Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.

Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.
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DOI:
10.1001/jama.2017.11389
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发表时间:
2017-09-05
期刊:
JAMA
影响因子:
--
通讯作者:
Halm EA
Halm EA
中科院分区:
其他
文献类型:
--
作者:
Singal AG;Gupta S;Skinner CS;Ahn C;Santini NO;Agrawal D;Mayorga CA;Murphy C;Tiro JA;McCallister K;Sanders JM;Bishop WP;Loewen AC;Halm EA

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对于增加 1 次结直肠癌 (CRC) 筛查,邮寄粪便免疫化学检测 (FIT) 推广比结肠镜检查推广更有效,但长期有效性可能需要重复检测并及时随访异常结果。比较 FIT 推广和结肠镜检查推广在 3 年内提高 CRC 筛查过程(筛查启动和随访)完成率的有效性。 2013 年 3 月至 2016 年 7 月期间,对 5999 名年龄在 50 岁至 64 岁之间的参与者进行了一项实用随机临床试验,这些参与者在帕克兰健康和医院系统中接受初级保健,但未及时进行结直肠癌筛查。随机分配至邮寄 FIT 外展 (n = 2400)、邮寄结肠镜外展 (n = 2400) 或基于临床筛查的常规护理 (n = 1199)。外展活动包括促进对 FIT 外展组中结果正常的个人进行重复年度检测的流程,以及对 FIT 结果异常或分配到结肠镜外展的人员完成诊断和筛查结肠镜检查的流程。主要结局是筛查过程的完成,定义为遵守结肠镜检查完成情况、每年检测正常 FIT 结果、诊断性结肠镜检查异常 FIT 结果或检测到 CRC 时进行治疗评估。次要结局包括检测任何腺瘤或晚期肿瘤(包括结直肠癌)以及筛查相关的危害(包括出血或穿孔)。所有 5999 名参与者(中位年龄 56 岁;女性,61.9%)均纳入意向筛选分析。结肠镜检查外展组的筛查过程完成率为 38.4%,FIT 外展组为 28.0%,常规护理组为 10.7%。与常规护理组相比,两个外展组的完成率差异均较高,其中结肠镜外展组的差异最高。与常规护理相比,两个外展组的腺瘤和晚期肿瘤检出率的组间差异均较高,其中结肠镜外展组最高。任何群体均未出现与筛查相关的危害。 在安全网机构接受初级保健的 50 至 64 岁人群中,与常规护理相比,提供 FIT 或结肠镜检查的邮寄外展邀请增加了 3 年内完成 CRC 筛查过程的比例。结肠镜检查的筛查过程完成率高于 FIT 外展。 ClinicalTrials.gov 标识符:NCT01710215
Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results. Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years. Pragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings. Random assignment to mailed FIT outreach (n = 2400), mailed colonoscopy outreach (n = 2400), or usual care with clinic-based screening (n = 1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach. Primary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation). All 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups, and highest in the colonoscopy outreach group. Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups, and highest in the colonoscopy outreach group. There were no screening-related harms in any groups. Among persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach. clinicaltrials.gov Identifier: NCT01710215
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