QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies

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.

[1]  Patrick M. M. Bossuyt,et al.  Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy , 2013 .

[2]  Brian H Willis,et al.  Uptake of newer methodological developments and the deployment of meta-analysis in diagnostic test research: a systematic review , 2010, BMC medical research methodology.

[3]  M Sculpher,et al.  Clinical effectiveness and cost-effectiveness of tests for the diagnosis and investigation of urinary tract infection in children: a systematic review and economic model. , 2006, Health technology assessment.

[4]  J. Sterne,et al.  The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials , 2011, BMJ : British Medical Journal.

[5]  J. Sterne,et al.  Accuracy of magnetic resonance imaging for the diagnosis of multiple sclerosis: systematic review , 2006, BMJ : British Medical Journal.

[6]  Patrick Bossuyt,et al.  Systematic Reviews of Diagnostic Test Accuracy , 2008, Annals of Internal Medicine.

[7]  Axel Ekkernkamp,et al.  Association between compliance with methodological standards of diagnostic research and reported test accuracy: meta-analysis of focused assessment of US for trauma. , 2005, Radiology.

[8]  M. Egger,et al.  The hazards of scoring the quality of clinical trials for meta-analysis. , 1999, JAMA.

[9]  P. Bossuyt,et al.  Sources of Variation and Bias in Studies of Diagnostic Accuracy , 2004, Annals of Internal Medicine.

[10]  E. Verdonschot,et al.  Factors involved in validity measurements of diagnostic tests for approximal caries--a meta-analysis. , 1995, Caries research.

[11]  Constantine Gatsonis,et al.  Analysing and Presenting Results , 2010 .

[12]  P. Bossuyt,et al.  BMC Medical Research Methodology , 2002 .

[13]  J. Sterne,et al.  Systematic Review: Accuracy of Anti–Citrullinated Peptide Antibodies for Diagnosing Rheumatoid Arthritis , 2010, Annals of Internal Medicine.

[14]  M. Leeflang,et al.  Bias in sensitivity and specificity caused by data-driven selection of optimal cutoff values: mechanisms, magnitude, and solutions. , 2008, Clinical chemistry.

[15]  D. Moher,et al.  Guidance for Developers of Health Research Reporting Guidelines , 2010, PLoS medicine.

[16]  P. Bossuyt,et al.  Empirical evidence of design-related bias in studies of diagnostic tests. , 1999, JAMA.

[17]  Penny Whiting,et al.  Bmc Medical Research Methodology Open Access No Role for Quality Scores in Systematic Reviews of Diagnostic Accuracy Studies , 2005 .

[18]  Johannes B Reitsma,et al.  Evaluation of QUADAS, a tool for the quality assessment of diagnostic accuracy studies , 2006, BMC medical research methodology.

[19]  L. Irwig,et al.  Observed differences in diagnostic test accuracy between patient subgroups: is it real or due to reference standard misclassification? , 2007, Clinical chemistry.