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: ComparatorOnlyEvidence

Profile of Evidence for Evidence Based Medicine IG. The ComparatorOnlyEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention, and a population that has an exposure with a categorical value that is the reference category for the exposure in a ComparativeEvidence Profile. The ComparatorOnlyEvidence describes the evidence for the comparator group.

Usage:

• Refer to this Resource Profile: EvidenceMap, SummaryOfFindings and SummaryOfNetEffect
• Examples for this Resource Profile: AllCauseMortalityControlGroup2022metaAnalysis, ComparatorOnlyEvidence_Additional_GI_surgical_procedure_without_bariatric_surgery_Control_Group_in_JAMA_2018_Norwegian_cohort_study, ComparatorOnlyEvidence_Treatment_with_opioids_without_bariatric_surgery_Control_Group_in_JAMA_2018_Norwegian_cohort_study, ComparatorOnlyEvidence_New_onset_depression_without_bariatric_surgery_Control_Group_in_JAMA_2018_Norwegian_cohort_study... Show 14 more, ComparatorOnlyEvidence_Remission_of_diabetes_without_bariatric_surgery_Control_Group_in_JAMA_2018_Norwegian_cohort_study, ComparatorOnlyEvidence_Myocardial_infarction_or_stroke_without_bariatric_surgery_Control_Group_in_Swedish_Obese_Subjects_SOS_study, All_cause_mortality_Comparator_Evidence_from_MAGICapp_313956, Cardiovascular_mortality_Comparator_Evidence_from_MAGICapp_313957, Nonfatal_myocardial_infarction_Comparator_Evidence_from_MAGICapp_313958, Nonfatal_stroke_Comparator_Evidence_from_MAGICapp_313959, End_stage_kidney_disease_Comparator_Evidence_from_MAGICapp_313960, Heart_failure_Comparator_Evidence_from_MAGICapp_313961, Diabetic_ketoacidosis_Comparator_Evidence_from_MAGICapp_313962, Serious_hyperglycaemia_Comparator_Evidence_from_MAGICapp_313963, Genital_infection_Comparator_Evidence_from_MAGICapp_313964, Severe_gastrointestinal_events_Comparator_Evidence_from_MAGICapp_313965, Health_related_quality_of_life_Comparator_Evidence_from_MAGICapp_109587 and Body_weight_Comparator_Evidence_from_MAGICapp_109588

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 NonComparativeEvidence

Name	Flags	Card.	Type	Description & Constraints
Evidence			NonComparativeEvidence
variableDefinition		2..*	BackboneElement	Evidence variable such as population, exposure, or outcome
Slices for variableDefinition				Content/Rules for all slices
variableDefinition:population		1..*	BackboneElement	Evidence variable such as population, exposure, or outcome
observed		0..1	Reference(ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup)	Definition of the actual variable related to the statistic(s)
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Evidence	C	0..*	NonComparativeEvidence	Single evidence bit cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
Slices for variableDefinition		2..*	BackboneElement	Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:variableRole ele-1: All FHIR elements must have a @value or children
variableDefinition:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. ele-1: All FHIR elements must have a @value or children
variableDefinition:population	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. ele-1: All FHIR elements must have a @value or children Required Pattern: population
observed	Σ	0..1	Reference(ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup)	Definition of the actual variable related to the statistic(s) ele-1: All FHIR elements must have a @value or children
variableDefinition:outcome	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. ele-1: All FHIR elements must have a @value or children Required Pattern: outcome
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Evidence.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition.variableRole	required	EvidenceVariableRole http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:population.variableRole	required	Pattern: population http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:outcome.variableRole	required	Pattern: outcome http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	Evidence	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

Name	Flags	Card.	Type	Description & Constraints
Evidence	C	0..*	NonComparativeEvidence	Single evidence bit cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
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
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this evidence, represented as a globally unique URI cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
identifier	Σ	0..*	Identifier	Additional identifier for the summary
version	Σ	0..1	string	Business version of this summary
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	C	0..1	string	Name for this summary (machine friendly)
title	Σ	0..1	string	Name for this summary (human friendly)
citeAs[x]		0..1		Citation for this evidence
citeAsReference			Reference(Citation)
citeAsMarkdown			markdown
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental		0..1	boolean	For testing purposes, not real usage
date	Σ	0..1	dateTime	Date last changed
approvalDate		0..1	date	When the summary was approved by publisher
lastReviewDate		0..1	date	When the summary was last reviewed by the publisher
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
author	Σ	0..*	ContactDetail	Who authored the content
editor		0..*	ContactDetail	Who edited the content
reviewer		0..*	ContactDetail	Who reviewed the content
endorser	Σ	0..*	ContactDetail	Who endorsed the content
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
purpose		0..1	markdown	Why this Evidence is defined
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
relatedArtifact		0..*	RelatedArtifact	Link or citation to artifact associated with the summary
description		0..1	markdown	Description of the particular summary
assertion		0..1	markdown	Declarative description of the Evidence
note		0..*	Annotation	Footnotes and/or explanatory notes
Slices for variableDefinition		2..*	BackboneElement	Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:variableRole
variableDefinition:All Slices				Content/Rules for all slices
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
description		0..1	markdown	A text description or summary of the variable
note		0..*	Annotation	Footnotes and/or explanatory notes
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays.
roleSubtype	Σ	0..1	CodeableConcept	subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier Binding: EvidenceVariableRoleSubtype (extensible): The sub-role that the variable plays.
comparatorCategory		0..1	string	The reference value used for comparison
observed	Σ	0..1	Reference(Group | EvidenceVariable)	Definition of the actual variable related to the statistic(s)
intended		0..1	Reference(Group | EvidenceVariable)	Definition of the intended variable related to the Evidence
directnessMatch		0..1	CodeableConcept	low | moderate | high | exact Binding: EvidenceDirectness (extensible): The quality of how direct the match is.
variableDefinition:population	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome
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
description		0..1	markdown	A text description or summary of the variable
note		0..*	Annotation	Footnotes and/or explanatory notes
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. Required Pattern: population
roleSubtype	Σ	0..1	CodeableConcept	subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier Binding: EvidenceVariableRoleSubtype (extensible): The sub-role that the variable plays.
comparatorCategory		0..1	string	The reference value used for comparison
observed	Σ	0..1	Reference(ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup)	Definition of the actual variable related to the statistic(s)
intended		0..1	Reference(Group)	Definition of the intended variable related to the Evidence
directnessMatch		0..1	CodeableConcept	low | moderate | high | exact Binding: EvidenceDirectness (extensible): The quality of how direct the match is.
variableDefinition:outcome	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome
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
description		0..1	markdown	A text description or summary of the variable
note		0..*	Annotation	Footnotes and/or explanatory notes
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. Required Pattern: outcome
roleSubtype	Σ	0..1	CodeableConcept	subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier Binding: EvidenceVariableRoleSubtype (extensible): The sub-role that the variable plays.
comparatorCategory		0..1	string	The reference value used for comparison
observed	Σ	0..1	Reference(VariableDefinition)	Definition of the actual variable related to the statistic(s)
intended		0..1	Reference(EvidenceVariable)	Definition of the intended variable related to the Evidence
directnessMatch		0..1	CodeableConcept	low | moderate | high | exact Binding: EvidenceDirectness (extensible): The quality of how direct the match is.
synthesisType		0..1	CodeableConcept	The method to combine studies Binding: StatisticSynthesisType (extensible): Types of combining results from a body of evidence (e.g. summary data meta-analysis).
studyDesign		0..*	CodeableConcept	The design of the study that produced this evidence Binding: StudyDesign (extensible): This is a set of terms for study design characteristics.
statistic		0..*	BackboneElement	Values and parameters for a single statistic
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
description		0..1	markdown	Description of content
note		0..*	Annotation	Footnotes and/or explanatory notes
statisticType		0..1	CodeableConcept	Type of statistic, e.g., relative risk Binding: StatisticType (extensible)
category		0..1	CodeableConcept	Associated category for categorical variable
quantity		0..1	Quantity	Statistic value
numberOfEvents		0..1	unsignedInt	The number of events associated with the statistic
numberAffected		0..1	unsignedInt	The number of participants affected
sampleSize		0..1	BackboneElement	Number of samples in the statistic
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
description		0..1	markdown	Textual description of sample size for statistic
note		0..*	Annotation	Footnote or explanatory note about the sample size
numberOfStudies		0..1	unsignedInt	Number of contributing studies
numberOfParticipants		0..1	unsignedInt	Cumulative number of participants
knownDataCount		0..1	unsignedInt	Number of participants with known results for measured variables
attributeEstimate		0..*	BackboneElement	An attribute of the Statistic
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
description		0..1	markdown	Textual description of the attribute estimate
note		0..*	Annotation	Footnote or explanatory note about the estimate
type		0..1	CodeableConcept	The type of attribute estimate, e.g., confidence interval or p value Binding: AttributeEstimateType (extensible)
quantity		0..1	Quantity	The singular quantity of the attribute estimate, for attribute estimates represented as single values; also used to report unit of measure
level		0..1	decimal	Level of confidence interval, e.g., 0.95 for 95% confidence interval
range		0..1	Range	Lower and upper bound values of the attribute estimate
attributeEstimate		0..*	See attributeEstimate (Evidence)	A nested attribute estimate; which is the attribute estimate of an attribute estimate
modelCharacteristic		0..*	BackboneElement	An aspect of the statistical model
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		1..1	CodeableConcept	Model specification Binding: StatisticModelCode (extensible)
value[x]		0..1		The specific value (when paired with code)
valueQuantity			Quantity(SimpleQuantity)
valueRange			Range
valueCodeableConcept			CodeableConcept
intended		0..1	boolean	The plan for analysis
applied		0..1	boolean	The analysis that was applied
variable		0..*	BackboneElement	A variable adjusted for in the adjusted analysis
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
variableDefinition		1..1	Reference(Group | EvidenceVariable)	Description of the variable
handling		0..1	code	continuous | dichotomous | ordinal | polychotomous Binding: EvidenceVariableHandling (required)
valueCategory		0..*	CodeableConcept	Description for grouping of ordinal or polychotomous variables
valueQuantity		0..*	Quantity	Discrete value for grouping of ordinal or polychotomous variables
valueRange		0..*	Range	Range of values for grouping of ordinal or polychotomous variables
attribute		0..*	See attributeEstimate (Evidence)	An attribute of the statistic used as a model characteristic
certainty		0..*	BackboneElement	Certainty or quality of the evidence
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
description		0..1	markdown	Textual description of certainty
note		0..*	Annotation	Footnotes and/or explanatory notes
type		0..1	CodeableConcept	Aspect of certainty being rated Binding: EvidenceCertaintyType (extensible): The aspect of quality, confidence, or certainty.
rating		0..1	CodeableConcept	Assessment or judgement of the aspect Binding: EvidenceCertaintyRating (extensible): The assessment of quality, confidence, or certainty.
rater		0..1	string	Individual or group who did the rating
subcomponent		0..*	See certainty (Evidence)	A domain or subdomain of certainty
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Evidence.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2 from the FHIR Standard
Evidence.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
Evidence.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition.variableRole	required	EvidenceVariableRole http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition.roleSubtype	extensible	EvidenceVariableRoleSubtype http://hl7.org/fhir/ValueSet/variable-role-subtype from the FHIR Standard
Evidence.variableDefinition.directnessMatch	extensible	EvidenceDirectness http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:population.variableRole	required	Pattern: population http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:population.roleSubtype	extensible	EvidenceVariableRoleSubtype http://hl7.org/fhir/ValueSet/variable-role-subtype from the FHIR Standard
Evidence.variableDefinition:population.directnessMatch	extensible	EvidenceDirectness http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:outcome.variableRole	required	Pattern: outcome http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:outcome.roleSubtype	extensible	EvidenceVariableRoleSubtype http://hl7.org/fhir/ValueSet/variable-role-subtype from the FHIR Standard
Evidence.variableDefinition:outcome.directnessMatch	extensible	EvidenceDirectness http://terminology.hl7.org/ValueSet/directness
Evidence.synthesisType	extensible	StatisticSynthesisType http://terminology.hl7.org/ValueSet/synthesis-type
Evidence.studyDesign	extensible	StudyDesign http://hl7.org/fhir/ValueSet/study-design from the FHIR Standard
Evidence.statistic.statisticType	extensible	StatisticType http://hl7.org/fhir/ValueSet/statistic-type from the FHIR Standard
Evidence.statistic.attributeEstimate.type	extensible	AttributeEstimateType http://hl7.org/fhir/ValueSet/attribute-estimate-type from the FHIR Standard
Evidence.statistic.modelCharacteristic.code	extensible	StatisticModelCode http://hl7.org/fhir/ValueSet/statistic-model-code from the FHIR Standard
Evidence.statistic.modelCharacteristic.variable.handling	required	EvidenceVariableHandling http://hl7.org/fhir/ValueSet/variable-handling|6.0.0-ballot2 from the FHIR Standard
Evidence.certainty.type	extensible	EvidenceCertaintyType http://hl7.org/fhir/ValueSet/certainty-type from the FHIR Standard
Evidence.certainty.rating	extensible	EvidenceCertaintyRating http://hl7.org/fhir/ValueSet/certainty-rating from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	Evidence	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1	warning	Evidence.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

This structure is derived from NonComparativeEvidence

Summary

Structures

This structure refers to these other structures:

• ExposureGroup (http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group)
• ComparatorGroup (http://hl7.org/fhir/uv/ebm/StructureDefinition/comparator-group)
• MetaanalysisStudyGroup (http://hl7.org/fhir/uv/ebm/StructureDefinition/metaanalysis-study-group)

Maturity: 1

Differential View

This structure is derived from NonComparativeEvidence

Name	Flags	Card.	Type	Description & Constraints
Evidence			NonComparativeEvidence
variableDefinition		2..*	BackboneElement	Evidence variable such as population, exposure, or outcome
Slices for variableDefinition				Content/Rules for all slices
variableDefinition:population		1..*	BackboneElement	Evidence variable such as population, exposure, or outcome
observed		0..1	Reference(ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup)	Definition of the actual variable related to the statistic(s)
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Evidence	C	0..*	NonComparativeEvidence	Single evidence bit cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
Slices for variableDefinition		2..*	BackboneElement	Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:variableRole ele-1: All FHIR elements must have a @value or children
variableDefinition:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. ele-1: All FHIR elements must have a @value or children
variableDefinition:population	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. ele-1: All FHIR elements must have a @value or children Required Pattern: population
observed	Σ	0..1	Reference(ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup)	Definition of the actual variable related to the statistic(s) ele-1: All FHIR elements must have a @value or children
variableDefinition:outcome	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. ele-1: All FHIR elements must have a @value or children Required Pattern: outcome
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Evidence.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition.variableRole	required	EvidenceVariableRole http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:population.variableRole	required	Pattern: population http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:outcome.variableRole	required	Pattern: outcome http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	Evidence	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Evidence	C	0..*	NonComparativeEvidence	Single evidence bit cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
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
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical identifier for this evidence, represented as a globally unique URI cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
identifier	Σ	0..*	Identifier	Additional identifier for the summary
version	Σ	0..1	string	Business version of this summary
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	C	0..1	string	Name for this summary (machine friendly)
title	Σ	0..1	string	Name for this summary (human friendly)
citeAs[x]		0..1		Citation for this evidence
citeAsReference			Reference(Citation)
citeAsMarkdown			markdown
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental		0..1	boolean	For testing purposes, not real usage
date	Σ	0..1	dateTime	Date last changed
approvalDate		0..1	date	When the summary was approved by publisher
lastReviewDate		0..1	date	When the summary was last reviewed by the publisher
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
author	Σ	0..*	ContactDetail	Who authored the content
editor		0..*	ContactDetail	Who edited the content
reviewer		0..*	ContactDetail	Who reviewed the content
endorser	Σ	0..*	ContactDetail	Who endorsed the content
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
purpose		0..1	markdown	Why this Evidence is defined
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
relatedArtifact		0..*	RelatedArtifact	Link or citation to artifact associated with the summary
description		0..1	markdown	Description of the particular summary
assertion		0..1	markdown	Declarative description of the Evidence
note		0..*	Annotation	Footnotes and/or explanatory notes
Slices for variableDefinition		2..*	BackboneElement	Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:variableRole
variableDefinition:All Slices				Content/Rules for all slices
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
description		0..1	markdown	A text description or summary of the variable
note		0..*	Annotation	Footnotes and/or explanatory notes
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays.
roleSubtype	Σ	0..1	CodeableConcept	subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier Binding: EvidenceVariableRoleSubtype (extensible): The sub-role that the variable plays.
comparatorCategory		0..1	string	The reference value used for comparison
observed	Σ	0..1	Reference(Group | EvidenceVariable)	Definition of the actual variable related to the statistic(s)
intended		0..1	Reference(Group | EvidenceVariable)	Definition of the intended variable related to the Evidence
directnessMatch		0..1	CodeableConcept	low | moderate | high | exact Binding: EvidenceDirectness (extensible): The quality of how direct the match is.
variableDefinition:population	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome
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
description		0..1	markdown	A text description or summary of the variable
note		0..*	Annotation	Footnotes and/or explanatory notes
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. Required Pattern: population
roleSubtype	Σ	0..1	CodeableConcept	subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier Binding: EvidenceVariableRoleSubtype (extensible): The sub-role that the variable plays.
comparatorCategory		0..1	string	The reference value used for comparison
observed	Σ	0..1	Reference(ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup)	Definition of the actual variable related to the statistic(s)
intended		0..1	Reference(Group)	Definition of the intended variable related to the Evidence
directnessMatch		0..1	CodeableConcept	low | moderate | high | exact Binding: EvidenceDirectness (extensible): The quality of how direct the match is.
variableDefinition:outcome	S	1..*	BackboneElement	Evidence variable such as population, exposure, or outcome
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
description		0..1	markdown	A text description or summary of the variable
note		0..*	Annotation	Footnotes and/or explanatory notes
variableRole	Σ	1..1	code	population | exposure | outcome | covariate Binding: EvidenceVariableRole (required): The role that the variable plays. Required Pattern: outcome
roleSubtype	Σ	0..1	CodeableConcept	subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier Binding: EvidenceVariableRoleSubtype (extensible): The sub-role that the variable plays.
comparatorCategory		0..1	string	The reference value used for comparison
observed	Σ	0..1	Reference(VariableDefinition)	Definition of the actual variable related to the statistic(s)
intended		0..1	Reference(EvidenceVariable)	Definition of the intended variable related to the Evidence
directnessMatch		0..1	CodeableConcept	low | moderate | high | exact Binding: EvidenceDirectness (extensible): The quality of how direct the match is.
synthesisType		0..1	CodeableConcept	The method to combine studies Binding: StatisticSynthesisType (extensible): Types of combining results from a body of evidence (e.g. summary data meta-analysis).
studyDesign		0..*	CodeableConcept	The design of the study that produced this evidence Binding: StudyDesign (extensible): This is a set of terms for study design characteristics.
statistic		0..*	BackboneElement	Values and parameters for a single statistic
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
description		0..1	markdown	Description of content
note		0..*	Annotation	Footnotes and/or explanatory notes
statisticType		0..1	CodeableConcept	Type of statistic, e.g., relative risk Binding: StatisticType (extensible)
category		0..1	CodeableConcept	Associated category for categorical variable
quantity		0..1	Quantity	Statistic value
numberOfEvents		0..1	unsignedInt	The number of events associated with the statistic
numberAffected		0..1	unsignedInt	The number of participants affected
sampleSize		0..1	BackboneElement	Number of samples in the statistic
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
description		0..1	markdown	Textual description of sample size for statistic
note		0..*	Annotation	Footnote or explanatory note about the sample size
numberOfStudies		0..1	unsignedInt	Number of contributing studies
numberOfParticipants		0..1	unsignedInt	Cumulative number of participants
knownDataCount		0..1	unsignedInt	Number of participants with known results for measured variables
attributeEstimate		0..*	BackboneElement	An attribute of the Statistic
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
description		0..1	markdown	Textual description of the attribute estimate
note		0..*	Annotation	Footnote or explanatory note about the estimate
type		0..1	CodeableConcept	The type of attribute estimate, e.g., confidence interval or p value Binding: AttributeEstimateType (extensible)
quantity		0..1	Quantity	The singular quantity of the attribute estimate, for attribute estimates represented as single values; also used to report unit of measure
level		0..1	decimal	Level of confidence interval, e.g., 0.95 for 95% confidence interval
range		0..1	Range	Lower and upper bound values of the attribute estimate
attributeEstimate		0..*	See attributeEstimate (Evidence)	A nested attribute estimate; which is the attribute estimate of an attribute estimate
modelCharacteristic		0..*	BackboneElement	An aspect of the statistical model
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		1..1	CodeableConcept	Model specification Binding: StatisticModelCode (extensible)
value[x]		0..1		The specific value (when paired with code)
valueQuantity			Quantity(SimpleQuantity)
valueRange			Range
valueCodeableConcept			CodeableConcept
intended		0..1	boolean	The plan for analysis
applied		0..1	boolean	The analysis that was applied
variable		0..*	BackboneElement	A variable adjusted for in the adjusted analysis
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
variableDefinition		1..1	Reference(Group | EvidenceVariable)	Description of the variable
handling		0..1	code	continuous | dichotomous | ordinal | polychotomous Binding: EvidenceVariableHandling (required)
valueCategory		0..*	CodeableConcept	Description for grouping of ordinal or polychotomous variables
valueQuantity		0..*	Quantity	Discrete value for grouping of ordinal or polychotomous variables
valueRange		0..*	Range	Range of values for grouping of ordinal or polychotomous variables
attribute		0..*	See attributeEstimate (Evidence)	An attribute of the statistic used as a model characteristic
certainty		0..*	BackboneElement	Certainty or quality of the evidence
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
description		0..1	markdown	Textual description of certainty
note		0..*	Annotation	Footnotes and/or explanatory notes
type		0..1	CodeableConcept	Aspect of certainty being rated Binding: EvidenceCertaintyType (extensible): The aspect of quality, confidence, or certainty.
rating		0..1	CodeableConcept	Assessment or judgement of the aspect Binding: EvidenceCertaintyRating (extensible): The assessment of quality, confidence, or certainty.
rater		0..1	string	Individual or group who did the rating
subcomponent		0..*	See certainty (Evidence)	A domain or subdomain of certainty
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Evidence.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2 from the FHIR Standard
Evidence.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
Evidence.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition.variableRole	required	EvidenceVariableRole http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition.roleSubtype	extensible	EvidenceVariableRoleSubtype http://hl7.org/fhir/ValueSet/variable-role-subtype from the FHIR Standard
Evidence.variableDefinition.directnessMatch	extensible	EvidenceDirectness http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:population.variableRole	required	Pattern: population http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:population.roleSubtype	extensible	EvidenceVariableRoleSubtype http://hl7.org/fhir/ValueSet/variable-role-subtype from the FHIR Standard
Evidence.variableDefinition:population.directnessMatch	extensible	EvidenceDirectness http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:outcome.variableRole	required	Pattern: outcome http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2 from the FHIR Standard
Evidence.variableDefinition:outcome.roleSubtype	extensible	EvidenceVariableRoleSubtype http://hl7.org/fhir/ValueSet/variable-role-subtype from the FHIR Standard
Evidence.variableDefinition:outcome.directnessMatch	extensible	EvidenceDirectness http://terminology.hl7.org/ValueSet/directness
Evidence.synthesisType	extensible	StatisticSynthesisType http://terminology.hl7.org/ValueSet/synthesis-type
Evidence.studyDesign	extensible	StudyDesign http://hl7.org/fhir/ValueSet/study-design from the FHIR Standard
Evidence.statistic.statisticType	extensible	StatisticType http://hl7.org/fhir/ValueSet/statistic-type from the FHIR Standard
Evidence.statistic.attributeEstimate.type	extensible	AttributeEstimateType http://hl7.org/fhir/ValueSet/attribute-estimate-type from the FHIR Standard
Evidence.statistic.modelCharacteristic.code	extensible	StatisticModelCode http://hl7.org/fhir/ValueSet/statistic-model-code from the FHIR Standard
Evidence.statistic.modelCharacteristic.variable.handling	required	EvidenceVariableHandling http://hl7.org/fhir/ValueSet/variable-handling|6.0.0-ballot2 from the FHIR Standard
Evidence.certainty.type	extensible	EvidenceCertaintyType http://hl7.org/fhir/ValueSet/certainty-type from the FHIR Standard
Evidence.certainty.rating	extensible	EvidenceCertaintyRating http://hl7.org/fhir/ValueSet/certainty-rating from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	Evidence	Name should be usable as an identifier for the module by machine processing applications such as code generation : name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1	warning	Evidence.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

This structure is derived from NonComparativeEvidence

Summary

Structures

This structure refers to these other structures:

• ExposureGroup (http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group)
• ComparatorGroup (http://hl7.org/fhir/uv/ebm/StructureDefinition/comparator-group)
• MetaanalysisStudyGroup (http://hl7.org/fhir/uv/ebm/StructureDefinition/metaanalysis-study-group)

Maturity: 1

Other representations of profile: CSV, Excel, Schematron