Current opinion in rheumatology · 2025
Patient-reported outcomes in systemic sclerosis: insights into quality of life and disease burden.
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Lescoat Alain, Chen Yen T, Khanna Dinesh
Аннотация
PURPOSE OF REVIEW: Assessing the impact of active therapy on how patients 'feel and function' is considered a necessary requirement by regulatory agencies for the approval of future treatments for SSc. In this context, patient-reported outcome measures (PROMs) have become a cornerstone of therapeutic assessment in randomized controlled trials (RCTs).
RECENT FINDINGS: This narrative review will discuss a selection of main available PROMs used in SSc RCTs, with a specific focus on recently developed PROMs, highlight ongoing initiatives related to SSc-PROMs, and provide points to consider for future use of SSc-PROMs.
SUMMARY: Several recent initiatives include a patient-centered approach [such as the Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP), the MCQ (Mawdsley Calcinosis Questionnaire], the COAST (Clinical Outcome Assessments for Systemic Sclerosis Clinical Trials), and the CRISTAL (Combined Response index for scleroderma trials assessing limited systemic sclerosis) initiatives] to develop new PROMs and actively involve patient partners in each step of the process. Using a combined response index incorporating PROMs as the primary outcome measure in future SSc trials, such as the CRISS index for diffuse cutaneous SSc, could ensure that the perspectives of both physicians and patients would be incorporated to assess the efficacy of future interventions.
RECENT FINDINGS: This narrative review will discuss a selection of main available PROMs used in SSc RCTs, with a specific focus on recently developed PROMs, highlight ongoing initiatives related to SSc-PROMs, and provide points to consider for future use of SSc-PROMs.
SUMMARY: Several recent initiatives include a patient-centered approach [such as the Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP), the MCQ (Mawdsley Calcinosis Questionnaire], the COAST (Clinical Outcome Assessments for Systemic Sclerosis Clinical Trials), and the CRISTAL (Combined Response index for scleroderma trials assessing limited systemic sclerosis) initiatives] to develop new PROMs and actively involve patient partners in each step of the process. Using a combined response index incorporating PROMs as the primary outcome measure in future SSc trials, such as the CRISS index for diffuse cutaneous SSc, could ensure that the perspectives of both physicians and patients would be incorporated to assess the efficacy of future interventions.