Effectiveness of screening for colorectal cancer in average risk adults: Colonoscopy vs FIT

平均风险成人结直肠癌筛查的有效性：结肠镜检查与 FIT

• 批准号: 10026306
• 负责人: DOUGLAS Allen CORLEY
• 金额: $ 38.16万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-10 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10026306
• 关键词: Access to Information; Address; Adherence; Adult; Advisory Committees; Age; California; Cancer Etiology; Caring; Case Study; Cessation of life; Clinical; Collaborations; Colon; Colon Carcinoma; Colonoscopy; Colorectal Cancer; Communities; Comparative Effectiveness Research; Conflict (Psychology); Consequentialism; Data; Decision Making; Diagnosis; Diagnostic Procedure; Diagnostic tests; Early Diagnosis; Effectiveness; Enrollment; Ethnic Origin; Fecal occult blood; Feces; Foundations; Future; Geographic Locations; Goals; Guaiac; Guidelines; Incidence; Indolent; Information Systems; Knowledge; Left; Lesion; Life; Link; Malignant Neoplasms; Methodology; Methods; Modernization; Modification; Observational Study; Outcome; Patients; Pattern; Policies; Population; Publishing; Race; Randomized Controlled Trials; Recommendation; Recording of previous events; Rectal Cancer; Rectum; Reporting; Research; Resources; Retrospective cohort; Risk; Role; Sampling; Scientist; Second Primary Cancers; Series; Sigmoidoscopy; Site; Socioeconomic Status; Source; Statistical Methods; Study models; Symptoms; System; Technology; Testing; Time; Underserved Population; United States; Woman; adenoma; base; cancer care; case control; clinical practice; cohort; colorectal cancer screening; comparative effectiveness; compare effectiveness; density; design; diagnostic screening; effectiveness evaluation; effectiveness testing; efficacy trial; end of life; evidence base; experience; health plan; innovation; member; men; method development; mortality; mortality risk; multidisciplinary; novel; premalignant; research study; routine screening; screening; screening guidelines; screening program; sex; simulation; theories; tv watching; uptake

PROJECT SUMMARY: Cancers of the colon and rectum are the second leading cause of cancer deaths in the United States, but are potentially preventable through early detection of invasive or precancerous lesions. Of the currently recommended tests for screening average risk people, colonoscopy is the most commonly used in the United States, but stool-based tests such as fecal immunochemical tests (FIT), are the most commonly used globally. However, there is currently no strong evidence to inform highly consequential decisions on these competing screening strategies, which contributes to conflicting recommendations from policy groups including a Canadian task force recommendation against using colonoscopy for routine screening. Microsimulation studies report that FIT and colonoscopy can achieve similar overall lifetime effectiveness, but are based on assumptions of efficacy and adherence to regular screening that are not attainable in real practice. An added challenge is the paucity of well-developed statistical approaches that can account for varying levels of adherence, patterns of use such as cross-overs, and time-dependent confounding when estimating the effectiveness of colorectal cancer (CRC) screening tests. Our proposed series of studies aim to: 1) estimate the effectiveness of FIT in reducing the risk of dying from CRC when compared with no screening, and 2) compare the effectiveness of FIT in reducing the risk of dying from CRC relative to screening colonoscopy. We will also assess for potential effect modification by race/ethnicity, sex, and socioeconomic status. We will use a nested case-control design with about 2000 cases and 8000 controls between 2014 and 2018 in a historical cohort of about 2 million screening-eligible people receiving care at Kaiser Permanente Northern and Southern California. Cases for the study will be men and women who were 52-89 years old at the date of death from CRC, each matched within health plan to four randomly selected controls based on age, sex, enrollment history, and geographic region. As secondary methodological aims, we will: 1) apply novel statistical methods to estimate FIT-colonoscopy comparative effectiveness in varying real-life screening patterns including imperfect adherence and crossover from FIT to colonoscopy; and 2) assess the use of a case-cohort design to inform future studies. As an exploratory aim, we will characterize the resources required to screen with FIT or colonoscopy as inputs for future microsimulation studies. Our study sites provide the full continuum of cancer care ranging from screening through end of life, and provide access to information on CRC screening that can be linked to diagnosis and cause-specific mortality data on large numbers of people. We will identify receipt of screening colonoscopy and screening FIT in the 10-year window prior to the reference date, differentiating screening from diagnostic procedures with selected chart audits to confirm colonoscopy screening indications. This will be the first observational study to address these critical scientific, clinical, and policy questions. The project will be implemented by an experienced team of high-impact scientists.

项目摘要：结肠癌和直肠癌是癌症死亡的第二大原因 美国，但可以通过早期检测侵袭性或癌前病变来预防。的 目前推荐的用于筛查一般风险人群的测试，结肠镜检查是最常用的 在美国，但基于粪便的测试（如粪便免疫化学测试 (FIT)）是最常见的 全球使用。然而，目前没有强有力的证据可以为这些重大决策提供依据。 相互竞争的筛选策略，这导致政策小组的建议相互矛盾，包括 加拿大工作组建议不要使用结肠镜检查进行常规筛查。微观模拟 研究报告称，FIT 和结肠镜检查可以实现相似的总体终生有效性，但基于 对功效和坚持定期筛查的假设在实际实践中是无法实现的。添加了一个 挑战在于缺乏成熟的统计方法来解释不同水平的 估计时的依从性、使用模式（例如交叉）以及时间相关的混杂因素 结直肠癌 (CRC) 筛查测试的有效性。我们提出的一系列研究旨在：1）估计 与不进行筛查相比，FIT 在降低 CRC 死亡风险方面的有效性，以及 2) 比较 FIT 与筛查结肠镜检查在降低 CRC 死亡风险方面的有效性。我们 还将评估种族/族裔、性别和社会经济地位的潜在影响修改。我们将使用一个 嵌套病例对照设计，2014 年至 2018 年间约有 2000 个病例和 8000 个对照 大约 200 万符合筛查资格的人在 Kaiser Permanente Northern 和 Southern 接受护理 加利福尼亚州。该研究的病例为死亡之日年龄为 52 至 89 岁的男性和女性 CRC，每个健康计划与根据年龄、性别、入学情况随机选择的四个对照相匹配 历史和地理区域。作为次要方法论目标，我们将：1）应用新颖的统计方法 评估 FIT 结肠镜检查在不同现实生活筛查模式中的比较有效性，包括 从 FIT 到结肠镜检查的不完美依从性和交叉； 2）评估案例队列设计的使用 告知未来的研究。作为探索性目标，我们将描述 FIT 筛选所需的资源或 结肠镜检查作为未来微观模拟研究的输入。我们的研究中心提供癌症的完整连续体 涵盖从筛查到临终的护理，并提供有关 CRC 筛查的信息，这些信息可以 与大量人群的诊断和特定原因死亡率数据相关联。我们将识别收据 在参考日期之前的 10 年窗口内筛查结肠镜检查和筛查 FIT，区分 通过选定的图表审核进行诊断程序筛查，以确认结肠镜检查筛查指征。 这将是第一项解决这些关键科学、临床和政策问题的观察性研究。这 该项目将由经验丰富的高影响力科学家团队实施。