Demir Semra, Eyice-Karabacak Deniz, Kocatürk Emek, Ünal Derya, Toprak İlkim Deniz, Korkmaz Pelin, Aslan Ayşe Feyza, İmren Işıl Göğem, Dikicier Bahar, Kahveci Nevzat, Öztop Nida, Kara Rabia Öztaş, İşsever Halim, Maurer Marcus, Weller Karsten, Gelincik Aslı
Division of Immunology and Allergy Diseases, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.
Department of Dermatology, Koç University Faculty of Medicine, Istanbul, Turkey.
Clin Transl Allergy. 2024 Mar;14(3):e12342. doi: 10.1002/clt2.12342.
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.
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.
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.
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.
确定复发性血管性水肿（RAE）的控制水平对于指导治疗很有必要。在此，我们验证了土耳其语版的4周血管性水肿控制测试（AECT - 4wk）和3个月血管性水肿控制测试（AECT - 3mth），并评估了它们在监测RAE中的效用。
完成了患者报告结局指标推荐的结构化翻译过程。最终版本应用于51例肥大细胞介导的血管性水肿（MMAE）患者和38例遗传性血管性水肿患者，并确定了最小临床重要差异（MCID）。此外，还进行了锚定调查，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、患者视角的控制水平李克特量表（LS - AEC）、血管性水肿生活质量、简短健康调查简表12（SF - 12）以及患者对治疗充分性的评估。
土耳其语版AECT与锚定工具具有良好的收敛效度，相关性显著，且具有已知组效度。观察到了出色的内部一致性和可重复性。AECT - 4wk和AECT - 3mth得分达到16分中的10分及以上表明疾病得到良好控制。疾病活动、控制和负担参数与根据AECT截止点10定义的疾病控制水平一致。AECT - 4wk和 - 3mth的三分变化能够检测出所有患者疾病控制中的MCID。
土耳其语版AECT是评估和监测RAE患者疾病控制的有效且可靠工具。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语版AECT。
