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

Raw json | Download

{
  "resourceType" : "EvidenceVariable",
  "id" : "mii-exa-studie-ein-auschluss-kriterium",
  "meta" : {
    "profile" : [
      🔗 "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-ein-auschluss-kriterium"
    ],
    "security" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
        "code" : "HTEST",
        "display" : "test health data"
      }
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<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>"
  },
  "status" : "active",
  "characteristic" : [
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionReference",
          "valueReference" : {
            🔗 "reference" : "EvidenceVariable/mii-exa-studie-evidence-variable-age-restriction"
          }
        }
      ],
      "description" : "Altersbeschränkung",
      "definitionCodeableConcept" : {
        "text" : "Altersbeschränkung"
      }
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionCanonical",
          "valueCanonical" : "https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender"
        }
      ],
      "description" : "Geschlecht",
      "definitionCodeableConcept" : {
        "text" : "Alle"
      },
      "exclude" : false
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId",
          "valueId" : "aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"
        }
      ],
      "description" : "Kognitive Fatigue (WeiMUS kognitive Skala >= 17)",
      "definitionCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }
        ]
      },
      "exclude" : false
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId",
          "valueId" : "8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"
        }
      ],
      "description" : "Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt",
      "definitionCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }
        ]
      },
      "exclude" : false
    },
    {
      "extension" : [
        {
          "extension" : [
            {
              "url" : "code",
              "valueCode" : "any-of"
            },
            {
              "url" : "characteristic",
              "valueId" : "aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"
            },
            {
              "url" : "characteristic",
              "valueId" : "8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"
            }
          ],
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByCombination"
        }
      ],
      "description" : "Weitere Einschlusskriterien",
      "definitionCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }
        ]
      },
      "exclude" : false
    },
    {
      "description" : "diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen",
      "definitionCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }
        ]
      },
      "exclude" : true
    },
    {
      "description" : "Einnahme von Antidepressiva, Opioiden, Antikonvulsiva",
      "definitionCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }
        ]
      },
      "exclude" : true
    },
    {
      "description" : "weitere neurologische Erkrankungen",
      "definitionCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }
        ]
      },
      "exclude" : true
    },
    {
      "extension" : [
        {
          "extension" : [
            {
              "url" : "type",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://snomed.info/sct",
                    "code" : "424144002",
                    "display" : "Current chronological age"
                  }
                ]
              }
            },
            {
              "url" : "value",
              "valueQuantity" : {
                "value" : 18,
                "comparator" : ">=",
                "unit" : "year",
                "system" : "http://unitsofmeasure.org",
                "code" : "a"
              }
            }
          ],
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByTypeAndValue"
        }
      ],
      "description" : "Alter mindestens 18 Jahre",
      "definitionCodeableConcept" : {
        "text" : "Mindestalter"
      },
      "exclude" : false
    }
  ]
}