Validity and responsiveness of the urticaria activity and impact measure (U-AIM), a new patient-reported tool

Publication date: Available online 19 March 2018
Source:Annals of Allergy, Asthma & Immunology
Author(s): Marcus Maurer, Susan D. Mathias, Ross D. Crosby, Yamina Rajput, James L. Zazzali
BackgroundChronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), may produce hives, itch, and angioedema. The Urticaria Activity and Impact Measure (U-AIM) is a newly developed 9-item patient-reported measure designed for use in routine clinical practice to assess CSU activity and impact over the previous 7 days.ObjectiveTo evaluate validity, responsiveness, and clinically meaningful change of the U-AIM.MethodsData from a 24-week open-label single-arm period of a randomized, placebo-controlled study of omalizumab were used to assess the psychometric properties of U-AIM items for itch, hives, and angioedema.Results206 patients (75% female, mean age 44.6 years) were enrolled. At baseline, U-AIM results included prevalent severe itch (55%) and >12 hives (67%), angioedema (15%), and bother by itch (84%), hives (84%), and angioedema (49%). Urticaria Patient Daily Diary (UPDD) mean weekly scores were 15.4 (itch severity), 16.8 (number of hives), and 32.2 (Urticaria Activity Score [UAS7]). At baseline, Weeks 12 and 24, U-AIM itch and hives items and UAS7 proxy scores (the sum of itch severity and number of hives over 7 days) demonstrated strong correlation coefficients with their corresponding measures from the UPDD (itch severity: 0.634-0.806; hives number: 0.735-0.843; UAS7 proxy: 0.724-0.852). Changes in U-AIM scores differentiated patients by their perspective of symptom improvement. Meaningful change thresholds were established for itch severity and number of hives scores (0.8-1.0 for both) and the UAS7 proxy score (10.5-12.5).ConclusionThe U-AIM is valid and responsive to change, and may help clinicians monitor CSU activity and track treatment effectiveness.



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