Economic Analysis of the Urinary Incontinence Treatment Network Trials (E-UITN)

描述(由申请人提供)：尿失禁(UI)是女性中的常见问题，会导致痛苦并限制日常活动。尿失禁的成本是巨大的，在美国每年占300亿美元，比所有乳腺癌和妇科癌症的总和还要多。大小便失禁大大降低了生活质量，与阿尔茨海默病和中风一样，与健康状况严重受损有关。 为了评估女性尿失禁常用治疗的长期结果，NIDDK赞助了尿失禁治疗网络(UITN)。UITN正在进行两项随机临床试验，比较应激性尿失禁手术的治愈率，以及一项评估药物与药物加行为疗法治疗应激性尿失禁疗效的试验。 虽然大小便失禁的干预费用高昂，但它们有可能改善尿失禁，降低相关成本，提高生活质量。然而，这些干预措施的健康益处值得付出这些代价吗？这项名为《UITN的经济分析》(E-UITN)的研究目的是比较每项UITN试验中两种干预措施的成本和健康收益。具体目标是：1)描述尿失禁治疗对尿失禁成本和健康相关生活质量的影响；2)评估治疗后尿失禁成本和健康相关生活质量变化的预测因素；3)估计成本效益(每次治疗成功的增量成本，由每次试验定义)；4)估计替代干预措施的相关性(即，每质量调整生命年的增量成本)。主要的成本-效用分析将是从社会角度进行的试验内意向治疗分析，时间跨度为两年。其他协作性分析将使用终生时间范围，并包括疾病建模以评估终生成本和收益。尿失禁的高经济和生活质量成本，以及每项研究中治疗效果不同的可能性，使这一领域成为成本-效用分析的重要领域。由于公用事业获取了所有潜在的与健康相关的好处，成本效用分析是检验这一假设的理想方法，该假设认为，更昂贵的干预措施将具有与当前接受的医疗干预措施相当的每QALY增量成本。 E-UITN提供了一个有效的机会来调查治疗尿失禁的成本和成本效用。这项研究汇集了一群在经济学、成本效益和尿失禁治疗方面具有专业知识的高级调查人员。E-UITN将为常用的尿失禁治疗提供关键的经济数据。

DESCRIPTION (provided by applicant): Urinary incontinence (UI) is a common problem among women, causing distress and limiting daily activities. The costs of UI are substantial, accounting for $30 billion per year in the U.S., more than for all breast and gynecological cancers combined. Incontinence substantially decreases quality of life and is associated with severely impaired rating of health status similar to Alzheimer's disease and stroke. To evaluate the long-term outcomes of commonly used treatments for female UI, the NIDDK is sponsoring the Urinary Incontience Treatment Network (UITN). The UITN is conducting two randomized clinical trials comparing cure rates of surgeries for stress UI and one trial evaluating the efficacy of drug vs. drug plus behavioral therapy for urge UI. Although interventions for incontinence are costly, they have the potential to improve UI, decrease associated costs and improve quality of life. Yet, are the health benefits of the interventions worth the costs? The goal of this study, the Economic Analyses of the UITN (E-UITN), is to compare the costs and health benefits of the two interventions in each UITN trial. The specific aims are to 1) describe the effect of UI treatment on UI costs and health-related quality of life; 2) assess predictors of changes in UI costs and health-related quality of life following treatment; 3) estimate the cost-effectiveness (incremental cost per treatment success, defined by each trial); and 4) estimate the costutility of the alternative interventions (i.e., incremental cost per quality-adjusted life year (QALY)). The primary cost-utility analyses will be within-trial, intention-to-treat analyses conducted from the societal perspective with a two-year time horizon. Additional costutility analyses will use the lifetime time horizon and include disease modeling to assess lifetime costs and benefits. The high economic and quality of life costs of UI and the probability of differential efficacy of the treatments within each study make this an important area to explore with cost-utility analysis. Since utilities capture all potential health-related benefits, cost-utility analysis is an ideal method to test the hypothesis that a more expensive intervention will have an incremental cost per QALY that is comparable with currently accepted medical interventions. The E-UITN offers an efficient opportunity to investigate the costs and cost-utility of treatments for UI. The study assembles a group of senior investigators with expertise in economics, cost-effectiveness and UI treatment. The E- UITN will provide critical economic data for commonly used treatments for incontinence.