[Risk on bias assessment: (6) A Revised Tool for the Quality Assessment on Diagnostic Accuracy Studies (QUADAS-2)]

Abstract

This paper introduced the Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2), including the development and comparison with the original QUADAS, and illustrated the application of QUADAS-2 in a published paper related to the study on diagnostic accuracy which was included in systematic review and Meta-analysis. QUADAS-2 presented considerable improvement over the original tool. Confused items that included in QUADAS had disappeared and the quality assessment of the original study replaced by the rating of risk on bias and applicability. This was implemented through the description on the four main domains with minimal overlapping and answering the signal questions in each domain. The risk of bias and applicability with 'high','low' or 'unclear' was in line with the risk of bias assessment of intervention studies in Cochrane, so to replace the total score of quality assessment in QUADAS. Meanwhile, QUADAS-2 was also applicable to assess the diagnostic accuracy studies in which follow-up without prognosis was involved in golden standard. It was useful to assess the overall methodological quality of the study despite more time consuming than the original QUADAS. However, QUADAS-2 needs to be modified to apply in comparative studies on diagnostic accuracy and we hope the users would follow the updates and give their feedbacks on line.

Keywords: Diagnostic accuracy studies; Risk of bias; Systematic review; Tool for assessment.