Diagnostic performance of serology against histologic assessment to diagnose Sjogren's syndrome: a systematic review.

The objective of this review was to assess and evaluate whether the published diagnostic accuracy studies provide evidence to sustain the current diagnostic guidelines put forth by ACR/EULAR used for patients with suspected Sjögren's syndrome (SS). Literature databases, including Medline, Embase, and EBM Reviews, were searched for relevant studies on the correlation between ACR/EULAR criteria, particularly those with a direct comparison between their accuracy in diagnosing Sjögren's syndrome. We followed Cochrane, QUADAS-2, and STARD guidelines and the four-phase flow diagram by the PRISMA Statement. Reports in several languages, but only human studies were considered. Three studies assessed the accuracy of the current diagnostic tests, and these did not present adequate designs that would allow a well-supported conclusion with a high level of certainty. Due to significant clinical and methodological heterogeneity, a meta-analysis was not performed. A qualitative review of the papers was undertaken. Neither the comparative nor the non-comparative study designs permit conclusive recommendations regarding an alternative diagnostic pathway for SS. Well-designed studies of the diagnostic accuracy of SS tests are needed to validate current guidelines or to suggest changes to the current guidelines.