Background Hepatocellular carcinoma (HCC) is plagued by failures across the cancer care continuum, leading to frequent late-stage diagnoses and high mortality. We evaluated the effectiveness of mailed outreach invitations plus patient navigation to promote HCC screening process completion in patients with cirrhosis. Methods Between April 2018 and September 2021, we conducted a multicentre pragmatic randomised clinical trial comparing mailed outreach plus patient navigation for HCC screening (n=1436) versus usual care with visit-based screening (n=1436) among patients with cirrhosis at three US health systems. Our primary outcome was screening process completion over a 36-month period, and our secondary outcome was the proportion of time covered (PTC) by screening. All patients were included in intention-to-screen analyses. Results All 2872 participants (median age 61.3 years; 32.3% women) were included in intention-to-screen analyses. Screening process completion was observed in 6.6% (95% CI: 5.3% to 7.9%) of patients randomised to outreach and 3.3% (95% CI: 2.4% to 4.3%) of those randomised to usual care (OR 2.05, 95% CI: 1.44 to 2.92). The intervention increased HCC screening process completion across most subgroups including age, sex, race and ethnicity, Child-Turcotte-Pugh class and health system. PTC was also significantly higher in the outreach arm than usual care (mean 37.5% vs 28.2%; RR 1.33, 95% CI: 1.31 to 1.35). Despite screening underuse, most HCC in both arms were detected at an early stage. Conclusion Mailed outreach plus navigation significantly increased HCC screening process completion versus usual care in patients with cirrhosis, with a consistent effect across most examined subgroups. However, screening completion remained suboptimal in both arms, underscoring a need for more intensive interventions. Trial registration number [NCT02582918][1]. Data are available on reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02582918&atom=%2Fgutjnl%2F73%2F12%2F2037.atom

中文翻译：

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邮寄外展和患者导航促进 HCC 筛查过程完成的有效性：一项多中心实用随机临床试验


背景 肝细胞癌 （HCC） 在整个癌症护理过程中都受到失败的困扰，导致频繁的晚期诊断和高死亡率。我们评估了邮寄外展邀请和患者导航促进肝硬化患者完成 HCC 筛查过程的有效性。方法 在 2018 年 4 月至 2021 年 9 月期间，我们进行了一项多中心实用随机临床试验，比较了邮寄外展加患者导航进行 HCC 筛查 （n=1436） 与常规护理加基于就诊的筛查 （n=1436） 在美国三个卫生系统的肝硬化患者中。我们的主要结局是 36 个月期间的筛选过程完成情况，次要结局是筛选覆盖的时间比例 （PTC）。所有患者均被纳入意向筛查分析。结果 所有 2872 名参与者 （中位年龄 61.3 岁;32.3% 为女性） 均被纳入意向筛查分析。在随机分配至外展护理的患者中，观察到 6.6% （95% CI： 5.3% 至 7.9%） 的患者和随机分配至常规护理组的 3.3% （95% CI： 2.4% 至 4.3%） 的患者 （OR 2.05， 95% CI： 1.44 至 2.92）。干预提高了大多数亚组的 HCC 筛查过程完成率，包括年龄、性别、种族和民族、Child-Turcotte-Pugh 等级和卫生系统。外展组的 PTC 也显著高于常规护理（平均 37.5% 对 28.2%;RR 1.33,95% CI：1.31 至 1.35）。尽管筛查未充分利用，但两组的大多数 HCC 都是在早期检测到的。结论 与常规护理相比，邮寄外展加导航显著提高了肝硬化患者的 HCC 筛查过程完成率，在大多数检查的亚组中效果一致。 然而，两组的筛查完成率仍然不理想，这凸显了需要更深入的干预。试验注册号 [NCT02582918][1]。数据可应合理要求提供。[1]： /lookup/external-ref？link_type=CLINTRIALGOV&access_num=NCT02582918&atom=%2Fgutjnl%2F73%2F12%2F2037.原子