Maximizing yield of the fecal immunochemical test for colorectal cancer screening

描述（由申请人提供）：结直肠癌（CRC）是美国癌症死亡的主要原因。CRC筛查降低了CRC死亡率，但在美国筛查率仍然很低。粪便隐血检测（FOBT）是唯一一种在获益和风险之间取得正平衡的CRC筛查方法，也是最便宜的方法，并且是近一半患者的首选方法。一种较新的粪便筛查试验，粪便免疫化学试验（FIT），提供了显着的改善FOBT。它更容易使用，在检测CRC和癌前腺瘤方面比FOBT更敏感。OC-Micro FIT特别令人感兴趣，因为它具有高度的灵敏度和特异性，并且是美国批准的唯一可以自动处理的FIT测试。因此，OC-Micro是用于大规模筛查计划以提高社区CRC筛查率的最佳方法。然而，OC-Micro的先前研究受到几个限制：它们是在美国评估平均风险患者筛查性能的最佳人群中进行的，并且这些研究没有明确确定所需样本的最佳数量和测试阳性的临界点。因此，MY-FIT（粪便免疫化学检测产量最大化）研究的总体目标是利用研究中心的高度集成和广泛的电子病历系统收集两组单独的数据，当合成时，将提供使用OC-Micro FIT的不同方案的比较患者依从性、灵敏度、特异性和成本的全面情况。具体而言，在年龄在50 - 75岁的KPNW成员中，平均风险为结直肠癌（CRC），并应进行CRC筛查（n = 78，000），我们建议：1。使用阳性检测的不同临界点，比较单样本FIT（1-FIT）和双样本FIT（2-FIT）之间结直肠癌和晚期腺瘤（晚期瘤形成）的灵敏度、特异性、阳性预测值和阴性预测值（n = 2100）。2.比较患者完成1-FIT与2-FIT方案的依从性（n = 3000）。3.评估并比较1-FIT与2-FIT方案的每次筛查成本，以及1-FIT与2-FIT方案中检测到的每例晚期肿瘤的成本（使用不同的阳性检测临界点）（n = 78，000）。回答上述问题将为使用OC-Micro FIT在美国普通人群中筛查CRC的最佳实践、成本效益高的方法提供急需的强有力证据基础。 公共卫生相关性：结直肠癌（CRC）是美国癌症死亡的第二大原因，对男性和女性的影响几乎相同。筛查CRC可以降低这种癌症的死亡率，但美国的筛查率仍然很低。该项目旨在提供证据，指导使用一种新的筛查试验，粪便免疫化学试验（FIT），以取代最广泛使用的粪便试验，FOBT。FIT比目前的粪便检测方法更容易使用，更准确，更便宜，非常适合用于普通人群。然而，这些测试尚未在大规模人群中进行过尝试。我们的项目将回答有关使用这种改进的结肠癌测试的最佳，最准确的方法的问题。

DESCRIPTION (provided by applicant): Colorectal cancer (CRC) is a leading cause of cancer death in the United States. Screening for CRC reduces CRC mortality, yet rates of screening in the United States remain low. Fecal occult blood testing (FOBT) is the only CRC screening method with an established positive balance of benefit and risk, is the least expensive, and is the preferred method for nearly half of patients. A newer fecal screening test, the fecal immunochemical test (FIT), offers significant improvements over the FOBT. It is easier to use and is more sensitive at detecting both CRC and precancerous adenomas than the FOBT. The OC-Micro FIT is of particular interest because it is highly sensitive and specific and it is the only FIT test approved in the US that can be processed in an automated manner. Thus, the OC-Micro is an optimal method for use in mass screening programs to improve community CRC-screening rates. However, prior studies of OC-Micro suffer from several limitations: they were conducted in populations not optimal for assessing screening performance in average risk patients in the U.S. and the studies did not clearly establish optimal number of samples required and cut-points for test positivity. Therefore, the overall goal of the MY-FIT (Maximizing the Yield of Fecal Immunochemical Tests) study is to capitalize on the highly integrated and extensive electronic medical record system of the study site to collect two separate sets of data that, when synthesized, will provide a thorough picture of the comparative patient adherence to, sensitivity, specificity, and costs of different protocols for using the OC-Micro FIT. Specifically, among KPNW members aged 50-75 who are at average risk for colorectal cancer (CRC) and who are due for CRC screening (n=78,000), we propose to: 1. Compare the sensitivity, specificity, positive predictive value, and negative predictive value for colorectal cancer and advanced adenoma (advanced neoplasia) between a single-sample FIT (1-FIT) and a two- sample FIT (2-FIT) using varying cut points for a positive test (n=2100). 2. Compare patient adherence to completion of a 1-FIT versus a 2-FIT protocol (n=3000). 3. Assess and compare cost per screen for a 1-FIT versus a 2-FIT protocol, and the cost per advanced neoplasia detected in a 1-FIT versus a 2-FIT protocol (using varying cut points for a positive test) (n=78,000). Answering the above questions will provide a much-needed strong evidence base for a best-practice, cost- effective method of using the OC-Micro FIT to screen for CRC in a general U.S. population. PUBLIC HEALTH RELEVANCE: Colorectal cancer (CRC) is the second leading cause of cancer death in the United States, and affects men and women almost equally. Screening for CRC reduces deaths from this cancer, yet rates of screening in the United States remain low. This project aims to provide evidence to guide use of a newer screening test, the fecal immunochemical test (FIT), to replace the most widely used fecal test, the FOBT. FITs are easier to use, more accurate, and cheaper than current methods of fecal testing, and are ideal for use in the general population. However, these tests have not been tried in large populations. Our project will answer questions about the best, most accurate way to use this improved test for colon cancer.