How does EQ-5D-5L perform in asthma patients?

B. Szentes, L. Schwarzkopf, M. Schuler, N. Lehbert, D. Nowak, M. Wittmann, H. Faller, K. Schultz
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Abstract

Background: EQ-5D-5L is a widely used generic health related quality of life (HRQL) tool, for evaluating interventions. Its performance in asthma patients has been sparsely investigated. Methods: We used data from 371 patients participating in the EPRA randomized controlled trial with waiting group design for pulmonary rehabilitation (PR). We assessed the EQ-5D and the visual analogue scale (VAS) at randomization (T0), at start (T1) and end of PR (T2), and three months post PR (T3). We calculated floor and ceiling effects (T0, T1, T2, T3), intraclass correlation (ICC) (T0-T1) and responsiveness to changes measured with the asthma control test (ACT) (T0-T1, T1-T2, T2-T3) through regression analysis. Our outcome variable was HRQL change adjusted for change on ACT (minimally important difference=3) in 5 categories (ACT change ≥3, 0 ACT change> -3, ACT change ≤ - 3), age, sex, BMI, smoking status, group, employed before PR (yes/no) and previous HRQL. Results: EQ-5D showed no floor effects but ceiling effects at T2 and T3 (32%) whereas VAS showed none of them. ICC was 0.85 for VAS and 0.82 for EQ-5D. EQ-5D was not responsible to changes in any of the waves. VAS detected ACT-changes bigger equal |MID| (T1: Δ VAS 5.67 (p=0.01) vs -7.05 (p=0.05), T2: Δ VAS 5.83 (p=0.02) vs -7.77 (p=0.01) and T3: Δ VAS 5.96 (p=0.01) vs -8.97 (p Discussion: EQ-5D showed good reliability but unsatisfactory responsiveness to changes. This could be an issue for the health economic evaluation of interventions. Considering an additional domain or using additional outcome variables (e.g. VAS) might mitigate the problem.
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EQ-5D-5L在哮喘患者中的表现如何?
背景:EQ-5D-5L是一种广泛使用的通用健康相关生活质量(HRQL)工具,用于评估干预措施。它在哮喘患者中的表现已经很少被调查。方法:我们使用371例参加EPRA随机对照试验的患者的数据,等待组设计用于肺康复(PR)。我们在随机化(T0)、PR开始(T1)和结束(T2)以及PR后3个月(T3)评估EQ-5D和视觉模拟量表(VAS)。通过回归分析计算下限和上限效应(T0、T1、T2、T3)、类内相关性(ICC) (T0-T1)和对哮喘控制试验(ACT)测量的变化的反应性(T0-T1、T1-T2、T2-T3)。我们的结局变量是根据ACT变化调整的HRQL变化(最小重要差异=3),分为5个类别(ACT变化≥3、ACT变化> -3、ACT变化≤-3)、年龄、性别、BMI、吸烟状况、组、PR前工作(是/否)和既往HRQL。结果:EQ-5D在T2、T3无下限效应,有上限效应(32%),VAS无下限效应。VAS的ICC为0.85,EQ-5D的ICC为0.82。EQ-5D对任何波的变化都不负责。VAS检测act -变化较大= |MID| T1: Δ VAS 5.67 (p=0.01) vs -7.05 (p=0.05), T2: Δ VAS 5.83 (p=0.02) vs -7.77 (p=0.01), T3: Δ VAS 5.96 (p=0.01) vs -8.97 (p)讨论:EQ-5D表现出良好的可靠性,但对变化的反应性不理想。这可能是干预措施的卫生经济评价的一个问题。考虑一个额外的领域或使用额外的结果变量(例如VAS)可能会缓解这个问题。
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