Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
JAMA Cardiol. 2022 Feb 1;7(2):140-148. doi: 10.1001/jamacardio.2021.4836.
In the Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial, a novel 12-week rehabilitation intervention demonstrated significant improvements in validated measures of physical function, quality of life, and depression, but no significant reductions in rehospitalizations or mortality compared with a control condition during the 6-month follow up. The economic implications of these results are important given the increasing pressures for cost containment in health care.
To report the economic outcomes of the REHAB-HF trial and estimate the potential cost-effectiveness of the intervention.
DESIGN, SETTING, PARTICIPANTS: The multicenter REHAB-HF trial randomized 349 patients 60 years or older who were hospitalized for acute decompensated heart failure to rehabilitation intervention or a control group; patients were enrolled from September 17, 2014, through September 19, 2019. For this preplanned secondary analysis of the economic outcomes, data on medical resource use and quality of life (via the 5-level EuroQol 5-Dimension scores converted to health utilities) were collected. Medical resource use and medication costs were estimated using 2019 US Medicare payments and the Federal Supply Schedule, respectively. Cost-effectiveness was estimated using the validated Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, which uses an individual-patient simulation model informed by the prospectively collected trial data. Data were analyzed from March 24, 2019, to December 1, 2020.
Rehabilitation intervention or control.
Costs, quality-adjusted life-years (QALYs), and the lifetime estimated cost per QALY gained (incremental cost-effectiveness ratio).
Among the 349 patients included in the analysis (183 women [52.4%]; mean [SD] age, 72.7 [8.1] years; 176 non-White [50.4%] and 173 White [49.6%]), mean (SD) cumulative costs per patient were $26 421 ($38 955) in the intervention group (excluding intervention costs) and $27 650 ($30 712) in the control group (difference, -$1229; 95% CI, -$8159 to $6394; P = .80). The mean (SD) cost of the intervention was $4204 ($2059). Quality of life gains were significantly greater in the intervention vs control group during 6 months (mean utility difference, 0.074; P = .001) and sustained beyond the 12-week intervention. Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively.
These analyses suggest that longer-term benefits of this novel rehabilitation intervention, particularly in the subgroup of patients with preserved ejection fraction, may yield good value to the health care system. However, long-term cost-effectiveness is currently uncertain and dependent on the assumption that benefits are sustained beyond study follow-up, which needs to be corroborated in future trials in this patient population.
在康复治疗老年急性心力衰竭患者(REHAB-HF)试验中,一种新的 12 周康复干预措施在经过 6 个月的随访后,与对照组相比,在经过 6 个月的随访后,在经过验证的体力功能、生活质量和抑郁的测量中显示出显著的改善,但在再住院率或死亡率方面没有显著降低。鉴于医疗保健成本控制的压力越来越大,这些结果的经济意义非常重要。
报告 REHAB-HF 试验的经济结果,并估计干预措施的潜在成本效益。
设计、地点、参与者:这项多中心的 REHAB-HF 试验随机纳入了 349 名年龄在 60 岁或以上、因急性失代偿性心力衰竭住院的患者,分为康复干预组或对照组;患者于 2014 年 9 月 17 日至 2019 年 9 月 19 日入组。对于该经济结果的预先计划的二次分析,收集了医疗资源使用和生活质量(通过 5 级欧洲五维健康量表分数转换为健康效用)的数据。使用 2019 年美国医疗保险支付和联邦供应时间表分别估计医疗资源使用和药物成本。使用经过验证的心力衰竭患者管理干预措施经济分析工具的经济分析工具(Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model)来估计成本效益,该工具使用基于前瞻性收集的试验数据的个体患者模拟模型。数据于 2019 年 3 月 24 日至 2020 年 12 月 1 日进行分析。
康复干预或对照。
成本、质量调整生命年(QALYs)和终生估计每获得一个 QALY 的成本(增量成本效益比)。
在分析的 349 名患者中(183 名女性[52.4%];平均[标准差]年龄 72.7[8.1]岁;176 名非白人[50.4%]和 173 名白人[49.6%]),干预组患者的累积人均费用为 26421 美元(38955 美元)(不包括干预费用),对照组为 27650 美元(30712 美元)(差异,-1229 美元;95%置信区间,-8159 至 6394 美元;P=0.80)。干预的平均(标准差)成本为 4204 美元(2059 美元)。在 6 个月的时间里,干预组的生活质量增益明显大于对照组(平均效用差异,0.074;P=0.001),并且在 12 周的干预后仍持续存在。增量成本效益比估计在全队列和射血分数保留的患者中分别为 58409 美元和 35600 美元/每获得一个 QALY。
这些分析表明,这种新的康复干预措施的长期益处,特别是在射血分数保留的患者亚组中,可能对医疗保健系统具有良好的价值。然而,长期成本效益目前尚不确定,取决于假设益处持续超过研究随访期,这需要在这一患者群体的未来试验中得到证实。