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Full details and terms of use are available upon registration, and access will be subject to your acceptance of these terms of use. For technical assistance: email [email protected] call 800-401-9962 (inside the US) / call +1-314-995-3200 (outside the US) Epidemiology This page intentionally left blank iii Section 3 APPLYING EPIDEMIOLOGY TO EVALUATION AND POLICY EPIDEMIOLOGY Fifth Edition Leon Gordis, MD, MPH, DrPH Professor Emeritus of Epidemiology Johns Hopkins University Bloomberg School of Public Health Professor Emeritus of Pediatrics Johns Hopkins University School of Medicine Baltimore, Maryland 1600 John F. Kennedy Blvd. Ste 1800 Philadelphia, PA 19103-2899 EPIDEMIOLOGY, FIFTH EDITION ISBN: 978-1-4557-3733-8 Copyright © 2014, 2009, 2004, 2000, 1996 by Saunders, an imprint of Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier. com/permissions. This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Library of Congress Cataloging-in-Publication Data Gordis, Leon, 1934- author. Epidemiology / Leon Gordis.—Fifth edition. p. ; cm. Includes bibliographical references and index. ISBN 978-1-4557-3733-8 (pbk. : alk. paper) I. Title. [DNLM: 1. Epidemiology. 2. Epidemiologic Methods. WA 105] RA651 614.4—dc23 2013025693 Senior Content Strategist: James Merritt Content Development Specialist: Andrea Vosburgh Publishing Services Manager: Catherine Jackson Project Manager: Rhoda Bontrager Senior Book Designer: Louis Forgione Printed in Canada Last digit is the print number: 9 8 7 6 5 4 3 2 1 For Dassy This page intentionally left blank Preface In recent years epidemiology has become an increasingly important approach in both public health and clinical practice. Epidemiology is the basic science of disease prevention and plays major roles in developing and evaluating public policy relating to health and to social and legal issues. Together with laboratory research, epidemiology is now used to identify environmental and genetic risk factors for disease and to shed light on the mecha- nisms involved in the pathogenesis of different diseases. The heightened media attention that epidemiology has recently received has major implications for health care providers and policy makers as well as for epidemiologists. As a result of this scrutiny, the approaches, methodology, and uses of epidemiology have garnered increasing interest from an ever- broadening group of professionals in different disciplines as well as from the public at large. This book is an introduction to epidemiology and to the epidemiologic approach to problems of health and disease. The basic principles and methods of epidemiology are presented together with many examples of the applications of epidemiology to public health and clinical practice. The fifth edition of this book retains the general organization and structure of the previous editions. In this edition, a list of learning objectives has been added at the begin- ning of most chapters to help direct the reader’s attention to the major issues to be found in that chapter, and a number of new review questions have been added at the end of certain chapters. The fifth edition consists of three sections. Section 1 focuses on the epidemiologic approach to understanding disease and to developing the basis for interventions designed to modify and improve its natural history. Chapter 1 provides a broad context and perspective for the discipline, and Chapter 2 discusses how disease is transmitted and acquired. Chapters 3 and 4 present the measures we use to assess the frequency and importance of disease and demonstrate how these measures are used in disease surveil- lance—one of the major roles of epidemiology in public health. Chapter 3 discusses measures of morbidity, and Chapter 4, measures of mortality. Chapter 5 addresses the critical issue of how to distinguish people who have a disease from those who do not, and how to assess the quality of the diagnostic and screening tests used for this purpose. Once people who have a certain disease have been identified, how do we characterize the natural history of their disease in quantitative terms? Will they die from their disease or develop some other serious outcome? Or will their disease be successfully managed? Such characterization is essential if we are to identify any changes in survival and severity that take place over time, or changes that result from preventive or therapeutic interven- tions (Chapter 6). Because our ultimate objective is to improve human health by modify- ing the natural history of disease, the next step is to select an appropriate and effective intervention—a selection that ideally is made using the results of randomized trials of prevention and of treatment (Chapters 7 and 8). Section 2 deals with the use of epidemiology to identify the causes of disease. Chapter 9 discusses the design of cohort studies and Chapter 10 introduces case-control, nested case-control, case-cohort, case-crossover, and cross-sectional studies. Chapters 11 and vii viii Preface 12 discuss how the results of these studies are used to estimate risk. We do so by determining whether there is an association of an exposure and a disease as reflected by an increase in risk in exposed people compared to the risk in nonexposed people. After a brief review and a comparison of the main types of study designs used in epidemiology (Chapter 13), Chapter 14 discusses how we move from epidemiologic evidence of an association to answering the important question: Does the observed association reflect a causal relationship? In so doing, it is critical to take into account issues of bias, confounding, and interaction, which are discussed in Chapter 15. Chapter 16 describes the use of epidemiology, often in conjunction with molecular biology, for assessing the relative contributions of genetic and environmental factors to disease causation. The exciting advances that have been made in recent years in the Human Genome Project and their interrelationships with epidemiologic thinking and approaches are also presented in this chapter. Section 3 discusses several important applications of epidemiology to major health issues. Chapter 17 addresses one of the major uses of epidemiology, which is to evaluate the effectiveness of different types of health services and different ways of providing them. Chapter 18 reviews the use of epidemiology in evaluating the quality and effectiveness of screening programs. Chapter 19 considers the place of epidemiology in formulating and evaluating public policy. These diverse applications have enhanced the importance of epidemiology, but at the same time have given rise to an array of new problems, both ethical and professional, in the conduct of epidemiologic studies and in the use of the results of such studies. A number of these issues are discussed in the final chapter (Chapter 20). In each edition of this book, illustrations and graphics have been used extensively to help the reader understand the principles and methods of epidemiology and to enhance presentation of the examples described in the text. This approach continues in the fifth edition. A major change in the fourth edition was publication of the book in color. The use of color has made new approaches possible for illustrating important principles and methods. The fifth edition provides many new color figures, while many previously used figures have been revised to enhance their clarity and quality. The colors in many of these figures have also been modified to maximize the reader’s understanding. The data cited and the examples used in this edition have been updated whenever possible, and new examples have been added to further clarify epidemiologic principles and methods. Some sections have been expanded, and others added, and numerous revi- sions and additions have been made throughout the book. Two new issues are addressed in the first chapter. The first is some aspects of the integration of prevention and therapy and the second is the question of who deserves the credit when the frequency of a disease declines over time. Among other new or expanded sections in the fifth edition are several relating to randomized trials including the main purpose of randomization, applying the results of such trials to individual patients, recruitment and retention of participants, and comparative effectiveness research. Expanded discussions include the history of causal inferences and recent developments in genetic research and their links of epidemiologic approaches for studying disease. Discussion of test validity and of the steps involved in calculation of kappa have also been expanded. Review questions are included at the end of most chapters or topics. The sequence of the three sections of this book is designed to provide the reader with a basic understanding of epidemiologic methods and study design and of the place of epidemiology in preventive and clinical medicine and in disease investigation. After fin- ishing this book, the reader should be able to assess the adequacy of the design and conduct of reported studies and the validity of the conclusions reached in published articles. It is my hope that the fifth edition of this book will continue to convey to its