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Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy

Edited by

Senior Editors

Jonathan J. Deeks Patrick M. Bossuyt

Associate Editors

Mariska M. Leeflang Yemisi Takwoingi

This work is a co- publication between The Cochrane Collaboration and John Wiley & Sons Ltd.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions.

The right of Jonathan J. Deeks, Patrick M. Bossuyt, Mariska M. Leeflang and Yemisi Takwoingi to be identified as the authors of the editorial material in this work has been asserted in accordance with law.

Registered Offices

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Limit of Liability/Disclaimer of Warranty

The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting scientific method, diagnosis, or treatment by physicians for any particular patient. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Library of Congress Cataloging- in- Publication Data

Names: Deeks, Jonathan J., editor. | Bossuyt, Patrick, editor. | Leeflang, Mariska M., editor. | Takwoingi, Yemisi, editor. | Cochrane Collaboration, publisher. Title: Cochrane handbook for systematic reviews of diagnostic test accuracy / edited by senior editors, Jonathan J. Deeks, Patrick M. Bossuyt ; associate editors, Mariska M. Leeflang, Yemisi Takwoingi. Other titles: Handbook for systematic reviews of diagnostic test accuracy Description: Hoboken, NJ : Wiley- Blackwell ; [London] : The Cochrane Collaboration, 2023. | Includes bibliographical references and index. Identifiers: LCCN 2022052835 (print) | LCCN 2022052836 (ebook) | ISBN 9781119756163 (cloth) | ISBN 9781119756170 (adobe pdf) | ISBN 9781119756187 (epub) Subjects: MESH: Systematic Reviews as Topic | Diagnostic Techniques and Procedures | Validation Studies as Topic Classification: LCC RC71.5 (print) | LCC RC71.5 (ebook) | NLM W 20.5 | DDC 616.07/5–dc23/eng/20230119 LC record available at https://lccn.loc.gov/2022052835 LC ebook record available at https://lccn.loc.gov/2022052836

Cover Design: Wiley Cover Images: © thanmano/Adobe Stock Photos; NVB Stocker/Adobe stock Photos; Kitreel/Adobe Stock Photos; angellodeco/Adobe Stock Photos; only4denn/Adobe Stock Photos; Tasha/Adobe Stock Photos; JarekKilian/Adobe Stock Photos; Nomad_Soul/Adobe Stock Photos; igorkol_ter/Adobe Stock Photos; utah51/Adobe Stock Photos; Marjan Apostolovic/Shutterstock

Set in 10/12pt SourceSansPro by Straive, Pondicherry, India

Contents

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Contributors xv Preface xix

Part One

1 Planning aCochrane Review ofdiagnostic test accuracy 3

1.1 Introduction 4

1.2 Why do asystematic review oftest accuracy? 4

1.3 Undertaking aCochrane Review ofdiagnostic test accuracy 5

1.3.1 The role ofthe Diagnostic Test Accuracy Editorial Team 5

1.3.2 Expectations forthe conduct andreporting ofCochrane Reviews of

1.3.3 Data management andquality assurance 6

1.3.4 Keeping theReview upto date 6

1.4 Proposing anew Cochrane Review ofdiagnostic test accuracy 6

1.5 Cochrane Protocols 7

1.6 The author team 11

1.6.1 The importance ofthe team 11

1.6.2 Criteria forauthorship 12

1.6.3 Incorporating relevant perspectives andstakeholder involvement 12

1.7 Resources andsupport 13

1.7.1 Identifying resources andsupport 13

1.7.2 Funding andconflicts ofinterest 14

1.7.3 Training 14

1.7.4 Software 15

1.8 Chapter information 15

1.9 References 16

About Cochrane Reviews ofdiagnostic test accuracy 1

diagnostic test accuracy 5

Part Two Introducing test accuracy 19

2 Evaluating medical tests 21

2.1 Introduction 21

2.2 Types ofmedical tests 22

2.3 Test accuracy 23

2.4 How do diagnostic tests affect patient outcomes? 24

Contents

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2.4.1 Direct test effects 25

2.4.2 Altering clinical decisions andactions 25

2.4.3 Changes totime frames andpopulations 25

2.4.4 Influencing patient andclinician perceptions 26

2.5 Evaluations oftest accuracy during test development 26

2.5.1 Evaluations ofaccuracy during biomarker discovery 26

2.5.2 Early evaluations oftest accuracy 27

2.5.3 Clinical evaluations oftest accuracy 28

2.6 Other purposes ofmedical testing 28

2.6.1 Predisposition 29

2.6.2 Risk stratification 29 Screening 29

2.6.3

2.6.4 Staging 29

2.6.5 Prognosis 30

2.6.6 Treatment selection 30

2.6.7 Treatment efficacy 31

2.6.8 Therapeutic monitoring 31

2.6.9 Surveillance forprogression or recurrence 31

2.7 Chapter information 32

2.8 References 32

3 Understanding thedesign oftest accuracy studies 35

3.1 Introduction 35

3.2 The basic design fora test accuracy study 36

3.3 Multiple groups ofparticipants 39

3.4 Multiple reference standards 42

3.5 More onreference standards 44

3.5.1 Delayed verification 44

3.5.2 Composite reference standard 44

3.5.3 Panel- based reference 44

3.5.4 Latent class analysis 45

3.5.5 Gold standard 45

3.5.6 Clinical reference standard 45

3.6 Comparative test accuracy studies 45

3.6.1 Paired comparative accuracy study 46

3.6.2 Randomized comparative accuracy study 46

3.6.3 Non- randomized comparative accuracy study 47

3.7 Additional aspects ofstudy designs 47

3.7.1 Prospective versus retrospective 48

3.7.2 Pragmatic versus explanatory 48

3.8 Concluding remarks 49

3.9 Chapter information 49

3.10 References 50

4 Understanding test accuracy measures 53

4.1 Introduction 53

4.2 Types oftest data 54

4.3 Inconclusive index test results 55

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4.4 Target condition 56

4.5 Analysis ofa primary test accuracy study 56

4.5.1 Sensitivity andspecificity 57

4.5.2 Predictive values 58

4.5.3 Proportion withthe target condition 58

4.5.4 Pre- test andpost- test probabilities 59

4.5.5 Interpretation ofsensitivity, specificity andpredictive values 59

4.5.6 Confidence intervals 60

4.5.7 Other test accuracy measures 61

4.6 Positivity thresholds 64 Receiver operating characteristic curves 66

4.7

4.8 Analysis ofa comparative accuracy study 68

4.9 Chapter information 71

4.10 References 72

Part Three Methods and presentation of systematic reviews of test accuracy 73

5 Defining thereview question 75

5.1 Introduction 75

5.2 Aims ofsystematic reviews oftest accuracy 76

5.2.1 Investigations ofheterogeneity 77

5.3 Identifying theclinical problem 77

5.3.1 Role ofa new test 77

5.3.2 Defining theclinical pathway 80

5.3.3 Unclear andmultiple clinical pathways 83

5.4 Defining thereview question 84

5.4.1 Population 84

5.4.2 Index test(s) 85

5.4.3 Target condition 85

5.4.4 The review question: PIT 86

5.4.5 From review question toobjectives 86

5.4.6 Broad versus narrow questions 87

5.5 Defining eligibility criteria 88

5.5.1 Types ofstudies 88

5.5.2 Participants 89

5.5.3 Index test(s) 90

5.5.4 Target condition 91

5.5.5 Reference standard 92

5.6 Chapter information 93

5.7 References 93

Contents

6 Searching forand selecting studies 97

6.1 Introduction 98

6.2 Searching forstudies 98

6.2.1 Working inpartnership 100

6.2.2 Advice forreview teams that do not include aninformation specialist 101

vii

Contents

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6.3 Sources tosearch 101

6.3.1 Bibliographic databases 101

6.3.1.1 MEDLINE, PubMed and Embase 102

6.3.1.2 National andregional databases 103

6.3.1.3 Subject- specific databases 103

6.3.1.4 Dissertations andtheses databases 104

6.3.2 Additional sources tosearch 104

6.3.2.1 Related reviews, guidelines andreference lists assources ofstudies 105

6.3.2.2 Handsearching 105

6.3.2.3 Forward citation searching andco- citation searching 105

Web searching 106

6.3.2.4

6.3.2.5 Grey literature databases 107

6.3.2.6 Trial registries 107

6.3.2.7 Contacting colleagues, study authors and manufacturers 108

6.4 Designing search strategies 108

6.4.1 Structuring thesearch strategy 109

6.4.2 Controlled vocabulary andtext words 110

6.4.3 Text word or keyword searching 112

6.4.4 Search filters 113

6.4.5 Language, date andtype ofdocument restrictions 113

6.4.6 Identifying fraudulent studies, other retracted publications, errata andcomments 114

6.4.7 Minimizing therisk ofbias through search methods 114

6.5 Documenting andreporting thesearch process 115

6.5.1 Documenting thesearch process 116

6.5.2 Reporting thesearch process 116

6.5.2.1 Reporting thesearch process inthe protocol 116

6.5.2.2 Reporting thesearch process inthe review 117

6.6 Selecting relevant studies 119

6.6.1 Examine full- text reports forcompliance ofstudies witheligibility criteria 120

6.7 Future developments inliterature searching andselection 121

6.8 Chapter information 121

6.9 References 122

7 Collecting data 131

7.1 Introduction 132

7.2 Sources ofdata 132

7.2.1 Studies (not reports) asthe unit ofinterest 133

7.2.2 Correspondence withinvestigators 134

7.3 What data tocollect 135

7.3.1 What are data? 135

7.3.2 Study methods (participant recruitment andsampling) 137

7.3.3 Participant characteristics andsetting 138

viii

7.3.4 Index test(s) 139

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7.3.5 Target condition andreference standard 140

7.3.6 Flow andtiming 140

7.3.7 Extracting study results andconverting tothe desired format 141

7.3.7.1 Obtaining 2×2data fromaccuracy measures 141

7.3.7.2 Using global measures 144

7.3.7.3 Challenges defining reference standard positive and negative:strategies when there are more than twocategories 145

7.3.7.4 Challenges defining index test positive andnegative: inconclusive results 145

Challenges defining index test positive andnegative:

7.3.7.5 test failures 147

7.3.7.6 Challenges defining index test positive and negative: dealing with multiple thresholds and extracting data from ROC curves or other graphics 147

7.3.7.7 Extracting data fromfigures withsoftware 148

7.3.7.8 Corrections formissing data: adjusting forpartial verification bias 148

7.3.7.9 Multiple index tests fromthe same study 148

7.3.7.10 Subgroups ofpatients 150

7.3.7.11 Individual patient data 150

7.3.7.12 Extracting covariates 151

7.3.8 Other information tocollect 151

7.4 Data collection tools 152

7.4.1 Rationale fordata collection forms 152

7.4.2 Considerations inselecting data collection tools 152

7.4.3 Design ofa data collection form 154

7.5 Extracting data fromreports 157

7.5.1 Introduction 157

7.5.2 Who should extract data? 157

7.5.3 Training data extractors 158

7.5.4

Extracting data frommultiple reports ofthe same study 158

7.5.5 Reliability andreaching consensus 159

7.5.6 Suspicions ofscientific misconduct 159

7.5.7 Key points inplanning andreporting data extraction 160

7.6 Managing andsharing data andtools 160

7.7 Chapter information 163

7.8 References 164

Contents

8 Assessing risk ofbias andapplicability 169

8.1 Introduction 170

8.2 Understanding bias andapplicability 171

8.2.1 Bias andimprecision 171

8.2.2 Bias versus applicability 171

8.2.3 Biases intest accuracy studies: empirical evidence 172

Contents

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8.3 QUADAS- 2 173

8.3.1 Background 173

8.3.2 Risk- of- bias assessment 173

8.3.3 Applicability assessment 174

8.3.4 Using and tailoring QUADAS- 2 174

8.3.5 Flow diagram 174

8.3.6 Performing the QUADAS- 2 assessment 175

8.4 Domain 1: Participant selection 176

8.4.1 Participant selection: risk- of- bias signalling questions (QUADAS- 2) 176

8.4.2 Participant selection: additional signalling questions for comparative accuracy studies (QUADAS- C) 178

Participant selection: concerns regarding applicability 181

8.4.3

8.5 Domain 2: Index test 182

8.5.1 Index test: risk- of- bias signalling questions (QUADAS- 2) 182

8.5.2 Index test: additional signalling questions for comparative accuracy studies (QUADAS- C) 183

8.5.3 Index test: concerns regarding applicability 186

8.6 Domain 3: Reference standard 187

8.6.1 Reference standard: risk- of- bias signalling questions (QUADAS- 2) 187

8.6.2 Reference standard: additional signalling questions for comparative accuracy studies (QUADAS- C) 188

8.6.3 Reference standard: concerns regarding applicability 189

8.7 Domain 4: Flow andtiming 191

8.7.1 Flow and timing: risk- of- bias signalling questions (QUADAS- 2) 191

8.7.2 Flow and timing: additional signalling questions for comparative accuracy studies (QUADAS- C) 193

8.8 Presentation ofrisk- of- bias andapplicability assessments 196

8.9 Narrative summary ofrisk- of- bias andapplicability assessments 197

8.10 Chapter information 197

8.11 References 198

9 Understanding meta- analysis 203

9.1 Introduction 203

9.1.1 Aims ofmeta- analysis forsystematic reviews oftest accuracy 204

9.1.2 When not touse ameta- analysis ina review 204

9.1.3 How does meta- analysis ofdiagnostic test accuracy differ frommetaanalysis ofinterventions? 205

9.1.4 Questions that can beaddressed intest accuracy analyses 206

9.1.4.1 What is theaccuracy ofa test? 206

9.1.4.2 How does theaccuracy vary withclinical andmethodological

9.1.4.3 How does theaccuracy oftwo or more tests compare? 206

9.1.5 Planning theanalysis 207

9.2 Graphical andtabular presentation 208

9.2.1 Coupled forest plots 208

9.2.2 Summary ROC plots 208

characteristics? 206

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