The 7-day recall period version of the Urticaria Control Test—UCT7

Background The Urticaria Control Test (UCT) is a well-established, very easy to use and calculate 4-item patient-reported outcome measure to assess chronic urticaria 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. Objectives We sought to develop and validate a UCT version with a 7-day recall period, the UCT7. Methods The UCT7 was developed, based on the UCT, and tested, in 152 patients with chronic urticaria (spontaneous: n = 101, inducible: n = 51) for its reliability, validity and screening accuracy, and clinimetric properties, in other words, the cutoff for well-controlled disease and the minimal clinically important difference. Results The UCT7 showed excellent internal consistency reliability with a Cronbach αvalue 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 minimal clinically important difference for improvement was estimated to be 2 points. Conclusions 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 patients with chronic urticaria in clinical studies and practice. The Urticaria Control Test (UCT) is a well-established, very easy to use and calculate 4-item patient-reported outcome measure to assess chronic urticaria 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. We sought 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 chronic urticaria (spontaneous: n = 101, inducible: n = 51) for its reliability, validity and screening accuracy, and clinimetric properties, in other words, the cutoff for well-controlled disease and the minimal clinically important difference. The UCT7 showed excellent internal consistency reliability with a Cronbach αvalue 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 minimal clinically important difference 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 patients with chronic urticaria in clinical studies and practice.