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Preface
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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 2introduces 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 metaanalysis. 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 (Chapter4), searching
for and selecting studies (Chapter6), assessing the risk of bias and applicability in
included studies (Chapter8), understanding meta- analysis (Chapter 9), presenting
findings (Chapter11) and drawing conclusions (Chapter12).
●
New guidance on planning a Cochrane Review of diagnostic test accuracy (Chapter1).
●
New guidance on evaluating medical tests (Chapter2).
●
New guidance on the design of test accuracy studies (Chapter3).
●
New guidance on defining the review question (Chapter5).
●
New guidance on data extraction (Chapter7).
●
New guidance on undertaking meta- analysis (Chapter10).
●
New guidance on writing a plain language summary (Chapter13).
How tocite 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.
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Preface
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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.
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Preface
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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.
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Part One
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About Cochrane Reviews ofdiagnostic test
accuracy
1
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Planning aCochrane Review ofdiagnostic
testaccuracy
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 highin a specific healthcare setting.
Systematic reviews of test accuracy, like all systematic reviews produced within
•
Cochrane, aim to minimize bias through the use of preand 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.
quality, relevant and up- to- date information regarding the use of a test
specified research questions
This chapter should be cited as: Flemyng E, Cumpston M S, Arevalo- Rodriguez I, Chandler J, Deeks JJ.
Chapter1: Planning a Cochrane Review of diagnostic test accuracy. 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: 3–18.
Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy, First Edition. Edited by
Jonathan J. Deeks, Patrick M. Bossuyt, Mariska M. Leeflang and Yemisi Takwoingi.
© 2023 The Cochrane Collaboration. Published 2023 by John Wiley & Sons Ltd.
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1 Planning aCochrane Review ofdiagnostic testaccuracy
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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 InterventionsVersion 6.1(updated September 2020). Cochrane,
2020. Available fromtraining.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 InterventionsVersion 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 asystematic review oftest 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,
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1.3 Undertaking aCochrane Review ofdiagnostic test accuracy
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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 aCochrane Review ofdiagnostic 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 ofthe 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 forthe conduct andreporting ofCochrane Reviews
ofdiagnostic 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
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1 Planning aCochrane Review ofdiagnostic testaccuracy
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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 andquality 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 theReview upto 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/livingsystematic- reviews) and follow specific guidance for the production and publication of
living systematic reviews.
1.4 Proposing anew Cochrane Review ofdiagnostic 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 Section1.6). The proposal process also
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1.5 Cochrane Protocols
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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 Chapter2 and
Chapter5, 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 Section1.5) 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- policyresource). 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 Chapter2 and details
on designs for test accuracy studies are available in Chapter3.
Four title formats are possible (Table1.4.a) depending on the number of tests being
evaluated (options 1 and 3 are for two or more tests, options 2 and 4work 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
forthe review in the context of the existing scientific literature and current diagnostic
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Table1.4.a Structure fortitles ofCochrane Reviews ofdiagnostic test accuracy
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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
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
3 The population or setting can also
occasionally be dropped where these
will be obvious from the tests or the
target condition
4 The simplest option drops both the
second test group and the 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)
<Index test(s)> for <target condition(s)>
in < population>
<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)
<Index test(s)> for <target condition(s)> Second trimester serum tests for Down’s
Computed tomography angiography or magnetic
resonance angiography for detection of
intracranial vascular malformations in people
with intracerebral haemorrhage
Ultrasound, CT, MRI or PET- CT for staging and
re- staging of adults with cutaneous melanoma
Optical coherence tomography (OCT) for
detection of macular oedema in patients with
diabetic retinopathy
Rapid diagnostic tests for diagnosing
uncomplicated P. falciparum malaria in endemic
countries
Plasma interleukin- 6 concentration for the
diagnosis of sepsis in critically ill adults
Human papillomavirus testing versus repeat
cytology for triage of minor cytological cervical
lesions
Transabdominal ultrasound or endoscopic
ultrasound for diagnosis of gallbladder polyps
Syndrome screening
Rapid diagnostic tests for plague
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