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Stratification of LIver Disease (SOLID): Protocol for a prospective observational cohort study to determine the optimum biomarker strategies for the detection of advanced liver disease at the primary-secondary care interface

Lookup NU author(s): Professor Stuart McPhersonORCiD, Helen JarvisORCiD, Dr Kate HallsworthORCiD, Trevor Liddle, Dr Dina Mansour, Professor Dawn Teare, Professor Quentin AnsteeORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2023 BMJ Publishing Group. All rights reserved.Introduction Undiagnosed fatty liver disease is prevalent in the community, due to high rates of harmful alcohol consumption and/or obesity. Fatty liver disease can progress to cirrhosis and its complications. Early identification of liver disease and treatment may prevent progression to cirrhosis. Biomarkers including FIB-4, enhanced liver fibrosis (ELF), PRO-C3 and vibration controlled transient elastography (VCTE) can stage liver fibrosis, but it is not known how well they perform in a primary care population. Moreover, no assessment of long-term prognostic ability of these biomarkers has been conducted in primary care. We aim to evaluate the performance of fibrosis biomarkers in primary care to develop a pathway to detect advanced fibrosis. Methods and analysis This prospective, observational cohort study will recruit 3000 individuals with fatty liver disease risk factors (obesity, type 2 diabetes or hazardous alcohol consumption) at their primary care 'annual chronic disease review'. Participants will have a 'liver health check'. Two pathways will be evaluated: (1) all have FIB-4, ELF and VCTE performed, and (2) patients have an initial assessment with FIB-4 and ELF, followed by VCTE in only those with increased FIB-4 and/or ELF. Individuals with suspected significant/advanced liver fibrosis (liver stiffness measurement>8 kPa), will be reviewed in secondary care to confirm their fibrosis stage and institute treatment. The performance of FIB-4, ELF, PRO-C3, VCTE and novel biomarkers alone or in combination for advanced fibrosis/cirrhosis will be evaluated. Participants will be followed longitudinally via their electronic health records to assess long-term clinical outcomes. Ethics and dissemination Ethical approval was obtained from the London-Chelsea Research Ethics Committee (22/PR/0535; 27 June 2022). Recruitment began on 31 October 2022. Outcomes of this study will be published in peer-reviewed journals and presented at scientific meetings. A lay summary of the results will be available for study participants and will be disseminated widely by LIVErNORTH.

Publication metadata

Author(s): McPherson S, Jarvis H, McGonigle J, Bedlington J, Dean J, Hallsworth K, Hanon E, Liddle T, Luvai A, Mansour D, Patel P, Renwick L, Teare D, Tanney C, Anstee Q

Publication type: Article

Publication status: Published

Journal: BMJ Open Gastroenterology

Year: 2023

Volume: 10

Issue: 1

Print publication date: 08/02/2023

Online publication date: 08/02/2023

Acceptance date: 24/01/2023

Date deposited: 06/03/2023

ISSN (electronic): 2054-4774

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjgast-2022-001092

DOI: 10.1136/bmjgast-2022-001092

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