Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
version: 9; Last updated: 2026-08-07 17:15:50+0000
Profile: StudyComponent
ArtifactPublicationStatus: Active
Artifact Author: Khalid Shahin:
ResearchStudySaeReportingMethod: Report serious adverse events to the coordinating centre within 24 hours of first awareness using the electronic SAE form. The coordinating centre forwards reports to the independent Data and Safety Monitoring Board and to the relevant regulatory authority within 7 calendar days for fatal or life-threatening events, and within 15 calendar days otherwise.
ResearchStudySponsorConfidentialityStatement: This study does not have a confidentiality statement, but this is an example of how the data would appear if there was such a statement.
url: https://fevir.net/resources/ResearchStudy/588219
identifier: FEvIR Object Identifier/588219
title: BP-CONTROL Cardiovascular Outcomes Component: intensive versus standard blood-pressure control in adults at increased cardiovascular risk
| Type | Value | Language |
| Acronym | BP-CONTROL-CV | English |
partOf: BP-CONTROL Master Protocol: blood-pressure targets in adults at increased cardiovascular risk
citeAs:
BP-CONTROL Cardiovascular Outcomes Component: intensive versus standard blood-pressure control in adults at increased cardiovascular risk [Database Entry: FHIR ResearchStudy Resource]. Contributors: Khalid Shahin [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 588219. Revised 2026-08-07. Available at: https://fevir.net/resources/ResearchStudy/588219. Computable resource at: https://fevir.net/resources/ResearchStudy/588219#json.
relatesTo
type: Part Of
target: BP-CONTROL Master Protocol: blood-pressure targets in adults at increased cardiovascular risk
relatesTo
RelatesToWithQuotation:
Enrolment was extended by 11 months relative to the original protocol following slower than anticipated recruitment during 2020.
type: Amended With
target:
An extension to the enrollment to get enough recruitment.
status: Active
purposeType: Treatment, Prevention
phase: Phase 3
studyDesign: Randomized controlled trial
condition: Hypertension with increased cardiovascular risk
keyword: blood pressure, cardiovascular prevention, treatment target
region: United States of America, Canada
descriptionSummary:
Randomized comparison of intensive versus standard blood-pressure control in adults aged 50 years or older with hypertension and at least one additional cardiovascular risk factor, conducted as one component of the BP-CONTROL master protocol.
description:
This ResearchStudy describes one component of a multi-part investigation conducted under the BP-CONTROL master protocol. Participants aged 50 years or older with a systolic blood pressure of 130-180 mmHg and at least one additional cardiovascular risk factor were randomly assigned in a 1:1 ratio to a systolic blood-pressure target of less than 120 mmHg (intensive control) or less than 140 mmHg (standard control).
Treatment was open-label; all primary and secondary endpoint events were adjudicated by a committee unaware of treatment assignment. The primary endpoint was a composite of myocardial infarction, other acute coronary syndrome, stroke, acute decompensated heart failure, or death from cardiovascular causes. Participants were followed until the common study end date or death.
Other components conducted under the same master protocol, and reported separately, address cognitive outcomes and kidney outcomes. Each component is represented as its own ResearchStudy pointing at the shared master protocol through partOf.
period: 2019-11-01 --> 2025-10-31
associatedParty
name: Example National Heart Institute
role: Lead sponsor
period: 2019-10-01 --> 2025-10-31
associatedParty
name: Example Independent Data Monitoring Committee
role: Data Monitoring
associatedParty
name: Example University Clinical Coordinating Centre
role: collaborator
classifier: Academic
progressStatus
state: Recruitment complete
actual: true
period: 2021-10-04 --> (ongoing)
progressStatus
state: Follow-up complete
actual: true
period: 2025-11-01 --> (ongoing)
| TargetNumber | ActualNumber | Description |
| 9200 | 9361 | Recruitment was conducted at 102 sites in the United States and Canada. Screening ran from November 2019 to October 2021. |
comparisonGroup
targetNumber: 4600
actualNumber: 4678
name: Intensive control
description:
Antihypertensive therapy titrated at monthly intervals to a systolic blood-pressure target of less than 120 mmHg.
comparisonGroup
targetNumber: 4600
actualNumber: 4683
name: Standard control
description:
Antihypertensive therapy titrated to a systolic blood-pressure target of less than 140 mmHg.
objective
name: Primary objective
type: Primary
description:
To determine whether a systolic blood-pressure target of less than 120 mmHg reduces the rate of major adverse cardiovascular events compared with a target of less than 140 mmHg.
OutcomeMeasures
Name Type Description Endpoint SummaryMeasure Major adverse cardiovascular events Primary Time to first occurrence of myocardial infarction, other acute coronary syndrome, stroke, acute decompensated heart failure, or death from cardiovascular causes, adjudicated by a committee unaware of treatment assignment.
Major adverse cardiovascular events (composite endpoint) Hazard ratio from a Cox proportional-hazards model stratified by site
objective
name: Safety objective
type: Secondary
description:
To compare the rate of serious adverse events of interest, including hypotension, syncope, electrolyte abnormality and acute kidney injury, between the two treatment targets.
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot5.
Generated
2026-08-17
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