ITA-MASLD: A national observational study to characterize the profile of patients with MASLD in specialistic care in Italy

Abstract

Metabolically-dysfunction-associated steatotic liver disease (MASLD) is a growing public health concern in Italy. Despite its prevalence, MASLD is often underdiagnosed and excluded from prevention strategies. Early detection and multidisciplinary management are crucial for addressing its systemic impact. To provide robust real-world evidence, the Istituto Superiore di Sanità and the Italian Association for the Study of the Liver (AISF), in collaboration with SID, SIGE, SIMI, SIO, CLEO, and AIGO, have launched ITA-MASLD, the first nationwide, multicenter, prospective observational study on MASLD in Italy. The study consecutively enrols adult patients with MASLD under specialist care in hepatology, internal medicine, diabetology, and obesity clinics across the country. Standardised electronic case report forms capture demographic, metabolic, and social determinants of health, alongside non-invasive and histological assessments of liver disease severity, comorbidities, treatments, and outcomes. More than 100 clinical centres are connected through a harmonised web-based system, ensuring data quality and enabling national representativeness and sub-studies. The ITA-MASLD study aims to characterise the clinical and epidemiological profile, as well as the social determinants, of MASLD in Italy, focusing also on unmet needs and regional disparities. It will generate predictive models for progression, cost-effectiveness analyses, and evidence to guide early detection, personalised care, and health policy.

Keywords: Health policy; Metabolic dysfunction-associated steatotic liver disease; Multidisciplinary study; Observational cohort; Real-world study; Screening.