BIOSTATISTICS

生物统计学

• 批准号: 8555522
• 负责人: DOUGLAS Allen CORLEY
• 金额: $ 24.91万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-26 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8555522
• 关键词: Colonoscopy; Communities; Screening procedure; Testing; base

The overall goal of the Research Center is the creation of a research unit that can evaluate the complete colorectal cancer (CRC) screening process. The specific goal is the characterization of remediable failures of the two most commonly used screening tests (optical colonoscopy and fecal immunochemical tests [FIT]). Two important problems in CRC are over-screening and under-diagnosis: 1) >95% of people will not die of CRC, thus, for most patients, screening results only in worry & risk; yet 2) many CRC deaths occur despite CRC screening (i.e. in persons with prior screening). It is unclear how many deaths result from remediable failures of the screening process. Our center will evaluate a community-based cohort that includes detailed CRC screening and medical data for >2 million screening-eligible people/year; >10 years of data; large numbers of outcomes (38,000 cancers); geographic diversity (>35 medical centers across California); demographic diversity (140,000 African Americans, 320,000 Hispanics, and 200,000 Asian-Americans among current members); socioeconomic diversity; diversity of screening methods; access to tissue/cancer blocks; and a full spectrum of individual cancer risk. Project 1 will evaluate FIT, an effective and efficient noninvasive screening method. Project 2 will evaluate colonoscopy, a sensitive, widely used test that is the final common exam for all CRC screening strategies. Projects 1 & 2 will both evaluate patterns of use, especially: screening failures (cancers diagnosed despite screening); surveillance failures, and surveillance over-use. We will investigate physician and patient components for these failures using a recently developed systematic process that includes establishing bases for interventions that target barriers in healthcare settings. Project 1 will also evaluate clinically available genetic markers to evaluate for potential biological differences between FIT detected vs. screen failure cancers. Project 3 will model the effectiveness of colonoscopy vs. FIT utilizing community-based data from the full screening process acquired in Projects 1 & 2, in collaboration with a proven NCI consortium Cancer Intervention and Surveillance Modeling Network (CISNET) site, including different screening strategies for different patient populations, tailored to risk. The Center includes a trans-disciplinary group of researchers including gastroenterologists, oncologists, family physicians, population scientists, modeling experts, quality experts, behavioral experts, and experts in health care delivery. The Center can efficiently evaluate the full screening process and can provide substantial human, institutional, and patient resources for collaborative projects within the PROSPR network.

研究中心的总体目标是创建一个能够评估完整结直肠癌 (CRC) 筛查过程的研究单位。具体目标是表征两种最常用的筛查测试（光学结肠镜检查和粪便免疫化学测试 [FIT]）的可补救失败的特征。 CRC的两个重要问题是过度筛查和诊断不足：1）>95%的人不会死于CRC，因此，对于大多数患者来说，筛查结果只是担心和风险；然而 2) 尽管进行了 CRC 筛查（即之前进行过筛查的人），还是发生了许多 CRC 死亡。目前尚不清楚有多少人因筛查过程中可补救的失败而死亡。我们的中心将评估基于社区的队列，其中包括每年超过 200 万符合筛查资格的人的详细 CRC 筛查和医疗数据； >10年的数据；大量结果（38,000 种癌症）；地理多样性（加州超过 35 个医疗中心）；人口多样性（现有成员中有 140,000 名非洲裔美国人、320,000 名西班牙裔美国人和 200,000 名亚裔美国人）；社会经济多样性；筛选方法的多样性；获取组织/癌症块；以及全方位的个人癌症风险。项目 1 将评估 FIT，一种有效且高效的无创筛查方法。项目 2 将评估结肠镜检查，这是一种敏感且广泛使用的测试，是所有 CRC 筛查策略的最终常见检查。项目 1 和 2 都将评估使用模式，特别是： 筛查失败（尽管筛查仍诊断出癌症）；监视失败和监视过度使用。我们将使用最近开发的系统流程来调查医生和患者造成这些失败的原因，其中包括建立针对医疗保健环境中障碍的干预措施基础。项目 1 还将评估临床可用的遗传标记，以评估 FIT 检测到的癌症与筛查失败的癌症之间的潜在生物学差异。项目 3 将与经过验证的 NCI 联盟癌症干预和监测建模网络 (CISNET) 站点合作，利用项目 1 和 2 中获得的完整筛查过程中基于社区的数据，对结肠镜检查与 FIT 的有效性进行建模，包括不同的筛查策略针对不同的患者人群，根据风险量身定制。该中心包括一个跨学科的研究人员小组，包括胃肠病学家、肿瘤学家、家庭医生、人口科学家、建模专家、质量专家、行为专家和医疗保健提供专家。该中心可以有效地评估整个筛查过程，并可以为 PROSPR 网络内的合作项目提供大量的人力、机构和患者资源。