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.