Diederick E. Grobbee - Clinical Epidemiology: Principles, Methods, and Applications for Clinical Research

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Library of Congress Cataloging-in-Publication Data

Grobbee, D. E., author.

Clinical Epidemiology: Principles, Methods, and Applications for Clinical Research / Diederick E. Grobbee and Arno W. Hoes.Second edition.

p. ; cm.

Includes bibliographical references and index.

ISBN 978-1-4496-7432-8 (pbk.) ISBN 1-4496-7432-1 (pbk.)

I. Hoes, Arno W., author. II. Title. [DNLM: 1. Epidemiologic Methods. 2. Epidemiologic Factors. 3. Prognosis. WA 950]

RA652.2.C55

614.4dc23

2013030779

6048

Printed in the United States of America

18 17 16 15 14 10 9 8 7 6 5 4 3 2 1

DEDICATION

To Sjoukje and Carin

PREFACE

In the current era of evidence-based medicine, with an abundance of published information and a clear need for relevant applied clinical research, clinical epidemiology is increasingly being recognized as an important tool in the critical appraisal of available evidence and the design of new studies.

This text is intended for those who are currently practicing medicine and related disciplines (such as pharmacy, health sciences, nursing sciences, veterinary medicine, and dentistry) as well as those involved in the design and conduct of applied clinical research. Apart from these users, doers of applied clinical research, notably undergraduate students and PhD fellows in medicine and related disciplines, will also benefit from the information provided. Clinical epidemiology instructors will find the text to be a valuable resource for their classes.

The purpose of the text is to teach both the users and doers of quantitative clinical research. Principles and methods of clinical epidemiology are used to obtain quantitative evidence on diagnosis, etiology, and prognosis of disease and on the effects of interventions. The content of this text reflects our teaching experience on the methodology of applied clinical research over the last 25 years. It was the ever-advancing development of clinical epidemiologic methodology, the increasing discrepancies between our teaching material and existing textbooks of epidemiology, and the many requests from students and practicing physicians for a concise text reflecting our courses that fueled our decision to prepare this novel text.

We hope that our text will contribute to a better understanding of the strengths of clinical epidemiology as well as help both researchers and users of quantitative clinical research in their endeavors to further improve patient care in daily clinical practice.

This edition has been revised and updated extensively. In doing so we benefited enormously from the comments given to us by many readers, specifically the PhD fellows and staff members at the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, and in the Department of Epidemiology, Radboud University Medical Center Nijmegen.

As more than three thousand copies of the first edition and reprints have found their way to readers across the globe, we are confident that this text is well appreciated by all those engaged in clinical epidemiologic research or using the results of such studies in clinical practice. We hope this new edition will be similarly appreciated and welcome any comments or suggestions for further improvement.

Diederick E. Grobbee and Arno W. Hoes

FOREWORD

Clinicians often think of epidemiology as distinct from clinical research. As a consequence, epidemiologic methods, disease causation, and preventive medicine, as well as strategic public health issues, have been taught chiefly in epidemiology departments and at schools of public health. Many of these institutions, however, have become too isolated from the practice of medicine and the conduct of clinical research. And both campsepidemiologic research and clinical researchhave suffered from this mutual isolation. Epidemiology would be fertilized by close interaction with clinical medicine, while offering a powerful toolbox derived from advanced methodologic developments to clinical researchers. Epidemiologic principles and methods are not only integral to public health, but also highly relevant to clinical research. However, this fundamental fact is still not adequately appreciated by many clinical investigators.