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-ballot2 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
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Evidence ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "367944"] ; #
fhir:meta [
fhir:versionId [ fhir:v "26" ] ;
fhir:lastUpdated [ fhir:v "2025-08-18T13:22:42.074Z"^^xsd:dateTime ] ;
( fhir:profile [
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fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 367944</b></p><a name=\"367944\"> </a><a name=\"hc367944\"> </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: 26; Last updated: 2025-08-18 13:22:42+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-comparative-evidence.html\">ComparativeEvidence</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>url</b>: <a href=\"https://fevir.net/resources/Evidence/367944\">https://fevir.net/resources/Evidence/367944</a></p><p><b>identifier</b>: FEvIR Object Identifier/367944, FEvIR Linking Identifier/NCT03640312-secondaryOutcomeMeasure-2-OutcomeAnalysis-3-BetweenGroupAnalysis-OG000-OG001</p><p><b>name</b>: NCT03640312_secondaryOutcomeMeasure_2_OutcomeAnalysis_3_BetweenGroupAnalysis_OG000_OG001</p><p><b>title</b>: Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312</p><p><b>citeAs</b>: </p><div><p>Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367944. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367944. Computable resource at: https://fevir.net/resources/Evidence/367944#json.</p>\n</div><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><p><b>description</b>: </p><div><p>This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>intended</b>: <a href=\"Group-367881.html\">Group NCT03640312 Eligibility Criteria</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Group Assignment: QUARTET LDQT vs. Candesartan</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>comparatorCategory</b>: Candesartan</p><p><b>observed</b>: Group Assignment: Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-367885.html\">Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>note</b>: </p><blockquote><div><p>Outcome Analysis NonInferiority Type: Superiority</p>\n</div></blockquote><p><b>statisticType</b>: <span title=\"Codes:\">Mean Difference (Net)</span></p><p><b>quantity</b>: -4.86 mm Hg</p><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000037}\">standard error of the mean</span></p><p><b>quantity</b>: 1.87 mm Hg</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></p><p><b>quantity</b>: 0.012</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>note</b>: </p><blockquote><div><p>CI Number of Sides: 2-Sided</p>\n</div></blockquote><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</span></p><p><b>level</b>: 0.95</p><p><b>range</b>: -8.62--1.11 mm Hg</p></blockquote><h3>ModelCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Mixed Models Analysis</span></td></tr></table></blockquote></div>"^^rdf:XMLLiteral
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fhir:name [ fhir:v "NCT03640312_secondaryOutcomeMeasure_2_OutcomeAnalysis_3_BetweenGroupAnalysis_OG000_OG001"] ; #
fhir:title [ fhir:v "Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"] ; #
fhir:citeAs [ fhir:v "Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367944. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367944. Computable resource at: https://fevir.net/resources/Evidence/367944#json."] ; #
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fhir:display [ fhir:v "Group Assignment: Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks." ] ]
] [
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fhir:unit [ fhir:v "mm Hg" ] ] ] ] ) ;
( fhir:modelCharacteristic [
fhir:code [
fhir:text [ fhir:v "Mixed Models Analysis" ] ] ] )
] ) . #
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot3. Generated 2025-09-04
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