Hypertension Longitudinal Data Platform Linked Electronic Health Records and Public Health Follow-up Database (HYLERP) in Tianjin, China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,172,280
- 试验地点
- 1
- 主要终点
- Prevalence of composite adervese events
研究概览
简要总结
Hypertension is one of the leading causes of death globally, and ranks among the top four risk factors for mortality and DALYs in China. However, large-scale population based longitudinal research data source for hypertension is lacking in China. Thus, we aimed to establish the first and most extensive hypertension database in China using healthcare data from the Tianjin city. This hypertension longitudinal data platformlinked electronic medical records (EMR) system 35 stores healthcare data of 1.17 million hypertension patients, from 43 tertiary hospitals and 39 secondary hospitals, along with a public health follow-up management system. Data on demographics, diagnosis, drug prescription, laboratory test, physical examination, and cost information were collected, the median follow-up time was 4.3 [ interquartile range (IQR): 2.7-5.8] years, and the median number of outpatient visits was 32 (IQR: 15-64) per patient. This database can address research needs including, drug utilization pattern analysis, policy implementation evaluation, digital medical device development, and other real world evidence studies. These researches would provide robust evidence to assist improving patient health outcomes and healthcare system decision-making.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension first diagnosed between January 1, 2015 and December 31, 2021
- •Aged 18 years or older
排除标准
- 未提供
结局指标
主要结局
Prevalence of composite adervese events
时间窗: From index diagnosis to the end of study date (Dec 31, 2021)
Counts of a composite adervese events after diagnosis including cardiac arrhythmia, gout, hyperkalaemia, hypocalaemia, hypotension, angioedema, fall, syncope, acute kidney injury and fracture. All ICD-10 diagnosis codes of adervese events among patients incurred after the index diagnosis were included to calculated the prevalence of adervese events.
Prescription patterns of antihypertensive medications
时间窗: From index prescrition to the end of study date (Dec 31, 2021)
(1) Prescribing rate of different antihypertensive drug classes; (2) Substiution of generic drugs; (3) Number of drug therapy; (4) Different combination therapies; (4) Index prescription patterns and prevalent prescription patterns.
Medical expenditures
时间窗: through study completion, an average of 7 year (from Jan 2015 to Dec 31, 2021)
Medical expenditures per outpatient visit or inpatient admission would be calculated including total expenditures, drug expenditures and non-drug related expenditures for patients undergoing treatment of hypertension, dyslipidemia, diabetes and chronic ischemic heart diesease. All medical expenditures statistcis were based on the cost information recorded in the electronic medical records database.
Incidence rate of major adverse cardiovascular events
时间窗: From index diagnosis to the end of study date (Dec 31, 2021)
The first occurence of stroke, acute myocardial infarcation and heart failure after index diagnosis. Cardiovasuclar events were determned from the first ICD-10 diagnosis code recorded in the database.
Mortality rate
时间窗: From index diagnosis to the end of study date (Dec 31, 2021)
The mortality records on patients were linked to the national mortality register information system, all-cause mortality and cardiovascular mortality were idenitified through death reaseon recoded in the mortality information system.
次要结局
未报告次要终点
研究者
Sun Xin
Professor and director of Chinese Evidence-based Medicine Center
West China Hospital