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
| Page standards status: Informative |
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QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>
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<div xmlns="http://www.w3.org/1999/xhtml">Patients randomized to the comparison arm took a once daily 8mg candesartan.
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<title value="Outcome Class List"/>
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<section>
<title value="Medication Adherence at 12 weeks (NCT03640312)"/>
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<div xmlns="http://www.w3.org/1999/xhtml">Data are available on only 28 participants in the intervention group for the mental health T score.</div>
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<div xmlns="http://www.w3.org/1999/xhtml">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.</div>
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QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
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<div xmlns="http://www.w3.org/1999/xhtml">Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>
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<display
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<display
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<div xmlns="http://www.w3.org/1999/xhtml">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.</div>
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<div xmlns="http://www.w3.org/1999/xhtml">Posted</div>
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<div xmlns="http://www.w3.org/1999/xhtml">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.</div>
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QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
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<div xmlns="http://www.w3.org/1999/xhtml">Patients randomized to the comparison arm took a once daily 8mg candesartan.
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<div xmlns="http://www.w3.org/1999/xhtml">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.
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<div xmlns="http://www.w3.org/1999/xhtml">Patients randomized to the comparison arm took a once daily 8mg candesartan.
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<display
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value="Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
</entry>
</section>
</section>
<section>
<title value="Outcome Class List"/>
<code>
<text value="OutcomeClassList"/>
</code>
<section>
<title
value="Mean Change in Blood Urea Nitrogen at 12 weeks (NCT03640312)"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="results"/>
<display value="Results"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/367901"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-5"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Blood Urea Nitrogen at 12 weeks (NCT03640312)"/>
</focus>
<entry>🔗
<reference value="Evidence/367937"/>
<type value="Evidence"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcomeMeasure-5--OG000"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Blood Urea Nitrogen at 12 weeks for QUARTET LDQT in NCT03640312"/>
</entry>
<entry>🔗
<reference value="Evidence/367938"/>
<type value="Evidence"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcomeMeasure-5--OG001"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Blood Urea Nitrogen at 12 weeks for Candesartan in NCT03640312"/>
</entry>
<entry>🔗
<reference value="Evidence/367957"/>
<type value="Evidence"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value
value="NCT03640312-otherOutcomeMeasure-5-OutcomeAnalysis-16-BetweenGroupAnalysis-OG000-OG001"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Blood Urea Nitrogen at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"/>
</entry>
</section>
</section>
</section>
<section>
<title value="Mean Change in Serum Creatinine at 12 weeks"/>
<focus>🔗
<reference value="EvidenceVariable/367902"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-6"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Serum Creatinine at 12 weeks (NCT03640312)"/>
</focus>
<section>
<title value="Outcome Measure Population Description"/>
<code>
<text value="OutcomeMeasurePopulationDescription"/>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">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.</div>
</text>
</section>
<section>
<title value="Outcome Measure Reporting Status"/>
<code>
<text value="OutcomeMeasureReportingStatus"/>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">Posted</div>
</text>
</section>
<section>
<title value="Outcome Measure Time Frame"/>
<code>
<text value="OutcomeMeasureTimeFrame"/>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">12 weeks</div>
</text>
</section>
<section>
<title value="Outcome Group List"/>
<code>
<text value="OutcomeGroupList"/>
</code>
<section>
<title value="QUARTET LDQT"/>
<code>
<text value="OG000"/>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">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.</div>
</text>
<entry>
<display
value="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."/>
</entry>
</section>
<section>
<title value="Candesartan"/>
<code>
<text value="OG001"/>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>
</text>
<entry>
<display
value="Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
</entry>
</section>
</section>
<section>
<title value="Outcome Class List"/>
<code>
<text value="OutcomeClassList"/>
</code>
<section>
<title
value="Mean Change in Serum Creatinine at 12 weeks (NCT03640312)"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="results"/>
<display value="Results"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/367902"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-6"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Serum Creatinine at 12 weeks (NCT03640312)"/>
</focus>
<entry>🔗
<reference value="Evidence/367939"/>
<type value="Evidence"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcomeMeasure-6--OG000"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Serum Creatinine at 12 weeks for QUARTET LDQT in NCT03640312"/>
</entry>
<entry>🔗
<reference value="Evidence/367940"/>
<type value="Evidence"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcomeMeasure-6--OG001"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Serum Creatinine at 12 weeks for Candesartan in NCT03640312"/>
</entry>
<entry>🔗
<reference value="Evidence/367958"/>
<type value="Evidence"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value
value="NCT03640312-otherOutcomeMeasure-6-OutcomeAnalysis-17-BetweenGroupAnalysis-OG000-OG001"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display
value="Mean Change in Serum Creatinine at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"/>
</entry>
</section>
</section>
</section>
</Composition>
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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