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

2019年7月16日 更新者:Professor Richard Lilford、University of Warwick

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (实际的)

1237

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

Inclusion Criteria:

  • Adult with abnormal liver function test (LFT) result

Exclusion Criteria:

  • Pre-existing or obvious liver disease

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Patients who Died
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Number of patients attending inpatient department, primary reason liver disease
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Richard J Lilford, FMedSci、University of Warwick

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2005年12月1日

初级完成 (实际的)

2010年5月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2019年7月12日

首先提交符合 QC 标准的

2019年7月16日

首次发布 (实际的)

2019年7月17日

研究记录更新

最后更新发布 (实际的)

2019年7月17日

上次提交的符合 QC 标准的更新

2019年7月16日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BALLETS-LT-Followup

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data is not available to be shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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