Dieses Profil beschreibt ob und wann ein Patient an einer Studie teilgenommen hat.
Es beinhaltet:
Im Falle einer pharmakologischen Studie SOLLTE am besten eine Referenz zu einer Procedure / Systemischen Therapie bestehen, entweder über Observation.partOf = Reference (SystemischeTherapie), Observation.basedOn = Reference (MedicationRequest); oder Procedure.basedOn.
Außerdem fehlen noch Informationen über die genaue Studie (Organisation, StudienID etc).
Name | Status | Version | Canonical | Basis |
---|---|---|---|---|
MII_PR_Onko_Studienteilnahme | draft | 2024.0.0-ballot | https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-studienteilnahme | http://hl7.org/fhir/StructureDefinition/Observation |
MII_PR_Onko_Tod (Observation) | I | Observation | |
id | Σ | 0..1 | string |
meta | Σ | 0..1 | Meta |
id | 0..1 | string | |
extension | I | 0..* | Extension |
versionId | Σ | 0..1 | id |
lastUpdated | Σ | 0..1 | instant |
source | Σ | 0..1 | uri |
profile | S Σ | 0..* | canonical(StructureDefinition) |
security | Σ | 0..* | CodingBinding |
tag | Σ | 0..* | Coding |
implicitRules | Σ ?! | 0..1 | uri |
language | 0..1 | codeBinding | |
text | 0..1 | Narrative | |
contained | 0..* | Resource | |
extension | I | 0..* | Extension |
modifierExtension | ?! I | 0..* | Extension |
identifier | Σ | 0..* | Identifier |
basedOn | Σ I | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) |
partOf | Σ I | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) |
status | Σ ?! | 1..1 | codeBinding |
category | 0..* | CodeableConceptBinding | |
code | S Σ | 1..1 | CodeableConcept |
id | 0..1 | string | |
extension | I | 0..* | Extension |
coding | Σ | 0..* | CodingPattern |
text | Σ | 0..1 | string |
subject | S Σ I | 1..1 | Reference(Patient) |
focus | S Σ I | 0..* | Reference(MII_PR_Onko_Diagnose) |
encounter | S Σ I | 0..1 | Reference(Encounter) |
effective[x] | S Σ | 0..1 | |
effectiveDateTime | dateTime | ||
issued | Σ | 0..1 | instant |
performer | Σ I | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) |
value[x] | S Σ I | 0..1 | Binding |
valueCodeableConcept | CodeableConcept | ||
id | 0..1 | string | |
extension | I | 0..* | Extension |
coding | Σ | 0..* | Coding |
id | 0..1 | string | |
extension | I | 0..* | Extension |
system | S Σ | 1..1 | uriPattern |
version | S Σ | 1..1 | string |
code | S Σ | 1..1 | code |
display | Σ | 0..1 | string |
userSelected | Σ | 0..1 | boolean |
text | Σ | 0..1 | string |
dataAbsentReason | I | 0..1 | CodeableConceptBinding |
interpretation | S | 0..* | CodeableConceptBinding |
id | 0..1 | string | |
extension | I | 0..* | Extension |
coding | Σ | 0..* | CodingBinding |
id | 0..1 | string | |
extension | I | 0..* | Extension |
system | S Σ | 0..1 | uriPattern |
version | Σ | 0..1 | string |
code | S Σ | 0..1 | code |
display | Σ | 0..1 | string |
userSelected | Σ | 0..1 | boolean |
text | Σ | 0..1 | string |
note | 0..* | Annotation | |
bodySite | 0..1 | CodeableConcept | |
method | 0..1 | CodeableConcept | |
specimen | I | 0..1 | Reference(Specimen) |
device | I | 0..1 | Reference(Device | DeviceMetric) |
referenceRange | I | 0..* | BackboneElement |
id | 0..1 | string | |
extension | I | 0..* | Extension |
modifierExtension | Σ ?! I | 0..* | Extension |
low | I | 0..1 | SimpleQuantity |
high | I | 0..1 | SimpleQuantity |
type | 0..1 | CodeableConceptBinding | |
appliesTo | 0..* | CodeableConcept | |
age | I | 0..1 | Range |
text | 0..1 | string | |
hasMember | Σ I | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) |
derivedFrom | Σ I | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) |
component | Σ | 0..* | BackboneElement |
id | 0..1 | string | |
extension | I | 0..* | Extension |
modifierExtension | Σ ?! I | 0..* | Extension |
code | Σ | 1..1 | CodeableConcept |
value[x] | Σ | 0..1 | |
valueQuantity | Quantity | ||
valueCodeableConcept | CodeableConcept | ||
valueString | string | ||
valueBoolean | boolean | ||
valueInteger | integer | ||
valueRange | Range | ||
valueRatio | Ratio | ||
valueSampledData | SampledData | ||
valueTime | time | ||
valueDateTime | dateTime | ||
valuePeriod | Period | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding |
interpretation | 0..* | CodeableConceptBinding | |
referenceRange | 0..* | see (referenceRange) |
Dieses Profil beschreibt Studienteilnahmen in der Onkologie |
Feldname | Kurzbeschreibung |
---|---|
Observation.meta.profile | |
Observation.code | Studienteilnahme laut oBDS |
Observation.subject | |
Observation.focus | |
Observation.encounter | |
Observation.effective[x] | |
Observation.value[x] | |
Observation.value[x].coding.code |
<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="mii-pr-onko-tod" /> <url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-tod" /> <version value="2024.0.0-ballot" /> <name value="MII_PR_Onko_Tod" /> <title value="MII PR Onkologie Tod" /> <status value="draft" /> <publisher value="Medizininformatik Initiative" /> <contact> <telecom> <system value="url" /> <value value="https://www.medizininformatik-initiative.de" /> </telecom> </contact> <description value="Tumorbedingter Tod" /> <fhirVersion value="4.0.1" /> <mapping> <identity value="oBDS" /> <name value="Mapping FHIR zu oBDS" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="Observation" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Observation" /> <derivation value="constraint" /> <differential> <element id="Observation.meta.profile"> <path value="Observation.meta.profile" /> <mustSupport value="true" /> </element> <element id="Observation.code"> <path value="Observation.code" /> <mustSupport value="true" /> </element> <element id="Observation.code.coding"> <path value="Observation.code.coding" /> <patternCoding> <system value="http://snomed.info/sct" /> <code value="184305005" /> </patternCoding> </element> <element id="Observation.subject"> <path value="Observation.subject" /> <min value="1" /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient" /> </type> <mustSupport value="true" /> </element> <element id="Observation.focus"> <path value="Observation.focus" /> <type> <code value="Reference" /> <targetProfile value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose" /> </type> <mustSupport value="true" /> </element> <element id="Observation.encounter"> <path value="Observation.encounter" /> <mustSupport value="true" /> </element> <element id="Observation.effective[x]"> <path value="Observation.effective[x]" /> <type> <code value="dateTime" /> </type> <mustSupport value="true" /> <mapping> <identity value="oBDS" /> <map value="20.1" /> <comment value="Sterbedatum" /> </mapping> </element> <element id="Observation.value[x]"> <path value="Observation.value[x]" /> <type> <code value="CodeableConcept" /> </type> <mustSupport value="true" /> <binding> <strength value="required" /> <valueSet value="http://fhir.de/ValueSet/bfarm/icd-10-gm" /> </binding> </element> <element id="Observation.value[x].coding.system"> <path value="Observation.value[x].coding.system" /> <min value="1" /> <patternUri value="http://fhir.de/CodeSystem/bfarm/icd-10-gm" /> <mustSupport value="true" /> </element> <element id="Observation.value[x].coding.version"> <path value="Observation.value[x].coding.version" /> <min value="1" /> <mustSupport value="true" /> <mapping> <identity value="oBDS" /> <map value="20.4" /> <comment value="Todesursache ICD-Version" /> </mapping> </element> <element id="Observation.value[x].coding.code"> <path value="Observation.value[x].coding.code" /> <min value="1" /> <mustSupport value="true" /> <mapping> <identity value="oBDS" /> <map value="20.3" /> <comment value="Todesursache ICD" /> </mapping> </element> <element id="Observation.interpretation"> <path value="Observation.interpretation" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding"> <path value="Observation.interpretation.coding" /> <binding> <strength value="required" /> <valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-tod" /> </binding> </element> <element id="Observation.interpretation.coding.system"> <path value="Observation.interpretation.coding.system" /> <patternUri value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-strahlentherapie-ende-tod" /> <mustSupport value="true" /> </element> <element id="Observation.interpretation.coding.code"> <path value="Observation.interpretation.coding.code" /> <mustSupport value="true" /> <mapping> <identity value="oBDS" /> <map value="20.2" /> <comment value="Tod tumorbedingt" /> </mapping> </element> </differential> </StructureDefinition>
{ "resourceType": "StructureDefinition", "id": "mii-pr-onko-tod", "url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-tod", "version": "2024.0.0-ballot", "name": "MII_PR_Onko_Tod", "title": "MII PR Onkologie Tod", "status": "draft", "publisher": "Medizininformatik Initiative", "contact": [ { "telecom": [ { "system": "url", "value": "https://www.medizininformatik-initiative.de" } ] } ], "description": "Tumorbedingter Tod", "fhirVersion": "4.0.1", "mapping": [ { "identity": "oBDS", "name": "Mapping FHIR zu oBDS" } ], "kind": "resource", "abstract": false, "type": "Observation", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Observation", "derivation": "constraint", "differential": { "element": [ { "id": "Observation.meta.profile", "path": "Observation.meta.profile", "mustSupport": true }, { "id": "Observation.code", "path": "Observation.code", "mustSupport": true }, { "id": "Observation.code.coding", "path": "Observation.code.coding", "patternCoding": { "code": "184305005", "system": "http://snomed.info/sct" } }, { "id": "Observation.subject", "path": "Observation.subject", "min": 1, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Patient" ] } ], "mustSupport": true }, { "id": "Observation.focus", "path": "Observation.focus", "type": [ { "code": "Reference", "targetProfile": [ "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose" ] } ], "mustSupport": true }, { "id": "Observation.encounter", "path": "Observation.encounter", "mustSupport": true }, { "id": "Observation.effective[x]", "path": "Observation.effective[x]", "type": [ { "code": "dateTime" } ], "mustSupport": true, "mapping": [ { "identity": "oBDS", "map": "20.1", "comment": "Sterbedatum" } ] }, { "id": "Observation.value[x]", "path": "Observation.value[x]", "type": [ { "code": "CodeableConcept" } ], "mustSupport": true, "binding": { "strength": "required", "valueSet": "http://fhir.de/ValueSet/bfarm/icd-10-gm" } }, { "id": "Observation.value[x].coding.system", "path": "Observation.value[x].coding.system", "min": 1, "patternUri": "http://fhir.de/CodeSystem/bfarm/icd-10-gm", "mustSupport": true }, { "id": "Observation.value[x].coding.version", "path": "Observation.value[x].coding.version", "min": 1, "mustSupport": true, "mapping": [ { "identity": "oBDS", "map": "20.4", "comment": "Todesursache ICD-Version " } ] }, { "id": "Observation.value[x].coding.code", "path": "Observation.value[x].coding.code", "min": 1, "mustSupport": true, "mapping": [ { "identity": "oBDS", "map": "20.3", "comment": "Todesursache ICD " } ] }, { "id": "Observation.interpretation", "path": "Observation.interpretation", "mustSupport": true }, { "id": "Observation.interpretation.coding", "path": "Observation.interpretation.coding", "binding": { "strength": "required", "valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-tod" } }, { "id": "Observation.interpretation.coding.system", "path": "Observation.interpretation.coding.system", "patternUri": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-strahlentherapie-ende-tod", "mustSupport": true }, { "id": "Observation.interpretation.coding.code", "path": "Observation.interpretation.coding.code", "mustSupport": true, "mapping": [ { "identity": "oBDS", "map": "20.2", "comment": "Tod tumorbedingt" } ] } ] } }
Mapping Datensatz zu FHIR
Datensatz | Erklaerung | FHIR |
---|---|---|
Studienteilnahme | Studienteilnahme | Observation |
Studienteilnahme Status | Einschluss in eine Studie mit Ethikvotum | Observation.valueCodeableConcept.coding.code |
Studienteilnahme Datum | Erstes Einschlussdatum einer Studie mit Ethikvotum | Observation.effectiveDateTime |
Mapping Einheitlicher onkologischer Basisdatensatz (oBDS) zu FHIR
oBDS | Definition | FHIR |
---|---|---|
24 | Studienteilnahme | Observation |
24.2 | Studienteilnahme Datum | Observation.effective[x] |
24.1 | Studienteilnahme Status | Observation.value[x].coding.code |
Suchparameter
Folgende Suchparameter sind für das Modul Onkologie relevant, auch in Kombination:
Der Suchparameter _id
MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?_id=1234
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]/Observation?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-tod
Anwendungshinweise: Weitere Informationen zur Suche nach "_profile" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter "code" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?code=http://fhir.de/CodeSystem/sct|70709491003
Anwendungshinweise: Weitere Informationen zur Suche nach "code" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter "subject" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?subject=Patient/example
Anwendungshinweise: Weitere Informationen zur Suche nach "subject" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Der Suchparameter "focus" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?focus=Condition/example
Anwendungshinweise: Weitere Informationen zur Suche nach "focus" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Der Suchparameter "encounter" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?encounter=Encounter/example
Anwendungshinweise: Weitere Informationen zur Suche nach "encounter" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Der Suchparameter "date" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?date=2024-02-08
Anwendungshinweise: Weitere Informationen zur Suche nach "date" finden sich in der FHIR-Basisspezifikation - Abschnitt "date".
Der Suchparameter "derived-from" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?derived-from=Observation/example
Anwendungshinweise: Weitere Informationen zur Suche nach "derived-from" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Beispiele
{ "resourceType": "Observation", "id": "mii-exa-onko-studienteilnahme", "meta": { "profile": [ "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-studienteilnahme" ] }, "code": { "coding": [ { "code": "70709491003", "system": "http://snomed.info/sct" } ] }, "status": "final", "subject": { "reference": "Patient/example" }, "focus": [ { "reference": "Condition/exampleOncologicCondition" } ], "effectiveDateTime": "2024-01-02", "valueCodeableConcept": { "coding": [ { "code": "J" } ] } }