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USERS" GUIDES

T O THE

MEDICAL

LITERATURE

Notice

Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, changes in treatment and drug therapy are required. The authors and the publisher of this work have checked with sources believed to be reliable in their efforts to provide information that is complete and gener- ally in accord with the standards accepted at the time of publica- tion. However, in view of the possibility of human error or changes in medical sciences, neither the authors nor the pub- lisher nor any other party who has been involved in the prepara- tion or publication of this work warrants that the information contained herein is in every respect accurate or complete, and they disclaim all responsibility for any errors or omissions or for the results obtained from use of the information contained in this work. Readers are encouraged to confirm the information contained herein with other sources. For example and in particu- lar, readers are advised to check the product information sheet included in the package of each drug they plan to administer to be certain that the information contained in this work is accurate and that changes have not been made in the recommended dose or in the contraindications for administration. This recommen- dation is of particular importance in connection with new or infrequently used drugs.

USERS" GUIDES

T O THE

MEDICAL

LITERATURE

ESSENTIALSOF EVIDENCE-BASED CLINICAL PRACTICE

SECOND EDITION

The Evidence-Based Medicine Working Group

Editors

Gordon Guyatt, MD, MSc

Departments of Clinical

Epidemiology and Biostatistics

and Medicine

Faculty of Health Sciences

McMaster University

Hamilton, Ontario, Canada

Maureen O. Meade, MD,

FRCPC, MSc

Departments of Medicine and

Clinical Epidemiology and

Biostatistics

Faculty of Health Sciences

McMaster University

Hamilton, Ontario, Canada

Drummond Rennie, MD

JAMA

Chicago, Illinois

Philip R. Lee Institute for Health

Policy Studies

University of California,

San Francisco

San Francisco, California, USA

Deborah J. Cook, MD, MSc

Departments of Medicine and

Clinical Epidemiology and

Biostatistics

Faculty of Health Sciences

McMaster University

Hamilton, Ontario, Canada

New York Chicago San Francisco Lisbon

London Madrid Mexico City Milan New Delhi

San Juan Seoul Singapore Sydney Toronto

JAMAevidence

Copyright © 2008 by the American Medical Association. All rights reserved. Manufactured in the United States of America. Except as permitted under the United States Copyright Act of 1976, no part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written permission of the publisher.

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DOI: 10.1036/0071590382

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To our students, in many countries, whose interest, passion, and probing questions made possible the development of the methods we use to communicate the concepts of evidence-based medicine.

GG, MOM, and DJC

To Deb, who has watched over and tended me while I have watched over and tended this wonderful group of authors, with gratitude for her love and her good humor. DR

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vii

CONTENTS

Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

1 How to Use the Medical Literature-and This Book-

to Improve Your Patient Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 The Philosophy of Evidence-Based Medicine . . . . . . . . . . . . . . . 5

3 What Is the Question? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4 Finding the Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

5 Why Study Results Mislead: Bias and Random Error. . . . . . . . 77

6 Therapy (Randomized Trials). . . . . . . . . . . . . . . . . . . . . . . . . . . 85

7 Does Treatment Lower Risk? Understanding the Results . . . 113

8 Confidence Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

9 Harm (Observational Studies) . . . . . . . . . . . . . . . . . . . . . . . . . 141

10 The Process of Diagnosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

11 Differential Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

12 Diagnostic Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 195

13 Prognosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . 223

14 Summarizing the Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

15 How to Use a Patient Management Recommendation . . . . . 265

Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349 For m o re inform a tion about this title, click here

JAMAevidence

JAMAevidence: Using Evidence to Improve Care

Founded around the Users" Guides to the Medical Literature and The Rational Clinical Examination: Evidence-Based Clinical Diagnosis, JAMAevidence offers an invaluable online resource for learning, teaching, and practicing evidence-based medicine. Updated regularly, the site includes fully searchable content of the Users" Guides to the Medical Literature and The Rational Clinical Examination and features podcasts from the leading minds in EBM, interactive worksheets, question wizards, functional calculators, and a comprehensive collec- tion of PowerPoint slides for educators and students. www.JAMAevidence.com Please visit the following Web site for information on subscrip- tion rates: www.mhprofessional.com/jama ix

CONTRIBUTORS

Alexandra Barratt, MBBS,

FAFPHM, MPH, PhD

Department of Epidemiology

School of Public Health

University of Sydney

Sydney, New South Wales,

Australia

Heiner C. Bucher, MD

Clinical Epidemiology

Basel Institute for Clinical

Epidemiology

University Hospital Basel

Basel, Switzerland

Deborah J. Cook, MD, MSc

Departments of Medicine and

Clinical Epidemiology and

Biostatistics

Faculty of Health Sciences

McMaster University

Hamilton, Ontario, Canada

P. J. Devereaux, BSc, MD, PhD

Departments of Clinical

Epidemiology and

Biostatistics and Medicine

McMaster University

Hamilton, Ontario, CanadaToshi A. Furukawa, MD, PhDDepartment of Psychiatry and

Cognitive-Behavioral

Medicine

City University Graduate School

of Medical Sciences

Mizuho-ku, Nagoya, Japan

Gordon Guyatt, MD, MSc

Chair, Evidence-Based Medicine

Working Group

Departments of Clinical

Epidemiology and

Biostatistics and Medicine

Faculty of Health Sciences

McMaster University

Hamilton, Ontario, Canada

Ted Haines, MD, MSc

Departments of Clinical

Epidemiology and Biostatistics

and Occupational Health

Program

McMaster University

Hamilton, Ontario, Canada

Brian Haynes, MD, MSc, PhD

Department of Clinical

Epidemiology and

Biostatistics

McMaster University

Hamilton, Ontario, Canada

Copyright © 2008 by the American Medical Association.

Click here for terms of use.

CONTRIBUTORSx

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