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1.5 Cochrane Protocols
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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.
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 Chapter1 (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 Box1.5.a,
along with which sections are found in the protocol. A full reporting template for
Box 1.5.a Sections ofa Cochrane Review ofdiagnostic 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
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●
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
Discussion
Authors’ conclusions
*
●
Results of search
●
Methodological quality of included studies
●
Findings
*
●
Summary of main results
●
Strengths and weaknesses of review
●
Applicability of findings to review question
*
●
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.
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*
1.6 The author team
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Cochrane Protocols of diagnostic test accuracy is available as online supplementary
material (1.S1Writing 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).
1.6 The author team
1.6.1 The importance ofthe 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 Section1.6.3 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 Chapter6, Chapter9 and Chapter10.
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 Section1.7). First- time review authors are also encouraged
to work with others who are experienced in the process of conducting systematic
reviews of test accuracy.
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1.6.2 Criteria forauthorship
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
(andwho 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.
1.6.3 Incorporating relevant perspectives andstakeholder involvement
Engaging consumers and other stakeholders, such as policy makers, research funders
and healthcare professionals, increases relevance, promotes mutual learning, improves
uptake and decreases research waste. Review author teams are therefore encouraged
to seek and incorporate the views of a variety of stakeholders and users during the
review process.
As a review author, mapping out all potential stakeholders specific to the review
question is a helpful first step to considering who might be invited to be involved in the
review’s development. Stakeholders typically include patients and consumers; consumer advocates; policy makers and other public officials; guideline developers; professional organizations; researchers; funders of health services and research; healthcare
practitioners; and, on occasion, journalists and other media professionals. Balancing
seniority, credibility within the given field and diversity should be considered. Review
authors should also take account of the needs of low- and middle- income countries and
regions, as well as vulnerable and marginalized people and societies, in the review process and invite appropriate input on the scope of the review and the questions it will
address (Lasserson 2020).
Some author teams decide to form an Advisory Group with representation from multiple stakeholders. The Effective Public Health Practice Project, Canada, found that six
members is generally large enough to cover all issues and is manageable for public
health reviews (Effective Public Health Practice Project2007). However, the broader the
review, the broader the experience required of Advisory Group members. Terms of
reference, job descriptions or person specifications for an Advisory Group may be
developed to ensure clarity about the task(s) required.
More ways of working with consumers and other stakeholders are detailed in
Chapter 1 (Starting a review) of the Cochrane Handbook for Systematic Review of
Interventions (Lasserson 2020).
It is established good practice to ensure that consumers are involved and engaged in
health research, including systematic reviews. Cochrane uses the term ‘consumers’ to
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1.7 Resources andsupport
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refer to a wide range of people, including patients or people with personal experience
of a healthcare condition, carers and family members, representatives of patients and
carers, service users and members of the public.
Cochrane believes that consumer involvement is important because it (i) promotes
transparency, accountability and trust in the way that research is produced; (ii) results in
evidence that addresses consumers’ needs, reduces waste in research, improves the
translation of research into policy and practice, and ultimately leads to improved benefits forhealth systems and outcomes for patients; and (iii) is consistent with current
health research approaches and isexpected or mandated by some funders, partners and
consumers. The benefits of consumer involvement are bestrealized when consumers
contribute throughout the process of production and dissemination of research (seethe
Statement of Principles for Consumer Involvement in Cochrane, www.consumers.
cochrane.org/news/statement-
principles- consumer- involvement- cochrane).
Whenever consumers (or others) contribute during the development of a protocol or
review, their contribution should be acknowledged in the Acknowledgements section
or as an author if they meet the criteria for authorship (see Section1.6.2).
1.7 Resources andsupport
1.7.1 Identifying resources andsupport
The main resource required by review authors is their own time. Most review authors
will contribute their time free of charge because it will be viewed as part of their existing
research or efforts to keep up to date in their areas of interest. However, Cochrane can
facilitate author training opportunities and methodological support, among other
support services.
The amount of time required to conduct a systematic review of test accuracy will vary,
depending on the review question, the number of studies identified by the search strategies, the methods used, the experience of the review authors and the types of support
available (Beese 2018). The workload associated with undertaking a review is thus very
variable. However, early consideration of the tasks involved and the time required for
each of these might help review authors to estimate the total amount of time that will
be required during the entire review process. These tasks include training, meetings,
protocol development, searching for studies, assessing citations and full- text reports of
studies for eligibility, assessing the risk of bias and applicability of included studies,
collecting data, pursuing missing data and unpublished studies, analysing the data,
interpreting the results, and writing the review.
A time chart with target dates for accomplishing key tasks can help with scheduling
the time needed to complete a review. Such targets may vary widely from review to
review. Review authors, together with Cochrane, should determine an appropriate time
frame for a specific review.
Resources that might be required for these tasks, in addition to the review authors’
time, include:
●
study- searching expertise;
●
additional library resources, including access to electronic databases for searching
and interlibrary loans;
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●
statistical support for synthesizing (if appropriate) the results of the included studies;
●
equipment (e.g. computing hardware and software);
●
supplies and services (internet connection, printing, telephone charges);
●
office space for staff; and
●
travel funds to attend review team meetings or present the results of the review.
1.7.2 Funding andconflicts ofinterest
Many organizations currently provide funding for high- priority systematic reviews.
These include research- funding agencies, organizations that provide or fund healthcare
services, those responsible for health technology assessment and those involved in the
development of clinical practice guidelines. Author teams may wish to identify and seek
funding from such organizations operating in their region or field of health care.
Conflict of interest in the funding and authorship of research gives rise to significant
issues, which Cochrane takes very seriously (Bero2018, Soares-
Weiser 2019). Under
Cochrane’s policy on conflict of interest (www.cochranelibrary.com/cdsr/editorialpolicies), a Cochrane Review cannot be funded or conducted by commercial sponsors
or commercial sources with a financial interest in the topic of a specific review.
All prospective review authors should complete a declaration of interests form when
proposing a review, and update this annually thereafter until publication, and just before
publication of the protocol and the completed review. Individuals who are employed by,
or own, a company that has a financial interest in the topic of the Cochrane Review
(including, but not limited to, drug companies or medical device manufacturers), or who
hold or have applied for a patent related to the topic of the Cochrane Review, are prohibited from being Cochrane Review authors. Additional restrictions apply for other financial
interests. If any interests change over time, review authors should alert Cochrane and
determine whether they affect the author’s involvement in the review.
Restrictions also apply to any authors of the review who were involved in the conduct of one or more of the review’s included studies. Review authors should not
determine the eligibility of these studies, extract data from them or assess the methodological quality of these studies. Neither should they be involved in assessing the
strength of the evidence involving studies they have (co- )authored. These tasks must
be undertaken by other members of the team.
Full details on conflicts of interest and Cochrane Reviews, including all of the implications for review authors, are available in the Conflict of Interest Policy for Cochrane
content (www.cochranelibrary.com/cdsr/editorial- policies).
Further discussion of the issues around conflicts of interest in research, and in particular how they apply to the studies included within a review, is outlined in Boutron
etal (2020).
1.7.3 Training
Review authors new to Cochrane Reviews of diagnostic test accuracy may have previous
training and experience in conducting Cochrane Reviews of interventions and other systematic reviews, but may benefit from additional guidance in the specialized methods
required for systematic reviews of test accuracy. Cochrane provides a range of support
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1.8 Chapter information
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services to facilitate learning of the specific methodology related to these reviews to
assist those contributing to Cochrane Reviews of diagnostic test accuracy in gaining the
knowledge and skills they need.
Cochrane also provides a range of online training resources, as well as face- to- face
events in locations around the world. Details of current resources and events are available
on the Cochrane Training website (training.cochrane.org) and via the Screening and
Diagnostic Tests Methods Group website (methods.cochrane.org/sdt).
Software
1.7.4
Cochrane Reviews are supported by an ecosystem of software tools to assist with different aspects of the review process (Elliott etal2014b). The primary piece of software is
the review authoring tool Review Manager (RevMan; training.cochrane.org/onlinelearning/core- software/revman). It provides structured text drafting, standard tables
and reference formats, meta- analysis, online help and error- checking mechanisms.
RevMan does not contain the statistical functionality required for meta- analysis of
systematic reviews of test accuracy. Review teams therefore need to use RevMan in conjunction with a statistical package capable of fitting hierarchical models, such as Stata,
SAS, R or WinBUGS. Study data entered into RevMan can be exported in a format suitable for import into these packages, and parameter estimates obtained from analyses in
these packages can be entered back into RevMan to create the final meta- analytical
summary receiver operating characteristic (SROC) plots and forest plots for inclusion in
the review. Chapter10 of this Handbook provides guidance on using these software
packages for test accuracy meta- analysis. Tutorial documents and a resource of helpful
computer macros are available on the Screening and Diagnostic Tests Methods Group
website (methods.cochrane.org/sdt/).
Review authors may wish to consider other software resources (community.cochrane.
org/help/tools- and- software) that might assist them with managing the review process
(e.g. the selection of references to be included in the review). The choice of software
tools may depend on the review authors’ preference, the availability of a stable internet
connection, the cost and other considerations. A register of tools designed for use in
systematic reviews is maintained in the Systematic Review Toolbox (www.
systematicreviewtools.com). Authors are advised to check with Cochrane and seek
methodological advice before incorporating new technologies into their reviews.
For editorial stages, Cochrane uses the editorial management system Editorial
Manager (training.cochrane.org/online-learning/em-training).
1.8 Chapter information
Authors: Ella Flemyng (Cochrane, London, UK), Miranda S. Cumpston (School of Public
Health and Preventive Medicine, Monash University, Cochrane Public Health, University of
Newcastle, Australia), Ingrid Arevalo- Rodriguez (Hospital Universitario Ramón y Cajal
(IRYCIS); CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain), Jacqueline
Chandler (Wessex Academic Health Science Network, Southampton, UK), Jonathan J.
Deeks (Institute of Applied Health Research, University of Birmingham, UK).
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Sources of support: Ella Flemyng is employed by and receives a salary from Cochrane.
Ingrid Arevalo- Rodriguez is funded by the Instituto de Salud Carlos III through the
“Acción Estrategica en Salud 2017- 2020 / Contratos Miguel Servet 2020/CD20/00152”.
Jonathan J. Deeks is a UK National Institute for Health Research (NIHR) Senior
Investigator Emeritus. Jonathan J. Deeks is 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. No other authors declare sources of support for writing this chapter.
Declarations of interest: Ella Flemyng works in Cochrane’s Evidence Production and
Methods Directorate, part of Cochrane’s Central Executive Team. Miranda S. Cumpston
is an Editor with Cochrane Public Health. Ingrid Arevalo-
Rodriguez and Jonathan J.
Deeks are members of Cochrane’s Diagnostic Test Accuracy Editorial Team. The authors
declare no other potential conflicts of interest relevant to the topic of this chapter.
Acknowledgements: 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: (1) 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. (2) Lasserson TJ, Thomas J, Higgins
JPT. Chapter1: 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.
The authors thank Ginny Brunton, Clare Davenport, Sally Green, Julian Higgins, Nicki
Jackson, Monica Kjeldstrøm, Toby Lasserson, Sandy Oliver and Susanna Wisniewski for
contributions to previous versions of this chapter. The authors also thank Liz Wager for
her assistance in preparing the text for the chapter previously titled ‘Guide to the contents
of a Cochrane Diagnostic Test Accuracy Protocol’, which was incorporated into this
chapter, and Nynke Smidt and Theresa Moore for their contributions to the previous
version of that chapter.
The authors would like to thank Sophie Beese, Stephanie Boughton, Isobel Harris,
Kayleigh Kew and Dimitrinka Nikolova for helpful peer review comments.
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