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

Author:

Demir Semra1ORCID,Eyice‐Karabacak Deniz1,Kocatürk Emek234,Ünal Derya1,Toprak İlkim Deniz1,Korkmaz Pelin1,Aslan Ayşe Feyza1,İmren Işıl Göğem1,Dikicier Bahar5,Kahveci Nevzat1,Öztop Nida6,Kara Rabia Öztaş5,İşsever Halim7,Maurer Marcus34ORCID,Weller Karsten3,Gelincik Aslı1ORCID

Affiliation:

1. Division of Immunology and Allergy Diseases Department of Internal Medicine Istanbul Faculty of Medicine Istanbul University Istanbul Turkey

2. Department of Dermatology Koç University Faculty of Medicine Istanbul Turkey

3. Institute of Allergology Charite‐Universitatsmedizin Corporate Member of Freie Universitat Berlin and Humboldt‐Universitat zu Berlin Berlin Germany

4. Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany

5. Faculty of Medicine Department of Dermatology Sakarya University Sakarya Turkey

6. Adult Allergy and Immunology Clinic Başakşehir Pine and Sakura City Hospital Istanbul Turkey

7. Istanbul Faculty of Medicine Department of Public Health Istanbul University Istanbul Turkey

Abstract

AbstractBackgroundDetermination 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.MethodThe 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.ResultsThe 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.ConclusionsTurkish 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.

Publisher

Wiley

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