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This is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS).
This is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS).
The retrospective cohort design allows for efficient use of existing clinical data to evaluate real-world practice against national guideline recommendations. The primary outcomes relate to treatment decisions and delays rather than interventional effects; therefore, an observational design is methodologically appropriate and ethically preferable.
The study will be conducted across 05 Brazilian municipalities participating in the epHealth Primary Care Solutions platform. These municipalities span multiple regions and reflect heterogeneity in socio-demographic context, healthcare infrastructure, and epidemiological profiles.
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| Measure | Description | Time Frame |
|---|---|---|
| Uncontrolled blood pressure | Proportion of patients with uncontrolled blood pressure (BP ≥ 140/90 mmHg) who did not receive treatment intensification within 3 months of a recorded elevated BP. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Antihypertensive treatment | Proportions receiving monotherapy vs. combination therapy; distribution by pharmacologic class. | through study completion, an average of 1 year |
| Risk stratification |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with incomplete data or not traceable in the registration systems
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Adults registered in the e-SUS PEC system who had encounters with primary healthcare services within the study period and had blood pressure measurements recorded. We will assess data from the entire population of approximately 05 muncipalities (comprising between 100.000 and 250.000 inhabitants). The municipalities will be seleceted from a pre-screened list of 20 cities located within all Brazilian regions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
| Name | Affiliation | Role |
|---|---|---|
| Julia Machline Carrion, Medical | EpHealth Soluções em Tecnologia da Informação Ltda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Florianópolis | Brazil |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal
Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Likelihood of treatment escalation stratified by low/moderate vs. high/very high CV risk.
| through study completion, an average of 1 year |