Systemic and Watchful Therapy

This profile describes a systemic or watchful therapy in oncology.
NameStatusVersionCanonicalBasis
MII_PR_Onko_Systemische_Therapieactive2025.1.0https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-systemische-therapiehttps://www.medizininformatik-initiative.de/fhir/core/modul-prozedur/StructureDefinition/Procedure

Description

In the oBDS, several clinical concepts are represented within systemic therapy:
  • Systemic therapies
    • Chemotherapy
    • Immunotherapy
    • Targeted therapy
    • Combination therapies of the above therapies
    • Hormone therapy
    • Stem cell and bone marrow transplantation
  • Watchful therapies
    • Watchful waiting
    • Active surveillance
    • Wait and see
For these individual therapies, additional data elements are recorded in the oBDS and represented here, including:
  • Start and end time of the therapy
  • Relationship to surgery and intention of the therapy
  • The reason for termination (whether successful or unsuccessful).

Category

  • The MII procedure recommends mapping the category using the OPS main categories transferred in SNOMED (https://www.medizininformatik-initiative.de/fhir/core/modul-prozedur/ValueSet/procedures-category-sct)
  • The present category SNOMED 277132007 | Therapeutic procedure, which corresponds to the OPS category 8 ("Non-operative therapeutic measures"), includes both radiation and nuclear medicine therapy as well as certain systemic therapies (e.g., chemo and immunotherapy), while other systemic drug therapies (e.g., hormone therapy, targeted therapy) can also be coded under category 6 "Drugs". It is therefore non-specific and not suitable for filtering specifically for nuclear medicine therapies within a research question.

Code

  • The code required by the MII procedure is an OPS code or a SNOMED code.
  • Medication-based systemic therapies are coded according to the type of therapy through different OPS categories.
  • For watchful therapies, no OPS codes are currently available in the catalog.
  • In the MII procedure, exactly one coding (OPS or SNOMED CT) SHOULD be used for exactly one therapy. Additional procedures are represented as individual Procedure resources.

Implementation Recommendation

Based on the above points, the following coding recommendation for systemic/watchful therapy from the oBDS is derived:
  • Category as SNOMED code
    • Category for systemic therapies 18629005 | Administration of drug or medicament (procedure)
    • Category for watchful therapies: none (no suitable parent concept, search directly via coding recommended)
  • Coding
    • Systemic therapy via OPS as follows. It should be noted that the exact active substance is coded using ATC as part of the MedicationStatement resource. Additional documentation of the medication via
      • Chemotherapy via OPS 8-54 or more specific
      • Immunotherapy via OPS 8-54 or more specific (additional specification of)
      • Stem cell therapy via OPS 8-86 or more specific
      • Hormone therapy via OPS 6-xxx.y (e.g., 6-009.0 for Olaparib, oral for prostate cancer)
    • Watchful therapy via SNOMED-CT as follows
      • Watchful waiting: SNOMED-CT 373818007 | No anti-cancer treatment - watchful waiting (finding)
      • Active surveillance: SNOMED-CT 424313000 | Active surveillance (regime/therapy)
      • Wait and see: SNOMED-CT 310341009 | Follow-up (wait and see) (finding)

Conformity

The present profiling is compatible with the procedure profile of the ISiK basic modules level 4. https://simplifier.net/isik-basis-v4/isikprozedur

Content

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Systemische Therapie. Dieses Profil beschreibt eine Systemische Therapie für den oBDS. Da die Granularität der Anforderungen des oBDS nicht deckungsgleich mit den FHIR-Profilen für Medikation sind, wurde die Systemische Therapie als Prozedur umgesetzt

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"definition": "Stellung der systemischen Therapie zu einer Operation gemäß 16.2 oBDS 2021.",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Stellung der systemischen Therapie zu einer Operation gemäß 16.2 oBDS 2021."
}
]
}
]
}
},
{
"id": "Procedure.extension:StellungZurOp.value[x].coding.code",
"path": "Procedure.extension.value[x].coding.code",
"mapping": [
{
"identity": "oBDS",
"map": "16.2",
"comment": "Systemische Therapie Stellung zu operativer Therapie"
}
]
},
{
"id": "Procedure.basedOn",
"path": "Procedure.basedOn",
"type": [
{
"code": "Reference",
"http://hl7.org/fhir/StructureDefinition/CarePlan"
]
}
],
"mustSupport": true
},
{
"id": "Procedure.partOf",
"path": "Procedure.partOf",
"mustSupport": true
},
{
"id": "Procedure.code",
"path": "Procedure.code",
"definition": "Enthält den Code, der neben der oBDS-spezifischen Kodierungden optional mit Codings für OPS und SNOMED annotiert werden kann",
"comment": "Primäre Befüllung aus den oBDS / Tumordokumentatiosndaten. Beim Zusammenführen mit Daten aus KIS und anderen Quellen können hier ebenfalls OPS- und SNOMED-CT-Codings hinterlegt werden"
},
{
"id": "Procedure.code.coding",
"path": "Procedure.code.coding"
},
{
"id": "Procedure.code.coding.code",
"path": "Procedure.code.coding.code",
"mapping": [
{
"identity": "oBDS",
"map": "16.3",
"comment": "Art der systemischen oder abwartenden Therapie"
}
]
},
{
"id": "Procedure.code.coding:systemische_therapie_art",
"path": "Procedure.code.coding",
"sliceName": "systemische_therapie_art",
"short": "Art der systemischen oder abwartenden Therapie",
"_short": {
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Art der systemischen oder abwartenden Therapie"
}
]
}
]
},
"definition": "Art der systemischen oder abwartenden Therapie gemäß 16.3 oBDS 2021.",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Art der systemischen oder abwartenden Therapie gemäß 16.3 oBDS 2021."
}
]
}
]
},
"min": 0,
"max": "1",
"binding": {
"strength": "required",
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-systemische-therapie-art"
}
},
{
"id": "Procedure.code.coding:systemische_therapie_art.system",
"path": "Procedure.code.coding.system",
"min": 1
},
{
"id": "Procedure.code.coding:systemische_therapie_art.code",
"path": "Procedure.code.coding.code",
"min": 1
},
{
"id": "Procedure.subject",
"path": "Procedure.subject",
"type": [
{
"code": "Reference",
"http://hl7.org/fhir/StructureDefinition/Patient"
]
}
]
},
{
"id": "Procedure.encounter",
"path": "Procedure.encounter",
"mustSupport": true
},
{
"id": "Procedure.performed[x]",
"path": "Procedure.performed[x]",
"type": [
{
"code": "Period"
}
]
},
{
"id": "Procedure.performed[x].start",
"path": "Procedure.performed[x].start",
"mapping": [
{
"identity": "oBDS",
"map": "16.6",
"comment": "Systemische Therapie Beginn"
}
]
},
{
"id": "Procedure.performed[x].end",
"path": "Procedure.performed[x].end",
"mapping": [
{
"identity": "oBDS",
"map": "16.8",
"comment": "Systemische Therapie Ende"
}
]
},
{
"id": "Procedure.performed[x]:performedPeriod",
"path": "Procedure.performed[x]",
"sliceName": "performedPeriod",
"type": [
{
"code": "Period"
}
]
},
{
"id": "Procedure.performed[x]:performedPeriod.start",
"path": "Procedure.performed[x].start",
"short": "Startdatum der systemischen oder abwartenden Therapie",
"_short": {
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Startdatum der systemischen oder abwartenden Therapie"
}
]
}
]
},
"definition": "Startdatum der systemischen oder abwartenden Therapie gemäß 16.6 oBDS 2021.",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Startdatum der systemischen oder abwartenden Therapie gemäß 16.6 oBDS 2021."
}
]
}
]
},
"min": 1,
"mustSupport": true
},
{
"id": "Procedure.performed[x]:performedPeriod.end",
"path": "Procedure.performed[x].end",
"short": "Enddatum der systemischen oder abwartenden Therapie",
"_short": {
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Enddatum der systemischen oder abwartenden Therapie"
}
]
}
]
},
"definition": "Enddatum der systemischen oder abwartenden Therapie gemäß 16.8 oBDS 2021.",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Enddatum der systemischen oder abwartenden Therapie - wenn vorhanden - gemäß 16.8 oBDS 2021."
}
]
}
]
},
"mustSupport": true
},
{
"id": "Procedure.reasonReference",
"path": "Procedure.reasonReference",
"type": [
{
"code": "Reference",
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor",
"http://hl7.org/fhir/StructureDefinition/Condition"
]
}
],
"mustSupport": true
},
{
"id": "Procedure.outcome",
"path": "Procedure.outcome",
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-systemische-therapie-ende-grund"
}
},
{
"id": "Procedure.outcome.coding",
"path": "Procedure.outcome.coding",
"short": "Grund für Ende der systemischen oder abwartenden Therapie",
"_short": {
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Grund für Ende der systemischen oder abwartenden Therapie"
}
]
}
]
},
"definition": "Grund für Ende der systemischen oder abwartenden Therapie gemäß 16.7 oBDS 2021.",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Grund für Ende der systemischen oder abwartenden Therapie gemäß 16.7 oBDS 2021."
}
]
}
]
}
},
{
"id": "Procedure.outcome.coding.system",
"path": "Procedure.outcome.coding.system",
"mustSupport": true
},
{
"id": "Procedure.outcome.coding.code",
"path": "Procedure.outcome.coding.code",
"mustSupport": true,
"mapping": [
{
"identity": "oBDS",
"map": "16.7",
"comment": "Systemische Therapie Ende Grund"
}
]
}
]
}
}

Mapping dataset to FHIR
DatasetExplanationFHIR
Systemische Therapie

Systemische Therapie

Intention der systemischen Therapie

Intention der systemischen Therapie

Procedure.extension[Intention].valueCodeableConcept.coding.code
Systemische Therapie Stellung zu operativer Therapie

Gibt an, in welchem Bezug zu einer operativen Therapie die systemische Therapie steht.

Procedure.extension[Stellung].valueCodeableConcept.coding.code
Art der systemischen oder abwartenden Therapie

Gibt an, welche Art der Therapie bzw. abwartende Strategie durchgeführt wurde.

Procedure.code.coding.code
Systemische Therapie Protokoll

Gibt an, nach welchem Protokoll die Systemtherapie durchgeführt wurde.

MedicationStatement.medicationCodeableConcept.text
Systemische Therapie Substanz

Gibt an, mit welcher Substanz die Systemtherapie durchgeführt wurde. Nach Möglichkeit ATC kodiert. Mehrere Substanzen sind jeweils einzeln zu kodieren.

MedicationStatement.medicationCodeableConcept[atcClassDe].coding.code
Systemische Therapie Beginn

Gibt an, wann die systemische Therapie begonnen wurde.

Procedure.performedPeriod.start
Systemische Therapie Ende Grund

Gibt den Grund an, warum die Systemtherapie beendet wurde.

Procedure.performedPeriod.end
Systemische Therapie Ende

Gibt an, wann die systemische Therapie beendet wurde.

Procedure.outcome.coding.code

Mapping Unified Oncological Basic Dataset (oBDS) to FHIR
oBDSDefinitionFHIR
16Systemische TherapieProcedure
16.1Intention der systemischen TherapieProcedure.extension.value[x].coding.code
16.2Systemische Therapie Stellung zu operativer TherapieProcedure.extension.value[x].coding.code
16.3Art der systemischen oder abwartenden TherapieProcedure.code.coding.code
16.6Systemische Therapie BeginnProcedure.performed[x].start
16.8Systemische Therapie EndeProcedure.performed[x].end
16.7Systemische Therapie Ende GrundProcedure.outcome.coding.code

Search ParametersThe following search parameters are relevant for the oncology module, also in combination:
  1. The search parameter "_id" MUST be supported:

    Examples:

    GET [base]/Procedure?_id=103270

    Application notes: Further information on searching by "_id" can be found in the FHIR base specification - section "Parameters for all resources".

  2. The search parameter "_profile" MUST be supported:

    Examples:

    GET [base]/Procedure?_profile=https://www.medizininformatik-initiative.de/fhir/core/modul-prozedur/StructureDefinition/Procedure

    Application notes: Further information on searching by "_profile" can be found in the FHIR base specification - section "Parameters for all resources".

  3. The search parameter "status" MUST be supported:

    Examples:

    GET [base]/Procedure?status=completed

    Application notes: Further information on searching by "Procedure.status" can be found in the FHIR base specification - section "Token Search".

  4. The search parameter "category" MUST be supported:

    Examples:

    GET [base]/Procedure?category=http://snomed.info/sct|103693007

    Application notes: Further information on searching by "Procedure.category" can be found in the FHIR base specification - section "Token Search".

  5. The search parameter "code" MUST be supported:

    Examples:

    GET [base]/Procedure?code=http://fhir.de/CodeSystem/bfarm/ops|5-37

    Application notes: Further information on searching by "Procedure.code" can be found in the FHIR base specification - section "Token Search".

  6. The search parameter "date" MUST be supported:

    Examples:

    GET [base]/Procedure?date=2022-01-01

    Application notes: Further information on searching by "Procedure.performed" can be found in the FHIR base specification - section "Date Search".

  7. The search parameter "subject" MUST be supported:

    Examples:

    GET [base]/Procedure?subject=Patient/test

    Application notes: Further information on searching by "Procedure.subject" can be found in the FHIR base specification - section "reference".

  8. The search parameter "patient" MUST be supported:

    Examples:

    GET [base]/Procedure?patient=Patient/test

    Application notes: Further information on searching by "Procedure.subject" can be found in the FHIR base specification - section "reference".

  9. The search parameter "bodySite" MUST be supported:

    Examples:

    GET [base]/Procedure?bodySite=http://snomed.info/sct|80891009

    Application notes: Further information on searching by "Procedure.bodySite" can be found in the FHIR base specification - section "Token Search".

  10. The search parameter "dokumentationsdatum" MUST be supported:

    Examples:

    GET [base]/Procedure?dokumentationsdatum=2022-01-01

    Application notes: Further information on searching by "Procedure.extension:Dokumentationsdatum" can be found in the FHIR base specification - section "Date Search".

  11. The search parameter "durchfuehrungsabsicht" MUST be supported:

    Examples:

    GET [base]/Procedure?durchfuehrungsabsicht=http://snomed.info/sct|262202000

    Application notes: Further information on searching by "Procedure.extension:Durchfuehrungsabsicht" can be found in the FHIR base specification - section "Token Search".

  12. The search parameter "outcome" MUST be supported:

    Examples:

    GET [base]/Procedure?outcome=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-residualstatus|R1

    Application notes: Further information on searching by "Procedure.extension:Durchfuehrungsabsicht" can be found in the FHIR base specification - section "Token Search".

  13. The search parameter "extension-intention" MUST be supported:

    Examples:

    GET [base]/Procedure?extension-intention=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-intention|K

    Application notes: Further information on searching by "Procedure.extension:Durchfuehrungsabsicht" can be found in the FHIR base specification - section "Token Search".

Examples
{
"resourceType": "Procedure",
"id": "mii-exa-onko-systemische-therapie-1",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-systemische-therapie"
]
},
{
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-systemische-therapie-intention",
"coding": [
{
"code": "K",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-intention"
}
]
}
},
{
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-systemische-therapie-stellungzurop",
"coding": [
{
"code": "A",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-therapie-stellungzurop"
}
]
}
}
],
"subject": {
"reference": "Patient/example"
},
"status": "completed",
"coding": [
{
"code": "367336001",
"system": "http://snomed.info/sct",
"display": "Chemotherapy (procedure)"
}
]
},
"code": {
"coding": [
{
"code": "CH",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-therapie-typ"
},
{
"code": "8-52",
"system": "http://fhir.de/CodeSystem/bfarm/ops",
"version": "2021"
}
]
},
"start": "2021-12-04",
"end": "2022-04-06"
}
}