Systemic sclerosis & Raynaud's
Assessment of digital perfusion as a surrogate outcome in Raynaud’s phenomenon clinical trials
Authors' conclusion
Digital perfusion, at rest or in response to a cold challenge, and whatever the method used, does not fulfil the criteria of a valid surrogate for existing patient-reported outcomes in RP trials.
Study context
- Population
- Patients with RP in n-of-1 trials and drug therapy trials in RP
- Participants
- 33 patients24 trials
- Outcome
- Potential surrogacy of digital perfusion for clinical outcomes in RP trials (coefficients of determination at individual and trial level)
Methodological detailsindividual data from a series of n-of-1 trials, trial data from a network meta-analysis, non-weighted linear regression, bootstrapped 95% CI
- Individual data from a series of n-of-1 trials
- Trial data from a network meta-analysis
- Non-weighted linear regression
- Bootstrapped 95% CI
Performance
As reported in the abstract
Surrogacy of digital perfusion for clinical outcomes
Individual level: no correlation between digital perfusion and clinical outcomes at rest and in response to cooling tests; highest R2ind [CI]
0.03
−0.07, 0.09
R2TEind (treatment effect, individual level) [CI]
0.07
0, 0.29
Trial level: highest R2trial [CI]
0.1
0, 0.477
Original publication
Assessment of digital perfusion as a surrogate outcome in Raynaud’s phenomenon clinical trials. Rheumatology (Oxford). Published 8 July 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →