MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

This page is part of the MII Implementation Guide Medizinisches Forschungsvorhaben (v2027.0.0-ballot: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

: mii-exa-studie-ein-auschluss-kriterium

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<EvidenceVariable xmlns="http://hl7.org/fhir">
  <id value="mii-exa-studie-ein-auschluss-kriterium"/>
  <meta>
    <profile
             value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-ein-auschluss-kriterium"/>
    <security>
      <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
      <code value="HTEST"/>
      <display value="test health data"/>
    </security>
  </meta>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xml:lang="en" lang="en"><hr/><p><b>English</b></p><hr/><p class="res-header-id"><b>Generated Narrative: EvidenceVariable mii-exa-studie-ein-auschluss-kriterium</b></p><a name="en-mii-exa-studie-ein-auschluss-kriterium"> </a><a name="en-hcmii-exa-studie-ein-auschluss-kriterium"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-mii-pr-studie-ein-auschluss-kriterium.html">MII PR Studie EinAuschlussKriterium</a></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>status</b>: Active</p><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport definitionReference</b>: <a href="EvidenceVariable-mii-exa-studie-evidence-variable-age-restriction.html">EvidenceVariable: status = active</a></p><p><b>description</b>: Altersbeschränkung</p><p><b>definition</b>: <span title="Codes:">Altersbeschränkung</span></p></blockquote><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport definitionCanonical</b>: <code>https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender</code></p><p><b>description</b>: Geschlecht</p><p><b>definition</b>: <span title="Codes:">Alle</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport linkId</b>: aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2</p><p><b>description</b>: Kognitive Fatigue (WeiMUS kognitive Skala &gt;= 17)</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport linkId</b>: 8e8f63ff-65f1-40cd-bf79-da83d7fb4e09</p><p><b>description</b>: Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><blockquote><p><b>MII EX Studie Backport DefinitionByCombination</b></p><ul><li>code: any-of</li><li>characteristic: aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2</li><li>characteristic: 8e8f63ff-65f1-40cd-bf79-da83d7fb4e09</li></ul></blockquote><p><b>description</b>: Weitere Einschlusskriterien</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>description</b>: diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>description</b>: Einnahme von Antidepressiva, Opioiden, Antikonvulsiva</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>description</b>: weitere neurologische Erkrankungen</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><blockquote><p><b>MII EX Studie Backport DefinitionByTypeAndValue</b></p><ul><li>type: <span title="Codes:{http://snomed.info/sct 424144002}">Current chronological age</span></li><li>value: &gt;=18 year<span style="background: LightGoldenRodYellow"> (Details: UCUM  codea = 'a')</span></li></ul></blockquote><p><b>description</b>: Alter mindestens 18 Jahre</p><p><b>definition</b>: <span title="Codes:">Mindestalter</span></p><p><b>exclude</b>: false</p></blockquote></div>
  </text>
  <status value="active"/>
  <characteristic>
    <extension
               url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionReference">
      <valueReference>🔗 
        <reference
                   value="EvidenceVariable/mii-exa-studie-evidence-variable-age-restriction"/>
      </valueReference>
    </extension>
    <description value="Altersbeschränkung"/>
    <definitionCodeableConcept>
      <text value="Altersbeschränkung"/>
    </definitionCodeableConcept>
  </characteristic>
  <characteristic>
    <extension
               url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionCanonical">
      <valueCanonical
                      value="https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender"/>
    </extension>
    <description value="Geschlecht"/>
    <definitionCodeableConcept>
      <text value="Alle"/>
    </definitionCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic>
    <extension
               url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId">
      <valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/>
    </extension>
    <description value="Kognitive Fatigue (WeiMUS kognitive Skala &gt;= 17)"/>
    <definitionCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
        <code value="unknown"/>
      </coding>
    </definitionCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic>
    <extension
               url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId">
      <valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/>
    </extension>
    <description
                 value="Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt"/>
    <definitionCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
        <code value="unknown"/>
      </coding>
    </definitionCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic>
    <extension
               url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByCombination">
      <extension url="code">
        <valueCode value="any-of"/>
      </extension>
      <extension url="characteristic">
        <valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/>
      </extension>
      <extension url="characteristic">
        <valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/>
      </extension>
    </extension>
    <description value="Weitere Einschlusskriterien"/>
    <definitionCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
        <code value="unknown"/>
      </coding>
    </definitionCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic>
    <description
                 value="diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen"/>
    <definitionCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
        <code value="unknown"/>
      </coding>
    </definitionCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <description
                 value="Einnahme von Antidepressiva, Opioiden, Antikonvulsiva"/>
    <definitionCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
        <code value="unknown"/>
      </coding>
    </definitionCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <description value="weitere neurologische Erkrankungen"/>
    <definitionCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
        <code value="unknown"/>
      </coding>
    </definitionCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <extension
               url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByTypeAndValue">
      <extension url="type">
        <valueCodeableConcept>
          <coding>
            <system value="http://snomed.info/sct"/>
            <code value="424144002"/>
            <display value="Current chronological age"/>
          </coding>
        </valueCodeableConcept>
      </extension>
      <extension url="value">
        <valueQuantity>
          <value value="18"/>
          <comparator value="&gt;="/>
          <unit value="year"/>
          <system value="http://unitsofmeasure.org"/>
          <code value="a"/>
        </valueQuantity>
      </extension>
    </extension>
    <description value="Alter mindestens 18 Jahre"/>
    <definitionCodeableConcept>
      <text value="Mindestalter"/>
    </definitionCodeableConcept>
    <exclude value="false"/>
  </characteristic>
</EvidenceVariable>