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 N 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 N M Bossuyt, Jonathan J. Deeks, Mariska M G Leeflang, Penny F Whiting

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

1 Citation (Scopus)

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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.

Original language	English
Article number	e2504943
Number of pages	25
Journal	Annals of Internal Medicine
Volume	179
Issue number	4
DOIs	https://doi.org/10.7326/ANNALS-25-04943
Publication status	Published - 17 Feb 2026

Bibliographical note

Publisher Copyright:
© 2026 American College of Physicians.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Research Groups and Themes

BrisTAG

Keywords

Clinical documentation
Clinical trials
Diagnostic medicine
Diagnostic tests
Infectious diseases
Phase 2 trials
Signs and symptoms
Specificity
Systematic reviews
Typhoid

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10.7326/ANNALS-25-04943

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This is the accepted author manuscript (AAM) of the article which has been made Open Access under the University of Bristol's Scholarly Works Policy. The final published version (Version of Record) can be found on the publisher's website. The copyright of any third-party content, such as images, remains with the copyright holder.
Accepted author manuscript, 377 KBLicence: CC BY
Supplementary information PDF
This is the accepted author manuscript (AAM) of the article which has been made Open Access under the University of Bristol's Scholarly Works Policy. The final published version (Version of Record) can be found on the publisher's website. The copyright of any third-party content, such as images, remains with the copyright holder.
Accepted author manuscript, 979 KBLicence: CC BY

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Bristol TAG
Whiting, P. F. (Co-Principal Investigator), Welton, N. J. (Co-Principal Investigator), Owen-Smith, A. L. (Co-Investigator), Phillippo, D. M. (Co-Investigator), Caldwell, D. (Co-Investigator), Marques, E. M. R. (Co-Investigator), Jones, H. E. (Co-Investigator), Thom, H. H. Z. (Co-Investigator), Pedder, H. (Co-Investigator), Savovic, J. (Co-Investigator), Higgins, J. P. T. (Co-Investigator), Sadek, A. S. (Co-Investigator), Lopez Manzano, C. (Co-Investigator), Cooper, C. (Co-Investigator), Tomlinson, E. (Co-Investigator), Carroll, J. S. (Co-Investigator), Walker, J. G. (Co-Investigator), Ward, M. E. (Co-Investigator) & James, R. M. (Co-Investigator)
1/04/22 → 31/03/27
Project: Research, Parent

Cite this

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. N. 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, 179(4), Article e2504943. https://doi.org/10.7326/ANNALS-25-04943

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

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.",

keywords = "Clinical documentation, Clinical trials, Diagnostic medicine, Diagnostic tests, Infectious diseases, Phase 2 trials, Signs and symptoms, Specificity, Systematic reviews, Typhoid",

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 N M\} and Deeks, \{Jonathan J.\} and Leeflang, \{Mariska M G\} and Whiting, \{Penny F\}",

note = "Publisher Copyright: {\textcopyright} 2026 American College of Physicians.",

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month = feb,

day = "17",

doi = "10.7326/ANNALS-25-04943",

language = "English",

volume = "179",

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issn = "0003-4819",

publisher = "American College of Physicians",

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Davenport, CF, Rutjes, AWS, Mallett, S, Tomlinson, E, Yang, B, Holmes, J, Westwood, ME, Takwoingi, Y, Reitsma, JB, Hyde, CJ, Bossuyt, PNM, Deeks, JJ, Leeflang, MMG & Whiting, PF 2026, 'QUADAS-3 Explanation and Elaboration: Guidance for Quality Assessment of Diagnostic Test Accuracy Studies', Annals of Internal Medicine, vol. 179, no. 4, e2504943. https://doi.org/10.7326/ANNALS-25-04943

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T1 - QUADAS-3 Explanation and Elaboration

T2 - Guidance for Quality Assessment of Diagnostic Test Accuracy Studies

AU - Davenport, Clare F

AU - Rutjes, Anne W S

AU - Mallett, Sue

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 N M

AU - Deeks, Jonathan J.

AU - Leeflang, Mariska M G

AU - Whiting, Penny F

PY - 2026/2/17

Y1 - 2026/2/17

N2 - 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.

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.

KW - Clinical documentation

KW - Clinical trials

KW - Diagnostic medicine

KW - Diagnostic tests

KW - Infectious diseases

KW - Phase 2 trials

KW - Signs and symptoms

KW - Specificity

KW - Systematic reviews

KW - Typhoid

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DO - 10.7326/ANNALS-25-04943

M3 - Article (Academic Journal)

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SN - 0003-4819

VL - 179

JO - Annals of Internal Medicine

JF - Annals of Internal Medicine

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M1 - e2504943

ER -

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

Abstract

Bibliographical note

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Keywords

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