OBJECTIVES: Atopic dermatitis (AD) and chronic hand eczema (CHE) are chronic, relapsing inflammatory skin diseases that often co-occur; AD is a risk factor for developing CHE. Both AD and CHE can result in signs and symptoms that are burdensome and negatively affect patients’ lives. Despite some overlap between the two diseases, each has a distinct set of signs, symptoms, burdens, and health-related quality of life (HRQoL) impacts. Patient-reported outcome measures (PROMs) provide an important complement to clinician-report outcome (ClinRO) measures in AD and CHE because many of the symptoms (e.g., itch, pain) and impacts of these diseases cannot be evaluated objectively. The aim of this study was to identify and evaluate PROMs used in studies of AD and CHE and to explore the assessment of key symptoms and impacts, including any gaps in the measures used.
METHODS: A structured PubMed review was conducted to identify PROMs used or developed for use in AD or CHE.
RESULTS: The Dermatology Life Quality Index, Pruritus/Itch Numeric Rating Scale, Patient-Oriented Eczema Measure, and Quality of Life in Hand Eczema Questionnaire were most frequently cited in the literature. The AD and CHE symptoms and impacts most commonly evaluated included dermatology-related HRQoL in the domains of symptoms, daily activities, leisure, work and school, personal relationships, and treatment side effects; sleep disturbance; AD-specific symptoms (dryness, itch, flaking, cracking, bleeding, and weeping/oozing); and CHE-specific symptoms (pain, itch, fissuring, redness, bleeding, and dryness).
CONCLUSIONS: Primary endpoints in clinical trials of AD, CHE, and other dermatologic diseases have traditionally been based on ClinROs. The increased use of patient-reported outcome assessments and patient experience data appear to be part of a broader trend in clinical trial design. Future research should explore the patient experience with symptoms and impacts of these conditions and the treatment-related changes that are most meaningful.
