Health research methodology: A guide for training in research methods H R M EALTH ESEARCH ETHODOLOGY A Guide for Training in Research Methods Second Edition WORLD HEALTH ORGANIZATION Regional Office for the Western Pacific Manila, 2001 i Health research methodology: A guide for training in research methods WHO Library Cataloguing in Publication Data Health Research Methodology: A guide for training in research methods. Second Edition. 1. Health services research - methods. 2. Research design. I. World Health Organization. Regional Office for the Western Pacific ISBN 92 9061 157 X The World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and enquiries should be addressed to the Office of Publications, World Health Organization, Geneva, Switzerland or to the Regional Office for the Western Pacific, Manila, Philippines, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available. © World Health Organization 2001 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. << Back to Publication >> Go to Table of Contents ii CONTENTS Foreword v Introduction vii Acknowledgements ix Chapter 1: Introduction to research 1 Chapter 2: Research strategies and design 11 Chapter 3: Descriptive epidemiological studies and clinical trials 43 Chapter 4: Experimental studies and clinical trials 55 Chapter 5: Sampling methods and sampling size 71 Chapter 6: Bias and confounding 85 Chapter 7: Basic risk measurement 97 Chapter 8: Tests of significance 107 Chapter 9: Association and causation 125 Chapter 10: Ethical aspects of health research 141 Chapter 11: Construction of a research proposal 147 Annexes: Annex 1: Questionnaire design 169 Annex 2: Descriptive statistics: Table, graphs, and charts 187 Annex 3: Organization of a workshop on research 211 methods in health sciences Index 232 << Back to Publication << Back to Main Page Health research methodology: A guide for training in research methods FOREWORD Scientific research plays a very important role in our efforts to maintain health and combating diseases. Research helps us create new knowledge and develop proper tools for the use of existing knowledge. Not only does it enable health care providers to diagnose and treat diseases, research also provides evidence for policies and decisions on health and development. WHO and its Member States are aware of the importance of research. However, health research has not been a priority in many developing countries in the Region. The lack of research methodology and the absence of qualified researchers hinder many developing countries to conduct health research by themselves. In many countries, the system for management and coordination of health research has not been established or is not functioning properly. WHO is committed to stimulating scientific research in developing countries. An articulate and clearly defined WHO framework and vision on research and partnership with Member States will strengthen research capacity in developing countries. The WHO Regional Office for the Western Pacific has organized more than 20 training courses on health research design and methodology in the last two decades. In 1992, the Regional Office published a training manual entitled Health Research Methodology: A Guide for Training in Research Methods. Since then, the manual, well received by readers worldwide, has been translated into Chinese, Khmer, Laotian, Mongolian and Vietnamese. To accommodate requests from readers to incorporate recent developments on research methodology and experiences of past training courses, the manual has been revised and reissued. v Health research methodology: A guide for training in research methods We hope this revised version of the landmark manual will help scientists, researchers, health practitioners and administrators to learn and practise the concepts and principles of scientific research. The knowledge of the scientific methods will help them design and conduct research projects with precision in their own countries. The publication of the revised manual also reiterates our commitment to developing countries in the Region to help them build and strengthen the health research systems. Shigeru Omi, MD, Ph.D. Regional Director WHO Western Pacific Regional Office << Back to Table of Contents vi Health research methodology: A guide for training in research methods INTRODUCTION This is a revised version of an earlier manual on Health Research Methodology and deals with the basic concepts and principles of scientific research methods with particular attention to research in the health field. The research process is the cornerstone for informed and effective decision-making, and is integral to countries’ efforts to improve the health of their populations and the effectiveness of their health systems, particularly during times of dramatic epidemiological, demographic, and economic changes that profoundly affect health systems. Research on (1) health policy and health systems, (2) epidemiology dealing with noncommunicable diseases and existing, new and emerging communicable diseases, (3) reproduction, child health and nutrition, including domestic or sexual violence, and (4) social-behaviour, including analysis of peoples’ health seeking processes and their beliefs, knowledge and practices about health and illness, conducted by multi-disciplinary teams will enhance developing countries’ efforts to fight diseases and maintain health for the public. The manual describes methods for planning and conducting scientific research: from formulation of problems to setting research objectives, to designing the study, including methods of data collection, statistical analysis as well as interpretation and dissemination of the results. The earlier manual, used as resource and guide for the conduct of workshops on health research methodology in various countries of the Western Pacific Region has been expanded to include more details on some of the commonly used statistical methods and to clarify the points raised during workshops. The discussion on biases has been expanded considerably. vii Health research methodology: A guide for training in research methods This manual is expected to be used by the WHO Western Pacific Regional Office as a reference guide in training young scientists to conduct health sciences research. It will be used as a starting point and not as a comprehensive textbook on research methods. Many excellent textbooks are available for this purpose and are referenced in the manual. We have tried to use real life examples from the Region for illustrating the principles and methods used in the manual to make it more relevant to the regional context. The manual will be useful in planning a research project, especially in preparing a research grant application for a donor agency. In particular, the attached copy of the application form of WHO serves as a guide. The issues discussed in the manual will help the researcher to focus on issues of importance before the study is proposed and undertaken. In addition, the manual would also be useful when writing a thesis to meet academic requirements of a degree in the health field. We hope that this manual will not only provide basic information on research methods in the health field, but also stimulate the reader to inquire further into the complex area of research methodology as well as increase the productivity of the young researcher in the Region. We hope it will attract researchers to conduct further studies in the health field, be it a clinical trial or field epidemiology or study of health services. << Back to Table of Contents viii Health research methodology: A guide for training in research methods ACKNOWLEDGEMENTS The World Health Organization - Regional Office for the Western Pacific acknowledges the original contributions of Professor Yung-Han Parik, Professor Ung-Ring Ko and Dr Kamini Mohan Patwary to the first edition of this manual. We also wish to acknowledge Dr Rama Nair and Dr Lye Munn Sann for their collaborative efforts in revising this manual. << Back to Table of Contents ix Health research methodology: A guide for training in research methods Chapter 1 Research and Scientific Methods 1.1 Definition Research is a quest for knowledge through diligent search or investigation or experimentation aimed at the discovery and interpretation of new knowledge. Scientific method is a systematic body of procedures and techniques applied in carrying out investigation or experimentation targeted at obtaining new knowledge. In the context of this manual, research and scientific methods may be considered a course of critical inquiry leading to the discovery of fact or information which increases our understanding of human health and disease. 1.2 Categories of research 1. Empirical and theoretical research The philosophical approach to research is basically of two types: empirical and theoretical. Health research mainly follows the empirical approach, i.e. it is based upon observation and experience more than upon theory and abstraction. Epidemiological research, for example, depends upon the systematic collection of observations on the health- related phenomena of interest in defined populations. Moreover, even in abstraction with mathematical models, advances in understanding of disease occurrence and causation cannot be made without a comparison of the theoretical constructs with that which we actually observe in populations. Empirical and theoretical research complement each other in developing an understanding of the phenomena, in predicting future events, and in the prevention of events harmful to the general welfare of the population of interest. 1
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