Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Allergy. 2013 Sep;68(9):1185-92. doi: 10.1111/all.12209. Epub 2013 Aug 6.
Recurrent angioedema (RecA) is a frequent clinical problem characterized by suddenly occurring cutaneous and/or mucosal swellings. Depending on their location, RecA may be painful, hindering, disfiguring, or even life-threatening. The assessment of disease activity in affected patients is important to guide treatment decisions. Currently, however, there is no standardized and validated outcome measure available to do so.
To develop and validate the first specific patient-reported outcome instrument to assess disease activity in RecA patients, the Angioedema Activity Score (AAS).
After a set of potential AAS items was developed, item evaluation and reduction were performed by means of impact analysis, factor analysis, regression analysis, and by checking for face validity. In addition, the items of the final AAS questionnaire were tested for their validity and reliability during a 12-week validation study.
In total, data from 110 and 80 RecA patients were used during the AAS item evaluation and validation phase, respectively. The resulting AAS consisted of five items and was found to have a one-dimensional structure and excellent internal consistency. It correlated well with other measures of disease activity and quality-of-life impairment, thus demonstrating its convergent validity. In addition, the known-groups validity and test-retest reliability of the AAS were found to be good.
The AAS is the first validated and reliable tool to determine disease activity in RecA patients, and it may serve as a valuable instrument in future clinical studies and routine patient care.
复发性血管性水肿（Recurrent angioedema，RecA）是一种常见的临床问题，其特征为突然出现的皮肤和/或黏膜肿胀。根据其位置，RecA 可能会引起疼痛、妨碍、畸形，甚至危及生命。评估受影响患者的疾病活动度对于指导治疗决策非常重要。然而，目前尚无标准化和经过验证的可用结局测量方法。
开发和验证首个专门用于评估 RecA 患者疾病活动度的患者报告结局（PRO）工具，即血管性水肿活动评分（Angioedema Activity Score，AAS）。
在确定了一组潜在的 AAS 项目后，通过影响分析、因子分析、回归分析以及检查表面效度来进行项目评估和简化。此外，在为期 12 周的验证研究中，还对最终 AAS 问卷的项目进行了有效性和可靠性测试。
在 AAS 项目评估和验证阶段，共分别纳入了 110 例和 80 例 RecA 患者的数据。由此产生的 AAS 由五个项目组成，具有一维结构和良好的内部一致性。它与其他疾病活动度和生活质量受损的衡量标准相关性良好，从而证明了其收敛效度。此外，AAS 的已知组间有效性和重测信度也很好。
AAS 是首个经过验证和可靠的工具，可用于确定 RecA 患者的疾病活动度，并且可能成为未来临床研究和常规患者护理中的有价值工具。
