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

Periodic Reporting for period 1 - LiverScreen (Screening for liver fibrosis - population-based study across European countries)

Reporting period: 2020-01-01 to 2021-06-30

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. 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.
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
During the first 18 months, main project activities were devoted to the preparation of population-based study and longitudinal study by finalising the protocol and getting the approvals by ethics committees and setting up the eCRF on the REDCap system. 11,830 patients by June 2021 have been included in the population based study, but the ongoing Covid-19 has had a negative impact on the number of subjects expected to be enrolled in the first reporting period.
Also the longitudinal study has been delayed due to closure of clinical centres during the Covid-19 waves. The participants included so far are: 2,100 from Barcelona-Spain, 1,400 from Rotterdam-Netherlands and 1,000 from Odense-Denmark.

Progress has been made on the development of a prognostic model that uses simple variables to accurately diagnose the presence of significant liver fibrosis in asymptomatic subjects. Preliminary results indicate that this model is also useful in predicting long-term overall mortality, liver-related mortality, and liver-related hospitalizations. This model could therefore be useful in the screening for chronic liver diseases in the population.
Besides, we have started activities of dissemination of the results and also raising awareness about chronic liver diseases in the population.
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.
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Progress of the LIVERSCREEN Project