Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands (B.Y., M.M.L.).
UCL Centre for Medical Imaging, University College London, London, United Kingdom (S.M.).
Ann Intern Med. 2021 Nov;174(11):1592-1599. doi: 10.7326/M21-2234. Epub 2021 Oct 26.
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.
比较诊断测试准确性研究评估和比较了两项或多项在同一项研究中的测试的准确性。尽管这些研究有可能产生关于比较准确性的可靠证据,但设计、进行和分析方面的缺陷可能会使研究结果产生偏差。目前推荐的诊断测试准确性研究质量评估工具 QUADAS-2(诊断准确性研究的质量评估-2)并不是为评估测试比较而设计的。QUADAS-C(诊断准确性研究的质量评估-比较)工具是 QUADAS-2 的扩展,用于评估比较诊断测试准确性研究中的偏倚风险。通过涉及 24 名测试评估国际专家的四轮德尔菲研究和一次面对面共识会议,开发了工具的初始版本,并在潜在用户中进行了试点研究后进行了修订和最终确定。QUADAS-C 工具保留了 QUADAS-2 的相同的 4 个领域结构(患者选择、索引测试、参考标准和流程和时间),并包含每个 QUADAS-2 领域的附加问题。比较准确性的偏倚风险判断需要对每个测试(源自 QUADAS-2)的准确性进行偏倚风险判断,以及针对测试比较的其他特定标准。此类附加标准的示例包括参与者是否接受了所有索引测试或是否随机分配到索引测试,以及索引测试是否在对其他索引测试结果进行盲法的情况下进行解释。QUADAS-C 工具将有助于系统地审查解决比较问题的诊断测试准确性。此外,研究人员在设计比较诊断测试准确性研究时可以使用此工具来识别和避免偏倚风险。
Ann Intern Med. 2021-11
Cochrane Database Syst Rev. 2022-2-1
Ann Intern Med. 2011-10-18
Zhonghua Liu Xing Bing Xue Za Zhi. 2022-6-10
Zhonghua Liu Xing Bing Xue Za Zhi. 2018-4-10
BMC Med Res Methodol. 2003-11-10
Health Technol Assess. 2004-6
Front Neurol. 2025-6-16
Cochrane Database Syst Rev. 2025-6-25
Diabetol Metab Syndr. 2025-6-23