Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study.
Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study.
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DOI：
10.1111/ner.12292
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发表时间：
2015-06
期刊：
影响因子：
--
通讯作者：
Mantovani LG
中科院分区：
文献类型：
--
作者：
Zucco F;Ciampichini R;Lavano A;Costantini A;De Rose M;Poli P;Fortini G;Demartini L;De Simone E;Menardo V;Cisotto P;Meglio M;Scalone L;Mantovani LG
旨在评估脊髓电刺激（SCS）在传统医疗管理（CMM）难治性腰椎手术失败综合征（FBSS）患者中的成本效益和成本效用。我们进行了一项观察性、多中心、纵向双向研究，在9家意大利中心招募了预期接受SCS+CMM治疗的CMM难治性主要腿部疼痛患者，并在SCS后随访24个月。我们收集了SCS干预前（SCS前）和SCS干预后（SCS后）的临床状态（疼痛强度、残疾）、健康相关生活质量（HRQoL）以及直接和间接成本数据。成本量化在2009年欧元，采用国家卫生服务（NHS），病人和社会的观点。比较SCS前与SCS后的受益和成本，以估计增量成本效益和成本效用比。招募了80例患者（40%为男性，平均年龄58岁）。在基线和SCS后24个月之间，临床结局和HRQoL显著改善。EQ-5D效用指数从0.421增加至0.630（p < 0.0001）。SCS术后6个月首次观察到统计学显著改善。社会成本从每例患者每年6600欧元（SCS前）增加至13，200欧元（SCS后）。因此，成本效用可接受性曲线表明，根据NHS和社会观点，如果决策者愿意为每个质量调整生命年（Qs）支付60，000欧元，则SCS植入术在80%和85%的病例中具有成本效益。我们的研究结果表明，在临床实践中，SCS+CMM治疗CMM难治性FBSS患者提供了良好的性价比。鼓励以更大规模、长期研究的形式进行进一步研究。
To assess the cost‐effectiveness and cost‐utility of Spinal Cord Stimulation (SCS) in patients with failed back surgery syndrome (FBSS) refractory to conventional medical management (CMM). We conducted an observational, multicenter, longitudinal ambispective study, where patients with predominant leg pain refractory to CMM expecting to receive SCS+CMM were recruited in 9 Italian centers and followed up to 24 months after SCS. We collected data on clinical status (pain intensity, disability), Health‐Related Quality‐of‐Life (HRQoL) and on direct and indirect costs before (pre‐SCS) and after (post‐SCS) the SCS intervention. Costs were quantified in € 2009, adopting the National Health Service's (NHS), patient and societal perspectives. Benefits and costs pre‐SCS versus post‐SCS were compared to estimate the incremental cost‐effectiveness and cost utility ratios. 80 patients (40% male, mean age 58 years) were recruited. Between baseline and 24 months post‐SCS, clinical outcomes and HRQoL significantly improved. The EQ‐5D utility index increased from 0.421 to 0.630 (p < 0.0001). Statistically significant improvement was first observed six months post‐SCS. Societal costs increased from €6600 (pre‐SCS) to €13,200 (post‐SCS) per patient per year. Accordingly, the cost‐utility acceptability curve suggested that if decision makers' willingness to pay per Quality‐Adjusted‐Life‐Years (QALYs) was €60,000, SCS implantation would be cost‐effective in 80% and 85% of cases, according to the NHS's and societal point of views, respectively. Our results suggest that in clinical practice, SCS+CMM treatment of FBSS patients refractory to CMM provides good value for money. Further research is encouraged in the form of larger, long‐term studies.
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