Whalley D, Morrison R, Balp MM, Joubert Y, McKenna SJ, Christen L, Naujoks C, Gardner DD, Dery E, Lacombe A. Adaptation of the urticaria patient daily diary for caregiver completion in pediatric chronic spontaneous urticaria. Poster presented at the ISPOR Europe 2022; November 8, 2022. Vienna, Austria.

OBJECTIVES: The Urticaria Patient Daily Diary (UPDD) assesses patient-reported symptoms (itch, hives, angioedema) and impacts in adults and adolescents with chronic spontaneous urticaria (CSU), a dermatological condition. This study reports the adaptation of the UPDD for caregiver completion for patients aged 2-11 years.

METHODS: Modification of the UPDD was conducted through two iterative rounds of hybrid concept-elicitation/cognitive-debriefing interviews with pediatric CSU clinical experts and caregivers of children with CSU recruited via patient organizations in the United States and Canada. Following concept elicitation, participants reviewed a draft UPDD–Caregiver Version with initial modifications for caregiver completion. Data were analyzed using thematic analysis.

RESULTS: Four clinicians and 12 caregivers (50% male; mean [range] age, 32.8 [26-48] years) of pediatric patients (67% male; mean [range] age, 6.4 [4-11] years) were interviewed (round 1: 4 clinicians, 5 caregivers; round 2: 7 caregivers). Key caregiver-reported symptoms were itch (n=12), hives (n=12), and swelling/angioedema (n=7). All four clinicians confirmed itch and hives as key symptoms in children aged 2-11 years, with angioedema also occurring in some patients. Scratching was confirmed as the key observable sign of itch. Caregiver-reported impacts included night awakening (n=10), difficulty getting to sleep (n=8), and daily life impacts, including school (n=10), play (n=8), activities with family/friends (n=4), and sports (n=3). Overall, round 1 participants reported the draft UPDD–Caregiver Version to be relevant and easy to complete. Based on feedback, minor revisions were made to enhance comprehension, and an overall symptom severity item was added. Relevance, acceptability, and comprehension of the final measure were confirmed by round 2 participants, and no further changes were required.

CONCLUSIONS: The UPDD–Caregiver Version is a relevant and acceptable measure for caregiver completion. The study provides evidence of the content validity of the measure to assess symptoms and impacts of CSU in children aged 2-11 years.

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