• J Clin Epidemiol · Jun 2020

    GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.

    • Holger J Schünemann, Reem A Mustafa, Jan Brozek, Karen R Steingart, Mariska Leeflang, Mohammad Hassan Murad, Patrick Bossuyt, Paul Glasziou, Roman Jaeschke, Stefan Lange, Joerg Meerpohl, Miranda Langendam, Monica Hultcrantz, Gunn E Vist, Elie A Akl, Mark Helfand, Nancy Santesso, Lotty Hooft, Rob Scholten, Måns Rosen, Anne Rutjes, Mark Crowther, Paola Muti, Heike Raatz, Mohammed T Ansari, John Williams, Regina Kunz, Jeff Harris, Ingrid Arévalo Rodriguez, Mikashmi Kohli, Gordon H Guyatt, and GRADE Working Group.
    • Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada. Electronic address: schuneh@mcmaster.ca.
    • J Clin Epidemiol. 2020 Jun 1; 122: 129-141.

    ObjectivesThis 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 SettingWe 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.ResultsSupplemented 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.ConclusionRating 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.Copyright © 2020 Elsevier Inc. All rights reserved.

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