Parallel Randomised Trial on Community Fibrosis Assessment for Non-Alcoholic Fatty Liver Disease
Objective
Non-alcoholic fatty liver disease (NAFLD) affects about one-third of adults in Australia, and its numbers are expected to grow. This increase poses a challenge for healthcare systems. The LOCATE-NAFLD trial aimed to create a community-based service using FibroScan to speed up the diagnosis of high-risk NAFLD and enhance patient care.
Methods
We conducted a 1:1 parallel randomised trial to compare two methods for diagnosing and assessing NAFLD. Participants suspected of having NAFLD were referred to a hepatology clinic at one of three major hospitals in South-East Queensland. After consenting, participants were randomly assigned to either the usual care group or the LOCATE intervention. Those in the intervention group received a FibroScan outside the hospital, and results were shared with their primary care provider and referring hepatologist. All participants were followed up 12 months later to assess their health outcomes.
Results
We recruited 97 participants between October 2020 and December 2022. In the intervention group, 48 out of 50 participants attended their FibroScan appointment, with 27% showing high liver stiffness (8.0 kPa or more). The analysis indicated a faster average time to diagnosis, although it was not statistically conclusive. Importantly, the intervention significantly reduced the time to get a FibroScan by nearly 1 year (median difference of 0.92 years). Other clinical outcomes showed minimal changes.
Conclusion
The LOCATE model has potential benefits, especially in reducing wait times for patients at high risk of severe liver disease from NAFLD. More extensive studies with larger participant groups and longer follow-ups are needed to assess additional health outcomes.
Clinical Trial Registration
Trial Registration Number: ACTRN12620000158965.
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