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In 2003, the QUADAS tool for systematic reviews of diagnostic accuracy studies was developed. Experience, anecdotal reports, and feedback suggested areas for improvement; therefore, QUADAS-2 was developed. This tool comprises 4 domains: patient selection, index test, reference standard, and flow and timing. Each domain is assessed in terms of risk of bias, and the first 3 domains are also assessed in terms of concerns regarding applicability. Signalling questions are included to help judge risk of bias. The QUADAS-2 tool is applied in 4 phases: summarize the review question, tailor the tool and produce review-specific guidance, construct a flow diagram for the primary study, and judge bias and applicability. This tool will allow for more transparent rating of bias and applicability of primary diagnostic accuracy studies.

Original publication

DOI

10.7326/0003-4819-155-8-201110180-00009

Type

Journal article

Journal

Ann Intern Med

Publication Date

18/10/2011

Volume

155

Pages

529 - 536

Keywords

Bias (Epidemiology), Diagnosis, Evidence-Based Medicine, Humans, Patient Selection, Quality Control, Reference Standards, Review Literature as Topic, Surveys and Questionnaires, Time Factors