Clarke Leigh, Shiell Alan, Dillon Michael P
Discipline of Prosthetics and Orthotics, Department of Physiotherapy, Podiatry, Prosthetics and Orthotics, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC, 3086, Australia.
Department of Public Health, School of Psychology and Public Health, La Trobe University, Melbourne, VIC, 3086, Australia.
Cost Eff Resour Alloc. 2025 Apr 12;23(1):15. doi: 10.1186/s12962-025-00611-1.
Health Economic Evaluations (HEEs) provide the necessary evidence of cost-benefit to inform policy and investment decisions. No HEEs have quantified the cost-benefit of passive suction (PS) vs vacuum assisted suction (VAS) suspension for trans-tibial prosthesis users. There are methodological challenges to conducting HEE in prosthetics given the benefit measures are not focused on the things most important to prosthesis users and funders, and the required time horizons are lengthy. To address these challenges, we propose a pilot study using two PROMIS instruments to measure benefits and trial the use of a Synthetic Cohort Method, to quantify the cost-effectiveness and cost-utility of PS and VAS suspension for people living with trans-tibial amputation.
An observational study will measure the costs and benefits of PS and VAS suspension for trans-tibial prosthesis users using a Synthetic Cohort Method, a technique used in epidemiological modelling of life-time risks. Each intervention will include 3 sub-groups, representing prosthesis users in the first, second, or third year of the intervention since fitting. A prosthetic payor perspective will be taken, with data collected over a 1-year period and synthesised to reflect the costs and benefits over a 3-year time horizon. Benefits will be measured using two PROMIS instruments reported to best measure the benefits most important to prosthesis users and funders. Costs will be calculated from actual billable costs to the funder. Costs and benefits will be discounted at 4%. Cost-effectiveness and cost-utility will be calculated using the incremental costs and incremental benefits, with results presented as incremental cost-effectiveness and incremental cost-utility ratios. Bootstrapping will be undertaken to assess uncertainty, and discounting will be analysed through a one-way sensitivity analysis.
This pilot will make a novel contribution by trailing the use of a Synthetic Cohort Method to reduce the lengthy time horizons required in prosthetic HEE. The HEE will use a two-pronged approach whereby cost-utility and cost-effectiveness are simultaneously evaluated using the PROMIS instruments to inform a wide range of policy and investment decisions. Additionally, this pilot will be the first HEE of suction suspension systems for people with transtibial amputation and will therefore make an important contribution to the prosthetic evidence base.
卫生经济评估（HEEs）提供成本效益的必要证据，以为政策和投资决策提供参考。尚无卫生经济评估对经胫假肢使用者的被动抽吸（PS）与真空辅助抽吸（VAS）悬吊的成本效益进行量化。鉴于效益衡量未聚焦于对假肢使用者和资助者最重要的事项，且所需的时间跨度较长，在假肢领域进行卫生经济评估存在方法学挑战。为应对这些挑战，我们提议开展一项试点研究，使用两种患者报告结局测量信息系统（PROMIS）工具来衡量效益，并试用合成队列法，以量化经胫截肢者使用PS和VAS悬吊的成本效益和成本效用。
一项观察性研究将使用合成队列法（一种用于终生风险流行病学建模的技术）来衡量经胫假肢使用者使用PS和VAS悬吊的成本和效益。每种干预措施将包括3个亚组，分别代表安装假肢后干预第1年、第2年或第3年的假肢使用者。将采用假肢支付方的视角，收集1年期间的数据并进行综合分析，以反映3年时间跨度内的成本和效益。效益将使用两种据报道能最佳衡量对假肢使用者和资助者最重要效益的PROMIS工具进行衡量。成本将根据向资助者收取的实际可计费成本进行计算。成本和效益将按4%进行贴现。成本效益和成本效用将使用增量成本和增量效益进行计算，结果以增量成本效益比和增量成本效用比表示。将采用自举法评估不确定性，并通过单向敏感性分析对贴现进行分析。
该试点将通过试用合成队列法以缩短假肢卫生经济评估所需的漫长时间跨度，做出新颖贡献。该卫生经济评估将采用双管齐下的方法，即使用PROMIS工具同时评估成本效用和成本效益，以为广泛的政策和投资决策提供参考。此外，该试点将是首例针对经胫截肢者的抽吸悬吊系统的卫生经济评估，因此将对假肢证据库做出重要贡献。
