Tulleners Ruth, Barnett Adrian, O'Beirne James, Powell Elizabeth, Hickman Ingrid J, Valery Patricia C, Kularatna Sanjeewa, Stuart Katherine, McIvor Carolyn, Witness Elen, Aikebuse Melanie, Brain David
Australian Centre for Health Services Innovation, Centre for Healthcare Transformation, School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Kelvin Grove, Queensland, Australia.
University of the Sunshine Coast, Birtinya, Queensland, Australia.
BMJ Open Gastroenterol. 2024 Dec 20;11(1):e001418. doi: 10.1136/bmjgast-2024-001418.
Non-alcoholic fatty liver disease (NAFLD) is estimated to affect a third of Australian adults, and its prevalence is predicted to rise, increasing the burden on the healthcare system. The LOCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD) trialled a community-based fibrosis assessment service using FibroScan to reduce the time to diagnosis of high-risk NAFLD and improve patient outcomes.
We conducted a 1:1 parallel randomised trial to compare two alternative models of care for NAFLD diagnosis and assessment. Participants had suspected NAFLD and were referred to a hepatology clinic in one of three major hospitals in South-East Queensland. Eligible consenting participants were randomised to receive usual care or the intervention (LOCATE). Participants in the intervention arm received a FibroScan outside of the hospital setting, with results provided to their primary care provider and the referring hepatologist. All participants were followed up 12 months after randomisation to measure their clinical and patient-reported outcomes.
97 participants were recruited from October 2020 to December 2022. Of the 50 participants randomised to the intervention arm, one failed to attend their appointment, and of the 48 (98%) who had a FibroScan 13 (27%) had a liver stiffness measurement of 8.0 kPa or greater. The HR for the time to diagnosis of high risk was 1.28 (95% CI 0.59 to 2.79), indicating a faster average time to diagnosis with the intervention, but failing to conclusively demonstrate a faster time. The intervention did greatly reduce the time to FibroScan by almost 1 year (median difference 0.92 years, 95% CI 0.56 to 1.45). Other clinical outcomes showed minimal changes.
The LOCATE model shows potential for impact, particularly in reducing waiting times for patients at high risk of developing severe liver disease due to NAFLD. A larger sample and longer follow-ups are needed to measure additional clinical outcomes.
ACTRN12620000158965.
据估计，非酒精性脂肪性肝病（NAFLD）影响着三分之一的澳大利亚成年人，且其患病率预计还会上升，这将增加医疗系统的负担。非酒精性脂肪性肝病的本地评估与分诊评估（LOCATE-NAFLD）试验了一项基于社区的纤维化评估服务，该服务使用FibroScan来缩短高危NAFLD的诊断时间并改善患者预后。
我们进行了一项1:1平行随机试验，以比较两种用于NAFLD诊断和评估的不同护理模式。参与者疑似患有NAFLD，并被转诊至昆士兰州东南部三家主要医院之一的肝病诊所。符合条件并同意参与的参与者被随机分配接受常规护理或干预措施（LOCATE）。干预组的参与者在医院外接受FibroScan检查，结果会提供给他们的初级保健提供者和转诊的肝病专家。所有参与者在随机分组后12个月接受随访，以测量他们的临床和患者报告的结局。
2020年10月至2022年12月招募了97名参与者。在随机分配到干预组的50名参与者中，有1名未参加预约，在进行FibroScan检查的48名（98%）参与者中，有13名（27%）的肝脏硬度测量值为8.0 kPa或更高。高危诊断时间的风险比为1.28（95%可信区间0.59至2.79），表明干预组的平均诊断时间更快，但未能确凿地证明时间更快。干预措施确实将进行FibroScan检查的时间大幅缩短了近1年（中位数差异0.92年，95%可信区间0.56至1.45）。其他临床结局变化极小。
LOCATE模式显示出有产生影响的潜力，特别是在减少因NAFLD而有发展为严重肝病高风险患者的等待时间方面。需要更大的样本量和更长时间的随访来测量其他临床结局。
ACTRN12620000158965。
