In contrast to cardiovascular disease, respiratory disease and cancer the incidence of deaths from chronic liver disease (CLD) is rising in patients under the age of 55. The UK was ranked number 3 for years of life lost from CLD, in those aged 20-54 in comparison to other EU countries (1).
Three independent reports by the Chief Medical officer (2011), an All-Party Parliamentary Inquiry (2014) and Lancet commission (2014) have called for improving the detection of CLD. Liver disease is asymptomatic until a late stage; 50 % of patients receive their initial diagnosis of severe liver disease only after presenting as an emergency admission.
Standard referral pathways rely on tests with a low sensitivity/specificity (liver enzyme tests) and lead to expensive/invasive (liver biopsy) diagnostics in secondary care. We challenged and re-designed the clinical pathway for detecting CLD. Our aim was to create a diagnostic pathway, the scarred liver project, targeting risk factors for liver disease and enabling novel diagnostics to be accessed directly within a community setting.
Our studies evidenced this approach was feasible, improved patient experience and cost-effective. This led to the first commissioned service of this kind in the UK in 2016.
We identified two major challenges in the existing diagnostic pathway. The first challenge was that the focus was on abnormal liver enzyme tests which are common and not an effective way of identifying liver disease.
A study in Tayside (2) reported that 25 % of the entire population had liver enzymes measured at least once over a 10 year period; 30 % of these tests had one abnormal reading and the yield of detecting significant liver disease was 1.15 % during follow up.
We changed the focus to identifying risk factors; namely hazardous alcohol and type 2 diabetes. The second challenge was that onward investigation of liver disease requires referral to secondary care specialists, resulting in delay/inconvenience to patients and expense to the healthcare system ( e.g. £350 tariff for new OPD and £546 for liver biopsy) .
We used an evidence approach to select and implement non-invasive diagnostics, in addition to incorporating NICE guidelines, within a novel pathway that integrates primary and secondary care. Our aims were to see if this pathway was feasible, improved the detection of significant liver disease, cost-effective and acceptable to patients.
We initially screened over 20,000 patients in 4 GP practices in Nottingham. We found over 2,000 patients with pre-defined risk factors for liver disease (hazardous alcohol and type 2 diabetes).
Approximately 900 patients attended for a portable liver examination transient elastography) in a community setting. The procedures were performed by trained nurses and all patients were given evidence-based lifestyle advice following the procedure.
We found 20 % of patients had readings consistent with significant liver disease; in addition we increased the detection of advanced liver disease/cirrhosis by 140 %. Approximately 70 % of the patients diagnosed with significant liver disease had normal level enzymes, and would not, therefore, have been identified by routine primary care liver tests (3).
We showed the pathway was cost-effective (4) with an ICER o £2,138 per extra quality adjusted life year (QALY); well below the £20,000 threshold set by NICE. In 2016 the pathway was commissioned by 4 CCGs covering a catchment area of 0.7 million and 108 GP practices; the first commissioned pathway of this kind in the UK. Over 3,000 patients have entered this commissioned pathway and had their liver disease stratified and received lifestyle intervention.
We engaged with key organisations to enable implementation. East Midlands Academic health science network (EMAHSN) funding allowed us to show feasibility in different socio-ethnic environments including inner city Nottingham (5) and Leicester (6) and demonstrate cost effectiveness which led to the commissioned service.
At a regional level, the AHSN have facilitated implementation at Chesterfield hospital. Nationally, Dr Neil Guha was appointed as an NHS innovation accelerator fellow in 2015 (initial cohort of 17 fellows). Neil is working with other CCGs and AHSNs to implement the pathway at other sites in the UK.
The pathway has been recognised by the British Royal College of General Practitioners and as example of innovation/best practice (7). Members of the scared liver project team are working with the British liver trust to produce a national commissioning document.
NICE has listed the scarred liver project as an exemplar of implementation of its cirrhosis guideline (8). Our project has been highlighted on a key report by the Kings fund on the adoption and spread of innovation. Internationally, Dr Neil Guha has been invited to join a European consortium looking at the detection of liver disease across Europe and Prof Aithal has instituted the project in Kerala, India.
The pathway shows value in different domains. The financial long term economic model has been validated by an independent group; the York Health economic consortium. They not only support the findings but suggest these may be conservative estimates.
Our local AHSN have calculated a short term annual return of investment of £165,505 based upon reducing unnecessary appointments and investigations. Over 3,000 patients have entered the pathway and in addition to receiving a diagnostic test they have all received brief intervention advice.
This is an important added value, evidence-based intervention, as liver fibrosis is reversible and intervening at an earlier stage will prevent future complications from liver related death. Patient engagement is high, the nonattendance for scans is less than 15 % (DNA rates of 40 % previously found in our centre for specialist tests) and the feedback using the friends and family test is excellent ( >95 % in all domains, n= 1,208).
Qualitative feedback from patients identified a number of themes including the lack of publicity surrounding risk factors for liver disease, underestimation of their own risk of liver disease and the community pathway providing an opportunity to provide lifestyle change.
This project represents a collaboration between clinical academics (University of Nottingham), patients, General practitioners, NHS hepatologists and commissioners. Specific examples are as follows. At a Public Patient Engagement event in 2011, a number of patients with established cirrhosis asked why non-invasive tests (which they accessed in secondary care) were not accessible by their GPs so they could have been diagnosed earlier.
This synergised with an opportunity for a pilot study funded by NHS England (30K) which commenced in 2012. Patients have been strong advocates for the pathway (see videos at www.scarredliverproject.org.uk). The success of the pathway has been possible because of support ( providing both finance and expertise) by the Nottingham NIHR biomedical research centre, NHS Innovations Challenge award in diagnostics 2013, NHS innovation accelerator fellowship (2015 to 2018) and EMAHSN support (2014 to 2020).
The commissioned pathway in 2016 was co-produced by members of the scarred liver team, consultant hepatologists, GPs, hospital managers and clinical commissioners sitting together initially in face to face meetings. The final pathway was then produced after extensive discussion resulting in iterations.