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

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Fatty Liver
• Intervention / Treatment: Other: BALLETS

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.

• Study Type: Observational
• Enrollment (Actual): 1237

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in primary care with no known liver disease, who had a liver function test (LFT)

Description

Inclusion Criteria:

• Adult with abnormal liver function test (LFT) result

Exclusion Criteria:

• Pre-existing or obvious liver disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-specific liver disease; Patients who were categorised as having a non-specific liver disease in the original BALLETS study.	Other: BALLETS; Cohort were not exposed to any intervention. There information will be analysed from database searches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients who Died	Death of patient, sub-categorised as either including liver disease, or liver disease not mentioned	From date of recruitment until the date of death, up to 14 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients attending inpatient department, primary reason liver disease	Number of patients attending hospital inpatient department, with their primary reason for attendance being liver disease, as measured by the hospital episode statistics database.	From date of recruitment until the date of database search, up to 14 years
Number of patients attending outpatient department, primary reason liver disease	Number of patients attending hospital outpatient department, with their primary reason for attendance being liver disease, as measured by the hospital episode statistics database.	From date of recruitment until the date of database search, up to 14 years

Collaborators and Investigators

• Sponsor: University of Warwick
• Collaborators: University Hospital Birmingham
• Investigators: Principal Investigator: Richard J Lilford, FMedSci, University of Warwick

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2005
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: BALLETS-LT-Followup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is not available to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No