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.

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Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult with abnormal liver function test (LFT) result

Exclusion criteria

Pre-existing or obvious liver disease

Treatment and study plan

BALLETS

Other

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

Primary outcomes

Number of Patients who Died

Time frame: From date of recruitment until the date of death, up to 14 years

Death of patient, sub-categorised as either including liver disease, or liver disease not mentioned

Secondary outcomes

Number of patients attending inpatient department, primary reason liver disease

Time frame: From date of recruitment until the date of database search, up to 14 years

Number 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 disease

Time frame: From date of recruitment until the date of database search, up to 14 years

Number of patients attending hospital outpatient department, with their primary reason for attendance being liver disease, as measured by the hospital episode statistics database.

Sponsors and collaborators

Lead sponsor

University of Warwick

Other

Collaborators

University Hospital Birmingham

Registry information

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2013
First posted: Jul 17, 2019
Registry last updated: Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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