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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adult with abnormal liver function test (LFT) result
Exclusion Criteria:
- Pre-existing or obvious liver disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Non-specific liver disease
Patients who were categorised as having a non-specific liver disease in the original BALLETS study.
|
Cohort were not exposed to any intervention.
There information will be analysed from database searches.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Patients who Died
Tidsramme: 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
|
From date of recruitment until the date of death, up to 14 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patients attending inpatient department, primary reason liver disease
Tidsramme: 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.
|
From date of recruitment until the date of database search, up to 14 years
|
|
Number of patients attending outpatient department, primary reason liver disease
Tidsramme: 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.
|
From date of recruitment until the date of database search, up to 14 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Richard J Lilford, FMedSci, University of Warwick
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BALLETS-LT-Followup
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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