Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 21, 2024
Date Accepted: Apr 10, 2024
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The impact of an automated population-level cirrhosis screening program using common pathology tests on rates of cirrhosis diagnosis and linkage to specialist care – The Cirrhosis Automated APRI and FIB-4 Screening Evaluation (CAPRISE) Study: Protocol for a pilot prospective single-arm intervention study
ABSTRACT
Background:
People with compensated cirrhosis derive the greatest benefit from risk factor modification and prevention programs to reduce liver decompensation and improve early liver cancer detection [1]. Blood-based liver fibrosis algorithms such as Aspartate 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.
Objective:
In this pilot study, we evaluate the impact of a population screening program for liver cirrhosis (CAPRISE), 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. This single-centre prospective single arm pre and post intervention study will compare the monthly rates of transient elastography (Fibroscan®) uptake, cirrhosis diagnosis and the proportion linked to specialist care in the 6 months post intervention to the 6 months prior to the intervention.
Methods:
We have partnered with a large pathology service in Victoria 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 weblink 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. Monthly rates of transient elastography referrals, liver cirrhosis diagnosis and linkage to specialist care at a single linked health service will be compared six months post intervention to six months prior to intervention.
Results:
Pre-intervention data collection will commence on 1st August 2023 and the intervention period is expected to commence on 1st February 2024. Data analysis is expected to begin following six months of intervention in August 2024 and publication of results with then follow.
Conclusions:
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. Clinical Trial: This study was registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) on 17th March 2023. ANZCTR Number: ACTRN12623000295640.
Citation
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