HL7.FHIR.UV.CDISC-MAPPING\Vital Signs

This page is part of the CDISC Mapping FHIR IG (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Vital Signs

Like laboratory results, vital signs are also typically captured in Observations. FHIR actually defines specific profiles for common vital sign measures, significantly increasing the consistency of basic vital signs data. These profiles mandate the declaration of the vital-signs category. This allows vital signs to be easily separated from other observations.

One consideration to be aware of is that Blood Pressure is typically captured as a single Observation with two components, however it is sometimes captured as two distinct resource instances. When converting, both approaches will need to be accounted for.

VS Mappings

Guidance on interpreting the table can be found here.

CDISC	FHIR map (or gap)	Comment
Study ID or Number	STUDYID	STUDYID	ResearchStudy.identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().partOf.resolve().identifier.value Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value	Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Study Site ID	SITEID	DM.SITEID	ResearchStudy.site	ResearchSubject.where(subject=Observation.subject).study.resolve().identifier.value Observation.extension(workflow-researchstudy).valueReference.resolve().identifier.value	Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Subject ID for the Study	SUBJID	DM.SUBJID	ResearchSubject.identifier	ResearchSubject.where(individual=Observation.subject).identifier.value	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. No standard way to decide which subject identifier to use
Visit Name	VISIT	VISIT	Encounter should have a standard instantiatesCanonical extension that would allow pointing to the ActivityDefinition. This would be the ActivityDefinition.name. Submit a change request to add the extension
Visit Date	VISDAT		Encounter.period.start	Observation.encounter.resolve().period.start	Linked via Observation.encounter
Vital Signs Performed	[VSTESTCD]_VSPERF	VSSTAT	Observation.status	Observation.status=('final' or 'cancelled')
Vital Signs Date	[VSTESTCD]_VSDAT	VSDTC	Observation.effectiveDateTime	Observation.effectiveDateTime
Vital Signs Time	[VSTESTCD]_VSTIM	VSDTC	Observation.effectiveDateTime	Observation.effectiveDateTime
Category for Vital Signs	VSCAT	VSCAT	Observation.category	Observation.category	FHIR allows multiple categorizations at various levels of granularity. Observation.category.coding.system="http://terminology.hl7.org/CodeSystem/observation-category" + Observation.category.coding.code="vital-signs". This combination can be used to extract vital sign data points from EHR system and correctly assign them to the VS domain.
Subcategory for Vital Signs	VSCAT	VSSCAT	Observation.category	Observation.category	FHIR allows multiple categorizations at various levels of granularity. Observation.category.coding.system="http://terminology.hl7.org/CodeSystem/observation-category" + Observation.category.coding.code="vital-signs". This combination can be used to extract vital sign data points from EHR system and correctly assign them to the VS domain.
Vital Signs Group ID	VSGRPID	VSGRPID	This would typically be done by having the related Observations being 'membersOf' a common parent Observation.
Vital Signs Planned Time Point Name	[VSTESTCD]_VSTPT	VSTPT	Observation.instantiates	Observation.instantiates.resolve().title	TimePoints will be represented in FHIR as PlanDefinition.activities.
Vital Signs Completion Status	[VSTESTCD]_VSSTAT	VSSTAT	Observation.status	Observation.status ServiceRequest.status IN {'cancelled'\|'on-hold'\|'revoked'\| 'entered-in-error'}	In some instances, VSSTAT="NOT DONE" records will come from FHIR Observation resources where Observation.status="cancelled".
ServiceRequest.status	Observation.status ServiceRequest.status IN {'cancelled'\|'on-hold'\|'revoked'\| 'entered-in-error'}
Vital Signs Results or Finding in Original Units	[VSTESTCD]_VSORRES	VSORRES	Observation.valueQuantity	Observation.valueQuantity.value	Ensure the value provided from the EHR is considered an actual value (result), an interpretation or range.
Vital Sign Original Units	[VSTESTCD]_VSORRESU	VSORRESU	Observation.valueQuantity	Observation.valueQuantity.unit
Vital Signs Clinical Significance	[VSTESTCD]_VSCLSIG	SUPPVS.QVAL	Observation.interpretation	Observation.interpretation	If clinical significance is a boolean, then the mapping is different from the existing http://hl7.org/fhir/ValueSet/observation-interpretation ValueSet. Meaning, the values of "normal", "high", :low", etc. can reside in the --NRIND variable. There are also cases where clinical significant outcome details can exist with corresponding details that don't fit into either of those mentioned buckets.
Vital Signs Position of Subject	[VSTESTCD]_VSPOS	VSPOS	Observation.code	Observation.code	This is often pre-coordinated into the Observation.code, but can also be expressed in the method
Observation.method	Observation.method
Location of Vital Signs Measurement	[VSTESTCD]_VSLOC	VSLOC	Observation.bodySite	Observation.bodySite	Requires knowledge or review of data to ensure location, laterality and directionality are included in the code and can be parsed.
Vital Signs Laterality	[VSTESTCD]_VSLAT	VSLAT	Observation.bodySite	Observation.bodySite	Requires knowledge or review of data to ensure location, laterality and directionality are included in the code and can be parsed.
Vital Signs Directionality	VSDIR	VSDIR	Observation.bodySite	Observation.bodySite	Requires knowledge or review of data to ensure location, laterality and directionality are included in the code and can be parsed.
Vital Signs Test code	VSTESTCD	VSTESTCD	Observation.code	Observation.code.coding.code	coding.display and coding.code (plus coding.system)
Vital Signs Test Name	VSTEST	VSTEST	Observation.code	Observation.code.coding.display	coding.display and coding.code (plus coding.system)
Vital Signs Sponsor Defined Identifier	VSSPID	VSSPID	Observation.identifier	Observation.identifier.where(assigner=[sponsor organization id])	The assigner of the identifier can be explicit or inferred by the Identifier.system. Example: "assigner=sponsor", the value of assigner can either be a simple name using "display" (e.g. "assigner.display=MyPharma" or a reference to an "Organization"
Vital Signs Repetition Number	VSREPNUM	SUPPVS.QVAL	This could be captured as a specific ActivityDefinition where you'd have a distinct ActivityDefinition for each occurrence. However, it is more likely to be a single ActivityDefinition for the test and an extension would be added on Observation.instantiates to indicate which occurrence is the Observation.

CDISC

FHIR map (or gap)

Comment

Name

CDASH

SDTM

Element

FHIRPath

Study ID or Number

STUDYID

ResearchStudy.identifier

ResearchSubject.where(subject=Observation.subject).study.resolve().partOf.resolve().identifier.value

Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value

Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy.

The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.

Study Site ID

SITEID

DM.SITEID

ResearchStudy.site

ResearchSubject.where(subject=Observation.subject).study.resolve().identifier.value

Observation.extension(workflow-researchstudy).valueReference.resolve().identifier.value

Subject ID for the Study

SUBJID

DM.SUBJID

ResearchSubject.identifier

ResearchSubject.where(individual=Observation.subject).identifier.value

Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation.

No standard way to decide which subject identifier to use

Visit Name

VISIT

Encounter should have a standard instantiatesCanonical extension that would allow pointing to the ActivityDefinition. This would be the ActivityDefinition.name. Submit a change request to add the extension

Visit Date

VISDAT

Encounter.period.start

Observation.encounter.resolve().period.start

Linked via Observation.encounter

Vital Signs Performed

[VSTESTCD]_VSPERF

VSSTAT

Observation.status

Observation.status=('final' or 'cancelled')

Vital Signs Date

[VSTESTCD]_VSDAT

VSDTC

Observation.effectiveDateTime

Vital Signs Time

[VSTESTCD]_VSTIM

VSDTC

Observation.effectiveDateTime

Category for Vital Signs

VSCAT

Observation.category

FHIR allows multiple categorizations at various levels of granularity.

Observation.category.coding.system="http://terminology.hl7.org/CodeSystem/observation-category" + Observation.category.coding.code="vital-signs". This combination can be used to extract vital sign data points from EHR system and correctly assign them to the VS domain.

Subcategory for Vital Signs

VSCAT

VSSCAT

Observation.category

Vital Signs Group ID

VSGRPID

This would typically be done by having the related Observations being 'membersOf' a common parent Observation.

Vital Signs Planned Time Point Name

[VSTESTCD]_VSTPT

VSTPT

Observation.instantiates

Observation.instantiates.resolve().title

TimePoints will be represented in FHIR as PlanDefinition.activities.

Vital Signs Completion Status

[VSTESTCD]_VSSTAT

VSSTAT

Observation.status

ServiceRequest.status IN {'cancelled'|'on-hold'|'revoked'| 'entered-in-error'}

In some instances, VSSTAT="NOT DONE" records will come from FHIR Observation resources where Observation.status="cancelled".

ServiceRequest.status

Observation.status

ServiceRequest.status IN {'cancelled'|'on-hold'|'revoked'| 'entered-in-error'}

Vital Signs Results or Finding in Original Units

[VSTESTCD]_VSORRES

VSORRES

Observation.valueQuantity

Observation.valueQuantity.value

Ensure the value provided from the EHR is considered an actual value (result), an interpretation or range.

Vital Sign Original Units

[VSTESTCD]_VSORRESU

VSORRESU

Observation.valueQuantity

Observation.valueQuantity.unit

Vital Signs Clinical Significance

[VSTESTCD]_VSCLSIG

SUPPVS.QVAL

Observation.interpretation

If clinical significance is a boolean, then the mapping is different from the existing http://hl7.org/fhir/ValueSet/observation-interpretation ValueSet. Meaning, the values of "normal", "high", :low", etc. can reside in the --NRIND variable. There are also cases where clinical significant outcome details can exist with corresponding details that don't fit into either of those mentioned buckets.

Vital Signs Position of Subject

[VSTESTCD]_VSPOS

VSPOS

Observation.code

This is often pre-coordinated into the Observation.code, but can also be expressed in the method

Observation.method

Location of Vital Signs Measurement

[VSTESTCD]_VSLOC

VSLOC

Observation.bodySite

Requires knowledge or review of data to ensure location, laterality and directionality are included in the code and can be parsed.

Vital Signs Laterality

[VSTESTCD]_VSLAT

VSLAT

Observation.bodySite

Requires knowledge or review of data to ensure location, laterality and directionality are included in the code and can be parsed.

Vital Signs Directionality

VSDIR

Observation.bodySite

Requires knowledge or review of data to ensure location, laterality and directionality are included in the code and can be parsed.

Vital Signs Test code

VSTESTCD

Observation.code

Observation.code.coding.code

coding.display and coding.code (plus coding.system)

Vital Signs Test Name

VSTEST

Observation.code

Observation.code.coding.display

coding.display and coding.code (plus coding.system)

Vital Signs Sponsor Defined Identifier

VSSPID

Observation.identifier

Observation.identifier.where(assigner=[sponsor organization id])

The assigner of the identifier can be explicit or inferred by the Identifier.system. Example: "assigner=sponsor", the value of assigner can either be a simple name using "display" (e.g. "assigner.display=MyPharma" or a reference to an "Organization"

Vital Signs Repetition Number

VSREPNUM

SUPPVS.QVAL

This could be captured as a specific ActivityDefinition where you'd have a distinct ActivityDefinition for each occurrence. However, it is more likely to be a single ActivityDefinition for the test and an extension would be added on Observation.instantiates to indicate which occurrence is the Observation.