Sjogren's Syndrome is a chronic autoimmune disease characterized by sicca (dryness) symptoms of the mouth and eyes. This autoimmune disease is less commonly studied and there are no licensed treatments to treat the underlying cause of disease and current management is based on clinical experience and/or small clinical studies. This study is based on DSP methodology, a multinational, cross-sectional, multi-sponsor survey of robust real-world data. DSP methodology collects quantitative market research data. The pSS DSP will survey a sample of approximately 230 to 325 rheumatologists and their prospectively consulting pSS subjects in France, Germany, Italy, Spain and the US. The data will be collected via physician interviews, physician workload questionnaires, detailed patient record forms (PRFs) to be completed by physicians, and a self-completion questionnaire by pSS subjects. The data collected using this method includes subjective and objective evidence, clinical information about individual patients, their disease and their treatment. This DSP will follow three key phases: preparatory phase, data collection phase and data processing/analysis phase.
Study Type
OBSERVATIONAL
Enrollment
2,223
A one hour survey interview will be completed by the rheumatologists which will contain open and closed questions to probe physician perception and behaviors in relation to pSS management and treatment
All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.
PRFs will be completed by the physicians for seven of their consulting pSS subjects.
Adelphi Real World Investigational Site
Cheshire, United Kingdom
Physician reported categorization of pSS subjects
The most common categorization of pSS subjects by rheumatologists will be described, alongside differences in humanistic and clinical burden of these categories.
Time frame: Baseline
Statistically derived clusters of pSS subjects
Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.
Time frame: Baseline
Description of subject's journey
Summary of subject's journeys from diagnosis to current management and treatment, including an overview of HCRU.
Time frame: As reported
Drivers of physician and subject reported satisfaction
Data for drivers of physician and subjects reported satisfaction with disease activity control and symptomatic relief will be derived.
Time frame: Baseline
Level of concordance/discordance between physician and patient reported satisfaction
Data for discordance/concordance between physicians and subjects across key measures will be derived.
Time frame: Baseline
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective will be described.
Time frame: As reported / Baseline
Physician experience of biologic therapy
Physicians' experience of biologic therapy, and attitudes towards biologic therapy for subjects with pSS will be described.
Time frame: Baseline
Physician perception of treatment targets
Physicians' perceptions of treatment targets in pSS will be described.
Time frame: Baseline
subjects attitude towards route of administration
Proportion of subjects willing to take medication by type of administration route (oral/tablet, subcutaneous injection, intravenously) will be described.
Time frame: Baseline
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