The scarred liver project: a new diagnostic pathway to detect chronic liver disease across primary and secondary care

1. Improve the diagnosis and management of chronic liver disease by introducing a new liver pathway between primary and secondary care.
2. Enable GPs to access diagnostics recommended by NICE for patients who have risk factors for developing cirrhosis.

Deaths from chronic liver disease in the UK continue to rise; in contrast to cardiovascular disease, respiratory disease and cancer the incidence is rising in patients under the age of 55. In a Lancet study (Murray et al 2013) the UK was ranked number 3 for years  of life lost for those aged 20-54 in comparison to 18 countries (including 15 EU countries). This represents an increase of 109% over 20 years. Similarly the disability adjusted life years (DALYS) have increased by 48% from 239 to 354 per 100,000.

Three independent reports highlight the need for the early detection of liver disease including the Chief Medical officer report (2011), the All-Party Parliamentary Hepatology Group Inquiry and the Lancet Commission in 2014.

We have created a diagnostic pathway to detect significant but asymptomatic chronic liver disease at a critical stage in which it can either progress or reverse. The pathway has three unique features:

1. Identification of individuals exposed to risk factors namely hazardous alcohol, diabetes and obesity.
2. It utilises validated diagnostics to detect and stratify those at risk of significant chronic liver disease; replacing conventional tests that have deficiencies in accuracy, cost and patient acceptability.
3. Creation of an organic interface between primary care and secondary care. 

Current strategies to identify liver disease within the community are inadequate. In primary care, liver function tests (LFTs) are the main diagnostic modality; however these are insensitive in diagnosing disease. Subsequently, in the UK, 50% of patients with cirrhosis are first diagnosed when hospitalised with symptoms of a decompensating event. This results in a reduced quality of life, a poor prognosis and an expensive associated healthcare cost. In contrast, many patients who have abnormal LFTs do not have any disease resulting in an avoidable referral to secondary care. Transient elastography (Fibroscan®, Echosens, Paris) is a non-invasive test that has extensive validation in secondary care and the availability of a portable device enables implementation into a community setting.

The pathway we have produced, encompasses NICE guidelines (NG50), but importantly it has an ambition beyond this. It fundamentally changes how liver disease is diagnosed and managed.

The Scarred Liver Project initially piloted the community diagnostic pathway in 5 GP practices across the East Midlands through 3 separate deployments in catchment area of approximately 25,000 patients. The first deployment (Nottingham) set out to determine the feasibility of this approach whilst further iterations (Nottingham and Leicester) tested the pathway within different socio-economic and geographical areas.

Further work has been occurring in parallel to facilitate and sustain implementation, support a commissioning case for the pathway and promote adoption of the pathway both regionally and nationally. This includes:

• A health economic evaluation.
• A service evaluation: The life cycle of service design from the participants perspective.
• Construction of an evaluation framework to assess the wider impact on other health care services of implementing the diagnostic pathway.
• Development of an implementation toolkit to enable others to adopt and adapt the pathway within their own health care setting. Resources can be found at www.scarredliverproject.org.uk

A commissioning case for the pathway was successfully developed and implemented across 4 CCGs in South Nottinghamshire in September 2016. The pathway is now accessible to more than 100 GPs serving a population of approximately 700,000 people. Following an algorithm GPs are able to refer patients with a defined risk factor for chronic liver disease directly for a specialist test (Fibroscan) before considering a referral to secondary care.

The major barriers we faced were the introduction of new service pathway requiring members of primary and secondary care to work in a different manner. The second challenge was that long term cost savings associated with chronic liver disease are a challenge in the current landscape in which the focus remains on short term cost savings. The involvement of key stake holders including patients, consultant hepatologists, GPs and commissioners was a critical to this project. An important aspect was the co-design of the pathway between commissioners and hospital specialists. The NICE guidelines and other benchmarks of clinical quality aligned to the project (e.g. NHS challenge prize winners in diagnostics and NHS innovation accelerator fellowship award) provided important levers. The East Midlands Academic Health Science Network supported implementation of the pathway by funding work related to missing pieces of evidence (e.g. health economic analysis and fidelity of the pathway in diverse socio-ethnic areas) and supporting the evaluation of the pathway.

Pilot

This successfully demonstrated the feasibility of implementing the community pathway in 3 separate areas of the East Midlands:

A population of 25,018 adults were analysed; 3688 patients were identified to be at risk:

• 20% of patients attending Fibroscan clinics had signs of significant liver disease and 39 new cases of cirrhosis were diagnosed – asymptomatic cases that would have otherwise gone undetected.
• All patients attending community clinics were given brief lifestyle interventions including information from the British Liver Trust on improving their liver health.

The commissioned pathway across South Nottinghamshire (Commenced September 2016)

• 1239 patients have attended for a Fibroscan and received brief intervention (correct as of December 2017).
• 171patients had a Fibroscan reading of 8-14.9kPa which suggests the presence of liver fibrosis.
• 63 patients had a Fibroscan reading of >15kPa which suggests the presence of advanced liver disease including cirrhosis.
• Over 100 GPs from across South Nottinghamshire have been trained by the project team.

Patient experience and engagement:

• Attendance rates for scans were 95% in community versus 60% in hospital.
• Over 90% of patients said they would recommend it to family and friends.

Health Economics:

• Economic evaluation has demonstrated that this pathway is cost effective compared to current standard of care and is within the NICE threshold of £20,000 per quality-adjusted life-year (QALY).
• For a patient diagnosed with NAFLD the pathway costs £2,138 per QALY gained and for ALD it costs £6,537 per QALY gained. 

Summary of the impact of this practice, project or intervention:

The Scarred Liver Project has successfully piloted a community-based risk stratification pathway for chronic liver disease which is now commissioned within the local area. The pathway integrates primary and secondary care enabling patients with liver disease to be diagnosed earlier where interventions could reduce, stop or even reverse the progression of disease. Patient satisfaction is consistently high and the pathway has been shown to be cost effective compared to current standard of care.

Pathway re-design is complex and challenging. It requires passionate clinicians that are motivated and credible. The co-design of the pathway was critical and allowed adoption to the local environment and in retrospect we could have engaged in these discussions at an earlier stage.

Our initial focus had been to obtain evidence that we “assumed” the CCGs would require before commissioning the pathway. Finding clinical champions within the CCG to help us develop the pathway was key. The face to face training events for GPs were important as it provided them with an understanding of what we were trying to achieve. It also provided us with feedback about the components that were not working well in the initial implementation period.

The importance of evaluation is accepted but there is often not the expertise and/or funding to perform this adequately. We were fortunate that our local AHSN facilitated this aspect but this should be part of any discussions for implementation in other regions. Finally, the recognition that there needs to be iteration of any new pathway and whilst there is always inherent uncertainty about medium and long term outcomes the ability to adapt and adjust is imperative.