Atopische Dermatitis: Zuverlässigkeit von PROs und deren Bedeutung in klinischer Praxis

Abstract

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus, skin pain, and sleep impacts, which are only reportable by patients themselves. The goal of this research is to evaluate the reliability, validity, and interpretability of the scores from three patient-reported outcome measures within the context of a clinical trial for adolescents and adults with moderate to severe AD. Methods: Data from a Phase 3 randomized, double-blind, placebo-controlled, multinational clinical trial for individuals 12–75years of age with moderate to severe AD (AD Up [ClinicalTrials.gov NCT03568318]) were used to assess the reliability, validity, and interpretability of scores on the Worst Pruritus Numerical Rating Scale (NRS) and the Atopic Dermatitis Symptom and Impact Scales (ADerm- SS and ADerm-IS). Analyses were conducted separately for the adult and adolescent subgroups. Results: Of the 882 participants included in the psychometric analyses, the majority were adults (n¼769, 87.2%), male (n¼536, 60.8%), and white (n¼630, 71.4%). Multi-item scores from the ADerm- SS and ADerm-IS had good internal consistency reliability, and most scores demonstrated acceptable test-retest reliability. Scores from the three questionnaires demonstrated adequate validity, exhibiting correlations with other conceptually related outcome assessments and score differences between clin-ically distinct subgroups. Finally, the score interpretation analyses provide estimates for meaningful within-person change and between-groups difference thresholds that may be useful for future research in adults and adolescents with moderate to severe AD.