The disease

The disease profile is used to represent the disease under study for which the patient was enrolled. This means that the patient must have a status (affected/unaffected) for the given disease.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Condition

Name	Flags	Card.	Type	Description & Constraints
Condition		0..*	Condition	Detailed information about conditions, problems or diagnoses
code		0..1	CodeableConcept	Identification of the condition, problem or diagnosis Binding: Disease Codes (extensible)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Condition.code	extensible	DiseaseCodes

Name	Flags	Card.	Type	Description & Constraints
Condition	C	0..*	Condition	Detailed information about conditions, problems or diagnoses
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
clinicalStatus	?!ΣC	0..1	CodeableConcept	active | recurrence | relapse | inactive | remission | resolved Binding: ConditionClinicalStatusCodes (required): The clinical status of the condition or diagnosis.
verificationStatus	?!ΣC	0..1	CodeableConcept	unconfirmed | provisional | differential | confirmed | refuted | entered-in-error Binding: ConditionVerificationStatus (required): The verification status to support or decline the clinical status of the condition or diagnosis.
code	Σ	0..1	CodeableConcept	Identification of the condition, problem or diagnosis Binding: Disease Codes (extensible)
subject	Σ	1..1	Reference(Patient | Group)	Who has the condition?
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Condition.clinicalStatus	required	ConditionClinicalStatusCodes
Condition.verificationStatus	required	ConditionVerificationStatus
Condition.code	extensible	DiseaseCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
con-3	best practice	Condition	Condition.clinicalStatus SHALL be present if verificationStatus is not entered-in-error and category is problem-list-item : clinicalStatus.exists() or verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code = 'entered-in-error').exists() or category.select($this='problem-list-item').empty()
con-4	error	Condition	If condition is abated, then clinicalStatus must be either inactive, resolved, or remission : abatement.empty() or clinicalStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-clinical' and (code='resolved' or code='remission' or code='inactive')).exists()
con-5	error	Condition	Condition.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code='entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	Condition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Condition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Condition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Condition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Condition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
Condition	C	0..*	Condition	Detailed information about conditions, problems or diagnoses
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	External Ids for this condition
clinicalStatus	?!ΣC	0..1	CodeableConcept	active | recurrence | relapse | inactive | remission | resolved Binding: ConditionClinicalStatusCodes (required): The clinical status of the condition or diagnosis.
verificationStatus	?!ΣC	0..1	CodeableConcept	unconfirmed | provisional | differential | confirmed | refuted | entered-in-error Binding: ConditionVerificationStatus (required): The verification status to support or decline the clinical status of the condition or diagnosis.
category		0..*	CodeableConcept	problem-list-item | encounter-diagnosis Binding: ConditionCategoryCodes (extensible): A category assigned to the condition.
severity		0..1	CodeableConcept	Subjective severity of condition Binding: Condition/DiagnosisSeverity (preferred): A subjective assessment of the severity of the condition as evaluated by the clinician.
code	Σ	0..1	CodeableConcept	Identification of the condition, problem or diagnosis Binding: Disease Codes (extensible)
bodySite	Σ	0..*	CodeableConcept	Anatomical location, if relevant Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
subject	Σ	1..1	Reference(Patient | Group)	Who has the condition?
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
onset[x]	Σ	0..1		Estimated or actual date, date-time, or age
onsetDateTime			dateTime
onsetAge			Age
onsetPeriod			Period
onsetRange			Range
onsetString			string
abatement[x]	C	0..1		When in resolution/remission
abatementDateTime			dateTime
abatementAge			Age
abatementPeriod			Period
abatementRange			Range
abatementString			string
recordedDate	Σ	0..1	dateTime	Date record was first recorded
recorder	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Who recorded the condition
asserter	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Person who asserts this condition
stage	C	0..*	BackboneElement	Stage/grade, usually assessed formally
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
summary	C	0..1	CodeableConcept	Simple summary (disease specific) Binding: ConditionStage (example): Codes describing condition stages (e.g. Cancer stages).
assessment	C	0..*	Reference(ClinicalImpression | DiagnosticReport | Observation)	Formal record of assessment
type		0..1	CodeableConcept	Kind of staging Binding: ConditionStageType (example): Codes describing the kind of condition staging (e.g. clinical or pathological).
evidence	C	0..*	BackboneElement	Supporting evidence
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	ΣC	0..*	CodeableConcept	Manifestation/symptom Binding: ManifestationAndSymptomCodes (example): Codes that describe the manifestation or symptoms of a condition.
detail	ΣC	0..*	Reference(Resource)	Supporting information found elsewhere
note		0..*	Annotation	Additional information about the Condition
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Condition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Condition.clinicalStatus	required	ConditionClinicalStatusCodes
Condition.verificationStatus	required	ConditionVerificationStatus
Condition.category	extensible	ConditionCategoryCodes
Condition.severity	preferred	Condition/DiagnosisSeverity
Condition.code	extensible	DiseaseCodes
Condition.bodySite	example	SNOMEDCTBodyStructures
Condition.stage.summary	example	ConditionStage
Condition.stage.type	example	ConditionStageType
Condition.evidence.code	example	ManifestationAndSymptomCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
con-1	error	Condition.stage	Stage SHALL have summary or assessment : summary.exists() or assessment.exists()
con-2	error	Condition.evidence	evidence SHALL have code or details : code.exists() or detail.exists()
con-3	best practice	Condition	Condition.clinicalStatus SHALL be present if verificationStatus is not entered-in-error and category is problem-list-item : clinicalStatus.exists() or verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code = 'entered-in-error').exists() or category.select($this='problem-list-item').empty()
con-4	error	Condition	If condition is abated, then clinicalStatus must be either inactive, resolved, or remission : abatement.empty() or clinicalStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-clinical' and (code='resolved' or code='remission' or code='inactive')).exists()
con-5	error	Condition	Condition.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code='entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	Condition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Condition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Condition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Condition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Condition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Differential View

This structure is derived from Condition

Name	Flags	Card.	Type	Description & Constraints
Condition		0..*	Condition	Detailed information about conditions, problems or diagnoses
code		0..1	CodeableConcept	Identification of the condition, problem or diagnosis Binding: Disease Codes (extensible)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Condition.code	extensible	DiseaseCodes

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Condition	C	0..*	Condition	Detailed information about conditions, problems or diagnoses
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
clinicalStatus	?!ΣC	0..1	CodeableConcept	active | recurrence | relapse | inactive | remission | resolved Binding: ConditionClinicalStatusCodes (required): The clinical status of the condition or diagnosis.
verificationStatus	?!ΣC	0..1	CodeableConcept	unconfirmed | provisional | differential | confirmed | refuted | entered-in-error Binding: ConditionVerificationStatus (required): The verification status to support or decline the clinical status of the condition or diagnosis.
code	Σ	0..1	CodeableConcept	Identification of the condition, problem or diagnosis Binding: Disease Codes (extensible)
subject	Σ	1..1	Reference(Patient | Group)	Who has the condition?
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Condition.clinicalStatus	required	ConditionClinicalStatusCodes
Condition.verificationStatus	required	ConditionVerificationStatus
Condition.code	extensible	DiseaseCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
con-3	best practice	Condition	Condition.clinicalStatus SHALL be present if verificationStatus is not entered-in-error and category is problem-list-item : clinicalStatus.exists() or verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code = 'entered-in-error').exists() or category.select($this='problem-list-item').empty()
con-4	error	Condition	If condition is abated, then clinicalStatus must be either inactive, resolved, or remission : abatement.empty() or clinicalStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-clinical' and (code='resolved' or code='remission' or code='inactive')).exists()
con-5	error	Condition	Condition.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code='entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	Condition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Condition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Condition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Condition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Condition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Condition	C	0..*	Condition	Detailed information about conditions, problems or diagnoses
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	External Ids for this condition
clinicalStatus	?!ΣC	0..1	CodeableConcept	active | recurrence | relapse | inactive | remission | resolved Binding: ConditionClinicalStatusCodes (required): The clinical status of the condition or diagnosis.
verificationStatus	?!ΣC	0..1	CodeableConcept	unconfirmed | provisional | differential | confirmed | refuted | entered-in-error Binding: ConditionVerificationStatus (required): The verification status to support or decline the clinical status of the condition or diagnosis.
category		0..*	CodeableConcept	problem-list-item | encounter-diagnosis Binding: ConditionCategoryCodes (extensible): A category assigned to the condition.
severity		0..1	CodeableConcept	Subjective severity of condition Binding: Condition/DiagnosisSeverity (preferred): A subjective assessment of the severity of the condition as evaluated by the clinician.
code	Σ	0..1	CodeableConcept	Identification of the condition, problem or diagnosis Binding: Disease Codes (extensible)
bodySite	Σ	0..*	CodeableConcept	Anatomical location, if relevant Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
subject	Σ	1..1	Reference(Patient | Group)	Who has the condition?
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
onset[x]	Σ	0..1		Estimated or actual date, date-time, or age
onsetDateTime			dateTime
onsetAge			Age
onsetPeriod			Period
onsetRange			Range
onsetString			string
abatement[x]	C	0..1		When in resolution/remission
abatementDateTime			dateTime
abatementAge			Age
abatementPeriod			Period
abatementRange			Range
abatementString			string
recordedDate	Σ	0..1	dateTime	Date record was first recorded
recorder	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Who recorded the condition
asserter	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Person who asserts this condition
stage	C	0..*	BackboneElement	Stage/grade, usually assessed formally
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
summary	C	0..1	CodeableConcept	Simple summary (disease specific) Binding: ConditionStage (example): Codes describing condition stages (e.g. Cancer stages).
assessment	C	0..*	Reference(ClinicalImpression | DiagnosticReport | Observation)	Formal record of assessment
type		0..1	CodeableConcept	Kind of staging Binding: ConditionStageType (example): Codes describing the kind of condition staging (e.g. clinical or pathological).
evidence	C	0..*	BackboneElement	Supporting evidence
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	ΣC	0..*	CodeableConcept	Manifestation/symptom Binding: ManifestationAndSymptomCodes (example): Codes that describe the manifestation or symptoms of a condition.
detail	ΣC	0..*	Reference(Resource)	Supporting information found elsewhere
note		0..*	Annotation	Additional information about the Condition
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Condition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Condition.clinicalStatus	required	ConditionClinicalStatusCodes
Condition.verificationStatus	required	ConditionVerificationStatus
Condition.category	extensible	ConditionCategoryCodes
Condition.severity	preferred	Condition/DiagnosisSeverity
Condition.code	extensible	DiseaseCodes
Condition.bodySite	example	SNOMEDCTBodyStructures
Condition.stage.summary	example	ConditionStage
Condition.stage.type	example	ConditionStageType
Condition.evidence.code	example	ManifestationAndSymptomCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
con-1	error	Condition.stage	Stage SHALL have summary or assessment : summary.exists() or assessment.exists()
con-2	error	Condition.evidence	evidence SHALL have code or details : code.exists() or detail.exists()
con-3	best practice	Condition	Condition.clinicalStatus SHALL be present if verificationStatus is not entered-in-error and category is problem-list-item : clinicalStatus.exists() or verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code = 'entered-in-error').exists() or category.select($this='problem-list-item').empty()
con-4	error	Condition	If condition is abated, then clinicalStatus must be either inactive, resolved, or remission : abatement.empty() or clinicalStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-clinical' and (code='resolved' or code='remission' or code='inactive')).exists()
con-5	error	Condition	Condition.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system='http://terminology.hl7.org/CodeSystem/condition-ver-status' and code='entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	Condition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Condition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Condition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Condition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Condition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Condition

Summary

Disease Designation

Patients identified as affected or unaffected for a given disease will have a condition object linked to their patient record containing one or more Coding entries assigned to Condition.code. Condition.code.text will contain the textual description of the disease. The first Coding object present must be one of the disease codes

Affected Status

Affection status is mapped to the standard parameter, Condition.verificationStatus using the corresponding hl7 codes.

recordedDate vs onset

Depending on the data available, data may be tagged with a date in either Condition.recordedDate or Condition.onset using the extension relativeDateTime where recordedDate is presumably the earliest date at which this disease was noted in the patient’s record. Onset would be specified only when the actual onset was established and recorded as such. The relative date targets the patient’s birth date.