Non-alcoholic steatohepatitis (NASH) is a form of liver disease that destroys the structure of the liver and can progress to more severe conditions. It is becoming more common in the UK and is more likely to occur among people who are older, obese, or have diabetes. Symptoms of NASH are not immediately obvious, leading to patients being diagnosed when the condition is more advanced and treatment options are limited.
There is limited research on the patient and healthcare burden due to NASH. We will use anonymous data from GP and hospital records from England to describe the pattern of NASH occurrence and progression, including the occurrence of death, as well as the burden NASH has on the healthcare system.
The results of our study will increase the understanding of the clinical and economic consequences of NASH in England, to guide possible improvements and standardisation of patient care and treatment to improve the well-being of people with the condition.
Non-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease (NAFLD). The prevalence of NASH is increasing, with UK estimates of 3-5% among adults. Economic cost estimates for NASH, from a societal perspective, range from £2.3-£4.2 billion. NASH symptoms are non-specific, leading to late-stage diagnosis requiring an invasive and costly liver biopsy, which can result in adverse events including death.
In this retrospective cohort study, we will use data from Clinical Practice Research Datalink (CPRD), Hospital Episode Statistics (HES), Diagnostic Imaging Dataset (DIDS), and Office for National Statistics (ONS) to investigate the burden of NASH and its progression to end-stage liver disease (ESLD, i.e., cirrhosis, liver transplant, and hepatocellular carcinoma) in England. We will use four definitions that utilise NASH and NAFLD diagnosis coding in primary and secondary care settings and suggested confirmatory procedures such as liver biopsy or FibroScans and describe the baseline demographic, lifestyle, and clinical characteristics (including the Patient Level Townsend Index for QRISK3 score calculation) of patients with NASH.
We will describe the incidence and prevalence of NASH, the incidence of major adverse cardiovascular events (defined as myocardial infarction, stroke, and acute heart failure) and disease progression among NASH patients, and quantify healthcare-resource use and costs for NASH and severity states. We will use Cox proportional hazards regression to explain progression in NASH and separately to assess time to death from NASH and its progression to a more severe state. We will also use a multivariable generalised linear model with gamma family and log link to compare annualised all-cause and annualised NASH-related costs by severity state adjusting for key covariates. The results will provide an overview of the occurrence of NASH and its more severe states to guide possible improvements and standardisation in patient care to improve the wellbeing of people with NASH.
Overall and annual incidence and prevalence of Non-alcoholic steatohepatitis (NASH); Incidence of major adverse cardiovascular events (MACE); Disease progression; Time to disease progression; Incidence of death; Time to death; All-cause and NASH-related primary or secondary care activity; All-cause or NASH-related primary or secondary care costs
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
harriet larvin - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Judith Ruzangi - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Mico Hamlyn - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data;Patient Level Townsend Index