Screening for liver fibrosis - population-based study across European countries

Project Information

LiverScreen

Grant agreement ID: 847989

DOI

10.3030/847989

Project closed

EC signature date 12 December 2019

Start date 1 January 2020

End date 31 December 2025

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 5 996 481,25

EU contribution

€ 5 996 481,25

Coordinated by

FUNDACIO DE RECERCA CLINIC BARCELONA-INSTITUT D INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER
Spain

Periodic Reporting for period 3 - LiverScreen (Screening for liver fibrosis - population-based study across European countries)

Reporting period: 2023-01-01 to 2024-06-30

Summary of the context and overall objectives of the project

Reducing the burden of liver disease in Europe requires a paradigm shift in how diagnosis, treatment and prevention are enacted. The LiverScreen project's overarching goal is to sustain this shift by enabling early diagnosis of chronic liver diseases, to allow for timely, personalised treatment efforts and prevention of disease progression into debilitating morbidity and mortality.
The LiverScreen project will set-up a targeted population-based screening intervention that will screen people at risk for liver disease to identify people with hidden liver disease an allow the application of effective personalized interventions. The LiverScreen project allows for early diagnosis of a disease that would otherwise continue to progress due to absence of symptoms until a very late disease stage. The need for the LiverScreen project is enormous, because over 60% of the European adult population is at risk and 3% is expected to already have hidden advanced liver disease.

We will accomplish our goal by setting up a targeted, easy-to-use, cost-beneficial screening program for detection of liver fibrosis in high-risk populations, using transient elastography (TE) as screening tool.

LiverScreen will screen over 21000 people in this project and combine the data with their current running cohort of 9.000. By analysing 30000 patients, the LiverScreen consortium can validate the diagnostic accuracy, cost-effectiveness and acceptability of using the TE technology to case-find advanced liver fibrosis in the general population. Moreover, LiverScreen will assess the prevalence of liver fibrosis within certain subpopulations based on health risk factors and will use this knowledge to fine-tune the case-finding. At project completion, we aim to have a targeted, population-based screening intervention program for chronic liver diseases in Europe, ready for implementation.
The LiverScreen project will achieve its goal by the following specific sub-objectives:
1. Validate the diagnostic accuracy of TE to screen for liver fibrosis in the general population and primary care, using liver biopsy as gold standard
2. Assess the prevalence of significant fibrosis as evidenced by increased liver stiffness in the general population and stratified according to subjects at risk for liver fibrosis
3. Identify optimal screening intervals and define population subgroups at highest risk of progressive liver fibrosis with the aim to design the ideal screening strategy
4. Create a medical-decision support prognostic model (in form of a digital tool) of liver fibrosis and estimate the long-term effects of screening for chronic liver disease
5. Estimate the incremental cost-effectiveness ratios of the screening program for different populations or groups and the budget impact for healthcare systems
6. Develop and evaluate a tailored screening program for four pilot EU countries, representative of the different European healthcare systems

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the last 18 months of the project, the recruitment of the expected 30,000 subjects has been completed both for the cross-sectional cohort and the follow-up of subjects in the longitudinal cohort has been finalised. Subject recruitment has been hampered by the COVID 19 pandemic because these are clinical studies being performed mainly in the community, and the community healthcare was severely altered by the pandemic in all European countries. Nevertheless, we have achieved 100% of the sample size both in the cross-sectional cohort and in the longitudinal cohort, which is quite remarkable given the situation of healthcare in the last 2 years.
Important progress has also been made with the development of a score, the ©LiverRisk score, that accurately predicts liver-related outcomes (hospitalization, mortality, and cancer) in adult subjects from the community without known liver disease. This score is reminiscent of the scores used to assess cardiovascular risk and will be very useful for the implementation of the screening strategies for the second part of the LiverScreen project as well as for assessment of risk prediction in the community and primary care.
Besides, the consortium has performed a large number of dissemination and educational activities as well as activities to raise awareness about chronic liver diseases in the population.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The LiverScreen project will set-up a targeted population-based screening interventions that will screen people at risk for liver disease to identify people with hidden liver disease. The LiverScreen project allows for early diagnosis of a disease that would otherwise continue to progress due to absence of symptoms until a very late disease stage. The need for the LiverScreen project is enormous, because over 60% of the European adult population is at risk and 3% is expected to already have hidden liver disease.
The development of a targeted personalized screening programme to identify patients at risk of liver fibrosis is aimed at improving health outcomes to European citizens by decreasing the risk of developing liver cirrhosis, a condition associated with high morbidity and mortality worldwide. The LiverScreen project is the first to propose a screening programme based on primary care aimed at reducing the incidence of liver cirrhosis by the early identification of liver fibrosis, both in Europe and worldwide. Therefore, this will place Europe as the leader in developing and implementing the first targeted screening programme for chronic liver diseases worldwide. Interestingly, the project will be developed by a European consortium including a wide range of professionals, from primary care physicians and nurses to hepatologists experts on the management of chronic liver diseases, together with economists and IT professionals. The implementation of such an innovative screening programme to European health care systems will be one of the most challenging tasks of this project. For this purpose, the LiverScreen project is expected to generate large amount of data to provide robust evidence to policy makers about the benefits, both in terms of outcomes and cost-effectiveness, of implementing a new screening programme in European health care systems.

Progress of the LIVERSCREEN Project third reporting

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Progress of the LIVERSCREEN Project second reporting

Progress of the LIVERSCREEN Project first reporting