OBJECTIVES: The Angioedema Activity Score (AAS) is a daily diary recommended for use in chronic spontaneous urticaria (CSU) to assess angioedema activity in terms of times of day affected, discomfort, appearance, impact on daily activities, and overall severity. The study objectives were to evaluate the content validity of the AAS in adults with CSU inadequately controlled by H1-antihistamines and explore meaningful change on Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) items of urticaria symptoms.
METHODS: Cognitive debriefing interviews were conducted with 15 adults with a physician-diagnosed CSU for at least 6 months, self-reported angioedema in the past 3 months, and self-reported itch/hives and use of H1-antihistamines in the past 6 weeks. During the interviews, participants described their experiences of CSU and provided feedback on the AAS content and meaningful changes on the PGIS and PGIC. Interview data were analyzed using directed content analysis.
RESULTS: Participants were aged 21-66 years (mean[standard deviation]=45.4[12.2] years); 66.7% were female. All participants (100%) confirmed they experienced angioedema, itch, and hives with their CSU. Angioedema was reported to cause physical discomfort (86.7%), affect participants’ physical appearance (80.0%), and interfere with daily activities (73.3%). Participants considered the AAS comprehensive and relevant, and the items were interpreted as intended. The 24-hour recall period was deemed appropriate, and participants made meaningful distinctions between the response categories. Participants found the PGIS and PGIC response categories appropriate and considered a 1-category change on the PGIS and “a lot better” on the PGIC to reflect meaningful improvement in urticaria symptoms.
CONCLUSIONS: Findings confirmed the content validity of the AAS to assess angioedema activity in adults with CSU inadequately controlled by H1-anthistamines. A 1-category change on the PGIS and “a lot better” on the PGIC reflect meaningful improvement in urticaria symptoms from the patient perspective.
