• Monica Hultcrantz, Reem A Mustafa, LeeflangMariska M GMMGDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health research institute, Amsterdam University Medical Centers, Meibergdreef 9, Amsterdam, The Netherlands., Valéry Lavergne, Kelly Estrada-Orozco, Mohammed T Ansari, Ariel Izcovich, Jasvinder Singh, Lee Yee Chong, Anne Rutjes, Karen Steingart, Airton Stein, Nigar Sekercioglu, Ingrid Arevalo-Rodriguez, Rebecca L Morgan, Gordon Guyatt, Patrick Bossuyt, Miranda W Langendam, and Holger J Schünemann.
• Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), S:t Eriksgatan 117, SE-102 33, Stockholm, Sweden. Electronic address: monica.hultcrantz@sbu.se.
• J Clin Epidemiol. 2020 Jan 1; 117: 138-148.

ObjectiveThe objective of the study was to clarify how the Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept of certainty of evidence applies to certainty ratings of test accuracy.Study Design And SettingAfter initial brainstorming with GRADE Working Group members, we iteratively refined and clarified the approaches for defining ranges when assessing the certainty of evidence for test accuracy within a systematic review, health technology assessment, or guideline.ResultsRanges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematic reviews and health technology assessments, approaches for defining ranges include some that do not require value judgments regarding downstream health outcomes. Key challenges arise in the context of a guideline that requires ranges for sensitivity and specificity that are set considering possible effects on all critical outcomes. We illustrate possible approaches and provide an example from a systematic review of a direct comparison between two test strategies.ConclusionsThis GRADE concept paper provides a framework for assessing, presenting, and making decisions based on the certainty of evidence for test accuracy. More empirical research is needed to support future GRADE guidance on how to best operationalize the candidate approaches.Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

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