Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

Extension: ResearchStudyOutcomeMeasure

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure Version: 1.0.0-ballot2
Standards status: Draft Maturity Level: 1 Computable Name: ResearchStudyOutcomeMeasure
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.92

A variable measured during the study.

Context of Use

Usage info

Usage:

Formal Views of Extension Content

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

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension A variable measured during the study
... extension 1..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:name 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "name"
..... value[x] 0..1 string Label for the outcome measure
.... extension:type 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Primary, secondary, or exploratory
Binding: ResearchStudyObjectiveType (preferred)
.... extension:description 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 markdown Description of the outcome measure
.... extension:endpoint 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "endpoint"
..... value[x] 0..1 Reference(EvidenceVariable) Definition of the outcome measure
.... extension:population 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "population"
..... value[x] 0..1 Reference(Group) Population for this estimand
.... extension:intervention 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "intervention"
..... value[x] 0..1 Reference(Group) Intervention is the Comparison group of interest
.... extension:comparator 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "comparator"
..... value[x] 0..1 Reference(Group) Comparator is the Comparison group for comparison
.... extension:summaryMeasure 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "summaryMeasure"
..... value[x] 0..1 CodeableConcept Statistical measure for treatment effect estimate
Binding: StatisticType (extensible)
.... extension:eventHandling 0..* Extension Handling of intercurrent event
..... Slices for extension Content/Rules for all slices
...... extension:event 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "event"
....... value[x] 0..1 CodeableConcept the event
...... extension:group 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "group"
....... value[x] 0..1 CodeableConcept the group that is affected by this event handling
...... extension:handling 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "handling"
....... value[x] 0..1 CodeableConcept how the data is handled
...... extension:description 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "description"
....... value[x] 0..1 markdown text summary of event handling
..... url 1..1 uri "eventHandling"
..... value[x] 0..0
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension A variable measured during the study
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:name 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "name"
..... value[x] 0..1 string Label for the outcome measure
.... extension:type 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Primary, secondary, or exploratory
Binding: ResearchStudyObjectiveType (preferred)
.... extension:description 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 markdown Description of the outcome measure
.... extension:endpoint 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "endpoint"
..... value[x] 0..1 Reference(EvidenceVariable) Definition of the outcome measure
.... extension:population 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "population"
..... value[x] 0..1 Reference(Group) Population for this estimand
.... extension:intervention 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "intervention"
..... value[x] 0..1 Reference(Group) Intervention is the Comparison group of interest
.... extension:comparator 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "comparator"
..... value[x] 0..1 Reference(Group) Comparator is the Comparison group for comparison
.... extension:summaryMeasure 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "summaryMeasure"
..... value[x] 0..1 CodeableConcept Statistical measure for treatment effect estimate
Binding: StatisticType (extensible)
.... extension:eventHandling 0..* Extension Handling of intercurrent event
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:event 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "event"
....... value[x] 0..1 CodeableConcept the event
...... extension:group 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "group"
....... value[x] 0..1 CodeableConcept the group that is affected by this event handling
...... extension:handling 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "handling"
....... value[x] 0..1 CodeableConcept how the data is handled
...... extension:description 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "description"
....... value[x] 0..1 markdown text summary of event handling
..... url 1..1 uri "eventHandling"
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: A variable measured during the study.

  • name: string: An Extension
  • type: CodeableConcept: An Extension
  • description: markdown: An Extension
  • endpoint: Reference: An Extension
  • population: Reference: An Extension
  • intervention: Reference: An Extension
  • comparator: Reference: An Extension
  • summaryMeasure: CodeableConcept: An Extension
  • event: CodeableConcept: An Extension
  • group: CodeableConcept: An Extension
  • handling: CodeableConcept: An Extension
  • description: markdown: An Extension

Maturity: 1

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension A variable measured during the study
... extension 1..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:name 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "name"
..... value[x] 0..1 string Label for the outcome measure
.... extension:type 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Primary, secondary, or exploratory
Binding: ResearchStudyObjectiveType (preferred)
.... extension:description 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 markdown Description of the outcome measure
.... extension:endpoint 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "endpoint"
..... value[x] 0..1 Reference(EvidenceVariable) Definition of the outcome measure
.... extension:population 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "population"
..... value[x] 0..1 Reference(Group) Population for this estimand
.... extension:intervention 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "intervention"
..... value[x] 0..1 Reference(Group) Intervention is the Comparison group of interest
.... extension:comparator 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "comparator"
..... value[x] 0..1 Reference(Group) Comparator is the Comparison group for comparison
.... extension:summaryMeasure 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "summaryMeasure"
..... value[x] 0..1 CodeableConcept Statistical measure for treatment effect estimate
Binding: StatisticType (extensible)
.... extension:eventHandling 0..* Extension Handling of intercurrent event
..... Slices for extension Content/Rules for all slices
...... extension:event 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "event"
....... value[x] 0..1 CodeableConcept the event
...... extension:group 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "group"
....... value[x] 0..1 CodeableConcept the group that is affected by this event handling
...... extension:handling 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "handling"
....... value[x] 0..1 CodeableConcept how the data is handled
...... extension:description 0..1 Extension Extension
....... extension 0..0
....... url 1..1 uri "description"
....... value[x] 0..1 markdown text summary of event handling
..... url 1..1 uri "eventHandling"
..... value[x] 0..0
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension A variable measured during the study
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:name 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "name"
..... value[x] 0..1 string Label for the outcome measure
.... extension:type 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Primary, secondary, or exploratory
Binding: ResearchStudyObjectiveType (preferred)
.... extension:description 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 markdown Description of the outcome measure
.... extension:endpoint 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "endpoint"
..... value[x] 0..1 Reference(EvidenceVariable) Definition of the outcome measure
.... extension:population 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "population"
..... value[x] 0..1 Reference(Group) Population for this estimand
.... extension:intervention 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "intervention"
..... value[x] 0..1 Reference(Group) Intervention is the Comparison group of interest
.... extension:comparator 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "comparator"
..... value[x] 0..1 Reference(Group) Comparator is the Comparison group for comparison
.... extension:summaryMeasure 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "summaryMeasure"
..... value[x] 0..1 CodeableConcept Statistical measure for treatment effect estimate
Binding: StatisticType (extensible)
.... extension:eventHandling 0..* Extension Handling of intercurrent event
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:event 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "event"
....... value[x] 0..1 CodeableConcept the event
...... extension:group 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "group"
....... value[x] 0..1 CodeableConcept the group that is affected by this event handling
...... extension:handling 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "handling"
....... value[x] 0..1 CodeableConcept how the data is handled
...... extension:description 0..1 Extension Extension
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "description"
....... value[x] 0..1 markdown text summary of event handling
..... url 1..1 uri "eventHandling"
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: A variable measured during the study.

  • name: string: An Extension
  • type: CodeableConcept: An Extension
  • description: markdown: An Extension
  • endpoint: Reference: An Extension
  • population: Reference: An Extension
  • intervention: Reference: An Extension
  • comparator: Reference: An Extension
  • summaryMeasure: CodeableConcept: An Extension
  • event: CodeableConcept: An Extension
  • group: CodeableConcept: An Extension
  • handling: CodeableConcept: An Extension
  • description: markdown: An Extension

Maturity: 1

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:type.value[x]preferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard
Extension.extension:summaryMeasure.value[x]extensibleStatisticType
http://hl7.org/fhir/ValueSet/statistic-type
from the FHIR Standard

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()