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

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

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

Active as of 2023-12-17

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Evidence ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "179635"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "4" ] ;
fhir:lastUpdated [ fhir:v "2023-12-03T09:56:07.995Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-participant-flow"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-participant-flow>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Evidence</b><a name=\"179635\"> </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\">Resource Evidence &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>StructureDefinition Work Group</b>: cds</p><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>: 2023-12-17 16:55:23+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: https://fevir.net/resources/CodeSystem/179423 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/5.3.0/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/5.3.0/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/5.3.0/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>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "cds" ]
  ] ) ; # 
  fhir:url [ fhir:v "https://fevir.net/resources/Evidence/179635"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACSN" ] ;
fhir:display [ fhir:v "Accession ID" ]       ] ) ;
fhir:text [ fhir:v "FEvIR Object Identifier" ]     ] ;
fhir:system [ fhir:v "https://fevir.net"^^xsd:anyURI ] ;
fhir:value [ fhir:v "179635" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0.0-ballot"] ; # 
  fhir:name [ fhir:v "ComparativeParticipantFlow_Dropout_due_to_stopping_intervention_Lofexidine_vs_Placebo_in_opioid_detoxification_trial"] ; # 
  fhir:title [ fhir:v "ComparativeParticipantFlow: Dropout due to stopping intervention Lofexidine vs. Placebo in opioid detoxification trial"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:date [ fhir:v "2023-12-17T16:55:23+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Clinical Decision Support" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/dss" ]     ] )
  ] ) ; # 
  fhir:author ( [
fhir:name [ fhir:v "Brian S. Alper" ]
  ] ) ; # 
  fhir:useContext ( [
fhir:code [
fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ] ;
fhir:code [ fhir:v "evidence-communication" ] ;
fhir:display [ fhir:v "Evidence Communication" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ComparativeParticipantFlow" ] ;
fhir:display [ fhir:v "ComparativeParticipantFlow" ]       ] )     ]
  ] ) ; # 
  fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # 
  fhir:relatedArtifact ( [
fhir:type [ fhir:v "cite-as" ] ;
fhir:citation [ fhir:v "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." ]
  ] [
fhir:type [ fhir:v "derived-from" ] ;
fhir:resourceReference [
fhir:reference [ fhir:v "Citation/179637" ] ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:display [ fhir:v "18508207 A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal" ]     ]
  ] ) ; # 
  fhir:description [ fhir:v "Dropout due to stopping intervention 18/33 with Lofexidine vs. 12/35 with Placebo in opioid detoxification trial"] ; # 
  fhir:variableDefinition ( [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code"^^xsd:anyURI ] ;
fhir:value [ fhir:v "population" ]     ] ) ;
fhir:description [ fhir:v "Participants in the opioid detoxification trial" ] ;
    ( fhir:note [
fhir:text [ fhir:v "population" ]     ] ) ;
fhir:variableRole [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/variable-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "population" ] ;
fhir:display [ fhir:v "population" ]       ] ) ;
fhir:text [ fhir:v "Use extension:variableRoleCode instead." ]     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code"^^xsd:anyURI ] ;
fhir:value [ fhir:v "exposure" ]     ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false" ]     ] ) ;
fhir:description [ fhir:v "GroupAssignment: Lofexidine vs. Placebo" ] ;
    ( fhir:note [
fhir:text [ fhir:v "exposure" ]     ] ) ;
fhir:variableRole [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/variable-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "exposure" ] ;
fhir:display [ fhir:v "exposure" ]       ] ) ;
fhir:text [ fhir:v "Use extension:variableRoleCode instead." ]     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code"^^xsd:anyURI ] ;
fhir:value [ fhir:v "outcome" ]     ] ) ;
fhir:description [ fhir:v "Dropout due to stopping intervention" ] ;
    ( fhir:note [
fhir:text [ fhir:v "outcome" ]     ] ) ;
fhir:variableRole [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/variable-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "measuredVariable" ] ;
fhir:display [ fhir:v "measured variable" ]       ] ) ;
fhir:text [ fhir:v "Use extension:variableRoleCode instead." ]     ] ;
fhir:observed [
fhir:reference [ fhir:v "EvidenceVariable/179636" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "PartiicipantFlowMeasure: Dropout due to stopping intervention" ]     ]
  ] ) ; # 
  fhir:statistic ( [
fhir:description [ fhir:v "18/33 (54.5%) with Lofexidine vs. 12/35 (34.3%) with Placebo (relative risk 1.59, p < 0.01)" ] ;
fhir:statisticType [
      ( fhir:coding [
fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ;
fhir:code [ fhir:v "STATO:0000245" ] ;
fhir:display [ fhir:v "Risk Ratio" ]       ] )     ] ;
fhir:quantity [
fhir:value [ fhir:v "1.59"^^xsd:decimal ]     ] ;
fhir:numberAffected [ fhir:v "30"^^xsd:nonNegativeInteger ] ;
fhir:sampleSize [
fhir:numberOfParticipants [ fhir:v "68"^^xsd:nonNegativeInteger ]     ] ;
    ( fhir:attributeEstimate [
fhir:description [ fhir:v "p < 0.01" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ;
fhir:code [ fhir:v "TBD:0000076" ] ;
fhir:display [ fhir:v "P-value" ]         ] )       ] ;
fhir:quantity [
fhir:value [ fhir:v "0.01"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<" ]       ]     ] )
  ] ) . #