QUADAS and STARD: evaluating the quality of diagnostic accuracy studies.

OBJECTIVE To compare the performance of two approaches, one based on the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) and another on the Standards for Reporting Studies of Diagnostic Accuracy (STARD), in evaluating the quality of studies validating the OptiMal® rapid malaria diagnostic test. METHODS Articles validating the rapid test published until 2007 were searched in the Medline/PubMed database. This search retrieved 13 articles. A combination of 12 QUADAS criteria and three STARD criteria were compared with the 12 QUADAS criteria alone. Articles that fulfilled at least 50% of QUADAS criteria were considered as regular to good quality. RESULTS Of the 13 articles retrieved, 12 fulfilled at least 50% of QUADAS criteria, and only two fulfilled the STARD/QUADAS criteria combined. Considering the two criteria combination (> 6 QUADAS and > 3 STARD), two studies (15.4%) showed good methodological quality. The articles selection using the proposed combination resulted in two to eight articles, depending on the number of items assumed as cutoff point. CONCLUSIONS The STARD/QUADAS combination has the potential to provide greater rigor when evaluating the quality of studies validating malaria diagnostic tests, given that it incorporates relevant information not contemplated in the QUADAS criteria alone.