Comprehension of the adapted Urticaria Activity Score measure and patient guidance document: qualitative interviews with adults and adolescents with chronic spontaneous urticaria.

OBJECTIVE

A key component of determining that a patient-reported outcome (PRO) measure is fit-for-purpose is to ensure that respondents understand its instructions and items. Any modification to a measure should be evaluated for relevance and understandability. The objective of the study was to assess comprehension of the adapted Urticaria Activity Score (UAS) questionnaire among adolescents aged populations with chronic spontaneous urticaria (CSU) and the modification to UAS question 2 to include patient-friendly terminology "wheals (hives)." A patient guidance document for completing the adapted UAS was also examined.

METHODS

A non-interventional, cross-sectional, qualitative study involving hybrid concept elicitation and cognitive interviews was conducted among adults and adolescents with CSU. Eligibility included clinician confirmation of CSU and experience of itch and hives for ≥ 6 weeks. Study participants were recruited from US clinical sites and online CSU patient communities. Telephone interviews were conducted using a semi-structured interview guide. Participants reviewed the UAS and provided their input on the UAS guidance document.

RESULTS

Twenty-two interviews were conducted (seven adolescents and 15 adults; mean age 34 ± 18 years, 64% female, 77% White, 77% non-Hispanic, and 59% moderate to severe CSU symptoms). All participants (n = 22/22, 100%) stated that the adapted UAS was clear and "easy" to understand. For the adapted UAS "wheals (hives)" item, several participants were unfamiliar with the term "wheals," but the term "hives" was well understood by US participants. Most participants reported that it was "easy" or "not difficult" to count and recall the number of hives they had over the past 24 h. Participants found the adapted UAS guidance document "helpful" and "easy to understand" for determining and counting hives in a 24-hour period. Suggestions for improving the guide included adding a picture to aid in counting hives.

CONCLUSIONS

Itch and hives are important symptoms of CSU. Results support the content validity of an adapted UAS as a daily measure of severity of itch and hives and provided valuable suggestions for improving its patient guidance, which can be used in future clinical trials involving adults and adolescents ≥ 12 years old with CSU to assess the severity of itch and hives.