Abstract

The Urticaria Control Test (UCT) is a well-established, very easy to use and calculate 4-item patient-reported outcome measure (PROM) to assess chronic urticaria (CU) disease control during the previous 4 weeks. Clinical trials and practice may benefit from the use of a UCT version with a shorter recall period, but this does not exist. To develop and validate a UCT version with a 7-day recall period, the UCT7. The UCT7 was developed, based on the UCT, and tested, in 152 patients with CU (spontaneous: n=101, inducible: n=51) for its reliability, validity and screening accuracy, and clinimetric properties, i.e. the cutoff for well-controlled disease and the minimal clinically important difference (MCID). The UCT7 showed excellent internal consistency reliability with a Cronbach alpha value of 0.91 and test-retest reliability with an intraclass correlation coefficient of 0.83. Convergent validity was high and strongly correlated with anchors of disease control, wheal and angioedema frequency, and urticaria-related quality of life impairment. The UCT7 showed excellent sensitivity to change, however, changes in angioedema activity and impact did not correlate well with changes in UCT7. Based on receiver-operating characteristic curve analysis, the proportion of correctly classified patients, and patients' assessment of treatment efficacy, we recommend a cutoff value of 12 points for identifying patients with well-controlled disease. The UCT7 MCID for improvement was estimated to be 2 points. The UCT7 is a validated 7-day recall period version of the UCT. It is ideal for the assessment of disease control at short intervals in CU patients in clinical studies and practice.

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