Research Methodology in Medical-Sciences 9789350431917, 9789350243091

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RESEARCH MEY"HODOLOGY IN MEDICAL-SCIENCES Dr. A.G. CHANDORKAR

Dr. B.S. NAGOBA

Dean, Maharashtra Institute of Medical Sciences and Research, Medical College, Latur - 413 531.

Professor & Head, Department of Microbiology, Maharashtra Institute of Medical Sciences and Research, Medical College, Latur - 413 531.

Hal GfIimalaya GJlublishingGJiouse MUMBAI • DELHI • NAGPUR • BANGALORE • HYDERABAD

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REVISED EDITION :2010

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Published by:

: 978-93-5024-309-1

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CONTENTS 1. Medical Research in the Last Two Decades

1- 5

Dr. A.G. Chandorkar

2. Introduction to Research

6 - 13 Dr. A.G. Chandorkar

3. Basics of Research Methodology

14 - 43

(i) The Research Question (ii) Hypothesis Formulation

(iii) Research Design Dr. A.G. Chandorkar

4. Serendipity in Research

44 - 48 Dr. A.G. Chandorkar

5. Clinical Trials

49 - 57 Dr. A. G. Chandorkar

6. Ethics in Medical Research

58 - 74 Dr. A. G. Chandorkar

7. Statistical Methods for Research

75 - 93 Dr. A.G. Chandorkar

8. Meta-Analysis

94 - 98 Dr. A.G. Chandorkar

9. How to Write a Paper?

99 - 113 Dr. B.S. Nagoba

10. Dissertation Writing

114 - 127 Dr. Mrs. S.N. Kothadia & Dr. B.S. Nagoba

11. Dissertation -

is it the only Method to

Teach Post-graduates?

128 - 131 Dr. A.G. Chandorkar

12. Critical Review & Evaluation of Scientific Research Paper

132 - 140 Dr. Mrs. M.S. Watve, Dr. B.S. Nagoba & Dr. A.G. Chandorkar

13. Contribution of Library in Research Process

141 - 150

Mr. V.N. Kale

14. Searching e-Medical Literature & Articles

151 - 158

Mr. S.M. Kolhe

159 - 163

15. Spoken Communication Dr. B.S. Nagoba

16. Visual Aids in Spoken Communication

164 - 170

• Preparation & Presentation of Slides Dr. B.S. Nagoba & Dr. A. G. Chandorkar

17. Use of Overhead Projector in Spoken Communication

171 - 178

Dr. A.G. Chandorkar & Dr. B.S. Nagoba

Further Readings

179

1 Medical Research in the Last Two Decades Dr. A.G. Chandorkar Research is an integral part of learning, development and innovations in any subject, especially in Medicine. However, the scenario which we see today deludes our expectations. The research in Medicine in India is not what it should be. It would be appropriate at this juncture of publishing this book on Research Methodology to take an overview of the medical research in India specially in the last two decades. It is with sadness that I bring to your notice that Nandy S. (1998) has published a data on Indian medical research, which is very revealing. It states that of the 128 Medical Colleges, less than ten were active, and most of their papers were published in 113 Indian Journals, of which only 27 were included in Index Medicus, while only three, viz. Indian Journal of Medical Research, Indian Paediatrics and National Medical Journal of India were included in Science Citation Index (S.c.I.). Thus, most of the Indian research was ignored by the international fraternity and we remained peripheral to the main stream of Medical Science. It is said that not only the quality of medical research was poor and low, but it was also headed in a wrong direction. The research carried out was irrelevant to the needs of the society or the country. The fields like tropical diseases, infectious diseases, childhood problems, respiratory

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RESEARCH METHODOLOGY IN MEDICAL SCIENCES

diseases, leprosy, etc. were ignored and the research was mainly carried out in fields like oncology, neurosciences and other problems which were more relevant to the problems of Western or American population, (Arunachalam 1998). Reddy et al. (1991), quoting the reference from S.CI. from 1981-88 regarding the research output of 128 medical institutions in India, stated that only 10 medical institutions were active in research and overall quality of their work was low. It is also sad to note that the quality of scientific output from India between 1981 to 1994 actually declined, whereas that of China, Thailand and Philippines actually improved (Robert May, 1997). The average impact factor of these articles had fallen by 40 % during 1981-1992 as stressed by Wayt Gibbs (1995).

What Ails our Research? There are various reasons for this state of medical research. The ones which are mostly quoted are the lack of funds, lack of motivation, lack of direction and lack of accountability. (1) Out of 81 Medical Colleges which received research grants, only 44 produced any papers at all, and (2) It was found that hardly 10 % of the projects funded by Indian Council of Medical Research (I.CM.R.) end as publication in indexed journals. Naturally most of the money given for these projects is wasted (Arora et al. 1996). Recent survey report of I.CM.R. (2002) has brought out the dismal picture of medical research in great details. It states: • 27 of 156 Medical Colleges did not produce a single paper during 1990-94. While 29 Medical Colleges published only one paper. • Only 8 institutions were active in research and produced more than 200 papers during 1990-94. The figures are being collated for the period after 1994, but the available preliminary data indicates that this trend continues. India's share in the global medical literature, published in Indexed Journals declined from 0.9% to 0.5%. It is worthwhile to find out, if this is due to lack of funds or lack of motivation. Almost all research carried out is in All India Institute of

MEDICAL RESEARCH IN THE LAST TWO DECADES

3

Medical Sciences, (A.I.I.M.S.) New Delhi, Post-graduate Institute of Medical Education and Research (PGIMER), Chandigarh or Jawaharlal Institute of Postgraduate Medical Education and Research UIPMER), Pondicherry or from National Institute of Mental Health and Neurosciences, (NIMHANS), Bangalore which are the prime institutions of India. Most of the I.CM.R. research awards go to the workers from these institutes. It would be of worthwhile to note that 17 out of 24 research aWdrds were awarded to scientists from the aforesaid self-financed institutions, which also attract the best 'brains' from all over India. Not only is there an apparent lack of motivation for research in most of the other Medical Colleges but also there is no spirit of enquiry so essential for scientific research (Prof. Valiathan 1997). There is also a lack of research ambience in our Medical Institutions (Prof Balaram P.1997). Dr. Prema Ramchandran (1997), Advisor, Planning Commission states that the basic, clinical, applied and operational research studies, relevant to major health and population problems in the country are the focus of research programmes but her statement seems to be only partly true, if we search the S.CI. or Medline data, it can be seen that most papers belong to General Medicine, Pharmacology, Tropical Medicine, Neuroscience, Radiology, Oncology and Pathology. But papers in other areas of needs and of national importance are few and need based research is often neglected. This non-directional, non-need based research is also a drawback in Indian medical research and greater stress needs to be given to need based research.

What can be done to ensure need based quality research? To remain globally competitive we need research with appropriate facilities. The important question is not whether the I;-:::!:~n medical research is of low quality or is non-directional, or non-n~ed based. This can be remedied by enforcing strict policies and control, but what can be done to encourage need based quality research?

Grants I.CM.R. grants have been increased from 11 % to 32% in the last two years but scientists are crippled due to poor infrastructure, old, aging and out dated equipments in the I.CM.R. National

4

RESEARCH METHODOLOGY IN MEDICAL SCIENCES

Laboratories which need to be replaced on a war footing. Rs. 1000 crores have been allotted in the 10th plan against the present allotment of Rs. 250 crores. But mere increase in funds will not be enough as it is seen that proper utilization of available funds is lacking and no adequate returns have been yielded. Therefore, it is imperative that not only do we increase the funds for research but ensure their proper and optimum utilization. A cost benefit analysis of research funding is also very necessary. Finally, we will have to get rid of chairbound bureaucrats entrenched in our research establishments and stop the mutual back scratching among those who constitute our award granting expert committees.

Motivation (1) We have to make sure that our young scientists are motivated and a spirit of enquiry is inculcated in them and due credit is given to them for their work. The young scientists, Ph.D. workers or postgraduates are the ones who actually slog but most of the times their work is suppressed or high-jacked by their bosses and published as their own work as first author and the name of the actual worker is relegated to an obscure corner included in the end of the acknowledgment section. This is demotivating. It is suggested that make the research "Non-hierarchical in Nature." Success in the U.K., the U.S.A., Canada, etc. is due to this. (2) Research papers or proposals often list scores of individuals as authors or researchers, though actually 1 or 2 persons do the actual work. Directors, Deans, Head of Deptartments consider it to be their right to be included as researcher on every project and paper. Some senior clinicians insist on inclusion of their names or they make it clear that unless that was done, they vvill '11 It refer patients for clinical studies. The "frequent flyers" and ;, ,n busy professors with considerable practice gather accold' It'S for studies carried out by their juniors, presenting these in international conferences as their own.

Quality Control Lots of paper published are "repetitive" in nature because there is not enough quality control in domestic medical literature. Many people repeatedly produce papers from their thesis or work done

MEDICAL RESEARCH IN THE LAST TWO DECADES

5

20-30 years ago and read the same at different conferences. Presentation of a paper from using data in retrospective studies from different departments or publishing just a review or analysis of data in their own name on a subject which has very little or no value, should be strongly discouraged. Hence, a system of quality assurance and for reducing mediocrity and dishonesty in research are the need of the time. Such poor quality research had prompted Groffman and Warren to state that we should stop research in India because, it is done best in the West, where expertise and resources are greater than ours. J. P. Kassireb, editor, New England Journal of Medicine quoted that poor countries have much more to worry about doing high quality research. There was no science in it. But journal editors, medical researchers are highly motivated with self interest and would not be interested in problems of our country which are not of their need, nor in fashion. We would also become forever dependent on the West for solutions which are often inappropriate to our health problems. Therefore, to avoid unethical research it is suggested that all proposals should be submitted through ethical committees. Ensure that quality of research by scrutiny by expert committee and only those with good quality and application to the needs of society and nation should be allowed. REFERENCES 1. Arora M., Banerjee J.K., Sohni P., Pande G.K. & Nandy S. Natl Med J India, 1996; 9: 135-40. 2. Arunachalam S. Natl Med J India, 1998; 11; 27-34. 3. Arunachalam S. Curr Sci 1997; 72: 912-22. 4. Das Anuprita, The Indian Express, Mumbai, Jan 30, 2002. 5. Groffman S. & Warren K. Scientific Information Systems and Principles of Selectivity, Prager-New York, 1976. 6. May R.M., Science, 1997; 225: 793-6. 7. N;andy S. Natl Med J India 1998; 11: 1-2. 8. Reddy S.K., Sahni P., Pande S.K. ~ Nandy S. Natl Med J India, 1991; 4: 90-2. 9. Valiathan M.S. Curr Sci 1997; 72: 911. 10. Wayt Gibbs W. Scientific American 1995: 76-84.

CHJ r.J

2 Introduction to Research Dr. A. C. Chandorkar

..

What constitutes research? What is a scientific discovery and what is invention? These are the questions which are asked most frequently. The difference in their definitions is artificial and all are concerned with advances in the scientific knowledge. Scientific discovery by definition is finding something which exists in nature like discovery of penicillin while technical invention creates device or substance which did not previously exist, e.g. plastics or television. The advances in scientific knowledge can be classified into: (a) Discovery of factual information by observation and

experiments. (b) Invention of concepts and theories from (a) above and

(c) Invention of technical processes and physical things such as machines, gadgets and new substances. The basis of all research is thus a systematic urge to re-examine or re-understand things. The Oxford English Dictionary defines research as a careful and systematic work to see facts, information, etc., i.e. acquiring new knowledge.

INTRODUCTION TO RESEARCH

Epistemology is a science of study of (a)

Nature of human knowledge

(b) Sources of human knowledge

(c) Methods of acquiring knowledge (d) Limitation of human knowledge.

and thus it is the basis of all learning and research. Knowledge is direct and indirect. Direct knowledge can be acquired by the five senses, e.g. touch, seeing, hearing, smell and taste but mostly through seeing, i.e. observation. Thus, knowledge is acquired through perception. Direct knowledge is based on observation and involves not merely a sense of perception but mental thinking which lends significance to what is perceived, e.g., discovery of penicillin by Fleming or connection between cowpox and smallpox by Edward Jenner. In contrast, Aristotle provides an example of non observation when he claimed that women have fewer teeth. He could have verified it by counting teeth of Mrs. Aristotle. While indirect knowledge is acquired, through inferences based on logic, through sharing information with other people or being told some thing by an expert/authority. Another method of obtaining knowledge is logical thinking and method of science.

What is ResearcM There are many different conceptions of wh::l.t constitutes research, e.g. research is a systematic way of asking questions, or/ a systematic method of enquiry. The purpose of research is to obtain knowledge or information that pertains to some question - simple or complex, but the emphasis is on the term systematic. Research is also a method of obtaining systematically an unbiased and objective information. Theobald Smith (American bacteriologist) defines research as "a fundamental state of mind involving continual reexamination of doctrines and axioms upon which current thought and action are based. It is therefore, critical of existing practice."

Misconception about Research (1) There are many misconceptions and the most common one is that research activity :~ shrourled in