Systemic sclerosis & Raynaud's

Development and Initial Validation of the Novel Scleroderma Clinical Trials Consortium Activity Index

Arthritis RheumatolPublished Instrument development and validation study

Authors' conclusion

We present a novel instrument to quantify the burden of disease activity in SSc.

Study context

Population
Patients with Systemic Sclerosis (SSc) in the Australian Scleroderma Cohort Study and the Canadian Scleroderma Research Group Study
Participants
1,254 vs 1,103
Comparison
Australian Scleroderma Cohort Study (ASCS) vs Canadian Scleroderma Research Group Study
  • ASCSn = 1,254
  • Canadian Scleroderma Research Group Studyn = 1,103
Outcome
Development of the SCTC-AI
Methodological detailsconsensus methodology, Delphi survey, time-dependent Cox proportional hazards regression, external validation, Disease activity defined by consensus as "aspects of disease that are reversible, or can be arrested, with time and, or effective therapy."
  • Consensus methodology
  • Delphi survey
  • Time-dependent Cox proportional hazards regression
  • External validation
  • Disease activity defined by consensus as "aspects of disease that are reversible, or can be arrested, with time and, or effective therapy."

Performance

As reported in the abstract

Provisional SCTC-AI items generated
141
Rounds of Delphi survey
3
Items in final index
24
Maximum possible score
140
Graded relationship between disease activity scores and survival in external cohort
P < 0.01

Original publication

Development and Initial Validation of the Novel Scleroderma Clinical Trials Consortium Activity Index. Arthritis Rheumatol. Published 26 August 2024. doi:10.1002/art.42939

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