OBJECTIVES: Emphasis on patient-focused drug development has resulted in increased interest in capturing the patient’s voice. Where patient input cannot be reported, caregivers’ input may be used. Atopic dermatitis (AD) is a chronic, itchy, inflammatory skin disorder that affects both children and adults. The objectives of this review were to (1) develop a literature-driven conceptual model for AD and (2) identify existing patient- and observer-reported outcome (PRO and ObsRO) measures that assess the literature-based AD concepts.

METHODS: A targeted search was conducted using Embase, PROQolid, and PubMed to identify PRO and ObsRO measures that assess AD-related signs/symptoms and associated impacts. These concepts were organized into a conceptual model. The identified measures were evaluated to identify concepts assessed by each measure.

RESULTS: Nine measures for use in pediatrics and adults were identified and reviewed. Only one of these measures, the Quality of Life Index for Atopic Dermatitis (QoLIAD), is an AD-specific measure. Based on literature, AD-related concepts included signs/symptoms (eg, itching, skin dryness, skin thickening); functional impacts (eg, impact on daily activity, trouble sleeping); emotional impacts (eg, self-esteem/self-confidence, frustration, embarrassment); and social impacts (eg, isolation, low social integration). The QoLIAD evaluated 27% of these literature-based concepts, while the Dermatology-Specific Quality of Life Instrument for Contact Dermatitis (DSQL) evaluated 55% of the concepts. While the DSQL evaluated more literature-based concepts, it is important to note it is not an AD-specific measure.

CONCLUSIONS: The identified measures were primarily developed for research purposes as opposed to making regulatory decisions. Based on the literature, AD-related concepts include signs/symptoms and associated impacts. While existing PRO and ObsRO measures include some of these AD concepts, the quality of the measures were not assessed. There appears to be a lack of comprehensive AD-specific measure; future research should focus on a gap analysis.