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A parallel randomised trial testing community fibrosis assessment for suspected non-alcoholic fatty liver disease: Outcomes from LOCATE-NAFLD
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A parallel randomised trial testing community fibrosis assessment for suspected non-alcoholic fatty liver disease: Outcomes from LOCATE-NAFLD

Ruth Tulleners, Adrian Barnett, James O'Beirne, Elizabeth Powell, Ingrid J Hickman, Patricia C Valery, Sanjeewa Kularatna, Katherine A Stuart, Carolyn McIvor, Elen Witness, …
Research Square, Vol.15 February 2024
Research Square Company
2024
DOI: https://doi.org/10.21203/rs.3.rs-3960262/v1
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Preprint VersionCC BY V4.0,  Open Access

Abstract

gastroenterology and hepatology health olicy non-alcoholic fatty liver disease randomised controlled trial fibroscan community
Background and Aims 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. 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. Methods 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. Results Ninety-seven participants were recruited from October 2020 to December 2022, of which 49 were randomised to receive the intervention. The intervention demonstrated a decrease in the time to high-risk diagnosis. However, the 95% credible interval for the hazard ratio was wide. The median reduction in ‘time to scan’ in the intervention was close to one year. Other clinical outcomes showed minimal changes. Conclusions 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.

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