MII IG Molekulares Tumorboard DE v2025

Extensions für Therapieempfehlung: Evidenzgraduierung

Inhalt

Diese Extension gibt den Evidenzgrad inkl. optionalem Zusatzverweis an, der vom Molekularen Tumorboard einer Empfehlung zugewiesen wurde.

Dieser Evidenzgrad basiert auf der höchsten Evidenz, die eine Therapie dieser Art bei einer vergleichbaren Patientenkohorte zum MTB-Zeitpunkt zu finden ist. Es ist anzunehmen, dass wirksame Therapien im Laufe der Zeit ein stärkeres Evidenzlevel bekommen.

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

Inhalt

MII_EX_MTB_Empfehlung_Evidenzgraduierung (Extension)	I		Extension	Element id Extension Short description MII EX MTB Empfehlung Evidenzgraduierung Definition Evidenzgraduierung der (einzelnen) Empfehlung 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 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	I	0..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 Sliced: 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	uriFixed 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 Fixed value https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-empfehlung-evidenzgraduierung Mappings rim: N/A
value[x]	S	1..1		Element id Extension.value[x] Short description Evidenzgraduierung Definition Evidenzgraduierung für Biomarker-basierte Empfehlung Comments Evidenzgraduierung wird durch einen Evidenzgrad und einen optionalen Zusatzverweis angegeben Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
valueCodeableConcept			CodeableConcept	Data type CodeableConcept
id		0..1	string	There are no (further) constraints on this element Element id Extension.value[x].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	I	0..*	Extension	There are no (further) constraints on this element Element id Extension.value[x].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 Sliced: 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..*	Coding	Element id Extension.value[x].coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. 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 Sliced: Unordered, Open, by system(Value) Slice für die Evidenzgraduierung anhand von `system` 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
Evidenzgrad	S Σ	1..1	Coding	Element id Extension.value[x].coding:Evidenzgrad Short description Evidenzgrad Definition Evidenzgrad der Empfehlung 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.value[x].coding:Evidenzgrad.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	I	0..*	Extension	There are no (further) constraints on this element Element id Extension.value[x].coding:Evidenzgrad.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 Sliced: 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	1..1	uriPattern	Element id Extension.value[x].coding:Evidenzgrad.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-empfehlung-evidenzgrad 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.value[x].coding:Evidenzgrad.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	code	There are no (further) constraints on this element Element id Extension.value[x].coding:Evidenzgrad.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 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.value[x].coding:Evidenzgrad.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.value[x].coding:Evidenzgrad.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 ]
Zusatzverweis	S Σ	0..*	Coding	Element id Extension.value[x].coding:Zusatzverweis Short description Zusatzverweis Definition Zusatzverweis zum Evidenzgrad 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.value[x].coding:Zusatzverweis.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	I	0..*	Extension	There are no (further) constraints on this element Element id Extension.value[x].coding:Zusatzverweis.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 Sliced: 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	1..1	uriPattern	Element id Extension.value[x].coding:Zusatzverweis.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-empfehlung-evidenzgrad-zusatzverweis 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.value[x].coding:Zusatzverweis.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	code	There are no (further) constraints on this element Element id Extension.value[x].coding:Zusatzverweis.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 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.value[x].coding:Zusatzverweis.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.value[x].coding:Zusatzverweis.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.value[x].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

Evidenzgraduierung der (einzelnen) Empfehlung

Feldname	Kurzbeschreibung	Hinweise
Extension.value[x]	Evidenzgraduierung	Evidenzgraduierung wird durch einen Evidenzgrad und einen optionalen Zusatzverweis angegeben
Extension.value[x].coding
Extension.value[x].coding:Evidenzgrad	Evidenzgrad
Extension.value[x].coding:Evidenzgrad.code
Extension.value[x].coding:Zusatzverweis	Zusatzverweis
Extension.value[x].coding:Zusatzverweis.code

<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="mii-ex-mtb-empfehlung-evidenzgraduierung" />
    <url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-empfehlung-evidenzgraduierung" />
    <version value="2024.0.0-ballot" />
    <name value="MII_EX_MTB_Empfehlung_Evidenzgraduierung" />
    <title value="MII EX MTB Empfehlung Evidenzgraduierung" />
    <status value="draft" />
    <publisher value="Medizininformatik Initiative" />
    <contact>
        <telecom>
            <system value="url" />
            <value value="https://www.medizininformatik-initiative.de" />
        </telecom>
    </contact>
    <description value="Evidenzgraduierung der (einzelnen) Empfehlung" />
    <fhirVersion value="4.0.1" />
    <kind value="complex-type" />
    <abstract value="false" />
    <context>
        <type value="element" />
        <expression value="RequestGroup" />
    </context>
    <context>
        <type value="element" />
        <expression value="MedicationRequest" />
    </context>
    <type value="Extension" />
    <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Extension" />
    <derivation value="constraint" />
    <differential>
        <element id="Extension">
            <path value="Extension" />
            <short value="MII EX MTB Empfehlung Evidenzgraduierung" />
            <definition value="Evidenzgraduierung der (einzelnen) Empfehlung" />
        </element>
        <element id="Extension.extension">
            <path value="Extension.extension" />
            <max value="0" />
        </element>
        <element id="Extension.url">
            <path value="Extension.url" />
            <fixedUri value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-empfehlung-evidenzgraduierung" />
        </element>
        <element id="Extension.value[x]">
            <path value="Extension.value[x]" />
            <short value="Evidenzgraduierung" />
            <definition value="Evidenzgraduierung f&#252;r Biomarker-basierte Empfehlung" />
            <comment value="Evidenzgraduierung wird durch einen Evidenzgrad und einen optionalen Zusatzverweis angegeben" />
            <min value="1" />
            <type>
                <code value="CodeableConcept" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Extension.value[x].coding">
            <path value="Extension.value[x].coding" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="system" />
                </discriminator>
                <description value="Slice f&#252;r die Evidenzgraduierung anhand von `system`" />
                <ordered value="false" />
                <rules value="open" />
            </slicing>
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Extension.value[x].coding:Evidenzgrad">
            <path value="Extension.value[x].coding" />
            <sliceName value="Evidenzgrad" />
            <short value="Evidenzgrad" />
            <definition value="Evidenzgrad der Empfehlung" />
            <min value="1" />
            <max value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Extension.value[x].coding:Evidenzgrad.system">
            <path value="Extension.value[x].coding.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-empfehlung-evidenzgrad" />
        </element>
        <element id="Extension.value[x].coding:Evidenzgrad.code">
            <path value="Extension.value[x].coding.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Extension.value[x].coding:Zusatzverweis">
            <path value="Extension.value[x].coding" />
            <sliceName value="Zusatzverweis" />
            <short value="Zusatzverweis" />
            <definition value="Zusatzverweis zum Evidenzgrad" />
            <min value="0" />
            <max value="*" />
            <mustSupport value="true" />
        </element>
        <element id="Extension.value[x].coding:Zusatzverweis.system">
            <path value="Extension.value[x].coding.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-empfehlung-evidenzgrad-zusatzverweis" />
        </element>
        <element id="Extension.value[x].coding:Zusatzverweis.code">
            <path value="Extension.value[x].coding.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
    </differential>
</StructureDefinition>

{
    "resourceType": "StructureDefinition",
    "id": "mii-ex-mtb-empfehlung-evidenzgraduierung",
    "url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-empfehlung-evidenzgraduierung",
    "version": "2024.0.0-ballot",
    "name": "MII_EX_MTB_Empfehlung_Evidenzgraduierung",
    "title": "MII EX MTB Empfehlung Evidenzgraduierung",
    "status": "draft",
    "publisher": "Medizininformatik Initiative",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.medizininformatik-initiative.de"
                }
            ]
        }
    ],
    "description": "Evidenzgraduierung der (einzelnen) Empfehlung",
    "fhirVersion": "4.0.1",
    "kind": "complex-type",
    "abstract": false,
    "context":  [
        {
            "expression": "RequestGroup",
            "type": "element"
        },
        {
            "expression": "MedicationRequest",
            "type": "element"
        }
    ],
    "type": "Extension",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Extension",
                "path": "Extension",
                "short": "MII EX MTB Empfehlung Evidenzgraduierung",
                "definition": "Evidenzgraduierung der (einzelnen) Empfehlung"
            },
            {
                "id": "Extension.extension",
                "path": "Extension.extension",
                "max": "0"
            },
            {
                "id": "Extension.url",
                "path": "Extension.url",
                "fixedUri": "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-empfehlung-evidenzgraduierung"
            },
            {
                "id": "Extension.value[x]",
                "path": "Extension.value[x]",
                "short": "Evidenzgraduierung",
                "definition": "Evidenzgraduierung für Biomarker-basierte Empfehlung",
                "comment": "Evidenzgraduierung wird durch einen Evidenzgrad und einen optionalen Zusatzverweis angegeben",
                "min": 1,
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Extension.value[x].coding",
                "path": "Extension.value[x].coding",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "system"
                        }
                    ],
                    "rules": "open",
                    "description": "Slice für die Evidenzgraduierung anhand von `system`",
                    "ordered": false
                },
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Extension.value[x].coding:Evidenzgrad",
                "path": "Extension.value[x].coding",
                "sliceName": "Evidenzgrad",
                "short": "Evidenzgrad",
                "definition": "Evidenzgrad der Empfehlung",
                "min": 1,
                "max": "1",
                "mustSupport": true
            },
            {
                "id": "Extension.value[x].coding:Evidenzgrad.system",
                "path": "Extension.value[x].coding.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-empfehlung-evidenzgrad"
            },
            {
                "id": "Extension.value[x].coding:Evidenzgrad.code",
                "path": "Extension.value[x].coding.code",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Extension.value[x].coding:Zusatzverweis",
                "path": "Extension.value[x].coding",
                "sliceName": "Zusatzverweis",
                "short": "Zusatzverweis",
                "definition": "Zusatzverweis zum Evidenzgrad",
                "min": 0,
                "max": "*",
                "mustSupport": true
            },
            {
                "id": "Extension.value[x].coding:Zusatzverweis.system",
                "path": "Extension.value[x].coding.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-empfehlung-evidenzgrad-zusatzverweis"
            },
            {
                "id": "Extension.value[x].coding:Zusatzverweis.code",
                "path": "Extension.value[x].coding.code",
                "min": 1,
                "mustSupport": true
            }
        ]
    }
}

MII EX MTB Empfehlung Evidenzgraduierung

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

Code	Display	Definition
m1A	m1A	In der gleichen Tumorentität wurde der prädiktive Wert des Biomarkers oder die klinische Wirksamkeit in einer Biomarker-stratifizierten Kohorte einer adäquat gepowerten prospektiven Studie oder Metaanalyse gezeigt.
m1B	m1B	In der gleichen Tumorentität wurde der prädiktive Wert des Biomarkers oder die klinische Wirksamkeit in einer retrospektiven Kohorte oder Fall-Kontroll-Studie gezeigt.
m1C	m1C	Ein oder mehrere Fallberichte in der gleichen Tumorentität.
m2A	m2A	In einer anderen Tumorentität wurde der prädiktive Wert des Biomarkers oder die klinische Wirksamkeit in einer Biomarker-stratifizierten Kohorte einer adäquat gepowerten prospektiven Studie oder Metaanalyse gezeigt.
m2B	m2B	In einer anderen Tumorentität wurde der prädiktive Wert des Biomarkers oder die Klinische Wirksamkeit in einer retrospektiven Kohorte oder Fall-Kontroll-Studie gezeigt.
m2C	m2C	Unabhängig von der Tumorentität wurde beim Vorliegen des Biomarkers eine klinische Wirksamkeit in einem oder mehreren Fallberichten gezeigt.
m3	m3	Präklinische Daten (in vitro-/in vivo-Modelle, funktionelle Untersuchungen) zeigen eine Assoziation des Biomarkers mit der Wirksamkeit der Medikation, welche durch eine wissenschaftliche Rationale gestützt wird.
m4	m4	Eine wissenschaftliche, biologische Rationale legt eine Assoziation des Biomarkers mit der Wirksamkeit der Medikation nahe, welche bisher nicht durch (prä)klinische Daten gestützt wird.
undefined	N/A	Nicht verfügbar

Additional Language Displays

Code	English (English, en)
m1A	Predictive value of the biomarker or clinical effectiveness of the corresponding drug in a molecularly stratified cohort was demonstrated in a prospective study or a meta-analysis in the same tumor type.
m1B	Predictive value of the biomarker or clinical effectiveness of the drug in a molecularly stratified cohort was demonstrated in a retrospective cohort or case–control study in the same tumor type.
m1C	Case study or single unusual responder indicates the biomarker is associated with response to the drug in the same tumor type.
m2A	Predictive value of the biomarker or clinical effectiveness of the corresponding drug in a molecularly stratified cohort was demonstrated in a prospective study or a meta-analysis in a different tumor type.
m2B	Predictive value of the biomarker or clinical effectiveness of the drug in a molecularly stratified cohort was demonstrated in a retrospective cohort or case–control study in a different tumor type.
m2C	Case study or single unusual responder indicates the biomarker is associated with response to the drug in a different tumor type.
m3	Preclinical data (in vitro, in vivo models or functional genomics studies) demonstrate that the biomarker predicts response to a specific drug treatment, supported by scientific rationale.
m4	Biological rationale that associates the biomarker with altered signaling pathway activity or drug sensitivity without direct clinical or preclinical evidence for response to the drug.
undefined	Not available

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

Code	Display	Definition
is	is	In situ-Daten aus Untersuchungen an Patientenmaterial (z.B. IHC, FISH) unterstützen den Evidenzgrad. Die unterstützende Methode kann in Klammern zusätzlich angegeben werden, z.B. Evidenzgrad 3 is (IHC).
iv	iv	In vitro-Daten/ in vivo-Modelle (z.B. PDX-Modelle) derselben Tumorentität unterstützen den Evidenzgrad. Die unterstützende Methode kann in Klammern angegeben werden, z.B. Evidenzgrad 2 iv (PDX).
Z	Z	Zusatzverweis für Zulassungsstatus (Z = EMA-Zulassung liegt vor; Z (FDA) = nur FDA-Zulassung vorhanden)
R	R	Verweis, dass es sich hierbei um einen Resistenzmarker für eine bestimmte Therapie handelt

Additional Language Displays

Code	English (English, en)
is	Several in situ data and studies on patient material (e.g., IHC, FISH) support the biomarker and the level of evidence.
iv	in vitro data
Z	Drug is approved for use with the specific biomarker [Z = EMA approval, Z(FDA) = FDA approval]
R	Biomarker predicts resistance to the drug.