ABC of Research Methodology and Applied Biostatistics—A Primer for Clinicians and Researchers Mahendra N Parikh, Nithya Gogtay
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1ABC of Research Methodology and Applied Biostatistics—A Primer for Clinicians and Researchers
2ABC of Research Methodology and Applied Biostatistics—A Primer for Clinicians and Researchers
Mahendra N Parikh MD, FICS, FICOG, FIMSA, FICMCH DA Professor Emeritus, Nowrosjee Wadia Maternity Hospital, Mumbai Editor Emeritus, The Journal of Obstetrics and Gynecology of India Consultant, Sushrusha Citizens' Cooperative Hospital, Mumbai, India Nithya Gogtay MD, DNB (Pharmacology), DNB (Clinical Pharmacology) Associate Editor, Journal of Postgraduate Medicine Associate Professor, Department of Clinical Pharmacology Seth GS Medical College and KEM Hospital, Mumbai, India Forewords S Arulkumaran K Satyanarayana
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ABC of Research Methodology and Applied Biostatistics—A Primer for Clinicians and Researchers
© 2009, Jaypee Brothers Medical Publishers
All rights reserved. No part of this publication should be reproduced, stored in a retrieval system, or transmitted in any form or by any means: electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the authors and the publisher.
First Edition: 2009
9788184485066
Typeset at JPBMP typesetting unit
Printed at
4To
(Late Smt) Shobha M Parikh
5Foreword
Medical research outcome of today is clinical practice tomorrow. Hence understanding research methodology is vital for the researcher and essential for the clinician. The ABC of Research Methodology and Applied Biostatistics – A Primer for Clinicians and Researchers is an excellent book for every clinician from beginners to those in established practice. The fifteen chapters provide a wealth of information and have been written in simple language. The chapters flow from one to the other in a format and design that will help the reader to understand research from “conception to delivery”. It covers every aspect from the type of research studies to planning ethics, execution, statistics, presentation of manuscript and presentations to avoid pitfalls. The chapters on misdeeds and misconduct and historical glimpses of medical research provide interesting information.
I enjoyed reading the book cover to cover and admit that I learnt a lot about medical research. I would highly recommend it to all those involved in research and clinical practice. The authors should be commended for a truly valuable contribution to science.
S Arulkumaran
Professor and Head of Obstetrics and Gynaecology
St George's University of London
6Foreword
The need for rigor in carrying out medical research that could lead to better leads and strategies for the prevention, diagnosis and management of disease is now beyond debate. This is in fact a global call. But unlike basic biomedical research with animals or in vitro systems, inherently endowed with strong experimental methodology for reliability, medical research has traditionally been handicapped to a large extent due to the involvement of human subjects. Due to this and other reasons, medical research is even accused of being ‘unscientific’ way of putting together evidences. Yet, medical scientists have been braving along picking up nuggets of new data, painstakingly analyzing and interpreting, generating new knowledge that eventually finds way into practice. The entire process of data-information-knowledge cycle has undergone a sea change in the recent past. New evidences are currently put to most stringent testing and evaluation before applied in the clinic.
Considering the challenge, research culture among medical scientists, especially from the clinical disciplines has always been found wanting. One of our studies a few years back showed that some medical colleges in India did not publish a single paper in an indexed journal over a five year period. So unlike other disciplines in science where the adage is ‘publish and perish’ in medical research it has been more of ‘publish or perish’. However, many who did publish ‘research papers’ could not transcend journals run by their respective learned societies that did not particularly encourage 7excellence. So, at a time when drastic revamp was called for, our collective failure ensured perpetuation of mediocrity. Even the hesitant and tentative hesitant steps were at best ad-hoc.
But things seem to be looking up, albeit slowly, at least in major cities like New Delhi, Mumbai, Chandigarh, if the number of young doctors flocking the training workshops on biomedical communication and research methodology is any indication. A perceptible shift in the mind-set among young and middle level medical professionals to learn - learn the right (best) way of not just doing science but also publish in the best international journals is visible. In the last three years or so, even some journals published by learned societies have changed, and for better. Evidence-based medicine is slowly but steadily making its way into clinical practice. Overall, the hunger for new knowledge that is on the rise, augers well for the medical research establishment, patients, and the country.
But the training to impart such skills has not been very widely spread being limited by the handful of committed individuals. The course material for most training workshops on research methodology and biomedical communication is largely borrowed from the west as several excellent books written by eminent experts are available. Unsurprisingly, most resource persons of workshops (being full time medical teachers) find it convenient to liberally borrow from these sources. Often, the content is not very appropriate to the Indian participants, despite ‘Indianization’. A good resource book on research methodology was always found wanting.
The ABC of Research Methodology and Applied Biostatistics: A Primer for Clinicians and Researchers, therefore, 8is a very welcome addition. What is pleasantly surprising is that the senior author Professor Mahendra Parikh is an obstetrician and gynaecologist by training, a discipline not exactly in forefront of medical research in India. Dr Parikh's passionate commitment to promote medical research, build skills and empower young medical researchers is evident by the widely attended workshops organized in various parts of India. Under his leadership, the Journal of Obstetrics and Gynecology of India has been running the very successful PICSEP (Program for Inculcating the Culture of Scientific Enquiry and Pursuit) Project since 2003. Co-authored with a young promising clinical pharmacologist Dr Nithya Gogtay, this booklet gives the elements of research methodology and biostatistics from a practitioners’ point of view. Written in a very simple and easily understandable way (especially medical statistics), the booklet contains little of everything a young researcher should know planning and designing a study, execution publication of a research paper, evidence-based medicine, application of biostatistics, ethics, research, misconduct etc.
I hope this is only the appetizer and Drs Parikh and Gogtay will dish out a comprehensive resource book in the not too distant future.
K Satyanarayana
Editor, IJMR
9Preface
Progress in every walk of human activity depends upon research based on new ideas. So it is in the field of medicine too. Medical students are exposed to epidemiological research while studying Preventive and Social Medicine. During undergraduate days, they have opportunities to learn Research Methodology if they wish to. But during postgraduate training they must learn Research Methodology while working on and writing their thesis or dissertation which is an essential and integral part of the postgraduate examination. Unfortunately, thesis writing is often not taken seriously and considered a mere formality at a vast majority of universities in the developing countries. The current scientific methods of conducting research developed over the past six decades, have been refined only in the last 30 years. Even the Heads of Departments in many medical colleges are ignorant of these new methods. As a result, most published research is poorly done and there is a great need to improve the quality of research done especially in developing countries.
The Senior Author became Editor of the Journal of Obstetrics and Gynecology of India in 2003 after working in many editorial positions for three decades and having a vast teaching experience. He soon realized the need for training postgraduate students and teaching staff in Research Methodology. Hence, he initiated the project designated as Program for Inculcating the Culture of Scientific Enquiry and Pursuit (PICSEP). The project has expanded in many different directions and is showing good results benefiting 10students, teachers and clinicians. Clinicians must become knowledgeable about the basics of Research Methodology including the basis of Applied Biostatistics to be able to evaluate the medical literature they read. The junior author is regularly conducting training programs of 12 half-day sessions for undergraduate and postgraduate medical students since 2003 besides being part of the editorial team of the Journal of Postgraduate Medicine and Journal of Association of Physicians of India for a decade. During these activities involving training hundreds of researchers and clinicians, we realized a great need for a simple, compact and comprehensive book on this subject, written in plain language, devoid of scientific jargon and directed at clinicians and research workers. Most western books are beyond the reach of readers in developing countries due to their prohibitive cost and complexity of writing.
This book is written keeping in mind the needs of undergraduate and postgraduate students and their teachers, junior researchers and their guides and the clinicians. The clinicians are consumers of research since they utilize it in their day-to-day practice.
It is hoped that the book will in a small way contribute to improving the quality of research done in developing countries and empower the clinicians to evaluate the quality of research that they read in journals and listen to in conferences. Suggestions and comments from the readers are most welcome.
Mahendra N Parikh
Nithya Gogtay