Adaptation of the urticaria patient daily diary for caregiver completion in pediatric chronic spontaneous urticaria

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Background: The Urticaria Patient Daily Diary (UPDD) assesses patient-reported symptoms (itch, hives, angioedema) and impacts in adults and adolescents with chronic spontaneous urticaria (CSU). Objective: The objective was to adapt the UPDD for caregiver completion for patients ages 2‐11 years. Methods: To inform modification of the UPDD, two iterative rounds of hybrid concept-elicitation/cognitive-debriefing interviews were conducted with clinical experts and caregivers of children with CSU recruited via patient organizations in the United States and Canada. After concept elicitation, the participants reviewed a draft UPDD‐Caregiver Version with initial modifications for caregiver completion. Data were analyzed by using thematic analysis. Results: Four clinicians and 12 caregivers were interviewed (round 1:4 clinicians, 5 caregivers; round 2:7 caregivers). Key symptoms reported by the caregivers were itch (n = 12), hives (n = 12), and swelling and/or angioedema (n = 7). All four clinicians confirmed itch and hives to be key symptoms in children ages 2‐11 years with CSU, with associated angioedema for some. Scratching was confirmed as the key observable sign of itch. Caregiver-reported impacts included waking in the night (n = 10); difficulty getting to sleep (n = 8); and daily life impacts, including activities at school (n = 10), play (n = 8), with family and/or friends (n = 4), and sports (n = 3). After round 1, minor revisions were made to enhance comprehension of the UPDD‐Caregiver Version, and an overall symptom severity item was added. Relevance, acceptability, and comprehension of the final measure were confirmed by round 2 participants; no further changes were required. Conclusion: The UPDD‐Caregiver Version is a relevant and acceptable measure for caregiver completion to assess symptoms and impacts of CSU in children ages 2‐11 years.

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