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

项目摘要。结直肠癌（CRC）是美国癌症死亡的第二大原因，尽管CRC 通过筛查可以减少死亡。然而，对于哪种筛查策略是最重要的， 从人口的角度来看，临床和成本效益，其目的是优化完成 整个筛选过程的连续性。模型研究表明结肠镜检查和粪便检查的益处和危害 血液检测策略相似，但通常假设100%参与，随后的临床 适当的随访-这在临床实践中从未实现。有效性比较研究 测试策略，包括特定测试的比较和优化有效测试使用的方法， 必要安全网卫生系统为CRC不良结局风险增加的人群提供护理，例如 没有保险的人和少数民族，资源更加有限。因此，安全网必须解决 最有效的筛查策略的不确定性。我们将进行一个系统级的随机 比较有效性试验的好处，危害，和成本的3个筛选策略，超过3年，其中 6000名年龄在50-64岁之间的患者，他们没有进行最新的CRC筛查，由一个大型的安全网健康服务 系统研究的三种策略将是：1）粪便免疫化学检测，每年邮寄邀请 外展（包括检测试剂盒），以及促进参与和完成临床随访的集中流程 2）结肠镜检查，每年邮寄邀请外展，并集中处理，以促进 参与和完整的临床随访（科洛）; 3）家庭护理，无邮寄邀请外展，以及 在初级保健访问中提供筛查。受益的主要衡量标准是一种结果衡量标准， 总结了患者特异性有效筛查的成功经验。“主要的危害措施将是筛查 不参与。成本的主要衡量标准将是有效筛查的每位患者的成本。我们的具体目标 1）比较FIT策略与科洛策略在以下人群中进行CRC筛查的获益、危害和成本： 患者没有进行最新的筛查，以及2）比较a）FIT策略与b）FIT策略的益处、危害和成本。 直肠护理和B）科洛策略与直肠护理用于CRC筛查。

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.