Comparative effectiveness of FIT vs. colonoscopy for colon cancer screening

描述(由申请人提供)：本申请涉及广泛的挑战领域(5)，比较有效性研究，特别是癌症筛查的比较有效性研究，05-CA-102。重要意义：由于我们的医疗保健系统处于金融危机之中，而结直肠癌(CRC)是癌症死亡的第二大原因，也是一种基本上可以预防的疾病，因此迫切需要对CRC筛查方式进行高质量的有效性比较研究。美国预防服务工作组(USPTF)最近的决策分析发现，在50至75.1岁的个人中，每10年进行一次结肠镜检查的CRC筛查与每年一次的粪便免疫化学检测相比，获得的寿命没有差异。1然而，尽管已经在非筛查人群2、3和美国以外的人群4-6中进行了FIT和结肠镜检查的比较研究，但在美国还没有对这些方法进行直接比较的使用中等风险患者的研究。我们将在700名接受结肠镜检查的平均风险个体中比较粪便免疫化学测试(FIT)和结肠镜检查的测试特征；在研究样本中评估患者对FIT和结肠镜检查的偏好；并使用这些筛查策略比较预计成本。这项研究将有助于为使用我们的爱荷华州研究网络(IERNE)进行两步结直肠癌筛查(FIT，然后对FIT检测呈阳性的人进行结肠镜检查)的多地点初级保健实践试验奠定基础。艾琳是一个以实践为基础的初级保健研究网络，由200家诊所的300多名家庭医生组成。这项试点研究和未来的更大规模研究的结果将允许根据实际的正常风险美国数据而不是仅根据高风险、非筛查美国人群和/或非美国数据来开发和推荐特定的临床建议，就像目前的情况一样。这项研究将提供有关在美国平均风险人群中筛查结肠癌的粪便免疫化学测试的测试特征以及个人对这些测试的态度和偏好的关键信息，这将有助于为我们以初级保健实践为基础的农村研究网络爱荷华州研究网络进行的更大规模的结直肠癌筛查试验奠定基础。未来规模更大的试验将包括粪便免疫化学测试，然后对健康呈阳性的人进行结肠镜检查，对整个爱荷华州的中等风险个体进行抽样。

DESCRIPTION (provided by applicant): This application addresses Broad Challenge Area (5), Comparative Effectiveness Research, and specifically Comparative Effectiveness Research on Cancer Screening, 05-CA-102. Significance: With our health care system in financial crisis, and colorectal cancer (CRC) both the second leading cause of cancer death and a largely preventable disease, there is a critical need for high quality comparative effectiveness studies of CRC screening modalities. The recent United States Preventive Services Task Force (USPTF) decision analysis found no difference in life-years gained by CRC screening using colonoscopy every 10 years vs. annual fecal immunochemical testing in individuals aged 50 to 75.1 However, although studies comparing FIT and colonoscopy have been conducted in non-screening populations2, 3 and populations outside the United States4-6, no studies using average-risk patients have been conducted in the United States directly comparing these methods. We will compare the test characteristics of a fecal immunochemical test (FIT) with colonoscopy in 700 average risk individuals undergoing screening colonoscopy; assess patient preferences for FIT vs. colonoscopy in the study sample; and compare projected costs using these screening strategies. This study will help lay the foundation for a multi-site primary care practice- based trial for two-step CRC screening (FIT followed by colonoscopy for those who test positive on FIT) using our Iowa Research Network (IRENE). IRENE is a primary care, practice-based research network of over 300 family physicians in 200 practices. The results of this pilot and the future larger scale study would allow specific clinical recommendations to be developed and recommended based on actual normal risk US data rather than on high risk, non-screening US populations and/or non-US data alone, as has been the case until now. This study will provide critical information on the test characteristics of a fecal immunochemical test for colon cancer screening in an average risk U.S. population and individual's attitudes and preferences for these tests, which will help lay the foundation for a larger colorectal cancer screening trial to be conducted in our primary care practice-based rural research network, the Iowa Research Network. The larger, future trial will involve fecal immunochemical testing, followed by colonoscopy for those who are FIT positive, in a sample of average-risk individuals across the state of Iowa.