Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

项目摘要。结直肠癌(CRC)是美国第二大癌症死亡原因，尽管 通过筛查可以减少死亡人数。然而，对于哪种筛选策略是最多的，还存在不确定性。 从人群的角度来看，从临床和成本效益角度来看，目标是优化完成 整个筛选过程连续不断。模拟研究表明结肠镜检查和大便检查的好处和坏处 验血策略相似，但通常假设100%参与，并随后临床 适当的随访--这在临床实践中从未实现过。两种药物的比较有效性研究 测试策略，包括具体测试的比较和优化有效测试使用的方法，包括 这是必要的。安全网卫生系统照顾儿童权利公约不良后果风险增加的人群，例如 没有保险的人和少数族裔，资源更有限。因此，安全网必须解决 关于最有效的筛查策略的不确定性。我们将进行系统层面的、随机化的 对3种筛查策略的益处、危害和成本进行为期3年的比较有效性试验， 6,000名年龄50-的患者，他们不是最新的结直肠癌筛查，有一个大的健康安全网服务 系统。研究的三个策略是：1)粪便免疫化学检测，每年邮寄邀请 外展(包括试剂盒)，以及促进参与和完成临床随访的集中化进程 UP(FIT)；2)结肠镜检查，每年邮寄邀请外展，并有一个集中的进程来促进 参与和完整的临床随访(COLO)；3)常规护理，不邮寄邀请外展，以及 在初级保健就诊时提供筛查。效益的主要衡量标准将是符合以下条件的成果衡量标准 总结了针对患者的有效筛查的“成功”。危害的主要衡量标准将是筛查 不参与。成本的主要衡量标准将是有效筛选每个患者的成本。我们的具体目标 目的是：1)比较FIT策略与COLO策略对结直肠癌筛查的益处、危害和成本 不是最新筛查的患者，以及2)比较a)适合策略与 普通护理和b)结肠直肠癌筛查的COLO策略与普通护理。

Project Summary. Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up—something never achieved in clinical practice. Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. We will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits. The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening "successes." The primary measure of harm will be screening non-participation. The primary measure of cost will be cost per-patient effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care and b) the Colo strategy vs. Usual Care for CRC screening.