Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - 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-ballot 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

: ComparativeParticipantFlow: Dropout due to stopping intervention Lofexidine vs. Placebo in opioid detoxification trial - XML Representation

Active as of 2024-05-16

Raw xml | Download



<Evidence xmlns="http://hl7.org/fhir">
  <id value="179635"/>
  <meta>
    <versionId value="4"/>
    <lastUpdated value="2023-12-03T09:56:07.995Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-participant-flow"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Evidence</b><a name="179635"> </a><a name="hc179635"> </a></p><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">ResourceEvidence &quot;179635&quot; Version &quot;4&quot; Updated &quot;2023-12-03 09:56:07+0000&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-comparative-participant-flow.html">ComparativeParticipantFlow</a></p></div><p><b>url</b>: <code>https://fevir.net/resources/Evidence/179635</code></p><p><b>identifier</b>: FEvIR Object Identifier/179635</p><p><b>version</b>: 1.0.0-ballot</p><p><b>name</b>: ComparativeParticipantFlow_Dropout_due_to_stopping_intervention_Lofexidine_vs_Placebo_in_opioid_detoxification_trial</p><p><b>title</b>: ComparativeParticipantFlow: Dropout due to stopping intervention Lofexidine vs. Placebo in opioid detoxification trial</p><p><b>status</b>: active</p><p><b>date</b>: 2024-05-16 12:17:54+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>author</b>: Brian S. Alper: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Evidence Communication (Details: Evidence Based Medicine on FHIR Implementation Guide Code System code evidence-communication = 'Evidence Communication', stated as 'Evidence Communication')</td><td>ComparativeParticipantFlow <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#ComparativeParticipantFlow)</span></td></tr></table><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><h3>RelatedArtifacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Citation</b></td><td><b>ResourceReference</b></td></tr><tr><td style="display: none">*</td><td>cite-as</td><td>ComparativeParticipantFlow: Dropout due to stopping intervention Lofexidine vs. Placebo in opioid detoxification trial [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 179635. Revised 2023-11-27. Available at: https://fevir.net/resources/Evidence/179635. Computable resource at: https://fevir.net/resources/Evidence/179635.</td><td> </td></tr><tr><td style="display: none">*</td><td>derived-from</td><td> </td><td><a href="Citation-179637.html">Citation/179637: 18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal</a></td></tr></table><p><b>description</b>: Dropout due to stopping intervention 18/33 with Lofexidine vs. 12/35 with Placebo in opioid detoxification trial</p><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: Participants in the opioid detoxification trial</p><p><b>note</b>: population</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#population &quot;population&quot;)</span></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>VariableDefinitionComparatorCategory</b>: false</p><p><b>description</b>: GroupAssignment: Lofexidine vs. Placebo</p><p><b>note</b>: exposure</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#exposure &quot;exposure&quot;)</span></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: outcome</p><p><b>description</b>: Dropout due to stopping intervention</p><p><b>note</b>: outcome</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#measuredVariable &quot;measured variable&quot;)</span></p><p><b>observed</b>: <a href="EvidenceVariable-179636.html">EvidenceVariable/179636: PartiicipantFlowMeasure: Dropout due to stopping intervention</a> &quot;ParticipantFlowMeasure_Dropout_due_to_stopping_intervention&quot;</p></blockquote><blockquote><p><b>statistic</b></p><p><b>description</b>: 18/33 (54.5%) with Lofexidine vs. 12/35 (34.3%) with Placebo (relative risk 1.59, p &lt; 0.01)</p><p><b>statisticType</b>: Risk Ratio <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#STATO:0000245)</span></p><p><b>quantity</b>: 1.59</p><p><b>numberAffected</b>: 30</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>NumberOfParticipants</b></td></tr><tr><td style="display: none">*</td><td>68</td></tr></table><h3>AttributeEstimates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Description</b></td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td>p &lt; 0.01</td><td>P-value <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#TBD:0000076)</span></td><td>&lt;0.01</td></tr></table></blockquote></div>
  </text>
  <url value="https://fevir.net/resources/Evidence/179635"/>
  <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"/>
    <value value="179635"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <version value="1.0.0-ballot"/>
  <name
        value="ComparativeParticipantFlow_Dropout_due_to_stopping_intervention_Lofexidine_vs_Placebo_in_opioid_detoxification_trial"/>
  <title
         value="ComparativeParticipantFlow: Dropout due to stopping intervention Lofexidine vs. Placebo in opioid detoxification trial"/>
  <status value="active"/>
  <date value="2024-05-16T12:17:54+00:00"/>
  <publisher value="HL7 International / Clinical Decision Support"/>
  <contact>
    <name value="HL7 International / Clinical Decision Support"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/dss"/>
    </telecom>
  </contact>
  <author>
    <name value="Brian S. Alper"/>
  </author>
  <useContext>
    <code>
      <system value="https://fevir.net/resources/CodeSystem/179423"/>
      <code value="evidence-communication"/>
      <display value="Evidence Communication"/>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="ComparativeParticipantFlow"/>
        <display value="ComparativeParticipantFlow"/>
      </coding>
    </valueCodeableConcept>
  </useContext>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <relatedArtifact>
    <type value="cite-as"/>
    <citation
              value="ComparativeParticipantFlow: Dropout due to stopping intervention Lofexidine vs. Placebo in opioid detoxification trial [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 179635. Revised 2023-11-27. Available at: https://fevir.net/resources/Evidence/179635. Computable resource at: https://fevir.net/resources/Evidence/179635."/>
  </relatedArtifact>
  <relatedArtifact>
    <type value="derived-from"/>
    <resourceReference>🔗 
      <reference value="Citation/179637"/>
      <type value="Citation"/>
      <display
               value="18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal"/>
    </resourceReference>
  </relatedArtifact>
  <description
               value="Dropout due to stopping intervention 18/33 with Lofexidine vs. 12/35 with Placebo in opioid detoxification trial"/>
  <variableDefinition>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
      <valueCode value="population"/>
    </extension>
    <description value="Participants in the opioid detoxification trial"/>
    <note>
      <text value="population"/>
    </note>
    <variableRole>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
        <code value="population"/>
        <display value="population"/>
      </coding>
      <text value="Use extension:variableRoleCode instead."/>
    </variableRole>
  </variableDefinition>
  <variableDefinition>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
      <valueCode value="exposure"/>
    </extension>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category">
      <valueString value="false"/>
    </extension>
    <description value="GroupAssignment: Lofexidine vs. Placebo"/>
    <note>
      <text value="exposure"/>
    </note>
    <variableRole>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
        <code value="exposure"/>
        <display value="exposure"/>
      </coding>
      <text value="Use extension:variableRoleCode instead."/>
    </variableRole>
  </variableDefinition>
  <variableDefinition>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
      <valueCode value="outcome"/>
    </extension>
    <description value="Dropout due to stopping intervention"/>
    <note>
      <text value="outcome"/>
    </note>
    <variableRole>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
        <code value="measuredVariable"/>
        <display value="measured variable"/>
      </coding>
      <text value="Use extension:variableRoleCode instead."/>
    </variableRole>
    <observed>🔗 
      <reference value="EvidenceVariable/179636"/>
      <type value="EvidenceVariable"/>
      <display
               value="PartiicipantFlowMeasure: Dropout due to stopping intervention"/>
    </observed>
  </variableDefinition>
  <statistic>
    <description
                 value="18/33 (54.5%) with Lofexidine vs. 12/35 (34.3%) with Placebo (relative risk 1.59, p &lt; 0.01)"/>
    <statisticType>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/181513"/>
        <code value="STATO:0000245"/>
        <display value="Risk Ratio"/>
      </coding>
    </statisticType>
    <quantity>
      <value value="1.59"/>
    </quantity>
    <numberAffected value="30"/>
    <sampleSize>
      <numberOfParticipants value="68"/>
    </sampleSize>
    <attributeEstimate>
      <description value="p &lt; 0.01"/>
      <type>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/181513"/>
          <code value="TBD:0000076"/>
          <display value="P-value"/>
        </coding>
      </type>
      <quantity>
        <value value="0.01"/>
        <comparator value="&lt;"/>
      </quantity>
    </attributeEstimate>
  </statistic>
</Evidence>