Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Department of Dermatology, University Medical Center Mainz, Mainz, Germany.
J Allergy Clin Immunol. 2014 May;133(5):1365-72, 1372.e1-6. doi: 10.1016/j.jaci.2013.12.1076. Epub 2014 Feb 9.
Chronic urticaria is a frequent and debilitating skin disease. Its symptoms commonly fluctuate considerably from day to day. As of yet, the only reliable tool to assess disease activity is the Urticaria Activity Score, which prospectively documents the signs and symptoms of urticaria for several days.
We sought to develop and validate a novel patient-reported outcome instrument to retrospectively assess urticaria control, the Urticaria Control Test (UCT).
Potential UCT items were developed by using established methods (literature research and expert and patient involvement). Subsequently, item reduction was performed by using a combined approach, applying impact and regression analysis. The resulting UCT instrument was then tested for its validity, reliability, and screening accuracy.
A 4-item UCT with a recall period of 4 weeks was developed based on 25 potential UCT items tested in 508 patients with chronic urticaria. A subsequent validation study with the 4-item UCT in 120 patients with chronic urticaria demonstrated that this new tool exhibits good convergent and known-groups validity, as well as excellent test-retest reliability. In addition, the screening accuracy to identify patients with urticaria with insufficiently controlled disease was found to be high.
The UCT is the first valid and reliable tool to assess disease control in patients with chronic urticaria (spontaneous and inducible). Its retrospective approach and simple scoring system make it an ideal instrument for the management of patients with chronic urticaria in clinical practice.
慢性荨麻疹是一种常见且使人虚弱的皮肤病。其症状通常每天都有很大波动。到目前为止，评估疾病活动度的唯一可靠工具是荨麻疹活动评分（Urticaria Activity Score），它前瞻性地记录了荨麻疹数天的体征和症状。
我们旨在开发和验证一种新的患者报告结局工具，以回顾性评估荨麻疹控制情况，即荨麻疹控制测试（Urticaria Control Test，UCT）。
通过使用已建立的方法（文献研究和专家及患者参与）开发潜在的 UCT 项目。随后，通过应用影响和回归分析的综合方法进行项目删减。然后，对得出的 UCT 工具进行有效性、可靠性和筛选准确性的测试。
根据在 508 例慢性荨麻疹患者中测试的 25 个潜在 UCT 项目，开发了一个 4 项 UCT，其回顾期为 4 周。随后在 120 例慢性荨麻疹患者中进行的验证性研究表明，这种新工具具有良好的收敛性和已知组有效性，以及极好的测试-重测信度。此外，发现该工具识别出疾病控制不足的荨麻疹患者的筛查准确性较高。
UCT 是评估慢性荨麻疹（自发性和诱导性）患者疾病控制情况的首个有效且可靠的工具。其回顾性方法和简单的评分系统使其成为临床实践中管理慢性荨麻疹患者的理想工具。
