Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
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
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<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>
</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>
</div><p><b>description</b>: </p><div><p>This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</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>
</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>
</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.
QUARTET 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.
Candesartan: 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>
</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>
</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>
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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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