QUADAS-C: A Tool for Assessing Risk of Bias in Comparative Diagnostic Accuracy Studies

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 - © 2021 American College of Physicians. This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details

PY - 2021/11/1

Y1 - 2021/11/1

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

U2 - 10.7326/M21-2234

DO - 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 -