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 |
<Composition xmlns="http://hl7.org/fhir">
<id value="397488"/>
<meta>
<versionId value="9"/>
<lastUpdated value="2025-09-03T12:20:32.624Z"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/summary-of-findings"/>
</meta>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><table><tbody><tr><th><div><p>Outcome</p></div></th><th><div><p>Sample Size</p></div></th><th><div><p>Result Without Treatment</p></div></th><th><div><p>Result With Treatment (Observed)</p></div></th><th><div><p>Result With Treatment (Calculated)</p></div></th><th><div><p>Effect Estimate</p></div></th><th><div><p>Certainty of Evidence</p></div></th><th><div><p>What this means</p></div></th></tr><tr><td><div><p>Systolic blood pressure at 12 weeks</p></div></td><td><div><p>62 participants, 60 analyzed, 53 without missing data</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><p>difference in means -4.5 mm Hg (95% confidence interval -10.82 mm Hg to 1.32 mm Hg)</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td></tr><tr><td><div><p>Diastolic blood pressure at 12 weeks</p></div></td><td><div><p>62 participants, 60 analyzed, 53 without missing data</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><p>[Not a proportion.]</p></div></td><td><div><p>difference in means -4.92 mm Hg (95% confidence interval -8.58 mm Hg to 0.27 mm Hg)</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td></tr><tr><td><div><p>Medication Adherence at 12 weeks</p></div></td><td><div><p>62 participants, 53 without missing data</p></div></td><td><div><p>70%</p></div></td><td><div><p>65.6%</p></div></td><td><div><p>46.33%</p></div></td><td><div><p>odds ratio 0.37 (95% confidence interval 0.19 to 2.08)</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td></tr><tr><td><div><p>Hypertension Control at 12 weeks</p></div></td><td><div><p>62 participants, 60 analyzed, 53 without missing data</p></div></td><td><div><p>54.17%</p></div></td><td><div><p>65.52%</p></div></td><td><div><p>77.11%</p></div></td><td><div><p>odds ratio 2.85 (95% confidence interval 0.94 to 8.59)</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td></tr><tr><td><div><p>Add-on Amlodipine at 6 weeks</p></div></td><td><div><p>62 participants, 60 analyzed, 62 without missing data, 22 events</p></div></td><td><div><p>53.33%</p></div></td><td><div><p>18.75%</p></div></td><td><div><p>51.25%</p></div></td><td><div><p>odds ratio 0.92 (95% confidence interval 0.02 to 0.41)</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td></tr><tr><td><div><p>Adverse event free and hypertension control at 12 weeks</p></div></td><td><div><p>62 participants, 53 analyzed, 53 without missing data, 13 events</p></div></td><td><div><p>33.33%</p></div></td><td><div><p>17.24%</p></div></td><td><div><p>29.33%</p></div></td><td><div><p>odds ratio 0.83 (95% confidence interval 0.22 to 3.16)</p></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td><td><div><div style="color: #AAAAAA;">[No summary statement.]</div></div></td></tr></tbody></table></div>
</text>
<url value="https://fevir.net/resources/Composition/397488"/>
<identifier>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="ACSN"/>
<display value="Accession ID"/>
</coding>
<text value="FEvIR Object Identifier"/>
</type>
<system value="https://fevir.net/FOI"/>
<value value="397488"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="SummaryOfFindings"/>
<display value="SummaryOfFindings"/>
</coding>
<text value="Summary of Findings"/>
</type>
<date value="2025-09-03T12:20:32.624Z"/>
<author>
<display value="Brian S. Alper, MD, MSPH"/>
</author>
<title value="Summary of Findings - QUARTET USA Trial"/>
<custodian>🔗
<reference value="Organization/118079"/>
<type value="Organization"/>
<display value="Computable Publishing LLC"/>
</custodian>
<relatesTo>
<type value="derived-from"/>
<targetReference>🔗
<reference value="Composition/375280"/>
<type value="Composition"/>
<display value="Outcome Measure Report for QUARTET USA Trial"/>
</targetReference>
</relatesTo>
<relatesTo>
<type value="cite-as"/>
<targetMarkdown
value="Summary of Findings - QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 397488. Revised 2025-09-03. Available at: https://fevir.net/resources/Composition/397488. Computable resource at: https://fevir.net/resources/Composition/397488."/>
</relatesTo>
<section>
<title value="Column Headers"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="column-headers"/>
<display value="Column Headers"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">No need for narrative text.</div>
</text>
<section>
<title value="Outcome Measure"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measure"/>
<display value="Outcome Measure"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Outcome</p></div>
</text>
</section>
<section>
<title value="Sample Size"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="sample-size"/>
<display value="Sample Size"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Sample Size</p></div>
</text>
</section>
<section>
<title value="Result Without Treatment"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-comparator-alone"/>
<display value="Result with comparator alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Result Without Treatment</p></div>
</text>
</section>
<section>
<title value="Result With Treatment--Observed"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone"/>
<display value="Result with intervention alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Result With Treatment (Observed)</p></div>
</text>
</section>
<section>
<title value="Result With Treatment--Derived"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone-calculated"/>
<display value="Result with intervention alone (calculated)"/>
</coding>
<text
value="result with intervention with calculated value derived from the control group and effect estimate"/>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Result With Treatment (Calculated)</p></div>
</text>
</section>
<section>
<title value="Effect Estimate"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-vs-comparator"/>
<display value="Result with intervention vs. comparator"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Effect Estimate</p></div>
</text>
</section>
<section>
<title value="Certainty of Evidence"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="certainty-of-evidence"/>
<display value="Certainty of Evidence"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Certainty of Evidence</p></div>
</text>
</section>
<section>
<title value="Assertion"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="assertion"/>
<display value="Assertion"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What this means</p></div>
</text>
</section>
</section>
<section>
<title value="Summary of Findings"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="summary-of-findings"/>
<display value="Summary of Findings"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
<section>
<title value="Results for Systolic blood pressure at 12 weeks"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="summary-of-findings-entry-for-a-single-outcome"/>
<display value="Summary of findings entry for a single outcome"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/375185"/>
<type value="EvidenceVariable"/>
<display value="Systolic blood pressure at 12 weeks"/>
</focus>
<section>
<title value="Outcome Measure"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measure"/>
<display value="Outcome Measure"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Systolic blood pressure at 12 weeks</p></div>
</text>
<entry>🔗
<reference value="EvidenceVariable/375185"/>
<type value="EvidenceVariable"/>
<display value="Systolic blood pressure at 12 weeks"/>
</entry>
</section>
<section>
<title value="Sample Size"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="sample-size"/>
<display value="Sample Size"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>62 participants, 60 analyzed, 53 without missing data</p></div>
</text>
<entry>🔗
<reference value="Evidence/397483"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Systolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Result Without Treatment"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-comparator-alone"/>
<display value="Result with comparator alone"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[Not a proportion.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/375594"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Systolic blood pressure at 12 weeks in QUARTET USA Trial Control Group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Observed"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone"/>
<display value="Result with intervention alone"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[Not a proportion.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/375628"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Systolic blood pressure at 12 weeks in QUARTET USA Trial Quadpill group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Derived"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone-calculated"/>
<display value="Result with intervention alone (calculated)"/>
</coding>
<text
value="result with intervention with calculated value derived from the control group and effect estimate"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
</section>
<section>
<title value="Effect Estimate"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-vs-comparator"/>
<display value="Result with intervention vs. comparator"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>difference in means -4.5 mm Hg (95% confidence interval -10.82 mm Hg to 1.32 mm Hg)</p></div>
</text>
<entry>🔗
<reference value="Evidence/397483"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Systolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Certainty of Evidence"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="certainty-of-evidence"/>
<display value="Certainty of Evidence"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No certainty rating found.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397483"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Systolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Assertion"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="assertion"/>
<display value="Assertion"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No assertion provided.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397483"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Systolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
</section>
<section>
<title value="Results for Diastolic blood pressure at 12 weeks"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="summary-of-findings-entry-for-a-single-outcome"/>
<display value="Summary of findings entry for a single outcome"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/375186"/>
<type value="EvidenceVariable"/>
<display value="Diastolic blood pressure at 12 weeks"/>
</focus>
<section>
<title value="Outcome Measure"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measure"/>
<display value="Outcome Measure"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Diastolic blood pressure at 12 weeks</p></div>
</text>
<entry>🔗
<reference value="EvidenceVariable/375186"/>
<type value="EvidenceVariable"/>
<display value="Diastolic blood pressure at 12 weeks"/>
</entry>
</section>
<section>
<title value="Sample Size"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="sample-size"/>
<display value="Sample Size"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>62 participants, 60 analyzed, 53 without missing data</p></div>
</text>
<entry>🔗
<reference value="Evidence/397482"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Diastolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Result Without Treatment"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-comparator-alone"/>
<display value="Result with comparator alone"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[Not a proportion.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/375932"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Diastolic blood pressure at 12 weeks in QUARTET USA Trial Control Group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Observed"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone"/>
<display value="Result with intervention alone"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[Not a proportion.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/375629"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Diastolic blood pressure at 12 weeks in QUARTET USA Trial Quadpill group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Derived"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone-calculated"/>
<display value="Result with intervention alone (calculated)"/>
</coding>
<text
value="result with intervention with calculated value derived from the control group and effect estimate"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
</section>
<section>
<title value="Effect Estimate"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-vs-comparator"/>
<display value="Result with intervention vs. comparator"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>difference in means -4.92 mm Hg (95% confidence interval -8.58 mm Hg to 0.27 mm Hg)</p></div>
</text>
<entry>🔗
<reference value="Evidence/397482"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Diastolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Certainty of Evidence"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="certainty-of-evidence"/>
<display value="Certainty of Evidence"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No certainty rating found.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397482"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Diastolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Assertion"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="assertion"/>
<display value="Assertion"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No assertion provided.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397482"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Diastolic blood pressure at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
</section>
<section>
<title value="Results for Medication Adherence at 12 weeks"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="summary-of-findings-entry-for-a-single-outcome"/>
<display value="Summary of findings entry for a single outcome"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/375201"/>
<type value="EvidenceVariable"/>
<display value="Medication Adherence at 12 weeks"/>
</focus>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
<section>
<title value="Outcome Measure"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measure"/>
<display value="Outcome Measure"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Medication Adherence at 12 weeks</p></div>
</text>
<entry>🔗
<reference value="EvidenceVariable/375201"/>
<type value="EvidenceVariable"/>
<display value="Medication Adherence at 12 weeks"/>
</entry>
</section>
<section>
<title value="Sample Size"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="sample-size"/>
<display value="Sample Size"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>62 participants, 53 without missing data</p></div>
</text>
<entry>🔗
<reference value="Evidence/397481"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Medication Adherence at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Result Without Treatment"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-comparator-alone"/>
<display value="Result with comparator alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>70%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379724"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Medication Adherence at 12 weeks in QUARTET USA Trial Control Group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Observed"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone"/>
<display value="Result with intervention alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>65.6%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379723"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Medication Adherence at 12 weeks in QUARTET USA Trial Quadpill group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Derived"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone-calculated"/>
<display value="Result with intervention alone (calculated)"/>
</coding>
<text
value="result with intervention with calculated value derived from the control group and effect estimate"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
</section>
<section>
<title value="Effect Estimate"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-vs-comparator"/>
<display value="Result with intervention vs. comparator"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>odds ratio 0.37 (95% confidence interval 0.19 to 2.08)</p></div>
</text>
<entry>🔗
<reference value="Evidence/397481"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Medication Adherence at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Certainty of Evidence"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="certainty-of-evidence"/>
<display value="Certainty of Evidence"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No certainty rating found.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397481"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Medication Adherence at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Assertion"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="assertion"/>
<display value="Assertion"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No assertion provided.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397481"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Medication Adherence at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
</section>
<section>
<title value="Results for Hypertension Control at 12 weeks"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="summary-of-findings-entry-for-a-single-outcome"/>
<display value="Summary of findings entry for a single outcome"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/375202"/>
<type value="EvidenceVariable"/>
<display value="Hypertension Control at 12 weeks"/>
</focus>
<section>
<title value="Outcome Measure"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measure"/>
<display value="Outcome Measure"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Hypertension Control at 12 weeks</p></div>
</text>
<entry>🔗
<reference value="EvidenceVariable/375202"/>
<type value="EvidenceVariable"/>
<display value="Hypertension Control at 12 weeks"/>
</entry>
</section>
<section>
<title value="Sample Size"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="sample-size"/>
<display value="Sample Size"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>62 participants, 60 analyzed, 53 without missing data</p></div>
</text>
<entry>🔗
<reference value="Evidence/397480"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Result Without Treatment"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-comparator-alone"/>
<display value="Result with comparator alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>54.17%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379737"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Hypertension Control at 12 weeks in QUARTET USA Trial Control Group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Observed"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone"/>
<display value="Result with intervention alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>65.52%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379736"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Hypertension Control at 12 weeks in QUARTET USA Trial Quadpill group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Derived"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone-calculated"/>
<display value="Result with intervention alone (calculated)"/>
</coding>
<text
value="result with intervention with calculated value derived from the control group and effect estimate"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
</section>
<section>
<title value="Effect Estimate"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-vs-comparator"/>
<display value="Result with intervention vs. comparator"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>odds ratio 2.85 (95% confidence interval 0.94 to 8.59)</p></div>
</text>
<entry>🔗
<reference value="Evidence/397480"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Certainty of Evidence"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="certainty-of-evidence"/>
<display value="Certainty of Evidence"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No certainty rating found.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397480"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Assertion"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="assertion"/>
<display value="Assertion"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No assertion provided.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397480"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
</section>
<section>
<title value="Results for Add-on Amlodipine at 6 weeks"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="summary-of-findings-entry-for-a-single-outcome"/>
<display value="Summary of findings entry for a single outcome"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/375203"/>
<type value="EvidenceVariable"/>
<display value="Add-on Amlodipine at 6 weeks"/>
</focus>
<section>
<title value="Outcome Measure"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measure"/>
<display value="Outcome Measure"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Add-on Amlodipine at 6 weeks</p></div>
</text>
<entry>🔗
<reference value="EvidenceVariable/375203"/>
<type value="EvidenceVariable"/>
<display value="Add-on Amlodipine at 6 weeks"/>
</entry>
</section>
<section>
<title value="Sample Size"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="sample-size"/>
<display value="Sample Size"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>62 participants, 60 analyzed, 62 without missing data, 22 events</p></div>
</text>
<entry>🔗
<reference value="Evidence/397479"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Result Without Treatment"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-comparator-alone"/>
<display value="Result with comparator alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>53.33%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379740"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Add-on Amlodipine at 6 weeks in QUARTET USA Trial Control Group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Observed"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone"/>
<display value="Result with intervention alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>18.75%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379739"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Add-on Amlodipine at 6 weeks in QUARTET USA Trial Quadpill group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Derived"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone-calculated"/>
<display value="Result with intervention alone (calculated)"/>
</coding>
<text
value="result with intervention with calculated value derived from the control group and effect estimate"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
</section>
<section>
<title value="Effect Estimate"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-vs-comparator"/>
<display value="Result with intervention vs. comparator"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>odds ratio 0.92 (95% confidence interval 0.02 to 0.41)</p></div>
</text>
<entry>🔗
<reference value="Evidence/397479"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Certainty of Evidence"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="certainty-of-evidence"/>
<display value="Certainty of Evidence"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No certainty rating found.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397479"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Assertion"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="assertion"/>
<display value="Assertion"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No assertion provided.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397479"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
</section>
<section>
<title
value="Results for Adverse event free and hypertension control at 12 weeks"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="summary-of-findings-entry-for-a-single-outcome"/>
<display value="Summary of findings entry for a single outcome"/>
</coding>
</code>
<focus>🔗
<reference value="EvidenceVariable/375278"/>
<type value="EvidenceVariable"/>
<display
value="Adverse event free and hypertension control at 12 weeks"/>
</focus>
<section>
<title value="Outcome Measure"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measure"/>
<display value="Outcome Measure"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Adverse event free and hypertension control at 12 weeks</p></div>
</text>
<entry>🔗
<reference value="EvidenceVariable/375278"/>
<type value="EvidenceVariable"/>
<display
value="Adverse event free and hypertension control at 12 weeks"/>
</entry>
</section>
<section>
<title value="Sample Size"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="sample-size"/>
<display value="Sample Size"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>62 participants, 53 analyzed, 53 without missing data, 13 events</p></div>
</text>
<entry>🔗
<reference value="Evidence/397478"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Result Without Treatment"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-comparator-alone"/>
<display value="Result with comparator alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>33.33%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379743"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Adverse event free and hypertension control at 12 weeks in QUARTET USA Trial Control Group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Observed"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone"/>
<display value="Result with intervention alone"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>17.24%</p></div>
</text>
<entry>🔗
<reference value="Evidence/379742"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Adverse event free and hypertension control at 12 weeks in QUARTET USA Trial Quadpill group"/>
</entry>
</section>
<section>
<title value="Result With Treatment--Derived"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-alone-calculated"/>
<display value="Result with intervention alone (calculated)"/>
</coding>
<text
value="result with intervention with calculated value derived from the control group and effect estimate"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
</section>
<section>
<title value="Effect Estimate"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="result-with-intervention-vs-comparator"/>
<display value="Result with intervention vs. comparator"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>odds ratio 0.83 (95% confidence interval 0.22 to 3.16)</p></div>
</text>
<entry>🔗
<reference value="Evidence/397478"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Certainty of Evidence"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="certainty-of-evidence"/>
<display value="Certainty of Evidence"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No certainty rating found.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397478"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</entry>
</section>
<section>
<title value="Assertion"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="assertion"/>
<display value="Assertion"/>
</coding>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No assertion provided.]</p></div>
</text>
<entry>🔗
<reference value="Evidence/397478"/>
<type value="Evidence"/>
<display
value="Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan"/>
</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 2025-09-13
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change