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基于患者报告结局的远程监测和预警干预在关节置换后早期发现关键康复中的成本效益:一项随机对照试验。

Cost-effectiveness of a patient-reported outcome-based remote monitoring and alert intervention for early detection of critical recovery after joint replacement: A randomised controlled trial.

机构信息

Department of Health Care Management, Technische Universität Berlin, Berlin, Germany.

Chair of Health Economics, Policy and Management, School of Medicine, University of St. Gallen, St. Gallen Switzerland.

出版信息

PLoS Med. 2024 Oct 9;21(10):e1004459. doi: 10.1371/journal.pmed.1004459. eCollection 2024 Oct.

Abstract

BACKGROUND

While the effectiveness of patient-reported outcome measures (PROMs) as an intervention to impact patient pathways has been established for cancer care, it is unknown for other indications. We assessed the cost-effectiveness of a PROM-based monitoring and alert intervention for early detection of critical recovery paths following hip and knee replacement.

METHODS AND FINDINGS

The cost-effectiveness analysis (CEA) is based on a multicentre randomised controlled trial encompassing 3,697 patients with hip replacement and 3,110 patients with knee replacement enrolled from 2019 to 2020 in 9 German hospitals. The analysis was conducted with a subset of 546 hip and 492 knee replacement cases with longitudinal cost data from 24 statutory health insurances. Patients were randomised 1:1 to a PROM-based remote monitoring and alert intervention or to a standard care group. All patients were assessed at 12-months post-surgery via digitally collected PROMs. Patients within the intervention group were additionally assessed at 1-, 3-, and 6-months post-surgery to be contacted in case of critical recovery paths. For the effect evaluation, a PROM-based composite measure (PRO-CM) was developed, combining changes across various PROMs in a single index ranging from 0 to 100. The PRO-CM included 6 PROMs focused on quality of life and various aspects of physical and mental health. The primary outcome was the incremental cost-effectiveness ratio (ICER). The intervention group showed incremental outcomes of 2.54 units PRO-CM (95% confidence interval (CI) [0.93, 4.14]; p = 0.002) for patients with hip and 0.87 (95% CI [-0.94, 2.67]; p = 0.347) for patients with knee replacement. Within the 12-months post-surgery period the intervention group had less costs of 376.43€ (95% CI [-639.74, -113.12]; p = 0.005) in patients with hip, and 375.50€ (95% CI [-767.40, 16.39]; p = 0.060) in patients with knee replacement, revealing a dominant ICER for both procedures. However, it remains unclear which step of the multistage intervention contributes most to the positive effect.

CONCLUSIONS

The intervention significantly improved patient outcomes at lower costs in patients with hip replacements when compared with standard care. Further it showed a nonsignificant cost reduction in knee replacement patients. This reinforces the notion that PROMs can be utilised as a cost-effective instrument for remote monitoring in standard care settings.

TRIAL REGISTRATION

Registration: German Register for Clinical Studies (DRKS) under DRKS00019916.

摘要

背景

虽然患者报告结局测量(PROMs)作为一种干预措施来影响患者路径的有效性已经在癌症护理中得到证实,但在其他适应症中尚不清楚。我们评估了基于 PROM 的监测和警报干预措施在髋关节和膝关节置换后早期发现关键康复路径方面的成本效益。

方法和发现

成本效益分析(CEA)基于一项多中心随机对照试验,该试验纳入了 2019 年至 2020 年期间来自德国 9 家医院的 3697 例髋关节置换和 3110 例膝关节置换患者。该分析是基于 24 家法定健康保险公司的 546 例髋关节和 492 例膝关节置换病例的纵向成本数据进行的。患者按 1:1 随机分配至基于 PROM 的远程监测和警报干预组或标准护理组。所有患者在手术后 12 个月通过数字收集的 PROM 进行评估。干预组的患者在手术后 1、3 和 6 个月额外进行评估,如果发现关键康复路径,将与他们联系。对于效果评估,开发了基于 PROM 的综合测量(PRO-CM),该测量将各种 PROM 中的变化组合在一个从 0 到 100 的单一指数中。PRO-CM 包括 6 个专注于生活质量以及身心健康各个方面的 PROM。主要结局是增量成本效益比(ICER)。干预组在髋关节患者中表现出 2.54 个单位的 PRO-CM(95%置信区间(CI)[0.93, 4.14];p = 0.002),在膝关节患者中表现出 0.87 个单位(95%CI [-0.94, 2.67];p = 0.347)。在手术后 12 个月期间,干预组髋关节患者的成本降低了 376.43 欧元(95%CI [-639.74, -113.12];p = 0.005),膝关节患者的成本降低了 375.50 欧元(95%CI [-767.40, 16.39];p = 0.060),这表明两种手术的 ICER 均具有优势。然而,目前尚不清楚多阶段干预措施的哪个步骤对积极效果贡献最大。

结论

与标准护理相比,该干预措施在髋关节置换患者中显著提高了患者的治疗效果,同时降低了成本。它还显示出膝关节置换患者的成本降低,但无统计学意义。这进一步证实了 PROM 可以作为一种经济有效的远程监测工具,用于标准护理环境。

试验注册

德国临床试验注册中心(DRKS),DRKS00019916。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abf6/11463742/5980df6c38cd/pmed.1004459.g001.jpg

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