QUADAS-3 Explanation and Elaboration: Guidance for Quality Assessment of Diagnostic Test Accuracy Studies

Clare F. Davenport; Anne W.S. Rutjes; Sue Mallett; Eve Tomlinson; Bada Yang; Jude Holmes; Marie E. Westwood; Yemisi Takwoingi; Johannes B. Reitsma; Christopher J. Hyde; Patrick M.M. Bossuyt; Jonathan J. Deeks; Mariska M.G. Leeflang; Penny F. Whiting

doi:10.7326/ANNALS-25-04943

QUADAS-3 Explanation and Elaboration: Guidance for Quality Assessment of Diagnostic Test Accuracy Studies

Clare F. Davenport
, Anne W.S. Rutjes
, Sue Mallett
, Eve Tomlinson
, Bada Yang
, Jude Holmes
, Marie E. Westwood
, Yemisi Takwoingi
, Johannes B. Reitsma
, Christopher J. Hyde
, Patrick M.M. Bossuyt
, Jonathan J. Deeks
, Mariska M.G. Leeflang
, Penny F. Whiting^*

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

Abstract

Assessing risk of bias and applicability is essential in diagnostic test accuracy reviews to produce reliable and relevant evidence that can guide clinical and policy decisions. To support this process, the authors have developed QUADAS-3, the latest version of the QUADAS tool, which is designed to assess the methodological strength and relevance of diagnostic test accuracy studies included in systematic reviews.

This article explains how to use the QUADAS-3 tool. The article guides the reviewer through the initial stages of defining the questions and conceptualizing the ideal test accuracy trial, how the domains and signaling questions should be interpreted and assessed, and how judgments of risk of bias and concerns regarding applicability should be made. Authors of systematic reviews of diagnostic test accuracy studies should use this article as a guide for applying the QUADAS-3 tool.

Original language	English
Number of pages	25
Journal	Annals of Internal Medicine
Early online date	17 Feb 2026
DOIs	https://doi.org/10.7326/ANNALS-25-04943
Publication status	E-pub ahead of print - 17 Feb 2026

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Davenport, C. F., Rutjes, A. W. S., Mallett, S., Tomlinson, E., Yang, B., Holmes, J., Westwood, M. E., Takwoingi, Y., Reitsma, J. B., Hyde, C. J., Bossuyt, P. M. M., Deeks, J. J., Leeflang, M. M. G., & Whiting, P. F. (2026). QUADAS-3 Explanation and Elaboration: Guidance for Quality Assessment of Diagnostic Test Accuracy Studies. Annals of Internal Medicine. Advance online publication. https://doi.org/10.7326/ANNALS-25-04943

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abstract = "Assessing risk of bias and applicability is essential in diagnostic test accuracy reviews to produce reliable and relevant evidence that can guide clinical and policy decisions. To support this process, the authors have developed QUADAS-3, the latest version of the QUADAS tool, which is designed to assess the methodological strength and relevance of diagnostic test accuracy studies included in systematic reviews. This article explains how to use the QUADAS-3 tool. The article guides the reviewer through the initial stages of defining the questions and conceptualizing the ideal test accuracy trial, how the domains and signaling questions should be interpreted and assessed, and how judgments of risk of bias and concerns regarding applicability should be made. Authors of systematic reviews of diagnostic test accuracy studies should use this article as a guide for applying the QUADAS-3 tool.",

author = "Davenport, \{Clare F.\} and Rutjes, \{Anne W.S.\} and Sue Mallett and Eve Tomlinson and Bada Yang and Jude Holmes and Westwood, \{Marie E.\} and Yemisi Takwoingi and Reitsma, \{Johannes B.\} and Hyde, \{Christopher J.\} and Bossuyt, \{Patrick M.M.\} and Deeks, \{Jonathan J.\} and Leeflang, \{Mariska M.G.\} and Whiting, \{Penny F.\}",

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AU - Tomlinson, Eve

AU - Yang, Bada

AU - Holmes, Jude

AU - Westwood, Marie E.

AU - Takwoingi, Yemisi

AU - Reitsma, Johannes B.

AU - Hyde, Christopher J.

AU - Bossuyt, Patrick M.M.

AU - Deeks, Jonathan J.

AU - Leeflang, Mariska M.G.

AU - Whiting, Penny F.

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AB - Assessing risk of bias and applicability is essential in diagnostic test accuracy reviews to produce reliable and relevant evidence that can guide clinical and policy decisions. To support this process, the authors have developed QUADAS-3, the latest version of the QUADAS tool, which is designed to assess the methodological strength and relevance of diagnostic test accuracy studies included in systematic reviews. This article explains how to use the QUADAS-3 tool. The article guides the reviewer through the initial stages of defining the questions and conceptualizing the ideal test accuracy trial, how the domains and signaling questions should be interpreted and assessed, and how judgments of risk of bias and concerns regarding applicability should be made. Authors of systematic reviews of diagnostic test accuracy studies should use this article as a guide for applying the QUADAS-3 tool.

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QUADAS-3 Explanation and Elaboration: Guidance for Quality Assessment of Diagnostic Test Accuracy Studies

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