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

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Resource Profile: StudyEligibilityCriteria

Profile of Group for Evidence Based Medicine IG. The StudyEligibilityCriteria Profile is used to describe inclusion and exclusion criteria for a clinical trial or other research study.

Usage:

• Examples for this Resource Profile: StudyEligibilityCriteria_Eligibility_Criteria_for_Bariatric_Surgery_Randomized_Trial_Diabetes_Surgery_Study, StudyEligibilityCriteria_Obese_patients_18_years_old, StudyEligibilityCriteria_Eligibility_Criteria_for_DIBASY_Trial, Group/267506 and Type_2_diabetes_and_elevated_BMI_in_2016_meta_analysis

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from CohortDefinition

Name	Flags	Card.	Type	Description & Constraints
Group		0..*	CohortDefinition	Group of multiple entities
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	CohortDefinition	Group of multiple entities cnl-2: Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated'
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension				Content/Rules for all slices
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations, etc. URL: http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact
characteristicExpression		0..1	Expression	Criteria for group membership URL: http://hl7.org/fhir/StructureDefinition/characteristicExpression
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
membership	Σ	1..1	code	definitional | conceptual | enumerated Binding: GroupMembershipBasis (required): The basis for membership in a group Required Pattern: definitional
combinationMethod	?!Σ	0..1	code	all-of | any-of | at-least | at-most | except-subset Binding: GroupCharacteristicCombination (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Group.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Group.membership	required	Pattern: definitional http://hl7.org/fhir/ValueSet/group-membership-basis|6.0.0-ballot2 from the FHIR Standard
Group.combinationMethod	required	GroupCharacteristicCombination http://hl7.org/fhir/ValueSet/group-characteristic-combination|6.0.0-ballot2 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-2	error	Group	Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated' : Group.type.exists() or (Group.membership = 'conceptual')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	CohortDefinition	Group of multiple entities cnl-2: Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated'
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations, etc. URL: http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact
characteristicExpression		0..1	Expression	Criteria for group membership URL: http://hl7.org/fhir/StructureDefinition/characteristicExpression
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this Group, represented as an absolute URI (globally unique) cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
identifier	Σ	0..*	Identifier	Business Identifier for this Group
version	Σ	0..1	string	Business version of the Group
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	Σ	0..1	string	Label for Group
title	Σ	0..1	string	Name for this Group (human friendly)
status	?!Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental	Σ	0..1	boolean	For testing purposes, not real usage
date	Σ	0..1	dateTime	Date last changed
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
description		0..1	markdown	Natural language description of the group
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
purpose		0..1	markdown	Why this Group is defined
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
type	Σ	0..1	code	person | animal | practitioner | device | careteam | healthcareservice | location | organization | relatedperson | specimen Binding: GroupType (required): Types of resources that are part of group.
membership	Σ	1..1	code	definitional | conceptual | enumerated Binding: GroupMembershipBasis (required): The basis for membership in a group Required Pattern: definitional
code	Σ	0..1	CodeableConcept	Use of the Group (and by implication, kind of members) Binding: GroupCode (extensible): A code that describes the kind of group, which usually dictates what kind if entities can be in the group.
managingEntity	Σ	0..1	Reference(Organization | RelatedPerson | Practitioner | PractitionerRole)	Entity that is the custodian of the Group's definition
combinationMethod	?!Σ	0..1	code	all-of | any-of | at-least | at-most | except-subset Binding: GroupCharacteristicCombination (required)
combinationThreshold		0..1	positiveInt	Provides the value of "n" when "at-least" or "at-most" codes are used
characteristic	Σ	0..*	BackboneElement	Include / Exclude group members by Trait
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Kind of characteristic Binding Description (No ValueSet): (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc.
value[x]	Σ	1..1		Value held by characteristic Binding Description (No ValueSet): (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc.
valueCodeableConcept			CodeableConcept
valueBoolean			boolean
valueQuantity			Quantity
valueRange			Range
valueReference			Reference(Any)
valueUri			uri
valueExpression			Expression
exclude	Σ	1..1	boolean	Group includes or excludes
description		0..1	markdown	Natural language description of the characteristic
method		0..*	CodeableConcept	Method for how the characteristic value was determined Binding: DefinitionMethod (example)
determinedBy[x]		0..1		Defines the characteristic
determinedByReference			Reference(Device | DeviceDefinition | DeviceMetric)
determinedByExpression			Expression
offset	?!Σ	0..1	CodeableConcept	Reference point for comparison Binding: CharacteristicOffset (example)
instances[x]		0..1		Number of occurrences meeting the characteristic
instancesQuantity			Quantity
instancesRange			Range
duration[x]		0..1		Length of time in which the characteristic is met
durationDuration			Duration
durationRange			Range
period		0..1	Period	Period over which characteristic is tested
timing		0..*	RelativeTime	Timing in which the characteristic is determined
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Group.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2 from the FHIR Standard
Group.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
Group.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Group.type	required	GroupType http://hl7.org/fhir/ValueSet/group-type|6.0.0-ballot2 from the FHIR Standard
Group.membership	required	Pattern: definitional http://hl7.org/fhir/ValueSet/group-membership-basis|6.0.0-ballot2 from the FHIR Standard
Group.code	extensible	GroupCode http://hl7.org/fhir/ValueSet/group-code from the FHIR Standard
Group.combinationMethod	required	GroupCharacteristicCombination http://hl7.org/fhir/ValueSet/group-characteristic-combination|6.0.0-ballot2 from the FHIR Standard
Group.characteristic.code	example
Group.characteristic.value[x]	example
Group.characteristic.method	example	DefinitionMethod http://hl7.org/fhir/ValueSet/definition-method from the FHIR Standard
Group.characteristic.offset	example	CharacteristicOffset http://hl7.org/fhir/ValueSet/characteristic-offset from the FHIR Standard
Group.member.involvement	example	GroupInvolvement http://hl7.org/fhir/ValueSet/group-involvement-set from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-1	warning	Group.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
cnl-2	error	Group	Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated' : Group.type.exists() or (Group.membership = 'conceptual')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from CohortDefinition

Summary

Maturity: 1

Differential View

This structure is derived from CohortDefinition

Name	Flags	Card.	Type	Description & Constraints
Group		0..*	CohortDefinition	Group of multiple entities
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	CohortDefinition	Group of multiple entities cnl-2: Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated'
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension				Content/Rules for all slices
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations, etc. URL: http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact
characteristicExpression		0..1	Expression	Criteria for group membership URL: http://hl7.org/fhir/StructureDefinition/characteristicExpression
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
membership	Σ	1..1	code	definitional | conceptual | enumerated Binding: GroupMembershipBasis (required): The basis for membership in a group Required Pattern: definitional
combinationMethod	?!Σ	0..1	code	all-of | any-of | at-least | at-most | except-subset Binding: GroupCharacteristicCombination (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Group.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Group.membership	required	Pattern: definitional http://hl7.org/fhir/ValueSet/group-membership-basis|6.0.0-ballot2 from the FHIR Standard
Group.combinationMethod	required	GroupCharacteristicCombination http://hl7.org/fhir/ValueSet/group-characteristic-combination|6.0.0-ballot2 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-2	error	Group	Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated' : Group.type.exists() or (Group.membership = 'conceptual')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	CohortDefinition	Group of multiple entities cnl-2: Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated'
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations, etc. URL: http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact
characteristicExpression		0..1	Expression	Criteria for group membership URL: http://hl7.org/fhir/StructureDefinition/characteristicExpression
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this Group, represented as an absolute URI (globally unique) cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
identifier	Σ	0..*	Identifier	Business Identifier for this Group
version	Σ	0..1	string	Business version of the Group
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	Σ	0..1	string	Label for Group
title	Σ	0..1	string	Name for this Group (human friendly)
status	?!Σ	0..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental	Σ	0..1	boolean	For testing purposes, not real usage
date	Σ	0..1	dateTime	Date last changed
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
description		0..1	markdown	Natural language description of the group
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
purpose		0..1	markdown	Why this Group is defined
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
type	Σ	0..1	code	person | animal | practitioner | device | careteam | healthcareservice | location | organization | relatedperson | specimen Binding: GroupType (required): Types of resources that are part of group.
membership	Σ	1..1	code	definitional | conceptual | enumerated Binding: GroupMembershipBasis (required): The basis for membership in a group Required Pattern: definitional
code	Σ	0..1	CodeableConcept	Use of the Group (and by implication, kind of members) Binding: GroupCode (extensible): A code that describes the kind of group, which usually dictates what kind if entities can be in the group.
managingEntity	Σ	0..1	Reference(Organization | RelatedPerson | Practitioner | PractitionerRole)	Entity that is the custodian of the Group's definition
combinationMethod	?!Σ	0..1	code	all-of | any-of | at-least | at-most | except-subset Binding: GroupCharacteristicCombination (required)
combinationThreshold		0..1	positiveInt	Provides the value of "n" when "at-least" or "at-most" codes are used
characteristic	Σ	0..*	BackboneElement	Include / Exclude group members by Trait
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Kind of characteristic Binding Description (No ValueSet): (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc.
value[x]	Σ	1..1		Value held by characteristic Binding Description (No ValueSet): (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc.
valueCodeableConcept			CodeableConcept
valueBoolean			boolean
valueQuantity			Quantity
valueRange			Range
valueReference			Reference(Any)
valueUri			uri
valueExpression			Expression
exclude	Σ	1..1	boolean	Group includes or excludes
description		0..1	markdown	Natural language description of the characteristic
method		0..*	CodeableConcept	Method for how the characteristic value was determined Binding: DefinitionMethod (example)
determinedBy[x]		0..1		Defines the characteristic
determinedByReference			Reference(Device | DeviceDefinition | DeviceMetric)
determinedByExpression			Expression
offset	?!Σ	0..1	CodeableConcept	Reference point for comparison Binding: CharacteristicOffset (example)
instances[x]		0..1		Number of occurrences meeting the characteristic
instancesQuantity			Quantity
instancesRange			Range
duration[x]		0..1		Length of time in which the characteristic is met
durationDuration			Duration
durationRange			Range
period		0..1	Period	Period over which characteristic is tested
timing		0..*	RelativeTime	Timing in which the characteristic is determined
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Group.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2 from the FHIR Standard
Group.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
Group.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Group.type	required	GroupType http://hl7.org/fhir/ValueSet/group-type|6.0.0-ballot2 from the FHIR Standard
Group.membership	required	Pattern: definitional http://hl7.org/fhir/ValueSet/group-membership-basis|6.0.0-ballot2 from the FHIR Standard
Group.code	extensible	GroupCode http://hl7.org/fhir/ValueSet/group-code from the FHIR Standard
Group.combinationMethod	required	GroupCharacteristicCombination http://hl7.org/fhir/ValueSet/group-characteristic-combination|6.0.0-ballot2 from the FHIR Standard
Group.characteristic.code	example
Group.characteristic.value[x]	example
Group.characteristic.method	example	DefinitionMethod http://hl7.org/fhir/ValueSet/definition-method from the FHIR Standard
Group.characteristic.offset	example	CharacteristicOffset http://hl7.org/fhir/ValueSet/characteristic-offset from the FHIR Standard
Group.member.involvement	example	GroupInvolvement http://hl7.org/fhir/ValueSet/group-involvement-set from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-1	warning	Group.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
cnl-2	error	Group	Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated' : Group.type.exists() or (Group.membership = 'conceptual')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from CohortDefinition

Summary

Maturity: 1

Other representations of profile: CSV, Excel, Schematron