NCPI FHIR Implementation Guide
0.2.0 - ci-build

NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions

Resource Profile: NCPI Study Data Dictionary Data Variable

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/study-data-dictionary-variable Version: 0.2.0
Draft as of 2023-08-08 Computable Name: StudyDataDictionaryVariable

FHIR profile used to describe single variable from the dataset. This resource should be as complete as possible including details such as description, data-type, permitted enumerations, quantity units, etc.

Key Guidelines for Usage

The StudyDataDictionaryVariable SHALL have the corresponding Code from the data-table associated with the specified variable as it’s Code. This provides a clear reference to the variable being described, and, when the code is properly used throughout transformed resources, it provides traceability to the origins of those transformed values.

Each variable SHALL describe, as completely as possible, everything a typical Data Dictionary entry might describe. The point of these is to aid researchers in knowing both what they should expect to find at any given column and how they may interpret the resulting information.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition 0..*ObservationDefinitionDefinition of an observation
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... code Σ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ObservationDefinition.codeexampleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationDefinitionIf 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-4errorObservationDefinitionIf 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-5errorObservationDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition 0..*ObservationDefinitionDefinition of an observation
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... category Σ0..*CodeableConceptCategory of observation
Binding: ObservationCategoryCodes (example): Codes for high level observation categories.


... code Σ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

... identifier Σ0..*IdentifierBusiness identifier for this ObservationDefinition instance
... permittedDataType 0..*codeQuantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Binding: ObservationDataType (required): Permitted data type for observation value.



Example General: CodeableConcept
... multipleResultsAllowed 0..1booleanMultiple results allowed
Example General: true
... method 0..1CodeableConceptMethod used to produce the observation
Binding: ObservationMethods (example): Methods for simple observations.

... preferredReportName 0..1stringPreferred report name
... quantitativeDetails 0..1BackboneElementCharacteristics of quantitative results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... customaryUnit 0..1CodeableConceptCustomary unit for quantitative results
Binding: UCUMCodes (extensible): Codes identifying units of measure.

.... unit 0..1CodeableConceptSI unit for quantitative results
Binding: UCUMCodes (extensible): Codes identifying units of measure.

.... conversionFactor 0..1decimalSI to Customary unit conversion factor
.... decimalPrecision 0..1integerDecimal precision of observation quantitative results
... qualifiedInterval 0..*BackboneElementQualified range for continuous and ordinal observation results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... category 0..1codereference | critical | absolute
Binding: ObservationRangeCategory (required): Codes identifying the category of observation range.


Example General: critical
.... range 0..1RangeThe interval itself, for continuous or ordinal observations
.... context 0..1CodeableConceptRange context qualifier
Binding: ObservationReferenceRangeMeaningCodes (extensible): Code identifying the health context of a range.

.... appliesTo 0..*CodeableConceptTargetted population of the range
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... gender 0..1codemale | female | other | unknown
Binding: AdministrativeGender (required): The gender of a person used for administrative purposes.


Example General: female
.... age 0..1RangeApplicable age range, if relevant
.... gestationalAge 0..1RangeApplicable gestational age range, if relevant
.... condition 0..1stringCondition associated with the reference range
... validCodedValueSet 0..1Reference(ValueSet)Value set of valid coded values for the observations conforming to this ObservationDefinition
... normalCodedValueSet 0..1Reference(ValueSet)Value set of normal coded values for the observations conforming to this ObservationDefinition
... abnormalCodedValueSet 0..1Reference(ValueSet)Value set of abnormal coded values for the observations conforming to this ObservationDefinition
... criticalCodedValueSet 0..1Reference(ValueSet)Value set of critical coded values for the observations conforming to this ObservationDefinition

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ObservationDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
ObservationDefinition.categoryexampleObservationCategoryCodes
ObservationDefinition.codeexampleLOINCCodes (a valid code from LOINC)
ObservationDefinition.permittedDataTyperequiredObservationDataType
ObservationDefinition.methodexampleObservationMethods
ObservationDefinition.quantitativeDetails.customaryUnitextensibleUCUMCodes (a valid code from UCUM)
ObservationDefinition.quantitativeDetails.unitextensibleUCUMCodes (a valid code from UCUM)
ObservationDefinition.qualifiedInterval.categoryrequiredObservationRangeCategory
ObservationDefinition.qualifiedInterval.contextextensibleObservationReferenceRangeMeaningCodes
ObservationDefinition.qualifiedInterval.appliesToexampleObservationReferenceRangeAppliesToCodes
ObservationDefinition.qualifiedInterval.genderrequiredAdministrativeGender

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ObservationDefinition

Summary

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition 0..*ObservationDefinitionDefinition of an observation
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... code Σ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ObservationDefinition.codeexampleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationDefinitionIf 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-4errorObservationDefinitionIf 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-5errorObservationDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ObservationDefinition 0..*ObservationDefinitionDefinition of an observation
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... category Σ0..*CodeableConceptCategory of observation
Binding: ObservationCategoryCodes (example): Codes for high level observation categories.


... code Σ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

... identifier Σ0..*IdentifierBusiness identifier for this ObservationDefinition instance
... permittedDataType 0..*codeQuantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Binding: ObservationDataType (required): Permitted data type for observation value.



Example General: CodeableConcept
... multipleResultsAllowed 0..1booleanMultiple results allowed
Example General: true
... method 0..1CodeableConceptMethod used to produce the observation
Binding: ObservationMethods (example): Methods for simple observations.

... preferredReportName 0..1stringPreferred report name
... quantitativeDetails 0..1BackboneElementCharacteristics of quantitative results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... customaryUnit 0..1CodeableConceptCustomary unit for quantitative results
Binding: UCUMCodes (extensible): Codes identifying units of measure.

.... unit 0..1CodeableConceptSI unit for quantitative results
Binding: UCUMCodes (extensible): Codes identifying units of measure.

.... conversionFactor 0..1decimalSI to Customary unit conversion factor
.... decimalPrecision 0..1integerDecimal precision of observation quantitative results
... qualifiedInterval 0..*BackboneElementQualified range for continuous and ordinal observation results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... category 0..1codereference | critical | absolute
Binding: ObservationRangeCategory (required): Codes identifying the category of observation range.


Example General: critical
.... range 0..1RangeThe interval itself, for continuous or ordinal observations
.... context 0..1CodeableConceptRange context qualifier
Binding: ObservationReferenceRangeMeaningCodes (extensible): Code identifying the health context of a range.

.... appliesTo 0..*CodeableConceptTargetted population of the range
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... gender 0..1codemale | female | other | unknown
Binding: AdministrativeGender (required): The gender of a person used for administrative purposes.


Example General: female
.... age 0..1RangeApplicable age range, if relevant
.... gestationalAge 0..1RangeApplicable gestational age range, if relevant
.... condition 0..1stringCondition associated with the reference range
... validCodedValueSet 0..1Reference(ValueSet)Value set of valid coded values for the observations conforming to this ObservationDefinition
... normalCodedValueSet 0..1Reference(ValueSet)Value set of normal coded values for the observations conforming to this ObservationDefinition
... abnormalCodedValueSet 0..1Reference(ValueSet)Value set of abnormal coded values for the observations conforming to this ObservationDefinition
... criticalCodedValueSet 0..1Reference(ValueSet)Value set of critical coded values for the observations conforming to this ObservationDefinition

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ObservationDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
ObservationDefinition.categoryexampleObservationCategoryCodes
ObservationDefinition.codeexampleLOINCCodes (a valid code from LOINC)
ObservationDefinition.permittedDataTyperequiredObservationDataType
ObservationDefinition.methodexampleObservationMethods
ObservationDefinition.quantitativeDetails.customaryUnitextensibleUCUMCodes (a valid code from UCUM)
ObservationDefinition.quantitativeDetails.unitextensibleUCUMCodes (a valid code from UCUM)
ObservationDefinition.qualifiedInterval.categoryrequiredObservationRangeCategory
ObservationDefinition.qualifiedInterval.contextextensibleObservationReferenceRangeMeaningCodes
ObservationDefinition.qualifiedInterval.appliesToexampleObservationReferenceRangeAppliesToCodes
ObservationDefinition.qualifiedInterval.genderrequiredAdministrativeGender

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ObservationDefinition

Summary

 

Other representations of profile: CSV, Excel, Schematron