ResearchStudyEstimand - Definitions - Evidence Based Medicine on FHIR Implementation Guide v2.0.0-ballot

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Extension: ResearchStudyEstimand - Detailed Descriptions

Page standards status: Draft

Maturity Level: 1

Definitions for the research-study-estimand extension.

Differential Elements Table
Key Elements Table
Snapshot Elements Table

Guidance on how to interpret the contents of this table can be found here

0. Extension
Definition	An outcome measure described with the estimand framework.
Short	An outcome measure described with the estimand framework
2. Extension.extension
Control	1..?
4. Extension.extension:label
Slice Name	label
Control	0..1
6. Extension.extension:label.extension
Control	0..0
8. Extension.extension:label.url
Fixed Value	`label`
10. Extension.extension:label.value[x]
Definition	Name or identiifer for internal referencing.
Short	Short name or identifier
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
12. Extension.extension:type
Slice Name	type
Control	0..1
14. Extension.extension:type.extension
Control	0..0
16. Extension.extension:type.url
Fixed Value	`type`
18. Extension.extension:type.value[x]
Definition	Classification of the estimand/outcome measure as a primary focus or not.
Short	Primary, secondary, or exploratory
Binding	The codes SHOULD be taken from ResearchStudyObjectiveType (preferred to `http://hl7.org/fhir/ValueSet/research-study-objective-type`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
20. Extension.extension:endpoint
Slice Name	endpoint
Control	1..1
22. Extension.extension:endpoint.extension
Control	0..0
24. Extension.extension:endpoint.url
Fixed Value	`endpoint`
26. Extension.extension:endpoint.value[x]
Definition	Outcome for each participant that is used in the treatment effect definition.
Short	Outcome measure/Endpoint
Type	Reference(EvidenceVariable, ObservationDefinition, PlanDefinition)
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
28. Extension.extension:population
Slice Name	population
Control	0..1
30. Extension.extension:population.extension
Control	0..0
32. Extension.extension:population.url
Fixed Value	`population`
34. Extension.extension:population.value[x]
Definition	Patients for whom researchers want to estimate the treatment effect.
Short	Population
Comments	List of key characteristics, such as demographic characteristics (e.g., age, sex) and clinical characteristics (e.g., prior therapies, symptoms, severity, biomarker status)
Type	Reference(Group)
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
36. Extension.extension:interventionGroup
Slice Name	interventionGroup
Control	0..1
38. Extension.extension:interventionGroup.extension
Control	0..0
40. Extension.extension:interventionGroup.url
Fixed Value	`interventionGroup`
42. Extension.extension:interventionGroup.value[x]
Definition	One of the intervention strategies being compared in the treatment effect definition.
Short	Intervention
Comments	The valueId value should match a ResearchStudy.comparisonGroup.linkId value. List of key aspects of treatment regimens in each study group, including at least investigational agents, dosage, and administration route
Type	id
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
44. Extension.extension:comparatorGroup
Slice Name	comparatorGroup
Control	0..1
46. Extension.extension:comparatorGroup.extension
Control	0..0
48. Extension.extension:comparatorGroup.url
Fixed Value	`comparatorGroup`
50. Extension.extension:comparatorGroup.value[x]
Definition	One of the intervention strategies being compared in the treatment effect definition, in the role of comparator.
Short	Comparator
Comments	The valueId value should match a ResearchStudy.comparisonGroup.linkId value. List of key aspects of treatment regimens in each study group, including at least investigational agents, dosage, and administration route
Type	id
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
52. Extension.extension:summaryMeasure
Slice Name	summaryMeasure
Control	0..1
54. Extension.extension:summaryMeasure.extension
Control	0..0
56. Extension.extension:summaryMeasure.url
Fixed Value	`summaryMeasure`
58. Extension.extension:summaryMeasure.value[x]
Definition	Method used to summarise and compare the endpoint between treatment conditions (eg, risk ratio, odds ratio).
Short	Statistical measure for treatment effect estimate
Comments	Description of the population-level summary (e.g., mean difference, relative risk)
Binding	Unless not suitable, these codes SHALL be taken from StatisticType (extensible to `http://hl7.org/fhir/ValueSet/statistic-type`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
60. Extension.extension:eventHandling
Slice Name	eventHandling
Definition	Strategies used to handle each intercurrent event in the treatment effect definition; different strategies could be used for different types of intercurrent events.
Short	Handling of intercurrent event
Control	0..*
62. Extension.extension:eventHandling.extension:event
Slice Name	event
Control	0..1
64. Extension.extension:eventHandling.extension:event.extension
Control	0..0
66. Extension.extension:eventHandling.extension:event.url
Fixed Value	`event`
68. Extension.extension:eventHandling.extension:event.value[x]
Definition	The situation that leads to a change in interpretation of the data.
Short	the event
Comments	For each intercurrent event, provide a Description of Intercurrent Event (e.g., permanent discontinuation of trial intervention).
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
70. Extension.extension:eventHandling.extension:group
Slice Name	group
Control	0..1
72. Extension.extension:eventHandling.extension:group.extension
Control	0..0
74. Extension.extension:eventHandling.extension:group.url
Fixed Value	`group`
76. Extension.extension:eventHandling.extension:group.value[x]
Definition	The group (intervention group, comparator group, both groups, a subgroup) that receives a change in interpretation of the data.
Short	the group that is affected by this event handling
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
78. Extension.extension:eventHandling.extension:handling
Slice Name	handling
Control	0..1
80. Extension.extension:eventHandling.extension:handling.extension
Control	0..0
82. Extension.extension:eventHandling.extension:handling.url
Fixed Value	`handling`
84. Extension.extension:eventHandling.extension:handling.value[x]
Definition	The method used for interpretation of the data.
Short	how the data is handled
Comments	For each intercurrent event, provide a Description of the strategy to address the intercurrent event (e.g., a treatment policy strategy).
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
86. Extension.extension:eventHandling.extension:description
Slice Name	description
Control	0..1
88. Extension.extension:eventHandling.extension:description.extension
Control	0..0
90. Extension.extension:eventHandling.extension:description.url
Fixed Value	`description`
92. Extension.extension:eventHandling.extension:description.value[x]
Definition	The human-readable summary of the handling of an intercurrent event.
Short	text summary of event handling
Type	markdown
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
94. Extension.extension:eventHandling.url
Fixed Value	`eventHandling`
96. Extension.extension:eventHandling.value[x]
Control	0..0
98. Extension.url
Fixed Value	`http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand`
100. Extension.value[x]
Control	0..0

Guidance on how to interpret the contents of this table can be found here

0. Extension
Definition	An outcome measure described with the estimand framework. Optional Extension Element - found in all resources.
Short	An outcome measure described with the estimand frameworkOptional Extensions Element
Control	0..*
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2. Extension.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	10..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
4. Extension.extension:label
Slice Name	label
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Extension.extension:label.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
8. Extension.extension:label.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`label`
10. Extension.extension:label.value[x]
Definition	Name or identiifer for internal referencing. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Short name or identifierValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Extension.extension:type
Slice Name	type
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Extension.extension:type.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
16. Extension.extension:type.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`type`
18. Extension.extension:type.value[x]
Definition	Classification of the estimand/outcome measure as a primary focus or not. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Primary, secondary, or exploratoryValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHOULD be taken from For codes, see ResearchStudyObjectiveType (preferred to `http://hl7.org/fhir/ValueSet/research-study-objective-type`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Extension.extension:endpoint
Slice Name	endpoint
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	10..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Extension.extension:endpoint.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
24. Extension.extension:endpoint.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`endpoint`
26. Extension.extension:endpoint.value[x]
Definition	Outcome for each participant that is used in the treatment effect definition. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Outcome measure/EndpointValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	Reference(EvidenceVariable, ObservationDefinition, PlanDefinition), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Extension.extension:population
Slice Name	population
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Extension.extension:population.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
32. Extension.extension:population.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`population`
34. Extension.extension:population.value[x]
Definition	Patients for whom researchers want to estimate the treatment effect. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	PopulationValue of extension
Comments	List of key characteristics, such as demographic characteristics (e.g., age, sex) and clinical characteristics (e.g., prior therapies, symptoms, severity, biomarker status)
Control	0..1 This element is affected by the following invariants: ext-1
Type	Reference(Group), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Extension.extension:interventionGroup
Slice Name	interventionGroup
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Extension.extension:interventionGroup.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
40. Extension.extension:interventionGroup.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`interventionGroup`
42. Extension.extension:interventionGroup.value[x]
Definition	One of the intervention strategies being compared in the treatment effect definition. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	InterventionValue of extension
Comments	The valueId value should match a ResearchStudy.comparisonGroup.linkId value. List of key aspects of treatment regimens in each study group, including at least investigational agents, dosage, and administration route
Control	0..1 This element is affected by the following invariants: ext-1
Type	id, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Extension.extension:comparatorGroup
Slice Name	comparatorGroup
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Extension.extension:comparatorGroup.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
48. Extension.extension:comparatorGroup.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`comparatorGroup`
50. Extension.extension:comparatorGroup.value[x]
Definition	One of the intervention strategies being compared in the treatment effect definition, in the role of comparator. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	ComparatorValue of extension
Comments	The valueId value should match a ResearchStudy.comparisonGroup.linkId value. List of key aspects of treatment regimens in each study group, including at least investigational agents, dosage, and administration route
Control	0..1 This element is affected by the following invariants: ext-1
Type	id, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Extension.extension:summaryMeasure
Slice Name	summaryMeasure
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Extension.extension:summaryMeasure.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
56. Extension.extension:summaryMeasure.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`summaryMeasure`
58. Extension.extension:summaryMeasure.value[x]
Definition	Method used to summarise and compare the endpoint between treatment conditions (eg, risk ratio, odds ratio). Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Statistical measure for treatment effect estimateValue of extension
Comments	Description of the population-level summary (e.g., mean difference, relative risk)
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from For codes, see StatisticType (extensible to `http://hl7.org/fhir/ValueSet/statistic-type`)
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Extension.extension:eventHandling
Slice Name	eventHandling
Definition	Strategies used to handle each intercurrent event in the treatment effect definition; different strategies could be used for different types of intercurrent events.
Short	Handling of intercurrent eventAdditional content defined by implementations
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Extension.extension:eventHandling.extension:event
Slice Name	event
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. Extension.extension:eventHandling.extension:event.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
66. Extension.extension:eventHandling.extension:event.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`event`
68. Extension.extension:eventHandling.extension:event.value[x]
Definition	The situation that leads to a change in interpretation of the data. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	the eventValue of extension
Comments	For each intercurrent event, provide a Description of Intercurrent Event (e.g., permanent discontinuation of trial intervention).
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Extension.extension:eventHandling.extension:group
Slice Name	group
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Extension.extension:eventHandling.extension:group.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
74. Extension.extension:eventHandling.extension:group.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`group`
76. Extension.extension:eventHandling.extension:group.value[x]
Definition	The group (intervention group, comparator group, both groups, a subgroup) that receives a change in interpretation of the data. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	the group that is affected by this event handlingValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. Extension.extension:eventHandling.extension:handling
Slice Name	handling
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Extension.extension:eventHandling.extension:handling.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
82. Extension.extension:eventHandling.extension:handling.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`handling`
84. Extension.extension:eventHandling.extension:handling.value[x]
Definition	The method used for interpretation of the data. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	how the data is handledValue of extension
Comments	For each intercurrent event, provide a Description of the strategy to address the intercurrent event (e.g., a treatment policy strategy).
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. Extension.extension:eventHandling.extension:description
Slice Name	description
Definition	An Extension
Short	ExtensionAdditional content defined by implementations
Control	0..1*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Extension.extension:eventHandling.extension:description.extension
Definition	An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	ExtensionAdditional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..0*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
90. Extension.extension:eventHandling.extension:description.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`description`
92. Extension.extension:eventHandling.extension:description.value[x]
Definition	The human-readable summary of the handling of an intercurrent event. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	text summary of event handlingValue of extension
Control	0..1 This element is affected by the following invariants: ext-1
Type	markdown, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Extension.extension:eventHandling.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`eventHandling`
96. Extension.extension:eventHandling.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..01 This element is affected by the following invariants: ext-1
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand`
100. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..01 This element is affected by the following invariants: ext-1
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. Extension
Definition	An outcome measure described with the estimand framework.
Short	An outcome measure described with the estimand framework
Control	0..*
Is Modifier	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
2. Extension.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
4. Extension.extension
Definition	An Extension
Short	Extension
Control	1..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
6. Extension.extension:label
Slice Name	label
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. Extension.extension:label.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
10. Extension.extension:label.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
12. Extension.extension:label.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`label`
14. Extension.extension:label.value[x]
Definition	Name or identiifer for internal referencing.
Short	Short name or identifier
Control	0..1 This element is affected by the following invariants: ext-1
Type	string
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
16. Extension.extension:type
Slice Name	type
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
18. Extension.extension:type.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
20. Extension.extension:type.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
22. Extension.extension:type.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`type`
24. Extension.extension:type.value[x]
Definition	Classification of the estimand/outcome measure as a primary focus or not.
Short	Primary, secondary, or exploratory
Control	0..1 This element is affected by the following invariants: ext-1
Binding	The codes SHOULD be taken from ResearchStudyObjectiveType (preferred to `http://hl7.org/fhir/ValueSet/research-study-objective-type`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. Extension.extension:endpoint
Slice Name	endpoint
Definition	An Extension
Short	Extension
Control	1..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. Extension.extension:endpoint.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
30. Extension.extension:endpoint.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
32. Extension.extension:endpoint.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`endpoint`
34. Extension.extension:endpoint.value[x]
Definition	Outcome for each participant that is used in the treatment effect definition.
Short	Outcome measure/Endpoint
Control	0..1 This element is affected by the following invariants: ext-1
Type	Reference(EvidenceVariable, ObservationDefinition, PlanDefinition)
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. Extension.extension:population
Slice Name	population
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. Extension.extension:population.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
40. Extension.extension:population.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
42. Extension.extension:population.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`population`
44. Extension.extension:population.value[x]
Definition	Patients for whom researchers want to estimate the treatment effect.
Short	Population
Comments	List of key characteristics, such as demographic characteristics (e.g., age, sex) and clinical characteristics (e.g., prior therapies, symptoms, severity, biomarker status)
Control	0..1 This element is affected by the following invariants: ext-1
Type	Reference(Group)
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. Extension.extension:interventionGroup
Slice Name	interventionGroup
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
48. Extension.extension:interventionGroup.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
50. Extension.extension:interventionGroup.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
52. Extension.extension:interventionGroup.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`interventionGroup`
54. Extension.extension:interventionGroup.value[x]
Definition	One of the intervention strategies being compared in the treatment effect definition.
Short	Intervention
Comments	The valueId value should match a ResearchStudy.comparisonGroup.linkId value. List of key aspects of treatment regimens in each study group, including at least investigational agents, dosage, and administration route
Control	0..1 This element is affected by the following invariants: ext-1
Type	id
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. Extension.extension:comparatorGroup
Slice Name	comparatorGroup
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. Extension.extension:comparatorGroup.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
60. Extension.extension:comparatorGroup.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
62. Extension.extension:comparatorGroup.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`comparatorGroup`
64. Extension.extension:comparatorGroup.value[x]
Definition	One of the intervention strategies being compared in the treatment effect definition, in the role of comparator.
Short	Comparator
Comments	The valueId value should match a ResearchStudy.comparisonGroup.linkId value. List of key aspects of treatment regimens in each study group, including at least investigational agents, dosage, and administration route
Control	0..1 This element is affected by the following invariants: ext-1
Type	id
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. Extension.extension:summaryMeasure
Slice Name	summaryMeasure
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
68. Extension.extension:summaryMeasure.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
70. Extension.extension:summaryMeasure.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
72. Extension.extension:summaryMeasure.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`summaryMeasure`
74. Extension.extension:summaryMeasure.value[x]
Definition	Method used to summarise and compare the endpoint between treatment conditions (eg, risk ratio, odds ratio).
Short	Statistical measure for treatment effect estimate
Comments	Description of the population-level summary (e.g., mean difference, relative risk)
Control	0..1 This element is affected by the following invariants: ext-1
Binding	Unless not suitable, these codes SHALL be taken from StatisticType (extensible to `http://hl7.org/fhir/ValueSet/statistic-type`)
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. Extension.extension:eventHandling
Slice Name	eventHandling
Definition	Strategies used to handle each intercurrent event in the treatment effect definition; different strategies could be used for different types of intercurrent events.
Short	Handling of intercurrent event
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. Extension.extension:eventHandling.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
80. Extension.extension:eventHandling.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short	Additional content defined by implementations
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control	0..*
Type	Extension
Is Modifier	false
Summary	false
Alternate Names	extensions, user content
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
82. Extension.extension:eventHandling.extension:event
Slice Name	event
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
84. Extension.extension:eventHandling.extension:event.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
86. Extension.extension:eventHandling.extension:event.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
88. Extension.extension:eventHandling.extension:event.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`event`
90. Extension.extension:eventHandling.extension:event.value[x]
Definition	The situation that leads to a change in interpretation of the data.
Short	the event
Comments	For each intercurrent event, provide a Description of Intercurrent Event (e.g., permanent discontinuation of trial intervention).
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
92. Extension.extension:eventHandling.extension:group
Slice Name	group
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
94. Extension.extension:eventHandling.extension:group.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
96. Extension.extension:eventHandling.extension:group.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
98. Extension.extension:eventHandling.extension:group.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`group`
100. Extension.extension:eventHandling.extension:group.value[x]
Definition	The group (intervention group, comparator group, both groups, a subgroup) that receives a change in interpretation of the data.
Short	the group that is affected by this event handling
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
102. Extension.extension:eventHandling.extension:handling
Slice Name	handling
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
104. Extension.extension:eventHandling.extension:handling.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
106. Extension.extension:eventHandling.extension:handling.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
108. Extension.extension:eventHandling.extension:handling.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`handling`
110. Extension.extension:eventHandling.extension:handling.value[x]
Definition	The method used for interpretation of the data.
Short	how the data is handled
Comments	For each intercurrent event, provide a Description of the strategy to address the intercurrent event (e.g., a treatment policy strategy).
Control	0..1 This element is affected by the following invariants: ext-1
Type	CodeableConcept
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
112. Extension.extension:eventHandling.extension:description
Slice Name	description
Definition	An Extension
Short	Extension
Control	0..1
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
114. Extension.extension:eventHandling.extension:description.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short	Unique id for inter-element referencing
Control	0..1 This element is affected by the following invariants: ele-1
Type	id
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
116. Extension.extension:eventHandling.extension:description.extension
Definition	An Extension
Short	Extension
Control	0..0
Type	Extension
Is Modifier	false
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing	This element introduces a set of slices on `Extension.extension.extension.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
118. Extension.extension:eventHandling.extension:description.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`description`
120. Extension.extension:eventHandling.extension:description.value[x]
Definition	The human-readable summary of the handling of an intercurrent event.
Short	text summary of event handling
Control	0..1 This element is affected by the following invariants: ext-1
Type	markdown
[x] Note	SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
122. Extension.extension:eventHandling.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`eventHandling`
124. Extension.extension:eventHandling.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..0 This element is affected by the following invariants: ext-1
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
126. Extension.url
Definition	Source of the definition for the extension code - a logical name or a URL.
Short	identifies the meaning of the extension
Comments	The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control	1..1
Type	uri
Is Modifier	false
XML Format	In the XML format, this property is represented as an attribute.
Summary	false
Fixed Value	`http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand`
128. Extension.value[x]
Definition	Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short	Value of extension
Control	0..0 This element is affected by the following invariants: ext-1
Type	Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
Is Modifier	false
Primitive Value	This primitive element may be present, or absent, or replaced by an extension
Summary	false
Invariants	ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)