EvidenceVariable

Description

We adapted the EvidenceVariable resource and created two profiles to collect information about the intervention or exposure in a study.

Title Canonical
NFDI4Health_PR_MDS_Evidence_Variable_Exposure https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-evidence-variable-exposure
NFDI4Health_PR_MDS_Evidence_Variable_Intervention https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-evidence-variable-intervention

References

Reference direction Title Path
referenced by NFDI4Health PR MDS Study ResearchStudy.extension[comparisonGroup].extension[intendedExposure]

Intervention

idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
urlΣ0..1uri
identifierΣ0..*Identifier
versionΣ0..1string
nameΣ I0..1string
titleΣ1..1string
shortTitleΣ0..1string
subtitle0..1string
statusΣ ?!1..1codeBinding
dateΣ0..1dateTime
publisherΣ0..1string
contactΣ0..*ContactDetail
descriptionΣ0..1markdown
note0..*Annotation
useContextΣ0..*UsageContext
jurisdictionΣ0..*CodeableConceptBinding
copyright0..1markdown
approvalDate0..1date
lastReviewDate0..1date
effectivePeriodΣ I0..1Period
topic0..*CodeableConcept
author0..*ContactDetail
editor0..*ContactDetail
reviewer0..*ContactDetail
endorser0..*ContactDetail
relatedArtifact0..*RelatedArtifact
typeΣ0..1codeBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
description0..1string
definitionCanonicalcanonical(ActivityDefinition)
definitionExpressionExpression
definitionDataRequirementDataRequirement
definitionTriggerDefinitionTriggerDefinition
definitionReferenceReference(Group)
definitionCodeableConceptΣ1..1CodeableConceptBinding
usageContext0..*UsageContext
exclude0..1boolean
participantEffectiveDateTimedateTime
participantEffectivePeriodPeriod
participantEffectiveDurationDuration
participantEffectiveTimingTiming
timeFromStartI0..1Duration
groupMeasure0..1codeBinding
idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
urlΣ0..1uri
identifierΣ0..*Identifier
versionΣ0..1string
nameΣ I0..1string
titleΣ1..1string
shortTitleΣ0..1string
subtitle0..1string
statusΣ ?!1..1codeBinding
dateΣ0..1dateTime
publisherΣ0..1string
contactΣ0..*ContactDetail
descriptionΣ0..1markdown
note0..*Annotation
useContextΣ0..*UsageContext
jurisdictionΣ0..*CodeableConceptBinding
copyright0..1markdown
approvalDate0..1date
lastReviewDate0..1date
effectivePeriodΣ I0..1Period
topic0..*CodeableConcept
author0..*ContactDetail
editor0..*ContactDetail
reviewer0..*ContactDetail
endorser0..*ContactDetail
relatedArtifact0..*RelatedArtifact
typeΣ0..1codeBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
description0..1string
definitionCanonicalcanonical(ActivityDefinition)
definitionExpressionExpression
definitionDataRequirementDataRequirement
definitionTriggerDefinitionTriggerDefinition
definitionReferenceReference(Group)
definitionCodeableConceptΣ1..1CodeableConceptBinding
usageContext0..*UsageContext
exclude0..1boolean
participantEffectiveDateTimedateTime
participantEffectivePeriodPeriod
participantEffectiveDurationDuration
participantEffectiveTimingTiming
timeFromStartI0..1Duration
groupMeasure0..1codeBinding
idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
urlΣ0..1uri
identifierΣ0..*Identifier
versionΣ0..1string
nameΣ I0..1string
titleΣ1..1string
shortTitleΣ0..1string
subtitle0..1string
statusΣ ?!1..1codeBinding
dateΣ0..1dateTime
publisherΣ0..1string
contactΣ0..*ContactDetail
descriptionΣ0..1markdown
note0..*Annotation
useContextΣ0..*UsageContext
jurisdictionΣ0..*CodeableConceptBinding
copyright0..1markdown
approvalDate0..1date
lastReviewDate0..1date
effectivePeriodΣ I0..1Period
topic0..*CodeableConcept
author0..*ContactDetail
editor0..*ContactDetail
reviewer0..*ContactDetail
endorser0..*ContactDetail
relatedArtifact0..*RelatedArtifact
typeΣ0..1codeBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
description0..1string
definitionCanonicalcanonical(ActivityDefinition)
definitionExpressionExpression
definitionDataRequirementDataRequirement
definitionTriggerDefinitionTriggerDefinition
definitionReferenceReference(Group)
definitionCodeableConceptΣ1..1CodeableConceptBinding
usageContext0..*UsageContext
exclude0..1boolean
participantEffectiveDateTimedateTime
participantEffectivePeriodPeriod
participantEffectiveDurationDuration
participantEffectiveTimingTiming
timeFromStartI0..1Duration
groupMeasure0..1codeBinding
{
    "resourceType": "StructureDefinition",
    "id": "nfdi4health-pr-mds-evidence-variable-intervention",
    "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-evidence-variable-intervention",
    "version": "0.9",
    "name": "NFDI4Health_PR_MDS_Evidence_Variable_Intervention",
    "title": "NFDI4Health PR MDS Evidence Variable Intervention",
    "status": "draft",
    "publisher": "NFDI4Health",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.nfdi4health.de"
                }
            ]
        }
    ],
    "description": "Information about the intervention or in a study.",
    "fhirVersion": "4.0.1",
    "mapping":  [
        {
            "identity": "workflow",
            "uri": "http://hl7.org/fhir/workflow",
            "name": "Workflow Pattern"
        },
        {
            "identity": "w5",
            "uri": "http://hl7.org/fhir/fivews",
            "name": "FiveWs Pattern Mapping"
        },
        {
            "identity": "objimpl",
            "uri": "http://hl7.org/fhir/object-implementation",
            "name": "Object Implementation Information"
        },
        {
            "identity": "rim",
            "uri": "http://hl7.org/v3",
            "name": "RIM Mapping"
        },
        {
            "identity": "NFDI4Health",
            "name": "NFDI4Health to FHIR Mapping"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "EvidenceVariable",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/EvidenceVariable",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "EvidenceVariable",
                "path": "EvidenceVariable",
                "short": "Interventions of the [RESOURCE]",
                "definition": "\nGroup of items providing information about the interventions of the [RESOURCE].",
                "comment": "Additional information: \nSpecification of the intervention(s) associated with each arm.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.interventions"
                    }
                ]
            },
            {
                "id": "EvidenceVariable.title",
                "path": "EvidenceVariable.title",
                "short": "Name of the intervention",
                "definition": "A short descriptive name of the intervention.",
                "comment": "If the same intervention is associated with more than one arm, please provide the information once and use the field 'Name(s) of the arm(s) associated with the given intervention' to associate it with more than one arm.",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.interventions.name"
                    }
                ]
            },
            {
                "id": "EvidenceVariable.description",
                "path": "EvidenceVariable.description",
                "short": "Additional information about the intervention",
                "definition": "If needed, additional descriptive information about the given intervention.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.interventions.description"
                    }
                ]
            },
            {
                "id": "EvidenceVariable.characteristic.definition[x]",
                "path": "EvidenceVariable.characteristic.definition[x]",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "type",
                            "path": "$this"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                }
            },
            {
                "id": "EvidenceVariable.characteristic.definition[x]:definitionCodeableConcept",
                "path": "EvidenceVariable.characteristic.definition[x]",
                "sliceName": "definitionCodeableConcept",
                "short": "Type of the intervention",
                "definition": "General type of the given intervention.",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-intervention-type-nci",
                    "description": "Value set defining codes to specify the general type of the given intervention in the study."
                },
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.interventions.type"
                    }
                ]
            }
        ]
    }
}


Exposure

idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
urlΣ0..1uri
identifierΣ0..*Identifier
versionΣ0..1string
nameΣ I0..1string
titleΣ1..1string
shortTitleΣ0..1string
subtitle0..1string
statusΣ ?!1..1codeBinding
dateΣ0..1dateTime
publisherΣ0..1string
contactΣ0..*ContactDetail
descriptionΣ0..1markdown
note0..*Annotation
useContextΣ0..*UsageContext
jurisdictionΣ0..*CodeableConceptBinding
copyright0..1markdown
approvalDate0..1date
lastReviewDate0..1date
effectivePeriodΣ I0..1Period
topic0..*CodeableConcept
author0..*ContactDetail
editor0..*ContactDetail
reviewer0..*ContactDetail
endorser0..*ContactDetail
relatedArtifact0..*RelatedArtifact
typeΣ0..1codeBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
description0..1string
definitionCanonicalcanonical(ActivityDefinition)
definitionExpressionExpression
definitionDataRequirementDataRequirement
definitionTriggerDefinitionTriggerDefinition
definitionReferenceReference(Group)
definitionCodeableConceptΣ1..1CodeableConceptBinding
usageContext0..*UsageContext
exclude0..1boolean
participantEffectiveDateTimedateTime
participantEffectivePeriodPeriod
participantEffectiveDurationDuration
participantEffectiveTimingTiming
timeFromStartI0..1Duration
groupMeasure0..1codeBinding
idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
urlΣ0..1uri
identifierΣ0..*Identifier
versionΣ0..1string
nameΣ I0..1string
titleΣ1..1string
shortTitleΣ0..1string
subtitle0..1string
statusΣ ?!1..1codeBinding
dateΣ0..1dateTime
publisherΣ0..1string
contactΣ0..*ContactDetail
descriptionΣ0..1markdown
note0..*Annotation
useContextΣ0..*UsageContext
jurisdictionΣ0..*CodeableConceptBinding
copyright0..1markdown
approvalDate0..1date
lastReviewDate0..1date
effectivePeriodΣ I0..1Period
topic0..*CodeableConcept
author0..*ContactDetail
editor0..*ContactDetail
reviewer0..*ContactDetail
endorser0..*ContactDetail
relatedArtifact0..*RelatedArtifact
typeΣ0..1codeBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
description0..1string
definitionCanonicalcanonical(ActivityDefinition)
definitionExpressionExpression
definitionDataRequirementDataRequirement
definitionTriggerDefinitionTriggerDefinition
definitionReferenceReference(Group)
definitionCodeableConceptΣ1..1CodeableConceptBinding
usageContext0..*UsageContext
exclude0..1boolean
participantEffectiveDateTimedateTime
participantEffectivePeriodPeriod
participantEffectiveDurationDuration
participantEffectiveTimingTiming
timeFromStartI0..1Duration
groupMeasure0..1codeBinding
idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
urlΣ0..1uri
identifierΣ0..*Identifier
versionΣ0..1string
nameΣ I0..1string
titleΣ1..1string
shortTitleΣ0..1string
subtitle0..1string
statusΣ ?!1..1codeBinding
dateΣ0..1dateTime
publisherΣ0..1string
contactΣ0..*ContactDetail
descriptionΣ0..1markdown
note0..*Annotation
useContextΣ0..*UsageContext
jurisdictionΣ0..*CodeableConceptBinding
copyright0..1markdown
approvalDate0..1date
lastReviewDate0..1date
effectivePeriodΣ I0..1Period
topic0..*CodeableConcept
author0..*ContactDetail
editor0..*ContactDetail
reviewer0..*ContactDetail
endorser0..*ContactDetail
relatedArtifact0..*RelatedArtifact
typeΣ0..1codeBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
description0..1string
definitionCanonicalcanonical(ActivityDefinition)
definitionExpressionExpression
definitionDataRequirementDataRequirement
definitionTriggerDefinitionTriggerDefinition
definitionReferenceReference(Group)
definitionCodeableConceptΣ1..1CodeableConceptBinding
usageContext0..*UsageContext
exclude0..1boolean
participantEffectiveDateTimedateTime
participantEffectivePeriodPeriod
participantEffectiveDurationDuration
participantEffectiveTimingTiming
timeFromStartI0..1Duration
groupMeasure0..1codeBinding
{
    "resourceType": "StructureDefinition",
    "id": "nfdi4health-pr-mds-evidence-variable-exposure",
    "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-evidence-variable-exposure",
    "version": "0.9",
    "name": "NFDI4Health_PR_MDS_Evidence_Variable_Exposure",
    "title": "NFDI4Health PR MDS Evidence Variable Exposure",
    "status": "draft",
    "publisher": "NFDI4Health",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.nfdi4health.de"
                }
            ]
        }
    ],
    "description": "Information about the exposure in a study.",
    "fhirVersion": "4.0.1",
    "mapping":  [
        {
            "identity": "workflow",
            "uri": "http://hl7.org/fhir/workflow",
            "name": "Workflow Pattern"
        },
        {
            "identity": "w5",
            "uri": "http://hl7.org/fhir/fivews",
            "name": "FiveWs Pattern Mapping"
        },
        {
            "identity": "objimpl",
            "uri": "http://hl7.org/fhir/object-implementation",
            "name": "Object Implementation Information"
        },
        {
            "identity": "rim",
            "uri": "http://hl7.org/v3",
            "name": "RIM Mapping"
        },
        {
            "identity": "NFDI4Health",
            "name": "NFDI4Health to FHIR Mapping"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "EvidenceVariable",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/EvidenceVariable",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "EvidenceVariable",
                "path": "EvidenceVariable",
                "short": "Design.exposures: Exposures of the [RESOURCE]",
                "definition": "Group of items providing information about the exposures of the [RESOURCE].",
                "comment": "Specification of the exposure(s) associated with each group.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.exposures"
                    }
                ]
            },
            {
                "id": "EvidenceVariable.title",
                "path": "EvidenceVariable.title",
                "short": "Name of the exposure",
                "definition": "A short descriptive name of the exposure.",
                "comment": "If the same exposure is associated with more than one group, please provide the information once and use the field 'Name(s) of the group(s) associated with the given exposure' to associate it with more than one group.",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.exposures.name"
                    }
                ]
            },
            {
                "id": "EvidenceVariable.description",
                "path": "EvidenceVariable.description",
                "short": "Additional information about the exposure",
                "definition": "If needed, additional descriptive information about the given exposure.",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.exposures.description"
                    }
                ]
            },
            {
                "id": "EvidenceVariable.characteristic.definition[x]",
                "path": "EvidenceVariable.characteristic.definition[x]",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "type",
                            "path": "$this"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                }
            },
            {
                "id": "EvidenceVariable.characteristic.definition[x]:definitionCodeableConcept",
                "path": "EvidenceVariable.characteristic.definition[x]",
                "sliceName": "definitionCodeableConcept",
                "short": "Design.exposures.type: Type of the exposure",
                "definition": "Design.exposures.type: General type of the given exposure.",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-exposure-type-nci",
                    "description": "Value set defining codes to specify the general type of the given intervention/exposure in the study."
                },
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.exposures.type"
                    }
                ]
            }
        ]
    }
}

Example

Example data for NFDI4Health PR MDS Evidence Variable used to represent an intervention in an interventional study.


Example of NFDI4Health PR MDS Evidence Variable representing the intervention in the interventional study Sport & Long-COVID-Syndrome (SPOVID)
InstanceOfEvidenceVariableSPOVID