Monitoring recurrent angioedema: Findings from the Turkish angioedema control test validation study

IF 4.6 2区 医学 Q2 ALLERGY Clinical and Translational Allergy Pub Date : 2024-02-28 DOI:10.1002/clt2.12342
Semra Demir, Deniz Eyice-Karabacak, Emek Kocatürk, Derya Ünal, İlkim Deniz Toprak, Pelin Korkmaz, Ayşe Feyza Aslan, Işıl Göğem İmren, Bahar Dikicier, Nevzat Kahveci, Nida Öztop, Rabia Öztaş Kara, Halim İşsever, Marcus Maurer, Karsten Weller, Aslı Gelincik
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Abstract

Background

Determination of control level in recurrent angioedema (RAE) is necessary to guide management. Here, we validated a Turkish version of the angioedema control test (AECT) for 4-week (AECT-4wk) and for 3-month (AECT-3mth) and assessed their utility in monitoring RAE.

Method

The recommended structured translation process for patient-reported outcome measures was completed. The final versions were administered to 51 patients with mast cell-mediated angioedema (MMAE) and 38 patients with hereditary angioedema, and the minimal clinically important difference (MCID) was determined. Additionally, anchor surveys comprising angioedema activity score for 28 days (AAS-28 day), visual analog score for angioedema control, Likert scale for the control level from the patient's perspective (LS-AEC), angioedema quality of life, short form-12 (SF-12) and patients' assessment of treatment sufficiency were applied.

Results

The Turkish AECT versions showed good convergent validity with a substantial correlation with anchor tools and known-group validity. Excellent internal consistency and reproducibility were observed. Equal or more than 10 of 16 points scored with the AECT-4wk and AECT-3mth identified patients with well-controlled disease. The disease activity, control and burden parameters were consistent with the disease control level defined depending on the cut-off point 10 of AECT. Three-point changes in AECT-4wk and -3 mt could detect MCID in disease control in all patients.

Conclusions

Turkish AECT versions are valid and reliable tools for assessing and monitoring disease control in patients with RAE. The use of the Turkish versions of the AECT in routine patient care, clinical trials and angioedema research is recommended.

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监测复发性血管性水肿:土耳其血管性水肿控制测试验证研究的结果。
背景:确定复发性血管性水肿(RAE)的控制水平对于指导治疗非常必要。在此,我们验证了土耳其版本的血管性水肿控制测试(AECT)4周(AECT-4wk)和3个月(AECT-3mth),并评估了其在监测RAE方面的实用性:方法:完成了建议的患者报告结果测量的结构化翻译过程。对51名肥大细胞介导的血管性水肿(MMAE)患者和38名遗传性血管性水肿患者实施了最终版本,并确定了最小临床重要差异(MCID)。此外,还采用了锚定调查,包括 28 天血管性水肿活动评分(AAS-28 天)、血管性水肿控制视觉模拟评分、患者角度的控制水平李克特量表(LS-AEC)、血管性水肿生活质量简表-12(SF-12)和患者对治疗充分性的评估:结果:土耳其 AECT 版本显示出良好的收敛效度,与锚定工具和已知组效度有很大的相关性。内部一致性和可重复性极佳。在 AECT-4wk 和 AECT-3mth 的 16 个得分点中,相同或超过 10 个得分点可识别出疾病控制良好的患者。疾病活动、控制和负担参数与根据 AECT 临界点 10 确定的疾病控制水平一致。AECT-4wk和-3mt的三点变化可检测出所有患者疾病控制的MCID:土耳其版 AECT 是评估和监测 RAE 患者疾病控制情况的有效而可靠的工具。建议在常规患者护理、临床试验和血管性水肿研究中使用土耳其版AECT。
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来源期刊
Clinical and Translational Allergy
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.
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