Incidence of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age, in the United Kingdom Clinical Practice Research Datalink (CPRD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161,429
- 主要终点
- Occurrence of new HepB diagnosis among patients between 0-80 years of age previously diagnosed with DM, between 2000 and 2012, in the UK CPRD or Hospital Episodes Statistics (HES).
研究概览
简要总结
This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large population-based cohort in United Kingdom (UK) using data from the CPRD database.
详细描述
The study is a retrospective, observational, descriptive, cohort study, in DM and non-DM patients of 0-80 years of age. As a first step the eligible baseline population from CPRD will be defined as per the data quality qualifiers, which include subjects aged 0-80 years, "acceptable for research" registered in practices classified as "up to standard" by the CPRD for the time period 2000- 2012. The following cohorts will be defined from the baseline population:
- DM cohort: Patients diagnosed with type 1 or type 2 DM, as confirmed by diagnosis medical codes with or without a DM related drug or monitoring devices prescription.
- Non-DM cohort: Patients with the absence of personal history of DM diagnosis or antidiabetic drug or monitoring devices prescriptions.
From the above defined cohorts, HepB cases will be identified based on clinical diagnosis codes, Hospital Episodes Statistics (HES) or positive diagnostic laboratory tests results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, 0 to 80 years of age during the study period.
- •Subjects acceptable for research as per CPRD definition:
- •Acceptable flag for research.
- •Subjects with at least 12 months of observation time at the time of inclusion in the study:
- •Subjects have to be registered in the CPRD database for at least 12 months at the date of inclusion in the study.
- •Subjects have to be registered in a general practitioner practice classified as 'up to standard' for at least 12 months at the date of inclusion in the study.
- •Particular Case of New Born Children.
- •To ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in CPRD.
- •Inclusion Date
- •Inclusion criteria will be assessed for each calendar year between the Years 2000 and 2012.
排除标准
- •For the analyses requiring the inclusion of HES data, HES records linked with more than one CPRD patient will be excluded from the analyses.
结局指标
主要结局
Occurrence of new HepB diagnosis among patients between 0-80 years of age previously diagnosed with DM, between 2000 and 2012, in the UK CPRD or Hospital Episodes Statistics (HES).
时间窗: Up to 12 years
Occurrence of new HepB diagnosis among non-DM patients between 0-80 years of age, in the UK CPRD or HES.
时间窗: Up to 12 years
次要结局
- HepB cause-specific mortality among DM and DM-free (non-DM) patients between 0-80 years of age, in the UK for whom CPRD-ONS mortality linkage is available.(Up to 12 years)
- New-onset or prevalent HepB diagnosis among new-onset or prevalent DM and DM-free (non-DM) patients between 0-80 years of age, in the UK, regardless of the onset of HepB in relation to the diagnosis of DM.(Up to 12 years)
- All cause mortality among HepB cases in the DM and DM-free (non-DM) patients between 0-80 years of age, in the UK.(Up to 12 years)
- Hospitalisation episode recorded in HES due to HepB infection or complications among patients between 0-80 years of age previously diagnosed with DM and in DM-free (non-DM) patients, in the UK, for whom CPRD-HES linkage is available.(Up to 12 years)