Maximizing yield of the fecal immunochemical test for colorectal cancer screening
最大限度地提高结肠直肠癌筛查粪便免疫化学检测的产量
基本信息
- 批准号:8024577
- 负责人:
- 金额:$ 59.7万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2011
- 资助国家:美国
- 起止时间:2011-05-01 至 2015-03-31
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAffectAgeBenefits and RisksCancer EtiologyCaringCessation of lifeCharacteristicsColon CarcinomaColonoscopyColorectal CancerCommunitiesComorbidityComputerized Medical RecordData SetEffectivenessEligibility DeterminationEquilibriumFecal occult bloodFecesGenderGeneral PopulationGoalsGuaiacHealthcareIsraelKoreaMalignant NeoplasmsMass ScreeningMethodsNeoplasmsOutcomePatientsPerformancePharmaceutical PreparationsPopulationPredictive ValuePremalignantProcessProtocols documentationQualitative MethodsRaceReportingResearchRiskSamplingScreening procedureSensitivity and SpecificitySiteSocietiesSystemTaiwanTestingUnited StatesWomanadenomaagedbasecolorectal cancer screeningcomparativecompliance behaviorcostcost effectiveevidence basehigh riskimprovedinterestmembermenmortalityprograms
项目摘要
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.
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。筛查结直肠癌可降低结直肠癌死亡率,但美国的筛查率仍然很低。粪便潜血检测(FOBT)是唯一一种确定了获益与风险正平衡的结直肠癌筛查方法,是最便宜的,是近一半患者的首选方法。一种新的粪便筛选试验,粪便免疫化学试验(FIT),比FOBT有了显著的改进。与FOBT相比,它更容易使用,在检测结直肠癌和癌前腺瘤方面更敏感。OC-Micro FIT特别令人感兴趣,因为它具有高度的敏感性和特异性,并且是美国唯一批准的可以自动处理的FIT测试。因此,OC-Micro是一种用于大规模筛查项目以提高社区crc筛查率的最佳方法。然而,之前的OC-Micro研究存在一些局限性:它们是在人群中进行的,不适合评估美国平均风险患者的筛查效果,研究没有明确建立所需的最佳样本数量和检测阳性的切点。因此,MY-FIT(最大化粪便免疫化学测试的产量)研究的总体目标是利用研究地点高度集成和广泛的电子病历系统来收集两组独立的数据,这些数据在合成后将提供一个全面的图片,比较患者对使用OC-Micro FIT的不同方案的依从性、敏感性、特异性和成本。具体而言,在年龄在50-75岁、处于结直肠癌(CRC)平均风险并应进行CRC筛查的KPNW成员中(n=78,000),我们建议:1。比较单样本FIT (1-FIT)和双样本FIT (2-FIT)对结直肠癌和晚期腺瘤(晚期肿瘤)的敏感性、特异性、阳性预测值和阴性预测值,采用不同的阳性检测切点(n=2100)。2. 比较患者完成1-FIT和2-FIT方案的依从性(n=3000)。3. 评估和比较1-FIT与2-FIT方案的每次筛查成本,以及1-FIT与2-FIT方案中检测到的每个晚期肿瘤的成本(对阳性测试使用不同的切割点)(n=78,000)。回答上述问题将为在美国普通人群中使用OC-Micro FIT筛查结直肠癌的最佳实践,成本效益的方法提供急需的强有力的证据基础。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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ADRIANNE C FELDSTEIN其他文献
ADRIANNE C FELDSTEIN的其他文献
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{{ truncateString('ADRIANNE C FELDSTEIN', 18)}}的其他基金
Maximizing yield of the fecal immunochemical test for colorectal cancer screening
最大限度地提高结肠直肠癌筛查粪便免疫化学检测的产量
- 批准号:
8261692 - 财政年份:2011
- 资助金额:
$ 59.7万 - 项目类别:
Focusing Implementation to Bring Effective Reminders: FIBER
聚焦落实,有效提醒:FIBER
- 批准号:
8034684 - 财政年份:2008
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$ 59.7万 - 项目类别:
Focusing Implementation to Bring Effective Reminders: FIBER
聚焦落实,有效提醒:FIBER
- 批准号:
7616581 - 财政年份:2008
- 资助金额:
$ 59.7万 - 项目类别:
Focusing Implementation to Bring Effective Reminders: FIBER
聚焦落实,有效提醒:FIBER
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7776892 - 财政年份:2008
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$ 59.7万 - 项目类别:
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7459017 - 财政年份:2007
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$ 59.7万 - 项目类别:
Forging Implementation of Cancer Screening Reminder Systems (FICSRS)
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