MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot -
Germany
This page is part of the MII Implementation Guide Medizinisches Forschungsvorhaben (v2027.0.0-ballot: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| 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. |
| Short | A 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). |
| Control | 0..* |
| Is Modifier | false |
| Summary | false |
| Invariants | dom-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. |
| Short | A 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. |
| Control | 0..1 |
| Type | uri |
| Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Invariants | ele-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). |
| Short | Extensions 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. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
| Summary | false |
| 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 Names | extensions, user content |
| Invariants | ele-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. |
| Short | Statusdraft | active | retired | unknown |
| Comments | Allows filtering of evidence variables that are appropriate for use versus not. |
| Control | 1..1 |
| Binding | The 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. |
| Type | code |
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | true |
| Summary | true |
| Invariants | ele-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. |
| Short | CharacteristicWhat 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. |
| Control | 1..* |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | true |
| Summary | true |
| Invariants | ele-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. |
| Short | ExtensionAdditional 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. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-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()) |
| Slicing | This element introduces a set of slices on EvidenceVariable.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 12. EvidenceVariable.characteristic.extension:linkId | |
| Slice Name | linkId |
| Definition | An Extension |
| Short | Extension |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | Extension(MII EX Studie Backport linkId) (Extension Type: id) |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Invariants | ele-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 Name | definitionReference |
| Definition | An Extension |
| Short | Extension |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | Extension(MII EX Studie Backport definitionReference) (Extension Type: Reference(EvidenceVariable, Evidence, Group)) |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Invariants | ele-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 Name | definitionCanonical |
| Definition | An Extension |
| Short | Extension |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | Extension(MII EX Studie Backport definitionCanonical) (Extension Type: canonical(EvidenceVariable, Evidence)) |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Invariants | ele-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 Name | definitionByTypeAndValue |
| Definition | An Extension |
| Short | Extension |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | Extension(MII EX Studie Backport DefinitionByTypeAndValue) (Complex Extension) |
| Is Modifier | false |
| Must Support | true |
| Invariants | ele-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 Name | definitionByCombination |
| Definition | An Extension |
| Short | Extension |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | Extension(MII EX Studie Backport DefinitionByCombination) (Complex Extension) |
| Is Modifier | false |
| Must Support | true |
| Invariants | ele-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). |
| Short | Extensions 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. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| 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 Names | extensions, user content, modifiers |
| Invariants | ele-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. |
| Short | Natural language description of the characteristic |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | true |
| Summary | false |
| Requirements | Need to be able to describe characteristics in natural language so that end users can understand the criteria. |
| Invariants | ele-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). |
| Short | What code or expression defines members? |
| Control | 1..1 |
| Type | Choice of: CodeableConcept, Expression, Reference(Group), TriggerDefinition, canonical(ActivityDefinition), DataRequirement |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Must Support | true |
| Must Support Types | No must-support rules about the choice of types/profiles |
| Summary | true |
| 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. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on EvidenceVariable.characteristic.definition[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 28. EvidenceVariable.characteristic.definition[x]:definitionReference | |
| Slice Name | definitionReference |
| 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). |
| Short | What code or expression defines members? |
| Control | 01..01 |
| Type | Reference(Group, Group), Expression, TriggerDefinition, canonical(ActivityDefinition), DataRequirement, CodeableConcept |
| Is Modifier | false |
| Summary | true |
| 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. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 30. EvidenceVariable.characteristic.definition[x]:definitionCanonical | |
| Slice Name | definitionCanonical |
| 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). |
| Short | What code or expression defines members? |
| Control | 01..01 |
| Type | canonical(ActivityDefinition, ActivityDefinition), Expression, Reference(Group), TriggerDefinition, DataRequirement, CodeableConcept |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| 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. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 32. EvidenceVariable.characteristic.definition[x]:definitionDataRequirement | |
| Slice Name | definitionDataRequirement |
| 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). |
| Short | What code or expression defines members? |
| Control | 01..01 |
| Type | DataRequirement, Expression, Reference(Group), TriggerDefinition, canonical(ActivityDefinition), CodeableConcept |
| Is Modifier | false |
| Summary | true |
| 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. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 34. EvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition | |
| Slice Name | definitionTriggerDefinition |
| 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). |
| Short | What code or expression defines members? |
| Control | 01..01 |
| Type | TriggerDefinition, Expression, Reference(Group), canonical(ActivityDefinition), DataRequirement, CodeableConcept |
| Is Modifier | false |
| Summary | true |
| 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. |
| Invariants | ele-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. |
| Short | What code/value pairs define members? |
| Control | 0..0* |
| Type | UsageContext |
| Is Modifier | false |
| Summary | false |
| Requirements | Need to be able to define members more structurally when more information can be communicated such as age range. |
| Invariants | ele-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. |
| Short | Whether the characteristic includes or excludes members |
| Control | 0..1 |
| Type | boolean |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | true |
| Summary | false |
| Meaning if Missing | False |
| Invariants | ele-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. |
| Short | Status |
| Must Support | true |
| 4. EvidenceVariable.characteristic | |
| Definition | Eine Eigenschaft, die die Mitglieder des Evidence-Elements definiert. Mehrere Eigenschaften werden mit einer "und"-Semantik angewendet. |
| Short | Characteristic |
| Must Support | true |
| 6. EvidenceVariable.characteristic.extension | |
| Must Support | true |
| Slicing | This element introduces a set of slices on EvidenceVariable.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 8. EvidenceVariable.characteristic.extension:linkId | |
| Slice Name | linkId |
| Control | 0..1 |
| Type | Extension(MII EX Studie Backport linkId) (Extension Type: id) |
| Must Support | true |
| 10. EvidenceVariable.characteristic.extension:definitionReference | |
| Slice Name | definitionReference |
| Control | 0..1 |
| Type | Extension(MII EX Studie Backport definitionReference) (Extension Type: Reference(EvidenceVariable, Evidence, Group)) |
| Must Support | true |
| 12. EvidenceVariable.characteristic.extension:definitionCanonical | |
| Slice Name | definitionCanonical |
| Control | 0..1 |
| Type | Extension(MII EX Studie Backport definitionCanonical) (Extension Type: canonical(EvidenceVariable, Evidence)) |
| Must Support | true |
| 14. EvidenceVariable.characteristic.extension:definitionByTypeAndValue | |
| Slice Name | definitionByTypeAndValue |
| Control | 0..1 |
| Type | Extension(MII EX Studie Backport DefinitionByTypeAndValue) (Complex Extension) |
| Must Support | true |
| 16. EvidenceVariable.characteristic.extension:definitionByCombination | |
| Slice Name | definitionByCombination |
| Control | 0..1 |
| Type | Extension(MII EX Studie Backport DefinitionByCombination) (Complex Extension) |
| Must Support | true |
| 18. EvidenceVariable.characteristic.description | |
| Must Support | true |
| 20. EvidenceVariable.characteristic.definition[x] | |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Must Support | true |
| Slicing | This element introduces a set of slices on EvidenceVariable.characteristic.definition[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 22. EvidenceVariable.characteristic.definition[x]:definitionReference | |
| Slice Name | definitionReference |
| Control | 0..0 |
| Type | Reference(Group) |
| 24. EvidenceVariable.characteristic.definition[x]:definitionCanonical | |
| Slice Name | definitionCanonical |
| Control | 0..0 |
| Type | canonical(ActivityDefinition) |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 26. EvidenceVariable.characteristic.definition[x]:definitionDataRequirement | |
| Slice Name | definitionDataRequirement |
| Control | 0..0 |
| Type | DataRequirement |
| 28. EvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition | |
| Slice Name | definitionTriggerDefinition |
| Control | 0..0 |
| Type | TriggerDefinition |
| 30. EvidenceVariable.characteristic.usageContext | |
| Control | 0..0 |
| 32. EvidenceVariable.characteristic.exclude | |
| Must Support | true |
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. | ||||
| Short | A 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). | ||||
| Control | 0..* | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | dom-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. | ||||
| Short | Logical 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. | ||||
| Control | 0..1 | ||||
| Type | id | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| 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. | ||||
| Short | Metadata about the resource | ||||
| Control | 0..1 | ||||
| Type | Meta | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | A 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. | ||||
| Control | 0..1 | ||||
| Type | uri | ||||
| Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Language 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). | ||||
| Control | 0..1 | ||||
| Binding | The codes SHOULD be taken from CommonLanguages (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)A human language.
| ||||
| Type | code | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | Text 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. | ||||
| Control | 0..1 | ||||
| Type | Narrative | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | narrative, html, xhtml, display | ||||
| Invariants | ele-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. | ||||
| Short | Contained, 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. | ||||
| Control | 0..* | ||||
| Type | Resource | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | inline 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. | ||||
| Short | Additional 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. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-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). | ||||
| Short | Extensions 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. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them | ||||
| Summary | false | ||||
| 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 Names | extensions, user content | ||||
| Invariants | ele-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. | ||||
| Short | Canonical 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. | ||||
| Control | 0..1 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Requirements | Allows the evidence variable to be referenced by a single globally unique identifier. | ||||
| Invariants | ele-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. | ||||
| Short | Additional 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. | ||||
| Note | This is a business identifier, not a resource identifier (see discussion) | ||||
| Control | 0..* | ||||
| Type | Identifier | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Requirements | Allows externally provided and/or usable business identifiers to be easily associated with the module. | ||||
| Invariants | ele-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. | ||||
| Short | Business 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]. | ||||
| Note | This is a business version Id, not a resource version Id (see discussion) | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Name 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. | ||||
| Control | 0..1 This element is affected by the following invariants: inv-0 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Requirements | Support human navigation and code generation. | ||||
| Invariants | ele-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. | ||||
| Short | Name for this evidence variable (human friendly) | ||||
| Comments | This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc. | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Title for use in informal contexts | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Requirements | Need to be able to reference the content by a short description, but still provide a longer, more formal title for the content. | ||||
| Invariants | ele-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. | ||||
| Short | Subordinate title of the EvidenceVariable | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | Status | ||||
| Comments | Allows filtering of evidence variables that are appropriate for use versus not. | ||||
| Control | 1..1 | ||||
| Binding | The codes SHALL be taken from PublicationStatus (required to http://hl7.org/fhir/ValueSet/publication-status|4.0.1)The lifecycle status of an artifact. | ||||
| Type | code | ||||
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Date 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. | ||||
| Control | 0..1 | ||||
| Type | dateTime | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Alternate Names | Revision Date | ||||
| Invariants | ele-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. | ||||
| Short | Name 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. | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Requirements | Helps establish the "authority/credibility" of the evidence variable. May also allow for contact. | ||||
| Invariants | ele-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. | ||||
| Short | Contact details for the publisher | ||||
| Comments | May be a web site, an email address, a telephone number, etc. | ||||
| Control | 0..* | ||||
| Type | ContactDetail | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Natural 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). | ||||
| Control | 0..1 | ||||
| Type | markdown | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Used for footnotes or explanatory notes | ||||
| Control | 0..* | ||||
| Type | Annotation | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | The 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. | ||||
| Control | 0..* | ||||
| Type | UsageContext | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Requirements | Assist in searching for appropriate content. | ||||
| Invariants | ele-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. | ||||
| Short | Intended 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. | ||||
| Control | 0..* | ||||
| Binding | Unless 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. | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Use and/or publishing restrictions | ||||
| Control | 0..1 | ||||
| Type | markdown | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Requirements | Consumers must be able to determine any legal restrictions on the use of the evidence variable and/or its content. | ||||
| Alternate Names | License, Restrictions | ||||
| Invariants | ele-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. | ||||
| Short | When 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. | ||||
| Control | 0..1 | ||||
| Type | date | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | When the evidence variable was last reviewed | ||||
| Comments | If specified, this date follows the original approval date. | ||||
| Control | 0..1 | ||||
| Type | date | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| 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. | ||||
| Invariants | ele-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. | ||||
| Short | When 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. | ||||
| Control | 0..1 | ||||
| Type | Period | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| 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. | ||||
| Invariants | ele-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. | ||||
| Short | The category of the EvidenceVariable, such as Education, Treatment, Assessment, etc. | ||||
| Control | 0..* | ||||
| Binding | For 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. | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Requirements | Repositories must be able to determine how to categorize the EvidenceVariable so that it can be found by topical searches. | ||||
| Invariants | ele-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. | ||||
| Short | Who authored the content | ||||
| Control | 0..* | ||||
| Type | ContactDetail | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | Who edited the content | ||||
| Control | 0..* | ||||
| Type | ContactDetail | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | Who reviewed the content | ||||
| Control | 0..* | ||||
| Type | ContactDetail | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | Who endorsed the content | ||||
| Control | 0..* | ||||
| Type | ContactDetail | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | Additional documentation, citations, etc. | ||||
| Comments | Each related artifact is either an attachment, or a reference to another resource, but not both. | ||||
| Control | 0..* | ||||
| Type | RelatedArtifact | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| 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. | ||||
| Invariants | ele-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. | ||||
| Short | dichotomous | continuous | descriptive | ||||
| Control | 0..1 | ||||
| Binding | The 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). | ||||
| Type | code | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Characteristic | ||||
| 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. | ||||
| Control | 1..* | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-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. | ||||
| Short | Unique id for inter-element referencing | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| XML Format | In the XML format, this property is represented as an attribute. | ||||
| Summary | false | ||||
| 74. EvidenceVariable.characteristic.extension | |||||
| Definition | An Extension | ||||
| Short | Extension | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Invariants | ele-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()) | ||||
| Slicing | This element introduces a set of slices on EvidenceVariable.characteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: | ||||
| 76. EvidenceVariable.characteristic.extension:linkId | |||||
| Slice Name | linkId | ||||
| Definition | An Extension | ||||
| Short | Extension | ||||
| Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
| Type | Extension(MII EX Studie Backport linkId) (Extension Type: id) | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Invariants | ele-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 Name | definitionReference | ||||
| Definition | An Extension | ||||
| Short | Extension | ||||
| Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
| Type | Extension(MII EX Studie Backport definitionReference) (Extension Type: Reference(EvidenceVariable, Evidence, Group)) | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Invariants | ele-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 Name | definitionCanonical | ||||
| Definition | An Extension | ||||
| Short | Extension | ||||
| Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
| Type | Extension(MII EX Studie Backport definitionCanonical) (Extension Type: canonical(EvidenceVariable, Evidence)) | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Invariants | ele-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 Name | definitionByTypeAndValue | ||||
| Definition | An Extension | ||||
| Short | Extension | ||||
| Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
| Type | Extension(MII EX Studie Backport DefinitionByTypeAndValue) (Complex Extension) | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Invariants | ele-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 Name | definitionByCombination | ||||
| Definition | An Extension | ||||
| Short | Extension | ||||
| Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
| Type | Extension(MII EX Studie Backport DefinitionByCombination) (Complex Extension) | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Invariants | ele-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). | ||||
| Short | Extensions 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. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them | ||||
| Summary | true | ||||
| 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 Names | extensions, user content, modifiers | ||||
| Invariants | ele-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. | ||||
| Short | Natural language description of the characteristic | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Requirements | Need to be able to describe characteristics in natural language so that end users can understand the criteria. | ||||
| Invariants | ele-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). | ||||
| Short | What code or expression defines members? | ||||
| Control | 1..1 | ||||
| Type | Choice of: CodeableConcept, Expression | ||||
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Must Support Types | No must-support rules about the choice of types/profiles | ||||
| Summary | true | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| Slicing | This element introduces a set of slices on EvidenceVariable.characteristic.definition[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators: | ||||
| 92. EvidenceVariable.characteristic.definition[x]:definitionReference | |||||
| Slice Name | definitionReference | ||||
| 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). | ||||
| Short | What code or expression defines members? | ||||
| Control | 0..0 | ||||
| Type | Reference(Group) | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 94. EvidenceVariable.characteristic.definition[x]:definitionCanonical | |||||
| Slice Name | definitionCanonical | ||||
| 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). | ||||
| Short | What code or expression defines members? | ||||
| Control | 0..0 | ||||
| Type | canonical(ActivityDefinition) | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 96. EvidenceVariable.characteristic.definition[x]:definitionDataRequirement | |||||
| Slice Name | definitionDataRequirement | ||||
| 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). | ||||
| Short | What code or expression defines members? | ||||
| Control | 0..0 | ||||
| Type | DataRequirement | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 98. EvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition | |||||
| Slice Name | definitionTriggerDefinition | ||||
| 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). | ||||
| Short | What code or expression defines members? | ||||
| Control | 0..0 | ||||
| Type | TriggerDefinition | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| 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. | ||||
| Invariants | ele-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. | ||||
| Short | What code/value pairs define members? | ||||
| Control | 0..0 | ||||
| Type | UsageContext | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Requirements | Need to be able to define members more structurally when more information can be communicated such as age range. | ||||
| Invariants | ele-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. | ||||
| Short | Whether the characteristic includes or excludes members | ||||
| Control | 0..1 | ||||
| Type | boolean | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Meaning if Missing | False | ||||
| Invariants | ele-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. | ||||
| Short | What time period do participants cover | ||||
| Control | 0..1 | ||||
| Type | Choice of: dateTime, Period, Duration, Timing | ||||
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | Observation time from study start | ||||
| Control | 0..1 | ||||
| Type | Duration | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-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. | ||||
| Short | mean | median | mean-of-mean | mean-of-median | median-of-mean | median-of-median | ||||
| Control | 0..1 | ||||
| Binding | The 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). | ||||
| Type | code | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||