Research Methodology Simplified: Every Clinician a Researcher Mahendra N Parikh, Joydev Mukherjee, Avijit Hazra, Nithya Gogtay
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1Research Methodology Simplified Every Clinician a Researcher2
3Research Methodology Simplified Every Clinician a Researcher
Mahendra N Parikh MD FICS FICOG FIMSA FCMCH, DA Professor Emeritus, Seth Gordhandas Sunderdas Medical College Nowrosjee Wadia Maternity Hospital, Mumbai, Maharashtra, India Consultant, Shushrusha Citizens' Cooperative Hospital Mumbai, Maharashtra, ‘India Deputy Editor, Fertility Sterility, India Editor Emeritus, The Journal of Obstetrics and Gynaecology of India Avijit Hazra Associate Professor, Department of Pharmacology Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, West Bengal, India Joydev Mukherjee Professor, Department of Obstetrics and Gynecology RG Kar Medical College, Kolkata, West Bengal, India Nithya Gogtay MD DNB (Pharmacology) DNB (Clinical Pharmacology) Associate Professor, Department of Clinical Pharmacology Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital Mumbai, Maharashtra, India Associate Editor, Journal of Postgraduate Medicine Forewords PC Mahapatra Mrudula Phadke
4
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Research Methodology Simplified: Every Clinician a Researcher
© 2010 Jaypee Brothers Medical Publishers (P) Ltd.
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: 2010
9789350250037
Typeset at JPBMP typesetting unit
Printed at
5To the memory of
Smt Shobha Parikh
6
7Foreword
The dynamic medical science has evolved over centuries and decades by scientific experts and igniters, innovators and researchers, academicians and prolific thinkers. The perceptible advance with one's notice is the end result of all the scientific expertise and research. Man is unique and different from all other living beings of the Universe in the sense that he has a “Power to Think”. This is the beginning of what is called Research. May it be a basic scientific foundation or a new concept or some form of technical innovation, the key is the inculcation of academic and scientific pursuit in the mind of an individual.
Keeping this basic fact in mind, the visionary personality and academician and clinician par excellence Professor MN Parikh has a brilliant idea to infuse this academic pursuit amongst the medical students, clinicians and practitioners to develop and evolve their inherent power for advancement of various faculties of medicine. The elaborate chapters in Research Methodology Simplified: Every Clinician a Researcher are so vividly presented in correct and appropriate sequence that I am sure that readers will certainly be benefited in a big way. The difficult and the least understood chapter on medical statistics has been depicted in such a simplified manner so as to facilitate the thesis work and dissertation particularly for the postgraduates. The authors of this unique book have tried their best to amalgamate every minute aspect related to medical research. I am confident that this will be a masterpiece for all time to come in the sense that every time you read a page, you inculcate a feeling of new ideas.
It is said that:
Knowledge is Piling of Facts
But
Wisdom lies in its Simplification
I hope this is appropriate for this masterpiece.
PC Mahapatra
Professor, Obstetrics and Gynecology
SCB Medical College
Cuttack, Orissa, India
President Elect Federation of Obstetric and Gynaecological Societies of India (FOGSI)
8
9Foreword
Mahendra N Parikh has come out with a second book titled Research Methodology Simplified: Every Clinician a Researcher within a year of publication of his first book titled ABC of Research Methodology: A Primer for Clinicians and Researchers. While the former was a pocket book to be used by young researchers, the latter is a more detailed and comprehensive book that covers a wide panorama of research methodology and will appeal to the medical teachers, postgraduate students and clinical researchers alike.
The book has many pluses. The language has been kept simple throughout and thus is not unnerving. Each of the twenty-five chapters is further subdivided into independent sections, each of which can be read without loss of continuity and thus at no point you feel like skipping a chapter. The chapter on biostatistics is particularly well presented and hopefully will motivate students not to skip the statistics section in peer reviewed publications. Chapters on Misdeeds in Research, Thesis Writing and Presentation at Conferences and Meetings are especially useful as these are nowhere addressed in the current postgraduate curriculum or in other standard books on research methodology.
The book will be a useful addition to any departmental or institute's library. I wish that medical college heads of departments and librarians purchase this book and encourage students to read and subsequently apply the knowledge gleaned. I also appeal to all postgraduates and teachers alike to read the book and apply its principles both in the practice and use of evidence-based medicine in day-to-day practice. Even if some of you after reading this book are motivated to write papers, present at conferences, apply for funding and simply appreciate statistics meaningfully, the book would have served its purpose.
Mrudula Phadke
Vice Chancellor
Maharashtra University of Health Sciences
Nashik, Maharashtra, India
10
11Preface
We were pleased to see the Forewords by Professors Arulkumaran and Dr Satyanarayana to our (MNP and NG) book ABC of Research Methodology and Applied Biostatistics: A Primer for Clinicians and Researchers published last year. However, we took the hope expressed by Dr Satyanarayana that we dish out a comprehensive resource book in the not too distant future very lightly as a wishful thinking. After our book saw the light of the day in January 2009, we were surprised by overwhelming highly appreciative response it received from everybody. Many readers, academicians and friends, coupled their response with a suggestion (in some cases a demand) that we produce a comprehensive book on the subject. This forced us to take the suggestions seriously, rework our heavy schedules and priorities for 2009, and undertake the writing of this badly needed book. Professor Nithya Gogtay had too many commitments and could only become an associate in this endeavor. However, I am extremely fortunate to have professors Joydev Mukherjee and Avijit Hazra as other associates. Both of them, just like Professor Nithya Gogtay, have great expertise in teaching and in conducting research besides imparting training in research methodology and biostatistics. I am indebted to all three of them without whose assured help I could not have even considered the writing of the book.
There are a large number of masterly books on various individual aspects of this vast topic Written by Western authors. But most of these lack simplicity of language, are not designed for easy understanding by clinicians, deal the topic in great depths not needed by most students, many researchers, and practicing clinicians, besides being unaffordably expensive. There are some books on Public Health and Preventive Medicine. There is hardly any book directed to clinical researchers and clinicians in general. I strongly believe that every practicing clinician must understand the basic nitty-gritty of research and fundamental role of biostatistics in clinical research. This is necessary to enable them evaluate the research studies presented to them in medical literature and at scientific conferences. It is this ability besides and understanding of quality of guidelines, strength of various recommendations, and value of consensus statements dished out to them by various agencies that can help them intelligently transfer relevant research into their own clinical practice for the benefit of their patients. Besides, every clinician, howsoever senior and busy he may be, must develop some expertise in conducting electronic search to guide him when faced by rare or unusual problems of individual patients. Most importantly, it is commonly believed that only those on the teaching faculty of medical colleges can do research while those involved only in day-to-day clinical practice cannot. I totally disagree with this. Many private practitioners, treat a vast number of patients. 12With this great treasure of clinical material at their disposal, they are in a position to conduct meaningful clinical research provided they keep thorough records of patients they see, desire to do research, and acquire basic training and understanding of clinical research methods. This is the main thrust and driving force behind the writing of this book.
The book is a humble effort to cater to the multiple needs of students — both undergraduate and postgraduate, teachers—both senior and junior, researchers, clinicians across all medical specialties, health care providers, medical administrators, and policy makers. I sincerely hope that all of them will find the book very useful. I earnestly solicit readers' comments, criticisms and suggestions. Lastly, I am indebted to Mr Prashant Kadam, a talented postgraduate student in Applied Biology, and my dear friend Kishore Dave, Electrical Engineer, for their valuable help, and to my publishers for their close cooperation.
Mahendra N Parikh
20Abbreviations AAAS :
American Association of Advancement of Science
ADR :
Adverse Drug Reaction
AR :
Attributable Risk
ARR/ARD :
Absolute Risk Reduction/Difference
AYUSH :
Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy
CDSR :
Cochrane's Databases of the Systematic Review
CIOMS :
Council for International Organization of Medical Science
CI :
Confidence Interval
CONSORT :
Consolidated Standard of the Report of Trial
COPE :
Committee of Publication Ethics
CPCSEA :
Committee for the Purpose of Control Supervision of Experiments on Animals
CRO :
Contract Research Organization
CSIR :
Council for Scientific and Industrial Research
CTRI :
Clinical Trial Registry of India
CV :
Coefficient of Variation
DARE :
Database of Abstracts of Reviews of Effects
DBT :
Department of Biotechnology
DST :
Department of Science and Technology
EBM :
Evidence-Based Medicine
EC :
Ethics Committee
EIND :
Exploratory Investigational New Drug
EmBase :
Excerpta Medica Database
FINER :
Feasibility, Interesting, Novel, Ethical and Relevant
FOGSI :
Federation of Obstetric and Gynaecological Societies of India
FHD :
Female Hyporesponsiveness Disorder
GIF :
Good Impact Factor
IAEC :
Institutional Animal Ethics Committee
ICC :
Interclass Correlation Coefficient
ICH :
International Conference on Harmonization
ICMJE :
International Committee/Council of Medical Journal Editors
ICMR :
Indian Council of Medical Research
ICRTP :
International Clinical Trial Registry Platform (Set-up WHO)
IDMC :
Independent Data Monitoring Committee
IEC :
Institutional Ethics Committee
IF :
Impact Factor
IMRaD :
Introduction, Methods, Results and Discussion
IND :
Investigational New Drug
INSA :
Indian National Science Academy
IPAB :
International Pharmaceutical Abstracts
IRB :
Institutional Review Board
JOGI :
Journal of Obstetrics and Gynaecology of India
21KVPY :
Kishore Vaigyanik Protsahan Yojana
LAR :
Legally Accepted Representative
LR :
Likelihood Ratio
MCI :
Medical Council of India
MOOSE :
Meta-analysis of Observational Studies in Epidemiology
MOU :
Memorandum of Understanding
MRC :
Medical Research Council (UK)
N/n :
Number
NGO :
Non-Government Organization
NIH :
National Institute of Health
NIMS :
National Institute of Medical Statistics
NLM :
National Library of Medicine (USA)
NNH :
Number Needed to Harm
NNT :
Number Needed to Treat
NPV :
Negative Predictive Value
OR :
Odds Ratio
P /p/P/p :
Probability
PASS :
Power Analysis and Sample Size
PI :
Principal Investigator
PPV :
Positive Predictive Value
PSTF :
Preventive Services Task Force (USA)
QUOROM :
Quality of Reporting of Meta-analysis
RIA :
Radioimmunoassay
R & D :
Research and Development
RR :
Relative Risk
SD :
Standard Deviation
SEM :
Standard Error of the Mean
SI :
International System of Unit (Syste'me Internationale Units)
SMART :
Specific, Measurable, Achievable, Relevant, and Time bound
SMO :
Site Management Organization
SNOSE :
Sequential Numbered, Opaque, Sealed Envelopes
SOP :
Standard Operating Procedure
TAKAR :
Title, Abstract, Keywords, Acknowledgment, and References
UTRN :
Unique Trial Registration Number (Provided by CTRI)
UTRN :
Universal Trial Registration Number (Provided by ICRTP)
WAME :
World Association of Medical Editors
Note:
A comprehensive list of abbreviation is not given here. Universally accepted abbreviations for measures of weight, volume, time, etc. are not given here. However, those wanting to interpret more or unusual abbreviations should refer to Jablonski S. Dictionary of Medical Acronyms and Abbreviations. 4th edn, Hanley and Balfus, INC, Philadelphia 2001