The study population will consist of adult patients with MASLD and/or MASH (inclusive of historical nomenclature NAFLD and NASH) receiving care at participating hepatology and gastroenterology sites in France, Germany, Italy, Spain, and the United Kingdom.
Patients will be identified from routine medical charts available at participating sites and included based on documented clinical information sufficient to support fibrosis-stage classification and assessment of study variables relevant to the research objectives.
The study will include patients across three main fibrosis-stage cohorts:
1) non-cirrhotic liver disease (F0–F3),
2) compensated liver cirrhosis, and
3) decompensated liver cirrhosis.
Cohort assignment will be based on documentation available in the medical chart, including staging information, non-invasive liver disease assessment results, imaging findings, liver biopsy results, and documentation of decompensation events.
The primary population of interest is patients with compensated MASH cirrhosis.
To support the study objectives, the population is intended to include patients representing different stages of disease severity and clinical management. This cohort structure will enable descriptive and comparative analyses across the three main fibrosis-stage groups, as well as assessment of progression across fibrosis stages.
Patients will be included only if adequate retrospective chart information is available to support evaluation of key study parameters within the predefined observation period.
The index date will be defined as the date on which a patient first meets the criteria for the assigned study cohort within the predefined cohort entry period. Patients will be eligible for inclusion in the study if they meet all of the following criteria:
1. Documented, confirmed diagnosis of MASH/MASLD in the medical chart (including historical documentation using the term NASH, where applicable);
2. Index date within the predefined cohort entry period, with the earliest eligible index date being 01 January 2022 and the latest eligible index date defined to ensure a minimum of 12 months of post-index observation. Cohort assignment will be based on chart-documented clinical information, with the date on which the patient first meets the criteria for the assigned study cohort will be considered the index date, namely: non-cirrhotic (F0-F3), compensated cirrhosis, or decompensated cirrhosis;
3. Availability of ≥24 months of observable baseline history and ≥12 months of post-index follow-up, unless death occurs earlier; and
4. Age ≥18 years at the index date.
Patients will be excluded from the study if they meet any of the following criteria:
1. Evidence of alternate chronic liver disease etiologies inconsistent with MASLD/MASH definitions, including but not limited to alcohol-associated liver disease, viral hepatitis (e.g., hepatitis B or C), autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson’s disease, hemochromatosis, alpha-1 antitrypsin deficiency, glycogen storage diseases, and other metabolic or cholestatic liver diseases;
2. Evidence of heavy alcohol use or alcohol use disorder, including other alcohol-related diagnoses (e.g., alcoholic pancreatitis), drug-induced liver disease;
3. History of liver transplant prior to or on index;
4. Hepatocellular carcinoma prior to or on index; or
5. Insufficient medical chart documentation to support reliable cohort assignment or abstraction of key study variables; or
6. Participation in an interventional clinical trial at any time during the pre-index period, inclusion, and follow-up period.