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综合卫生系统中基于血液的结直肠癌筛查:患者依从性的随机试验

Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence.

作者信息

Coronado Gloria D, Jenkins Charisma L, Shuster Elizabeth, Johnson Cheryl, Amy David, Cook Jennifer, Sahnow Samantha, Zepp Jamilyn M, Mummadi Rajasekhara

机构信息

Kaiser Permanente Center for Health Research, Portland, Oregon, USA

The University of Arizona Cancer Center - North Campus, Tucson, Arizona, USA.

出版信息

Gut. 2024 Mar 7;73(4):622-628. doi: 10.1136/gutjnl-2023-330980.

Abstract

OBJECTIVE

We evaluated whether people who had not completed a faecal immunochemical test (FIT) for colorectal cancer (CRC) screening would complete a blood-based testing option if offered one during health encounters. Blood-based screening tests for CRC could add to the total number of people screened for CRC by providing another testing alternative.

DESIGN

Study participants were patients aged 45-75 years at a large, integrated health system who were offered but did not complete an FIT in the prior 3-9 months and were scheduled for a clinical encounter. Individuals were randomised (1:1) to be offered a commercially available CRC blood test (Shield, Guardant Health) versus usual care. We compared 3-month CRC screening proportions in the two groups.

RESULTS

We randomised 2026 patients; 2004 remained eligible following postrandomisation exclusions (1003 to usual care and 1001 to blood draw offer; mean age: 60, 62% female, 80% non-Hispanic white). Of the 1001 allocated to the blood test group, 924 were recruited following chart-review exclusions; 548 (59.3%) were reached via phone, of which 280 (51.1%) scheduled an appointment with the research team. CRC screening proportions were 17.5 percentage points higher in the blood test group versus usual care (30.5% vs 13.0%; OR 2.94, 95% CI 2.34 to 3.70; p<0.001).

CONCLUSION

Among adults who had declined prior CRC screening, the offer of a blood-based screening test boosted CRC screening by 17.5 percentage points over usual care. Further research is needed on how to balance the favourable adherence with lower advanced adenoma detection compared with other available tests.

TRIAL REGISTRATION NUMBER

NCT05987709.

摘要

目的

我们评估了那些尚未完成用于结直肠癌(CRC)筛查的粪便免疫化学检测(FIT)的人,如果在健康检查期间提供基于血液的检测选项,他们是否会完成该检测。基于血液的CRC筛查检测可以通过提供另一种检测选择来增加接受CRC筛查的总人数。

设计

研究参与者是一家大型综合医疗系统中年龄在45 - 75岁之间的患者,他们在前3 - 9个月内被提供了FIT但未完成,并且已安排了临床就诊。个体被随机(1:1)分配接受一种商用的CRC血液检测(Shield,Guardant Health)或常规护理。我们比较了两组在3个月时的CRC筛查比例。

结果

我们随机分配了2026名患者;随机分组后排除不符合条件者,2004名患者仍符合条件(1003名接受常规护理,1001名接受血液检测;平均年龄:60岁,62%为女性,80%为非西班牙裔白人)。在分配到血液检测组的1001名患者中,经过病历审查排除后,924名被招募;通过电话联系到其中548名(59.3%),其中280名(51.1%)与研究团队预约了就诊。血液检测组的CRC筛查比例比常规护理组高17.5个百分点(30.5%对13.0%;OR 2.94,95%CI 2.34至3.70;p<0.001)。

结论

在之前拒绝CRC筛查的成年人中,提供基于血液的筛查检测比常规护理使CRC筛查率提高了17.5个百分点。与其他现有检测相比,如何在良好的依从性与较低的高级腺瘤检测率之间取得平衡,还需要进一步研究。

试验注册号

NCT05987709。

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