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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adult with abnormal liver function test (LFT) result
Exclusion Criteria:
- Pre-existing or obvious liver disease
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients who Died
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of patients attending inpatient department, primary reason liver disease
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Richard J Lilford, FMedSci、University of Warwick
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。