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Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study

Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04022681
Enrollment
1237
Registered
2019-07-17
Start date
2005-12-01
Completion date
2013-07-01
Last updated
2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Liver Diseases

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.

Interventions

OTHERBALLETS

Cohort were not exposed to any intervention. There information will be analysed from database searches.

Sponsors

University Hospital Birmingham
CollaboratorOTHER
University of Warwick
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Adult with abnormal liver function test (LFT) result

Exclusion criteria

* Pre-existing or obvious liver disease

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients who DiedFrom date of recruitment until the date of death, up to 14 yearsDeath of patient, sub-categorised as either including liver disease, or liver disease not mentioned

Secondary

MeasureTime frameDescription
Number of patients attending inpatient department, primary reason liver diseaseFrom date of recruitment until the date of database search, up to 14 yearsNumber of patients attending hospital inpatient department, with their primary reason for attendance being liver disease, as measured by the hospital episode statistics database.
Number of patients attending outpatient department, primary reason liver diseaseFrom date of recruitment until the date of database search, up to 14 yearsNumber of patients attending hospital outpatient department, with their primary reason for attendance being liver disease, as measured by the hospital episode statistics database.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026