Recommendations for commissioning bodies to improve the early detection of chronic liver disease in UK primary care

Mortality from liver disease is increasing in the UK. It is a leading cause of death in working age, yet 90% is preventable. Three quarters of people are currently diagnosed at a late stage when it is often too late for effective interventions or treatment. The same level of attention that has previously been given to the prevention of cardiovascular disease and cancer now needs to be directed at the other major causes of years of life lost (YLLs), such as liver disease.  

The Royal College of General Practitioners and British Liver Trust have worked with stakeholders to create recommendations and a set of resources to support primary care commissioning bodies in the UK to plan and commission effective liver services for adults, adapted to local needs and circumstances. These recommendations have been developed from the latest NICE and British Society of Gastroenterology guidelines. 

The resources are divided into the following sections:

1. The rationale for change, the burden of chronic liver disease and finding out your local population needs 

2. Review the data, assess your local population needs and scope what needs to be done in your area

3. Develop an agreed local pathway for assessing the risk of liver disease, finding patients at risk, testing, following up and referring to secondary care 

4. Exemplar pathways to adapt for your local needs 

5. Links to NICE and British Society of Gastroenterology guidelines and other resources

These recommendations were developed by a stakeholder group led by the Royal College of General Practitioners and the British Liver Trust liver disease priority programme. Stakeholders invited included GPs, commissioners, public health professionals, hepatologists, third sector representatives and representatives from the devolved nations. These recommendations have been reviewed and endorsed by the Lancet Liver commission, British Association for the Study of the Liver (BASL) and the British Society of Gastroenterology (BSG).  

1) The rationale for change, the burden of chronic liver disease and finding out your local population needs

These recommendations will improve early detection and better initial management of chronic liver disease in primary care. This will lead to:

  • More appropriate referrals to secondary/tertiary care
  • Fewer admissions with decompensated liver cirrhosis
  • Less repeat blood testing without decision making
  • Long term improvement in morbidity and mortality for people with chronic liver disease
  • Significant cost savings for the NHS 
Liver disease mortality rates have increased 400% since 1970, and in people younger than 65 years have risen by almost five-times. Liver disease constitutes the third commonest cause of working age death in the UK. The three main types of liver disease accounting for 90% of all cases are alcohol related, NAFLD and viral hepatitis. The first two are treatable with behaviour modification and there is now a very effective cure for hepatitis C.  However, in order for these treatments to be effective we must detect disease early. 

It is shocking that three quarters of patients currently present too late. With education of GPs and access to easy testing we can change this trend.

2) Review the data, assess your local population needs and scope what needs to be done in your area

Public Health England’s Atlas of Variation in risk factors and healthcare for liver disease demonstrates geographical variation in healthcare provision, access and outcomes which cannot be explained by the underlying prevalence of risk factors or liver disease. The data can be used by clinical commissioning groups to identify the need for action. 
In addition, liver disease profiles for all regions of England are available here.
There is public health information for Scotland relating to: Chronic liver diseaseLiver disease mortalityChronic liver disease morbidity.

Public Health Wales have information on the prevalence of a range of liver diseases in Wales.

The data in these resources will enable commissioners to understand the local population and its associated needs in relation to liver disease and compare yourself with the national picture. This is the starting point for commissioning appropriate services and reducing the burden of liver disease. 

3) Develop an agreed local pathway for assessing the risk of liver disease, finding patients at risk, testing, following up and referring to secondary care

Look at whether there is an existing pathway that GPs are aware of and using in your area.  Assess whether this meets the steps below. in different regions of the country, it is important that any pathway is agreed with secondary care, particularly around agreed methods of fibrosis testing and cut-offs for referrals. Examples of pathways working in parts of the UK are given below. They can be adapted according to your local needs and resources and all groups are happy to be contacted to discuss their pathways in more detail. 

It is very important that the agreed pathway does not rely solely on liver blood tests or LFTs(liver enzymes) but adequately assesses liver fibrosis. The exemplar pathways showcase potential approaches for doing this. 

The locally agreed pathway should include the following:

(i) Assessing the risk of liver disease for individuals – how to find patients at risk 

The main drivers of chronic liver disease in the UK are alcohol and the combined effects of obesity and type 2 diabetes. We recommend that services are commissioned so that liver disease is considered regularly in people with these risk factors as well as those with risk factors for viral hepatitis. 

Alcohol related liver disease:

Recommendation 1: Assess and code alcohol risk (both dependence and non-dependent excessive drinking) using NICE/BSG guidelines and recognised tools

  • At new patient registration
  • During annual hypertension reviews
  • As part of any NHS/other routine ‘health check’
  • Opportunistically during consultations
  • Aim for all registered adults to have their alcohol risk assessed at least every 5 years

Those at risk of alcohol related liver disease are defined by NICE as men who regularly drink over 50 units of alcohol or women who drink over 35 units of alcohol weekly.

Rationale for recommendation: Information on drinking behaviour is unlikely to be volunteered or coded unless people are routinely and regularly asked about their alcohol consumption. Alcohol-related liver disease contributes the biggest morbidity and mortality burden of all liver disease.

Non-alcohol related fatty liver disease:

Recommendation 2: Assess metabolic risk (obesity, Type 2 diabetes, other metabolic risk factors) leading to non-alcohol related fatty liver disease (NAFLD)

  • Keep a register of all patients coded as having NAFLD 
  • Assess for NAFLD every 3-5 years in all registered patients with Type 2 diabetes (set up recall as for other chronic disease management)
  • Code people with a liver ultrasound showing fatty liver 
  • Consider keeping a register of all patients meeting criteria for the metabolic syndrome and assessing for NAFLD in these patients as for people with Type 2 diabetes 

Rationale for recommendation: Most patients at risk of NAFLD are likely to be under review for other reasons due to common metabolic and cardiovascular risk profiles. Only minor systems changes are needed to ensure liver disease is also routinely considered and coded in these patients.

Recommendation 3: Investigate incidental abnormal liver enzyme blood tests (LFTs)

These individuals are at risk of liver disease and should be investigated regardless of level of abnormality (use BSG guidelines to triage these patients and identify those at risk of common chronic liver disease as well as ruling out and referring on for rarer causes)

Rationale for recommendation: Patients with even minor abnormalities in their liver enzymes can have significant liver disease and a diagnosis should be sought /ruled out in all cases rather than re-testing/not acting on results. This is a cost effective approach and nationally recommended. 

Viral Hepatitis:

Recommendation 4: Offer tests to those who inject drugs or have other risk factors for viral hepatitis

  • People who inject drugs (PWID) should be offered testing for Hepatitis C routinely. 90% of HCV is acquired through injecting drugs
  • Follow NICE guidelines to ensure testing for Hepatitis B and C is being carried out in high risk patients
  • All patients testing positive for Hepatitis B and C should be offered referral to  consider treatment options

Rationale for recommendation: Untreated hepatitis C infection causes cirrhosis and liver cancer. Very effective, well tolerated oral therapies are now available on the NHS. There are national and international targets to eliminate Hepatitis C within the next 15 years. There are also effective treatments to control Hepatitis B. 

(ii) How to test – diagnosing liver disease and assessing for fibrosis/cirrhosis 

Recommendation 5: Diagnostic testing in patients at risk of chronic liver disease (Alcohol related and NAFLD) should focus on diagnosing/ruling out liver fibrosis

  • Assessing fibrosis can be done using blood-based algorithms, serum fibrosis markers, transient elastography (fibroscan) or these methods in combination. The choice of tests depends on local availability.
  • Do not use a set of normal routine liver enzymes (LFTs or liver blood tests) to rule out fibrosis in those identified as individuals at risk (including those with alcohol risk, NAFLD risk or viral hepatitis risk)
  • Fibrosis assessment should run in parallel with brief interventions/lifestyle advice
  • All patients where an initial liver screen, based on risk factors, has identified a cause other than alcohol or NAFLD should be referred to gastroenterology/hepatology

Rationale for recommendation: Liver fibrosis is the best predictor of progression to cirrhosis and poor clinical outcomes in patients with chronic liver disease. There are now several methods of assessing for fibrosis in the community. There is a lack of consensus around which is the best initial test of fibrosis to use, but it is important that ONE of the assessment methods is employed consistently according to local resources. All patients with liver disease aetiology other than alcohol or NAFLD require further investigation and management, which is not currently available in the community for most.

Recommendation 6: Test individuals with a high risk of alcohol or NAFLD related liver disease for fibrosis according to NICE and British Society of Gastroenterology guidelines  
Alcohol risk identified as high (>50 units/wk men or >35 women or AUDIT-C positive)
  • Direct to fibroscan if available
  • If not available then direct to ELF testing
  • If neither available then referral to gastroenterology/hepatology 
NAFLD risk high (based on metabolic risk assessment or abnormal blood tests with no other cause identified or fat on ultrasound with no other cause identified)
  • Direct to ELF test if available (see NICE guidance) 
  • Or serum based algorithm test (Fib 4, NAFLD fibrosis score, AST:ALT ratio) followed by fibroscan if available
  • If neither ELF or direct access fibroscan are available to request from primary care then referral on the basis of an indeterminate Fib 4, NAFLD fibrosis score or high AST:ALT ratio to gastroenterology/hepatology 

Rationale for recommendation: There is a lack of consensus around which is the best initial test of fibrosis to use, but it is important that ONE of the assessment methods is employed consistently according to local resources. See example pathways later in this document.

Recommendation 7: Develop robust systems for follow up

  • Individuals identified as being at low risk of liver fibrosis should be coded and re-assessed for fibrosis in the community using routine recall facilities every 3-5 years 
  • It is essential that follow up should include targeted brief interventions and lifestyle advice which should be coded and repeated if risk factors remain
  • Alcohol support services and weight loss services should be used as available and commissioned to expand to meet demand
  • High risk individuals* should be referred for specialist follow up. Local referral pathways should be determined by local resource availability and capacity, in discussion with primary care, secondary care and commissioners.  

Rationale for recommendation: If risk factors remain, patients at low risk of fibrosis may become high risk over time and it is crucial that these people are coded and followed up. To reduce this risk, brief interventions (both alcohol and weight loss) have been shown to be clinically and cost effective

*Note : There is some dispute around which ELF values and fibroscan scores should warrant referral/ cirrhosis assessment  - commissioners should review the evidence and make locally agreed decisions in conjunction with the clinicians who will be receiving referrals 

Recommendation 8: Audit any new pathway introduced to drive quality improvement making use of RCGP QI resources 

Quality Improvement (QI) is an evidence-based approach that helps primary care free up time to deliver and evaluate initiatives, and embed new approaches more effectively and efficiently into practice. QI helps us to make the most of our systems, organisations, talents and expertise to deliver better outcomes for patients. Read more

QI Ready is a free resource for all practices and has been developed to support GPs and practice teams with QI activities in practices. It is your starting place for all QI tools, guidance and case studies. Read more about the this RCGP programme here.

 

4) Exemplar pathways to adapt for your local needs

The Scarred Liver Project, Greater Nottingham

The Scarred Liver Project is risk factor focussed and uses Fibroscan to stratify patients at risk of liver disease. Developed out of pilot project in 2014 a fully integrated CCG commissioned pathway is now in place across Greater Nottingham. 

The scarred liver project has implemented an integrated pathway within the community to identify patients with risk factors for liver disease. GPs opportunistically identifying patients with risk factors for alcohol related liver disease, NAFLD or with unexplained abnormal liver enzymes are able to refer directly to liver fibrosis assessment using Fibroscan. All patients who attend for a Fibroscan® receive brief lifestyle intervention about their liver health. Patients stratified to have significant liver disease or cirrhosis are referred to a hepatologist for further review. 

The pathway has been demonstrated to be cost effective (ICER per QALY £2138 for NAFLD and £6537 for ALD) and has seen over 3000 patients in its first 18months since full implementation in September 2016

Full details of the pathway, its evaluation, associated publications and contact details for the clinicians involved are available on the website. 

The Gwent AST project

All blood tests sent from primary care where  ALT is raised have a ‘reflex’ AST measured in the laboratory. If the AST:ALT ratio is >1 and no other diagnosed reason, advice to refer directly for transient elastography (fibroscan).All fibroscan >15 Kpa (likely cirrhosis) referred to hepatologist

Results so far (19 months of pathway in action):

  • 13 % of abnormal ALT results revealed an AST:ALT ratio over 1 (1826 from 13929 ALTs requested in Gwent area)
  • 648 were referred for fibroscan  (some had other clear cause requiring alternative action, others not referred ?reason)
  • 271 have had a fibroscan to date. 120 Fibroscan <8kPa = 44% (low risk of significant liver fibrosis; 73 Fibroscan 8-15 kPa = 27% (possible fibrosis/early cirrhosis); 76 Fibroscan >15 kPa = 28% (probably cirrhosis or advanced fibrosis)

Take home message: up to 30% of patients investigated along this pathway had likely cirrhosis of the liver. Simple pathway requiring minimal additional tests/GP time which picks up significant numbers of previously undiagnosed cirrhosis of the liver

For more information about this project please contact Dr. Andrew Yeoman, clinical lead for Welsh Liver Plan: andrew.yeoman@wales.nhs.uk

Tayside project iLFT project

A Scottish Government supported, research funded, development of an automated investigation algorithm which maximises diagnosis and management.

1. GP requests LFTs via electronic system, entering data about patients’ alcohol consumption, BMI and features of metabolic syndrome.
2. In the laboratory, the finding of abnormal LFT results triggers an automated cascade of additional tests on the same sample to find an cause (viral serology, liver immunology, iron studies, alpha 1 anti-trypsin, and caeruloplasmin) and stage fibrosis (Fib 4 and NAFLD fibrosis score) This information automatically populates diagnostic algorithms and management plans.
3. The report is made available to the GP in real time for them to action. Access to the management plans is delivered electronically as web hyperlinks.

Results: In a trial of iLFT, the diagnosis rate was increased by 43% and it was cost-effective, with a saving to the NHS of £3,216 over a patient lifetime. It is now being rolled out in other sites across Scotland.

For more information about this project please contact Professor John Dillon, lead clinician on iLFT project at j.f.dillon@Dundee.ac.uk

Southampton 

St Marys (a large, inner city practice) worked in partnership with secondary care to develop a pathway for the management of patients at risk of liver disease/ with abnormal LFTS. This was integrated in to the clinical system and liver health was promoted to patients through work with the British Liver trust (2016). The pathway was shared city wide in December 2017 and led to the commissioning of direct access fibroscan in October 2018. 
Outcomes:

Within St Marys surgery population steep rise in coded / diagnosed liver disease: 

City wide data will be available shortly.

For more information about this project please contact Dr Mead Mathews, lead clinician and RCGP/British Liver Trust Liver Disease Clinical Priority Clinical Fellow, on meadmathews@nhs.net 

5) Links to NICE and British Society of Gastroenterology guidelines and other resources

British Society of Gastroenterology guidelines on the management of abnormal liver blood tests. These guidelines deal specifically with the management of abnormal liver blood tests in children and adults in both primary and secondary care and cover what constitutes an abnormal liver blood test; what constitutes a standard liver blood test panel;  Further investigation and response.

NICE Quality standard for the management of liver disease. This quality standard covers identifying, assessing and managing chronic liver disease in children, young people and adults, and cirrhosis in young people and adults. It describes high-quality care in priority areas for improvement.

NICE NAFLD  guideline. This guideline covers how to identify the adults, young people and children with non-alcoholic fatty liver disease (NAFLD) who have advanced liver fibrosis and are most at risk of further complications. It outlines the lifestyle changes and pharmacological treatments that can manage NAFLD and advanced liver fibrosis.

NICE cirrhosis guideline. This guideline covers assessing and managing suspected or confirmed cirrhosis in people who are 16 years or older.

Hep C elimination material for GPs. The World Health Organisation aims to eliminate hepatits C by 2030. Public Health England has produced information for GPs about the NHS England and Public Health England initiative to support finding undiagnosed patients and ensuring they are treated. 

FIb 4 calculator

NAFLD fibrosis score calculator

AUDIT C/Full AUDIT calculators


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