Hypertension Longitudinal Data Platform in Tianjin

Hypertension Longitudinal Data Platform Linked Electronic Health Records and Public Health Follow-up Database (HYLERP) in Tianjin, China

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 1172280

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • The West China Hospital of Sichuan university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our study population consisted of 1,172,280 patients aged 18 years or older with hypertension diagnosed between January 1, 2015 and December 31, 2021 in database. Hypertension was defined as having at least two outpatient diagnoses or one hospital discharge diagnosis of hypertension.

Description

Inclusion Criteria:

• Hypertension first diagnosed between January 1, 2015 and December 31, 2021
• Aged 18 years or older

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with hypertension	Other: No intervention; Exposures of interest would be clearly defined according to a specific research question and identified from the database

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of major adverse cardiovascular events	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.	From index diagnosis to the end of study date (Dec 31, 2021)
Prevalence of composite adervese events	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.	From index diagnosis to the end of study date (Dec 31, 2021)
Mortality rate	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.	From index diagnosis to the end of study date (Dec 31, 2021)
Prescription patterns of antihypertensive medications	(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.	From index prescrition to the end of study date (Dec 31, 2021)
Medical expenditures	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.	through study completion, an average of 7 year (from Jan 2015 to Dec 31, 2021)

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: Tianjin Health Care Big Data Ltd.; Tianjin Health Commission
• Investigators: Study Director: Xin Sun, Phd, West China Second University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Electronic health records; Longitudinal data platform; Public health follow-up database
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HYLERP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the policy of Tianjin Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjetced to approved by the Tianjin Health Care Big Data Ltd. and the Chinese Evidence -based Medicine Center. Ethical review and research registration are mandatory for all studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No