Boisen Esben Bo, Cawson Matthew, de Fries Jensen Lasse, Mealing Stuart, van Hest Naomi
Coloplast A/S, Holtedam 1, 3050, Humlebæk, Denmark.
Coloplast Ltd., Peterborough, UK.
Pharmacoeconomics. 2025 May 6. doi: 10.1007/s40273-025-01498-9.
People with stomas report a substantial negative impact of stomal effluent leaking outside the ostomy baseplate and subsequent complications in their professional and social lives, causing immense worry. However, many patients are not able to recognize leakages in a timely manner. We conducted a cost-effectiveness study to evaluate the impact of a digital leakage notification system (DLNS) to reduce leakages outside the baseplate (LOB) and worry about leakage for people with intestinal stomas from a UK National Health Service and Personal Social Services perspective.
A Markov model for ostomy care was used to compare health-related quality of life and costs for adults with ileostomies or colostomies using UK standard of care ostomy products with the DLNS (intervention) or without the DLNS (comparator). The base case model used a 3-year time horizon with 1-week cycles and an annual 3.5% discounting of utilities and costs. Patients in all health states experience LOB events and/or worry about leakage as events associated with one-time utility decrements and costs of additional healthcare provider visits and ostomy product use. Probabilities of LOB (DLNS, 46.5%; comparator, 78.6%) and worry about leakage (DLNS, 39.1%; comparator, 78.6%) were based on clinical trial results. Peristomal skin complications were included in the model with the same probabilities of occurrence in the intervention and comparator arms. Sensitivity and scenario analyses were performed to test the robustness of the base case model assumptions.
In the base case analysis, the DLNS arm had 49.81 fewer LOB events per person than the comparator arm, resulting in 0.309 incremental quality-adjusted life-years (QALYs) and cost savings of British Pound Sterling (GBP) £1703 per person over 3 years (2023/2024 costing year). The DLNS arm had 56.98 fewer worry about leakage events per person, resulting in cost savings of £403 per person. Total costs and QALYs were £18,600 and 1.818 for the intervention arm, respectively, and £18,566 and 1.509 for the comparator arm. Overall, the DLNS provided 0.309 incremental QALYs at an incremental cost of £34 versus the comparator arm for an incremental cost-effectiveness ratio of £110/QALY gained, well below a willingness-to-pay threshold of £20,000/QALY. Sensitivity analyses showed the DLNS was cost-effective in 97.6% of simulations.
This analysis suggests that the DLNS added to standard of care ostomy products is a cost-effective intervention to help prevent LOB events and reduce worry about leakage for people with stomas in the UK. Results of the present study suggest that timely awareness of leakage has a positive impact on the health-related quality of life of people with stomas and on the direct costs of stoma management in the UK.
造口患者报告称，造口排泄物从造口底盘外漏及其在职业和社会生活中引发的后续并发症会产生重大负面影响，令人极为担忧。然而，许多患者无法及时察觉渗漏情况。我们开展了一项成本效益研究，从英国国家医疗服务体系和个人社会服务的角度，评估数字渗漏通知系统（DLNS）对减少肠道造口患者底盘外渗漏（LOB）及渗漏担忧的影响。
采用造口护理马尔可夫模型，比较使用英国标准护理造口产品并配备DLNS（干预组）或不配备DLNS（对照组）的回肠造口术或结肠造口术成年患者的健康相关生活质量和成本。基础病例模型采用3年时间范围，以1周为周期，效用和成本每年贴现3.5%。所有健康状态的患者都会经历LOB事件和/或担心渗漏，这些事件与一次性效用降低以及额外就医和使用造口产品的成本相关。LOB概率（DLNS为46.5%；对照组为78.6%）和渗漏担忧概率（DLNS为39.1%；对照组为78.6%）基于临床试验结果。造口周围皮肤并发症纳入模型，干预组和对照组发生概率相同。进行敏感性和情景分析以检验基础病例模型假设的稳健性。
在基础病例分析中，DLNS组每人的LOB事件比对照组少49.81起，在3年（2023/2024成本核算年度）内每人增加0.309个质量调整生命年（QALY），成本节省1703英镑。DLNS组每人的渗漏担忧事件少56.98起，每人成本节省403英镑。干预组的总成本和QALY分别为18,600英镑和1.818，对照组分别为18,566英镑和1.509。总体而言，与对照组相比，DLNS以34英镑的增量成本提供了0.309个增量QALY，增量成本效益比为每获得1个QALY花费110英镑，远低于20,000英镑/QALY的支付意愿阈值。敏感性分析表明，在97.6%的模拟中，DLNS具有成本效益。
该分析表明，在标准护理造口产品基础上增加DLNS是一种具有成本效益的干预措施，有助于预防英国造口患者的LOB事件并减少对渗漏的担忧。本研究结果表明，及时察觉渗漏对英国造口患者的健康相关生活质量和造口管理直接成本具有积极影响。
