Malignant neoplastic diseases


Parameter Case Report Form and Response Options

Does the patient suffer from at least one active tumor or cancer disease? Yes No Unknown
Active malignant neoplastic disease
Malignant neoplastic disease in remission

This is an example of how the case report form could look like when such a data collection tool is used.


To integrate data from clinical care and research such as clinical trials, the guide relies on FHIR resources for data-exchange from the clinical and diagnostic healthcare process rather than constructing a plain questionnaire.

This profile of a FHIR Condition is derived from the Diagnosis-profile of the Medical Informatics Initiative (MII). The valueset bindings on the Condition.code element have been constrained to solely feature the response options for this particular parameter of the case report form. For the explicitly listed diseases in the case report form, the SNOMED and ICD codes are also explicitly specified in the ValueSets below. Note that for the 'Other' option the ValueSets contain filters that allow a number of other codes for this category that are included in the expansion.

A separate instance of a Condition resource is created for each of the requested diseases.

To represent the presence, absence or uncertainty of findings, use Condition.verificationStatus or uncertaintyOfPresence on Condition.modifierExtension. This is used to map the Yes/No/Unknown scheme from case report forms to the Condition resource. Note the additional constraint on Condition that checks if either verificationStatus or the extension is present:

keyseverityhumanexpression
unk-1errorIf verificationStatus is present, uncertaintyOfPresence-Extension SHALL NOT be present.verificationStatus.exists() != Condition.modifierExtension.where(url = 'https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/uncertainty-of-presence').exists()

Profile - Malignant neoplastic diseases

Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/malignant-neoplastic-disease

Snapshot

idS Σ0..1string
id0..1string
extensionC0..*Extension
versionIdΣ0..1id
lastUpdatedΣ0..1instant
sourceS Σ0..1uri
profileS Σ0..*canonical(StructureDefinition)
securityΣ0..*CodingBinding
tagΣ0..*Coding
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
ReferenzPrimaerdiagnoseS C0..1Extension(Reference(Condition))
uncertaintyOfPresenceS ?! C0..1Extension(CodeableConcept)
identifierΣ0..*Identifier
clinicalStatusS Σ ?! C0..1CodeableConceptBinding
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemΣ1..1uriPattern
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
id0..1string
extensionC0..*Extension
systemΣ1..1uriPattern
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemS Σ1..1uriPattern
versionΣ0..1string
codeS Σ1..1codePattern
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
severity0..1CodeableConceptBinding
id0..1string
extensionC0..*Extension
id0..1string
Mehrfachcodierungs-KennzeichenS C0..1Extension(Coding)
SeitenlokalisationS C0..1Extension(Coding)
DiagnosesicherheitS C0..1Extension(Coding)
systemS Σ1..1uriFixed ValuePattern
versionS Σ1..1string
codeS Σ C1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
id0..1string
extensionC0..*Extension
systemS Σ1..1uriFixed ValuePattern
versionΣ1..1string
codeS Σ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
id0..1string
extensionC0..*Extension
systemS Σ1..1uriPattern
versionΣ0..1string
codeS Σ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
id0..1string
extensionC0..*Extension
systemS Σ1..1uriPattern
versionΣ0..1string
codeS Σ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemS Σ1..1uriPattern
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
subjectS Σ C1..1MII-Reference(Group | Patient)
encounterS Σ C0..1MII-Reference(Encounter)
id0..1string
extensionC0..*Extension
id0..1string
lebensphase-vonS C0..1Extension(CodeableConcept)
value0..1System.DateTime
id0..1string
lebensphase-bisS C0..1Extension(CodeableConcept)
value0..1System.DateTime
onsetDateTimeS Σ0..1dateTime
abatementAgeAge
abatementDateTimedateTime
abatementPeriodPeriod
abatementRangeRange
abatementStringstring
recordedDateS Σ1..1dateTime
recorderΣ C0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)
asserterΣ C0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
summaryC0..1CodeableConcept
assessmentC0..*Reference(ClinicalImpression | DiagnosticReport | Observation)
type0..1CodeableConcept
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
codeΣ C0..*CodeableConcept
detailΣ C0..*Reference(Resource)
noteS0..*Annotation


Extension - Uncertainty of Presence

Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/uncertainty-of-presence

Snapshot

id0..1string
extensionC0..0Extension
url1..1uriFixed Value
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string


ValueSets

Valuesets are provided with both SNOMED-CT and ICD-10-GM codes.


Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/ValueSet/malignant-neoplastic-diseases

This value set includes codes from the following code systems:

  • Include codes from SNOMED_CT where concept IsA 363346000


Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/ValueSet/malignant-neoplastic-diseases-icd

This value set includes codes from the following code systems:


Examples

Malignant neoplastic disease active
Example condition that is confirmed present

{
"resourceType": "Condition",
"id": "malignant-neoplastic-disease-present",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/malignant-neoplastic-disease"
]
},
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/condition-clinical",
"code": "active",
"display": "Active"
}
]
},
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/condition-ver-status",
"code": "confirmed",
"display": "Confirmed"
},
{
"system": "http://snomed.info/sct",
"code": "410605003",
"display": "Confirmed present (qualifier value)"
}
]
},
{
"coding": [
{
"system": "http://snomed.info/sct",
"code": "394593009",
"display": "Medical oncology (qualifier value)"
}
]
}
],
"code": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "363346000",
"display": "Malignant neoplastic disease"
}
]
},
"subject": {
"reference": "Patient/gecco-patient"
},
"recordedDate": "2020-10-06"
}


Malignant neoplastic disease in remission
Example condition that is confirmed absent

{
"resourceType": "Condition",
"id": "malignant-neoplastic-disease-remission",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/malignant-neoplastic-disease"
]
},
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/condition-clinical",
"code": "remission",
"display": "Remission"
}
]
},
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/condition-ver-status",
"code": "confirmed",
"display": "Confirmed"
},
{
"system": "http://snomed.info/sct",
"code": "410605003",
"display": "Confirmed present (qualifier value)"
}
]
},
{
"coding": [
{
"system": "http://snomed.info/sct",
"code": "394593009",
"display": "Medical oncology (qualifier value)"
}
]
}
],
"code": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "363346000",
"display": "Malignant neoplastic disease"
}
]
},
"subject": {
"reference": "Patient/gecco-patient"
},
"recordedDate": "2020-10-06"
}


Malignant neoplastic disease absent
Example condition that is confirmed absent

{
"resourceType": "Condition",
"id": "malignant-neoplastic-disease-absent",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/malignant-neoplastic-disease"
]
},
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/condition-ver-status",
"code": "refuted",
"display": "Refuted"
},
{
"system": "http://snomed.info/sct",
"code": "410594000",
"display": "Definitely NOT present (qualifier value)"
}
]
},
{
"coding": [
{
"system": "http://snomed.info/sct",
"code": "394593009",
"display": "Medical oncology (qualifier value)"
}
]
}
],
"code": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "363346000",
"display": "Malignant neoplastic disease"
}
]
},
"subject": {
"reference": "Patient/gecco-patient"
},
"recordedDate": "2020-10-06"
}


Malignant neoplastic disease unknown
Example condition where the presence is unknown

{
"resourceType": "Condition",
"id": "malignant-neoplastic-disease-unknown",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/malignant-neoplastic-disease"
]
},
{
"url": "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/uncertainty-of-presence",
"coding": [
{
"system": "http://snomed.info/sct",
"code": "261665006",
"display": "Unknown (qualifier value)"
}
],
"text": "Presence of condition is unknown."
}
}
],
{
"coding": [
{
"system": "http://snomed.info/sct",
"code": "394593009",
"display": "Medical oncology (qualifier value)"
}
]
}
],
"code": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "363346000",
"display": "Malignant neoplastic disease"
}
]
},
"subject": {
"reference": "Patient/gecco-patient"
},
"recordedDate": "2020-10-06"
}