Institute of Health Economics, Edmonton, Alberta, Canada.
BJOG. 2011 Apr;118(5):550-6. doi: 10.1111/j.1471-0528.2010.02845.x. Epub 2011 Feb 4.
To conduct an economic evaluation of the use of trans-obturator tape (TOT) compared with tension-free vaginal tape (TVT) in the surgical treatment of stress urinary incontinence (SUI) in women.
Cost utility analysis from public-payer perspective, conducted alongside a randomised clinical trial (RCT).
Health services provided in Alberta, Canada.
A total of 194 women who participated in the RCT, followed to 1 year from surgery.
Data collected on all women in the RCT, over 12 months following surgery. Comparisons undertaken between RCT groups for cost and quality-adjusted life-years (QALYs). Multiple imputation used for the 10% missing data. Bootstrapping used to account for sampling uncertainty. One-way sensitivity analysis conducted for productivity loss due to time away from work.
Utility--15D questionnaire was used to calculate QALYs. Costs over 12 months--from trial data, health provider and provincial ministry of health.
The TOT group had a non-significant average saving of $1133 (95% CI -2793; 442), with no difference in average QALYs between groups (95% CI -0.02; 0.01). TOT was cost-saving in over 80% of bootstrapping replications, over a wide range of willingness-to-pay.
The bootstrapping replication results suggest that TOT could be cost-effective compared with TVT in the treatment of SUI. However, these results must be confirmed by longer-term assessment of clinical and economic outcomes, because of concern that surgical tape palpable at 12 months may lead to vaginal erosion and further treatment.
对经闭孔吊带(TOT)与无张力阴道吊带(TVT)治疗女性压力性尿失禁(SUI)的效果进行经济学评价。
从公共支付方角度进行成本效用分析,与随机临床试验(RCT)同时进行。
加拿大艾伯塔省提供的医疗服务。
共有 194 名参加 RCT 的女性,随访至术后 1 年。
收集所有参加 RCT 的女性在术后 12 个月的数据。对 RCT 组间的成本和质量调整生命年(QALYs)进行比较。对于 10%缺失的数据采用多重插补法。采用 bootstrap 法对抽样不确定性进行校正。对于因离开工作岗位而导致的生产力损失进行单因素敏感性分析。
采用 15D 问卷来计算效用。12 个月的成本:来自试验数据、医疗服务提供者和省级卫生部。
TOT 组的平均节省额为 1133 美元(95%CI-2793;442),但两组间的平均 QALY 无差异(95%CI-0.02;0.01)。在 bootstrap 复制的 80%以上情况下,TOT 的成本均低于 TVT,且在支付意愿的广泛范围内均具有成本效益。
bootstrap 复制结果表明,TOT 治疗 SUI 的效果可能优于 TVT,但由于担心术后 12 个月时可触及的手术吊带会导致阴道侵蚀和进一步治疗,需要通过对临床和经济结局的更长期评估来证实这些结果。