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

基本信息

批准号：
9905394
负责人：
DOUGLAS Allen CORLEY
金额：
$ 59.91万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
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/9905394
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

项目摘要

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的科学、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。