Cost-effectiveness of bioimpedance-guided fluid management in patients undergoing haemodialysis: the BISTRO RCT.

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Mandana Zanganeh, John Belcher, James Fotheringham, David Coyle, Elizabeth J Lindley, David F Keane, Fergus J Caskey, Indranil Dasgupta, Andrew Davenport, Ken Farrington, Sandip Mitra, Paula Ormandy, Martin Wilkie, Jamie H Macdonald, Ivonne Solis-Trapala, Julius Sim, Simon J Davies, Lazaros Andronis
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引用次数: 0

Abstract

Background: The BioImpedance Spectroscopy to maintain Renal Output randomised controlled trial investigated the effect of bioimpedance spectroscopy added to a standardised fluid management protocol on the risk of anuria and preservation of residual kidney function (primary trial outcomes) in incident haemodialysis patients. Despite the economic burden of kidney disease, the cost-effectiveness of using bioimpedance measurements to guide fluid management in haemodialysis is not known.

Objectives: To assess the cost-effectiveness of bioimpedance-guided fluid management against current fluid management without bioimpedance.

Design: Within-trial economic evaluation (cost-utility analysis) carried out alongside the open-label, multicentre BioImpedance Spectroscopy to maintain Renal Output randomised controlled trial.

Setting: Thirty-four United Kingdom outpatient haemodialysis centres, both main and satellite units, and their associated inpatient hospitals.

Participants: Four hundred and thirty-nine adult haemodialysis patients with > 500 ml urine/day or residual glomerular filtration rate > 3 ml/minute/1.73 m2.

Intervention: The study intervention was the incorporation of bioimpedance technology-derived information about body composition into the clinical assessment of fluid status in patients with residual kidney function undergoing haemodialysis. Bioimpedance measurements were used in conjunction with usual clinical judgement to set a target weight that would avoid excessive fluid depletion at the end of a dialysis session.

Main outcome measures: The primary outcome measure of the BioImpedance Spectroscopy to maintain Renal Output economic evaluation was incremental cost per additional quality-adjusted life-year gained over 24 months following randomisation. In the main (base-case) analysis, this was calculated from the perspective of the National Health Service and Personal Social Services. Sensitivity analyses explored the impact of different scenarios, sources of resource use data and value sets.

Results: The bioimpedance-guided fluid management group was associated with £382 lower average cost per patient (95% CI -£3319 to £2556) and 0.043 more quality-adjusted life-years (95% CI -0.019 to 0.105) compared with the current fluid management group, with neither values being statistically significant. The probability of bioimpedance-guided fluid management being cost-effective was 76% and 83% at commonly cited willingness-to-pay threshold of £20,000 and £30,000 per quality-adjusted life-year gained, respectively. The results remained robust to a series of sensitivity analyses.

Limitations: The missing data level was high for some resource use categories collected through case report forms, due to COVID-19 disruptions and a significant dropout rate in the informing BioImpedance Spectroscopy to maintain Renal Output trial.

Conclusions: Compared with current fluid management, bioimpedance-guided fluid management produced a marginal reduction in costs and a small improvement in quality-adjusted life-years. Results from both the base-case and sensitivity analyses suggested that use of bioimpedance is likely to be cost-effective.

Future work: Future work exploring the association between primary outcomes and longer-term survival would be useful. Should an important link be established, and relevant evidence becomes available, it would be informative to determine whether and how this might affect longer-term costs and benefits associated with bioimpedance-guided fluid management.

Funding details: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number HTA 14/216/01 (NIHR136142).

生物阻抗指导血液透析患者液体管理的成本效益:BISTRO RCT。
背景:生物阻抗分光光度法维持肾排出量随机对照试验调查了在标准化液体管理方案中加入生物阻抗分光光度法对血液透析患者无尿风险和残余肾功能保存(主要试验结果)的影响。尽管肾病造成了经济负担,但使用生物阻抗测量来指导血液透析中的液体管理的成本效益尚不清楚:评估在生物阻抗指导下进行液体管理与目前不使用生物阻抗进行液体管理的成本效益:设计:在开放标签、多中心生物阻抗频谱仪维持肾排出量随机对照试验的同时进行试验内经济评估(成本效用分析):环境:英国 34 家门诊血液透析中心(包括主透析中心和附属透析中心)及其相关住院医院:四百三十九名成人血液透析患者,尿量大于 500 毫升/天或残余肾小球滤过率大于 3 毫升/分钟/1.73 平方米:研究干预措施是将生物阻抗技术获得的身体成分信息纳入对接受血液透析的残余肾功能患者体液状况的临床评估中。生物阻抗测量结果与通常的临床判断相结合,设定目标体重,以避免透析疗程结束时体液消耗过多:生物阻抗能谱法维持肾排出量经济评估的主要结果指标是随机化后 24 个月内每增加一个质量调整生命年的增量成本。在主要(基本情况)分析中,这是从国民健康服务和个人社会服务的角度进行计算的。敏感性分析探讨了不同方案、资源使用数据来源和价值集的影响:结果:与目前的输液管理组相比,生物阻抗指导下的输液管理组每名患者的平均成本降低了 382 英镑(95% CI -3319 英镑至 2556 英镑),质量调整生命年增加了 0.043 年(95% CI -0.019 至 0.105 年),这两个数值均无统计学意义。在通常引用的支付意愿阈值(每质量调整生命年收益 2 万英镑和 3 万英镑)下,生物阻抗引导的输液管理具有成本效益的概率分别为 76% 和 83%。这些结果在一系列敏感性分析中仍保持稳健:局限性:由于 COVID-19 试验的中断以及生物阻抗频谱仪维持肾排出量试验的显著辍学率,通过病例报告表收集的某些资源使用类别的数据缺失率较高:结论:与目前的输液管理相比,生物阻抗指导下的输液管理成本略有降低,质量调整生命年略有改善。基础案例分析和敏感性分析的结果表明,使用生物阻抗可能具有成本效益:未来的工作:探索主要结果与长期生存之间的联系将是有益的。如果建立了重要联系并获得了相关证据,那么确定这是否以及如何影响与生物阻抗指导下输液管理相关的长期成本和效益将是很有意义的:本文是由美国国家健康与护理研究所(NIHR)健康技术评估项目资助的独立研究,获奖编号为HTA 14/216/01 (NIHR136142)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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