DIALS – DIAgnosis of Liver diseaSe in primary care

Health Technology Assessment Award

Plain English Summary of Research:

Background to the study:
Liver disease is a major problem, especially in people under 65 years. It often develops without showing any symptoms, over many years. People might only realise they have it when they suddenly become very unwell. At this point, the disease is at a very advanced stage.

Many factors can lead to liver disease, but the common ones are:
• Consuming alcohol excessively.
• Being overweight.
• Having Type 2 diabetes

Not everyone with these risk factors develops liver disease. It is important to identify those with liver damage before they become seriously unwell. However, at the moment, there is no good way to do this.

Currently, blood tests do not always identify liver disease or its severity. However, several new tests are now available. These look for liver scarring (fibrosis), which is a build-up of scar tissue that occurs when the liver is damaged. Usually, this damage builds up over a long time. If it becomes severe, it is called cirrhosis.

Examples of these new tests include specialist blood tests called “FIB-4 and ELF”. There is also a liver scan called “FibroScan”. This scan is quick and painless, similar to the scan people have during pregnancy.

The FIB-4 and ELF blood tests and FibroScan, a “liver health check”, will pick up signs of liver scarring. If found early, people can have treatment before they become very unwell. However, these blood tests and scans are often not available in GP surgeries.

Aims of the research:
The DIALS trial will compare the normal testing provided by a GP with people who have the FIB-4 and ELF blood tests and FibroScan. What we want to know is:

(1) Does a liver health check in primary care find more patients with cirrhosis (severe liver damage)?
(2) Is this testing value for money?

Design of the study:
The trial will take place at 110 GP practices. At each practice, we will identify 100 people with risk factors for liver disease. Half of the GP practices will continue to treat people as normal. The other half will invite people to have all the liver scarring tests. People will be able to choose if they want to have the liver health check or not. If these tests show that someone might have cirrhosis, they will be referred to a specialist in hospital for further tests and treatment.

Patient and public involvement: Finding liver disease early can make a huge difference to the lives of patients and was chosen as a priority by a workshop of patients with this health condition and the public. The research team will include members of the public with an interest and/or lived experience in this area and people who work for liver charities. They will work closely with researchers and join a steering
group which will guide each stage of the study. The invitation for patients to have a liver health check will be an important part of this study. The approach for recruiting patients for a liver health check will be co-produced to make sure it is designed correctly and meets the needs of the potential participants.

Dissemination:
Results from this work will be shared at conferences, published on the British Liver Trust website and in scientific journals. We will also work with our steering group to create different ways to share information about the study findings to patient advocacy groups and the wider public. We will also speak with people who can change local and national policies on liver health in the National Health Service and Parliament.