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

<b>Background:</b> The Urticaria Patient Daily Diary (UPDD) assesses patient-reported symptoms (itch, hives, angioedema) and impacts in adults and adolescents with chronic spontaneous urticaria (CSU). <b>Objective:</b> The objective was to adapt the UPDD for caregiver completion for patients ages 2-11 years. <b>Methods:</b> 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 <i>via</i> 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. <b>Results:</b> 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. <b>Conclusion:</b> 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.