The QUADAS-3 tool was published in Annals of Internal Medicine in February 2026.  It should be cited as follows:

Whiting PF, Tomlinson E, Rutjes AWS, et al. QUADAS-3: A revised tool for the quality assessment of diagnostic test accuracy studies. Ann Intern Med. 17 February 2026. [Epub ahead of print]. doi:10.7326/ANNALS-25-02104

QUADAS-3 structure

The QUADAS-3 tool comprises 6 phases: 

Phase 1: State the systematic review synthesis questions	Once per review
Phase 2: Define the ideal test accuracy trial for each synthesis question	Once per review
Phase 3: Draw a flow diagram	Once per study
Phase 4: Identify the accuracy estimates to assess for risk of bias and applicability	Once per study
Phase 5: Assess risk of bias and concerns regarding applicability	For each selected estimate
Phase 6: Overall judgment	For each selected estimate

Explanation and Elaboration

Detailed guidance on applying the tool is found in the Explanation and Elaboration document published in Annals of Internal Medicine.  This should be cited as follows:

Davenport CF, Rutjes AWS, Mallett S, et al. QUADAS-3 explanation and elaboration: guidance for quality assessment of diagnostic test accuracy studies. Ann Intern Med. 2026;179:e2504943. doi:10.7326/ANNALS-25-04943

Overview of Phase 5: Assess risk of bias and concerns regarding applicability

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 Table below provides a summary of the full Phase 5 components of the tool.