LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries
Author
Graupera, IsabelThiele, Maja
Ma, Ann T
Serra-Burriel, Miquel
Pich, Judit
Fabrellas, Núria
Caballeria, Llorenç
de Knegt, Robert J
Grgurevic, Ivica
Reichert, Mathias
Roulot, Dominique
Schattenberg, Jörn M
Pericas, Juan M
Angeli, Paolo
Tsochatzis, Emmanuel A
Guha, Indra Neil
Garcia-Retortillo, Montserrat
Morillas, Rosa M
Hernández, Rosario
Hoyo, Jordi
Fuentes, Matilde
Madir, Anita
Juanola, Adrià
Soria, Anna
Juan, Marta
Carol, Marta
Diaz, Alba
Detlefsen, Sönke
Toran, Pere
Pera, Guillem
Fournier, Céline
Llorca, Anne
Newsome, Phillip N
Manns, Michael
de Koning, Harry J
Serra-Burriel, Feliu
Cucchietti, Fernando
Arslanow, Anita
Korenjak, Marko
van Kleef, Laurens
Falcó, Josep Lluis
Kamath, Patrick S
Karlsen, Tom H
Castera, Laurent
Lammert, Frank
Krag, Aleksander
Ginès, Pere
Publication date
2022-07-19Subject
Public health. Health statistics. Occupational health. Health educationPharmacology
Clinical pathology
Metadata
Show full item recordAbstract
Background: The development of liver cirrhosis is usually an asymptomatic process until late stages when complications occur. The potential reversibility of the disease is dependent on early diagnosis of liver fibrosis and timely targeted treatment. Recently, the use of non-invasive tools has been suggested for screening of liver fibrosis, especially in subjects with risk factors for chronic liver disease. Nevertheless, large population-based studies with cost-effectiveness analyses are still lacking to support the widespread use of such tools. The aim of this study is to investigate whether non-invasive liver stiffness measurement in the general population is useful to identify subjects with asymptomatic, advanced chronic liver disease. Methods: This study aims to include 30,000 subjects from eight European countries. Subjects from the general population aged ≥ 40 years without known liver disease will be invited to participate in the study either through phone calls/letters or through their primary care center. In the first study visit, subjects will undergo bloodwork as well as hepatic fat quantification and liver stiffness measurement (LSM) by vibration-controlled transient elastography. If LSM is ≥ 8 kPa and/or if ALT levels are ≥1.5 x upper limit of normal, subjects will be referred to hospital for further evaluation and consideration of liver biopsy. The primary outcome is the percentage of subjects with LSM ≥ 8kPa. In addition, a health economic evaluation will be performed to assess the cost-effectiveness and budget impact of such an intervention. The project is funded by the European Commission H2020 program. Discussion: This study comes at an especially important time, as the burden of chronic liver diseases is expected to increase in the coming years. There is consequently an urgent need to change our current approach, from diagnosing the disease late when the impact of interventions may be limited to diagnosing the disease earlier, when the patient is asymptomatic and free of complications, and the disease potentially reversible. Ultimately, the LiverScreen study will serve as a basis from which diagnostic pathways can be developed and adapted to the specific socio-economic and healthcare conditions in each country. Trial registration: This study is registered on Clinicaltrials.gov ( NCT03789825 ).Citation
Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernández R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falcó JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Ginès P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6. Erratum in: BMC Public Health. 2023 May 22;23(1):923.Type
ArticleAdditional Links
https://bmcpublichealth.biomedcentral.com/https://www.ncbi.nlm.nih.gov/pmc/journals/63/
PMID
35854275Journal
BMC Public HealthPublisher
BMCae974a485f413a2113503eed53cd6c53
10.1186/s12889-022-13724-6