Clinical trial NCT04022681: Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study
Official title: Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatty Liver
Liver Diseases
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: University Hospital Birmingham
First posted: 2019-07-17
Enrollment: 1237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in primary care with no known liver disease, who had a liver function test (LFT)

Brief summary: This study will follow-up a cohort of patients from the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study using a database search based on their individual National Health Service (NHS) numbers. The investigators will interrogate the Hospital Episode Statistics database and the Office of National Statistics database, and examine three categories of end points: death, inpatient attendance primarily due to liver disease, and outpatient attendance primarily due to liver disease.

A logistic regression analysis will then be conducted to determine associations between these end points and the presence, and degree, of fatty liver in the original BALLETS study, adjusted for age, sex, alcohol intake, BMI, and baseline ALT measurement.

Detailed description: The Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study was a prospective study of people in General Practice who had an abnormal liver function test result. Recruitment took place between 2005 and 2008, and patients were able to be grouped into four primary categories: hepato-cellular disease, hepato-biliary disease, tumour, non-specific with or without fatty liver. This study will focus on the fourth, non-specific, group of which there were 1,237 patients.

This study will follow-up this cohort of patients using a database search based on their individual National Health Service (NHS) numbers. The investigators will interrogate the Hospital Episode Statistics database (health outcomes) and the Office of National Statistics database (death), and examine three categories of end points: death, inpatient attendance primarily due to liver disease, and outpatient attendance primarily due to liver disease. Deaths would be sub-categorised as including liver disease, or not.

A logistic regression analysis will then be conducted to determine associations between these end points and the presence, and degree, of fatty liver in the original BALLETS study, with adjustment for age and sex. Similar age- and sex-adjusted analyses will be conducted to investigate the association with other patient risk factors - alcohol intake and BMI. The analyses will be repeated incorporating an additional adjustment for baseline Alanine Aminotransferase (ALT) measurement.

Eligibility criteria: Inclusion Criteria:

* Adult with abnormal liver function test (LFT) result

Exclusion Criteria:

* Pre-existing or obvious liver disease

Primary outcomes:
measure: Number of Patients who Died
timeFrame: From date of recruitment until the date of death, up to 14 years
Secondary outcomes:
measure: Number of patients attending inpatient department, primary reason liver disease
timeFrame: From date of recruitment until the date of database search, up to 14 years
measure: Number of patients attending outpatient department, primary reason liver disease
timeFrame: From date of recruitment until the date of database search, up to 14 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Warwick
name: Richard J Lilford, FMedSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lilford RJ, Bentham L, Girling A, Litchfield I, Lancashire R, Armstrong D, Jones R, Marteau T, Neuberger J, Gill P, Cramb R, Olliff S, Arnold D, Khan K, Armstrong MJ, Houlihan DD, Newsome PN, Chilton PJ, Moons K, Altman D. Birmingham and Lambeth Liver Evaluation Testing Strategies (BALLETS): a prospective cohort study. Health Technol Assess. 2013 Jul;17(28):i-xiv, 1-307. doi: 10.3310/hta17280.