Analyzing Health-Related Quality of Life Data to Estimate Parameters for Cost-Effectiveness Models: An Example Using Longitudinal EQ-5D Data from the SHIFT Randomized Controlled Trial.
Analyzing Health-Related Quality of Life Data to Estimate Parameters for Cost-Effectiveness Models: An Example Using Longitudinal EQ-5D Data from the SHIFT Randomized Controlled Trial.
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DOI：
10.1007/s12325-016-0471-x
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发表时间：
2017-03
影响因子：
3.8
通讯作者：
Sculpher M
中科院分区：
文献类型：
--
作者：
Griffiths A;Paracha N;Davies A;Branscombe N;Cowie MR;Sculpher M
本文的目的是讨论用于分析来自决策分析模型的随机对照试验 (RCT) 的健康相关生活质量 (HRQoL) 数据的方法。本文提出的分析用于为慢性心力衰竭的伊伐布雷定健康技术评估 (HTA) 提交提供 HRQoL 数据。我们使用来自 If 抑制剂伊伐布雷定治疗收缩性心力衰竭试验 (SHIFT) 的大型纵向 EuroQol 五维问卷 (EQ-5D) 数据集（clinicaltrials.gov：NCT02441218）来说明问题和方法。 HRQoL 权重（效用值）根据使用 SHIFT EQ-5D 数据开发的混合回归模型进行估计（n = 5313 名患者）。该回归模型用于根据心率≥75 bpm 的患者的治疗、患者特征和关键临床结果来预测 HRQoL 结果。伊伐布雷定与 HRQoL 体重增加 0.01 相关。 HRQoL 权重根据纽约心脏协会 (NYHA) 分级而有所不同（NYHA I–IV，无需住院：标准护理 0.82–0.46；伊伐布雷定 0.84–0.47）。 HRQoL 重量的减少与 HRQoL 评估访视后 30 天内的住院治疗相关，这种减少因 NYHA 等级的不同而异 [−0.07 (NYHA I) 至 -0.21 (NYHA IV)]。混合模型根据关键临床结果和患者特征解释了 EQ-5D 数据的变化，为成本效益模型中患者 HRQoL 的长期预测提供了重要信息。该模型还用于估计与住院相关的 HRQoL 损失。在 SHIFT 中，许多住院治疗并不是在接近 EQ-5D 就诊时发生的；因此，与此类事件相关的 HRQoL 的任何临时变化不会在观察到的 RCT 证据中得到充分捕获，但可以在我们使用混合模型的成本效益分析中进行预测。鉴于与伊伐布雷定相关的住院治疗大幅减少，这是该分析的一个重要特征。 资助：施维雅研究小组。
The aim of this article is to discuss methods used to analyze health-related quality of life (HRQoL) data from randomized controlled trials (RCTs) for decision analytic models. The analysis presented in this paper was used to provide HRQoL data for the ivabradine health technology assessment (HTA) submission in chronic heart failure. We have used a large, longitudinal EuroQol five-dimension questionnaire (EQ-5D) dataset from the Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial (SHIFT) (clinicaltrials.gov: NCT02441218) to illustrate issues and methods. HRQoL weights (utility values) were estimated from a mixed regression model developed using SHIFT EQ-5D data (n = 5313 patients). The regression model was used to predict HRQoL outcomes according to treatment, patient characteristics, and key clinical outcomes for patients with a heart rate ≥75 bpm. Ivabradine was associated with an HRQoL weight gain of 0.01. HRQoL weights differed according to New York Heart Association (NYHA) class (NYHA I–IV, no hospitalization: standard care 0.82–0.46; ivabradine 0.84–0.47). A reduction in HRQoL weight was associated with hospitalizations within 30 days of an HRQoL assessment visit, with this reduction varying by NYHA class [−0.07 (NYHA I) to −0.21 (NYHA IV)]. The mixed model explained variation in EQ-5D data according to key clinical outcomes and patient characteristics, providing essential information for long-term predictions of patient HRQoL in the cost-effectiveness model. This model was also used to estimate the loss in HRQoL associated with hospitalizations. In SHIFT many hospitalizations did not occur close to EQ-5D visits; hence, any temporary changes in HRQoL associated with such events would not be captured fully in observed RCT evidence, but could be predicted in our cost-effectiveness analysis using the mixed model. Given the large reduction in hospitalizations associated with ivabradine this was an important feature of the analysis. Funding: The Servier Research Group.