Sensitivity to change and minimal clinically important difference of the angioedema control test

IF 4.6 2区医学 Q2 ALLERGY

Clinical and Translational Allergy Pub Date : 2023-09-01 DOI:10.1002/clt2.12295

Lauré M. Fijen, Carolina Vera, Thomas Buttgereit, Hanna Bonnekoh, Marcus Maurer, Markus Magerl, Karsten Weller

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Abstract

Background

The Angioedema Control Test (AECT) is a patient-reported outcome measure developed and validated for the assessment of disease control in patients with recurrent angioedema. Its sensitivity to change and minimal clinically important difference (MCID) have hitherto not been established.

Methods

Patients with recurrent angioedema due to chronic spontaneous urticaria, hereditary angioedema, or acquired C1-inhibitor deficiency were repeatedly asked to complete the AECT along with the Angioedema Quality of Life Questionnaire (AE-QoL), Dermatology Life Quality Index (DLQI), and anchors for disease control and whether treatment was sufficient during routine care visits. The sensitivity to the change of the AECT was determined by correlating changes in its scores over time with changes in the applied anchors. The MCID was determined using anchor-based and distributional criterion-based approaches.

Results

Eighty-six cases were used for this analysis. Changes in AECT scores correlated well with AE-QoL changes (but less with changes in the DLQI) as well as other applied anchors, demonstrating its sensitivity to change. The MCID was found to be three points for improvement of angioedema control. The available number of cases with meaningful deterioration in our dataset was too low to reach a definite conclusion on the MCID for deterioration of angioedema control.

Conclusion

The AECT is a valuable tool to assess changes in disease control in patients with recurrent angioedema over time. The lowest AECT score change that reflects a meaningful improvement of disease control to patients (MCID) is three points.

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血管性水肿对照试验对变化的敏感性和最小临床重要差异。

背景：血管性水肿控制测试（AECT）是一种患者报告的结果测量方法，用于评估复发性血管性水肿患者的疾病控制。其对变化的敏感性和最小临床重要差异（MCID）迄今尚未确定。方法：反复要求因慢性自发性荨麻疹、遗传性血管性水肿或获得性C1抑制剂缺乏而复发的血管性水肿患者完成AECT，同时填写血管性水肿生活质量问卷（AE QoL）、皮肤病学生活质量指数（DLQI）和疾病控制锚固件，以及在常规护理访视期间治疗是否充分。通过将AECT评分随时间的变化与所用锚固件的变化相关联来确定对AECT变化的敏感性。MCID使用基于锚和基于分布标准的方法来确定。结果：86例病例用于本分析。AECT评分的变化与AE生活质量的变化（但与DLQI的变化相关性较小）以及其他应用锚固件的变化密切相关，表明其对变化的敏感性。MCID被发现是改善血管性水肿控制的三点。在我们的数据集中，有意义恶化的可用病例数太低，无法就血管性水肿控制恶化的MCID得出确切结论。结论：AECT是评估复发性血管性水肿患者疾病控制随时间变化的有价值的工具。反映患者疾病控制（MCID）有意义改善的最低AECT评分变化为3分。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

期刊介绍： Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience. Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.