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近期心力衰竭出院患者的家庭远程监测或结构化电话支持计划:系统评价和经济评估。

Home telemonitoring or structured telephone support programmes after recent discharge in patients with heart failure: systematic review and economic evaluation.

机构信息

School of Health and Related Research, University of Sheffield, Sheffield, UK.

出版信息

Health Technol Assess. 2013 Aug;17(32):1-207, v-vi. doi: 10.3310/hta17320.

DOI:10.3310/hta17320
PMID:23927840
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4781365/
Abstract

BACKGROUND

Remote monitoring (RM) strategies have the potential to deliver specialised care and management to patients with heart failure (HF).

OBJECTIVE

To determine the clinical effectiveness and cost-effectiveness of home telemonitoring (TM) or structured telephone support (STS) strategies compared with usual care for adult patients who have been recently discharged (within 28 days) from acute care after a recent exacerbation of HF.

DATA SOURCES

Fourteen electronic databases (including MEDLINE, EMBASE, PsycINFO and The Cochrane Library) and research registers were searched to January 2012, supplemented by hand-searching relevant articles and contact with experts. The review included randomised controlled trials (RCTs) or observational cohort studies with a contemporaneous control group that included the following RM interventions: (1) TM (including cardiovascular implanted monitoring devices) with medical support provided during office hours or 24/7; (2) STS programmes delivered by human-to-human contact (HH) or human-to-machine interface (HM).

REVIEW METHODS

A systematic review and network meta-analysis (where appropriate) of the clinical evidence was carried out using standard methods. A Markov model was developed to evaluate the cost-effectiveness of different RM packages compared with usual care for recently discharged HF patients. TM 24/7 or using cardiovascular monitoring devices was not considered in the economic model because of the lack of data and/or unsuitability for the UK setting. Given the heterogeneity in the components of usual care and RM interventions, the cost-effectiveness analysis was performed using a set of costing scenarios designed to reflect the different configurations of usual care and RM in the UK.

RESULTS

The literature searches identified 3060 citations. Six RCTs met the inclusion criteria and were added to the 15 trials identified from the previous systematic reviews giving a total of 21 RCTs included in the systematic review. No trials of cardiovascular implanted monitoring devices or observational studies met the inclusion criteria. The methodological quality of the studies varied widely and reporting was generally poor. Compared with usual care, RM was beneficial in reducing all-cause mortality for STS HH [hazard ratio (HR) 0.77, 95% credible interval (CrI) 0.55 to 1.08], TM during office hours (HR 0.76, 95% CrI 0.49 to 1.18) and TM 24/7 (HR 0.49, 95% CrI 0.20 to 1.18); however, these results were statistically inconclusive. The results for TM 24/7 should be treated with caution because of the poor methodological quality of the only included study in this network. No favourable effect on mortality was observed with STS HM. Similar reductions were observed in all-cause hospitalisations for TM interventions, whereas STS interventions had no major effect. A sensitivity analysis, in which a study was excluded because it provided better-than-usual support to the control group, showed larger beneficial effects for most outcomes, particularly for TM during office hours. In the cost-effectiveness analyses, TM during office hours was the most cost-effective strategy with an estimated incremental cost-effectiveness ratio (ICER) of £11,873 per quality-adjusted life-year (QALY) compared with usual care, whereas STS HH had an ICER of £228,035 per QALY compared with TM during office hours. STS HM was dominated by usual care. Similar results were observed in scenario analyses performed using higher costs of usual care, higher costs of STS HH and lower costs of TM during office hours.

LIMITATIONS

The RM interventions included in the review were heterogeneous in terms of monitored parameters and HF selection criteria and lacked detail in the components of the RM care packages and usual care (e.g. communication protocols, routine staff visits and resources used). As a result, the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods. Although the users can decide which of these scenarios is most representative of their setting, uncertainties still remain about the assumptions made in the estimation of these costs. In addition, the model assumed that the effectiveness of the interventions was constant over time, irrespective of the duration of deployment, and that the intervention was equally effective in different age/severity groups.

CONCLUSION

Despite wide variation in usual care and RM strategies, cost-effectiveness analyses suggest that TM during office hours was an optimal strategy (in most costing scenarios). However, clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs. Further research is needed in these areas.

STUDY REGISTRATION

PROSPERO registration no. CRD42011001368.

FUNDING

The National Institute for Health Research Health Technology Assessment programme.

摘要

背景

远程监测(RM)策略有可能为心力衰竭(HF)患者提供专门的护理和管理。

目的

确定家庭远程监测(TM)或结构化电话支持(STS)策略与常规护理相比,对最近急性加重后出院(28 天内)的成年患者的临床效果和成本效益。

数据来源

14 个电子数据库(包括 MEDLINE、EMBASE、PsycINFO 和 The Cochrane Library)和研究登记处,截至 2012 年 1 月,补充了相关文章的手工搜索和与专家的联系。该综述包括随机对照试验(RCT)或具有同期对照组的观察性队列研究,包括以下 RM 干预措施:(1)TM(包括心血管植入监测设备),医疗支持在办公时间或 24/7 提供;(2)STS 计划通过人与人之间的联系(HH)或人与机器之间的接口(HM)提供。

研究方法

使用标准方法对临床证据进行系统评价和网络荟萃分析(如适用)。开发了一个马尔可夫模型,以评估不同 RM 包与常规护理相比对最近出院 HF 患者的成本效益。由于数据缺乏和/或不适合英国环境,TM 24/7 或使用心血管监测设备未在经济模型中考虑。鉴于常规护理和 RM 干预措施的组成部分存在异质性,使用一组成本核算方案进行成本效益分析,这些方案旨在反映英国常规护理和 RM 的不同配置。

结果

文献检索共检索到 3060 篇引文。六项 RCT 符合纳入标准,并从之前的系统评价中添加了 15 项试验,共纳入 21 项 RCT 进行系统评价。没有心血管植入监测设备的试验或观察性研究符合纳入标准。研究的方法学质量差异很大,报告通常很差。与常规护理相比,STS HH 降低了所有原因死亡率(HR 0.77,95%可信区间(CrI)0.55 至 1.08),TM 办公时间(HR 0.76,95% CrI 0.49 至 1.18)和 TM 24/7(HR 0.49,95% CrI 0.20 至 1.18);然而,这些结果在统计学上没有定论。由于只有一项纳入的研究网络中的网络质量较差,因此应谨慎对待 TM 24/7 的结果。STS HM 对死亡率没有有利影响。TM 干预措施也观察到全因住院率降低,而 STS 干预措施没有主要影响。一项敏感性分析排除了一项因向对照组提供更好支持而被排除的研究,结果表明,大多数结果,特别是 TM 办公时间,都有更大的有益效果。在成本效益分析中,TM 办公时间是最具成本效益的策略,与常规护理相比,估计增量成本效益比(ICER)为每质量调整生命年(QALY)11873 英镑,而 STS HH 与 TM 办公时间相比,ICER 为每 QALY 228035 英镑。STS HM 被常规护理所主导。使用更高的常规护理成本、STS HH 更高的成本和 TM 办公时间更低的成本进行情景分析也观察到了类似的结果。

局限性

综述中纳入的 RM 干预措施在监测参数和 HF 选择标准方面存在异质性,并且缺乏 RM 护理包和常规护理(例如,沟通协议、常规工作人员访问和使用的资源)的详细信息。因此,开发的经济模型为不同的 RM 分类及其成本制定了方案,并使用自下而上的成本核算方法估算了这些成本。尽管用户可以决定哪些方案最能代表他们的情况,但在估计这些成本时仍然存在不确定性。此外,该模型假设干预措施的有效性是恒定的,而不管部署的持续时间如何,并且干预措施在不同的年龄/严重程度组中同样有效。

结论

尽管常规护理和 RM 策略存在广泛差异,但成本效益分析表明,TM 办公时间是一种最优策略(在大多数成本核算方案中)。然而,RM 包和常规护理组件的描述缺乏清晰度,并且对成本的估计缺乏稳健性。需要在这些领域进行进一步研究。

研究注册

PROSPERO 注册编号 CRD42011001368。

资金来源

英国国家卫生研究院卫生技术评估计划。