Validation of the PROFAD-SSI-SF in Patients with Primary Sjögren's Syndrome with Organ Involvement: Results of Qualitative Interviews and Psychometric Analyses.
Kimberly RaymondStephen MaherCory D SaucierMeaghan O'ConnorAaron YarlasMark KosinskiWen-Hung ChenKerry GairyPublished in: Rheumatology and therapy (2022)
The final disease model confirmed that the PROFAD-SSI-SF assesses concepts that are relevant and important to patients with pSS. Our findings support the content validity and measurement properties of the PROFAD-SSI-SF as a fit-for-purpose PRO measure appropriate for use in clinical trials in patients with pSS. CLINICAL TRIAL REGISTRATION NUMBER FOR THE PHASE 2 TRIAL: Clinicaltrials.gov NCT02631538.