Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy, Australia.
Department of Medicine, University of Melbourne, Parkville, Australia.
JMIR Res Protoc. 2024 May 22;13:e56607. doi: 10.2196/56607.
People with compensated cirrhosis receive the greatest benefit from risk factor modification and prevention programs to reduce liver decompensation and improve early liver cancer detection. Blood-based liver fibrosis algorithms such as the Aspartate Transaminase-to-Platelet Ratio Index (APRI) and Fibrosis-4 (FIB-4) index are calculated using routinely ordered blood tests and are effective screening tests to exclude cirrhosis in people with chronic liver disease, triaging the need for further investigations to confirm cirrhosis and linkage to specialist care.
This pilot study aims to evaluate the impact of a population screening program for liver cirrhosis (CAPRISE [Cirrhosis Automated APRI and FIB-4 Screening Evaluation]), which uses automated APRI and FIB-4 calculation and reporting on routinely ordered blood tests, on monthly rates of referral for transient elastography, cirrhosis diagnosis, and linkage to specialist care.
We have partnered with a large pathology service in Victoria, Australia, to pilot a population-level liver cirrhosis screening package, which comprises (1) automated calculation and reporting of APRI and FIB-4 on routinely ordered blood tests; (2) provision of brief information about liver cirrhosis; and (3) a web link for transient elastography referral. APRI and FIB-4 will be prospectively calculated on all community-ordered pathology results in adults attending a single pathology service. This single-center, prospective, single-arm, pre-post study will compare the monthly rates of transient elastography (FibroScan) referral, liver cirrhosis diagnosis, and the proportion linked to specialist care in the 6 months after intervention to the 6 months prior to the intervention.
As of January 2024, in the preintervention phase of this study, a total of 120,972 tests were performed by the laboratory. Of these tests, 78,947 (65.3%) tests were excluded, with the remaining 42,025 (34.7%) tests on 37,872 individuals meeting inclusion criteria with APRI and FIB-4 being able to be calculated. Of these 42,025 tests, 1.3% (n=531) had elevated APRI>1 occurring in 446 individuals, and 2.3% (n=985) had elevated FIB-4>2.67 occurring in 816 individuals. Linking these data with FibroScan referral and appointment attendance is ongoing and will continue during the intervention phase, which is expected to commence on February 1, 2024.
We will determine the feasibility and effectiveness of automated APRI and FIB-4 reporting on the monthly rate of transient elastography referrals, liver cirrhosis diagnosis, and linkage to specialist care.
Australian New Zealand Clinical Trials Registry ACTRN12623000295640; https://tinyurl.com/58dv9ypp.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56607.
代偿性肝硬化患者通过改变风险因素和预防方案获益最大，可以减少肝失代偿和提高早期肝癌的检出率。基于血液的肝纤维化算法，如天门冬氨酸氨基转移酶与血小板比值指数（APRI）和纤维化-4 指数（FIB-4 指数），是通过常规检测的血液检测计算得出的，是一种有效的筛查试验，可以排除慢性肝病患者的肝硬化，对需要进一步检查以确认肝硬化和链接到专科护理的患者进行分类。
本试点研究旨在评估肝硬化人群筛查计划（CAPRISE [肝硬化自动化 APRI 和 FIB-4 筛查评估]）对每月转诊进行瞬时弹性成像、肝硬化诊断和链接到专科护理的影响。
我们与澳大利亚维多利亚州的一家大型病理服务机构合作，试点开展了一项基于人群的肝硬化筛查方案，包括：（1）在常规血液检测中自动计算和报告 APRI 和 FIB-4；（2）提供有关肝硬化的简要信息；（3）提供瞬时弹性成像转诊的网络链接。APRI 和 FIB-4 将前瞻性地计算所有参加单一病理服务的成人社区订购的病理结果。这项单中心、前瞻性、单臂、前后对照研究将比较干预后 6 个月与干预前 6 个月之间瞬时弹性成像（FibroScan）转诊、肝硬化诊断和与专科护理联系的比例。
截至 2024 年 1 月，在本研究的干预前阶段，实验室共进行了 120972 次检测。在这些检测中，有 78947 次（65.3%）被排除，剩余的 42025 次（34.7%）检测在 37872 名符合 APRI 和 FIB-4 计算条件的个体上进行。在这 42025 次检测中，1.3%（n=531）的 APRI>1 升高，发生在 446 例个体中，2.3%（n=985）的 FIB-4>2.67升高，发生在 816 例个体中。正在对这些数据进行瞬时弹性成像转诊和预约参加的链接，预计将在 2024 年 2 月 1 日开始的干预阶段继续进行。
我们将确定自动化 APRI 和 FIB-4 报告对瞬时弹性成像转诊、肝硬化诊断和与专科护理联系的每月比率的可行性和有效性。
澳大利亚和新西兰临床试验注册 ACTRN12623000295640；https://tinyurl.com/58dv9ypp。
国际注册报告标识符（IRRID）：DERR1-10.2196/56607。
