Health Economics Research Unit, University of Aberdeen, Aberdeen, UK; Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
BJU Int. 2013 Dec;112(8):1169-77. doi: 10.1111/bju.12388.
OBJECTIVES: To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust(®) , C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O™, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence. PATIENTS AND METHODS: A total of 137 women, in a secondary care setting, were randomized between October 2009 and October 2011 to undergo SIMS placement (n = 69) under local anaesthesia as an opt-out policy or SMUS placement (n = 68) under general anaesthesia. Clinical outcome measures included the patient-reported success rate (Patient Global Impression of Improvement [PGI-I]) and the impact on the patients' QoL (King's Health Questionnaire [KHQ]). Health economic data (cost and quality-adjusted life year [QALY] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness. RESULTS: There were no significant differences between the groups in terms of the KHQ total score (P = 0.27) or the patient-reported success rate (P = 1.00, odds ratio: 0.895; 95% confidence interval [CI]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: -0.003; 95% CI: -0.008 to +0.002). The SIMS was on average less costly, -£142.41 95% CI: (-316.99 to 32.17) and generated cost savings of £48 419 per QALY loss with 94% probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group (P = 0.006, 95% CI: 11.756 to 17.217), there was an increase in cost savings to -£477, (95% CI: -823.65 to -129.63), with a probability of 100% of cost savings to the wider economy. CONCLUSIONS: The adjustable anchored SIMS (Ajust), performed under local anaesthesia as an opt-out policy, delivers cost savings to the health service provider when compared with the SMUS (TVT-O), and is likely to be cost-effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow-up and should explore patient preferences alongside an adequately powered non-inferiority randomized controlled trial.
目的:评估单切口迷你吊带(SIMS;Ajust ® ,C. R. Bard Inc.,新泽西州普林斯顿)与标准中尿道吊带(SMUS;TVT-O™,Ethicon Inc.,新泽西州Somerville)在女性压力性尿失禁的手术治疗中的成本、生活质量(QoL)和成本效益。
患者和方法:共有 137 名女性在二级保健机构中于 2009 年 10 月至 2011 年 10 月间随机分为 SIMS 组(n=69),接受局部麻醉下的 SIMS 置入术,作为一种选择退出政策,或 SMUS 组(n=68),接受全身麻醉下的 SMUS 置入术。临床结局测量包括患者报告的成功率(患者总体印象改善[PGI-I])和对患者 QoL 的影响(King's 健康问卷[KHQ])。使用线性回归模型比较健康经济学数据(成本和质量调整生命年[QALY]数据),以生成增量成本每 QALY 估计值,以确定成本效益的衡量标准。确定性敏感性分析调查了结果的不确定性,并且使用非参数引导技术来估计成本效益的概率。
结果:两组在 KHQ 总分(P=0.27)或患者报告的成功率(P=1.00,优势比:0.895;95%置信区间[CI]:0.344 至 2.330)方面均无显著差异。与 SMUS 组相比,SIMS 组的 QALY 无显著差异(平均差异:-0.003;95%CI:-0.008 至 +0.002)。SIMS 平均成本较低,-£142.41(95%CI:-316.99 至 32.17),并且每 QALY 损失节省 £48419,94%的可能性为卫生服务节省成本。通过对成本分析进行更广泛的视角,包括与 SIMS 组更早返回工作相关的更广泛的社区效益(P=0.006,95%CI:11.756 至 17.217),成本节省增加至-£477(95%CI:-823.65 至-129.63),更广泛的经济节省成本的可能性为 100%。
结论:当与 SMUS(TVT-O)相比时,可调节锚定的单切口迷你吊带(Ajust)在局部麻醉下作为一种选择退出政策,可为医疗服务提供者节省成本,并且在放置后 1 年内可能具有成本效益。应进行进一步的研究,以在更长的随访时间内确认我们研究的结果,并应在适当的非劣效性随机对照试验的基础上,探讨患者的偏好。
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