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。意义：由于我们的医疗保健系统处于财政危机之中，结直肠癌（CRC）既是癌症死亡的第二大原因，也是一种很大程度上可预防的疾病，因此迫切需要对结直肠癌筛查方式进行高质量的比较有效性研究。最近美国预防服务工作组（USPTF）的决策分析发现，在50岁至75.1岁的人群中，每10年进行一次结肠镜检查的结直肠癌筛查与每年进行一次粪便免疫化学检查的结直肠癌筛查的寿命年没有差异。然而，尽管在未进行筛查的人群和美国以外的人群中进行了比较FIT和结肠镜检查的研究。在美国，没有针对平均风险患者的研究直接比较这些方法。我们将比较700名接受筛查性结肠镜检查的平均风险个体的粪便免疫化学试验（FIT）和结肠镜检查的测试特征；评估研究样本中FIT与结肠镜检查的患者偏好；并比较使用这些筛选策略的预计成本。这项研究将有助于为使用我们的爱荷华研究网络（IRENE）进行两步结直肠癌筛查（FIT随后为FIT阳性患者进行结肠镜检查）的多地点初级保健实践试验奠定基础。IRENE是一个初级保健、以实践为基础的研究网络，由200多个实践的300多名家庭医生组成。该试点和未来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制定具体的临床建议，而不是像迄今为止那样仅根据高风险、非筛查的美国人群和/或非美国数据进行推荐。本研究将为美国平均风险人群中用于结肠癌筛查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提供关键信息，这将有助于为在我们基于初级保健实践的农村研究网络（爱荷华研究网络）中进行更大规模的结直肠癌筛查试验奠定基础。未来更大规模的试验将包括粪便免疫化学测试，然后对那些FIT阳性的人进行结肠镜检查，样本来自爱荷华州的平均风险个体。

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.