Study Enrolment and Questionnaires
Our CU registry was approved by the Centre for Applied Ethics from the McGill University Health Centre Research Ethics Board (REB 12-255 GEN, June 3, 2013). From 2013-2021 we consecutively recruited pediatric patients (0-17 years) presenting with CU (defined as urticaria persisting at least 6 weeks) from the allergy clinics at the Montreal Children’s Hospital and from the Children’s Clinic in Montreal, Canada. Written informed consent was obtained from the patients’ parent/guardian, and for patients aged 7 years or older an assent form was obtained. As part of standard of care, at study entry participants were assessed both for CSU and CIndU, based on history and provocation testing.
Standardized questionnaires were administered at study entry by a member of the study team which queried on demographics, comorbidities, and management (i.e., second-generation antihistamines (sgAHs)). All participants completed the UCT and the written version of the CDLQI at study entry. Patients less than 12 years old were permitted to answer the questionnaires with the help of their parent/guardian. Follow-ups were conducted over the phone and queried on the management and resolution of CU (defined as one year without symptoms and treatment), as well as the UCT and CDLQI. In case of loss of follow-up, patients were contacted at least five times at multiple times of day.