QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies
2011/10/18 by Penny Whiting, Penny F. Whiting, Anne W.S. Rutjes +8 · 14,255 citations
Decision Sciences · Economics, Econometrics and Finance · Medicine · #Clinical Reasoning and Diagnostic Skills #Diagnostic accuracy #Diagnostic test #Health Systems, Economic Evaluations, Quality of Life #Medical physics #Medicine #Meta-analysis and systematic reviews #Pathology #Pediatrics #Radiology #Selection bias
paper · open access · doi:10.7326/0003-4819-155-8-201110180-00009
published in Annals of Internal Medicine 155(8), 529-536 (American College of Physicians)
openalex publication_date 2011/10/18 · openalex created_date 2016/06/24 · openalex updated_date 2026/08/05
Abstract
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.
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