Dominitz Jason A, Robertson Douglas J, Ahnen Dennis J, Allison James E, Antonelli Margaret, Boardman Kathy D, Ciarleglio Maria, Del Curto Barbara J, Huang Grant D, Imperiale Thomas F, Larson Meaghan F, Lieberman David, O'Connor Theresa, O'Leary Timothy J, Peduzzi Peter, Provenzale Dawn, Shaukat Aasma, Sultan Shahnaz, Voorhees Amy, Wallace Robert, Guarino Peter D
VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle, Washington, USA.
VA Medical Center, White River Junction, Vermont and Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.
Am J Gastroenterol. 2017 Nov;112(11):1736-1746. doi: 10.1038/ajg.2017.286. Epub 2017 Oct 10.
Colorectal cancer (CRC) is preventable through screening, with colonoscopy and fecal occult blood testing comprising the two most commonly used screening tests. Given the differences in complexity, risk, and cost, it is important to understand these tests' comparative effectiveness.
The CONFIRM Study is a large, pragmatic, multicenter, randomized, parallel group trial to compare screening with colonoscopy vs. the annual fecal immunochemical test (FIT) in 50,000 average risk individuals. CONFIRM examines whether screening colonoscopy will be superior to a FIT-based screening program in the prevention of CRC mortality measured over 10 years. Eligible individuals 50-75 years of age and due for CRC screening are recruited from 46 Veterans Affairs (VA) medical centers. Participants are randomized to either colonoscopy or annual FIT. Results of colonoscopy are managed as per usual care and study participants are assessed for complications. Participants testing FIT positive are referred for colonoscopy. Participants are surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC. The primary endpoint is CRC mortality. The secondary endpoints are (1) CRC incidence (2) complications of screening colonoscopy, and (3) the association between colonoscopists' characteristics and neoplasia detection, complications and post-colonoscopy CRC. CONFIRM leverages several key characteristics of the VA's integrated healthcare system, including a shared medical record with national databases, electronic CRC screening reminders, and a robust national research infrastructure with experience in conducting large-scale clinical trials. When completed, CONFIRM will be the largest intervention trial conducted within the VA (ClinicalTrials.gov identifier: NCT01239082).
结直肠癌（CRC）可通过筛查预防，结肠镜检查和粪便潜血检测是两种最常用的筛查方法。鉴于其复杂性、风险和成本存在差异，了解这些检测方法的相对有效性很重要。
CONFIRM研究是一项大型、实用、多中心、随机、平行组试验，旨在比较结肠镜检查与年度粪便免疫化学检测（FIT）对50000名平均风险个体进行筛查的效果。CONFIRM研究旨在检验在10年期间，筛查结肠镜检查在预防CRC死亡方面是否优于基于FIT的筛查方案。从46个退伍军人事务（VA）医疗中心招募年龄在50 - 75岁且应进行CRC筛查的符合条件个体。参与者被随机分配接受结肠镜检查或年度FIT。结肠镜检查结果按照常规护理进行处理，并对研究参与者的并发症进行评估。FIT检测呈阳性的参与者会被转诊进行结肠镜检查。每年对参与者进行调查，以确定他们是否接受了结肠镜检查或被诊断患有CRC。主要终点是CRC死亡率。次要终点包括：（1）CRC发病率；（2）筛查结肠镜检查的并发症；（3）结肠镜检查医生的特征与肿瘤检测、并发症及结肠镜检查后CRC之间的关联。CONFIRM研究利用了VA综合医疗系统的几个关键特征，包括与国家数据库共享的医疗记录、电子CRC筛查提醒以及具有开展大规模临床试验经验的强大国家研究基础设施。完成后，CONFIRM研究将成为在VA内部开展的最大规模干预试验（ClinicalTrials.gov标识符：NCT01239082）。
