Systemic sclerosis & Raynaud's
Identifying candidate core domains for clinical trials in systemic sclerosis-associated Raynaud’s phenomenon and digital ulcers
Authors' conclusion
Patients with SSc and clinicians identified core domains for use in clinical trials in SSc-associated RP and DUs, with several Life Impact domains common to both vascular manifestations of disease.
Study context
- Population
- Patients with systemic sclerosis (SSc) and clinicians, invited through international patient advocacy groups and clinical networks; OMERACT Scleroderma Vascular Disease Working Groupseparate SSc-RP and SSc-DU panels
- Comparison
- Patients vs Others
- Outcome
- Core domains: consensus agreement (≥ 70% ratings of 'critical' in both patient and other participant groups)
- Follow-up
- After three rounds of the Delphi
Methodological details3-round Delphi, separate Delphi exercises for SSc-RP and SSc-DUs, international, Candidate domains from previous qualitative work and systematic literature reviews
- 3-round Delphi
- Separate Delphi exercises for SSc-RP and SSc-DUs
- International
- Candidate domains from previous qualitative work and systematic literature reviews
Recommendations
As reported in the abstract
Domains reaching consensus as critically important (core domains) · after three Delphi rounds
SSc-RP: domains reaching consensus
9
SSc-DUs: domains reaching consensus
16
Original publication
Identifying candidate core domains for clinical trials in systemic sclerosis-associated Raynaud’s phenomenon and digital ulcers. Semin Arthritis Rheum. Published 4 June 2026. doi:10.
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