MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

MII Implementation Guide Medizinisches Forschungsvorhaben - Downloaded Version 2027.0.0-ballot See the Directory of published versions

Ressourcenprofil: MII PR Studie EinAuschlussKriterium - Detaillierte Beschreibungen

Active Stand: 2026-01-09

Definitionen für das mii-pr-studie-ein-auschluss-kriterium ressourcenprofil

Guidance on how to interpret the contents of this table can be foundhere

0. EvidenceVariable
Definition

The EvidenceVariable resource describes a "PICO" element that knowledge (evidence, assertion, recommendation) is about.

ShortA population, intervention, or exposure definition
Comments

PICO stands for Population (the population within which exposures are being compared), Intervention (the conditional state or exposure state being described for its effect on outcomes), Comparison (the alternative conditional state or alternative exposure state being compared against), and Outcome (the result or effect of the intervention in the population).

Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
evv-0: Name should be usable as an identifier for the module by machine processing applications such as code generation (name.matches('[A-Z]([A-Za-z0-9_]){0,254}'))
evv-0: Name should be usable as an identifier for the module by machine processing applications such as code generation (name.matches('[A-Z]([A-Za-z0-9_]){0,254}'))
2. EvidenceVariable.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. EvidenceVariable.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. EvidenceVariable.status
Definition

Der Status dieser EvidenceVariable. Ermöglicht die Verfolgung des Lebenszyklus des Inhalts.


The status of this evidence variable. Enables tracking the life-cycle of the content.

ShortStatusdraft | active | retired | unknown
Comments

Allows filtering of evidence variables that are appropriate for use versus not.

Control1..1
BindingThe codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/publication-status|4.0.1)

The lifecycle status of an artifact.

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. EvidenceVariable.characteristic
Definition

Eine Eigenschaft, die die Mitglieder des Evidence-Elements definiert. Mehrere Eigenschaften werden mit einer "und"-Semantik angewendet.


A characteristic that defines the members of the evidence element. Multiple characteristics are applied with "and" semantics.

ShortCharacteristicWhat defines the members of the evidence element
Comments

Characteristics can be defined flexibly to accommodate different use cases for membership criteria, ranging from simple codes, all the way to using an expression language to express the criteria.

Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. EvidenceVariable.characteristic.extension
Definition

An Extension


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 manageable, 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.

ShortExtensionAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Must Supporttrue
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on EvidenceVariable.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 12. EvidenceVariable.characteristic.extension:linkId
    Slice NamelinkId
    Definition

    An Extension

    ShortExtension
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Backport linkId) (Extension Type: id)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    14. EvidenceVariable.characteristic.extension:definitionReference
    Slice NamedefinitionReference
    Definition

    An Extension

    ShortExtension
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Backport definitionReference) (Extension Type: Reference(EvidenceVariable, Evidence, Group))
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    16. EvidenceVariable.characteristic.extension:definitionCanonical
    Slice NamedefinitionCanonical
    Definition

    An Extension

    ShortExtension
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Backport definitionCanonical) (Extension Type: canonical(EvidenceVariable, Evidence))
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    18. EvidenceVariable.characteristic.extension:definitionByTypeAndValue
    Slice NamedefinitionByTypeAndValue
    Definition

    An Extension

    ShortExtension
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Backport DefinitionByTypeAndValue) (Complex Extension)
    Is Modifierfalse
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    20. EvidenceVariable.characteristic.extension:definitionByCombination
    Slice NamedefinitionByCombination
    Definition

    An Extension

    ShortExtension
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(MII EX Studie Backport DefinitionByCombination) (Complex Extension)
    Is Modifierfalse
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    22. EvidenceVariable.characteristic.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, 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. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    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.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    24. EvidenceVariable.characteristic.description
    Definition

    A short, natural language description of the characteristic that could be used to communicate the criteria to an end-user.

    ShortNatural language description of the characteristic
    Control0..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summaryfalse
    Requirements

    Need to be able to describe characteristics in natural language so that end users can understand the criteria.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. EvidenceVariable.characteristic.definition[x]
    Definition

    Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

    ShortWhat code or expression defines members?
    Control1..1
    TypeChoice of: CodeableConcept, Expression, Reference(Group), TriggerDefinition, canonical(ActivityDefinition), DataRequirement
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    Summarytrue
    Requirements

    Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on EvidenceVariable.characteristic.definition[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • type @ $this
    • 28. EvidenceVariable.characteristic.definition[x]:definitionReference
      Slice NamedefinitionReference
      Definition

      Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

      ShortWhat code or expression defines members?
      Control01..01
      TypeReference(Group, Group), Expression, TriggerDefinition, canonical(ActivityDefinition), DataRequirement, CodeableConcept
      Is Modifierfalse
      Summarytrue
      Requirements

      Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. EvidenceVariable.characteristic.definition[x]:definitionCanonical
      Slice NamedefinitionCanonical
      Definition

      Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

      ShortWhat code or expression defines members?
      Control01..01
      Typecanonical(ActivityDefinition, ActivityDefinition), Expression, Reference(Group), TriggerDefinition, DataRequirement, CodeableConcept
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. EvidenceVariable.characteristic.definition[x]:definitionDataRequirement
      Slice NamedefinitionDataRequirement
      Definition

      Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

      ShortWhat code or expression defines members?
      Control01..01
      TypeDataRequirement, Expression, Reference(Group), TriggerDefinition, canonical(ActivityDefinition), CodeableConcept
      Is Modifierfalse
      Summarytrue
      Requirements

      Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      34. EvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition
      Slice NamedefinitionTriggerDefinition
      Definition

      Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

      ShortWhat code or expression defines members?
      Control01..01
      TypeTriggerDefinition, Expression, Reference(Group), canonical(ActivityDefinition), DataRequirement, CodeableConcept
      Is Modifierfalse
      Summarytrue
      Requirements

      Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      36. EvidenceVariable.characteristic.usageContext
      Definition

      Use UsageContext to define the members of the population, such as Age Ranges, Genders, Settings.

      ShortWhat code/value pairs define members?
      Control0..0*
      TypeUsageContext
      Is Modifierfalse
      Summaryfalse
      Requirements

      Need to be able to define members more structurally when more information can be communicated such as age range.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. EvidenceVariable.characteristic.exclude
      Definition

      When true, members with this characteristic are excluded from the element.

      ShortWhether the characteristic includes or excludes members
      Control0..1
      Typeboolean
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summaryfalse
      Meaning if MissingFalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

      Guidance on how to interpret the contents of this table can be foundhere

      0. EvidenceVariable
      2. EvidenceVariable.status
      Definition

      Der Status dieser EvidenceVariable. Ermöglicht die Verfolgung des Lebenszyklus des Inhalts.

      ShortStatus
      Must Supporttrue
      4. EvidenceVariable.characteristic
      Definition

      Eine Eigenschaft, die die Mitglieder des Evidence-Elements definiert. Mehrere Eigenschaften werden mit einer "und"-Semantik angewendet.

      ShortCharacteristic
      Must Supporttrue
      6. EvidenceVariable.characteristic.extension
      Must Supporttrue
      SlicingThis element introduces a set of slices on EvidenceVariable.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 8. EvidenceVariable.characteristic.extension:linkId
        Slice NamelinkId
        Control0..1
        TypeExtension(MII EX Studie Backport linkId) (Extension Type: id)
        Must Supporttrue
        10. EvidenceVariable.characteristic.extension:definitionReference
        Slice NamedefinitionReference
        Control0..1
        TypeExtension(MII EX Studie Backport definitionReference) (Extension Type: Reference(EvidenceVariable, Evidence, Group))
        Must Supporttrue
        12. EvidenceVariable.characteristic.extension:definitionCanonical
        Slice NamedefinitionCanonical
        Control0..1
        TypeExtension(MII EX Studie Backport definitionCanonical) (Extension Type: canonical(EvidenceVariable, Evidence))
        Must Supporttrue
        14. EvidenceVariable.characteristic.extension:definitionByTypeAndValue
        Slice NamedefinitionByTypeAndValue
        Control0..1
        TypeExtension(MII EX Studie Backport DefinitionByTypeAndValue) (Complex Extension)
        Must Supporttrue
        16. EvidenceVariable.characteristic.extension:definitionByCombination
        Slice NamedefinitionByCombination
        Control0..1
        TypeExtension(MII EX Studie Backport DefinitionByCombination) (Complex Extension)
        Must Supporttrue
        18. EvidenceVariable.characteristic.description
        Must Supporttrue
        20. EvidenceVariable.characteristic.definition[x]
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        SlicingThis element introduces a set of slices on EvidenceVariable.characteristic.definition[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • type @ $this
        • 22. EvidenceVariable.characteristic.definition[x]:definitionReference
          Slice NamedefinitionReference
          Control0..0
          TypeReference(Group)
          24. EvidenceVariable.characteristic.definition[x]:definitionCanonical
          Slice NamedefinitionCanonical
          Control0..0
          Typecanonical(ActivityDefinition)
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          26. EvidenceVariable.characteristic.definition[x]:definitionDataRequirement
          Slice NamedefinitionDataRequirement
          Control0..0
          TypeDataRequirement
          28. EvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition
          Slice NamedefinitionTriggerDefinition
          Control0..0
          TypeTriggerDefinition
          30. EvidenceVariable.characteristic.usageContext
          Control0..0
          32. EvidenceVariable.characteristic.exclude
          Must Supporttrue

          Guidance on how to interpret the contents of this table can be foundhere

          0. EvidenceVariable
          Definition

          The EvidenceVariable resource describes a "PICO" element that knowledge (evidence, assertion, recommendation) is about.

          ShortA population, intervention, or exposure definition
          Comments

          PICO stands for Population (the population within which exposures are being compared), Intervention (the conditional state or exposure state being described for its effect on outcomes), Comparison (the alternative conditional state or alternative exposure state being compared against), and Outcome (the result or effect of the intervention in the population).

          Control0..*
          Is Modifierfalse
          Summaryfalse
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
          dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
          dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          evv-0: Name should be usable as an identifier for the module by machine processing applications such as code generation (name.matches('[A-Z]([A-Za-z0-9_]){0,254}'))
          2. EvidenceVariable.id
          Definition

          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

          ShortLogical id of this artifact
          Comments

          The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

          Control0..1
          Typeid
          Is Modifierfalse
          Summarytrue
          4. EvidenceVariable.meta
          Definition

          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

          ShortMetadata about the resource
          Control0..1
          TypeMeta
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. EvidenceVariable.implicitRules
          Definition

          A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

          ShortA set of rules under which this content was created
          Comments

          Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

          Control0..1
          Typeuri
          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          8. EvidenceVariable.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

          Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

          Control0..1
          BindingThe codes SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

          A human language.

          Additional BindingsPurpose
          AllLanguagesMax Binding
          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. EvidenceVariable.text
          Definition

          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

          Control0..1
          TypeNarrative
          Is Modifierfalse
          Summaryfalse
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. EvidenceVariable.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

          ShortContained, inline Resources
          Comments

          This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

          Control0..*
          TypeResource
          Is Modifierfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          14. EvidenceVariable.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, 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.

          ShortAdditional content defined by implementations
          Comments

          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.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          16. EvidenceVariable.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored
          Comments

          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.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
          Summaryfalse
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          18. EvidenceVariable.url
          Definition

          An absolute URI that is used to identify this evidence variable when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which at which an authoritative instance of this evidence variable is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the evidence variable is stored on different servers.

          ShortCanonical identifier for this evidence variable, represented as a URI (globally unique)
          Comments

          Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.

          The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in Technical and Business Versions.

          In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the meta.source element to indicate where the current master source of the resource can be found.

          Control0..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Allows the evidence variable to be referenced by a single globally unique identifier.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. EvidenceVariable.identifier
          Definition

          A formal identifier that is used to identify this evidence variable when it is represented in other formats, or referenced in a specification, model, design or an instance.

          ShortAdditional identifier for the evidence variable
          Comments

          Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this evidence variable outside of FHIR, where it is not possible to use the logical URI.

          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..*
          TypeIdentifier
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows externally provided and/or usable business identifiers to be easily associated with the module.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. EvidenceVariable.version
          Definition

          The identifier that is used to identify this version of the evidence variable when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the evidence variable author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions can be placed in a lexicographical sequence. To provide a version consistent with the Decision Support Service specification, use the format Major.Minor.Revision (e.g. 1.0.0). For more information on versioning knowledge assets, refer to the Decision Support Service specification. Note that a version is required for non-experimental active artifacts.

          ShortBusiness version of the evidence variable
          Comments

          There may be different evidence variable instances that have the same identifier but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the evidence variable with the format [url]|[version].

          NoteThis is a business version Id, not a resource version Id (see discussion)
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          24. EvidenceVariable.name
          Definition

          A natural language name identifying the evidence variable. This name should be usable as an identifier for the module by machine processing applications such as code generation.

          ShortName for this evidence variable (computer friendly)
          Comments

          The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.

          Control0..1
          This element is affected by the following invariants: inv-0
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Support human navigation and code generation.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. EvidenceVariable.title
          Definition

          A short, descriptive, user-friendly title for the evidence variable.

          ShortName for this evidence variable (human friendly)
          Comments

          This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. EvidenceVariable.shortTitle
          Definition

          The short title provides an alternate title for use in informal descriptive contexts where the full, formal title is not necessary.

          ShortTitle for use in informal contexts
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Need to be able to reference the content by a short description, but still provide a longer, more formal title for the content.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. EvidenceVariable.subtitle
          Definition

          An explanatory or alternate title for the EvidenceVariable giving additional information about its content.

          ShortSubordinate title of the EvidenceVariable
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. EvidenceVariable.status
          Definition

          Der Status dieser EvidenceVariable. Ermöglicht die Verfolgung des Lebenszyklus des Inhalts.

          ShortStatus
          Comments

          Allows filtering of evidence variables that are appropriate for use versus not.

          Control1..1
          BindingThe codes SHALL be taken from PublicationStatus
          (required to http://hl7.org/fhir/ValueSet/publication-status|4.0.1)

          The lifecycle status of an artifact.

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. EvidenceVariable.date
          Definition

          The date (and optionally time) when the evidence variable was published. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the evidence variable changes.

          ShortDate last changed
          Comments

          Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the evidence variable. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

          Control0..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Alternate NamesRevision Date
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. EvidenceVariable.publisher
          Definition

          The name of the organization or individual that published the evidence variable.

          ShortName of the publisher (organization or individual)
          Comments

          Usually an organization but may be an individual. The publisher (or steward) of the evidence variable is the organization or individual primarily responsible for the maintenance and upkeep of the evidence variable. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the evidence variable. This item SHOULD be populated unless the information is available from context.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Helps establish the "authority/credibility" of the evidence variable. May also allow for contact.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. EvidenceVariable.contact
          Definition

          Contact details to assist a user in finding and communicating with the publisher.

          ShortContact details for the publisher
          Comments

          May be a web site, an email address, a telephone number, etc.

          Control0..*
          TypeContactDetail
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. EvidenceVariable.description
          Definition

          A free text natural language description of the evidence variable from a consumer's perspective.

          ShortNatural language description of the evidence variable
          Comments

          This description can be used to capture details such as why the evidence variable was built, comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the evidence variable as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the evidence variable is presumed to be the predominant language in the place the evidence variable was created).

          Control0..1
          Typemarkdown
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          42. EvidenceVariable.note
          Definition

          A human-readable string to clarify or explain concepts about the resource.

          ShortUsed for footnotes or explanatory notes
          Control0..*
          TypeAnnotation
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. EvidenceVariable.useContext
          Definition

          The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate evidence variable instances.

          ShortThe context that the content is intended to support
          Comments

          When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.

          Control0..*
          TypeUsageContext
          Is Modifierfalse
          Summarytrue
          Requirements

          Assist in searching for appropriate content.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          46. EvidenceVariable.jurisdiction
          Definition

          A legal or geographic region in which the evidence variable is intended to be used.

          ShortIntended jurisdiction for evidence variable (if applicable)
          Comments

          It may be possible for the evidence variable to be used in jurisdictions other than those for which it was originally designed or intended.

          Control0..*
          BindingUnless not suitable, these codes SHALL be taken from Jurisdiction ValueSet
          (extensible to http://hl7.org/fhir/ValueSet/jurisdiction|4.0.1)

          Countries and regions within which this artifact is targeted for use.

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. EvidenceVariable.copyright
          Definition

          A copyright statement relating to the evidence variable and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the evidence variable.

          ShortUse and/or publishing restrictions
          Control0..1
          Typemarkdown
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Requirements

          Consumers must be able to determine any legal restrictions on the use of the evidence variable and/or its content.

          Alternate NamesLicense, Restrictions
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. EvidenceVariable.approvalDate
          Definition

          The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.

          ShortWhen the evidence variable was approved by publisher
          Comments

          The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.

          Control0..1
          Typedate
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. EvidenceVariable.lastReviewDate
          Definition

          The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.

          ShortWhen the evidence variable was last reviewed
          Comments

          If specified, this date follows the original approval date.

          Control0..1
          Typedate
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Requirements

          Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          54. EvidenceVariable.effectivePeriod
          Definition

          The period during which the evidence variable content was or is planned to be in active use.

          ShortWhen the evidence variable is expected to be used
          Comments

          The effective period for a evidence variable determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 might be published in 2015.

          Control0..1
          TypePeriod
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the evidence variable are or are expected to be used instead.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. EvidenceVariable.topic
          Definition

          Descriptive topics related to the content of the EvidenceVariable. Topics provide a high-level categorization grouping types of EvidenceVariables that can be useful for filtering and searching.

          ShortThe category of the EvidenceVariable, such as Education, Treatment, Assessment, etc.
          Control0..*
          BindingFor example codes, see DefinitionTopic
          (example to http://hl7.org/fhir/ValueSet/definition-topic|4.0.1)

          High-level categorization of the definition, used for searching, sorting, and filtering.

          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          Repositories must be able to determine how to categorize the EvidenceVariable so that it can be found by topical searches.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. EvidenceVariable.author
          Definition

          An individiual or organization primarily involved in the creation and maintenance of the content.

          ShortWho authored the content
          Control0..*
          TypeContactDetail
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          60. EvidenceVariable.editor
          Definition

          An individual or organization primarily responsible for internal coherence of the content.

          ShortWho edited the content
          Control0..*
          TypeContactDetail
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          62. EvidenceVariable.reviewer
          Definition

          An individual or organization primarily responsible for review of some aspect of the content.

          ShortWho reviewed the content
          Control0..*
          TypeContactDetail
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. EvidenceVariable.endorser
          Definition

          An individual or organization responsible for officially endorsing the content for use in some setting.

          ShortWho endorsed the content
          Control0..*
          TypeContactDetail
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. EvidenceVariable.relatedArtifact
          Definition

          Related artifacts such as additional documentation, justification, or bibliographic references.

          ShortAdditional documentation, citations, etc.
          Comments

          Each related artifact is either an attachment, or a reference to another resource, but not both.

          Control0..*
          TypeRelatedArtifact
          Is Modifierfalse
          Summaryfalse
          Requirements

          EvidenceVariables must be able to provide enough information for consumers of the content (and/or interventions or results produced by the content) to be able to determine and understand the justification for and evidence in support of the content.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. EvidenceVariable.type
          Definition

          The type of evidence element, a population, an exposure, or an outcome.

          Shortdichotomous | continuous | descriptive
          Control0..1
          BindingThe codes SHALL be taken from EvidenceVariableType
          (required to http://hl7.org/fhir/ValueSet/variable-type|4.0.1)

          The possible types of variables for exposures or outcomes (E.g. Dichotomous, Continuous, Descriptive).

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          70. EvidenceVariable.characteristic
          Definition

          Eine Eigenschaft, die die Mitglieder des Evidence-Elements definiert. Mehrere Eigenschaften werden mit einer "und"-Semantik angewendet.

          ShortCharacteristic
          Comments

          Characteristics can be defined flexibly to accommodate different use cases for membership criteria, ranging from simple codes, all the way to using an expression language to express the criteria.

          Control1..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          72. EvidenceVariable.characteristic.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          74. EvidenceVariable.characteristic.extension
          Definition

          An Extension

          ShortExtension
          Control0..*
          TypeExtension
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on EvidenceVariable.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 76. EvidenceVariable.characteristic.extension:linkId
            Slice NamelinkId
            Definition

            An Extension

            ShortExtension
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Backport linkId) (Extension Type: id)
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            78. EvidenceVariable.characteristic.extension:definitionReference
            Slice NamedefinitionReference
            Definition

            An Extension

            ShortExtension
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Backport definitionReference) (Extension Type: Reference(EvidenceVariable, Evidence, Group))
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            80. EvidenceVariable.characteristic.extension:definitionCanonical
            Slice NamedefinitionCanonical
            Definition

            An Extension

            ShortExtension
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Backport definitionCanonical) (Extension Type: canonical(EvidenceVariable, Evidence))
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            82. EvidenceVariable.characteristic.extension:definitionByTypeAndValue
            Slice NamedefinitionByTypeAndValue
            Definition

            An Extension

            ShortExtension
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Backport DefinitionByTypeAndValue) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            84. EvidenceVariable.characteristic.extension:definitionByCombination
            Slice NamedefinitionByCombination
            Definition

            An Extension

            ShortExtension
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(MII EX Studie Backport DefinitionByCombination) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            86. EvidenceVariable.characteristic.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, 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. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            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.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            88. EvidenceVariable.characteristic.description
            Definition

            A short, natural language description of the characteristic that could be used to communicate the criteria to an end-user.

            ShortNatural language description of the characteristic
            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summaryfalse
            Requirements

            Need to be able to describe characteristics in natural language so that end users can understand the criteria.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            90. EvidenceVariable.characteristic.definition[x]
            Definition

            Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

            ShortWhat code or expression defines members?
            Control1..1
            TypeChoice of: CodeableConcept, Expression
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Must Supporttrue
            Must Support TypesNo must-support rules about the choice of types/profiles
            Summarytrue
            Requirements

            Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on EvidenceVariable.characteristic.definition[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 92. EvidenceVariable.characteristic.definition[x]:definitionReference
              Slice NamedefinitionReference
              Definition

              Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

              ShortWhat code or expression defines members?
              Control0..0
              TypeReference(Group)
              Is Modifierfalse
              Summarytrue
              Requirements

              Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              94. EvidenceVariable.characteristic.definition[x]:definitionCanonical
              Slice NamedefinitionCanonical
              Definition

              Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

              ShortWhat code or expression defines members?
              Control0..0
              Typecanonical(ActivityDefinition)
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              96. EvidenceVariable.characteristic.definition[x]:definitionDataRequirement
              Slice NamedefinitionDataRequirement
              Definition

              Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

              ShortWhat code or expression defines members?
              Control0..0
              TypeDataRequirement
              Is Modifierfalse
              Summarytrue
              Requirements

              Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              98. EvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition
              Slice NamedefinitionTriggerDefinition
              Definition

              Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

              ShortWhat code or expression defines members?
              Control0..0
              TypeTriggerDefinition
              Is Modifierfalse
              Summarytrue
              Requirements

              Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              100. EvidenceVariable.characteristic.usageContext
              Definition

              Use UsageContext to define the members of the population, such as Age Ranges, Genders, Settings.

              ShortWhat code/value pairs define members?
              Control0..0
              TypeUsageContext
              Is Modifierfalse
              Summaryfalse
              Requirements

              Need to be able to define members more structurally when more information can be communicated such as age range.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              102. EvidenceVariable.characteristic.exclude
              Definition

              When true, members with this characteristic are excluded from the element.

              ShortWhether the characteristic includes or excludes members
              Control0..1
              Typeboolean
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summaryfalse
              Meaning if MissingFalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              104. EvidenceVariable.characteristic.participantEffective[x]
              Definition

              Indicates what effective period the study covers.

              ShortWhat time period do participants cover
              Control0..1
              TypeChoice of: dateTime, Period, Duration, Timing
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              106. EvidenceVariable.characteristic.timeFromStart
              Definition

              Indicates duration from the participant's study entry.

              ShortObservation time from study start
              Control0..1
              TypeDuration
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              108. EvidenceVariable.characteristic.groupMeasure
              Definition

              Indicates how elements are aggregated within the study effective period.

              Shortmean | median | mean-of-mean | mean-of-median | median-of-mean | median-of-median
              Control0..1
              BindingThe codes SHALL be taken from GroupMeasure
              (required to http://hl7.org/fhir/ValueSet/group-measure|4.0.1)

              Possible group measure aggregates (E.g. Mean, Median).

              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))