Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy E-Book
60,99 €
Mehr erfahren.
- Herausgeber: John Wiley & Sons
- Kategorie: Fachliteratur
- Serie: Wiley Cochrane Series
- Sprache: Englisch
Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy
A guide to conducting systematic reviews of test accuracy
In Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy, a team of distinguished researchers deliver the official guide to preparing and maintaining systematic reviews of test accuracy in healthcare. This first edition of the Handbook contains guidance on understanding test accuracy measures, search strategies and study selection, understanding meta-analysis and risk of bias and applicability assessments, presentation of findings, and drawing conclusions.
Readers will also find:
- An introduction to test evaluation, including the purposes of medical testing, test accuracy and the impact of tests on patient outcomes
- Comprehensive explorations of the design of test accuracy studies, including discussions of reference standards and comparative test accuracy studies
- Considerations of the methods and presentation of systematic reviews of test accuracy
- Elaboration of study selection, data collection, and undertaking risk of bias and applicability assessments
Perfect for medical practitioners and clinicians, Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy will also benefit professionals in epidemiology and students in related fields.
Sie lesen das E-Book in den Legimi-Apps auf:
Seitenzahl: 848
Veröffentlichungsjahr: 2023
Ähnliche
Table of Contents
Cover
Title Page
Copyright Page
Contributors
Preface
About Cochrane
About this
Handbook
Key details about this edition
How to cite this book
Acknowledgements
The
Handbook
editorial team
Part One: About Cochrane Reviews of diagnostic test accuracy
1 Planning a Cochrane Review of diagnostic test accuracy
1.1 Introduction
1.2 Why do a systematic review of test accuracy?
1.3 Undertaking a Cochrane Review of diagnostic test accuracy
1.4 Proposing a new Cochrane Review of diagnostic test accuracy
1.5 Cochrane Protocols
1.6 The author team
1.7 Resources and support
1.8 Chapter information
1.9 References
Part Two: Introducing test accuracy
2 Evaluating medical tests
2.1 Introduction
2.2 Types of medical tests
2.3 Test accuracy
2.4 How do diagnostic tests affect patient outcomes?
2.5 Evaluations of test accuracy during test development
2.6 Other purposes of medical testing
2.7 Chapter information
2.8 References
3 Understanding the design of test accuracy studies
3.1 Introduction
3.2 The basic design for a test accuracy study
3.3 Multiple groups of participants
3.4 Multiple reference standards
3.5 More on reference standards
3.6 Comparative test accuracy studies
3.7 Additional aspects of study designs
3.8 Concluding remarks
3.9 Chapter information
3.10 References
4 Understanding test accuracy measures
4.1 Introduction
4.2 Types of test data
4.3 Inconclusive index test results
4.4 Target condition
4.5 Analysis of a primary test accuracy study
4.6 Positivity thresholds
4.7 Receiver operating characteristic curves
4.8 Analysis of a comparative accuracy study
4.9 Chapter information
4.10 References
Part Three: Methods and presentation of systematic reviews of test accuracy
5 Defining the review question
5.1 Introduction
5.2 Aims of systematic reviews of test accuracy
5.3 Identifying the clinical problem
5.4 Defining the review question
5.5 Defining eligibility criteria
5.6 Chapter information
5.7 References
6 Searching for and selecting studies
6.1 Introduction
6.2 Searching for studies
6.3 Sources to search
6.4 Designing search strategies
6.5 Documenting and reporting the search process
6.6 Selecting relevant studies
6.7 Future developments in literature searching and selection
6.8 Chapter information
6.9 References
7 Collecting data
7.1 Introduction
7.2 Sources of data
7.3 What data to collect
7.4 Data collection tools
7.5 Extracting data from reports
7.6 Managing and sharing data and tools
7.7 Chapter information
7.8 References
8 Assessing risk of bias and applicability
8.1 Introduction
8.2 Understanding bias and applicability
8.3 QUADAS‐2
8.4 Domain 1: Participant selection
8.5 Domain 2: Index test
8.6 Domain 3: Reference standard
8.7 Domain 4: Flow and timing
8.8 Presentation of risk‐of‐bias and applicability assessments
8.9 Narrative summary of risk‐of‐bias and applicability assessments
8.10 Chapter information
8.11 References
9 Understanding meta‐analysis
9.1 Introduction
9.2 Graphical and tabular presentation
9.3 Meta‐analytical summaries
9.4 Fitting hierarchical models
9.5 Special topics
9.6 Chapter information
9.7 References
10 Undertaking meta‐analysis
10.1 Introduction
10.2 Estimation of a summary point
10.3 Estimation of a summary curve
10.4 Comparison of summary points
10.5 Comparison of summary curves
10.6 Meta‐analysis of sparse data and a typical data sets
10.7 Meta‐analysis with multiple thresholds per study
10.8 Meta‐analysis with imperfect reference standard: latent class meta‐analysis
10.9 Concluding remarks
10.10 Chapter information
10.11 References
11 Presenting findings
11.1 Introduction
11.2 Results of the search
11.3 Description of included studies
11.4 Methodological quality of included studies
11.5 Individual and summary estimates of test accuracy
11.6 Comparisons of test accuracy
11.7 Investigations of sources of heterogeneity
11.8 Re‐expressing summary estimates numerically
11.9 Presenting findings when meta‐analysis cannot be performed
11.10 Chapter information
11.11 References
12 Drawing conclusions
12.1 Introduction
12.2 ‘Summary of findings’ tables
12.3 Assessing the strength of the evidence
12.4 GRADE approach for assessing the certainty of evidence
12.5 Summary of main results in the Discussion section
12.6 Strengths and weaknesses of the review
12.7 Applicability of findings to the review question
12.8 Drawing conclusions
12.9 Chapter information
12.10 References
13 Writing a plain language summary
13.1 Introduction
13.2 Audience and writing style
13.3 Contents and structure of a plain language summary
13.4 Chapter information
13.5 References
13.6 Appendix: Additional example plain language summary
Index
End User License Agreement
List of Tables
Chapter 1
Table 1.4.a Structure for titles of Cochrane Reviews of diagnostic test accu...
Chapter 2
Table 2.2.a Major types of tests
Table 2.6.a Purposes of medical testing
Chapter 4
Table 4.5.a 2×2 cross‐classification of index test results and reference sta...
Table 4.5.b Evaluation of the Innova lateral flow antigen test to detect SAR...
Table 4.8.a Joint classification of paired index tests and reference standar...
Table 4.8.b Comparison of T‐SPOT.TB and second‐generation IGRA for diagnosis...
Chapter 5
Table 5.4.a Examples of aims and objectives of systematic reviews of test ac...
Chapter 6
Table 6.4.a Multi‐stranded search to find brief psychometric instruments to ...
Chapter 7
Table 7.3.a Checklist of items to consider in data collection
Table 7.3.b Estimating 2×2 contingency table data from reported sensitivity ...
Table 7.3.c Estimating 2×2 contingency table data from reported PPV and NPV...
Table 7.3.d Estimating 2×2 contingency table data from reported specificity ...
Table 7.3.e Estimating 2×2 contingency table data when there are multiple re...
Table 7.3.f Estimating 2×2 contingency table data when there are multiple in...
Table 7.3.g Calculating 2×2 contingency table data from a cross‐tabulation o...
Table 7.4.a Considerations in selecting data collection tools
Table 7.6.a Example of a simple review with a single ‘test’
Table 7.6.b Example of a more complex review with multiple ‘tests’
Table 7.6.c Example of a more complex review with multiple ‘tests’ and refer...
Table 7.6.d Example of a review with a study with multiple centres
Chapter 8
Table 8.4.a Summary of risk‐of‐bias assessment for Domain 1: Participant sel...
Table 8.4.b Comparative accuracy, additional signalling questions for the pa...
Table 8.4.c Summary of main issues when evaluating applicability for the par...
Table 8.5.a Summary of risk‐of‐bias assessment for Domain 2: Index test
Table 8.5.b Comparative accuracy, additional signalling questions for the in...
Table 8.5.c Summary of the main issues when evaluating applicability for the...
Table 8.6.a Summary of risk‐of‐bias assessment for Domain 3: Reference stand...
Table 8.6.b Comparative accuracy, additional signalling questions for the re...
Table 8.6.c Summary of the main issues when judging applicability for the re...
Table 8.7.a Summary of risk‐of‐bias assessment for Domain 4: Flow and timing...
Table 8.7.b Comparative accuracy, additional signalling questions for the fl...
Chapter 9
Table 9.4.a Bivariate model parameter estimates for accuracy of anti‐CCP for...
Table 9.4.b HSROC parameter estimates for rheumatoid factor model
Table 9.4.c Bivariate parameter estimates for comparison of the accuracy of ...
Table 9.4.d HSROC parameter estimates to compare RF techniques
Table 9.4.e Bivariate model estimates for comparison of CT and MRI
Table 9.4.f Bivariate model estimates for simplified model to compare CT and...
Chapter 10
Table 10.2.a Summary of packages for meta‐analysis of test accuracy in R
Table 10.4.a Summary sensitivity and specificity (and 95% confidence interva...
Table 10.6.a Parameter and summary estimates for IOC from models with differ...
Chapter 11
Table 11.5.a Accuracy of Xpert MTB/RIF for detection of extrapulmonary tuber...
Table 11.5.b Sensitivity and likelihood ratios for 11C‐PIB‐PET at fixed valu...
Table 11.6.a Accuracy of chest ultrasonography and chest radiography for dia...
Table 11.6.b Comparison of the accuracy of non‐invasive tests for
Helicobact
...
Table 11.7.a Investigation of heterogeneity between studies of type 1 rapid ...
Chapter 12
Table 12.2.a
‘Summary of findings’ table:
What is the diagnostic...
Table 12.2.b
‘Summary of findings’ table:
What is the diagnostic...
Table 12.2.c
‘Summary of findings’ table:
What is the diagnostic...
Table 12.2.d
‘Summary of findings’ table:
What is the diagnostic...
List of Illustrations
Chapter 3
Figure 3.2.a An example of the basic design for a test accuracy study
Figure 3.2.b A variation on the basic design for a test accuracy study
Figure 3.3.a A two‐group (or two‐gate) test accuracy study
Figure 3.4.a A test accuracy study with multiple reference standards
Figure 3.6.a A panel‐based reference standard in a paired comparative accura...
Figure 3.6.b An example of a randomized comparative accuracy study
Chapter 4
Figure 4.5.a Diagnostic odds ratios achieved at different values of sensitiv...
Figure 4.6.a Relationship between sensitivity, specificity and the positivit...
Figure 4.7.a Examples of ROC curves
Chapter 5
Figure 5.3.a
Clinical pathway for neck injuries in children (<18 years).
...
Figure 5.3.b
Clinical pathway for a molecular WHO‐recommended rapid diagnost
...
Chapter 6
Figure 6.4.a
Combining concepts as search sets in a simple structure.
Exampl...
Figure 6.5.a
The PRISMA 2020 flow diagram for new systematic reviews that in
...
Chapter 7
Figure 7.3.a
Example of a dot plot for estimation of sensitivity and specifi
...
Chapter 8
Figure 8.3.a Example of a study flow diagram for a test accuracy study
Figure 8.8.a
Risk‐of‐bias and applicability concerns summary table
...
Figure 8.8.b
Risk‐of‐bias and applicability concerns graph
.
Chapter 9
Figure 9.2.a Coupled forest plot of the sensitivity and specificity of Anti‐...
Figure 9.2.b SROC plot of Anti‐CCP for the diagnosis of rheumatoid arthritis...
Figure 9.4.a Summary sensitivity and specificity of anti‐CCP for the diagnos...
Figure 9.4.b SROC plot and SROC curve for accuracy of rheumatoid factor
Figure 9.4.c Summary estimates of sensitivity and specificity for CCP1 and C...
Figure 9.4.d SROC curves with and without a difference in shape
Figure 9.4.e SROC curves to compare accuracy of RF techniques
Figure 9.4.f Summary estimates of accuracy of CT and MRI for the diagnosis o...
Figure 9.4.g SROC plot of direct comparisons of CT vs MRI for the diagnosis ...
Figure 9.4.h Summary estimates of sensitivity and specificity for CT vs MRI ...
Chapter 10
Figure 10.2.a Screenshot of MetaDTA (version 2.0) showing anti‐CCP data uplo...
Figure 10.2.b Screenshot of MetaDTA (version 2.0) showing the SROC plot for ...
Figure 10.2.c MCMC diagnostics plots for a parameter (Summary_Se) from the b...
Figure 10.2.d SROC plot of anti‐CCP for rheumatoid arthritis showing 95% cre...
Figure 10.3.a
Coupled forest plot of the sensitivity and specificity of rheu
...
Figure 10.3.b MCMC diagnostics plots for a parameter (LAMBDA) from the HSROC...
Figure 10.3.c SROC plot of rheumatoid factor for rheumatoid arthritis
Figure 10.4.a
SROC plots produced using estimates from (a) model 1: equal va
...
Figure 10.4.b
Summary estimates of accuracy of CT and MRI for the diagnosis
...
Figure 10.4.c MCMC diagnostics plots for a parameter (prob_Sp) from the Baye...
Figure 10.5.a MCMC diagnostics plots for a parameter (LAMBDA) from the HSROC...
Figure 10.6.a
Forest plot of intraoperative cholangiography for diagnosis of
...
Figure 10.6.b
Forest plot of comparative studies of CT versus MRI for corona
...
Figure 10.6.c
Forest plot of Xpert Ultra against a composite reference stand
...
Figure 10.6.d
Sensitivity at a 5% false positive rate for nine first‐trimest
...
Figure 10.7.a
Graphical output from diagmeta for meta‐analysis of multiple t
...
Figure 10.7.b SROC curve and summary point for the threshold that maximizes ...
Figure 10.7.c Summary true‐positive rate (TPR or sensitivity) and false posi...
Figure 10.8.a MCMC diagnostics plots for parameters from the bivariate laten...
Figure 10.8.b Comparison of credible and prediction regions from bivariate l...
Chapter 11
Figure 11.5.a Symmetrical summary receiver operating characteristic (SROC) c...
Figure 11.7.a Forest plot of the NT, PAPP‐A, free ßhCG and maternal age test...
Figure 11.8.a
Using a calculator to convert sensitivity and specificity to p
...
Figure 11.9.a
SROC plot with point estimates of sensitivity and specificity
...
Chapter 13
Figure 13.3.a
Template for a test consequence graphic
. Text in square bracke...
Figure 13.3.b
Application of the test consequence graphic.
How accurate are
...
Guide
Cover Page
Title Page
Copyright Page
Contributors
Preface
Table of Contents
Begin Reading
Index
WILEY END USER LICENSE AGREEMENT
Pages
iii
iv
xv
xvi
xvii
xix
xx
xxi
xxii
xxiii
xxiv
1
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
21
22
23
24
25
26
27
28
29
30
31
32
33
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392
393
394
395
396
397
399
400
401
402
403
404
405
406
407
408
409
Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy
Edited by
Senior Editors
Jonathan J. DeeksPatrick M. Bossuyt
Associate Editors
Mariska M. LeeflangYemisi Takwoingi
This edition first published 2023© 2023 The Cochrane Collaboration
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 OfficesJohn Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, USAJohn Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK
For details of our global editorial offices, customer services, and more information about Wiley products visit us at www.wiley.com.
Wiley also publishes its books in a variety of electronic formats and by print‐on‐demand. Some content that appears in standard print versions of this book may not be available in other formats.
Trademarks: Wiley and the Wiley logo are trademarks or registered trademarks of John Wiley & Sons, Inc. and/or its affiliates in the United States and other countries and may not be used without written permission. All other trademarks are the property of their respective owners. John Wiley & Sons, Inc. is not associated with any product or vendor mentioned in this book.
Limit of Liability/Disclaimer of WarrantyThe 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 DataNames: 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 accuracyDescription: 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 TopicClassification: LCC RC71.5 (print) | LCC RC71.5 (ebook) | NLM W 20.5 | DDC 616.07/5–dc23/eng/20230119LC record available at https://lccn.loc.gov/2022052835LC ebook record available at https://lccn.loc.gov/2022052836
Cover Design: WileyCover 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
Contributors
Arevalo‐Rodriguez, IngridHospital Universitario Ramón y Cajal (IRYCIS)CIBER Epidemiology and Public Health (CIBERESP)MadridSpain
Bossuyt, Patrick MDepartment of Epidemiology and Data ScienceAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
Chandler, JacquelineWessex Academic Health Science NetworkSouthamptonUK
Cumpston, Miranda SSchool of Public Health and Preventive MedicineMonash University Melbourne;Cochrane Public HealthSchool of Medicine and Public HealthUniversity of NewcastleNewcastle Australia
Davenport, ClareInstitute of Applied Health ResearchUniversity of BirminghamBirminghamUK
Deeks, Jonathan JInstitute of Applied Health ResearchUniversity of BirminghamBirminghamUK
Dendukuri, NandiniMcGill UniversityMontrealCanada
Dinnes, JacquelineInstitute of Applied Health ResearchUniversity of BirminghamBirminghamUK
Eisinga, AnneCochrane UKOxford University Hospitals NHS Foundation TrustOxfordUK
Flemyng, EllaCochraneLondonUK
Gatsonis, ConstantineSchool of Public HealthBrown UniversityProvidence, RIUSA
Glanville, Julieglanville.infoYorkUK
Jones, Hayley EPopulation Health SciencesBristol Medical SchoolUniversity of BristolBristolUK
Leeflang, Mariska MDepartment of Epidemiology and Data ScienceAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
Li, TianjingDepartment of OphthalmologySchool of MedicineUniversity of Colorado Anschutz Medical CampusAurora, COUSA
Macaskill, PetraSydney School of Public HealthFaculty of Medicine and HealthUniversity of SydneySydneyAustralia
Partlett, ChristopherNottingham Clinical Trials UnitUniversity of NottinghamNottinghamUK
Reitsma, Johannes BJulius Center for Health Sciences and Primary CareUniversity Medical Center UtrechtUtrecht UniversityUtrechtThe Netherlands
Rücker, GertaInstitute of Medical Biometry and StatisticsFaculty of Medicine and Medical CenterUniversity of FreiburgFreiburgGermany
Rutjes, Anne WDepartment of Medical and Surgical Sciences SMECHIMAIUniversity of Modena and Reggio Emilia ModenaItaly
Schiller, IanCentre for Outcomes ResearchMcGill University Health Centre – Research InstituteMontrealCanada
Scholten, Rob JCochrane NetherlandsJulius Center for Health Sciences and Primary CareUniversity Medical Center UtrechtUtrecht UniversityUtrechtThe Netherlands
Spijker, RenéCochrane NetherlandsJulius Center for Health Sciences and Primary CareUniversity Medical Center UtrechtUtrecht UniversityUtrecht;Medical LibraryAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
Steingart, Karen RDepartment of Clinical SciencesLiverpool School of Tropical MedicineLiverpool UK
Takwoingi, YemisiInstitute of Applied Health ResearchUniversity of BirminghamBirminghamUK
Whiting, PennyPopulation Health SciencesBristol Medical SchoolUniversity of BristolBristolUK
Yang, BadaJulius Center for Health Sciences and Primary CareUniversity Medical Center UtrechtUtrecht UniversityUtrechtThe Netherlands
Preface
Patrick M. Bossuyt, Jonathan J. Deeks, Mariska M. Leeflang, Yemisi Takwoingi and Ella Flemyng
Medical tests are an indispensable element of modern‐day health care. Clinicians rely on medical tests to find the likely cause of a patient’s signs and symptoms, to evaluate the extent of disease, to predict the future course of the condition, to screen for asymptomatic disease and in many other situations.
Like any other intervention in health care, a medical test should be properly evaluated before its use can be recommended. Tests must make little error in measuring chemical, biological or physical quantities, or in detecting features, whether a clinical doctor assessing symptoms, a pathologist seeing a biopsy or a radiologist identifying an image. However, as well as being accurate, tests must also provide the right information to guide clinical actions. For this reason, a medical test must be evaluated for its clinical performance.
For diagnostic tests, this clinical performance is referred to as diagnostic accuracy: the ability of a test to correctly identify people who have or do not have the target condition. A diagnostic accuracy study assesses the results of an index test (test of interest) against a reference standard and provides estimates of the test’s performance. Such evaluations of clinical performance should be done in a real‐world setting within the context of a clinical pathway taking into account the intended use and target population.
For many tests a range of diagnostic accuracy studies have been reported in the medical literature. As in other areas of science, systematic reviews of such studies can provide informative syntheses of the available evidence. A systematic review can provide decision makers and other stakeholders with an overview of the currently available evidence about a test’s diagnostic accuracy. We expect such reviews to include a well‐defined review question, systematic searches of all relevant studies, evaluations of the risk of bias and applicability of identified studies and, if possible, meta‐analyses that statistically combine the results of multiple studies.
The methods for systematic reviews of diagnostic accuracy studies were slow to develop, compared to methods for systematic reviews of randomized controlled trials of interventions. This difference parallels a difference in rigour in the primary studies and an understanding of sources of bias. Other explanations can be found as well: the wide differences in study objectives and designs of test accuracy studies, ranging from biomarker discovery studies to large‐scale clinical applications in the intended use setting. This variation and complexity of study designs can lead to results that are either not relevant or not valid for answering a test accuracy review question. This is further compounded by the fact that measures of test accuracy are not automatically transferable across different populations and settings. Unlike randomized controlled trials, test accuracy studies typically provide paired proportions to indicate how well the test performs in those who have and those who do not have the target condition, i.e. the test’s sensitivity and specificity. This poses specific challenges for meta‐analysis. Furthermore, sensitivity and specificity vary considerably more across studies than estimates of relative risk from clinical trials because they are proportions, not relative or absolute differences.
“Another challenge is in addressing clinically important comparative questions when there are competing tests that can be used at the same point in the clinical pathway. Systematic reviews of test accuracy can evaluate and compare the accuracy of two or more tests. While many studies evaluate the accuracy of a single index test, far fewer compare the accuracy of two or more index tests. Such comparative test accuracy studies, which can provide robust evidence to inform test selection, deserve greater appreciation from clinical investigators, researchers, grant‐awarding organizations funding test research, and those developing test use recommendations.”
“Evidence on how the results of primary studies differ according to methodological features may be provided by meta‐epidemiological studies. These meta‐epidemiological studies often use data collected from systematic reviews. For example, the earliest meta‐epidemiological studies based on Cochrane reviews strengthened the importance of allocation concealment in randomised trials. Similar empirical studies using systematic reviews of diagnostic accuracy have confirmed essential elements of valid test accuracy studies, from avoiding the unnecessary inclusion of healthy controls to the need for appropriate statistical methods.”
“This Handbook is informed by currently available empirical evidence and theoretical understanding of primary diagnostic accurarcy studies, review methods, and techniques for meta‐analysis. The ongoing creation of Cochrane reviews will provide data for future studies that will shape our knowledge of how primary test accuracy studies and systematic reviews could be better performed.”
This Handbook has a long history. Its development started around 2002, when a number of us felt that the methodology for systematic reviews of test accuracy studies had sufficiently advanced to guide researchers. Since then, an incredible number of colleagues have contributed to its gestation. Many of these have become authors of chapters in this Handbook. Others are explicitly acknowledged in various chapters for their contribution. Yet many more have contributed, through various discussions in methods groups sessions, conferences and other meetings. While we worked on this Handbook progress did not halt and in several steps of the review process more methodological advances were made, while best practices emerged in other areas.
Considerable progress has been made in searching, in evaluating risk of bias and applicability and in meta‐analysis. The continuing development of software programs and user‐written macros has made meta‐analysis methods more accessible. A challenging area remains the communication of findings from reviews to decision makers and other stakeholders. Systematic reviews typically reveal substantial variability across studies and this variability makes it challenging to appreciate the true diagnostic accuracy of medical tests.
The authors of this Handbook have aimed to develop guidance based on the best current knowledge. We expect that several of the methods and practices will be advanced even further in the coming years, necessitating an update of this Handbook in the future. We are confident that the guidance in this Handbook will enable researchers in Cochrane and beyond to prepare informative reviews of the available literature to benefit patients and clinicians. In short: to all of us.
About Cochrane
Cochrane is an international network of health practitioners, researchers, methodologists, patients and carers, and others, with a vision of a world of better health for all people where decisions about health and care are informed by high‐quality evidence (www.cochrane.org). Founded as The Cochrane Collaboration in 1993, it is a not‐for‐profit organization whose members aim to produce credible, accessible health information that is free from commercial sponsorship and other conflicts of interest.
Cochrane works collaboratively with health professionals, policy makers and international organizations, such as the World Health Organization (WHO), to support the development of evidence‐informed guidelines and policy. WHO guidelines on critical public health issues such as the consolidated guidelines on systematic screening for tuberculosis disease (2021) and rapid diagnostics for tuberculosis detection (2021), and the WHO Essential Diagnostics List (2021), are underpinned by Cochrane Reviews.
There are examples of the impact of Cochrane Reviews on health and health care. Globally in 2020, a WHO‐recommended rapid molecular test was used as the initial diagnostic test for 1.9 million (33%) of the 5.8 million people newly diagnosed with tuberculosis in 2020 (Global Tuberculosis Report 2021). Several rapid diagnostic tests (RDTs) for tuberculosis have been endorsed by the WHO since 2010 based on evidence from many Cochrane Reviews. A Cochrane Special Collection on diagnosing tuberculosis, first published in 2019 and last updated in March 2022 to celebrate World Tuberculosis Day (www.cochranelibrary.com/collections/doi/SC000034/full), highlighted the influential Cochrane reviews that have informed the two WHO consolidated guidelines on systematic screening and rapid diagnostics for tuberculosis. The use of RDTs for tuberculosis has contributed to the decentralization of testing and allowed patients to be diagnosed quickly with earlier initiation of appropriate treatment in many low‐ and middle‐income countries. Rapid and reliable testing has also facilitated earlier detection of drug resistance and reduced mortality from tuberculosis among persons living with HIV.
Cochrane Reviews are published in full online in the Cochrane Database of Systematic Reviews, which is a core component of the Cochrane Library (www.cochranelibrary.com). The Cochrane Library was first published in 1996, and is now an online collection of multiple databases. The first Cochrane Review of diagnostic test accuracy was published in 2008.
About this Handbook
Work on a handbook to support authors of Cochrane Reviews of diagnostic test accuracy began in 2002, with draft chapters shared with the community online. It has evolved and grown into this second version since 2020, which is also the first print edition of the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy.
This Handbook is the official guide that describes in detail the process of preparing and maintaining systematic reviews of test accuracy for Cochrane. The Handbook has been produced by the Cochrane Screening and Diagnostic Tests Methods Group (www.methods.cochrane.org/sdt). It is a step‐by‐step guide for those conducting systematic reviews of test accuracy and a reference for more experienced authors.
The Handbook is divided into three parts. Part 1 covers information specific to Cochrane Reviews of diagnostic test accuracy. Part 2 introduces test accuracy studies and discusses when it might be appropriate to conduct them. Part 3 covers the methods used in systematic reviews of test accuracy and how to present the findings, including collecting data, assessing risk of bias in the included studies, and undertaking meta‐analysis. It is applicable to all systematic reviews of test accuracy, though it is specifically relevant to Cochrane Reviews.
The Handbook is updated regularly to reflect advances in systematic review methodology and in response to feedback from users. Please refer to training.cochrane.org/handbook‐diagnostic‐test‐accuracy for the most recent online version, for interim updates to the guidance and for details of previous versions of the Handbook. Feedback and corrections to the Handbook are also welcome via the contact details on the website.
Key details about this edition
This edition is the first complete version of this Handbook. The Handbook has been restructured, with reorganization or splitting of existing chapters and the addition of several new chapters. The Handbook covers:
Updated guidance on understanding test accuracy measures (
Chapter 4
), searching for and selecting studies (
Chapter 6
), assessing the risk of bias and applicability in included studies (
Chapter 8
), understanding meta‐analysis (
Chapter 9
), presenting findings (
Chapter 11
) and drawing conclusions (
Chapter 12
).
New guidance on planning a Cochrane Review of diagnostic test accuracy (
Chapter 1
).
New guidance on evaluating medical tests (
Chapter 2
).
New guidance on the design of test accuracy studies (
Chapter 3
).
New guidance on defining the review question (
Chapter 5
).
New guidance on data extraction (
Chapter 7
).
New guidance on undertaking meta‐analysis (
Chapter 10
).
New guidance on writing a plain language summary (
Chapter 13
).
How to cite this book
Deeks JJ, Bossuyt PM, Leeflang MM, Takwoingi Y, editors. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy. 1st edition. Chichester (UK): John Wiley & Sons, 2023.
Acknowledgements
We thank all of our contributing authors and chapter editors for their patience and responsiveness in preparing this Handbook. We are also indebted to all those who have contributed to previous versions of the Handbook, and particularly to past editor Rob J. Scholten.
Many people contributed constructive and timely peer review for this edition. We thank Alex Sutton, Anna Noel‐Storr, April Coombe, Bada Yang, Bella Harris, Brian Duncan, Chris Hyde, Cochrane Information Specialist Executive, Daniël Korevaar, Danielle van der Windt, Denise Mitchell, Dimitrinka Nikolova, Eleanor Ochodo, Gianni Virgili, Ingrid Arevalo‐Rodriguez, Jean‐Paul Salameh, Jacqueline Dinnes, Jenny Doust, Jenny Negus, Jérémie Cohen, Karen R. Steingart, Kayleigh Kew, Kurinchi Gurusamy, Marta Roque, Matthew McInnes, Mia Schmidt‐Hansen, Miranda Langendam, Sarah Berhane, Stephanie Boughton, Sophie Beese and Trevor McGrath.
Specific administrative support and copyediting for this version of the Handbook were provided by Laura Mellor, and we are deeply indebted to Laura for her many contributions. We would also like to thank staff at Wiley for their patience, support and advice, including Priyanka Gibbons (Commissioning Editor), Jennifer Seward (Senior Project Editor) and Samras Johnson Vanathaiya (Content Refinement Specialist). Finally, we thank Sally Osborn for copyediting the whole volume.
This Handbook would not have been possible without the generous support provided to the editors by colleagues at the University of Birmingham, the University of Amsterdam, and the Cochrane Evidence Production and Methods Directorate at Cochrane Central Executive. We particularly thank Karla Soares‐Weiser (Editor in Chief, Cochrane) and acknowledge Ella Elliot (Wiley), Ingrid Arevalo‐Rodriguez and other people from Wiley involved in the cover design.
Finally, the Editors would like to thank the thousands of Cochrane authors who volunteer their time to collate evidence for people making decisions about health care, and the methodologists, editors and trainers who support them.
Additional sources of support the editors would like to declare include that Jonathan J. Deeks is a UK National Institute for Health Research (NIHR) Senior Investigator Emeritus. Yemisi Takwoingi is funded by a UK National Institute for Health Research (NIHR) Postdoctoral Fellowship. Jonathan J. Deeks and Yemisi Takwoingi are supported by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
The Handbook editorial team
Jonathan J. Deeks (Senior Editor) is Professor at the Institute of Applied Health Research, University of Birmingham, UK, as well as a member of Cochrane’s Diagnostic Test Accuracy Editorial Team.
Patrick M. Bossuyt (Senior Editor) is Professor at the Amsterdam UMC, University of Amsterdam, Department of Epidemiology and Data Science, The Netherlands; and a member of Amsterdam Public Health, Methodology, The Netherlands.
Mariska M. Leeflang (Associate Editor) is Associate Professor at the Amsterdam UMC, University of Amsterdam, Department of Epidemiology and Data Science, The Netherlands; a member of Amsterdam Public Health, Methodology, The Netherlands; as well as a Convenor of Cochrane’s Screening and Diagnostic Tests Methods Group and member of Cochrane’s Diagnostic Test Accuracy Editorial Team.
Yemisi Takwoingi (Associate Editor) is Professor at the Institute of Applied Health Research, University of Birmingham, UK, as well as a Convenor of Cochrane’s Screening and Diagnostic Tests Methods Group and a member of Cochrane’s Diagnostic Test Accuracy Editorial Team.
Ella Flemyng (Managing Editor) is Editorial Product Lead in Cochrane’s Evidence Production and Methods Directorate, part of Cochrane’s Central Executive Team, UK.
Note
This chapter should be cited as: Bossuyt PM, Deeks JJ, Leeflang, MM, Takwoingi Y, Flemyng E. Preface. In: Deeks JJ, Bossuyt PM, Leeflang MM, Takwoingi Y, editors.
Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy
. 1st edition. Chichester (UK): John Wiley & Sons, 2023: xix–xxiv.
Part OneAbout Cochrane Reviews of diagnostic test accuracy
1Planning a Cochrane Review of diagnostic test accuracy
Ella Flemyng, Miranda S. Cumpston, Ingrid Arevalo-Rodriguez, Jacqueline Chandler and Jonathan J. Deeks
KEY POINTS
Systematic reviews of test accuracy (i.e. systematic reviews of studies of the accuracy of one or more medical tests) aim to address a need for health decision makers to have access to high‐quality, relevant and up‐to‐date information regarding the use of a test in a specific healthcare setting.
Systematic reviews of test accuracy, like all systematic reviews produced within Cochrane, aim to minimize bias through the use of pre‐specified research questions and methods that are documented in protocols, and by basing their findings on reliable research.
Author teams of systematic reviews of test accuracy should include members with appropriate methodological expertise in diagnostic test accuracy research.
Proposals for new Cochrane Reviews of diagnostic test accuracy are generally submitted by author teams to Cochrane for approval before they are started.
The Diagnostic Test Accuracy Editorial Team provides input into the editorial process for Cochrane Reviews of diagnostic test accuracy, by advising from the title stage to the final publication, offering methodological feedback on protocols and reviews.
Review authors should be familiar with, and follow, the guidance developed by Cochrane for the conduct and reporting of their systematic reviews of test accuracy, as well as Cochrane’s editorial policies such as avoiding and declaring potential conflicts of interest.
This chapter re‐uses and builds on material included in the following chapters of the Cochrane Handbook for Systematic Reviews of Interventions to ensure consistency in guidance for authors of Cochrane Reviews.
Cumpston M, Chandler J. Chapter II: Planning a Cochrane Review. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 6.1 (updated September 2020). Cochrane, 2020. Available from training.cochrane.org/handbook.
Lasserson TJ, Thomas J, Higgins JPT. Chapter 1: Starting a review. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 6.1 (updated September 2020). Cochrane, 2020. Available from training.cochrane.org/handbook.
1.1 Introduction
This chapter describes the general process for considering, planning and organizing a Cochrane Review of diagnostic test accuracy.
The process of preparing and publishing a Cochrane Review is different from that for other journals. This chapter builds on the information detailed in Chapter II (Planning a Cochrane Review) of the Cochrane Handbook for Systematic Reviews of Interventions with specific details on planning and preparing a Cochrane Review of diagnostic test accuracy (Lasserson 2020).
1.2 Why do a systematic review of test accuracy?
In general, systematic reviews were developed out of a need to ensure that decisions affecting people’s lives can be informed by an up‐to‐date and complete understanding of the relevant research evidence. A systematic review attempts to collate all the empirical evidence that fits pre‐specified eligibility criteria in order to answer a specific research question. It uses explicit, systematic methods that are selected with a view to minimizing bias, thus providing more reliable findings from which conclusions can be drawn and decisions made (Antman 1992, Oxman 1993).
Systematic review methodology, pioneered and developed by Cochrane, sets out a highly structured, transparent and reproducible methodology (Chandler and Hopewell 2013). This involves specifying a research question a priori; clarity on the scope of the review and which studies are eligible for inclusion; making every effort to find all relevant research and to ensure that issues of bias in included studies are accounted for; and analysing the included studies in order to draw conclusions based on all the identified research in an impartial and objective way (Lasserson 2020).
Cochrane Reviews can be categorized by the type of question they seek to address. Cochrane’s first Handbook was dedicated to systematic reviews that seek to assess the benefits and harms of interventions, commonly referred to as Cochrane Reviews of interventions, which is the most common type of Cochrane Review. The Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy focuses on the second most common type of Cochrane Review, which aims for the formal evaluation, including assessments of the methodological quality, of the available evidence on the performance of one or more medical tests, in a specific population and healthcare setting, for a specific testing purpose (Leeflang 2013, McInnes 2018, Schünemann 2020a).
The methods used are different for systematic reviews of test accuracy compared to systematic reviews of interventions, and this Handbook focuses on the methods recommended by Cochrane to plan, conduct and report the former to a high standard.
1.3 Undertaking a Cochrane Review of diagnostic test accuracy
Cochrane Reviews of diagnostic test accuracy have specific features that set them apart from reviews for other journals.
1.3.1 The role of the Diagnostic Test Accuracy Editorial Team
The Cochrane Diagnostic Test Accuracy Editorial Team currently supports the editorial process for Cochrane Reviews of diagnostic test accuracy. In 2023, Cochrane moves to a centralised editorial process for all evidence syntheses published on the Cochrane Library in 2023 and so this role may change. The Diagnostic Test Accuracy Editorial team consists of methodologists and clinicians with expertise in test accuracy research. They provide advice during all stages of the process, including the review of new titles, if requested, as well as methodological peer review and editorial assessment of all Cochrane Protocols and Reviews of diagnostic test accuracy. If improvements are needed, the Diagnostic Test Accuracy Editorial Team provides comprehensive guidance to be shared with the review authors, detailing the changes required to meet Cochrane’s publication standards. The most up to date information about the Diagnostic Test Accuracy Editorial Team is available via the Screening and Diagnostic Tests Methods Group website (www.methods.cochrane.org/sdt).
1.3.2 Expectations for the conduct and reporting of Cochrane Reviews of diagnostic test accuracy
For Cochrane Reviews of diagnostic test accuracy, authors should follow the methodological expectations detailed in this Handbook. Some specific expectations for plain language summaries of Cochrane Reviews of diagnostic test accuracy are detailed in Chapter 13. These expectations, informed by Cochrane editors and review authors, draw on experience of publishing systematic reviews of test accuracy since 2009.
Authors of Cochrane Reviews of diagnostic test accuracy should follow the Preferred Reporting Items for Systematic reviews and Meta‐Analyses extension for Diagnostic Test Accuracy (PRISMA‐DTA) Statement, as ensuring compliance with these reporting standards facilitates a full assessment of the methods and findings of the review (McInnes 2018).
Finally, as with all medical writing, it is important to consider the readers when deciding on the writing style, language, detail and level of assumed knowledge. In general, Cochrane Protocols and Reviews are read by informed patients as well as by clinicians, other healthcare professionals and policy makers. They are widely read by people whose first language is not English. It is thus important that the content and writing style, as far as possible, ensure that these reviews are accessible to this wide audience. Full details are available in the Cochrane Style Manual (www.community.cochrane.org/style‐manual).
1.3.3 Data management and quality assurance
Cochrane Reviews of diagnostic test accuracy should be recorded and reported in sufficient detail for them to be replicable. Retaining a record of inclusion decisions, data collection and any transformations or adjustment to the extracted data will help to establish a secure and retrievable audit trail (Stegeman 2020).
Systematic reviews of test accuracy can be operationally complex projects, often involving large research teams working from different sites across the world. Good data management processes are essential to ensure that data and decisions are not inadvertently lost, facilitating the identification and correction of errors and supporting future efforts to update and maintain the review. Transparent reporting of review decisions enables readers to assess the reliability of the review for themselves (Lasserson 2020).
Further details about data management and quality assurance are available in Chapter 1 (Starting a review) of the Cochrane Handbook for Systematic Reviews of Interventions (Lasserson 2020).
1.3.4 Keeping the Review up to date
Cochrane Reviews should be updated if new, relevant evidence becomes available, especially when it would have an impact on the authors’ conclusions. When proposing a new review, author teams should be committed both to completing the review and to maintaining it once it is published. However, there can be flexibility in this. Further details on updating are available in Chapter IV (Updating a review) of the Cochrane Handbook for Systematic Reviews of Interventions (Cumpston 2020b).
A ‘living’ systematic review is a systematic review that is continually updated, with new (or newly identified) evidence incorporated as soon as it becomes available (Elliott 2014a, Elliott 2017). Cochrane Reviews of diagnostic test accuracy can be conducted in living mode in situations where the evidence base is growing or evolving rapidly, to ensure that policy and practice are underpinned by the most up‐to‐date research. Any Cochrane Review in living mode should have approval from Cochrane, meet certain criteria (community.cochrane.org/review‐production/production‐resources/living‐systematic‐reviews) and follow specific guidance for the production and publication of living systematic reviews.
1.4 Proposing a new Cochrane Review of diagnostic test accuracy
Cochrane Reviews of diagnostic test accuracy go through a proposal process to check that the scope of the proposed review is appropriate and avoids duplication with existing and ongoing Cochrane Reviews, and that the author team have the skills, experience and resources to conduct the review (see Section 1.6). The proposal process also allows Cochrane staff to provide early editorial support and signposting to methods resources. Information about how to propose a Cochrane Review of diagnostic test accuracy is available online (www.methods.cochrane.org/sdt).
A proposal for a Cochrane Review of diagnostic test accuracy is checked for the suitability of the review question, approach and methods. As explained in Chapter 2 and Chapter 5, some test evaluation issues are not suitable for evaluation in test accuracy studies, including the reliability of a test, the agreement among different users when the test is applied, and the consequences for patient‐important outcomes when the test is used (Lord 2006, Schünemann 2019, Schünemann 2020a, Schünemann 2020b).
Once a title is registered, the review authors will be required to develop and submit a formal protocol (see Section 1.5) incorporating feedback provided on the review proposal. Following peer review and approval, the protocol will be published in the Cochrane Database of Systematic Reviews (CDSR). Author teams can then proceed to complete the full review. Both protocols and reviews should meet Cochrane’s standards and adhere to Cochrane’s editorial policies (www.community.cochrane.org/review‐production/production‐resources/cochrane‐editorial‐and‐publishing‐policy‐resource). Cochrane may reject manuscripts that are not of a sufficient standard for publication following Cochrane’s rejection policy (www.cochranelibrary.com/cdsr/editorial‐policies#rejection‐appeals).
The review title should succinctly reflect the review’s objective. Typically, the key components of the title are:
the population (stating what symptoms they present with, the healthcare setting, and what tests they have received before);
the target condition or health status to be diagnosed (including the stage or subtype of disease that, for example, may determine eligibility for subsequent treatment);
the diagnostic test or tests being evaluated (including their intended role and place in the current clinical diagnostic pathway).
An overview of test accuracy and test evaluation is available in Chapter 2 and details on designs for test accuracy studies are available in Chapter 3.
Four title formats are possible (Table 1.4.a) depending on the number of tests being evaluated (options 1 and 3 are for two or more tests, options 2 and 4 work for either a single test or a single group of tests) and whether the patient description is required (options 1 and 2) or can be omitted (options 3 and 4). Options 3 and 4, which do not include a patient description, should only be used where the target condition clearly implies a particular patient group.
1.5 Cochrane Protocols
Protocols for systematic reviews of test accuracy provide clear statements of the objectives of the research, including a focus on the comparisons that will be made, if needed, as well as the methods to conduct the review. They communicate important background information to provide a clinical context and define key clinical issues regarding the index test under assessment. The protocol also justifies the rationale and need for the review in the context of the existing scientific literature and current diagnostic pathways to detect the target condition. Crucially, the protocol defines the methods by which the review will be undertaken, stating study eligibility criteria; search strategies, selection and quality assessment methods; and a statistical analysis plan.
Table 1.4.a Structure for titles of Cochrane Reviews of diagnostic test accuracy
Option
Scenario
Structure
Examples
1
The full structure for a review title can include a comparison of two or more named index tests, a target condition and a population
<Index test(s) 1>
versus
/or <index test(s) 2†> versus/or …
for
<target condition(s)>
in
<population>(† if the comparison is with current diagnostic practice, the second index test will be the comparator test – for instance, the test intended to be replaced)
Computed tomography angiography or magnetic resonance angiography for detection of intracranial vascular malformations in people with intracerebral haemorrhageUltrasound, CT, MRI or PET‐CT for staging and re‐staging of adults with cutaneous melanoma
2
The second index test can be dropped when only a single test is considered, or when there is a name that describes the group of tests being compared
<Index test(s)>
for
<target condition(s)>
in
< population>
Optical coherence tomography (OCT) for detection of macular oedema in patients with diabetic retinopathyRapid diagnostic tests for diagnosing uncomplicated P. falciparum malaria in endemic countriesPlasma interleukin‐6 concentration for the diagnosis of sepsis in critically ill adults
3
The population or setting can also occasionally be dropped where these will be obvious from the tests or the target condition
<Index test(s) 1>
versus
/or <index test(s) 2†> versus/or …
for
<target condition(s)>(† if the comparison is with current diagnostic practice, the second index test will be the comparator test)
Human papillomavirus testing versus repeat cytology for triage of minor cytological cervical lesionsTransabdominal ultrasound or endoscopic ultrasound for diagnosis of gallbladder polyps
4
The simplest option drops both the second test group and the population
<Index test(s)>
for
<target condition(s)>
Second trimester serum tests for Down’s Syndrome screeningRapid diagnostic tests for plague
Given the complexity of preparing Cochrane Reviews, a protocol should be written prospectively. There are a number of reasons that Cochrane Reviews should have a published protocol, including but not limited to the following: to reduce the risk of introducing bias in the review process; to improve the quality of the review as protocols undergo editorial, clinical and methodological peer review to ensure the methods are appropriate for the review question before the review is started; and to reduce the risk of duplicating efforts if other similar reviews are already underway. More details on the rationale for protocols is available in Chapter 1 (Starting a review) of the Cochrane Handbook of Systematic Reviews of Interventions (Lasserson 2020).
Cochrane Protocols and Reviews of diagnostic test accuracy follow a standard structure that facilitates review reporting and peer review. Most headings are common between the protocol and the review, including the Background and Methods sections, so only minor changes will be required between stages, such as a change in writing tense (from future to past). The exception will be where there are declared differences between a published protocol and a review, which should be described in the ‘Differences between protocol and review’ section of the completed review.
The full structure of a Cochrane Review of diagnostic test accuracy is seen in Box 1.5.a, along with which sections are found in the protocol. A full reporting template for Cochrane Protocols of diagnostic test accuracy is available as online supplementary material (1.S1 Writing a Cochrane Protocol of diagnostic test accuracy) and more details about protocol development in Cochrane more generally are available in Chapter 1 (Starting the review) in the Cochrane Handbook for Systematic Reviews of Interventions (Lasserson 2020).
Box 1.5.aSections of a Cochrane Review of diagnostic test accuracy
Title
Abstract*
Plain language summary*
Summary of findings*
Background
Target condition being diagnosed
Index test(s)
Clinical pathway
Prior test(s)
Role of index test(s)
Alternative test(s)
Rationale
Objectives
Methods
Criteria for considering studies for this review
Types of studies
Participants
Index tests
Target conditions
Reference standards
Search methods for identification of studies
Electronic searches
Searching other resources
Data collection and analysis
Selection of studies
Data extraction and management
Assessment of methodological quality
Statistical analysis and data synthesis
Investigations of heterogeneity
Sensitivity analyses
Assessment of reporting bias
Results*
Results of search
Methodological quality of included studies
Findings
Discussion*
Summary of main results
Strengths and weaknesses of review
Applicability of findings to review question
Authors’ conclusions*
Implications for practice
Implications for research
Appendices
Search strategy
Review‐specific tailoring of QUADAS2
Information
Authors
Contribution of authors
Sources of support
Declarations of interest
Acknowledgements
Version history
Differences between protocol and review
*
References
Characteristics of studies*
Data and analyses*
Figures and tables
*Sections of a completed Review, not required in a Protocol.
1.6 The author team
1.6.1 The importance of the team
Synthesizing research about tests is more complex than synthesizing intervention studies (Naaktgeboren 2014, Beese 2018). In addition, the quality of systematic reviews of test accuracy published in the medical literature is currently poor (Mallett 2006, Willis 2011, Arevalo‐Rodriguez 2014, Spencer‐Bonilla 2017). It is imperative that the team planning the development of a systematic review of test accuracy includes individuals with the multidisciplinary skills needed to successfully complete the task from the beginning of the process.
In all cases Cochrane Reviews should be undertaken by more than one person and often require more than two. Review teams should include clinical and methodological expertise in the topic area being reviewed, as well as the perspectives of stakeholders (see Section 1.6.3 on which stakeholders are recommended for systematic reviews of test accuracy). For systematic reviews of test accuracy, it is often helpful to include both health professionals who use the index test in daily practice for the purpose specified in the review, and experts who are familiar with the relevant technical details related to its implementation. This will ensure that the team includes both those who face the clinical problem and those able to fully understand the study reports at a technical level.
Given the technical nature and complexity of test accuracy study reports and the clinical nuances that should be considered in making diagnoses in real‐world settings, it is important to include on the team people with both topic and methodological expertise. This should help to ensure a balanced approach and a good mix of skills and knowledge, as well as a comprehensive assessment of the evidence regarding the accuracy of the index test.
For systematic reviews of test accuracy, author teams should include members with expertise in literature searching, completing systematic reviews, test research methods and statistics. The information specialists and statistical experts should be aware of the particular methodology for searching and data analysis for systematic reviews of test accuracy, as detailed in this Handbook in Chapter 6, Chapter 9 and Chapter 10.
When a proposal for a new review is under consideration, Cochrane’s editorial teams will consider not only the clarity of the review question, but also the skills and experience of the team proposing the new review. All review authors are encouraged to make use of Cochrane training and guidance resources to ensure they have the skills required to conduct the review (see Section 1.7). First‐time review authors are also encouraged to work with others who are experienced in the process of conducting systematic reviews of test accuracy.
1.6.2 Criteria for authorship
Authorship of all scientific publications (including Cochrane Protocols and Reviews) establishes accountability, responsibility and credit. Cochrane follows the International Committee of Medical Journal Editors (ICMJE) criteria for authorship (ICMJE 2018). When deciding who should appear in the byline of a Cochrane Review, it is important to distinguish individuals who have made a substantial contribution to the review (and who should be listed) from those who have helped in other ways (who should be mentioned in the Acknowledgements section). More information about authorship and contributorship is available in the Cochrane Editorial and Publishing Policy Resource (community.cochrane.org/review‐production/production‐resources/cochrane‐editorial‐and‐publishing‐policy‐resource).
Methodological specialists such as statisticians and information specialists should be included as review authors where they meet the ICMJE authorship criteria, particularly where they have been substantively involved in the design and execution of the review’s methods.
