Evidence Based Medicine on FHIR Implementation Guide
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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

: Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for Candesartan in NCT03640312 - XML Representation

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<Evidence xmlns="http://hl7.org/fhir">
  <id value="367924"/>
  <meta>
    <versionId value="26"/>
    <lastUpdated value="2025-08-18T13:22:42.074Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Evidence 367924</b></p><a name="367924"> </a><a name="hc367924"> </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-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>url</b>: <a href="https://fevir.net/resources/Evidence/367924">https://fevir.net/resources/Evidence/367924</a></p><p><b>identifier</b>: FEvIR Object Identifier/367924, FEvIR Linking Identifier/NCT03640312-secondaryOutcomeMeasure-7-Change-in-Mental-Health-T-score--OPEN---PROMIS---CLOSE--OG001</p><p><b>name</b>: NCT03640312_secondaryOutcomeMeasure_7_Change_in_Mental_Health_T_score_OPEN_PROMIS_CLOSE_OG001</p><p><b>title</b>: Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for Candesartan in NCT03640312</p><p><b>citeAs</b>: </p><div><p>Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for 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 367924. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367924. Computable resource at: https://fevir.net/resources/Evidence/367924#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>description</b>: </p><div><p>Candesartan</p>
</div><p><b>note</b>: , </p><blockquote><div><p>Outcome Measure Population Description: Data are available on only 28 participants in the intervention group for the mental health T score.</p>
</div></blockquote><blockquote><div><p>Outcome Measure Denominator Units: Participants</p>
</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm took a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. (Identifier: ClinicalTrials.gov Outcome Measurement Group Id/OG001)</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="EvidenceVariable-370509.html">Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) (NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Least Squares Mean</span></p><p><b>quantity</b>: 2.76 score on a scale</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>25</td></tr></table><h3>AttributeEstimates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Standard Deviation</span></td><td>7.63 score on a scale</td></tr></table></blockquote></div>
  </text>
  <url value="https://fevir.net/resources/Evidence/367924"/>
  <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="367924"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <type>
      <text value="FEvIR Linking Identifier"/>
    </type>
    <system value="https://fevir.net/FLI"/>
    <value
           value="NCT03640312-secondaryOutcomeMeasure-7-Change-in-Mental-Health-T-score--OPEN---PROMIS---CLOSE--OG001"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <name
        value="NCT03640312_secondaryOutcomeMeasure_7_Change_in_Mental_Health_T_score_OPEN_PROMIS_CLOSE_OG001"/>
  <title
         value="Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for Candesartan in NCT03640312"/>
  <citeAs
          value="Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for 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 367924. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367924. Computable resource at: https://fevir.net/resources/Evidence/367924#json."/>
  <status value="active"/>
  <author>
    <name
          value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
  </author>
  <publisher value="Computable Publishing LLC"/>
  <contact>
    <telecom>
      <system value="email"/>
      <value value="support@computablepublishing.com"/>
    </telecom>
  </contact>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <description
               value="This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide."/>
  <variableDefinition>
    <description value="Candesartan"/>
    <note>
      <text
            value="Outcome Measure Population Description: Data are available on only 28 participants in the intervention group for the mental health T score."/>
    </note>
    <note>
      <text value="Outcome Measure Denominator Units: Participants"/>
    </note>
    <variableRole value="population"/>
    <observed>
      <identifier>
        <type>
          <text value="ClinicalTrials.gov Outcome Measurement Group Id"/>
        </type>
        <value value="OG001"/>
      </identifier>
      <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."/>
    </observed>
  </variableDefinition>
  <variableDefinition>
    <variableRole value="outcome"/>
    <observed>🔗 
      <reference value="EvidenceVariable/370509"/>
      <type value="EvidenceVariable"/>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-secondaryOutcome-7-Change-in-Mental-Health-T-score--OPEN---PROMIS---CLOSE--"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <display
               value="Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) (NCT03640312)"/>
    </observed>
  </variableDefinition>
  <statistic>
    <statisticType>
      <text value="Least Squares Mean"/>
    </statisticType>
    <quantity>
      <value value="2.76"/>
      <unit value="score on a scale"/>
    </quantity>
    <sampleSize>
      <knownDataCount value="25"/>
    </sampleSize>
    <attributeEstimate>
      <type>
        <text value="Standard Deviation"/>
      </type>
      <quantity>
        <value value="7.63"/>
        <unit value="score on a scale"/>
      </quantity>
    </attributeEstimate>
  </statistic>
</Evidence>