Table 1 Patient selection criteria in the ASSURE-CSU study
Inclusion criteria | Exclusion criteria |
|---|---|
• Clinician-confirmed diagnosis of CSU/CIU, defined as occurrence of spontaneous hives and/or angioedema for at least 6 weeks without an obvious cause | • Symptoms resolved within 12 months of diagnosis |
• Symptomatic for more than 12 months at least 3 days per week and currently symptomatic despite treatment | • Determined to be in remission/resolved, defined as more than 6 months untreated and without symptoms |
• Under care of the participating site/physician for at least 12 months or the participating site/physician has documentation of the patient’s relevant medical information (e.g., referral letters) for the 12 months prior to enrolment | • Urticaria is predominantly of the inducible form (i.e., physical, cholinergic); however, patients with comorbid inducible urticaria may be included in the study provided that it is of secondary importance to CSU/CIU |
• Received at least one treatment course with an H1-antihistamine (licensed dose) | • Participated in a CSU/CIU interventional study or clinical trial during the data collection period |
• Able to provide informed consent | • Unable to provide informed consent |
• Willing and able to complete the surveys | • Not able and not willing to complete the surveys |
• Aged 18 years or older at the time of study enrolment |