Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren's syndrome.
Raphaèle SerorGabriel BaronMarine CamusDivi CornecElodie PerrodeauSimon J BowmanMichele BombardieriHendrika BootsmaJacques-Eric GottenbergBenjamin A FisherWolfgang HueberJoel A van RoonValérie Devauchelle-PensecPeter GergelyXavier MarietteRaphael Porchernull nullnull nullPublished in: Annals of the rheumatic diseases (2022)
The candidate STAR is a composite responder index that includes all main disease features in a single tool and is designed for use as a primary endpoint in pSS RCTs. The rigorous and consensual development process ensures its face and content validity. The candidate STAR showed good sensitivity to change and will be prospectively validated by the NECESSITY consortium in a dedicated RCT.