Cochrane Handbook for Systematic Reviews of Interventions

1 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name: Yet to ComeCochrane Handbook for SystematicReviews of InterventionsCochrane Handbook for Systematic Reviews of Interventions : Cochrane Book Series Edited by Julian PT Higgins and Sally Green 2008 The Cochrane Collaboration. ISBN: 978-0-470-69951-5 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name: Yet to ComeCochrane Handbook forSystematic Reviews ofInterventionsCochrane Book SeriesEdited byJulian PT Higgins and Sally GreenA John Wiley & Sons, Ltd., PublicationTHE Cochrane COLLABORATION OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name: Yet to ComeCopyrightC 2008 The Cochrane CollaborationThis work is a co-publication between The Cochrane Collaboration and John Wiley & Sons by John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex PO19 8SQ, EnglandTelephone (+44) 1243 779777 Email (for orders and customer service enquiries): our Home Page on Rights Reserved.

2 No part of this publication may be reproduced, stored in a retrieval system or transmittedin any form or by any means, electronic, mechanical, photocopying, recording, scanning or otherwise, exceptunder the terms of the Copyright, Designs and Patents Act 1988 or under the terms of a licence issued by theCopyright Licensing Agency Ltd, 90 Tottenham Court Road, London W1T 4LP, UK, without the permission inwriting of the copyright used by companies to distinguish their products are often claimed as trademarks. All brand namesand product names used in this book are trade names, service marks, trademarks or registered trademarks oftheir respective owners. The Publisher is not associated with any product or vendor mentioned in this book. Thispublication is designed to provide accurate and authoritative information in regard to the subject matter is sold on the understanding that the Publisher is not engaged in rendering professional services.

3 Ifprofessional advice or other expert assistance is required, the services of a competent professional should Wiley Editorial OfficesJohn Wiley & Sons Inc., 111 River Street, Hoboken, NJ 07030, USAJ ossey-Bass, 989 Market Street, San Francisco, CA 94103-1741, USAW iley-VCH Verlag GmbH, Boschstr. 12, D-69469, Weinheim, GermanyJohn Wiley & Sons Australia Ltd, 42 McDougall Street, Milton, Queensland 4064, AustraliaJohn Wiley & Sons (Asia) Pte Ltd, 2 Clementi Loop #02-01, Jin Xing Distripark, Singapore 129809 John Wiley & Sons Canada Ltd, 6045 Freemont Blvd, Mississauga, Ontario, L5R 4J3, CanadaWiley also publishes its books in a variety of electronic formats. Some content that appears in print may not beavailable in electronic of Congress Cataloging-in-Publication DataCochrane Handbook for Systematic Reviews of Interventions / edited by Julian Higgins and Sally ; cm. ( Cochrane book series)Includes bibliographical references and 978-0-470-69951-5 (alk.)

4 Paper) ISBN 978-0-470-05796-4 (alk. paper)1. Evidence-based medicine Methodology. 2. Medicine Research Evaluation. 3. Outcomeassessment (Medical care) 4. Meta-analysis. I. Higgins, Julian. II. Green, Sally, Prof. III. CochraneCollaboration. IV. Series.[DNLM: 1. Outcome and Process Assessment (Health Care) 2. Evidence-Based Medicine Meta-Analysis as Topic. 4. review Literature as Topic. WA C663 2008] dc222008022132 British Library Cataloguing in Publication DataA catalogue record for this book is available from the British LibraryISBN 978-0-470-51845-8 Typeset in Times by Aptara Inc., New Delhi, IndiaPrinted and bound in Great Britain by Antony Rowe Ltd, Chippenham, WiltshireThis book is printed on acid-free paper responsibly manufactured from sustainable forestryin which at least two trees are planted for each one used for paper 22, 200820:58 Printer Name: Yet to ComeContentsPrefacexiiiAcknowledgementsx vTheHandbookeditorsxviiMajor contributorsxixPart 1 Cochrane REVIEWS11 Introduction3 Sally Green, Julian PT Higgins, Philip Alderson, Mike Clarke, Cynthia D Mulrowand Andrew D The Cochrane Systematic About Contributors to Chapter References92 Preparing a Cochrane review11 Edited by Sally Green and Julian PT Rationale for Format of a Cochrane Logistics of doing a Publication of Cochrane Reviews in print journals and Publication of previously published Reviews as Cochrane Declaration of interest and commercial Chapter References293 Maintaining Reviews : updates, amendments and feedback31 Julian PT Higgins, Sally Green and Rob JPM Some important definitions32 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name.

5 Yet to Important dates associated with Cochrane Considerations when updating a Cochrane What s new and History Incorporating and addressing feedback in a Cochrane Chapter References494 Guide to the contents of a Cochrane protocol and review51 Edited by Julian PT Higgins and Sally Title and review information (or protocol information) Plain language Main Studies and Data and Sources of support to the Chapter References78 Part 2 GENERAL METHODS FOR Cochrane REVIEWS815 Defining the review question and developing criteria forincluding studies83 Edited by Denise O Connor, Sally Green and Julian PT Questions and eligibility Defining types of participants: which people and populations? Defining types of Interventions : which comparisons to make? Defining types of outcomes: which outcome measures are most important? Defining types of Defining the scope of a review question (broad versus narrow) Changing review Chapter References946 Searching for studies95 Carol Lefebvre, Eric Manheimer and Julie Glanville on behalf of the CochraneInformation Retrieval Methods Sources to Planning the search Designing search Managing references142 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name.

6 Yet to Documenting and reporting the search Chapter References1477 Selecting studies and collecting data151 Edited by Julian PT Higgins and Jonathan J Selecting What data to Sources of Data collection Extracting data from Extracting study results and converting to the desired Managing Chapter References1838 Assessing risk of bias in included studies187 Edited by Julian PT Higgins and Douglas G Altman on behalf of the CochraneStatistical Methods Group and the Cochrane Bias Methods What is bias? Tools for assessing quality and risk of Introduction to sources of bias in clinical The Cochrane Collaboration s tool for assessing risk of Presentation of assessments of risk of Summary assessments of risk of Incorporating assessments into Sequence Allocation sequence Blinding of participants, personnel and outcome Incomplete outcome Selective outcome Other potential threats to Chapter References2359 Analysing data and undertaking meta-analyses243 Edited by Jonathan J Deeks, Julian PT Higgins and Douglas G Altman on behalfof the Cochrane Statistical Methods Types of data and effect Study designs and identifying the unit of Summarizing effects across Investigating Sensitivity Chapter References293 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name.

7 Yet to ComeviiiCONTENTS10 Addressing reporting biases297 Edited by Jonathan AC Sterne, Matthias Egger and David Moher on behalfof the Cochrane Bias Methods Types of reporting biases and the supporting Avoiding reporting Detecting reporting Chapter References32511 Presenting results and Summary of findings tables335 Holger J Sch unemann, Andrew D Oxman, Julian PT Higgins, Gunn E Vist, PaulGlasziou and Gordon H Guyatt on behalf of the Cochrane Applicability andRecommendations Methods Group and the Cochrane Statistical Methods Characteristics of included studies Data and Summary of findings Additional Presenting results in the Writing an Writing a plain language Chapter References35712 Interpreting results and drawing conclusions359 Holger J Sch unemann, Andrew D Oxman, Gunn E Vist, Julian PT Higgins,Jonathan J Deeks, Paul Glasziou and Gordon H Guyatt on behalf of theCochrane Applicability and Recommendations Methods Assessing the quality of a body of Issues in Interpreting results of statistical Interpreting results from dichotomous outcomes (including numbers neededto treat) Interpreting results from continuous outcomes (including standardized meandifferences) Drawing Chapter References383 Part 3 SPECIAL TOPICS38913 Including non-randomized studies391 Barnaby C Reeves, Jonathan J Deeks, Julian PT Higgins and George A Wells onbehalf of the Cochrane Non-Randomised Studies Methods Developing criteria for including non-randomized studies396 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name.

8 Yet to Searching for non-randomized Selecting studies and collecting Assessing risk of bias in non-randomized Synthesis of data from non-randomized Interpretation and Chapter References42914 Adverse effects433 Yoon K Loke, Deirdre Price and Andrew Herxheimer on behalf of the CochraneAdverse Effects Methods Scope of a review addressing adverse Choosing which adverse effects to Types of Search methods for adverse Assessing risk of bias for adverse Chapter References44615 Incorporating economics evidence449 Ian Shemilt, Miranda Mugford, Sarah Byford, Michael Drummond, Eric Eisenstein,Martin Knapp, Jacqueline Mallender, David McDaid, Luke Vale and DamianWalker on behalf of the Campbell and Cochrane Economics Methods The role and relevance of economics evidence in Cochrane Planning the economics component of a Cochrane Locating Selecting studies and collecting Addressing risk of Analysing and presenting Addressing reporting Interpreting Chapter References47616 Special topics in statistics481 Edited by Julian PT Higgins, Jonathan J Deeks and Douglas G Altman on behalfof the Cochrane Statistical Methods Missing Intention-to-treat Cluster-randomized Cross-over Studies with more than two intervention Indirect comparisons and multiple-treatments Multiplicity and the play of Bayesian and hierarchical approaches to Rare events (including zero frequencies) Chapter References524 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name.

9 Yet to ComexCONTENTS17 Patient-reported outcomes531 Donald L Patrick, Gordon H Guyatt and Catherine Acquadro on behalf of theCochrane Patient Reported Outcomes Methods What are patient-reported outcomes? Patient-reported outcomes and Cochrane Health status and quality of life as PRO Issues in the measurement of patient-reported Locating and selecting studies with patient-reported Assessing and describing patient-reported Comparability of different patient-reported outcome Interpreting Chapter References54418 Reviews of individual patient data547 Lesley A Stewart, Jayne F Tierney and Mike Clarke on behalf of the CochraneIndividual Patient Data Meta-analysis Methods The collaborative nature of IPD Dealing with Limitations and Chapter References55719 Prospective meta-analysis559 Davina Ghersi, Jesse Berlin and Lisa Askie on behalf of the Cochrane ProspectiveMeta-analysis Methods The collaborative nature of prospective The prospective meta-analysis Data collection in prospective Analysis issues in prospective Chapter References56920 Qualitative research and Cochrane reviews571 Jane Noyes, Jennie Popay, Alan Pearson, Karin Hannes and Andrew Boothon behalf of the Cochrane Qualitative Research Methods Incorporating evidence from qualitative research in Cochrane Interventionreviews: concepts and Qualitative evidence Chapter Further selected reading587 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name.

10 Yet to ComeCONTENTSxi21 Reviews in public health and health promotion593 Edited by Rebecca Armstrong, Elizabeth Waters and Jodie Study designs to Assessment of study quality and risk of Ethics and Applicability and Chapter References60322 Overviews of reviews607 Lorne A Becker and Andrew D Preparing a Cochrane Overview of Format of a Cochrane Chapter References631 Index633 OTE/SPHOTE/SPHJWBK247-FMAugust 22, 200820:58 Printer Name: Yet to ComePrefaceTheCochrane Handbook for Systematic Reviews of Interventions (theHandbook) pro-vides guidance to authors for the preparation of Cochrane Intervention Reviews (in-cluding Cochrane Overviews of Reviews ). TheHandbookis a long-standing documentand is updated regularly to reflect advances in Systematic review methodology and inresponse to feedback from users. This book coincides with version of the onlinepublication of up to datePlease refer to the following web site for the most recent version, for interim updatesto the guidance and for details of previous versions of of theHandbookare encouraged to send feedback and corrections to theHand-bookeditors.