Faced with a growing burden of liver disease, researchers at the NIHR Nottingham Biomedical Research Centre reimagined the way that patients could be diagnosed in community settings. Their pathway has been tested and is being taken up by the NHS to the benefit of patients.
Published: 22 January 2021
The challenges of liver disease
Scarring, or cirrhosis, of the liver caused by long-term liver damage. Liver scarring has a number of causes, including alcohol consumption, long-term hepatitis infection, and severe form of non-alcoholic fatty liver disease (NAFLD).
Half of patients with severe liver scarring are only diagnosed once they present in hospital in crisis. A striking fact, particularly as the liver is the only solid organ in the body which can regenerate, and earlier diagnosis would give people the option to make lifestyle changes to allow the liver to recover.
Dr Neil Guha and Professor Guru Aithal are clinical academics at the University of Nottingham. They are both part of the gastrointestinal and liver research theme at the NIHR Nottingham Biomedical Research Centre. They and their colleagues have spent nearly a decade improving the diagnosis of liver scarring and cirrhosis.
“The problem we were trying to address is that liver disease is increasing in its burden, primarily because of alcohol and obesity. It doesn’t necessarily present with symptoms and is often diagnosed late, when the liver is starting to fail, and this is difficult to manage,” explains Dr Guha. “Liver transplantation is a cure but is a limited resource: we perform around 900-1,000 transplants a year, yet around 13,000-20,000 people in the UK die each year from liver diseases at a conservative estimate. So we need better tests for earlier diagnosis to give people options.”
When the team began their research in 2012, the main diagnosis was via blood tests known as liver enzyme tests that are undertaken specialist hospital hepatology departments. The results did not necessarily enlighten specialists as to the condition of the liver: a high result does not give insight into the scarring of the liver and it is possible to have severe disease and a normal test. If the result suggested further investigation was needed, patients were referred for biopsy, which is uncomfortable and requires time off work.
Clearer, more immediate results
Dr Guha, Professor Aithal and colleagues got funding from the Department of Health and Social Care for a pilot series of research - the Scarred Liver Project - to develop a new diagnosis pathway based in primary care.
The new pathway uses a test called FibroScan, which has been around for many years and has been extensively validated in a hospital setting. It has an unusual origin, as Professor Guha explains: “The technology was originally made in France to look for the ripeness of cheese. Some bright spark said, 'hang on a minute, if cheese gets hard as it ripens, so does the liver,' and poised the question of whether it could be used for the liver."
FibroScan sends a radiowave through the liver to measure the degree of scarring. "We like the machine because it is simple to use. It is based on some basic principles of physics; a wave is sent across the liver and the faster it travels corresponds to the degree of scarring within the liver," says Professor Guha. "Patients can be fed back their results in real time, you can train nurses and healthcare assistants to use the machine and it can be easily deployed in community settings.”
The new pathway combines non-invasive diagnostic tests such as Fibroscan with actively seeking out patients at risk of chronic liver disease , through identifying people from the general practitioners’ register who were at risk of liver disease.
Working with partners such as the East Midlands Academic Health Sciences Network (EMAHSN), the pilots showed increased detection of both significant liver diseases and cirrhosis by almost twofold. Importantly, a lot of these patients would have had normal levels of enzymes that would not have been detected using traditional pathways of care.
Dr Guha says: “To be able to give people a diagnosis and ask them to change their lifestyle, whether that be by reducing alcohol intake or via weight loss, can be effective. Of course, it’s challenging and not everyone responds to those lifestyle changes, we should be honest about that, but with this earlier diagnosis you give people the opportunity and importantly the time to be able to implement changes so their liver can heal.”
The seeds of change
The researchers went on to test the feasibility of this new approach in an inner city area after doing it in an affluent area, and adapted some of the risk factors. This time there was economic modelling and some qualitative work, as well as discussions with local practitioners facilitated by the EMAHSN.
This diagnosis pathway is now available at more than 100 GP practices across four Clinical Commissioning Groups (the local organisations responsible for planning and funding NHS care) serving a population of approximately 700,000 people.
Much of the NHS Long Term Plan is focused on moving away from hospital care back to care in community settings. ProfessorGuha continues: “To be fair to our primary care colleagues, hepatology has been somewhat of a dark art that has been practiced in specialist centres, and we haven’t given them the tools to be able to identify liver disease. I think access to those tools is important so that they begin to better understand the disease.
"The nice thing about our pathway is that GPs can directly access tests. Previously to our pathway those tests were reserved for hospital specialists or to researchers.”
This research has been recognised in various forums. Dr Guha was awarded an NHS Innovation Accelerator fellowship to bring the research into a clinical setting. The team won an NHS Innovation Challenge Award in 2013 for the new care pathway and were awarded a prize by NICE for their shared learning account. The Health Service Journal ‘Improving the Value of Diagnostic Services Award’ in 2019, and the King’s Fund, highlighted the pathway as a success in the adoption of new technologies. The team have been asked to join an European Consortium to understand the identification of people with significant liver scarring.
And there are a growing number of patient advocates too. “The concept of early diagnosis was brought up in a patient focus group on a NIHR study on patients with liver cirrhosis. One of the things that came out of one of those workshops was patients complaining why wasn’t I diagnosed earlier?" says Dr Guha. "We said 'it’s difficult,' but they weren’t interested in the difficulties; they just wanted us to accelerate access to the diagnostics."
“The NIHR was really important for us in this project for a number of reasons. We used our expertise in liver diseases and understanding diagnostics and our relationships with our NHS partners to be able to create evidence around implementing a novel pathway," Dr Guha adds.
The fact that we ran the first pilot in 2012 and got the research commissioned in 2016 is quite staggering, and having the NIHR behind us was really important in accelerating that.