Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

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

: Outcome Measure Report for QUARTET USA Trial - XML Representation

Page standards status: Informative

Raw xml | Download


<Composition xmlns="http://hl7.org/fhir">
  <id value="375280"/>
  <meta>
    <versionId value="88"/>
    <lastUpdated value="2025-09-02T18:35:51.376Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="additional"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><table><tbody><tr><th>Variable Name</th><th>QUARTET USA Trial Quadpill group</th><th>QUARTET USA Trial Control Group</th><th>GroupAssignment: Quadpill vs. Candesartan</th></tr><tr><td>Systolic blood pressure at 12 weeks</td><td><p>out of 32: mean 122.3 mm Hg (95% confidence interval 118.2 to 126.5 mm Hg)</p></td><td><p>out of 24: mean 127.1 mm Hg (95% confidence interval 118.2 to 126.5 mm Hg)</p></td><td><p>out of 60: difference in means -4.5 mm Hg (95% confidence interval -10.82 to 1.32 mm Hg, p-value 0.123)</p></td></tr><tr><td>Results for Diastolic blood pressure at 12 weeks</td><td>out of 32: mean 73 mm Hg (95% confidence interval 70.5 to 75.5 mm Hg)</td><td>out of 28: mean 77.9 mm Hg (95% confidence interval 75.2 to 80.6 mm Hg)</td><td>out of 60: difference in means -4.92 mm Hg (95% confidence interval -8.58 to 0.27 mm Hg)</td></tr><tr><td>Medication Adherence at 12 weeks</td><td><p>out of 32: percentage 65.6 %; The published study report (https://fevir.net/resources/Citation/367878) reported 20 affected with 65.6%, but the 65.6% implies 21 affected. The results reported at ClinicalTrials.gov (https://fevir.net/resources/Composition/370504) was 21 affected with 65.6% for this outcome.</p></td><td><p>out of 24: percentage 70 %; 30 (numberOfParticipants) matches 70% reported in table 2 of the published article and the data reported in ClinicalTrials.gov, instead of 28 as number analyzed as reported in Figure 1, so numberAnalyzed not reported in this Evidence Resource.</p></td><td><p>out of 54: odds ratio -0.37 (95% confidence interval 0.19 to 2.08, p-value 0.444)</p></td></tr><tr><td>Hypertension Control at 12 weeks</td><td><p>out of 32: percentage 65.517 %; The statistic as reported appears to use the number of participants without missing data (29) as the denominator rather than the number analyzed (32) as suggested in the paper. Either way, the reported percentage does not match the value reported for this outcome in ClinicalTrials.gov results reporting (66.7% at https://fevir.net/resources/Composition/370504)</p></td><td><p>out of 28: percentage 54.167 %; The statistic as reported appears to use the number of participants without missing data (24) as the denominator rather than the number analyzed (28) as suggested in the paper. Either way, the reported percentage does not match the value reported for this outcome in ClinicalTrials.gov results reporting (57.7% at https://fevir.net/resources/Composition/370504)</p></td><td><p>out of 60: odds ratio 2.85 (95% confidence interval 0.94 to 8.59, p-value 0.063)</p></td></tr><tr><td>Add-on Amlodipine at 6 weeks</td><td><p>out of 32: percentage 18.75 %</p></td><td><p>out of 28: percentage 53.333 %</p></td><td><p>out of 60: odds ratio -0.92 (95% confidence interval 0.02 to 0.41, p-value 0.003)</p></td></tr><tr><td>Adverse event free and hypertension control at 12 weeks</td><td><p>out of 29: percentage 17.241 %; The reported percentage (17.2%) does not match the value reported for this outcome in ClinicalTrials.gov results reporting (20% at https://fevir.net/resources/Composition/370504)</p></td><td><p>out of 24: percentage 33.333 %; The reported percentage (33.3%) does not match the value reported for this outcome in ClinicalTrials.gov results reporting (34.6% at https://fevir.net/resources/Composition/370504)</p></td><td><p>out of 53: odds ratio 0.83 (95% confidence interval 0.22 to 3.16, p-value 0.775)</p></td></tr></tbody></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/artifact-description">
    <valueMarkdown
                   value="This is an example of an Outcome Measure Report describing the QUARTET USA Randomized Clinical Trial for the EBM on FHIR Implementation Guide."/>
  </extension>
  <url value="https://fevir.net/resources/Composition/375280"/>
  <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="375280"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <status value="final"/>
  <type>
    <coding>
      <system value="https://fevir.net/resources/CodeSystem/179423"/>
      <code value="OutcomeMeasureReport"/>
      <display value="OutcomeMeasureReport"/>
    </coding>
    <text value="Outcome Measure Report"/>
  </type>
  <date value="2025-09-02T18:35:51.376Z"/>
  <author>
    <display value="Joanne Dehnbostel"/>
  </author>
  <title value="Outcome Measure Report for QUARTET USA Trial"/>
  <custodian>🔗 
    <reference value="Organization/118079"/>
    <type value="Organization"/>
    <display value="Computable Publishing LLC"/>
  </custodian>
  <relatesTo>
    <type value="part-of"/>
    <targetReference>🔗 
      <reference value="Composition/372776"/>
      <type value="Composition"/>
      <display value="Comparative Evidence Report for QUARTET USA Trial"/>
    </targetReference>
  </relatesTo>
  <relatesTo>
    <type value="cite-as"/>
    <targetMarkdown
                    value="Outcome Measure Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 375280. Revised 2025-09-02. Available at: https://fevir.net/resources/Composition/375280. Computable resource at: https://fevir.net/resources/Composition/375280."/>
  </relatesTo>
  <section>
    <title value="Group List"/>
    <code>
      <text value="GroupList"/>
    </code>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
    </text>
    <entry>🔗 
      <reference value="Group/375175"/>
      <type value="Group"/>
      <display value="QUARTET USA Trial Quadpill group"/>
    </entry>
    <entry>🔗 
      <reference value="Group/375182"/>
      <type value="Group"/>
      <display value="QUARTET USA Trial Control Group"/>
    </entry>
    <entry>🔗 
      <reference value="EvidenceVariable/375183"/>
      <type value="EvidenceVariable"/>
      <display value="GroupAssignment: Quadpill vs. Candesartan"/>
    </entry>
  </section>
  <section>
    <title value="Results for Systolic blood pressure at 12 weeks"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>🔗 
      <reference value="EvidenceVariable/375185"/>
      <type value="EvidenceVariable"/>
      <display value="Systolic blood pressure at 12 weeks"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</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>
    <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>
    <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="Results for Diastolic blood pressure at 12 weeks"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>🔗 
      <reference value="EvidenceVariable/375186"/>
      <type value="EvidenceVariable"/>
      <display value="Diastolic blood pressure at 12 weeks"/>
    </focus>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><table><tr><td>Results for Diastolic blood pressure at 12 weeks</td><td>out of 32: mean 73 mm Hg (95% confidence interval 70.5 to 75.5 mm Hg)</td><td>out of 28: mean 77.9 mm Hg (95% confidence interval 75.2 to 80.6 mm Hg)</td><td>out of 60: difference in means -4.92 mm Hg (95% confidence interval -8.58 to 0.27 mm Hg)</td></tr></table></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>
    <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>
    <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="Results for Medication Adherence at 12 weeks"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>🔗 
      <reference value="EvidenceVariable/375201"/>
      <type value="EvidenceVariable"/>
      <display value="Medication Adherence at 12 weeks"/>
    </focus>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><table><tr><td>Results for Medication Adherence at 12 weeks</td><td>out of 32: percentage 65.6 %; The published study report (https://fevir.net/resources/Citation/367878) reported 20 affected with 65.6%, but the 65.6% implies 21 affected. The results reported at ClinicalTrials.gov (https://fevir.net/resources/Composition/370504) was 21 affected with 65.6% for this outcome.</td><td>out of 24: percentage 70 %; 30 (numberOfParticipants) matches 70% reported in table 2 of the published article and the data reported in ClinicalTrials.gov, instead of 28 as number analyzed as reported in Figure 1, so numberAnalyzed not reported in this Evidence Resource.</td><td>out of 53: odds ratio 0.37 (95% confidence interval 0.19 to 2.08, p-value 0.444)</td></tr></table></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>
    <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>
    <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="Results for Hypertension Control at 12 weeks"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>🔗 
      <reference value="EvidenceVariable/375202"/>
      <type value="EvidenceVariable"/>
      <display value="Hypertension Control at 12 weeks"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</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>
    <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>
    <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="Results for Add-on Amlodipine at 6 weeks"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>🔗 
      <reference value="EvidenceVariable/375203"/>
      <type value="EvidenceVariable"/>
      <display value="Add-on Amlodipine at 6 weeks"/>
    </focus>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><table><tr><td>Results for Add-on Amlodipine at 6 weeks</td><td>out of 32: percentage 18.75 %</td><td>out of 28: percentage 53.333 %</td><td>out of 60: odds ratio 0.92 (95% confidence interval 0.02 to 0.41, p-value 0.003)</td></tr></table></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>
    <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>
    <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="Results for Adverse event free and hypertension control at 12 weeks"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>🔗 
      <reference value="EvidenceVariable/375278"/>
      <type value="EvidenceVariable"/>
      <display
               value="Adverse event free and hypertension control at 12 weeks"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</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>
    <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>
    <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>
</Composition>