Abstract
BackgroundAsthma patients experience impairments in health-related quality of life (HRQL). Interventions are available to improve HRQL. EQ-5D-5L is a common generic tool used to evaluate health interventions. However, there is debate over whether the use of this measure is adequate in asthma patients.MethodsWe used data from 371 asthma patients participating in a pulmonary rehabilitation (PR) program from the EPRA randomized controlled trial. We used four time points: T0 randomization, T1 start PR, T2 end PR, T3 3 months follow-up. We calculated floor and ceiling effects, intra-class correlation (ICC), Cohen’s d, and regression analysis to measure the sensitivity to changes of EQ-5D-5 L (EQ-5D index and Visual Analog Scale (VAS)) and the disease-specific Asthma Quality of Life Questionnaire (AQLQ). Furthermore, we estimated the minimally important difference (MID). Based on the Asthma Control Test (ACT) scores, we defined three groups: 1. ACT-A (ACT> 19) controlled asthma, 2. ACT-B (14 < ACT≤19) not well-controlled asthma, and 3. ACT-C (ACT≤14) very poorly controlled asthma.ResultsOnly the EQ-5D index showed ceiling effects at T2 and T3 (32%). ICC (between T0 and T1) was moderate or good for all measures. Cohen’s d at T2 and T3 was better at differentiating between ACT-A and ACT-B than between ACT-B and ACT-C. The EQ-5D index showed moderate effect sizes (0.63–0.75), while AQLQ showed large effect sizes (0.74–1,48). VAS was responsive to pronounced positive and negative ACT changes in every period, and AQLQ mostly to the positive changes, whereas the EQ-5D index was less responsive. We estimated a MID of 0.08 for the EQ-5D index, 12.3 for VAS, and 0.65 for AQLQ.ConclusionAll presented HRQL tools had good discriminatory power and good reliability. However, EQ-5D-5 L did not react very sensitively to small changes in asthma control. Therefore, we would suggest using supplementary measures in addition to EQ-5D-5 L to evaluate asthma-specific interventions more comprehensively.Trial registrationGerman Clinical Trial Register, DRKS00007740 (date of registration: 05/15/2015), https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007740. The registration took place prospectively.
Highlights
Asthma patients experience impairments in health-related quality of life (HRQL)
We aim to provide a minimally important difference (MID) value for the five-level version for asthma patients, which has not to our knowledge been provided in previous studies
Intra-class correlation To estimate the reliability of the HRQL questionnaires, we evaluated intra-class correlation (ICC) [30] between T0 and T1 for patients who were stable according to their Asthma Control Test (ACT)
Summary
Asthma patients experience impairments in health-related quality of life (HRQL). Interventions are available to improve HRQL. Wheeze, and shortness of breath in varying intensity and frequency [1] This symptom profile is associated with impairments in health-related quality of life (HRQL) [2,3,4]. Disease-specific assessment tools are developed for specific diseases They mainly focus on the impact of disease symptoms and the related consequences, but might cover aspects of diseaseassociated impairments in social participation or emotional and general wellbeing. They enable comparisons between patients at different stages of the same disease and help to monitor disease development. They might not always fully capture HRQL impairments in the context of diseasespecific symptoms, especially in the early stages of a disease [9]
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