Prospective study of the drivers of late diagnosis of alcohol-related liver disease to implement and evaluate interventions to reduce its burden (StopALD): Study Protocol (Preprint)

BACKGROUND One of the limitations to reduce the burden of alcohol-related liver disease (ArLD) is the lack of early detection of silent liver disease among patients with alcohol use disorder and heavy drinkers. To overcome this, it is crucial to identify patients at risk of advanced ArLD during the asymptomatic phases of the disease, as well as to uncover the health and socio-economic factors leading to late diagnosis. OBJECTIVE Evaluate the cost-effectiveness of the proposed screening and intervention strategy to inform future implementation in routine clinical practice and public health policies METHODS StopALD is a multicentric prospective study that aims to test a screening pathway for the detection of asymptomatic forms of ArLD encompassing a multidisciplinary intervention to tackle harmful alcohol consumption. Secondary objectives are as follows: 1) Compare the intervention with a control group in order to establish a better strategy to prevent alcohol relapses and to avoid the progression of fibrosis with quarterly visits during a 1 year follow-up 2) Characterize the patients presenting features of both ArLD and MASLD (MetALD); 3) Tackle alcohol risk use among youth individuals through a brief psychological intervention; and 4) Identify the factors leading to late ArLD diagnosis. RESULTS The study will be conducted in accordance with the Declaration of Helsinki. All patients will provide written informed consent prior to participation in the study. Publications relating to each of the primary end points will be released after 12 months of follow-up is complete. CONCLUSIONS - CLINICALTRIAL NCT06403332.