Determining the frequency of abnormal hepatic fibrosis measures and liver cirrhosis/decompensation in UK primary care

Study type
Protocol
Date of Approval
Study reference ID
17_235
Lay Summary

Liver problems in people in the UK and internationally are becoming increasingly common, but are difficult to identify early in the course of the disease. As the liver becomes more diseased scaring forms within it (fibrosis) and this is termed advanced liver disease. We intend to look at the potential of using blood test indicators of advanced liver disease as screening in primary care in the UK.

Firstly, we plan to use general practice data (CPRD) to determine how using different blood test indicators of advanced liver disease (fibrosis) as a screening tool would affect NHS health services. We will work out how many people would need to be referred to see a hospital consultant as a result of the screening test.

Secondly, we plan to look and see how many people who we know end up in hospital with advanced liver disease and its complications (such as liver cancer) would have been identified earlier if we used the possible blood test indicators of advanced liver disease (fibrosis) as a screening test.

The results will help us decide if and how to screen for advanced liver disease in general practice and will guide the future health care of patients.

Technical Summary

Overall aim:
To investigate the potential burden on UK health services of screening for chronic liver disease in UK primary care.
Methodology:
We will conduct a population based cohort study to examine firstly the prevalence of probable hepatic fibrosis as determined by non-invasive markers, and secondly rates of liver cirrhosis and hepatic decompensation.
We will extract all patients with the necessary measures available to determine the prevalence of hepatic fibrosis and will phenotype them using non-invasive markers (AST/ALT ratio, APRI, FIB4, NAFLD Fibrosis Score). The components of each marker will be extracted as laboratory measures or READ codes from the linked clinical file and the composite score calculated.
Hepatic decompensation will be defined as a composite outcome including liver cirrhosis, oesophageal varices, hepatocellular cancer and ascites.
Ability of each of the markers to predict hepatic decompensation will be determined separately using Cox proportional hazards regression and net benefit analyses for diagnostic test prediction models (as described by Vickers et al BMJ 2016;352:i6).
Scientific and medical opportunities:
This research will improve the applicability and reliability of clinical guidelines for the diagnosis of CLD in primary care.

Health Outcomes to be Measured

Liver cirrhosis
- Oesophageal varices
- Death
- Advanced liver disease
- Hepatocellular cancer
- Decompensated liver disease
- Ascites

Collaborators

Joanne Morling - Chief Investigator - University of Nottingham
Joanne Morling - Corresponding Applicant - University of Nottingham
Polly Scutt - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of Nottingham
Yusef Alenezi - Collaborator - University of Nottingham

Linkages

HES Accident and Emergency;HES Admitted Patient Care;NCRAS Cancer Registration Data;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation