AstraZeneca, Cambridge, UK.
Formerly of AstraZeneca, Cambridge, UK.
Qual Life Res. 2024 Apr;33(4):1029-1039. doi: 10.1007/s11136-023-03582-z. Epub 2024 Jan 11.
Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with deteriorating health and health-related quality of life (HRQoL) among people with COPD during and after events. HRQoL data are key to evaluating treatment cost-effectiveness and informing reimbursement decisions in COPD. EuroQoL 5-dimension 5-level (EQ-5D-5L) utility scores, based on various HRQoL measures, are used in economic evaluations of pharmacotherapy. These analyses estimated associations between EQ-5D-5L utility scores and exacerbations (new and previous) in patients with moderate-to-very severe COPD.
Longitudinal mixed models for repeated measures (MMRM), adjusted for time and treatment, were conducted using data from the ETHOS study (NCT02465567); models regressed EQ-5D-5L on current and past exacerbations that occurred during the study, adjusting for other patient reported outcomes and clinical factors.
Based on the simplest covariate adjusted model (adjusted for current exacerbations and number of previous exacerbations during the study), a current moderate exacerbation was associated with an EQ-5D-5L disutility of 0.055 (95% confidence interval: 0.048, 0.062) with an additional disutility of 0.035 (0.014, 0.055) if the exacerbation was severe. After resolving, each prior exacerbation was associated with a disutility that persisted for the remainder of the study (moderate exacerbation, 0.014 [0.011, 0.016]; further disutility for severe exacerbation, 0.011 [0.003, 0.018]).
An EQ-5D-5L disutility of 0.090 was associated with a current severe exacerbation in ETHOS. Our findings suggest incorporating the effects of current, recently resolved, and cumulative exacerbations into economic models when estimating benefits and costs of COPD pharmacotherapy, as exacerbations have both acute and persistent effects.
慢性阻塞性肺疾病(COPD)加重与 COPD 患者在事件期间和之后的健康状况和健康相关生活质量(HRQoL)恶化有关。HRQoL 数据是评估 COPD 治疗成本效益并为其报销决策提供信息的关键。基于各种 HRQoL 措施的欧洲五维健康量表 5 级(EQ-5D-5L)效用评分用于药物治疗的经济评估。这些分析估计了 EQ-5D-5L 效用评分与中重度 COPD 患者的加重(新发和既往)之间的关联。
使用 ETHOS 研究(NCT02465567)的数据,通过纵向重复测量混合模型(MMRM)进行调整,模型根据当前和过去发生在研究期间的加重情况对 EQ-5D-5L 进行回归,同时调整其他患者报告的结果和临床因素。
基于最简单的经协变量调整模型(调整当前加重和研究期间发生的既往加重次数),当前中度加重与 EQ-5D-5L 不效用值 0.055(95%置信区间:0.048,0.062)相关,如果加重为重度,则不效用值为 0.035(0.014,0.055)。每次加重后,每次既往加重都会导致研究剩余时间内持续存在的不效用(中度加重,0.014[0.011,0.016];进一步加重为重度时,0.011[0.003,0.018])。
ETHOS 中当前重度加重与 EQ-5D-5L 不效用值 0.090 相关。我们的研究结果表明,在估计 COPD 药物治疗的获益和成本时,应将当前、近期缓解和累积加重的影响纳入经济模型,因为加重既有急性影响又有持续影响。