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在服务不足人群中提高结直肠癌筛查率的粪便免疫化学试验外展、结肠镜外展与常规护理的效果比较:一项随机临床试验。

Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial.

出版信息

JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.

Abstract

IMPORTANCE

Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited.

OBJECTIVE

To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population.

DESIGN, SETTING, AND PARTICIPANTS: We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system.

INTERVENTIONS

Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n = 1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n = 479). The third group was assigned to usual care, consisting of opportunistic primary care visit–based screening (n = 3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion.

MAIN OUTCOME MEASURES

Screening participation in any CRC test within 1 year after randomization.

RESULTS

Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P < .001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P < .001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P < .005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P < .05 for colonoscopy vs usual care advanced adenoma comparison; P > .05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy. CONCLUSIONS AND REVELANCE: Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01191411.

摘要

重要性

结直肠癌(CRC)筛查可以挽救生命,但在服务不足的人群中,参与率仍然很低。对于服务不足人群,有效的筛查方法(包括提供哪种最佳检测类型)知识有限。

目的

确定(1)有组织的邮寄外展是否比常规护理更能提高 CRC 筛查率,以及(2)在服务不足的人群中,粪便免疫化学测试(FIT)是否优于结肠镜检查外展用于 CRC 筛查参与。

设计、地点和参与者:我们确定了未参保、不符合 CRC 筛查要求、年龄在 54 至 64 岁之间的患者,他们由德克萨斯州沃思堡和塔兰特县的约翰·彼得·史密斯健康网络(John Peter Smith Health Network)提供服务,这是一个安全网健康系统。

干预措施

患者被随机分配到 3 个组中的 1 个。一组被分配到粪便免疫化学测试(FIT)外展组,包括邮寄邀请使用并退回免费 FIT(n=1593)。第二组被分配到结肠镜检查外展组,包括邮寄邀请安排免费结肠镜检查(n=479)。第三组被分配到常规护理组,包括机会性初级保健就诊为基础的筛查(n=3898)。此外,FIT 和结肠镜检查外展组接受电话随访以促进检测完成。

主要观察指标

随机分组后 1 年内任何 CRC 检测的筛查参与率。

结果

患者平均年龄为 59 岁;64%的患者为女性。该样本中,白人占 41%,黑人占 24%,西班牙裔占 29%,其他种族/族裔占 7%。FIT(40.7%)和结肠镜检查外展(24.6%)的筛查参与率明显高于常规护理(12.1%)(与常规护理相比,差异均<.001)。FIT 的筛查率明显高于结肠镜检查外展(P<.001)。在分层分析中,FIT 和结肠镜检查外展的筛查率均高于常规护理,在白人、黑人和西班牙裔中,FIT 的筛查率也高于结肠镜检查外展(所有比较的 P<.005)。FIT 外展组的 CRC 检出率和高级腺瘤检出率分别为 0.4%和 0.8%,结肠镜外展组分别为 0.4%和 1.3%,常规护理组分别为 0.2%和 0.4%(结肠镜检查与常规护理高级腺瘤比较,P<.05;所有其他比较,P>.05)。60 名 FIT 结果异常的患者中有 11 名未完成结肠镜检查。

结论和相关性

在 CRC 筛查未达标的服务不足患者中,与常规护理相比,邮寄外展邀请可显著提高 CRC 筛查率。FIT 外展比结肠镜检查邀请更有效。

试验注册

clinicaltrials.gov 标识符:NCT01191411。

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