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Cited by 60Meta-analysis and systematic reviewsStatistical Methods in EpidemiologyClinical practice guidelines implementation

The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.

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

Open access
Whiting, Penny F., Tomlinson, Eve, Rutjes, Anne W.S., Davenport, Clare F., Yang, Bada, Westwood, Marie E., Takwoingi, Yemisi, Reitsma, Johannes B., Hyde, Christopher, Bossuyt, Patrick M.M., Deeks, Jonathan J., Leeflang, Mariska M.G., Mallett, Sue·2026·Annals of Internal Medicine
DOI 10.7326/annals-25-02104
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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.

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Crossref · 10.7326/annals-25-02104

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Metadata

Authors
Whiting, P. F., Tomlinson, E., Rutjes, A. W. S., Davenport, C. F., Yang, B., Westwood, M. E., Takwoingi, Y., Reitsma, J. B., Hyde, C., Bossuyt, P. M. M., Deeks, J. J., Leeflang, M. M. G., & Mallett, S.
Affiliations
  • University of Bristol (GB)
  • Saint Camillus International University of Health and Medical Sciences (IT)
  • National Institute for Health and Care Research (GB)
  • Amsterdam University Medical Centers (NL)
  • Utrecht University (NL)
  • University of Exeter (GB)
  • UCL Centre for Medical Imaging, University College London, London, United Kingdom (S.M.).
ORCID
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2026-04
Volume
179
Issue
4
Pages
548-555
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/annals-25-02104
OpenAlex
W7129060162
Semantic Scholar
ceb4a6d2e452212b5ca8298a82ed8df14aa60dcc
Cited by
60
References
11
Citations by year
2026: 60
FWCI
144.80
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • University of Birmingham Research Portal (University of Birmingham) (publishedVersion)
  • Explore Bristol Research (publishedVersion, cc-by)
  • Bristol Research (University of Bristol) (publishedVersion, cc-by)
  • Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords
QUADAS-2, diagnostic accuracy, risk of bias, applicability, quality assessment tools, flowcharts, meta-analysis of diagnostic accuracy
MeSH terms
Systematic Reviews as Topic, Diagnostic Tests, Routine, Humans, Bias

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