Abstract

BackgroundThe Angioedema Quality of Life (AE-QoL) is the first patient reported outcome measure developed for the assessment of quality of life (QoL) impairment in patients with recurrent angioedema (RAE). This study aimed to evaluate the clinimetric properties of the AE-QoL in Thai patients and to establish categories of QoL impairment assessed by the AE-QoL.MethodsThe validated Thai version of the Dermatology Life Quality Index (DLQI) and Patient Global Assessment of Quality of Life (PGA-QoL) were used to comparatively evaluate the Thai version of AE-QoL. Spearman correlations between the Thai AE-QoL and two other standard measurements (DLQI and PGA-QoL) were investigated to determine convergent validity. The Thai DLQI and PGA-QoL were used to categorize patients according to their QoL. Known-group validity of the Thai AE-QoL was later analyzed. The reliability of the Thai AE-QoL was investigated using Cronbach’s alpha and intraclass correlation. Three different approaches including the distribution method, receiver operating characteristic curve analysis, and the anchor based-method were used for the interpretability.ResultsA total of 86 patients with RAE with a median age of 38.0 ± 15.1 years (range 18–76) were enrolled. Of those, 76 patients (88%) had RAE with concomitant wheals, and 10 patients (11.6%) had RAE only. The AE-QoL assessed RAE-mediated QoL impairment with high convergent validity and known-groups validity, high internal consistency and test-retest reliability, and good sensitivity to change. Although the AE-QoL did not differentiate between patients with moderate and large effect as measured by PGA-QoL or DLQI in this study, AE-QoL total values of 0–23, 24 to 38, and ≥ 39 could define patients with “no effect”, “small effect”, and “moderate to large effect” of RAE on their QoL, respectively.ConclusionsThis study supports the validity and reliability of the Thai version of the AE-QoL, which is a very different language from the original version. Categories allow to classify the effect of RAE on patients’ QoL as “none”, “small”, and “moderate to large”. Further studies are needed to confirm the applicability of AE-QoL in other Asian populations”.

Highlights

  • The Angioedema Quality of Life (AE-QoL) is the first patient reported outcome measure developed for the assessment of quality of life (QoL) impairment in patients with recurrent angioedema (RAE)

  • RAE most commonly occurs in chronic spontaneous urticaria (CSU) patients, with or without wheals [3]

  • RAE is associated with markedly impaired health-related quality of life (HRQoL) [4, 5]

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Summary

Introduction

The Angioedema Quality of Life (AE-QoL) is the first patient reported outcome measure developed for the assessment of quality of life (QoL) impairment in patients with recurrent angioedema (RAE). This study aimed to evaluate the clinimetric properties of the AE-QoL in Thai patients and to establish categories of QoL impairment assessed by the AE-QoL. Recurrent angioedema (RAE) is characterized by the unpredictable, sudden and recurrent onset of nonpitting swelling of the skin, subcutaneous tissues, and/or mucous membranes [1]. Swellings in RAE patients can cause itch or a burning sensation, often they do not. RAE is associated with markedly impaired health-related quality of life (HRQoL) [4, 5]. Effective management of RAE requires the use of angioedema specific instruments designed to evaluate patients’ impairment in HRQoL

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