MII IG Molekulares Tumorboard DE v2025

Extensions für Behandlungsepisode: Leitliniendokumentation

Inhalt

Diese Erweiterung wird genutzt, um Vortherapien mit dem entsprechenden Therapielinie und Zulassungsstatus annotieren zu können.

Die Angabe der Therapielinie erfolgt ganzzahlig. Über den Zulassungsstatus kann eine Medikamentengabe als in-label, off-label oder leitliniengerecht gekennzeichnet werden.

Es werden in der ersten Version keine Vorgaben gemacht, nach welcher Logik die exakte Bestimmung der Therapielinien zu erfolgen hat (Kontraindikationen, wann Leitlinientherapie ausgereizt ist, etc.).

Dies erfordert übergreifende Abstimmungen, an die sich die MII mit ihrer Erfahrung gerne beteiligt, die aber sektor- und standortübergreifend einheitlich verstanden werden müssen.

Name	Status	Version	Canonical	Basis
MII_EX_MTB_Leitlinie_Dokumentation	draft	2024.0.0-ballot	https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-leitlinie-dokumentation	http://hl7.org/fhir/StructureDefinition/Extension

Inhalt

Leitliniendokumentation

MII_EX_MTB_Leitlinie_Dokumentation (Extension)	C		Extension	Element id Extension Short description MII EX MTB Leitlinie Dokumentation Definition Dokumentation zur Leitlinien-konformen Umsetzung der Prozedur Data type Extension Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints 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()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Extension.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id Extension.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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. 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. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
Therapielinie	S C	0..1	Extension	There are no (further) constraints on this element Element id Extension.extension:Therapielinie Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Extension.extension:Therapielinie.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..0	Extension	There are no (further) constraints on this element Element id Extension.extension:Therapielinie.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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. 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. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
url		1..1	uriAuto Value	Element id Extension.extension:Therapielinie.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Auto value Therapielinie Mappings rim: N/A
value[x]	S	1..1		Element id Extension.extension:Therapielinie.value[x] Short description Therapielinie Definition Therapielinie 0 bis 9 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
valueUnsignedInt			unsignedInt	Data type unsignedInt
Zulassungsstatus	S C	0..1	Extension	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..0	Extension	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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. 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. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
url		1..1	uriAuto Value	Element id Extension.extension:Zulassungsstatus.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Auto value Zulassungsstatus Mappings rim: N/A
value[x]		0..1		Element id Extension.extension:Zulassungsstatus.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Slicing Unordered, Open, by $this(Type) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
valueBase64Binary			base64Binary	There are no (further) constraints on this element Data type base64Binary
valueBoolean			boolean	There are no (further) constraints on this element Data type boolean
valueCanonical			canonical()	There are no (further) constraints on this element Data type canonical()
valueCode			code	There are no (further) constraints on this element Data type code
valueDate			date	There are no (further) constraints on this element Data type date
valueDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
valueDecimal			decimal	There are no (further) constraints on this element Data type decimal
valueId			id	There are no (further) constraints on this element Data type id
valueInstant			instant	There are no (further) constraints on this element Data type instant
valueInteger			integer	There are no (further) constraints on this element Data type integer
valueMarkdown			markdown	There are no (further) constraints on this element Data type markdown
valueOid			oid	There are no (further) constraints on this element Data type oid
valuePositiveInt			positiveInt	There are no (further) constraints on this element Data type positiveInt
valueString			string	There are no (further) constraints on this element Data type string
valueTime			time	There are no (further) constraints on this element Data type time
valueUnsignedInt			unsignedInt	There are no (further) constraints on this element Data type unsignedInt
valueUri			uri	There are no (further) constraints on this element Data type uri
valueUrl			url	There are no (further) constraints on this element Data type url
valueUuid			uuid	There are no (further) constraints on this element Data type uuid
valueAddress			Address	There are no (further) constraints on this element Data type Address
valueAge			Age	There are no (further) constraints on this element Data type Age
valueAnnotation			Annotation	There are no (further) constraints on this element Data type Annotation
valueAttachment			Attachment	There are no (further) constraints on this element Data type Attachment
valueCoding			Coding	There are no (further) constraints on this element Data type Coding
valueContactPoint			ContactPoint	There are no (further) constraints on this element Data type ContactPoint
valueCount			Count	There are no (further) constraints on this element Data type Count
valueDistance			Distance	There are no (further) constraints on this element Data type Distance
valueDuration			Duration	There are no (further) constraints on this element Data type Duration
valueHumanName			HumanName	There are no (further) constraints on this element Data type HumanName
valueIdentifier			Identifier	There are no (further) constraints on this element Data type Identifier
valueMoney			Money	There are no (further) constraints on this element Data type Money
valuePeriod			Period	There are no (further) constraints on this element Data type Period
valueQuantity			Quantity	There are no (further) constraints on this element Data type Quantity
valueRange			Range	There are no (further) constraints on this element Data type Range
valueRatio			Ratio	There are no (further) constraints on this element Data type Ratio
valueSampledData			SampledData	There are no (further) constraints on this element Data type SampledData
valueSignature			Signature	There are no (further) constraints on this element Data type Signature
valueTiming			Timing	There are no (further) constraints on this element Data type Timing
valueContactDetail			ContactDetail	There are no (further) constraints on this element Data type ContactDetail
valueContributor			Contributor	There are no (further) constraints on this element Data type Contributor
valueDataRequirement			DataRequirement	There are no (further) constraints on this element Data type DataRequirement
valueExpression			Expression	There are no (further) constraints on this element Data type Expression
valueParameterDefinition			ParameterDefinition	There are no (further) constraints on this element Data type ParameterDefinition
valueRelatedArtifact			RelatedArtifact	There are no (further) constraints on this element Data type RelatedArtifact
valueTriggerDefinition			TriggerDefinition	There are no (further) constraints on this element Data type TriggerDefinition
valueUsageContext			UsageContext	There are no (further) constraints on this element Data type UsageContext
valueDosage			Dosage	There are no (further) constraints on this element Data type Dosage
valueMeta			Meta	There are no (further) constraints on this element Data type Meta
valueReference			Reference()	There are no (further) constraints on this element Data type Reference()
valueCodeableConcept		0..1	CodeableConcept	Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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. 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. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
coding	S Σ	1..1	Coding	Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding Short description Zulassungsstatus Definition Zulassungsstatus der Leitlinientherapie Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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. 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. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
system	Σ	0..1	uriPattern	Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-zulassungsstatus Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	codeBinding	Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Binding MII_VS_MTB_Zulassungsstatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
url		1..1	uriAuto Value	Element id Extension.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Auto value https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-leitlinie-dokumentation Mappings rim: N/A
value[x]		0..0		There are no (further) constraints on this element Element id Extension.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A

Dokumentation zur Leitlinien-konformen Umsetzung der Prozedur

Feldname	Kurzbeschreibung
Extension.extension:Therapielinie
Extension.extension:Therapielinie.value[x]	Therapielinie
Extension.extension:Zulassungsstatus
Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding	Zulassungsstatus
Extension.extension:Zulassungsstatus.value[x]:valueCodeableConcept.coding.code

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Concepts

This code system https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-zulassungsstatus defines the following codes:

Code	Display	Definition
in-label	In-Label	Verwendung des Arzneimittels entsprechend der zugelassenen Indikation, Dosierung, Darreichungsform und Patientengruppe
off-label	Off-Label	Verwendung des Arzneimittels abweichend von der zugelassenen Indikation, Dosierung, Darreichungsform oder Patientengruppe
leitlinie	Leitlinie	Verwendung des Arzneimittels gemäß Leitlinienempfehlungen