto da Ted.e Tendering: https://​etendering​.ted​.europa​.eu/​document/​ document​-search​.html Lehoux P. et al., 2019, What health system challenges should responsible innovation in health address? Insights from an international scoping review, Int J Health Policy Manag., 8(2), 63–75 Miller F.A. and Lehoux P., 2020, The innovation impacts of public procurement offices: The case of healthcare procurement, Research Policy, 49(7) Torvatn T. and de Boer L., 2017, Public procurement reform in the EU: Start of a new era? IMP Journal, 11(3), 431‒451 Uyarra E. et al., 2020, Public procurement, innovation and industrial policy: Rationales, roles, capabilities and implementation, Research Policy, 49(1)

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113. Managed entry agreements (MEA)

These kinds of agreements can be classified as (Figure 113.1):

The World Health Organization, in collaboration with the Organisation for Economic Co-operation and Development, has defined MEAs as follows: An arrangement between a manufacturer and payer/provider that enables access to (coverage/reimbursement of) a health technology subject to specified conditions. These arrangements can use a variety of mechanisms to address uncertainty about the performance of technologies or to manage the adoption of technologies in order to maximize their effective use or limit their budget impact. Despite the diversity in the different models of MEAs these agreements are introduced in an attempt to address one or more of three objectives: ● first, to limit the budget impact and address uncertainty regarding expenditure on new therapies; ● second, to address uncertainties regarding clinical effectiveness and cost-effectiveness and/or in a specific context (e.g., validate cost-effectiveness information from another country with local data); ● and third, to manage utilization with a view to optimizing performance. There is a broad range of MEAs. Arguably, each MEA could be considered unique because of its particular elements and the purpose of the MEA between the manufacturer and payers.

Figure 113.1

● financial-based agreements (FBAs), to control budget impact; ● performance-based agreements (PBAs), to manage uncertainties on efficacy and safety of high-cost new technologies. FBAs are widely diffused in European countries, where 75% of all MEA schemes aim to address budget impact, even though in Italy, there’s also a wide implementation of performance-based agreements. Below are the types of financial based agreements:

Price-volume agreements

Price-volume agreements are a tool aimed at ensuring sustainability in cases where the drug price is high and the population is large. These agreements in fact determine a progressive price reduction as more and more patients are treated. From a conceptual point of view, price-volume agreements are straightforward because the cost of treatment per patient is modelled to be progressively reduced as more and more patients access the treatment. In using price-volume agreements, the most critical point is how to determine the quantitative relationship that relates the reduction in price to the increase in the number of treated patients.

Budget cap

Spending caps are used when there is a decision rule that spending should not exceed

Different types of MEAs

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a predetermined threshold; caps may be either fixed or variable (e.g., the spending cap amount depends on any number of factors, potentially including value). In the event that spending exceeds the threshold, either the price of the product or service must be lowered or utilization of the service or biopharmaceutical must be reduced to satisfy the spending cap.

Confidential discounts

Official drug prices, also referred to as “publicly available prices” or “list prices”, should reflect the actual ex-factory drug prices. However, in the past years so-called “rebates” or “discounts” were introduced in many European countries (e.g., Germany, France and England), that is, the national authority and the manufacturer agree that the actual price for a specific drug differs from and is lower than the official drug price.

Cost sharing

Cost sharing is a discount for initial cycles of treatment for all eligible patients. It is a simpler system to manage than the reimbursement for non-responders used in the “risk sharing” and “payment-by-results” schemes and it is applied when reliable data on the efficacy and safety of the medicines are available. Below are the types of performance-based agreements.

Payment by result

Payment by result sets a total reimbursement by the manufacturer for non-responders. Usually, risk sharing and payment-by-results schemes are applied in the case of medicinal products whose risk–benefit ratio has a greater degree of uncertainty, thus requiring a definition of non-responders that derives from the characteristics and the results of pivotal clinical trials.

Risk sharing

Risk sharing sets a partial reimbursement for eligible non-responders only after a clinical evaluation.

Payment at result

The arrival of novel, innovative health technologies, such as gene and cell therapies, will require specific and separate consideration. These products have the potential to cure patients and provide long-term (potentially lifelong) benefits with a single-time or short-term duration administration. Recently, an installment payment plan has been considered as the MEA of choice to match the benefit duration and the payment. The payments for a high-cost product should be spread over a period of time during which the benefits of the health technology may be accrued, while at the same time, payments and costs of the disease are continuously reduced as time goes on. These payments spread out over time occur on an agreed upon basis, at specific milestones, between manufacturers and payers, whereas manufacturers may profit from revenues on the same basis or another agreed upon financial milestone schedule. These agreements and payment milestones may be tied directly to outcomes as well as patients, as payers are followed over time. If at any time, outcomes or agreed upon milestones are not reached in the agreement, payments may cease and the payment for the full treatment may not be fulfilled, and the manufacturer will bear this cost.

Success fee

It consists of an ex post payment to the manufacturer, applied only for those patients receiving a real benefit from therapy. The drug is provided by the company at no initial cost for the NHS. Depending on the disease characteristics, clinical trials data available, and therapy duration, the NHS and the pharmaceutical company establish a temporal threshold for the evaluation of effectiveness to separate responders from non-responders. Effectiveness is based on clinical outcomes defined specifically for each disease and relies on the efficacy. The primary end point is reported in the registration clinical trial. After the predefined period of treatment, the NHS provides payment only for those treatments that have shown effectiveness. Benjamin Oskar and Francesca Randon

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Bibliography

Dabbous, M., Chachoua, L., Caban, A., & Toumi, M. (2020). Managed entry agreements: policy analysis from the European perspective. Value in Health: the journal of the International Society for Pharmacoeconomics and Outcomes Research, 23(4), 425–433. https://​doi​.org/​10​ .1016/​j​.jval​.2019​.12​.008 Kanavos, P., Ferrario, A., Tafuri, G., & Siviero, P. (2017). Managing risk and uncertainty in health

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technology introduction: the role of managed entry agreements. Global Policy, 8, 84‒92. World Health Organization. Regional Office for Europe. (2015). Access to new medicines in Europe: technical review of policy initiatives and opportunities for collaboration and research. World Health Organization. Regional Office for Europe. https://​apps​.who​.int/​iris/​ handle/​10665/​159405

114. Value-based procurement In order to talk about value-based procurement, it’s fundamental to understand what value is, why we talk about value and why it’s important to focus on value in healthcare. Value-based healthcare is defined as “outcomes achieved per money spent”. Value focuses on improving patient health outcomes: it is the measured improvement in a patient’s health outcomes for the cost of achieving that improvement. The European Commission (EC) has decomposed value into four pillars: appropriate care to achieve patients’ personal goals (personal value), achievement of best possible outcomes with available resources (technical value), equitable resource distribution across all patient groups (allocative value) and contribution of healthcare to social participation and connectedness (societal value) (Pennestrì et al., 2019). Better outcomes reduce the costs and decrease the need for ongoing care: 1. Value-based healthcare reduces the compounding complexity and disease progression that would drive the need for more care. A patient whose diabetes does not progress to kidney failure, blindness, and neuropathy is, over time, dramatically less expensive for the health system than a patient whose condition continually worsens. 2. Costs accumulate from the care provided for individuals. If multi professional teams care for individuals with similar needs, expertise and efficiency increase, outcomes are better and costs reduce. This would also support the professionalism of clinicians and strengthen the clinician–patient relationship, for more effective and appropriate care. Moreover, better outcomes improve population health, which occurs only when the health outcomes of many individuals improve. Thence, value-based healthcare is how we can achieve the aspirational goals of the Institute for Healthcare Improvement’s “triple aim”: (i) improving the patient experience of care, (ii) improving the health of populations, (iii) reducing the per capita cost of

healthcare and (iv) improving clinician experience, a fourth aim that has been proposed. Value-based healthcare procurement (VBP) is the process in which providers purchase medical technologies and devices in order to provide good quality healthcare at competitive or sustainable prices. That means, making purchasing decisions to have the best outcomes with the least total cost of care – rather than focusing exclusively on purchasing a specific product at the lowest possible price. VBP requires a permanent collaboration between society, clinicians and scientists. The concept of VBP is growing so much since the focus on cost reduction has been taken to such an extreme that clinical benefits and long-term value is often deprioritized for the sake of short-term savings. Our current healthcare mainly prioritizes short-term benefits such as single-unit cost-savings (i.e., stents, prostheses, diagnostic exams), in order to: minimize perioperative complications, improve early functional recovery, shorten hospitalization, deliver highly sensitive but poorly specific diagnostic investigations. Precedence to volume (i.e., the number of patients treated or performances delivered) is given, rather than to value. As a consequence: (a) the economic and social burden of long-term care is on the patient’s family (b) non-appropriate diagnostic investigations generate limited clinical benefit and increase the cost (c) long-term readmissions following predictable complications are higher and represent a substantial burden. What should be done, thus, is a shift from this traditional approach (short-term savings) to a more comprehensive approach. This extends the benefits of healthcare to: patients (lower costs and better outcomes), providers (higher patient-satisfaction rates and better care efficiencies), payers (stronger cost controls and reduced risks), suppliers (alignment of prices with patient outcomes) and society (reduced healthcare spending and better overall health). The following principles define VBP in practice: ● It is not the purchaser who specifies how the assignment should be fulfilled, but the provider, based on its personal experience;

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● The provider takes maximum responsibility for the end result of an assignment; ● The purchaser does not set minimum product requirements throughout the selection process for suppliers; ● Selection of providers encompasses mainly on objective and measurable evidence of past-performance, and not lower price or costs; ● The patient should be involved: patient experience is fundamental. These principles have already been proved to be successful in Canada and they are being implemented in the Netherlands (in particular in five pilot projects: cataract surgery, breast cancer surgery, maternal and neonatal care, depression and anxiety, substance abuse). Elective orthopaedic surgery represents a pragmatic example of the holistic benefits achievable by a valuable medical intervention, whose main goal is not saving patients from acute or life-threatening disease, but re-establishing a certain degree of autonomy from loss of function (and possibly improving quality of life on the long-term). In fact, the best prostheses are not the cheapest, but those providing the best clinical and economic benefits in the long term.

The new value-based procurement framework

Currently there’s a price-based approach to procurement, for which healthcare systems continue to face escalating costs, low-value care, and huge disparities in patient outcomes. To be mentioned: ● Among countries in the Organisation for Economic Co-operation and Development (OECD), average mortality rates for stroke patients in some countries can be four times higher than for patients in other countries; ● Reoperation rates following hip replacement surgery in Germany are 18 times higher in the worst performing hospitals than in the best; ● Across the EU, healthcare costs are rising faster than GDP growth. In particular, the costs of care delivery are rising disproportionately, according to Eurostat. These costs make up roughly 70% of total healthcare spend;1 Silvia Tarricone

● The problem of low-value care is also large. A 2017 OECD report found that 10% to 34% of healthcare spending is wasted on inappropriate care.2 Considering all these challenges, a singular focus on cutting the costs will not resolve them; a more holistic approach is needed. In 2014, the European Parliament sought to alleviate some issues associated with price-only-based procurement (Gerecke et al., 2015). A new framework for value-based procurement has been developed: a guide for contracting authorities building a tender, as well as for medtech companies shaping their product and service solutions. It lays out a menu of recommended quality and cost criteria to be used in evaluating tenders. It encourages each industry to define the best price-quality ratio for its specific situation. The framework is structured into three layers: 1. The core is the most important one. Here there is the value-based healthcare equation: patient outcomes relative to the cost of delivering these outcomes; not only initial product costs but also the total cost of care delivery must be included. This means, for example, that if a device can shorten the length of a patient’s hospital stay, the equivalent cost savings should be captured. The same principle applies to the outcomes side. 2. There are also secondary benefits for patients, healthcare professionals, providers, and healthcare systems. These are those reflected around the core. For example, contracting authorities might consider the following benefits: ● The relative convenience and comfort for patients ● The safety and the ease of use for healthcare professionals ● Better care pathways for providers ● Reduced overall costs for the health system 3. Eventually, there is an outer ring: VBP has a broader impact on society in terms of innovation, sustainability, and socioeconomic impact. For each element of the framework, a broad set of criteria exists; from these, contracting

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authorities choose those that are most important for their specific application. It is worth noting that the framework is not intended to serve as a formal algorithm that yields a mathematical solution. It is, instead, a set of considerations that contracting authorities can modify for individual tenders on a case-by-case basis, and that medtech companies can use to improve their offerings. It creates a common language that can make it easier for healthcare providers and companies in the industry to improve value, and it moves the focus away from price as the central consideration. Silvia Tarricone

Notes 1. 2.

See https://​ec​.europa​.eu/​eurostat/​statistics​-explained/​ index​.php​?title​=​Healthcare​_expenditure​_statistics (2022). See https://​health​.ec​.europa​.eu/​system/​files/​2019​ -11/​024​_defining​-value​-vbhc​_en​_0​.pdf (page 4).

Bibliography

Gerecke, G., Clawson, J., & Verboven, Y. (2015). Procurement: The unexpected driver of value-based health care. BCG https://​www​.bcg​ .com/​it​-it/​publications/​2015/​medical​-devices​ -technology​-procurement​-unexpected​-driver​ -value​-based​-health​-care Pennestrì, F., Lippi, G., & Banfi, G. Pay less and spend more-the real value in healthcare procurement. Annals of Translational Medicine. 2019;7(22):688. https://​doi​.org/​10​.21037/​atm​ .2019​.10​.93 Prada, G. Value-based procurement: Canada’s healthcare imperative. Healthcare Management Forum. 2016;29(4):162–164. doi:10.1177/0840470416646119 Teisberg, E., Wallace, S. & O’Hara, S. Defining and implementing value-based health care: A strategic framework. Acad Med. 2020 May;95(5):682–685. doi: 10.1097/ ACM.0000000000003122. PMID: 31833857; PMCID: PMC7185050

Silvia Tarricone

PART XXIII QUALITY Healthcare quality is the degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes. Quality of care plays an important role in describing the iron triangle of healthcare relationships between quality, cost, and accessibility of healthcare within a community. Reaching a set level of quality is an essential requirement to operate in the healthcare market, but also plays an important role in accessing a new market, gaining growing shares of a market, and improving the clinical and financial performance.

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115. Accreditation in healthcare There is a growing worldwide demand for quality in healthcare and for mechanisms to promote and maintain it. Those mechanisms include quality assessment programs such as ISO standards, Total Quality Management, Six-Sigma or Quality Awards. Accreditation is one of the most attractive forms of External Quality Assessment for healthcare organizations. Here, we discuss its definition, history, aims, procedure itself as well as challenges and its future perspectives. Accreditation is a process in which trained external peer reviewers evaluate whether a healthcare organization meets a set of pre-established performance standards. Unlike licensure, accreditation focuses on continuous improvement and achieving optimal quality standards, rather than fulfilling minimal standards to assure public safety. It usually involves measuring an organization against other equivalent organizations and providing feedback to the accredited organization on progress towards quality goals, and areas requiring greatest attention. Accreditation dates back to 1917 when it was introduced in the United States as a mechanism for recognition posts in surgery. The program shifted from a focus on surgical training to multidisciplinary assessments of healthcare functions, organizations and networks called the Joint Commission on the Accreditation of Healthcare Organization. First, the model spread to other English-speaking countries in the 1970s and to Europe in the 1980s. Later, during the 1990s, it arrived in Latin America, Africa and the Western Pacific. To date, an operational accreditation program exists in at least 28 countries. The aims of accreditation can be summarized as (i) creating the right environment for clinical practice; (ii) monitoring safety and functioning of hospital organization; (iii) informing the public and purchasers about the accreditation status of their hospital and reassuring that all necessary safety precautions are being taken; (iv) providing comparative information to the public about how well the hospital is doing compared with other similar providers.

Assessment is performed by a recognized body, usually a non-governmental organization, consisting of a multidisciplinary team of health professionals which determines if a health organization meets standards designed to improve quality of care. The standards adopted nationally derive from an amalgamation of national statutes, governmental guidance, independent reports, overseas accreditation standards, and biomedical and health service research. It’s usually a voluntary process although in some countries (Italy or France) it is mandatory. The mandated assessments have different goals and are likely to achieve different results from voluntary ones. According to ALPHA standards, which is a foundation of ISQua which aims to align healthcare standards and accreditation processes, the accreditation body is responsible for maintaining a system for the determination, awarding and maintenance of accreditation that ensures the integrity of the process. The accreditation process is a multistep process. First of all, the accreditor needs to create a team project, choose a model of standard and train the staff members. Then, the assessment process itself usually comprises of a self-assessment questionnaire and a detailed guidance on preparation and external facilitation to help the hospital (or service) towards compliance with the standards. Site visits are generally preceded by an external examination of a defined set of internal documents. An on-site survey is carried out by a specialized multidisciplinary team and usually lasts from 1 to 5 days depending on the size and the complexity of the organization, and on the size of the visiting team. The site visit includes extensive interviews with staff (and patients), access to management, personnel and patient records and systematic observation of clinical and support services. Finally, a detailed report of findings is delivered with an outcome of accreditation and selection of priority and areas which should be improved, followed by a periodic review. According to research carried out by Bohigas et al. (1996), the principal source of revenue of six accrediting bodies they had analyzed consisted of fees for accreditation services. Half of the currently running programs however – and especially those introduced in the past five years – have

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been funded or managed directly by national governments. As previously mentioned, there are many accrediting organizations operating throughout the world. Below, six accrediting bodies which operate in five different countries: ● Joint Commission on Accreditation of Healthcare Organizations, USA; ● Canadian Council on Health Services Accreditation, Canada; ● Australian Council on Healthcare Standards, Australia; ● Health Quality Service, UK; ● King’s Fund Organisational Audit, UK; ● Japanese Council for Quality Health Care, Japan. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has been acknowledged as the leader in developing the highest standards for quality and safety in the delivery of healthcare and evaluating organization performance based on these standards. To date, JCAHO accredits and certifies over 22,000 healthcare organizations and programs in the United States. The standards used by this organization are listed below, divided into four sections: Section I: Accreditation Participation Requirements Section II: Patient-Centered Standards ● ● ● ● ● ● ● ●

International Patient Safety Goals Access to Care and Continuity of Care Patient and Family Rights Assessment of Patients Care of Patients Anesthesia and Surgical Care Medication Management and Use Patient and Family Education

Section III: Health Care Management Standards ● ● ● ● ● ●

Organization

Quality Improvement and Patient Safety Prevention and Control of Infections Governance, Leadership, and Direction Facility Management and Safety Staff Qualification and Education Management of Information

Marta Szlaszynska

Section IV: Academic Medical Center Hospital Standards ● Medical Professional Education ● Human Subjects Research Programs Issues and challenges Given the high cost and extra workload associated with accreditation, systematic evaluation of the value of accreditation would be extremely helpful. Although some evidence is available, it is inconsistent. According to the review of Alkhenizan and Shaw (2011), accreditation programs in some specialties and subspecialities improve the structure and organization of healthcare facilities as well as clinical outcomes and the quality of care. Other authors, including Brubakk et al. (2015), argue that due to scant evidence, no conclusions could be reached to support effectiveness of accreditation. Moreover, Jha (2018) believes that accredited hospitals do not seem to provide better care as there was no significant difference found in mortality and readmission rates between accredited and non-accredited hospitals in the study they carried out. To sum up, current guidelines do recommend accreditation but are cautious about the evidence, judged as inconclusive. A further debate is about the use of hospital accreditation programs in low-income countries. Some reviews concluded that accreditation can be used as a tool to improve the quality of healthcare in developing countries. Nevertheless, the implementation and sustainability of these programs are a major challenge if resources are scarce. International actors therefore have a substantial influence on the development of accreditation in those countries and there is a need to provide help for the successful development and implementation of accreditation programs. On the other hand, some experts argue that hospital accreditation programs are not a good resource allocation in low-income developing countries. Money should be rather invested in the expansion of the already existing healthcare to improve its quality. Lastly, independent reviews in the USA and Australia have emphasized the need for active collaboration between public and private agencies in order to reconcile the conflict between regulations and development. They concluded that a partnership between the public sector and any accreditation agency is essential for accreditation to succeed.

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To ensure that accreditation achieves the desirable goals there’s a need for a clear delineation of high-quality care through bringing clarity, consistency and transparency to accreditation programs. On an international level, the solution to that is the multinational accreditation standards developed by JCAHO as well as ALPHA through which an accreditation program may apply to have its standards and processes assessed and internationally accredited (it is essentially accreditor of accreditation organizations). That will lead to further international harmonization of different assessment programs. Accrediting bodies should focus on those processes and structural factors that have been shown to be associated with good outcomes. Marta Szlaszynska

Bibliography

Alkhenizan A, Shaw CD. Impact of accreditation on the quality of healthcare services: a systematic review of the literature. Ann Saudi Med. 2011 Jul–Aug;31(4):407‒16 Bohigas L, Smith D, Brooks T, Donahue T, Heidemann E, Donaldson B, Shaw CD. Accreditation programs for hospitals: funding and operation. Int J Qual Health Care. 1996 Dec;8(6):583‒9 Brubakk K, Vist GE, Bukholm G, Barach P, Tjomsland O. A systematic review of hospital accreditation: the challenges of measuring complex intervention effects. BMC Health Serv Res. 2015 Jul 23;15:280 Jaafaripooyan E, Agrizzi D, Akbari-Haghighi F. Healthcare accreditation systems: further per-

spectives on performance measures. Int J Qual Health Care. 2011 Dec;23(6):645‒56 Jha AK. Accreditation, quality, and making hospital care better. JAMA. 2018;320(23):2410–11 Jovanović B. Hospital accreditation as a method for assessing quality in healthcare. Arch Oncol. 2005; 13(3‒4):156‒7 Mansour W, Boyd A, Walshe K. The development of hospital accreditation in low- and middle-income countries: a literature review. Health Policy Plan. 2020 Jul 1;35(6):684‒700 Øvretveit J. Improving the quality of health services in developing countries: lessons for the West. Qual Saf Health Care. 2002 Dec;11(4):301‒2 Øvretveit J. What are the best strategies for ensuring quality in hospitals? Copenhagen, WHO Regional Office for Europe. Health Evidence Network report; http://​www​.euro​.who​.int/​ document/​e82995​.pdf, accessed 27 November 2003 Shaw CD. External assessment of health care. BMJ. 2001 Apr 7;322(7290):851‒4 Shaw CD. External quality mechanisms for health care: summary of the ExPeRT project on visitatie, accreditation, EFQM and ISO assessment in European Union countries. External Peer Review Techniques. European Foundation for Quality Management. International Organization for Standardization. Int J Qual Health Care. 2000 Jun;12(3):169‒75 Shaw CD. Quality and accreditation in health care sevices, a global review. WHO/ISQua, Geneva 2003 Shaw CD. Toolkit for accreditation programs. The International Society for Quality in Healthcare, Australia 2004 Shaw CD, Kutryba B, Braithwaite J, Bedlicki M, Warunek A. Sustainable healthcare accreditation: messages from Europe in 2009. Int J Qual Health Care. 2010 Oct;22(5):341‒50 Shaw CD, World Health Organization. Developing hospital accreditation in Europe. Copenhagen: WHO Regional Office for Europe, 2006 www​ The Joint Commission 2021, http://​ .jointcommission​.org, accessed 13 April 2021.

Marta Szlaszynska

116. Audit Audit is a word used to identify an evaluation made by an examinator (auditor) with the aim to objectively obtain proofs about a certain matter or a certain process of a specific company in order to establish if criteria, goals or other indicators have been reached or respected. For extension, an audit can be useful to verify the personnel who manage the data audited.

to obtain evidence and to evaluate them objectively. In this context, the auditor is the person involved in running the audit and they have got the personal features and the skills to run an audit. Because the audit is run using samples of proofs and documents, resources for running an audit for an auditor are limited. Both the terms audit and auditor have different meanings depending on the category of the particular audit. At the end of the procedure of auditing, the auditor releases a “compliance certificate”.

Aims

Internal and external audit

Definition

It is of paramount importance knowing and understanding the meaning of this word because this kind of process is often used by companies to evaluate the truthfulness of their work. In healthcare, it should be mandatory to evaluate the report obtained by previous audits when a hospital, public or private, decides to buy instruments or whatever could be useful in clinical practice by a particular company. Every health company could be subjected to audits, internal and external, and it is important to know the minimum criteria which could be audited. In this context, health managers should be able to read an audit report and should have the skills to evaluate the truthfulness and the strength of the information reported.

Definition – details

The term audit identifies the system of procedures and verifications to which a company can be subjected. This concept could be applied to several activities, for example in healthcare it is called a “clinical audit”. The audit can investigate the quality of production of the company, the quality of the services provided and every single area in the company. An audit is often based on samples of evidence and in this way this kind of evaluation has naturally got a margin of error because it aims to explain a general situation using a limited selection of elements. For the Italian legislation, UNI EN ISO 19011:2018 (1) (guidelines for the audit of the management systems), the definition of the word audit is the telematic process, independent and documented, made in order

There are essentially two big categories of the auditing procedure: internal and external audit. ● Internal audit: this kind of auditing procedure is run constantly by the internal organs of a company, and it aims to control and manage the regular working processes of the different sectors of the company. An internal audit aims to search and evaluate inefficiencies, understand causes and propose solutions. ● External audit: this kind of audit is made by external auditors, and it focuses on the results and documents which derive from the final reports of the company. External audit is also divided into optional and mandatory external audits. The main difference between these subclasses of external audit is that the mandatory audit could be requested by the juridical authority, while the optional audit is often requested by the company itself in order to objectify its quality to potential commercial partners. While the general evaluation processes are not always scheduled and perfectly objectified, the audit is always characterized by several main elements. 1. Aims and criteria a. The audit must have an aim. Usually this aim is the verification of the degree of compliance of a company, but there could be different kinds of aims: i. Verification of a supplier in order to re-use its services. This could be the main aim of an audit made

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by a private company or made in a hospital context; ii. Verification of corrective action made in order to supply a negative judgment received in a previous audit; iii. Evaluation of the material or of the quality of products, equipment and so on in order to declare the adequacy of the product; iv. Evaluation of a service before it is made available to the public; v. Evaluation of the acquisition of skills and verification of the skills of the personnel of a company; vi. Rating; b. Criteria i. Criteria are the elements that are evaluated by the auditor in order to run the auditing process and in general they are the main requirements used to formulate the final report because they will be compared by the auditor with the evidence obtained by the company audited. 2. Plan, program, procedure a. Every audit: i. must be scheduled and planned; ii. must have a declared aim and the perimeters in which it is run must be declared: the group or the people that will be audited, the location, the date, every single aspect of the object of the evaluation and other details must be clear, and it must be defined how, where and by who the audit will be run. 3. Evidence a. NORMA ISO 9000 (2) defines evidence: i. Evidence is data that supports the existence or the truthfulness of something. Therefore, evidence could be: 1. Documents 2. Specific and objectified information acquired by measurements, monitoring, interviews 3. Materials, products, equipment (products audit) 4. Activities and the specific locations in which these activities are made

ii. The significance and the strength of an auditing process and of a compliance certificate is based upon the reliability and on the strength of the evidence acquired, depending on the budget available and the ability of the auditor. 4. Objectivity a. The auditor must be objective and completely impartial. In everyday practice, this concept is synthetized by the absence of conflicts of interest. 5. Report a. Results and outcomes of an audit must be communicated and documented through an audit report; b. In this report, every anomaly must be communicated, like weakness, defects and every finding of the audit. These results must be communicated in detail; c. The report should contain also the instructions to correct the non-compliance findings; d. The release of the checklist is not mandatory.

History of the term audit

The word “audit” probably derives from the Latin word “auditor” or from the Latin verb “audire”. “Auditores” were people who exerted the action of control on the administration of the public money through the audition of the accounting results. During the Middle Ages, in Italy, with the municipalities there was the flowering of public reviewers and in 1314, in England, was instituted the charge of the auditor who periodically checked statal money balance. These institutional figures evolved and created real companies, which became more skilled in these kinds of evaluations until they reached complete control of auditing the truthfulness of how the government acts. In this context, in Italy was born the “corte dei conti”, in France the “cour des comptes” and the federal court in Germany. During the nineteenth century, in England the review of the corporations was encoded in the companies act of 1862 and was based on independent auditors elected by the shareholders’ assembly of the companies. In the United States the first audit company was instituted five years after, in 1867. Francesco Mazziotta

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Both the two English speaking models were scheduled and finalized to check the ability of a company to communicate accounting documents which are truthful and complete. In the same period, in 1889, in Germany a law was written in which the review procedure of the audit became mandatory and it was introduced for cooperative companies. In Italy, it was necessary to wait more than thirty years, until 1924, to see the first institute of company reviews, in Milan. The year before, the Italian trust institution was born. On 7 June 1974, with the introduction of law 216 in Italy, the review and the audit of balances of joint stock companies became

Francesco Mazziotta

mandatory and during the years after, this kind of control was extended to other specific categories of companies.

Future horizons

The history and the experience of recent events teach how the checking and the truthfulness of societies is always important. In a context in which has become very easy to falsify documents, the figure of the auditor and the audit process will have, but yet has, a crucial importance in order to verify whether a company is what it says it is or not. Francesco Mazziotta

117. Quality management Quality means doing it right when no one is looking (Henry Ford)

Background

Quality management originates at the beginning of the twentieth century, together with the increase in industrial mass production. It is defined as the process of overseeing all activities that must be accomplished to reach and maintain a desired level of excellence, with the main objective of promoting customer satisfaction. The process of quality management requires the participation of all stakeholders to improve products and services and spread the culture within the organization itself, besides regulatory compliance (standard ISO 9001:2015). The elements of Quality Management can be summarized as follows: ● Activity planning and control; ● Suppliers’ qualifications; ● Process and services monitoring (also by improving specific indicators); ● Customer experience and satisfaction

Quality management in the healthcare system

In healthcare organizations, the customer satisfaction can be translated as the availability of safe, prompt and opportune care. Also, a patient-centered approach to care, which includes the establishment of clear and reassuring communication, is central to providing a positive experience and can contribute to avoiding dissatisfaction, claims – and their related economical loss – and lack of trust in the healthcare system. A Quality Management System requires the mapping and description of all the activities, processes and responsibilities inside specific procedures, to provide a control checklist able to measure compliance and individuate any area that needs to be improved. Also, the procedures can be used as a tool for monitoring quality over time, providing feedback about process operations. The main role of the Quality Manager (QM) is the improvement and review of Standard Operating Procedures in collaboration with the subject matter experts (e.g. medical doctors, nurses, technical staff, …),

considering regulatory compliance and good quality standards, such as the ones listed by the Joint Commission International (JCI).1 Also, the QM is involved in training and quality check activities: it is their responsibility to provide specific training for healthcare operators and improve a monitoring system with periodical and systematic checks on processes, procedures and activities.

Why is quality management useful (and necessary)

Considering the main purpose of quality management – customer satisfaction – the process of improving, controlling and correcting the actions in healthcare supply is central for: ● The healthcare system, bettering the welfare level of the population by providing excellent services; ● The healthcare organizations, providing a systematic tool to measure their processes and services aimed to increase effective and perceived quality level; ● The organization’s Quality Management System and all the human resources (including the medical, nursing and technical staff), collaborating for the same goal of enhancing quality care and sharing a common culture; ● The patients, experiencing care in a safe and controlled setting.

Main theories about quality management The Deming Cycle – PDCA The Deming Cycle is a methodology for quality management and continuous improvement, composed of four cyclical steps: ● PLAN: identification of a goal or purpose, improvement of success metrics and indicators, activity planning; ● DO: actuation of planned activities; ● CHECK: monitoring of the outcomes to test the validity of the plan, bringing to attention any problems and areas for improvement; ● ACT: integration of the learnings generated by the process, which can be used to adjust the goal or change the actions and procedures going back to the PLAN step.

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The main purpose of the Deming Cycle is to measure the effectiveness of planned actions and correct or re-plan them when needed in order to pursue the goal guaranteeing the quality of products and services through an evidence-based methodology. In God we trust. All others bring data. (Deming, 1982)

The Donabedian model The Donabedian model is a conceptual approach that defines a framework for the evaluation of healthcare quality. According to Donabedian, information about quality of care can be deduced from the following three categories: ● Structure: a combination of the factors defining the context in which care is provided, including the physical facility, equipment, and human resources, as well as organizational characteristics and processes; ● Process: the sum of all actions that take place in the healthcare system to provide care and benefit the services. It includes the research of services by the patient, the diagnosis and treatment pathway, long-term care and continuity of care. Also, Donabedian believed the ethical dimension to be a central part of the healthcare process, including the ability to effectively establish a patient-centered setting and communication; ● Outcome: the effects of healthcare systems and services on patients or populations. The measurement of these factors through specific indicators provides a tool for quality management and monitoring, focusing on the elements that make up the healthcare system and their combination. Also, the model is flexible and applicable to every healthcare facility. Systems awareness and systems design are important for health professionals, but they are not enough. They are enabling mechanisms only. It is the ethical dimensions of individuals that are essential to a system’s success. (Donabedian, 1988, p. 1743)

Francesca Montesi Righetti

Quality management process

As previously stated, quality management in healthcare organizations is the combination of actions aimed to map the processes, improve procedures that regulate them and evaluate their compliance with the standards. This complex process can be divided into the following main phases: ● Quality planning: establishment of quality and success metrics, which must be linked to the strategic objectives of the organization, department or unit. Metrics help to define the actions to be performed in order to reach the goal (e.g. surgical procedures safety improvement, first aid patient pathway optimization, …) and pursue the standards. The Donabedian model can help to define the metrics for structures, processes and outcomes, in compliance with the regulatory system. ● Quality assurance: improvement of a measurement system that analyzes the processes through accurate, precise, repeatable and reproduceable data. This phase is associated with continuous improvement and is central to promote quality care. ● Quality control: monitoring of metrics identified in the quality planning phase and evaluation of the effectiveness of implemented procedures. The organization could elaborate specific board charts in order to trace any progress or areas that need to be improved. These processes must be systematically carried out in order to ensure standard compliance and patient safety.

Future developments

Quality management, as stated, is a complex process being part of complex organizations, like hospitals. To be effective and useful, it must be included in an integrated system that also considers risk management, claims management, customer satisfaction and every other element either positively or negatively affecting patient safety. An integrated approach to risk and quality can help to define the areas in the organization which need improvement, listing the priorities of intervention and optimizing the efforts to reach excellence and safety goals. Francesca Montesi Righetti

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Note 1.

See https://​www​.jointcom​missionint​ernational​.org/​.

Bibliography

Deming, W. Edwards (1982). Out of the Crisis, Cambridge, MA, Center for Advanced

Engineering Study, Massachusetts Institute of Technology. Donabedian, A. (1988). The quality of care: How can it be assessed? JAMA 260(12), 1743‒1748. Feigenbaum, A.V. (1961). Total Quality Control, New York, Mc Graw Hill. Norma ISO 9001:2015 Qualità. From https://​www​ .uni​.com/​index​.php​?option​=​com​_content​&​ view​=​article​&​id​=​361​&​Itemid​=​2445

Francesca Montesi Righetti

Index

AAMI see Association for the Advancement of Medical Instrumentation (AAMI) AAN see American Academy of Nursing (AAN) Aberdeen Varicose Vein Questionnaire (AVVQ) 311 ACA see Affordable Care Act (ACA) ACCE see American College of Clinical Engineering (ACCE) access control 3 access to healthcare 108–9 accountability 173, 237 accountable care organization (ACO) see accountable care plan accountable care plan 174–5 accreditation 282, 292, 337–9 aims of 337 bodies 337–8 JCAHO standards 338–9 process 337 programs 338 activities of daily living (ADL) 91 acute care 77, 79, 80 acute care beds 305 acute myocardial infraction (AMI) 122 adjusted per capita payments 51–2 ADL see activities of daily living (ADL) administering therapies 256–7 adult social care 131 advanced practice nurses 136–7 adverse selection 44, 45 Affordable Care Act (ACA) 45 Agenda 2030 62 Alagille syndrome 9 Alkhenizan, A. 338 All™ Methodology 288 ALOS see average length of stay (ALOS) ALPHA standards 337, 339 ambulatory activities 216 American Academy of Nursing (AAN) 291, 292 American College of Clinical Engineering (ACCE) 205, 206 AMI see acute myocardial infraction (AMI) antenatal screening 97 Anthony, R. 211 area capitation 51 artifacts 273 artificial intelligence (AI) 3–4, 254 Association for the Advancement of Medical Instrumentation (AAMI) 205

audit defined 340 future horizons 342 history of 341–2 internal and external 340–41 main elements 340–41 auditor 340 authentication 2 autocratic leadership 208 average length of stay (ALOS) 305 AVVQ see Aberdeen Varicose Vein Questionnaire (AVVQ) balanced scorecard (BSC) 294–7 bank debt 71 Barsanti, S. 150 basic underlying assumptions 273 Batalden, M. 110 Baumol’s cost disease 40–41 Beaglehole, R. 12 bed-based intermediate care 147 beliefs systems 314 Best Workplaces Award® 289 Beveridge Model 22–3, 56 Beveridge, W. 22 big data 2–3, 127, 254 see also artificial intelligence (AI) biologicals 37 biotech 36–7 biotechnological drug 37 biotechnological vaccines 36 Bismarck model 24–5, 55, 56 Bismarck, Otto von 24, 62 Black, N. 310 black swan theory 233–4 blinding 244–5 blood pressure 96 Bohigas, L. 337 Bolsin, S. 237 Bonciani, M. 150 bonds 71 Bonita, R. 12 boundaryless hospital 142–3 boundary systems 314 BPI see business process innovation (BPI) Brubakk, K. 338 BSC see balanced scorecard (BSC) budget 52–3, 299 cap 330–31

346

Index  347 financial 299 management control 298–300 operational 299 process in healthcare companies 298 sheets 298 budget-driven archetypes 31 budgeting 299 of controllers 213 and planning system 298–9 bundled payments 53–4, 139 burden of diseases 142 Burgoyne, J. 268 Bury, E. 178 business models 157 business planning 69 of healthcare services 69–70 business process innovation (BPI) 261 cancer screening 100 capacity planning 254 capital expenditure 69 capitation payment 139 car accidents 96 cardiovascular diseases 122 prevention 96 caregiver burden 91 CARE Measure 310, 311 care model redesign 265 care robots 20 case-based payments 52 case-finding 98, 99 Case Management Society of America (CMSA) 203 case managers 203 role of 203–4 case mix index (CMI) 303 applications 304 formula 303 limitations 304 origin of 303 cash budget 299 cash flow statement 299 catastrophic coverage 44 CCE program see clinical engineering certification (CCE) program CCI see Commission on Chronic Illness (CCI) CCM see chronic care model (CCM) CCMC see Commission for Case Manager Certification (CCMC) CDs see clinical directorates (CDs) Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life Program 66 centralization vs. decentralization 276–7 centralized procurement 324–6 Certificate of Need policy 48 CEs see clinical engineers (CEs) CFTR gene 16

Chalmers, I. 116 Chandler, A. D. 278 change/innovation vs. stability/standardization 277–8 change leaders 194 change management 193–4 Charter of Fundamental Rights of EU 139 chief of specialty 269 children’s social care 131 China, telemedicine 165 chronic care 79–81 chronic care model (CCM) 79–80 chronic conditions 79–81 chronic diseases 97 Class of Recommendation (COR) 239–40 cleaning and disinfection robotics 20 clinical audit 238 effectiveness 238 engagement 285–6 integration 264–5 transformation 265 uncertainty 48 clinical activity, pharmacist 228 clinical differentiation archetypes 30 clinical directorates (CDs) 271–2 clinical engineering certification (CCE) program 206 clinical engineers (CEs) 205–7 certification process 205–6 management activities 206 Plan-Do-Check-Act (PDCA) 206 role of 205 services 207 clinical governance 237, 253, 261 application 237 seven pillars of 237–8 clinical leadership 208–9 classroom learning 209 clinical/organizational multidisciplinary activities, of pharmacist 231 clinical practice guidelines 239 benefits and limitations 240–41 component of 239 goal of 240 recommendations 239–40 clinical risk management 233 future scenarios 234–5 main theories 233–4 objectives of 233 process 234 clinical service lines 264 analytics and innovation 265 and centers 153, 161 clinical integration 264–5 clinical transformation 265 governance and leadership 264 clinical trial

348  Elgar encyclopedia of healthcare management aims of 243 blinding 244–5 participation in 243 pharmacist 228–9 phases of 243–4 randomized controlled 244 clustered regularly interspaced short palindromic repeats (CRISPR-Cas9) 10 CMI see case mix index (CMI) CMSA see Case Management Society of America (CMSA) Cochrane, A. 116 code of business conduct 314 Cohen, I. G. 13 collaboration 123, 144, 187, 188, 229 collective efficacy 200 collective leadership 200 co-location of services 150 Colombier, C. 40 Commission for Case Manager Certification (CCMC) 203 Commission on Chronic Illness (CCI) 98 communication 104, 193, 220, 321 community-based intermediate care 147 community care 83, 84 community hospitals 144–6 community pharmacist 228, 231 competence 119 compliance 119–20 certificate 340 Concierge Practice 157 concordance 119–20 confidential discounts 331 consortium purchasing 324 context analysis 234 contract 46–7 controlled professionalism 182 controllers activities 211, 213 defined 211 hard and soft skills 213–14 in healthcare 212–13 history 211–12 roles 211–12 skills 213 control system 212, 313–16 converging trends, in hospital transformation 267–9 cooperative purchasing approaches 325 benefits 325–6 drawbacks 326 initiatives 325 coordination 321 co-ordination forms 278 co-pay 44 co-production 110–11 COR see Class of Recommendation (COR)

coronary heart disease 122 corporate credos 314 corporate governance 237, 271 corporate leadership 190 corporatization 177–9 cost accounting, of controllers 213 cost of care 138–9 reduction 226 sharing 331 COVID-19 pandemic 11, 286 digital therapeutics (DTx) 34 intermediate care in 148 medical tourism 13 primary healthcare (PHC) 102 response of hospitals 89 telemedicine for 166–7 crew resource management (CRM) 162 critical care 77 CRM see crew resource management (CRM); customer relationship management (CRM) crowdfunding 72 CS see customer satisfaction (CS) Cuba, Beveridge Model 22 cultural paradigm 273–4 culture audit 289 customer relationship management (CRM) 302 customer satisfaction (CS) 301–2, 343 future development 302 customer service quality improvement CYP2C9 gene 16 data

encryption 2–3 masking 3 mining 251–2 security 252 Davies, H. T. O. 273 Da Vinci robot 20 Davison, G. 163 debt 71 decentralization 159–60, 277 deconcentration 159 deinstitutionalization, of home care 83 delegation 136, 159 demedicalization 113–14 Deming Cycle see Plan-Do-Check-Act (PDCA) devolution 159–60 diagnosis related groups (DRG) 303, 304 diagnostic control systems 315 diagnostic robotics 19 differentiated cultures 274–5 digital therapeutics (DTx) 33–4 advantages and disadvantages of 34 direct capitation 51–2 direct primary care (DPC) 157 disaster management 195 future developments 197

Index  349 goals 195–6 implementation 196–7 disease awareness campaign 42 disease mongering 42–3 disruptive innovation 6–7 divisionalization 271 DNA sequencing 8 doctor–patient relationship 48–9, 256 Donabedian classification of quality of care 308 model 344 donations 55–6, 71 DPC see direct primary care (DPC) Drescher, C. W. 16 DRG see diagnosis related groups (DRG) drugs advertisements 42 DTx see digital therapeutics (DTx) Dunn, J. R. 133 earmarked taxation 55 earnings before interest and taxes (EBIT) 70 earnings before interest, taxes, depreciation and amortization (EBITDA) 69–70 EBHC see evidence-based healthcare (EBHC) EBIT see earnings before interest and taxes (EBIT) EBITDA see earnings before interest, taxes, depreciation and amortization (EBITDA) EBM see evidence-based medicine (EBM) EBP see evidence-based practice (EBP) education and training, clinical governance of 238 EHR see electronic health record (EHR) elective orthopaedic surgery 334 electronic health record (EHR) 251–2 for patient care and safety 251 emergency care 77 Emilia-Romagna Regional Health and Social Agency 246 employee engagement 285 ENhANCE European project 215–16 EQ-5D 311 equality 60–61 equity 60–61 EQ-VAS 311 espoused values 273 ethics 184 European network of Health Technology Assessment Agencies (EUnetHTA) 246–7 evidence-based data collection 308 evidence-based healthcare (EBHC) 116 health management 117–18 evidence-based management 307 evidence-based medicine (EBM) 115–18, 161, 265, 307 aims of 115 benefits 116 key components 115 key milestones in the development of 115–16

limitations 117 limit to application of 117 quality of care 118 strategies 118 evidence-based practice (EBP) 116 ex ante moral hazard 44 ex post moral hazard 44 external audit 340–41 family and community nurse (FCN) 215–17 interventions of 216 Italy 215 object of 215 three levels 216 WHO definition 215 family doctors see general practitioners (GPs) FBAs see financial-based agreements (FBAs) FCF see free cash flow (FCF) FCN see family and community nurse (FCN) Feachem, R. 11 feedback mechanisms 313, 315, 316 feedforward mechanisms 313, 315, 316 fee-for-service (FFS) 52, 138, 174 financial accounting 212, 213 financial-based agreements (FBAs) 330–31 financial budget 299 see also operational budget financial indicators 120 Finland Beveridge Model 22 telemedicine 165 Fitzgerald, A. 163 focused factory model 254–5 force field analysis 194 Ford Model 6, 254 fragmented cultures 274 France, telemedicine in 165, 166 free cash flow (FCF) 70 free-market competition 31 Freidson, E. 184 funding sources 55–6 for investments 71–5 fundraising 72 gatekeeper capitation strategy 52 gate-keeping 218 gender inequalities 61 medicine 121–2 general practitioners (GPs) 144, 215, 218–19 longitudinality 218 shortage of 145 general taxation 55 genetic screening 98 genomics 8–10 GIN see global identification numbers (GIN) GLIF see guideline interchange format (GLIF) global

350  Elgar encyclopedia of healthcare management budgets 53 epidemics 11 health 11–12, 123–4 global identification numbers (GIN) 258 globalization 11–12 glycogen storage disease (GSD) 9 GM-CSF see granulocyte-macrophage colony stimulating factor (GM-CSF) Goleman, D. 199, 208 González-Calle, D. 148 Goodall, A. H. 208 Goold, M. 313 governance 152, 155, 178, 196 clinical see clinical governance corporate 271 and leadership 264 model 278 GPs see general practitioners (GPs) granulocyte-macrophage colony stimulating factor (GM-CSF) 9 Gray, M. 116 Great Place to Work® 288–90 Great Place to Work certification® 288–9 Greenblatt, D. J. 122 Grimes, K. 286 gross national income (GNI) per capita 71 group health insurance 45 group purchasing 324 GSD see glycogen storage disease (GSD) guideline execution engines 239 guideline interchange format (GLIF) 239 Gupta, G. R. 61 Guyatt, G. 116 Hammick, M. 187 hard skills, of controllers 213–14 HAs see health authorities (HAs) Hayes, M. V. 133 HBHTA see hospital-based HTA (HBHTA) head of nurses 269 health equity 60–61 expenditures 24–5 inequalities 123, 133 literacy 125–6 management 117–18 outcome 138–9 promotion 64 health authorities (HAs) 46 healthcare data analytics 2 expenditures 80, 174 managers 174, 188 operations and production models 254–5 healthcare management, patient satisfaction for 301–2 healthcare operations management 225–7 activities 225

application of 225 healthcare organizations 80 balanced scorecard (BSC) in 294–7 healthcare quality 344 evaluation of 344 healthcare systems 79 micro-, meso-, and macro-levels 80 health economic archetypes 30–31 health information technology (HIT) 302 health insurance 26–8 coverage 108 moral hazard in 44–5 health organizations, corporatization of 178–9 health technology assessment (HTA) 30, 206, 246–8 for drugs and medical devices 247 levels 248 Health Technology Assessment Division (HTAD) 248 health technology management (HTM) 205 “Healthy People 2020External” initiative 66 Hendrick, T. 324 Hippocratic medicine 229 HIT see health information technology (HIT) home care 83, 91 deinstitutionalization of 83 financing the 83 future challenges 85 integration with community services 84 professionals 83–4 technology for 85 horizontal differentiation 276 horizontal integration 130 hospital architecture 87 defined 86 future developments 89 history 86–7 innovations in 88 medicine 221 modern 86, 88 pandemic response of 89 recent developments 87–8 resilience to COVID-19 89 stays 220 value chain 143 hospital accreditation programs 338 hospital-based HTA (HBHTA) 206 hospitalists 220–21 hospitalization 86 negative aspects of 142 house call practice 157 household activities 216 HR department see human resources (HR) department HTA see health technology assessment (HTA) HTAD see Health Technology Assessment Division (HTAD)

Index  351 HTM see health technology management (HTM) hub and spoke 168 history in healthcare 169 in Italy 171 models benefits of 169–70 history 168–9 transport disruption 171 W.K. health system 169–70 network 168 hubs, congestion at 170 human resources (HR) department 213 hybrid professionalism 182–3 IADL see instrumental activities of daily living (IADL) iatrocracy 177 ICU see intensive care unit (ICU) identity/belonging vs. openness to exterior 277 IFMBE see International Federation for Medical and Biological Engineering (IFMBE) IHI Triple Aim 134 IMCUs see intermediate care units (IMCUs) implementation facilitators 197 INAHTA see International Network of Agencies for Health Technology Assessment (INAHTA) incomplete contracts 47 individualized stepped care 256 individual performance evaluations, of controllers 213 indoctrination 177 inequalities in access to healthcare 108–9 infectious diseases, prevention of 95–6 information and IT, clinical governance 238 information asymmetry 48, 49, 69 information innovation 254 information system design, of controllers 213 information technology (IT) 162 initiative medicine 127–9 innovation 88, 136 in hospitals 88 primary healthcare (PHC) 102 innovation procurement 327–9 application to healthcare 328–9 future developments 329 objectives of 328 innovative biotechnology 36 instrumental activities of daily living (IADL) 91 integrated care 130–31 definitions 130 delivery system 139 models 143 types 130 integrated cultures 274 integration 321 of teamwork 188 vs. differentiation 276

intensive care unit (ICU) 147, 148 interactive control systems 315 intermediate care 147 in COVID-19 pandemic 148 evidence of effectiveness and costs 147–8 intermediate care units (IMCUs) 147, 148 internal audit 340–41 internal rate of return (IRR) 70 International Federation for Medical and Biological Engineering (IFMBE) 247–8 international health 11, 123 International Network of Agencies for Health Technology Assessment (INAHTA) 246 interprofessional collaboration 188 inter-professionality 161–3 beneficial outcomes of 162 investments, funding sources for 71–5 IRR see internal rate of return (IRR) ISS see Italian national institute of health (ISS) Italian National Health Service (NHS) 56, 57, 63, 246 Italian national institute of health (ISS) 121 Italy Beveridge Model 23 family and community nurse (FCN) 215 gender medicine 122 hub and spoke in 171 NHS pharmacist 228 primary care center (PCC) model (Case della Salute) 151 role of medical director 223 telemedicine 165–7 ivacaftor 16 Jha, A. K. 338 Joint Action 1 (2010–2012) 247 Joint Action 2 (2012–2015) 247 Joint Action 3 (2016–2020) 247 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 338–9 Kaplan, R. S. 294–6 key performance indicators (KPIs) 206, 265, 296 Kickbusch, I. 12 Kindig, D. A. 133 knowledge 184 Koplan, J. P. 11, 12 Kotter’s change management 193 KPIs see key performance indicators (KPIs) laissez-faire leadership 199 Lameire, N. 25 Lancet commission 61 Langabeer, J. R. 226 Lawrence, P. R. 276 leadership 190, 196, 264 defined 199–200 styles 199–200

352  Elgar encyclopedia of healthcare management Lean approach 254–5, 282 Management 261–2 production 261 Lee, J. Y., 274 legacy payment model 174 Legato, M. J. 122 length of stay (LOS) 305 Level of Evidence (LOE) 239–40 LHUs see local health units (LHUs) line item budget 53 local governments 159 local health units (LHUs) 46 LOE see Level of Evidence (LOE) long term care 91–2 Lorbiecki, A. 268 Lorsch J. W. 276 LOS see length of stay (LOS) Louis, P. C. A. 115 Luo, W. 108 machine bureaucracies 185 machine learning 3, 4 magnet hospital (MH) 291 current situation and future development 291–2 status and benefits 291 Magnet Recognition Program (MRP) certification 291 managed entry agreements (MEA) 330–31 management accounting 211–12 management control, budget 298–300 management skills, medical director 223 managerial culture 182–3 managerial objectives, medical director 223 manager of ward 269 mandatory audit 340 mandatory private health insurance systems 108 mapping techniques 186 market access 30–31 market-driven model 26–8 marketization 46 Martin, J. 274 mass screening 99 MEA see managed entry agreements (MEA) measurement, patient satisfaction 301 medical leadership 285, 286 service portfolio 142–3 teleconsultation 164, 166–7 tourism 13–14 value chain 143 medical biotechnology 36–7 medical devices 247 medical director 223–4 activities 224 role of 223–4 USA federal regulations 223

medical engagement scale (MES) 285 medicalization 113 medical technologies (MT) 205 Medicare 78, 175 medicracy 177 membership practice 157 MES see medical engagement scale (MES) MH see magnet hospital (MH) mid-change 194 Mintzberg, H. 271, 279, 314, 320 political games 180–81 modern hospitals 86, 88 molecular diagnostics 37 monoclonal antibodies (mAbs) 30 moral hazard, in health insurance 44–5 MRP certification see Magnet Recognition Program (MRP) certification MT see medical technologies (MT) multidimensionality 308, 309 multidisciplinarity 161–3, 189–90 beneficial outcomes of 162 multidisciplinary care teams 268 multi-specialty hospitals 267 narrative-based medicine 117 National Health Service (NHS) 33, 237, 331 British 46 Italian 56, 57, 63, 246 pharmacist 228–9, 231 National Institute for Health and Care Excellence (NICE) 239 National Institute for Health and Care Research (NIHR) 215 National Recovery and Resilience Program (NRRP) 166 natural language processing (NLP) 3–4 neonatal screening 97 Netflix 6 net present value (NPV) 70 neuroticism 65 new public management (NPM) 307, 318 next generation sequencing (NGS) 9 NHS see National Health Service (NHS) NICE see National Institute for Health and Care Excellence (NICE) NIHR see National Institute for Health and Care Research (NIHR) NLP see natural language processing (NLP) noncommunicable diseases 125–6 non-teaching hospitals 155 Noordegraaf, M. 182 NORMA ISO 9000 (2) 341 Norton, D. P. 294–6 Norway, telemedicine 165 Nottingham City Hospital (UK) 292 NPM see new public management (NPM) NPV see net present value (NPV)

Index  353 NRRP see National Recovery and Resilience Program (NRRP) nurse-on-call 102 nursing home 91 Nursing Word Index (NWI) 292 Nya Karolinska (NK) University Hospital 88–9 Obamacare see Affordable Care Act (ACA) occupational health psychology (OHP) 65 OHP see occupational health psychology (OHP) OHS see The Oxford Hip Score (OHS) OKS see the Oxford Knee Score (OKS) OM see operations management (OM) operating expense 69 operational budget 299 operational critical factors, disaster management 196 operations management (OM) 254 operations managers 225–7 goals 226 qualitative methods 227 quality improvement 226 quantitative management 226–7 role of 225–6 organizational critical factors, disaster management 196 cultures 188, 273–5 development 278, 279 mechanisms 278 needs 276, 278, 279 politics 180 resilience 89 structure 278 well-being 65 organizational cultures 188, 273–5 organizational design 276–9 strategy 278–9 organizational-logistic function, pharmacist 228 osteopenia 43 osteoporosis 43 Ostrom, E. 110 outcome indicators 308 out-of-pocket expenses 26, 28 payment 13, 56 overdiagnosis 100 The Oxford Hip Score (OHS) 311 the Oxford Knee Score (OKS) 311 Pang, T. 11 paper medical records 251–2 see also electronic health record (EHR) Parkinson’s law 48 participation in strategy making 320, 322 participatory medicine 128–9 passive/avoidant leadership 199 patient-centered approach 282

care 119, 281–2 hospital 281 organization 281–2 patient flow logistics 225, 253–5 drivers and performance dimensions 253–4 healthcare operations 254 problems 253 production models 254–5 patient-focused drug development (PFDD) 31 patient-induced demand 48 patient-reported experience measures (PREMs) 310–11 patient-reported outcome measures (PROMs) 310–11 patients engagement 302 experience 119–20 grouping 267–8 information 256 management 256–7, 291 out-of-pocket archetypes 31 patient satisfaction measurement and dimensions 301 role of citizen and 301–2 Payer, L. 42 pay for outcomes 53 pay for performance (P4P) 53, 282 payment mechanisms 51–4 payments by results (PBR) 53, 331 PBAs see performance-based agreements (PBAs) PBR see payments by results (PBR) PCC see primary care center (PCC) PCT see primary care teams (PCT) PDCA see Plan-Do-Check-Act (PDCA) Pecchia, L. 248 per capita payments 51 per diem 52 performance-based agreements (PBAs) 330 performance measurement and management (PMM) systems 307–9 personalized medicine 16–17, 121–2, 128 personal thresholds 16 personal well-being 65 Pettigrew, A. 180 pharmacist 228 activities, tools 230–31 future developments 231 goals 228–9 history 229–30 pharmacogenomics 8 PHC see primary health care (PHC) physical activity 96 physical robots 4 PICO see population/patient, intervention, comparison and outcome (PICO) P&L account see profit and loss (P&L) account Plan-Do-Check-Act (PDCA) 206, 343–4 planning and budgeting 304

354  Elgar encyclopedia of healthcare management pluralism 321, 322 P4 medicine 128–9 PMM systems see performance measurement and management (PMM) systems political arena 180–81 political games 180–81 poor health literacy 125–6 population health management 133–4 population/patient, intervention, comparison and outcome (PICO) 248 Porter, M. E. 138 post-acute care 78 post-change 194 Powell, E. 48 power equilibrium 274 politics 180 P4P see pay for performance (P4P) pre-change planning 193–4 precision medicine 16–17, 128 pre-commercial procurement 327 predictive medicine 127 prehospital care 77 premise control 315 premiums 26 prevention 93, 101 goals of 93 historical development 93–4 primary 93, 94 screening for disease 93, 95 secondary 93–5, 97 tertiary 93, 95 preventive medicine 127–8 price, tariff vs. 52 price-volume agreements 330 primary care center (PCC) 150 Italian model 151 primary care teams (PCT) 218 primary health care (PHC) 101–4, 150, 215, 218 primary medicine 102 primary prevention 93, 94, 128 primordial prevention 128 Prins J. 285 private health insurance 24, 26–8, 55 privatization 46, 159 proactive medicine 127 process indicators 308 productivity improvement 226 profession 184 professional bureaucracy 177–8, 185, 271 credos 314 culture 182–3 engagement 286 entrepreneurialism 185 license 189 professionalism 184–5 profit and loss (P&L) account 70

program evaluation, case mix index (CMI) 304 progressive patient care model 282 project finance 72–3 prosthetics 20 public health 11 concept 123 education 42 public health insurance (PHI) 26–8 public–private partnerships (PPP) 72–3 history and literature 73 purchasing centralization 324 quali-quantitative objectives, medical director 223 qualitative methods 227 quality assurance 344 care 233, 234, 310, 344 control 304, 344 planning 344 quality improvement 118, 162, 226 programs 221 quality management 261–2, 343 future developments 344 in healthcare system 343 pharmacist 228 process 344 purpose of 343 theories 343–4 Quality Management System 343 quality manager (QM) 343 quantitative management 226–7 quantitative methods 275 quasi-markets 46–7 quaternary healthcare 105, 128 Quinn, J. J. 313 RACMA see Royal Australasian College of Medical Administrators (RACMA) radio frequency identification (RFID) 258 radiology 190 randomized controlled trials 240, 244 rapid whole-exome sequencing (rWES) 9 Reason, J. T. 234 Recombivax HB 36 redesign of organizational mechanisms 268 of physical environment 268 rehabilitation robotics 19–20 reimbursement case mix index (CMI) 304 of digital therapies 34 of treatment 31 remote consultations 166–7 Replacement Priority Index (RPI) 206 report production, of controllers 213 research hospital critical issues and future developments 153 definition 152

Index  355 organizational structure 152–3 role and goals 152 resources pooling 267 revenues 69 RFID see radio frequency identification (RFID) risk management clinical governance 238 pharmacist 228 risk manager, role of 233 risks identification, evaluation and mitigation 234 management 233 clinical risk see clinical risk management sharing 331 rituximab 30 robotic process automation (RPA) 4 robotics 19–20 robust ideology 277 Roemer’s law 48 Rogers’ change theory 193, 194 Rondinelli, D. A., 159 Rooke, D. 208 Royal Australasian College of Medical Administrators (RACMA) 209 RPI see Replacement Priority Index (RPI) rule-based expert systems 4 rWES see rapid whole-exome sequencing (rWES) Sackett, D. L. 116 Sanger sequencing 8, 9 Santa Maria della Misericordia 292 SARS-CoV-2 pandemic 94, 126 satellite hospitals 169–70 Savedoff, W. 28 Schein, E. H. 273 Schieber, G. 27 Schotanus, F. 324, 325 SCM see supply chain management (SCM) screening 93, 95 defined 97 false positives and negatives 100 genetic 98 historical development of 97–9 motivation for 98 objective and benefits of 97 and overdiagnosis 100 potential harms of 99–100 principles and practice of 98 programme 99, 100 test performance 99 types of 99 uneconomical 100 SCUs see standard care units (SCUs) SDGs see Sustainable Development Goals (SDGs) Sean, R. 45 secondary care 104

secondary prevention 93–5, 128 Sekhri, N. 28 selective screening 99 self-management of patient 256 self-regulation 184 Sepah, S. C. 33 service line leaders 264 service line management (SLM) 179 service robots 20 shaky alliances 181 shared decision-making method 49 Shaw, C. D. 338 SHI see Statutory Health Insurance (SHI) short-term stabilisation 77 Sick Funds 24 SID see supplier-induced demand (SID) Simons’ model of levers of control 314 skill mix 136–7 skills, of controllers 213–14 smoking prevention 96 social activities 216 social care 131 social health insurance 55, 56, 62, 108 soft skills, of controllers 213–14 spending caps 330–31 spokes overextension of 170 staff dissatisfaction at 170–71 staff management, clinical governance of 238 stakeholder analysis and mapping186 management 186 theory 186 standard care units (SCUs) 147 Starfield, B. 101, 218 Statutory Health Insurance (SHI) 24 Stoddart, G. 133 strategic activity 321 change 321 control 313–16 decisions 70 planning 318 surveillance 315 strategy making 320–22 strategy-tools 322 structural critical factors, disaster management 196 structure indicators 308 sub-acute care 77–8 sub-cultures 274 substitution 136 success fee 331 supervisory functions, pharmacist 228 supplementary cover 27 supplier-induced demand (SID) 48–9, 52, 69 supply chain 258 advantages of 258

356  Elgar encyclopedia of healthcare management automation system 260 cost savings 260 unit processes to 258–9 supply chain management (SCM) hospitals’ investment in 260 limitations 259–60 surgical robotics 19 surveillance screening 99 Sustainable Development Goals (SDGs) 61–3, 123 Swettenham, J. 286 “Swiss cheese” model 234 Switzerland, health insurance 26 systematic benchmarking 308 system failure approach 234 systems medicine 127 Taleb, N. N. 233–4 tariff vs. price 52 task shifting 136–7 teaching hospital 154 managing the 154–5 vs. non-teaching hospitals 155 team Leader 269 teamwork defined 187 effective 187–8 barriers to 188 integration of 188 role of leaders and senior healthcare managers 188 technological innovation 254 technology for home care 85 teleconsultation 164, 166 teleECG initiative 165 telemedicine 144, 164–7 advantages of 164, 166 barriers to 166 for COVID-19 pandemic 166–7 guidelines for 166 in international level 165 major macro-areas 164–5 practice 157 regulations 166–7 telephone triage 165 teleprevention 165 telerefertation 164 televisita 164 Telgen, J. 324, 325 territorial pharmacist 228 tertiary care 104–5 tertiary prevention 93, 95, 128 Thailand, medical tourism 14 Thallon, J. 285 therapeutic alliance 119 therapeutic plan 256 timeliness 308 tobacco use prevention 96

traditional biotechnology 36 traditional internal medicine 221 transactional leadership 199 transformation leadership 199 transitional care 147 trauma care & acute care surgery 77 traveling practice/pendulum 157 triple aim approach 142, 143 triple value model 139 troika model 271 Trust Index method 288, 289 Tulchinsky, T. H. 24 Turf war 189 causes and consequences 189 organizational solution 190 prevention and management 189–90 turnover 69 UK, telemedicine 165 units grouping 267 universal health coverage (UHC) 62–3 universalism 62–3 urgent care 77 U.S. Medicare program 175 Valetudinaria 86 “The Value Agenda” 138 value-based healthcare 88, 138–40, 207, 255, 333–4 value-based procurement (VBP) 333–5 new framework 334–5 principles 333–4 variability reduction 226 vertical differentiation 276 vertical integration 130 VKORC1 gene 16 volume-based healthcare 138–9 von Moltke, L. L 122 WACC see weighted average cost of capital (WACC) Wachter, R. 220 Wagner, E. H. 79 Wang, F. 108 warfarin 16 weighted average cost of capital (WACC) 70 well-being 64–6 measures 66 programs and initiatives 66 wellness 101 Wernli, D. 123 WES see whole exome sequencing (WES) West, M. A, 208 WGS see whole genome sequencing (WGS) whole exome sequencing (WES) 9 whole genome sequencing (WGS) 9 Whole System Demonstrator (WSD) Program 165

Index  357 W.K. health system 169–70 workload analysis, of controllers 213 World Economic Forum 66 World Health Organization (WHO) 60, 62, 71, 123, 205, 215, 237, 248, 282 concept of health 64 family and community nurse (FCN) 215, 216 globalization 11 goals of accountability 173 health equity 60 health literacy 125

Health 21 policy 215 multidimensional conception of health 64 screening principles 98–9 universal health coverage (UHC) 262 universalism 62 WSD Program see Whole System Demonstrator (WSD) Program Young, T.K. 133 Zorg Instituut of the Netherlands 175