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 |
{
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"id" : "588219",
"meta" : {
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"lastUpdated" : "2026-08-07T17:15:50.878Z",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy 588219</b></p><a name=\"588219\"> </a><a name=\"hc588219\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 9; Last updated: 2026-08-07 17:15:50+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-study-component.html\">StudyComponent</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>Artifact Author</b>: Khalid Shahin: </p><p><b>ResearchStudySaeReportingMethod</b>: 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.</p><p><b>ResearchStudySponsorConfidentialityStatement</b>: 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.</p><p><b>url</b>: <a href=\"https://fevir.net/resources/ResearchStudy/588219\">https://fevir.net/resources/ResearchStudy/588219</a></p><p><b>identifier</b>: FEvIR Object Identifier/588219</p><p><b>title</b>: BP-CONTROL Cardiovascular Outcomes Component: intensive versus standard blood-pressure control in adults at increased cardiovascular risk</p><h3>Labels</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/title-type acronym}\">Acronym</span></td><td>BP-CONTROL-CV</td><td>English</td></tr></table><p><b>partOf</b>: <a href=\"ResearchStudy-588222.html\">BP-CONTROL Master Protocol: blood-pressure targets in adults at increased cardiovascular risk</a></p><p><b>citeAs</b>: </p><div><p>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.</p>\n</div><blockquote><p><b>relatesTo</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/artifact-relationship-type part-of}\">Part Of</span></p><p><b>target</b>: <a href=\"ResearchStudy-588222.html\">BP-CONTROL Master Protocol: blood-pressure targets in adults at increased cardiovascular risk</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>RelatesToWithQuotation</b>: </p><div><p>Enrolment was extended by 11 months relative to the original protocol following slower than anticipated recruitment during 2020.</p>\n</div><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/artifact-relationship-type amended-with}\">Amended With</span></p><p><b>target</b>: </p><div><p>An extension to the enrollment to get enough recruitment.</p>\n</div></blockquote><p><b>status</b>: Active</p><p><b>purposeType</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type treatment}\">Treatment</span>, <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type prevention}\">Prevention</span></p><p><b>phase</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-phase phase-3}\">Phase 3</span></p><p><b>studyDesign</b>: <span title=\"Codes:\">Randomized controlled trial</span></p><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 38341003}\">Hypertension with increased cardiovascular risk</span></p><p><b>keyword</b>: <span title=\"Codes:\">blood pressure</span>, <span title=\"Codes:\">cardiovascular prevention</span>, <span title=\"Codes:\">treatment target</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 US}\">United States of America</span>, <span title=\"Codes:{urn:iso:std:iso:3166 CA}\">Canada</span></p><p><b>descriptionSummary</b>: </p><div><p>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.</p>\n</div><p><b>description</b>: </p><div><p>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).</p>\n<p>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.</p>\n<p>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 <code>partOf</code>.</p>\n</div><p><b>period</b>: 2019-11-01 --> 2025-10-31</p><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Example National Heart Institute</p><p><b>role</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-party-role lead-sponsor}\">Lead sponsor</span></p><p><b>period</b>: 2019-10-01 --> 2025-10-31</p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Example Independent Data Monitoring Committee</p><p><b>role</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-party-role data-monitoring}\">Data Monitoring</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Example University Clinical Coordinating Centre</p><p><b>role</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-party-role collaborator}\">collaborator</span></p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/research-study-party-organization-type academic}\">Academic</span></p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title=\"Codes:\">Recruitment complete</span></p><p><b>actual</b>: true</p><p><b>period</b>: 2021-10-04 --> (ongoing)</p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title=\"Codes:\">Follow-up complete</span></p><p><b>actual</b>: true</p><p><b>period</b>: 2025-11-01 --> (ongoing)</p></blockquote><h3>Recruitments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>TargetNumber</b></td><td><b>ActualNumber</b></td><td><b>Description</b></td></tr><tr><td style=\"display: none\">*</td><td>9200</td><td>9361</td><td><div><p>Recruitment was conducted at 102 sites in the United States and Canada. Screening ran from November 2019 to October 2021.</p>\n</div></td></tr></table><blockquote><p><b>comparisonGroup</b></p><p><b>targetNumber</b>: 4600</p><p><b>actualNumber</b>: 4678</p><p><b>name</b>: Intensive control</p><p><b>description</b>: </p><div><p>Antihypertensive therapy titrated at monthly intervals to a systolic blood-pressure target of less than 120 mmHg.</p>\n</div></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>targetNumber</b>: 4600</p><p><b>actualNumber</b>: 4683</p><p><b>name</b>: Standard control</p><p><b>description</b>: </p><div><p>Antihypertensive therapy titrated to a systolic blood-pressure target of less than 140 mmHg.</p>\n</div></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Primary objective</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}\">Primary</span></p><p><b>description</b>: </p><div><p>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.</p>\n</div><h3>OutcomeMeasures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Description</b></td><td><b>Endpoint</b></td><td><b>SummaryMeasure</b></td></tr><tr><td style=\"display: none\">*</td><td>Major adverse cardiovascular events</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}\">Primary</span></td><td><div><p>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.</p>\n</div></td><td><a href=\"EvidenceVariable-588221.html\">Major adverse cardiovascular events (composite endpoint)</a></td><td><span title=\"Codes:\">Hazard ratio from a Cox proportional-hazards model stratified by site</span></td></tr></table></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Safety objective</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}\">Secondary</span></p><p><b>description</b>: </p><div><p>To compare the rate of serious adverse events of interest, including hypotension, syncope, electrolyte abnormality and acute kidney injury, between the two treatment targets.</p>\n</div></blockquote></div>"
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"title" : "BP-CONTROL Cardiovascular Outcomes Component: intensive versus standard blood-pressure control in adults at increased cardiovascular risk",
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🔗 "reference" : "ResearchStudy/588222",
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"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.",
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🔗 "reference" : "ResearchStudy/588222",
"display" : "BP-CONTROL Master Protocol: blood-pressure targets in adults at increased cardiovascular risk"
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"keyword" : [
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"text" : "cardiovascular prevention"
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"region" : [
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"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).\n\nTreatment 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.\n\nOther 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`.",
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"code" : "lead-sponsor",
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"period" : [
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"end" : "2025-10-31"
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"role" : {
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"code" : "collaborator",
"display" : "collaborator"
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"classifier" : [
{
"coding" : [
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"code" : "academic",
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"progressStatus" : [
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"period" : {
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"recruitment" : {
"targetNumber" : 9200,
"actualNumber" : 9361,
"description" : "Recruitment was conducted at 102 sites in the United States and Canada. Screening ran from November 2019 to October 2021."
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"comparisonGroup" : [
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"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."
},
{
"targetNumber" : 4600,
"actualNumber" : 4683,
"name" : "Standard control",
"description" : "Antihypertensive therapy titrated to a systolic blood-pressure target of less than 140 mmHg."
}
],
"objective" : [
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"name" : "Primary objective",
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"coding" : [
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"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.",
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"name" : "Major adverse cardiovascular events",
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"description" : "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.",
"endpoint" : {
🔗 "reference" : "EvidenceVariable/588221",
"display" : "Major adverse cardiovascular events (composite endpoint)"
},
"summaryMeasure" : {
"text" : "Hazard ratio from a Cox proportional-hazards model stratified by site"
}
}
]
},
{
"name" : "Safety objective",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "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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