Department of Health Care Management, Institute of Technology and Management, Technische Universität Berlin, Straße des 17. Juni 135, 10623, Berlin, Germany.
Planetary & Public Health, University of Bayreuth, Universitätsstraße 30, 95447, Bayreuth, Germany.
BMC Geriatr. 2024 Mar 6;24(1):231. doi: 10.1186/s12877-024-04833-5.
Prehabilitation aims to improve patients' functional capacity before surgery to reduce perioperative complications, promote recovery and decrease probability of disability. The planned economic evaluation is performed alongside a large German multi-centre pragmatic, two-arm parallel-group, randomized controlled trial on prehabilitation for frail elderly patients before elective surgery compared to standard care (PRAEP-GO RCT). The aim is to determine the cost-effectiveness and cost-utility of prehabilitation for frail elderly before an elective surgery.
The planned health economic evaluation comprises cost-effectiveness, and cost-utility analyses. Analyses are conducted in the German context from different perspectives including the payer perspective, i.e. the statutory health insurance, the societal perspective and the health care provider perspective. Data on outcomes and costs, are collected alongside the ongoing PRAEP-GO RCT. The trial population includes frail or pre-frail patients aged ≥70 years with planned elective surgery. The intervention consists of frailty screening (Fried phenotype), a shared decision-making conference determining modality (physiotherapy and unsupervised physical exercises, nutrition counselling, etc.) and setting (inpatient, day care, outpatient etc.) of a 3-week individual multimodal prehabilitation prior to surgery. The control group receives standard preoperative care. Costs include the intervention costs, the costs of the index hospital stay for surgery, and health care resources consumed during a 12-month follow-up. Clinical effectiveness outcomes included in the economic evaluation are the level of care dependency, the degree of disability as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality-adjusted life years (QALY) derived from the EQ-5D-5L and the German utility set, and complications occurring during the index hospital stay. Each adopted perspective considers different types of costs and outcomes as outlined in the protocol. All analyses will feature Intention-To-Treat analysis. To explore methodological and parametric uncertainties, we will conduct probabilistic and deterministic sensitivity analyses. Subgroup analyses will be performed as secondary analyses.
The health economic evaluation will provide insights into the cost-effectiveness of prehabilitation in older frail populations, informing decision-making processes and contributing to the evidence base in this field. Potential limitation includes a highly heterogeneous trial population.
PRAEP-GO RCT: NCT04418271; economic evaluation: OSF ( https://osf.io/ecm74 ).
术前预康复旨在提高患者手术前的功能能力，以减少围手术期并发症，促进康复并降低残疾的可能性。该计划的经济评估是与一项大型德国多中心实用、双臂平行组、随机对照试验同时进行的，该试验比较了术前虚弱老年患者的预康复与标准护理（PRAEP-GO RCT）。目的是确定术前虚弱老年患者预康复的成本效益和成本效用。
计划中的健康经济评估包括成本效益和成本效用分析。分析在德国语境下，从不同视角进行，包括付款人视角（法定健康保险）、社会视角和医疗保健提供者视角。结果和成本数据与正在进行的 PRAEP-GO RCT 同时收集。试验人群包括计划接受择期手术的 70 岁以上虚弱或衰弱前期患者。干预措施包括虚弱筛查（Fried 表型）、确定模式（物理治疗和非监督体育锻炼、营养咨询等）和设定（住院、日间护理、门诊等）的 3 周个体化多模式术前预康复的共同决策会议。对照组接受标准术前护理。成本包括干预成本、手术住院期间的医院费用以及 12 个月随访期间消耗的医疗资源。经济评估中包含的临床有效性结果包括护理依赖程度、世界卫生组织残疾评估表 2.0（WHODAS 2.0）测量的残疾程度、质量调整生命年（QALY）来自 EQ-5D-5L 和德国效用集，以及索引住院期间发生的并发症。每个采用的视角都考虑了协议中概述的不同类型的成本和结果。所有分析都将采用意向治疗分析。为了探索方法学和参数不确定性，我们将进行概率和确定性敏感性分析。亚组分析将作为次要分析进行。
健康经济评估将提供关于老年虚弱人群预康复成本效益的见解，为决策过程提供信息，并为该领域的证据基础做出贡献。潜在的限制包括试验人群高度异质。
PRAEP-GO RCT：NCT04418271；经济评估：OSF（https://osf.io/ecm74）。
