QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies

What the paper explores

The QUADAS-2 paper describes a revised tool organized around patient selection, the index test, the reference standard, and flow and timing. It uses signaling questions to guide judgments about bias and, for the relevant domains, concerns about applicability to the review question.

How to interpret the evidence

The tool requires judgments tailored to a defined question. A checklist response should not be collapsed into an unsupported claim that a study is universally reliable.

Questions for MedTech teams

When reviewing diagnostic literature, distinguish an internally credible result from evidence that actually matches your product’s intended population and clinical setting.