Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial
Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial
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DOI：
10.1002/hep.30129
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发表时间：
2019-01-01
期刊：
影响因子：
13.5
通讯作者：
Halm, Ethan A.
中科院分区：
文献类型：
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作者：
Singal, Amit G.;Tiro, Jasmin A.;Halm, Ethan A.
肝细胞癌(HCC)监测与早期发现肿瘤和提高肝硬变患者的生存率相关；然而，有效性受到使用不足的限制。我们比较了邮寄外展和患者导航策略在不同种族的肝硬变患者队列中增加肝细胞癌监测的有效性。我们进行了一项务实的随机临床试验，比较了2014年12月至2017年3月在大型安全网卫生系统的1800名肝硬变患者中，邮寄外展筛查超声(n=600)、邮寄外展+患者导航(n=600)或常规护理与基于访问的筛查(n=600)。在2周内没有回应外展邀请的患者会收到提醒电话。患者导航包括对监测障碍的评估和鼓励监测参与。主要结果是18个月期间的肝细胞癌监测(每6个月进行一次腹部成像)。所有1800名患者都被纳入意向筛查分析。23.3%的外展/导航患者、17.8%的外展患者和7.3%的常规护理患者接受了肝细胞癌监测。外展组的肝细胞癌监测比常规护理(P<；0.001)高16.0%(95%可信区间：12.0%-20.0%)和10.5%(95%CI：6.8%-14.2%)，外展/导航比单独外展高5.5%(95%CI：0.9%-10.1%)(P=0.02)。这两种干预措施都增加了对预先定义的患者亚组的肝细胞癌监测。早期发现的肝癌患者的比例在不同组之间没有差异；然而，跨组筛查发现的肝癌患者中早期肿瘤的比例高于偶然或有症状发现的肝癌患者(83.3%对30.8%，P=0.003)。结论：与常规护理相比，邮寄的外展邀请和导航显著增加了对肝硬变患者的肝细胞癌监测。
Hepatocellular carcinoma (HCC) surveillance is associated with early tumor detection and improved survival in patients with cirrhosis; however, effectiveness is limited by underuse. We compared the effectiveness of mailed outreach and patient navigation strategies to increase HCC surveillance in a racially diverse cohort of patients with cirrhosis. We conducted a pragmatic randomized clinical trial comparing mailed outreach for screening ultrasound (n = 600), mailed outreach plus patient navigation (n = 600), or usual care with visit-based screening (n = 600) among 1800 patients with cirrhosis at a large safety-net health system from December 2014 to March 2017. Patients who did not respond to outreach invitations within 2 weeks received reminder telephone calls. Patient navigation included an assessment of barriers to surveillance and encouragement of surveillance participation. The primary outcome was HCC surveillance (abdominal imaging every 6 months) over an 18-month period. All 1800 patients were included in intention-to-screen analyses. HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach-alone patients, and 7.3% of usual care patients. HCC surveillance was 16.0% (95% confidence interval [CI]: 12.0%-20.0%) and 10.5% (95% CI: 6.8%-14.2%) higher in outreach groups than usual care (P < 0.001 for both) and 5.5% (95% CI: 0.9%-10.1%) higher for outreach/navigation than outreach alone (P = 0.02). Both interventions increased HCC surveillance across predefined patient subgroups. The proportion of HCC patients detected at an early stage did not differ between groups; however, a higher proportion of patients with screen-detected HCC across groups had early-stage tumors than those with HCC detected incidentally or symptomatically (83.3% versus 30.8%, P = 0.003). Conclusion: Mailed outreach invitations and navigation significantly increased HCC surveillance versus usual care in patients with cirrhosis.