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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022681
• Other study ID #: BALLETS-LT-Followup
• Status: Completed
• Start date: December 1, 2005
• Est. completion date: July 1, 2013

Study information

• Verified date: July 2019
• Source: University of Warwick
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1237
• Est. completion date: July 1, 2013
• Est. primary completion date: May 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult with abnormal liver function test (LFT) result

Exclusion Criteria:

• Pre-existing or obvious liver disease

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Warwick	University Hospital Birmingham

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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