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

Schünemann, Holger J., Mustafa, Reem A., Brozek, Jan, Steingart, Karen, Leeflang, Mariska, Murad, Mohammad Hassan, Bossuyt, Patrick, Glasziou, Paul, Jaeschke, Roman, Lange, Stefan, Meerpohl, Joerg, Langendam, Miranda, Hultcrantz, Monica, Vist, Gunn E., Akl, Elie A., Helfand, Mark, Santesso, Nancy, Hooft, Lotty, Scholten, Rob, Rosen, Måns, Rutjes, Anne, Crowther, Mark, Muti, Paola, Raatz, Heike, Ansari, Mohammed T., Williams, John, Kunz, Regina, Harris, Jeff, Rodriguez, Ingrid Arévalo, Kohli, Mikashmi and Guyatt, Gordon H. (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'. Journal of Clinical Epidemiology, Vol 122, pp. 129-141.

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This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments (HTA) 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 overiew of the domains and describe risk of bias and indirectness specifically.
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.
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.

Item Type: Article
Subjects: WA Public Health > Statistics. Surveys > WA 900 Public health statistics
WA Public Health > Statistics. Surveys > WA 950 Theory or methods of medical statistics. Epidemiologic methods
WB Practice of Medicine > Diagnosis > General Diagnosis > WB 293 Collections of clinical case reports
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):
Depositing User: Stacy Murtagh
Date Deposited: 18 Feb 2020 11:18
Last Modified: 12 Feb 2021 02:02


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