TY - JOUR
T1 - QUADAS-C
T2 - A Tool for Assessing Risk of Bias in Comparative Diagnostic Accuracy Studies
AU - QUADAS-C Group†
AU - Yang, Bada
AU - Mallett, Sue
AU - Takwoingi, Yemisi
AU - Davenport, Clare F
AU - Hyde, Christopher J
AU - Whiting, Penny F
AU - Deeks, Jonathan J
AU - Leeflang, Mariska M G
AU - Bossuyt, Patrick M M
AU - Brazzelli, Miriam G
AU - Dinnes, Jacqueline
AU - Gurusamy, Kurinchi S
AU - Jones, Hayley E
AU - Lange, Stefan
AU - Langendam, Miranda W
AU - Macaskill, Petra
AU - McInnes, Matthew D F
AU - Reitsma, Johannes B
AU - Rutjes, Anne W S
AU - Sinclair, Alison
AU - de Vet, Henrica C W
AU - Virgili, Gianni
AU - Wade, Ros
AU - Westwood, Marie E
N1 - Funding Information: Grant Support: By an NIHR Postdoctoral Fellowship (Dr. Takwoingi) and by the NIHR Birmingham Biomedical Research Centre (Drs. Takwoingi, Deeks, and Davenport). This article presents independent research supported by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. Publisher Copyright: © 2021 American College of Physicians. All rights reserved.
PY - 2021/11
Y1 - 2021/11
N2 - Comparative diagnostic test accuracy studies assess and compare the accuracy of 2 or more tests in the same study. Although these studies have the potential to yield reliable evidence regarding comparative accuracy, shortcomings in the design, conduct, and analysis may bias their results. The currently recommended quality assessment tool for diagnostic test accuracy studies, QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2), is not designed for the assessment of test comparisons. The QUADAS-C (Quality Assessment of Diagnostic Accuracy Studies-Comparative) tool was developed as an extension of QUADAS-2 to assess the risk of bias in comparative diagnostic test accuracy studies. Through a 4-round Delphi study involving 24 international experts in test evaluation and a face-to-face consensus meeting, an initial version of the tool was developed that was revised and finalized following a pilot study among potential users. The QUADAS-C tool retains the same 4-domain structure of QUADAS-2 (Patient Selection, Index Test, Reference Standard, and Flow and Timing) and comprises additional questions to each QUADAS-2 domain. A risk-of-bias judgment for comparative accuracy requires a risk-of-bias judgment for the accuracy of each test (resulting from QUADAS-2) and additional criteria specific to test comparisons. Examples of such additional criteria include whether participants either received all index tests or were randomly assigned to index tests, and whether index tests were interpreted with blinding to the results of other index tests. The QUADAS-C tool will be useful for systematic reviews of diagnostic test accuracy addressing comparative questions. Furthermore, researchers may use this tool to identify and avoid risk of bias when designing a comparative diagnostic test accuracy study.
AB - Comparative diagnostic test accuracy studies assess and compare the accuracy of 2 or more tests in the same study. Although these studies have the potential to yield reliable evidence regarding comparative accuracy, shortcomings in the design, conduct, and analysis may bias their results. The currently recommended quality assessment tool for diagnostic test accuracy studies, QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2), is not designed for the assessment of test comparisons. The QUADAS-C (Quality Assessment of Diagnostic Accuracy Studies-Comparative) tool was developed as an extension of QUADAS-2 to assess the risk of bias in comparative diagnostic test accuracy studies. Through a 4-round Delphi study involving 24 international experts in test evaluation and a face-to-face consensus meeting, an initial version of the tool was developed that was revised and finalized following a pilot study among potential users. The QUADAS-C tool retains the same 4-domain structure of QUADAS-2 (Patient Selection, Index Test, Reference Standard, and Flow and Timing) and comprises additional questions to each QUADAS-2 domain. A risk-of-bias judgment for comparative accuracy requires a risk-of-bias judgment for the accuracy of each test (resulting from QUADAS-2) and additional criteria specific to test comparisons. Examples of such additional criteria include whether participants either received all index tests or were randomly assigned to index tests, and whether index tests were interpreted with blinding to the results of other index tests. The QUADAS-C tool will be useful for systematic reviews of diagnostic test accuracy addressing comparative questions. Furthermore, researchers may use this tool to identify and avoid risk of bias when designing a comparative diagnostic test accuracy study.
KW - Bias
KW - Diagnosis
KW - Evidence-Based Medicine
KW - Humans
KW - Quality Assurance, Health Care
KW - Review Literature as Topic
KW - Surveys and Questionnaires
UR - http://www.scopus.com/inward/record.url?scp=85119588475&partnerID=8YFLogxK
U2 - https://doi.org/10.7326/M21-2234
DO - https://doi.org/10.7326/M21-2234
M3 - Article
C2 - 34698503
SN - 0003-4819
VL - 174
SP - 1592
EP - 1599
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 11
ER -