QUADAS-3: A Revised Tool for the Quality Assessment of Diagnostic Test Accuracy Studies

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

doi:10.7326/ANNALS-25-02104

QUADAS-3: A Revised Tool for the Quality Assessment of Diagnostic Test Accuracy Studies

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

^*Corresponding author for this work

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Abstract

Assessing risk of bias and applicability is critical in diagnostic test accuracy reviews to ensure valid, relevant findings that can inform decision making and policy. This article introduces QUADAS-3, an updated version of the widely used QUADAS-2 tool that was developed in response to the latest evidence, feedback from users of QUADAS-2, and comprehensive piloting.

The QUADAS-3 tool comprises 6 phases: 1) define the systematic review synthesis question, 2) define the ideal test accuracy trial for each synthesis question, 3) draw a flow diagram, 4) identify estimates of accuracy for assessment, 5) assess risk of bias and applicability, and 6) make an overall judgment. Risk of bias is assessed across 4 domains: Participants, Index Test, Target Condition, and Analysis. The first 3 domains are also assessed in terms of concerns regarding applicability to the synthesis question. Signaling questions are included to help judge risk of bias. The QUADAS-3 tool incorporates several changes compared with the previous version (QUADAS-2) which will ideally improve its validity, usability, and usefulness. Key changes from QUADAS-2 include introduction of the concept of an ideal test accuracy trial, assessment at the estimate level rather than the study level, replacement of the “Flow and Timing” domain with a new “Analysis” domain, introduction of sections on the rationale for judgments, and formal introduction of overall judgment of risk of bias and concerns regarding applicability. Some changes to domains and signaling questions have also been made.

Original language	English
Pages (from-to)	548-555
Number of pages	8
Journal	Annals of Internal Medicine
Volume	179
Issue number	4
DOIs	https://doi.org/10.7326/ANNALS-25-02104
Publication status	Published - 17 Feb 2026

Bibliographical note

Publisher Copyright:
© 2026 American College of Physicians.

Research Groups and Themes

BrisTAG

Keywords

Algorithms
Clinical documentation
Clinical trials
Diagnostic tests
Global health
Health care
Health care quality assessment
Medical risk factors
Phase 2 trials
Systematic reviews

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10.7326/ANNALS-25-02104

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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, 137 KBLicence: CC BY
Supplementary information 1 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, 250 KBLicence: CC BY
Supplementary information 2 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, 326 KBLicence: CC BY

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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

Whiting, P. F., Tomlinson, E., Rutjes, A. W. S., Davenport, C. F., Yang, B., Westwood, M. E., Takwoingi, Y., Reitsma, J. B., Hyde, C. J., Bossuyt, P. N. M., Deeks, J. J., Leeflang, M. M. G., & Mallett, S. (2026). QUADAS-3: A Revised Tool for the Quality Assessment of Diagnostic Test Accuracy Studies. Annals of Internal Medicine, 179(4), 548-555. https://doi.org/10.7326/ANNALS-25-02104

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AU - Yang, Bada

AU - Westwood, Marie E

AU - Takwoingi, Yemisi

AU - Reitsma, Johannes B

AU - Hyde, Christopher J

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ER -

QUADAS-3: A Revised Tool for the Quality Assessment of Diagnostic Test Accuracy Studies

Abstract

Bibliographical note

Research Groups and Themes

Keywords

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Bristol TAG

Cite this