QUADAS-3 Explanation and Elaboration: Guidance for Quality Assessment of Diagnostic Test Accuracy Studies

Assessing risk of bias and applicability is essential in diagnostic test accuracy reviews to produce reliable and relevant evidence that can guide clinical and policy decisions. To support this process, the authors have developed QUADAS-3, the latest version of the QUADAS tool, which is designed to assess the methodological strength and relevance of diagnostic test accuracy studies included in systematic reviews. This article explains how to use the QUADAS-3 tool. The article guides the reviewer through the initial stages of defining the questions and conceptualizing the ideal test accuracy trial, how the domains and signaling questions should be interpreted and assessed, and how judgments of risk of bias and concerns regarding applicability should be made. Authors of systematic reviews of diagnostic test accuracy studies should use this article as a guide for applying the QUADAS-3 tool.