Consensus on a Core Outcome Set for Rosacea in Clinical Trials and Practice
According to a study published in JAMA Dermatology, the development of a core outcome set (COS) for rosacea clinical trials addresses inconsistencies in reported outcomes, which have hindered accurate data pooling and meta-analyses. A standardized set of outcomes could facilitate more effective data comparison across studies, improving research and clinical care for rosacea.
To create this COS, researchers conducted a systematic review of outcomes from rosacea clinical trials, followed by discussions with stakeholders and focus groups. They extracted 192 initial outcomes, which were refined to 50 unique items. These items were then rated by an international panel of 88 participants, comprising 63 physicians from 17 countries and 25 US patients with rosacea, using a 9-point Likert scale. Based on round 1 feedback, an additional 11 outcomes were included in round 2. Outcomes rated as critical (scoring 7-9 by ≥70% of both patients and physicians) were discussed further in consensus meetings. Ultimately, outcomes considered essential by at least 85% of participants were incorporated into the final COS.
The final core outcome set consists of 8 domains critical for assessing rosacea interventions: (1) ocular signs and symptoms, (2) skin signs of disease, (3) skin symptoms, (4) overall severity, (5) patient satisfaction, (6) quality of life, (7) degree of improvement, and (8) treatment-related adverse events.
The adoption of this core domain set in future rosacea clinical trials could enhance the comparability of study results and facilitate more robust meta-analyses. Moreover, these standardized domains may offer a useful framework for evaluating rosacea outcomes in clinical practice, ultimately supporting more effective patient care.
Reference
Dirr MA, Ahmed A, Schlessinger DI, et al. Rosacea core domain set for clinical trials and practice: a consensus statement. JAMA Dermatol. 2024;160(6):658-666. doi:10.1001/jamadermatol.2024.0636
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