Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University, Mainz, Germany; Cirrhosis Center Mainz (CCM), University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
J Hepatol. 2022 Sep;77(3):695-701. doi: 10.1016/j.jhep.2022.04.009. Epub 2022 Apr 23.
BACKGROUND & AIMS: Detection of patients with early cirrhosis is of importance to prevent the occurrence of complications and improve prognosis. The SEAL program aimed at evaluating the usefulness of a structured screening procedure to detect cirrhosis as early as possible.
SEAL was a prospective cohort study with a control cohort from routine care data. Individuals participating in the general German health check-up after the age of 35 ("Check-up 35") at their primary care physicians were offered a questionnaire, liver function tests (aspartate and alanine aminotransferase [AST and ALT]), and follow-up. If AST/ALT levels were elevated, the AST-to-platelet ratio index (APRI) score was calculated, and patients with a score >0.5 were referred to a liver expert in secondary and/or tertiary care.
A total of 11,859 participants were enrolled and available for final analysis. The control group comprised 349,570 participants of the regular Check-up 35. SEAL detected 488 individuals with elevated APRI scores (4.12%) and 45 incident cases of advanced fibrosis/cirrhosis. The standardized incidence of advanced fibrosis/cirrhosis in the screening program was slightly higher than in controls (3.83‰ vs. 3.36‰). The comparison of the chance of fibrosis/cirrhosis diagnosis in SEAL vs. in standard care was inconclusive (marginal odds ratio 1.141, one-sided 95% CI 0.801, +Inf). Of note, when patients with decompensated cirrhosis at initial diagnosis were excluded from both cohorts in a post hoc analysis, SEAL was associated with a 59% higher chance of early cirrhosis detection on average than routine care (marginal odds ratio 1.590, one-sided 95% CI 1.080, +Inf; SEAL 3.51‰, controls: 2.21‰).
The implementation of a structured screening program may increase the early detection rate of cirrhosis in the general population. In this context, the SEAL pathway represents a feasible and potentially cost-effective screening program.
DRKS00013460 LAY SUMMARY: Detection of patients with early liver cirrhosis is of importance to prevent the occurrence of complications and improve prognosis. This study demonstrates that the implementation of a structured screening program using easily obtainable measures of liver function may increase the early detection rate of cirrhosis in the general population. In this context, the 'SEAL' pathway represents a feasible and potentially cost-effective screening program.
检测早期肝硬化患者对于预防并发症和改善预后具有重要意义。SEAL 项目旨在评估一种结构化筛查程序的有效性，以尽早发现肝硬化。
SEAL 是一项前瞻性队列研究，同时纳入了常规护理数据中的对照队列。在初级保健医生处接受常规健康检查（“35 岁健康检查”）的 35 岁以上个体被提供了一份问卷、肝功能检查（天门冬氨酸氨基转移酶和丙氨酸氨基转移酶[AST 和 ALT]）和随访。如果 AST/ALT 水平升高，则计算 AST-血小板比值指数（APRI）评分，且评分>0.5 的患者被转诊至二级和/或三级保健的肝脏专家处。
共纳入 11859 名参与者并进行了最终分析。对照组由常规“35 岁健康检查”的 349570 名参与者组成。SEAL 检测到 488 名 APRI 评分升高（4.12%）的个体和 45 例进展性纤维化/肝硬化的病例。筛查项目中进展性纤维化/肝硬化的标准化发病率略高于对照组（3.83‰比 3.36‰）。SEAL 与标准护理的纤维化/肝硬化诊断机会的比较尚无定论（边缘优势比 1.141，单侧 95%CI 0.801，+无穷大）。值得注意的是，在事后分析中排除两个队列中初始诊断为失代偿性肝硬化的患者后，SEAL 平均比常规护理更早发现肝硬化的机会增加了 59%（边缘优势比 1.590，单侧 95%CI 1.080，+无穷大；SEAL 为 3.51‰，对照组为 2.21‰）。
实施结构化筛查方案可能会提高一般人群中肝硬化的早期检出率。在此背景下，SEAL 方案代表了一种可行且具有潜在成本效益的筛查方案。
DRKS00013460 概要：检测早期肝硬化患者对于预防并发症和改善预后具有重要意义。本研究表明，使用易于获得的肝功能测量指标实施结构化筛查方案可能会提高一般人群中肝硬化的早期检出率。在此背景下，“SEAL”方案代表了一种可行且具有潜在成本效益的筛查方案。
