PackagesCanonicalsLogsProblems
    Packages
    hl7.fhir.uv.ebm@1.0.0-ballot2
    http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure
{
  "description": "A variable measured during the study.",
  "_filename": "StructureDefinition-research-study-outcome-measure.json",
  "package_name": "hl7.fhir.uv.ebm",
  "date": "2025-03-28T17:11:38+00:00",
  "derivation": "constraint",
  "publisher": "HL7 International / Clinical Decision Support",
  "fhirVersion": "6.0.0-ballot2",
  "jurisdiction": [ {
    "coding": [ {
      "code": "001",
      "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "display": "World"
    } ]
  } ],
  "name": "ResearchStudyOutcomeMeasure",
  "mapping": [ {
    "uri": "http://hl7.org/v3",
    "name": "RIM Mapping",
    "identity": "rim"
  } ],
  "abstract": false,
  "type": "Extension",
  "experimental": null,
  "resourceType": "StructureDefinition",
  "title": null,
  "package_version": "1.0.0-ballot2",
  "extension": [ {
    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
    "valueCode": "can-bind"
  }, {
    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger": 1
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    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode": "cds"
  }, {
    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode": "draft"
  } ],
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        "human": "All FHIR elements must have a @value or children",
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        "human": "All FHIR elements must have a @value or children",
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        "expression": "hasValue() or (children().count() > id.count())"
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        "max": "1",
        "min": 1,
        "path": "Extension.url"
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      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
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      "path": "Extension.extension.value[x]",
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      "definition": "Label for the outcome measure.",
      "isModifier": false,
      "short": "Label for the outcome measure",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
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      "type": [ {
        "code": "string"
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      "max": "1",
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        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
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        "expression": "hasValue() or (children().count() > id.count())"
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        "code": "Extension"
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      "short": "Unique id for inter-element referencing",
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          "valueUrl": "id"
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        "path": "Element.id"
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        "human": "All FHIR elements must have a @value or children",
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        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
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      "path": "Extension.extension.extension",
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      "definition": "An Extension",
      "isModifier": false,
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      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "type",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
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      "type": [ {
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          "valueUrl": "uri"
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        "max": "1",
        "min": 1,
        "path": "Extension.url"
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    }, {
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        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
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        "expression": "hasValue() or (children().count() > id.count())"
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      "definition": "The kind of outcome measure.",
      "isModifier": false,
      "short": "Primary, secondary, or exploratory",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
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      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "preferred",
        "valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type"
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      "max": "1",
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        "path": "Extension.value[x]"
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    }, {
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        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
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      "path": "Extension.extension",
      "min": 0,
      "definition": "An Extension",
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      "short": "Extension",
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        "min": 0,
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      "short": "Unique id for inter-element referencing",
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        "map": "n/a",
        "identity": "rim"
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        "code": "http://hl7.org/fhirpath/System.String",
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          "valueUrl": "id"
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      "representation": [ "xmlAttr" ],
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        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
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      "path": "Extension.extension.extension",
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      "definition": "An Extension",
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        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
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        "min": 0,
        "path": "Element.extension"
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      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "description",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
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        "code": "http://hl7.org/fhirpath/System.String",
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          "valueUrl": "uri"
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      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
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    }, {
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      "type": [ {
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        "code": "Extension"
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        "max": "*",
        "min": 0,
        "path": "Element.extension"
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      "isModifier": false,
      "short": "Unique id for inter-element referencing",
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        "map": "n/a",
        "identity": "rim"
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        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
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      "isModifier": false,
      "short": "Extension",
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        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
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        "min": 0,
        "path": "Element.extension"
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      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "endpoint",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
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        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
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      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:endpoint.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
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        "max": "1",
        "min": 1,
        "path": "Extension.url"
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      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
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      "path": "Extension.extension.value[x]",
      "min": 0,
      "definition": "Definition of the outcome measure.",
      "isModifier": false,
      "short": "Definition of the outcome measure",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
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      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/EvidenceVariable" ]
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      "max": "1",
      "id": "Extension.extension:endpoint.value[x]",
      "condition": [ "ext-1" ],
      "base": {
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        "path": "Extension.value[x]"
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        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
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      "path": "Extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
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      "sliceName": "population",
      "max": "1",
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      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
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      "isSummary": false
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      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
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      "type": [ {
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        "extension": [ {
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          "valueUrl": "id"
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      "representation": [ "xmlAttr" ],
      "max": "1",
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        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:population.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "population",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:population.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.value[x]",
      "min": 0,
      "definition": "Patients for whom researchers want to estimate the treatment effect.",
      "isModifier": false,
      "short": "Population for this estimand",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ]
      } ],
      "max": "1",
      "id": "Extension.extension:population.value[x]",
      "condition": [ "ext-1" ],
      "comment": "List of key characteristics, such as demographic characteristics (e.g., age, sex) and clinical characteristics (e.g., prior therapies, symptoms, severity, biomarker status)",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "intervention",
      "max": "1",
      "id": "Extension.extension:intervention",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:intervention.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:intervention.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "intervention",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:intervention.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.value[x]",
      "min": 0,
      "definition": "One of the intervention strategies being compared in the treatment effect definition.",
      "isModifier": false,
      "short": "Intervention is the Comparison group of interest",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ]
      } ],
      "max": "1",
      "id": "Extension.extension:intervention.value[x]",
      "condition": [ "ext-1" ],
      "comment": "To do: How to reference internally to the comparisonGroup.id",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "comparator",
      "max": "1",
      "id": "Extension.extension:comparator",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:comparator.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:comparator.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "comparator",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:comparator.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.value[x]",
      "min": 0,
      "definition": "One of the intervention strategies being compared in the treatment effect definition, in the role of comparator.",
      "isModifier": false,
      "short": "Comparator is the Comparison group for comparison",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ]
      } ],
      "max": "1",
      "id": "Extension.extension:comparator.value[x]",
      "condition": [ "ext-1" ],
      "comment": "To do: How to reference internally to the comparisonGroup.id",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "summaryMeasure",
      "max": "1",
      "id": "Extension.extension:summaryMeasure",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:summaryMeasure.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:summaryMeasure.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "summaryMeasure",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:summaryMeasure.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.value[x]",
      "min": 0,
      "definition": "Method used to summarise and compare the endpoint between treatment conditions (eg, risk ratio, odds ratio).",
      "isModifier": false,
      "short": "Statistical measure for treatment effect estimate",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "valueSet": "http://hl7.org/fhir/ValueSet/statistic-type"
      },
      "max": "1",
      "id": "Extension.extension:summaryMeasure.value[x]",
      "condition": [ "ext-1" ],
      "comment": "Description of the population-level summary (e.g., mean difference, relative risk)",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension",
      "min": 0,
      "definition": "Strategies used to handle each intercurrent event in the treatment effect definition; different strategies could be used for different types of intercurrent events.",
      "isModifier": false,
      "short": "Handling of intercurrent event",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "eventHandling",
      "max": "*",
      "id": "Extension.extension:eventHandling",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "isModifier": false,
      "short": "Additional content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "Extension.extension:eventHandling.extension",
      "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "event",
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:event",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:event.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:eventHandling.extension:event.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "event",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:event.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.value[x]",
      "min": 0,
      "definition": "The situation that leads to a change in interpretation of the data.",
      "isModifier": false,
      "short": "the event",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:event.value[x]",
      "condition": [ "ext-1" ],
      "comment": "For each intercurrent event, provide a Description of Intercurrent Event (e.g., permanent discontinuation of trial intervention).",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "group",
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:group",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:group.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:eventHandling.extension:group.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "group",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:group.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.value[x]",
      "min": 0,
      "definition": "The group (intervention group, comparator group, both groups, a subgroup) that receives a change in interpretation of the data.",
      "isModifier": false,
      "short": "the group that is affected by this event handling",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:group.value[x]",
      "condition": [ "ext-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "handling",
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:handling",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:handling.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:eventHandling.extension:handling.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "handling",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:handling.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.value[x]",
      "min": 0,
      "definition": "The method used for interpretation of the data.",
      "isModifier": false,
      "short": "how the data is handled",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:handling.value[x]",
      "condition": [ "ext-1" ],
      "comment": "For each intercurrent event, provide a Description of the strategy to address the intercurrent event (e.g., a treatment policy strategy).",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "type": [ {
        "code": "Extension"
      } ],
      "sliceName": "description",
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:description",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.id",
      "min": 0,
      "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "isModifier": false,
      "short": "Unique id for inter-element referencing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "id"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:description.id",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.extension",
      "min": 0,
      "definition": "An Extension",
      "isModifier": false,
      "short": "Extension",
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "max": "0",
      "id": "Extension.extension:eventHandling.extension:description.extension",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "description",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:description.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.extension.value[x]",
      "min": 0,
      "definition": "The human-readable summary of the handling of an intercurrent event.",
      "isModifier": false,
      "short": "text summary of event handling",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "markdown"
      } ],
      "max": "1",
      "id": "Extension.extension:eventHandling.extension:description.value[x]",
      "condition": [ "ext-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "path": "Extension.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "eventHandling",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.extension:eventHandling.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.extension.value[x]",
      "min": 0,
      "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html) for a list).",
      "isModifier": false,
      "short": "Value of extension",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "base64Binary"
      }, {
        "code": "boolean"
      }, {
        "code": "canonical"
      }, {
        "code": "code"
      }, {
        "code": "date"
      }, {
        "code": "dateTime"
      }, {
        "code": "decimal"
      }, {
        "code": "id"
      }, {
        "code": "instant"
      }, {
        "code": "integer"
      }, {
        "code": "integer64"
      }, {
        "code": "markdown"
      }, {
        "code": "oid"
      }, {
        "code": "positiveInt"
      }, {
        "code": "string"
      }, {
        "code": "time"
      }, {
        "code": "unsignedInt"
      }, {
        "code": "uri"
      }, {
        "code": "url"
      }, {
        "code": "uuid"
      }, {
        "code": "Address"
      }, {
        "code": "Age"
      }, {
        "code": "Annotation"
      }, {
        "code": "Attachment"
      }, {
        "code": "CodeableConcept"
      }, {
        "code": "CodeableReference"
      }, {
        "code": "Coding"
      }, {
        "code": "ContactPoint"
      }, {
        "code": "Count"
      }, {
        "code": "Distance"
      }, {
        "code": "Duration"
      }, {
        "code": "HumanName"
      }, {
        "code": "Identifier"
      }, {
        "code": "Money"
      }, {
        "code": "Period"
      }, {
        "code": "Quantity"
      }, {
        "code": "Range"
      }, {
        "code": "Ratio"
      }, {
        "code": "RatioRange"
      }, {
        "code": "Reference"
      }, {
        "code": "SampledData"
      }, {
        "code": "Signature"
      }, {
        "code": "Timing"
      }, {
        "code": "ContactDetail"
      }, {
        "code": "DataRequirement"
      }, {
        "code": "Expression"
      }, {
        "code": "ParameterDefinition"
      }, {
        "code": "RelatedArtifact"
      }, {
        "code": "TriggerDefinition"
      }, {
        "code": "UsageContext"
      }, {
        "code": "Availability"
      }, {
        "code": "ExtendedContactDetail"
      }, {
        "code": "Dosage"
      }, {
        "code": "Meta"
      } ],
      "max": "0",
      "id": "Extension.extension:eventHandling.value[x]",
      "condition": [ "ext-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    }, {
      "path": "Extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "isModifier": false,
      "short": "identifies the meaning of the extension",
      "fixedUri": "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "http://hl7.org/fhirpath/System.String",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
          "valueUrl": "uri"
        } ]
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "Extension.url",
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      },
      "isSummary": false
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "source": "http://hl7.org/fhir/StructureDefinition/Element",
        "severity": "error",
        "expression": "hasValue() or (children().count() > id.count())"
      } ],
      "path": "Extension.value[x]",
      "min": 0,
      "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html) for a list).",
      "isModifier": false,
      "short": "Value of extension",
      "mapping": [ {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "base64Binary"
      }, {
        "code": "boolean"
      }, {
        "code": "canonical"
      }, {
        "code": "code"
      }, {
        "code": "date"
      }, {
        "code": "dateTime"
      }, {
        "code": "decimal"
      }, {
        "code": "id"
      }, {
        "code": "instant"
      }, {
        "code": "integer"
      }, {
        "code": "integer64"
      }, {
        "code": "markdown"
      }, {
        "code": "oid"
      }, {
        "code": "positiveInt"
      }, {
        "code": "string"
      }, {
        "code": "time"
      }, {
        "code": "unsignedInt"
      }, {
        "code": "uri"
      }, {
        "code": "url"
      }, {
        "code": "uuid"
      }, {
        "code": "Address"
      }, {
        "code": "Age"
      }, {
        "code": "Annotation"
      }, {
        "code": "Attachment"
      }, {
        "code": "CodeableConcept"
      }, {
        "code": "CodeableReference"
      }, {
        "code": "Coding"
      }, {
        "code": "ContactPoint"
      }, {
        "code": "Count"
      }, {
        "code": "Distance"
      }, {
        "code": "Duration"
      }, {
        "code": "HumanName"
      }, {
        "code": "Identifier"
      }, {
        "code": "Money"
      }, {
        "code": "Period"
      }, {
        "code": "Quantity"
      }, {
        "code": "Range"
      }, {
        "code": "Ratio"
      }, {
        "code": "RatioRange"
      }, {
        "code": "Reference"
      }, {
        "code": "SampledData"
      }, {
        "code": "Signature"
      }, {
        "code": "Timing"
      }, {
        "code": "ContactDetail"
      }, {
        "code": "DataRequirement"
      }, {
        "code": "Expression"
      }, {
        "code": "ParameterDefinition"
      }, {
        "code": "RelatedArtifact"
      }, {
        "code": "TriggerDefinition"
      }, {
        "code": "UsageContext"
      }, {
        "code": "Availability"
      }, {
        "code": "ExtendedContactDetail"
      }, {
        "code": "Dosage"
      }, {
        "code": "Meta"
      } ],
      "max": "0",
      "id": "Extension.value[x]",
      "condition": [ "ext-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      },
      "isSummary": false
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
      "valueString": "6.0.0-ballot2"
    } ]
  },
  "status": "draft",
  "id": "310e5631-265e-43bc-9ce0-02c243e34928",
  "kind": "complex-type",
  "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure",
  "identifier": [ {
    "value": "urn:oid:2.16.840.1.113883.4.642.40.44.42.92",
    "system": "urn:ietf:rfc:3986"
  } ],
  "context": [ {
    "type": "element",
    "expression": "ResearchStudy.objective"
  } ],
  "version": "1.0.0-ballot2",
  "differential": {
    "element": [ {
      "id": "Extension",
      "path": "Extension",
      "short": "A variable measured during the study",
      "definition": "An outcome measure, endpoint, effect measure or measure of effect is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment."
    }, {
      "id": "Extension.extension",
      "min": 1,
      "path": "Extension.extension"
    }, {
      "id": "Extension.extension:name",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "sliceName": "name"
    }, {
      "id": "Extension.extension:name.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:name.url",
      "path": "Extension.extension.url",
      "fixedUri": "name"
    }, {
      "id": "Extension.extension:name.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "string"
      } ],
      "short": "Label for the outcome measure",
      "definition": "Label for the outcome measure."
    }, {
      "id": "Extension.extension:type",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "sliceName": "type"
    }, {
      "id": "Extension.extension:type.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:type.url",
      "path": "Extension.extension.url",
      "fixedUri": "type"
    }, {
      "id": "Extension.extension:type.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "short": "Primary, secondary, or exploratory",
      "binding": {
        "strength": "preferred",
        "valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type"
      },
      "definition": "The kind of outcome measure."
    }, {
      "id": "Extension.extension:description",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "sliceName": "description"
    }, {
      "id": "Extension.extension:description.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:description.url",
      "path": "Extension.extension.url",
      "fixedUri": "description"
    }, {
      "id": "Extension.extension:description.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "markdown"
      } ],
      "short": "Description of the outcome measure",
      "definition": "Description of the outcome measure."
    }, {
      "id": "Extension.extension:endpoint",
      "max": "1",
      "min": 1,
      "path": "Extension.extension",
      "sliceName": "endpoint"
    }, {
      "id": "Extension.extension:endpoint.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:endpoint.url",
      "path": "Extension.extension.url",
      "fixedUri": "endpoint"
    }, {
      "id": "Extension.extension:endpoint.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/EvidenceVariable" ]
      } ],
      "short": "Definition of the outcome measure",
      "definition": "Definition of the outcome measure."
    }, {
      "id": "Extension.extension:population",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "sliceName": "population"
    }, {
      "id": "Extension.extension:population.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:population.url",
      "path": "Extension.extension.url",
      "fixedUri": "population"
    }, {
      "id": "Extension.extension:population.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ]
      } ],
      "short": "Population for this estimand",
      "comment": "List of key characteristics, such as demographic characteristics (e.g., age, sex) and clinical characteristics (e.g., prior therapies, symptoms, severity, biomarker status)",
      "definition": "Patients for whom researchers want to estimate the treatment effect."
    }, {
      "id": "Extension.extension:intervention",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "sliceName": "intervention"
    }, {
      "id": "Extension.extension:intervention.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:intervention.url",
      "path": "Extension.extension.url",
      "fixedUri": "intervention"
    }, {
      "id": "Extension.extension:intervention.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ]
      } ],
      "short": "Intervention is the Comparison group of interest",
      "comment": "To do: How to reference internally to the comparisonGroup.id",
      "definition": "One of the intervention strategies being compared in the treatment effect definition."
    }, {
      "id": "Extension.extension:comparator",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "sliceName": "comparator"
    }, {
      "id": "Extension.extension:comparator.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:comparator.url",
      "path": "Extension.extension.url",
      "fixedUri": "comparator"
    }, {
      "id": "Extension.extension:comparator.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ]
      } ],
      "short": "Comparator is the Comparison group for comparison",
      "comment": "To do: How to reference internally to the comparisonGroup.id",
      "definition": "One of the intervention strategies being compared in the treatment effect definition, in the role of comparator."
    }, {
      "id": "Extension.extension:summaryMeasure",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "sliceName": "summaryMeasure"
    }, {
      "id": "Extension.extension:summaryMeasure.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:summaryMeasure.url",
      "path": "Extension.extension.url",
      "fixedUri": "summaryMeasure"
    }, {
      "id": "Extension.extension:summaryMeasure.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "short": "Statistical measure for treatment effect estimate",
      "binding": {
        "strength": "extensible",
        "valueSet": "http://hl7.org/fhir/ValueSet/statistic-type"
      },
      "comment": "Description of the population-level summary (e.g., mean difference, relative risk)",
      "definition": "Method used to summarise and compare the endpoint between treatment conditions (eg, risk ratio, odds ratio)."
    }, {
      "id": "Extension.extension:eventHandling",
      "max": "*",
      "min": 0,
      "path": "Extension.extension",
      "short": "Handling of intercurrent event",
      "sliceName": "eventHandling",
      "definition": "Strategies used to handle each intercurrent event in the treatment effect definition; different strategies could be used for different types of intercurrent events."
    }, {
      "id": "Extension.extension:eventHandling.extension:event",
      "max": "1",
      "min": 0,
      "path": "Extension.extension.extension",
      "sliceName": "event"
    }, {
      "id": "Extension.extension:eventHandling.extension:event.extension",
      "max": "0",
      "path": "Extension.extension.extension.extension"
    }, {
      "id": "Extension.extension:eventHandling.extension:event.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "event"
    }, {
      "id": "Extension.extension:eventHandling.extension:event.value[x]",
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "short": "the event",
      "comment": "For each intercurrent event, provide a Description of Intercurrent Event (e.g., permanent discontinuation of trial intervention).",
      "definition": "The situation that leads to a change in interpretation of the data."
    }, {
      "id": "Extension.extension:eventHandling.extension:group",
      "max": "1",
      "min": 0,
      "path": "Extension.extension.extension",
      "sliceName": "group"
    }, {
      "id": "Extension.extension:eventHandling.extension:group.extension",
      "max": "0",
      "path": "Extension.extension.extension.extension"
    }, {
      "id": "Extension.extension:eventHandling.extension:group.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "group"
    }, {
      "id": "Extension.extension:eventHandling.extension:group.value[x]",
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "short": "the group that is affected by this event handling",
      "definition": "The group (intervention group, comparator group, both groups, a subgroup) that receives a change in interpretation of the data."
    }, {
      "id": "Extension.extension:eventHandling.extension:handling",
      "max": "1",
      "min": 0,
      "path": "Extension.extension.extension",
      "sliceName": "handling"
    }, {
      "id": "Extension.extension:eventHandling.extension:handling.extension",
      "max": "0",
      "path": "Extension.extension.extension.extension"
    }, {
      "id": "Extension.extension:eventHandling.extension:handling.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "handling"
    }, {
      "id": "Extension.extension:eventHandling.extension:handling.value[x]",
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "short": "how the data is handled",
      "comment": "For each intercurrent event, provide a Description of the strategy to address the intercurrent event (e.g., a treatment policy strategy).",
      "definition": "The method used for interpretation of the data."
    }, {
      "id": "Extension.extension:eventHandling.extension:description",
      "max": "1",
      "min": 0,
      "path": "Extension.extension.extension",
      "sliceName": "description"
    }, {
      "id": "Extension.extension:eventHandling.extension:description.extension",
      "max": "0",
      "path": "Extension.extension.extension.extension"
    }, {
      "id": "Extension.extension:eventHandling.extension:description.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "description"
    }, {
      "id": "Extension.extension:eventHandling.extension:description.value[x]",
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "markdown"
      } ],
      "short": "text summary of event handling",
      "definition": "The human-readable summary of the handling of an intercurrent event."
    }, {
      "id": "Extension.extension:eventHandling.url",
      "path": "Extension.extension.url",
      "fixedUri": "eventHandling"
    }, {
      "id": "Extension.extension:eventHandling.value[x]",
      "max": "0",
      "path": "Extension.extension.value[x]"
    }, {
      "id": "Extension.url",
      "path": "Extension.url",
      "fixedUri": "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"
    }, {
      "id": "Extension.value[x]",
      "max": "0",
      "path": "Extension.value[x]"
    } ]
  },
  "contact": [ {
    "name": "HL7 International / Clinical Decision Support",
    "telecom": [ {
      "value": "http://www.hl7.org/Special/committees/dss",
      "system": "url"
    } ]
  } ],
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}