Abstract
Objectives
This article provides updated GRADE guidance about how authors of systematic reviews
and health technology assessments and guideline developers can assess the results
and the certainty of evidence (also known as quality of the evidence or confidence
in the estimates) of a body of evidence addressing test accuracy (TA).
Study Design and Setting
We present an overview of the GRADE approach and guidance for rating certainty in
TA in clinical and public health and review the presentation of results of a body
of evidence regarding tests. Part 1 of the two parts in this 21st guidance article
about how to apply GRADE focuses on understanding study design issues in test accuracy,
provide an overview of the domains, and describe risk of bias and indirectness specifically.
Results
Supplemented by practical examples, we describe how raters of the evidence using GRADE
can evaluate study designs focusing on tests and how they apply the GRADE domains
risk of bias and indirectness to a body of evidence of TA studies.
Conclusion
Rating the certainty of a body of evidence using GRADE in Cochrane and other reviews
and World Health Organization and other guidelines dealing with in TA studies helped
refining our approach. The resulting guidance will help applying GRADE successfully
for questions and recommendations focusing on tests.
Keywords
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Article info
Publication history
Published online: February 11, 2020
Accepted:
December 30,
2019
Footnotes
Conflict of interest: The authors are members of the GRADE Working Group. ML is Co-convenor of Cochrane's Screening and Diagnostic Test Methods Group. As part of the employment of H.R. with Kleijnen Systematic Reviews Ltd., he has been working on projects for Bayer and Grunenthal.
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
