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

• Published in: BMJ open gastroenterology Vol. 10; no. 1; p. e001092
• Main Authors: McPherson, Stuart, Jarvis, Helen, McGonigle, John, Bedlington, Joan, Dean, Jill, Hallsworth, Kate, Hanon, Elodie, Liddle, Trevor, Luvai, Ahai, Mansour, Dina, Patel, Preya, Renwick, Laura, Teare, Dawn, Tanney, Christina, Anstee, Quentin
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd 01.02.2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Accuracy; alcohol; Alcohol use; Biomarkers; Body mass index; Chronic illnesses; cirrhosis; Cohort analysis; Complement C3; Diabetes; diabetes mellitus; Diabetes Mellitus, Type 2; Enzymes; fatty liver; Hepatology; Humans; Liver cancer; Liver cirrhosis; Liver Cirrhosis - complications; Liver Cirrhosis - diagnosis; Liver Cirrhosis - epidemiology; Liver diseases; Non-alcoholic Fatty Liver Disease - complications; Non-alcoholic Fatty Liver Disease - diagnosis; Non-alcoholic Fatty Liver Disease - epidemiology; Obesity; Obesity - complications; Observational studies; Observational Studies as Topic; Primary care; Prospective Studies; Risk factors; Secondary Care; alcohol; primary care; diabetes mellitus; fatty liver; cirrhosis
• ISSN: 2054-4774; 2054-4774
• DOI: 10.1136/bmjgast-2022-001092

IntroductionUndiagnosed 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 analysisThis 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 disseminationEthical 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.