Class: Estimand (Estimand)
A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarises at a population level what the outcomes would be in the same patients under different treatment conditions being compared. (ICH E9 R1 Addendum)
URI: https://example.org/usdm/v4/linkml/Estimand
classDiagram
class Estimand
click Estimand href "../../classes/Estimand/"
Estimand : analysisPopulationId
Estimand --> "1" AnalysisPopulation : analysisPopulationId
click AnalysisPopulation href "../../classes/AnalysisPopulation/"
Estimand : description
Estimand : extensionAttributes
Estimand --> "*" ExtensionAttribute : extensionAttributes
click ExtensionAttribute href "../../classes/ExtensionAttribute/"
Estimand : id
Estimand : intercurrentEvents
Estimand --> "1..*" IntercurrentEvent : intercurrentEvents
click IntercurrentEvent href "../../classes/IntercurrentEvent/"
Estimand : interventionIds
Estimand --> "1..*" StudyIntervention : interventionIds
click StudyIntervention href "../../classes/StudyIntervention/"
Estimand : label
Estimand : name
Estimand : notes
Estimand --> "*" CommentAnnotation : notes
click CommentAnnotation href "../../classes/CommentAnnotation/"
Estimand : populationSummary
Estimand : variableOfInterestId
Estimand --> "1" Endpoint : variableOfInterestId
click Endpoint href "../../classes/Endpoint/"
Class Properties
| Property | Value |
|---|---|
| Class URI | usdm:Estimand |
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| id | 1 string |
direct | |
| populationSummary | 1 string |
A synopsis of the clinical endpoint of interest within the analysis target study population. | direct |
| name | 1 string |
The literal identifier (i.e., distinctive designation) of the estimand. | direct |
| label | 0..1 string |
The short descriptive designation for the estimand. | direct |
| description | 0..1 string |
A narrative representation of the estimand. | direct |
| notes | * CommentAnnotation |
A brief written record relevant to the study estimand. | direct |
| analysisPopulationId | 1 AnalysisPopulation |
A USDM relationship between the Estimand and AnalysisPopulation classes which provides the details associated with an instance of the analysis population used to partially define a study estimand. | direct |
| variableOfInterestId | 1 Endpoint |
A USDM relationship between the Estimand and Endpoint classes which provides the details associated with an instance of the variable of interest within a study endpoint used to partially define a study estimand. | direct |
| intercurrentEvents | 1..* IntercurrentEvent |
A USDM relationship between the Estimand and IntercurrentEvent classes which identifies the set of intercurrent events associated with a study estimand. | direct |
| interventionIds | 1..* StudyIntervention |
A USDM relationship between the Estimand and StudyIntervention classes which identifies the set of study interventions associated with the Estimand. | direct |
| extensionAttributes | * ExtensionAttribute |
direct |
Usages
| used by | used in | type | used |
|---|---|---|---|
| InterventionalStudyDesign | estimands | range | Estimand |
| ObservationalStudyDesign | estimands | range | Estimand |
| StudyDesign | estimands | range | Estimand |
Identifier and Mapping Information
Schema Source
- from schema: https://example.org/usdm/v4/linkml
Mappings
| Mapping Type | Mapped Value |
|---|---|
| self | https://example.org/usdm/v4/linkml/Estimand |
| native | https://example.org/usdm/v4/linkml/Estimand |
| exact | ncit:C188813 |
Examples
Example: Estimand-02-Standard-Instance
id: estimand-002
name: Composite Estimand for Heart Failure
label: Composite Efficacy Estimand
description: Evaluation of treatment effect considering death as a component of the outcome.
populationSummary: Proportion of subjects alive and without heart failure hospitalization at Month 12.
analysisPopulationId: pop-target-cv-risk
variableOfInterestId: endpoint-composite-outcome
intercurrentEvents:
- id: ice-002
text: Death due to any cause prior to the Month 12 assessment.
strategy: Composite strategy where death is treated as a failure
interventionIds:
- drug-a-10mg
- drug-b-standard-care
Example: Estimand-01-Minimal-Data-Instance
id: estimand-001
name: Primary Efficacy - ITT Analysis
populationSummary: Difference in mean change from baseline in HbA1c at Week 52
analysisPopulationId: pop-all-randomized
variableOfInterestId: endpoint-hba1c-52wk
intercurrentEvents:
- id: ice-001
text: Discontinuation of investigational medicinal product for any reason.
strategy: Treatment policy regardless of whether study drug was discontinued
interventionIds:
- trt-active-drug
- trt-placebo
Example: Estimand-03-Detailed-Instance
LinkML Source
Direct
name: Estimand
description: A precise description of the treatment effect reflecting the clinical
question posed by a given clinical trial objective. It summarises at a population
level what the outcomes would be in the same patients under different treatment
conditions being compared. (ICH E9 R1 Addendum)
title: Estimand
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188813
rank: 1000
attributes:
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
domain_of:
- Abbreviation
- Activity
- Address
- AdministrableProduct
- AdministrableProductProperty
- Administration
- AliasCode
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- Code
- CommentAnnotation
- ConditionAssignment
- DocumentContentReference
- Duration
- EligibilityCriterion
- Encounter
- Estimand
- ExtensionAttribute
- ExtensionClass
- GeographicScope
- GovernanceDate
- Identifier
- Indication
- Ingredient
- Masking
- MedicalDevice
- NarrativeContent
- NarrativeContentItem
- Organization
- ParameterMap
- PersonName
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- QuantityRange
- ResponseCode
- ScheduleTimeline
- ScheduleTimelineExit
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyAmendmentImpact
- StudyAmendmentReason
- StudyArm
- StudyCell
- StudyChange
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- StudyTitle
- StudyVersion
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: true
populationSummary:
name: populationSummary
description: A synopsis of the clinical endpoint of interest within the analysis
target study population.
title: Population-Level Summary
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188853
rank: 1000
domain_of:
- Estimand
range: string
required: true
name:
name: name
description: The literal identifier (i.e., distinctive designation) of the estimand.
title: Estimand Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215522
domain_of:
- Activity
- AdministrableProduct
- AdministrableProductProperty
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- NarrativeContent
- NarrativeContentItem
- Organization
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ResponseCode
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: true
label:
name: label
description: The short descriptive designation for the estimand.
title: Estimand Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215524
domain_of:
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- Organization
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ResponseCode
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: false
description:
name: description
description: A narrative representation of the estimand.
title: Estimand Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215523
domain_of:
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConceptCategory
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: false
notes:
name: notes
description: A brief written record relevant to the study estimand.
title: Estimand Notes
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215521
domain_of:
- Abbreviation
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- EligibilityCriterion
- Encounter
- Estimand
- Indication
- MedicalDevice
- PopulationDefinition
- Procedure
- StudyAmendment
- StudyAmendmentImpact
- StudyArm
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudyVersion
- SyntaxTemplate
range: CommentAnnotation
required: false
multivalued: true
inlined: true
inlined_as_list: true
analysisPopulationId:
name: analysisPopulationId
description: A USDM relationship between the Estimand and AnalysisPopulation classes
which provides the details associated with an instance of the analysis population
used to partially define a study estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- Estimand
range: AnalysisPopulation
required: true
inlined: false
variableOfInterestId:
name: variableOfInterestId
description: A USDM relationship between the Estimand and Endpoint classes which
provides the details associated with an instance of the variable of interest
within a study endpoint used to partially define a study estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- Estimand
range: Endpoint
required: true
inlined: false
intercurrentEvents:
name: intercurrentEvents
description: A USDM relationship between the Estimand and IntercurrentEvent classes
which identifies the set of intercurrent events associated with a study estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- Estimand
range: IntercurrentEvent
required: true
multivalued: true
inlined: true
inlined_as_list: true
interventionIds:
name: interventionIds
description: A USDM relationship between the Estimand and StudyIntervention classes
which identifies the set of study interventions associated with the Estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- Estimand
range: StudyIntervention
required: true
multivalued: true
inlined: false
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
domain_of:
- Abbreviation
- Activity
- Address
- AdministrableProduct
- AdministrableProductIdentifier
- AdministrableProductProperty
- Administration
- AliasCode
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- Characteristic
- Code
- CommentAnnotation
- Condition
- ConditionAssignment
- DocumentContentReference
- Duration
- EligibilityCriterion
- EligibilityCriterionItem
- Encounter
- Endpoint
- Estimand
- ExtensionAttribute
- ExtensionClass
- GeographicScope
- GovernanceDate
- Indication
- Ingredient
- IntercurrentEvent
- InterventionalStudyDesign
- Masking
- MedicalDevice
- MedicalDeviceIdentifier
- NarrativeContent
- NarrativeContentItem
- Objective
- ObservationalStudyDesign
- Organization
- ParameterMap
- PersonName
- Procedure
- ProductOrganizationRole
- Quantity
- Range
- ReferenceIdentifier
- ResponseCode
- ScheduleTimeline
- ScheduleTimelineExit
- ScheduledActivityInstance
- ScheduledDecisionInstance
- Strength
- Study
- StudyAmendment
- StudyAmendmentImpact
- StudyAmendmentReason
- StudyArm
- StudyCell
- StudyChange
- StudyCohort
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesignPopulation
- StudyElement
- StudyEpoch
- StudyIdentifier
- StudyIntervention
- StudyRole
- StudySite
- StudyTitle
- StudyVersion
- SubjectEnrollment
- Substance
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: ExtensionAttribute
required: false
multivalued: true
inlined: true
inlined_as_list: true
class_uri: usdm:Estimand
Induced
name: Estimand
description: A precise description of the treatment effect reflecting the clinical
question posed by a given clinical trial objective. It summarises at a population
level what the outcomes would be in the same patients under different treatment
conditions being compared. (ICH E9 R1 Addendum)
title: Estimand
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188813
rank: 1000
attributes:
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
alias: id
owner: Estimand
domain_of:
- Abbreviation
- Activity
- Address
- AdministrableProduct
- AdministrableProductProperty
- Administration
- AliasCode
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- Code
- CommentAnnotation
- ConditionAssignment
- DocumentContentReference
- Duration
- EligibilityCriterion
- Encounter
- Estimand
- ExtensionAttribute
- ExtensionClass
- GeographicScope
- GovernanceDate
- Identifier
- Indication
- Ingredient
- Masking
- MedicalDevice
- NarrativeContent
- NarrativeContentItem
- Organization
- ParameterMap
- PersonName
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- QuantityRange
- ResponseCode
- ScheduleTimeline
- ScheduleTimelineExit
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyAmendmentImpact
- StudyAmendmentReason
- StudyArm
- StudyCell
- StudyChange
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- StudyTitle
- StudyVersion
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: true
populationSummary:
name: populationSummary
description: A synopsis of the clinical endpoint of interest within the analysis
target study population.
title: Population-Level Summary
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188853
rank: 1000
alias: populationSummary
owner: Estimand
domain_of:
- Estimand
range: string
required: true
name:
name: name
description: The literal identifier (i.e., distinctive designation) of the estimand.
title: Estimand Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215522
alias: name
owner: Estimand
domain_of:
- Activity
- AdministrableProduct
- AdministrableProductProperty
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- NarrativeContent
- NarrativeContentItem
- Organization
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ResponseCode
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: true
label:
name: label
description: The short descriptive designation for the estimand.
title: Estimand Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215524
alias: label
owner: Estimand
domain_of:
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- Organization
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ResponseCode
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: false
description:
name: description
description: A narrative representation of the estimand.
title: Estimand Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215523
alias: description
owner: Estimand
domain_of:
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConceptCategory
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: false
notes:
name: notes
description: A brief written record relevant to the study estimand.
title: Estimand Notes
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215521
alias: notes
owner: Estimand
domain_of:
- Abbreviation
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- EligibilityCriterion
- Encounter
- Estimand
- Indication
- MedicalDevice
- PopulationDefinition
- Procedure
- StudyAmendment
- StudyAmendmentImpact
- StudyArm
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudyVersion
- SyntaxTemplate
range: CommentAnnotation
required: false
multivalued: true
inlined: true
inlined_as_list: true
analysisPopulationId:
name: analysisPopulationId
description: A USDM relationship between the Estimand and AnalysisPopulation classes
which provides the details associated with an instance of the analysis population
used to partially define a study estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: analysisPopulationId
owner: Estimand
domain_of:
- Estimand
range: AnalysisPopulation
required: true
inlined: false
variableOfInterestId:
name: variableOfInterestId
description: A USDM relationship between the Estimand and Endpoint classes which
provides the details associated with an instance of the variable of interest
within a study endpoint used to partially define a study estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: variableOfInterestId
owner: Estimand
domain_of:
- Estimand
range: Endpoint
required: true
inlined: false
intercurrentEvents:
name: intercurrentEvents
description: A USDM relationship between the Estimand and IntercurrentEvent classes
which identifies the set of intercurrent events associated with a study estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: intercurrentEvents
owner: Estimand
domain_of:
- Estimand
range: IntercurrentEvent
required: true
multivalued: true
inlined: true
inlined_as_list: true
interventionIds:
name: interventionIds
description: A USDM relationship between the Estimand and StudyIntervention classes
which identifies the set of study interventions associated with the Estimand.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: interventionIds
owner: Estimand
domain_of:
- Estimand
range: StudyIntervention
required: true
multivalued: true
inlined: false
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
alias: extensionAttributes
owner: Estimand
domain_of:
- Abbreviation
- Activity
- Address
- AdministrableProduct
- AdministrableProductIdentifier
- AdministrableProductProperty
- Administration
- AliasCode
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- Characteristic
- Code
- CommentAnnotation
- Condition
- ConditionAssignment
- DocumentContentReference
- Duration
- EligibilityCriterion
- EligibilityCriterionItem
- Encounter
- Endpoint
- Estimand
- ExtensionAttribute
- ExtensionClass
- GeographicScope
- GovernanceDate
- Indication
- Ingredient
- IntercurrentEvent
- InterventionalStudyDesign
- Masking
- MedicalDevice
- MedicalDeviceIdentifier
- NarrativeContent
- NarrativeContentItem
- Objective
- ObservationalStudyDesign
- Organization
- ParameterMap
- PersonName
- Procedure
- ProductOrganizationRole
- Quantity
- Range
- ReferenceIdentifier
- ResponseCode
- ScheduleTimeline
- ScheduleTimelineExit
- ScheduledActivityInstance
- ScheduledDecisionInstance
- Strength
- Study
- StudyAmendment
- StudyAmendmentImpact
- StudyAmendmentReason
- StudyArm
- StudyCell
- StudyChange
- StudyCohort
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesignPopulation
- StudyElement
- StudyEpoch
- StudyIdentifier
- StudyIntervention
- StudyRole
- StudySite
- StudyTitle
- StudyVersion
- SubjectEnrollment
- Substance
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: ExtensionAttribute
required: false
multivalued: true
inlined: true
inlined_as_list: true
class_uri: usdm:Estimand