Beschreibung
Dieses Profil beschreibt ein Ein- und Auschlusskriterium innerhalb einer Studie in der Medizininformatik-Initiative.
Name | Canonical |
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MII_PR_Studie_EinAuschlussKriterium | https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-ein-auschluss-kriterium |
Differential
EvidenceVariable | I | EvidenceVariable | There are no (further) constraints on this element Element IdEvidenceVariable A population, intervention, or exposure definition DefinitionThe EvidenceVariable resource describes a "PICO" element that knowledge (evidence, assertion, recommendation) is about. 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).
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url | Σ | 0..1 | uri | There are no (further) constraints on this element Element IdEvidenceVariable.url Canonical identifier for this evidence variable, represented as a URI (globally unique) DefinitionAn 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. Allows the evidence variable to be referenced by a single globally unique identifier. 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.
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identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdEvidenceVariable.identifier Additional identifier for the evidence variable DefinitionA 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. Allows externally provided and/or usable business identifiers to be easily associated with the module. 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.
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version | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.version Business version of the evidence variable DefinitionThe 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. 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].
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name | Σ I | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.name Name for this evidence variable (computer friendly) DefinitionA 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. Support human navigation and code generation. 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.
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title | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.title Name for this evidence variable (human friendly) DefinitionA short, descriptive, user-friendly title for the evidence variable. This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.
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shortTitle | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.shortTitle Title for use in informal contexts DefinitionThe short title provides an alternate title for use in informal descriptive contexts where the full, formal title is not necessary. Need to be able to reference the content by a short description, but still provide a longer, more formal title for the content. Note that FHIR strings SHALL NOT exceed 1MB in size
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subtitle | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.subtitle Subordinate title of the EvidenceVariable DefinitionAn explanatory or alternate title for the EvidenceVariable giving additional information about its content. Note that FHIR strings SHALL NOT exceed 1MB in size
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status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element IdEvidenceVariable.status draft | active | retired | unknown DefinitionThe status of this evidence variable. Enables tracking the life-cycle of the content. Allows filtering of evidence variables that are appropriate for use versus not. The lifecycle status of an artifact. PublicationStatus (required)Constraints
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date | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdEvidenceVariable.date Date last changed Alternate namesRevision Date DefinitionThe 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. 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.
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publisher | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.publisher Name of the publisher (organization or individual) DefinitionThe name of the organization or individual that published the evidence variable. Helps establish the "authority/credibility" of the evidence variable. May also allow for contact. 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.
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contact | Σ | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.contact Contact details for the publisher DefinitionContact details to assist a user in finding and communicating with the publisher. May be a web site, an email address, a telephone number, etc.
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description | Σ | 0..1 | markdown | There are no (further) constraints on this element Element IdEvidenceVariable.description Natural language description of the evidence variable DefinitionA free text natural language description of the evidence variable from a consumer's perspective. 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).
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note | 0..* | Annotation | There are no (further) constraints on this element Element IdEvidenceVariable.note Used for footnotes or explanatory notes DefinitionA human-readable string to clarify or explain concepts about the resource. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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useContext | Σ | 0..* | UsageContext | There are no (further) constraints on this element Element IdEvidenceVariable.useContext The context that the content is intended to support DefinitionThe 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. Assist in searching for appropriate content. When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.
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jurisdiction | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdEvidenceVariable.jurisdiction Intended jurisdiction for evidence variable (if applicable) DefinitionA legal or geographic region in which the evidence variable is intended to be used. It may be possible for the evidence variable to be used in jurisdictions other than those for which it was originally designed or intended. Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible)Constraints
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copyright | 0..1 | markdown | There are no (further) constraints on this element Element IdEvidenceVariable.copyright Use and/or publishing restrictions Alternate namesLicense, Restrictions DefinitionA 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. Consumers must be able to determine any legal restrictions on the use of the evidence variable and/or its content. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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approvalDate | 0..1 | date | There are no (further) constraints on this element Element IdEvidenceVariable.approvalDate When the evidence variable was approved by publisher DefinitionThe date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage. The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.
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lastReviewDate | 0..1 | date | There are no (further) constraints on this element Element IdEvidenceVariable.lastReviewDate When the evidence variable was last reviewed DefinitionThe date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date. 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. If specified, this date follows the original approval date.
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effectivePeriod | Σ I | 0..1 | Period | There are no (further) constraints on this element Element IdEvidenceVariable.effectivePeriod When the evidence variable is expected to be used DefinitionThe period during which the evidence variable content was or is planned to be in active use. 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. 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.
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topic | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdEvidenceVariable.topic The category of the EvidenceVariable, such as Education, Treatment, Assessment, etc. DefinitionDescriptive 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. Repositories must be able to determine how to categorize the EvidenceVariable so that it can be found by topical searches. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. High-level categorization of the definition, used for searching, sorting, and filtering. DefinitionTopic (example)Constraints
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author | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.author Who authored the content DefinitionAn individiual or organization primarily involved in the creation and maintenance of the content.
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editor | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.editor Who edited the content DefinitionAn individual or organization primarily responsible for internal coherence of the content.
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reviewer | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.reviewer Who reviewed the content DefinitionAn individual or organization primarily responsible for review of some aspect of the content.
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endorser | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.endorser Who endorsed the content DefinitionAn individual or organization responsible for officially endorsing the content for use in some setting.
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relatedArtifact | 0..* | RelatedArtifact | There are no (further) constraints on this element Element IdEvidenceVariable.relatedArtifact Additional documentation, citations, etc. DefinitionRelated artifacts such as additional documentation, justification, or bibliographic references. 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. Each related artifact is either an attachment, or a reference to another resource, but not both.
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type | Σ | 0..1 | codeBinding | There are no (further) constraints on this element Element IdEvidenceVariable.type dichotomous | continuous | descriptive DefinitionThe type of evidence element, a population, an exposure, or an outcome. Note that FHIR strings SHALL NOT exceed 1MB in size The possible types of variables for exposures or outcomes (E.g. Dichotomous, Continuous, Descriptive). EvidenceVariableType (required)Constraints
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characteristic | S Σ | 1..* | BackboneElement | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic What defines the members of the evidence element DefinitionA characteristic that defines the members of the evidence element. Multiple characteristics are applied with "and" semantics. 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.
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extension | S I | 0..* | Extension | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Constraints
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linkId | S I | 0..1 | Extension(id) | Element IdEvidenceVariable.characteristic.extension:linkId MII EX Studie Backport linkId Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId Constraints
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definitionReference | S I | 0..1 | Extension(Reference(EvidenceVariable | Evidence | Group)) | Element IdEvidenceVariable.characteristic.extension:definitionReference MII EX Studie Backport definitionReference Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Reference(EvidenceVariable | Evidence | Group)) Extension URL Constraints
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definitionCanonical | S I | 0..1 | Extension(canonical(EvidenceVariable | Evidence)) | Element IdEvidenceVariable.characteristic.extension:definitionCanonical MII EX Studie Backport definitionCanonical Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(canonical(EvidenceVariable | Evidence)) Extension URL Constraints
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definitionByTypeAndValue | S I | 0..1 | Extension(Complex) | Element IdEvidenceVariable.characteristic.extension:definitionByTypeAndValue MII EX Studie Backport DefinitionByTypeAndValue Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Complex) Extension URL Constraints
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definitionByCombination | S I | 0..1 | Extension(Complex) | Element IdEvidenceVariable.characteristic.extension:definitionByCombination MII EX Studie Backport DefinitionByCombination Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Complex) Extension URL Constraints
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description | S | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.description Natural language description of the characteristic DefinitionA short, natural language description of the characteristic that could be used to communicate the criteria to an end-user. Need to be able to describe characteristics in natural language so that end users can understand the criteria. Note that FHIR strings SHALL NOT exceed 1MB in size
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definition[x] | S Σ | 1..1 | Element IdEvidenceVariable.characteristic.definition[x] What code or expression defines members? DefinitionDefine 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). 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. Unordered, Open, by $this(Type) Constraints
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definitionCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
definitionExpression | Expression | There are no (further) constraints on this element Data Type | ||
definitionReference | Σ | 0..0 | Reference(Group) | Element IdEvidenceVariable.characteristic.definition[x]:definitionReference What code or expression defines members? DefinitionDefine 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). 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.
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definitionCanonical | Σ | 0..0 | canonical(ActivityDefinition) | Element IdEvidenceVariable.characteristic.definition[x]:definitionCanonical What code or expression defines members? DefinitionDefine 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). 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.
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definitionDataRequirement | Σ | 0..0 | DataRequirement | Element IdEvidenceVariable.characteristic.definition[x]:definitionDataRequirement What code or expression defines members? DefinitionDefine 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). 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.
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definitionTriggerDefinition | Σ | 0..0 | TriggerDefinition | Element IdEvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition What code or expression defines members? DefinitionDefine 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). 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.
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usageContext | 0..0 | UsageContext | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.usageContext What code/value pairs define members? DefinitionUse UsageContext to define the members of the population, such as Age Ranges, Genders, Settings. Need to be able to define members more structurally when more information can be communicated such as age range.
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exclude | S | 0..1 | boolean | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.exclude Whether the characteristic includes or excludes members DefinitionWhen true, members with this characteristic are excluded from the element. False
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participantEffective[x] | 0..1 | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.participantEffective[x] What time period do participants cover DefinitionIndicates what effective period the study covers.
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participantEffectiveDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
participantEffectivePeriod | Period | There are no (further) constraints on this element Data Type | ||
participantEffectiveDuration | Duration | There are no (further) constraints on this element Data Type | ||
participantEffectiveTiming | Timing | There are no (further) constraints on this element Data Type | ||
timeFromStart | I | 0..1 | Duration | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.timeFromStart Observation time from study start DefinitionIndicates duration from the participant's study entry. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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groupMeasure | 0..1 | codeBinding | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.groupMeasure mean | median | mean-of-mean | mean-of-median | median-of-mean | median-of-median DefinitionIndicates how elements are aggregated within the study effective period. Note that FHIR strings SHALL NOT exceed 1MB in size Possible group measure aggregates (E.g. Mean, Median). GroupMeasure (required)Constraints
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Hinweise
FHIR-Element | Erklärung |
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EvidenceVariable.id | Must-support, jedoch optional |
EvidenceVariable.meta | Must-support, jedoch optional |
EvidenceVariable.meta.profile | Verpflichtend für die Abfrage im DIZ-Repository inkl. Versionsnummer des Profils. Siehe CapabilityStatement. In allen anderen Fällen optional. |
EvidenceVariable.characteristic.description | Textuelle Beschreibung dess Kriteriums |
EvidenceVariable.characteristic.definition[x] | In den dazugehöirgen Backport-Extensions aus FHIR R5 sind weitere Datentypen als in FHIR R4 erlaubt. Sollte z.B. die Extension definitionByCombination oder definitionByTypeAndValue verwendet werden, so muss definitionCodeableConcept mit dem Data-Absent-Reason Code "unknown" befüllt werden, sodass die Kardinalität von 1..1 erfüllt bleibt. |
EvidenceVariable.characteristic.exclude | Boolesches Element welches definiert, ob es sich um ein Einschluss- oder Ausschlusskriterium handelt |
Mapping
FHIR Element | Logischer Datensatz |
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EvidenceVariable.characteristic.description | Forschungsvorhaben.Studiendesign.Einschlusskriterien.Kriterium |
EvidenceVariable.characteristic.extension:definitionByTypeAndValue | Forschungsvorhaben.Studiendesign.Einschlusskriterien.Operator |
EvidenceVariable.characteristic.extension:definitionByTypeAndValue | Forschungsvorhaben.Studiendesign.Einschlusskriterien.Masseinheit |
EvidenceVariable.characteristic.extension:definitionByTypeAndValue | Forschungsvorhaben.Studiendesign.Einschlusskriterien.Wert |
EvidenceVariable.characteristic.description | Forschungsvorhaben.Studiendesign.Ausschlusskriterien.Kriterium |
EvidenceVariable.characteristic.extension:definitionByTypeAndValue | Forschungsvorhaben.Studiendesign.Ausschlusskriterien.Operator |
EvidenceVariable.characteristic.extension:definitionByTypeAndValue | Forschungsvorhaben.Studiendesign.Ausschlusskriterien.Masseinheit |
EvidenceVariable.characteristic.extension:definitionByTypeAndValue | Forschungsvorhaben.Studiendesign.Ausschlusskriterien.Wert |
Snapshot
EvidenceVariable | I | EvidenceVariable | There are no (further) constraints on this element Element IdEvidenceVariable A population, intervention, or exposure definition DefinitionThe EvidenceVariable resource describes a "PICO" element that knowledge (evidence, assertion, recommendation) is about. 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).
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url | Σ | 0..1 | uri | There are no (further) constraints on this element Element IdEvidenceVariable.url Canonical identifier for this evidence variable, represented as a URI (globally unique) DefinitionAn 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. Allows the evidence variable to be referenced by a single globally unique identifier. 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.
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identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdEvidenceVariable.identifier Additional identifier for the evidence variable DefinitionA 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. Allows externally provided and/or usable business identifiers to be easily associated with the module. 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.
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version | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.version Business version of the evidence variable DefinitionThe 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. 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].
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name | Σ I | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.name Name for this evidence variable (computer friendly) DefinitionA 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. Support human navigation and code generation. 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.
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title | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.title Name for this evidence variable (human friendly) DefinitionA short, descriptive, user-friendly title for the evidence variable. This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.
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shortTitle | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.shortTitle Title for use in informal contexts DefinitionThe short title provides an alternate title for use in informal descriptive contexts where the full, formal title is not necessary. Need to be able to reference the content by a short description, but still provide a longer, more formal title for the content. Note that FHIR strings SHALL NOT exceed 1MB in size
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subtitle | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.subtitle Subordinate title of the EvidenceVariable DefinitionAn explanatory or alternate title for the EvidenceVariable giving additional information about its content. Note that FHIR strings SHALL NOT exceed 1MB in size
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status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element IdEvidenceVariable.status draft | active | retired | unknown DefinitionThe status of this evidence variable. Enables tracking the life-cycle of the content. Allows filtering of evidence variables that are appropriate for use versus not. The lifecycle status of an artifact. PublicationStatus (required)Constraints
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date | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdEvidenceVariable.date Date last changed Alternate namesRevision Date DefinitionThe 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. 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.
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publisher | Σ | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.publisher Name of the publisher (organization or individual) DefinitionThe name of the organization or individual that published the evidence variable. Helps establish the "authority/credibility" of the evidence variable. May also allow for contact. 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.
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contact | Σ | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.contact Contact details for the publisher DefinitionContact details to assist a user in finding and communicating with the publisher. May be a web site, an email address, a telephone number, etc.
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description | Σ | 0..1 | markdown | There are no (further) constraints on this element Element IdEvidenceVariable.description Natural language description of the evidence variable DefinitionA free text natural language description of the evidence variable from a consumer's perspective. 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).
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note | 0..* | Annotation | There are no (further) constraints on this element Element IdEvidenceVariable.note Used for footnotes or explanatory notes DefinitionA human-readable string to clarify or explain concepts about the resource. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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useContext | Σ | 0..* | UsageContext | There are no (further) constraints on this element Element IdEvidenceVariable.useContext The context that the content is intended to support DefinitionThe 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. Assist in searching for appropriate content. When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.
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jurisdiction | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdEvidenceVariable.jurisdiction Intended jurisdiction for evidence variable (if applicable) DefinitionA legal or geographic region in which the evidence variable is intended to be used. It may be possible for the evidence variable to be used in jurisdictions other than those for which it was originally designed or intended. Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible)Constraints
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copyright | 0..1 | markdown | There are no (further) constraints on this element Element IdEvidenceVariable.copyright Use and/or publishing restrictions Alternate namesLicense, Restrictions DefinitionA 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. Consumers must be able to determine any legal restrictions on the use of the evidence variable and/or its content. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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approvalDate | 0..1 | date | There are no (further) constraints on this element Element IdEvidenceVariable.approvalDate When the evidence variable was approved by publisher DefinitionThe date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage. The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.
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lastReviewDate | 0..1 | date | There are no (further) constraints on this element Element IdEvidenceVariable.lastReviewDate When the evidence variable was last reviewed DefinitionThe date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date. 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. If specified, this date follows the original approval date.
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effectivePeriod | Σ I | 0..1 | Period | There are no (further) constraints on this element Element IdEvidenceVariable.effectivePeriod When the evidence variable is expected to be used DefinitionThe period during which the evidence variable content was or is planned to be in active use. 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. 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.
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topic | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdEvidenceVariable.topic The category of the EvidenceVariable, such as Education, Treatment, Assessment, etc. DefinitionDescriptive 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. Repositories must be able to determine how to categorize the EvidenceVariable so that it can be found by topical searches. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. High-level categorization of the definition, used for searching, sorting, and filtering. DefinitionTopic (example)Constraints
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author | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.author Who authored the content DefinitionAn individiual or organization primarily involved in the creation and maintenance of the content.
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editor | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.editor Who edited the content DefinitionAn individual or organization primarily responsible for internal coherence of the content.
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reviewer | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.reviewer Who reviewed the content DefinitionAn individual or organization primarily responsible for review of some aspect of the content.
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endorser | 0..* | ContactDetail | There are no (further) constraints on this element Element IdEvidenceVariable.endorser Who endorsed the content DefinitionAn individual or organization responsible for officially endorsing the content for use in some setting.
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relatedArtifact | 0..* | RelatedArtifact | There are no (further) constraints on this element Element IdEvidenceVariable.relatedArtifact Additional documentation, citations, etc. DefinitionRelated artifacts such as additional documentation, justification, or bibliographic references. 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. Each related artifact is either an attachment, or a reference to another resource, but not both.
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type | Σ | 0..1 | codeBinding | There are no (further) constraints on this element Element IdEvidenceVariable.type dichotomous | continuous | descriptive DefinitionThe type of evidence element, a population, an exposure, or an outcome. Note that FHIR strings SHALL NOT exceed 1MB in size The possible types of variables for exposures or outcomes (E.g. Dichotomous, Continuous, Descriptive). EvidenceVariableType (required)Constraints
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characteristic | S Σ | 1..* | BackboneElement | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic What defines the members of the evidence element DefinitionA characteristic that defines the members of the evidence element. Multiple characteristics are applied with "and" semantics. 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.
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extension | S I | 0..* | Extension | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Constraints
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linkId | S I | 0..1 | Extension(id) | Element IdEvidenceVariable.characteristic.extension:linkId MII EX Studie Backport linkId Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId Constraints
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definitionReference | S I | 0..1 | Extension(Reference(EvidenceVariable | Evidence | Group)) | Element IdEvidenceVariable.characteristic.extension:definitionReference MII EX Studie Backport definitionReference Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Reference(EvidenceVariable | Evidence | Group)) Extension URL Constraints
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definitionCanonical | S I | 0..1 | Extension(canonical(EvidenceVariable | Evidence)) | Element IdEvidenceVariable.characteristic.extension:definitionCanonical MII EX Studie Backport definitionCanonical Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(canonical(EvidenceVariable | Evidence)) Extension URL Constraints
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definitionByTypeAndValue | S I | 0..1 | Extension(Complex) | Element IdEvidenceVariable.characteristic.extension:definitionByTypeAndValue MII EX Studie Backport DefinitionByTypeAndValue Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Complex) Extension URL Constraints
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definitionByCombination | S I | 0..1 | Extension(Complex) | Element IdEvidenceVariable.characteristic.extension:definitionByCombination MII EX Studie Backport DefinitionByCombination Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Complex) Extension URL Constraints
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description | S | 0..1 | string | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.description Natural language description of the characteristic DefinitionA short, natural language description of the characteristic that could be used to communicate the criteria to an end-user. Need to be able to describe characteristics in natural language so that end users can understand the criteria. Note that FHIR strings SHALL NOT exceed 1MB in size
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definition[x] | S Σ | 1..1 | Element IdEvidenceVariable.characteristic.definition[x] What code or expression defines members? DefinitionDefine 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). 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. Unordered, Open, by $this(Type) Constraints
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definitionCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
definitionExpression | Expression | There are no (further) constraints on this element Data Type | ||
definitionReference | Σ | 0..0 | Reference(Group) | Element IdEvidenceVariable.characteristic.definition[x]:definitionReference What code or expression defines members? DefinitionDefine 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). 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.
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definitionCanonical | Σ | 0..0 | canonical(ActivityDefinition) | Element IdEvidenceVariable.characteristic.definition[x]:definitionCanonical What code or expression defines members? DefinitionDefine 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). 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.
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definitionDataRequirement | Σ | 0..0 | DataRequirement | Element IdEvidenceVariable.characteristic.definition[x]:definitionDataRequirement What code or expression defines members? DefinitionDefine 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). 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.
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definitionTriggerDefinition | Σ | 0..0 | TriggerDefinition | Element IdEvidenceVariable.characteristic.definition[x]:definitionTriggerDefinition What code or expression defines members? DefinitionDefine 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). 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.
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usageContext | 0..0 | UsageContext | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.usageContext What code/value pairs define members? DefinitionUse UsageContext to define the members of the population, such as Age Ranges, Genders, Settings. Need to be able to define members more structurally when more information can be communicated such as age range.
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exclude | S | 0..1 | boolean | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.exclude Whether the characteristic includes or excludes members DefinitionWhen true, members with this characteristic are excluded from the element. False
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participantEffective[x] | 0..1 | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.participantEffective[x] What time period do participants cover DefinitionIndicates what effective period the study covers.
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participantEffectiveDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
participantEffectivePeriod | Period | There are no (further) constraints on this element Data Type | ||
participantEffectiveDuration | Duration | There are no (further) constraints on this element Data Type | ||
participantEffectiveTiming | Timing | There are no (further) constraints on this element Data Type | ||
timeFromStart | I | 0..1 | Duration | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.timeFromStart Observation time from study start DefinitionIndicates duration from the participant's study entry. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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groupMeasure | 0..1 | codeBinding | There are no (further) constraints on this element Element IdEvidenceVariable.characteristic.groupMeasure mean | median | mean-of-mean | mean-of-median | median-of-mean | median-of-median DefinitionIndicates how elements are aggregated within the study effective period. Note that FHIR strings SHALL NOT exceed 1MB in size Possible group measure aggregates (E.g. Mean, Median). GroupMeasure (required)Constraints
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Suchparameter
Folgende Suchparameter sind für das Modul Studie relevant, auch in Kombination:
Der Suchparameter "_id" MUSS unterstützt werden:
Beispiele:
GET [base]/ResearchStudy?_id=103270
Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter "_profile" MUSS unterstützt werden:
Beispiele:
GET [base]/ResearchStudy?_profile=https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-ein-auschluss-kriterium
Anwendungshinweise: Weitere Informationen zur Suche nach "_profile" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter "status" MUSS unterstützt werden:
Beispiele
GET [base]/ResearchStudy?status=active
Anwendungshinweise: Weitere Informationen zur Suche nach "EvidenceVariable.status" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter "characteristicDescription" MUSS unterstützt werden:
Beispiele
GET [base]/EvidenceVariable?characteristicDescription=Höchstalter
Anwendungshinweise: Weitere Informationen zur Suche nach "EvidenceVariable.characteristic.description" finden sich in der FHIR-Basisspezifikation - Abschnitt "string".
Beispiele
Beispiel (minimal):
{ "resourceType": "EvidenceVariable", "id": "mii-exa-studie-ein-auschluss-kriterium", "meta": { "profile": [ "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-ein-auschluss-kriterium" ] }, "characteristic": [ { "definitionCodeableConcept": { "text": "kein Höchstalter" }, "description": "Höchstalter", "exclude": false }, { "definitionCodeableConcept": { "text": "18 Jahre" }, "description": "Mindestalter", "exclude": false }, { "definitionCodeableConcept": { "text": "Alle" }, "description": "Geschlecht", "exclude": false }, { "extension": [ { "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId", "valueId": "aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2" } ], "definitionCodeableConcept": { "coding": [ { "code": "unknown", "system": "http://terminology.hl7.org/CodeSystem/data-absent-reason" } ] }, "description": "Kognitive Fatigue (WeiMUS kognitive Skala >= 17)", "exclude": false }, { "extension": [ { "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId", "valueId": "8e8f63ff-65f1-40cd-bf79-da83d7fb4e09" } ], "definitionCodeableConcept": { "coding": [ { "code": "unknown", "system": "http://terminology.hl7.org/CodeSystem/data-absent-reason" } ] }, "description": "Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt", "exclude": false }, { "extension": [ { "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByCombination", "extension": [ { "url": "code", "valueCode": "any-of" }, { "url": "characteristic", "valueId": "aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2" }, { "url": "characteristic", "valueId": "8e8f63ff-65f1-40cd-bf79-da83d7fb4e09" } ] } ], "definitionCodeableConcept": { "coding": [ { "code": "unknown", "system": "http://terminology.hl7.org/CodeSystem/data-absent-reason" } ] }, "description": "Weitere Einschlusskriterien", "exclude": false }, { "definitionCodeableConcept": { "coding": [ { "code": "unknown", "system": "http://terminology.hl7.org/CodeSystem/data-absent-reason" } ] }, "description": "diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen", "exclude": true }, { "definitionCodeableConcept": { "coding": [ { "code": "unknown", "system": "http://terminology.hl7.org/CodeSystem/data-absent-reason" } ] }, "description": "Einnahme von Antidepressiva, Opioiden, Antikonvulsiva", "exclude": true }, { "definitionCodeableConcept": { "coding": [ { "code": "unknown", "system": "http://terminology.hl7.org/CodeSystem/data-absent-reason" } ] }, "description": "weitere neurologische Erkrankungen", "exclude": true } ], "status": "active" }
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