Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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 1.0.0-ballot3 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

Resource Profile: ComparativeEvidence

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: ComparativeEvidence
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.20

Profile of Evidence for Evidence Based Medicine IG. The ComparativeEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention, and an exposure variable with two or more categories that are being compared.

See Understanding the Evidence Resource for additional information.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Evidence C 0..* Evidence Single evidence bit
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... 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
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... status ?!Σ 0..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... Slices for variableDefinition 3..* BackboneElement Description, classification, and definition of a single variable
Slice: Unordered, Open by value:variableRole
.... variableDefinition:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
.... variableDefinition:population 1..* BackboneElement Description, classification, and definition of a single variable
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
Required Pattern: population
..... observed Σ 0..1 Reference(StudyGroup | 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
.... variableDefinition:exposure 1..1 BackboneElement Description, classification, and definition of a single variable
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
Required Pattern: exposure
..... comparatorCategory 1..1 string The reference value used for comparison
..... observed Σ 0..1 Reference(GroupAssignment) Definition of the actual variable related to the statistic(s)
..... intended 0..1 Reference(VariableDefinition) Definition of the intended variable related to the Evidence
.... variableDefinition:outcome S 1..* BackboneElement Description, classification, and definition of a single variable
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
Required Pattern: outcome
..... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Evidence.status Base required PublicationStatus 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:population.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:exposure.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:outcome.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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())

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Evidence 0..* Evidence Single evidence bit
Interfaces Implemented: MetadataResource
... Slices for extension Content/Rules for all slices
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... relatesTo
.... Slices for extension Content/Rules for all slices
..... extension:quotation 0..1 markdown Quoted portion from related artifact
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
..... extension:classifier 0..1 CodeableConcept A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
... Slices for variableDefinition 3..* BackboneElement Description, classification, and definition of a single variable
Slice: Unordered, Open by value:variableRole
.... variableDefinition:population 1..* BackboneElement Description, classification, and definition of a single variable
..... variableRole 1..1 code population | exposure | outcome | covariate
Required Pattern: population
..... observed 0..1 Reference(StudyGroup | 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
.... variableDefinition:exposure 1..1 BackboneElement Description, classification, and definition of a single variable
..... variableRole 1..1 code population | exposure | outcome | covariate
Required Pattern: exposure
..... comparatorCategory 1..1 string The reference value used for comparison
..... observed 0..1 Reference(GroupAssignment) Definition of the actual variable related to the statistic(s)
..... intended 0..1 Reference(VariableDefinition) Definition of the intended variable related to the Evidence
.... variableDefinition:outcome S 1..* BackboneElement Description, classification, and definition of a single variable
..... variableRole 1..1 code population | exposure | outcome | covariate
Required Pattern: outcome
..... comparatorCategory 0..0 The reference value used for comparison
..... observed 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

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Evidence C 0..* Evidence Single evidence bit
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... 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 BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... url ΣC 0..1 uri Canonical identifier for this evidence, represented as a globally unique URI
Constraints: cnl-1
... 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 0..1 markdown Display of how to cite this Evidence
... status ?!Σ 0..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... experimental 0..1 boolean For testing only - never for 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
... author Σ 0..* ContactDetail Who authored the content
... publisher Σ 0..1 string Name of the publisher/steward (organization or individual)
... contact Σ 0..* ContactDetail Contact details for the publisher
... recorder 0..* ContactDetail Who entered the data for the evidence
... editor 0..* ContactDetail Who edited the content
... reviewer 0..* ContactDetail Who reviewed the content
... endorser 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 Intellectual property ownership, may include restrictions on use
... copyrightLabel 0..1 string Copyright holder and year(s)
... relatesTo 0..* BackboneElement Relationships to other Resources
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:quotation 0..1 markdown Quoted portion from related artifact
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
..... extension:classifier 0..1 CodeableConcept A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... type 1..1 CodeableConcept documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes
Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact.
.... target[x] 1..1 The artifact that is related to this Evidence
..... targetUri uri
..... targetAttachment Attachment
..... targetCanonical canonical(Resource)
..... targetReference Reference(Resource)
..... targetMarkdown markdown
... description Σ 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
... classification Σ 0..* BackboneElement The assignment to an organizing scheme
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... type 0..1 CodeableConcept The kind of classifier (e.g. population, intervention)
Binding: EvidenceClassifierTypeExample (example)
.... classifier 0..* CodeableReference(Resource) The specific classification value
Binding: ConditionProblemDiagnosisCodes (example)
... Slices for variableDefinition 3..* BackboneElement Description, classification, and definition of a single variable
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
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): 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 (example): The quality of how direct the match is.
.... variableDefinition:population 1..* BackboneElement Description, classification, and definition of a single variable
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): The sub-role that the variable plays.
..... comparatorCategory 0..1 string The reference value used for comparison
..... observed Σ 0..1 Reference(StudyGroup | 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 (example): The quality of how direct the match is.
.... variableDefinition:exposure 1..1 BackboneElement Description, classification, and definition of a single variable
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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: exposure
..... roleSubtype 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): The sub-role that the variable plays.
..... comparatorCategory 1..1 string The reference value used for comparison
..... observed Σ 0..1 Reference(GroupAssignment) Definition of the actual variable related to the statistic(s)
..... intended 0..1 Reference(VariableDefinition) Definition of the intended variable related to the Evidence
..... directnessMatch 0..1 CodeableConcept low | moderate | high | exact
Binding: EvidenceDirectness (example): The quality of how direct the match is.
.... variableDefinition:outcome S 1..* BackboneElement Description, classification, and definition of a single variable
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): The sub-role that the variable plays.
..... 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 (example): The quality of how direct the match is.
... synthesisType 0..* CodeableConcept The design of the synthesis (combination of studies) that produced this evidence
Binding: StatisticSynthesisType (example): 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: Study Design (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
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... description 0..1 markdown A natural language summary of the statistic
.... note 0..* Annotation Footnotes and/or explanatory notes
.... statisticType Σ 0..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: Statistic Type (extensible)
.... category 0..1 CodeableConcept Associated category for categorical variable
.... quantity Σ 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 Count of participants in the study sample
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 Total number of participants
..... knownDataCount 0..1 unsignedInt Number of participants with known results for measured variables
..... numberAnalyzed 0..1 unsignedInt Total number of participants who were analayzed
.... 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
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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: StatisticAttributeEstimateType (extensible)
..... quantity 0..1 Quantity The singular quantity of the attribute estimate, for attribute estimates represented as single values, which may include a 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
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... code 1..1 CodeableConcept Model specification
Binding: Statistic Model Code (example)
..... 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 This model characteristic is part of the analysis that was applied, whether or not the analysis followed the plan
..... 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
Slice: Unordered, Open by value:url
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
...... variableDefinition 1..1 Reference(Group | EvidenceVariable) Description and definition of the variable
...... handling 0..1 CodeableConcept boolean | continuous | dichotomous | ordinal | polychotomous | time-to-event | not-specified
Binding: Evidence Variable Handling (extensible)
...... valueCategory 0..* CodeableConcept Qualitative label used for grouping values of a dichotomous, ordinal, or polychotomous variable
...... valueQuantity 0..* Quantity Quantitative label used for grouping values of a dichotomous, ordinal, or polychotomous variable
...... valueRange 0..* Range Range of quantitative labels used for grouping values of a dichotomous, ordinal, or polychotomous variable
..... attribute 0..* See attributeEstimate (Evidence) An attribute of the 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
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... 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: Evidence Certainty Type (example): The aspect of quality, confidence, or certainty.
.... rating 0..1 CodeableConcept Assessment or judgement of the aspect
Binding: StatisticCertaintyRating (example): The assessment of quality, confidence, or certainty.
.... rater 0..* string Individual or group who did the rating
.... subcomponent 0..* See certainty (Evidence) A domain or subdomain of certainty

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Evidence.language Base required All Languages 📍6.0.0-ballot5 FHIR Std.
Evidence.versionAlgorithm[x] Base extensible Version Algorithm 📍6.0.0-ballot5 FHIR Std.
Evidence.status Base required PublicationStatus 📍6.0.0-ballot5 FHIR Std.
Evidence.relatesTo.type Base extensible Artifact Relationship Type 📦1.0.0 THO v7.3
Evidence.classification.​type Base example Evidence Classifier Type Example 📍6.0.0-ballot5 FHIR Std.
Evidence.classification.​classifier Base example Condition/Problem/Diagnosis Codes 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.variableDefinition:population.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:population.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition:population.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.variableDefinition:exposure.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:exposure.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition:exposure.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.variableDefinition:outcome.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:outcome.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition:outcome.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.synthesisType Base example StatisticSynthesisType 📦2.0.0 THO v7.3
Evidence.studyDesign Base extensible Study Design 📦1.0.0 THO v7.3
Evidence.statistic.statisticType Base extensible Statistic Type 📦2.0.0 THO v7.3
Evidence.statistic.attributeEstimate.​type Base extensible StatisticAttributeEstimateType 📦2.0.0 THO v7.3
Evidence.statistic.modelCharacteristic.​code Base example Statistic Model Code 📦1.0.0 THO v7.3
Evidence.statistic.modelCharacteristic.​variable.handling Base extensible Evidence Variable Handling 📦1.0.0 THO v7.3
Evidence.certainty.type Base example Evidence Certainty Type 📦1.0.0 THO v7.3
Evidence.certainty.rating Base example StatisticCertaintyRating 📦2.0.0 THO v7.3

Constraints

Id Grade Path(s) Description Expression
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())

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Evidence C 0..* Evidence Single evidence bit
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... 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
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... status ?!Σ 0..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... Slices for variableDefinition 3..* BackboneElement Description, classification, and definition of a single variable
Slice: Unordered, Open by value:variableRole
.... variableDefinition:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
.... variableDefinition:population 1..* BackboneElement Description, classification, and definition of a single variable
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
Required Pattern: population
..... observed Σ 0..1 Reference(StudyGroup | 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
.... variableDefinition:exposure 1..1 BackboneElement Description, classification, and definition of a single variable
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
Required Pattern: exposure
..... comparatorCategory 1..1 string The reference value used for comparison
..... observed Σ 0..1 Reference(GroupAssignment) Definition of the actual variable related to the statistic(s)
..... intended 0..1 Reference(VariableDefinition) Definition of the intended variable related to the Evidence
.... variableDefinition:outcome S 1..* BackboneElement Description, classification, and definition of a single variable
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... variableRole Σ 1..1 code population | exposure | outcome | covariate
Binding: EvidenceVariableRole (required): The role that the variable plays.
Required Pattern: outcome
..... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Evidence.status Base required PublicationStatus 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:population.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:exposure.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:outcome.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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())

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Evidence 0..* Evidence Single evidence bit
Interfaces Implemented: MetadataResource
... Slices for extension Content/Rules for all slices
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... relatesTo
.... Slices for extension Content/Rules for all slices
..... extension:quotation 0..1 markdown Quoted portion from related artifact
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
..... extension:classifier 0..1 CodeableConcept A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
... Slices for variableDefinition 3..* BackboneElement Description, classification, and definition of a single variable
Slice: Unordered, Open by value:variableRole
.... variableDefinition:population 1..* BackboneElement Description, classification, and definition of a single variable
..... variableRole 1..1 code population | exposure | outcome | covariate
Required Pattern: population
..... observed 0..1 Reference(StudyGroup | 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
.... variableDefinition:exposure 1..1 BackboneElement Description, classification, and definition of a single variable
..... variableRole 1..1 code population | exposure | outcome | covariate
Required Pattern: exposure
..... comparatorCategory 1..1 string The reference value used for comparison
..... observed 0..1 Reference(GroupAssignment) Definition of the actual variable related to the statistic(s)
..... intended 0..1 Reference(VariableDefinition) Definition of the intended variable related to the Evidence
.... variableDefinition:outcome S 1..* BackboneElement Description, classification, and definition of a single variable
..... variableRole 1..1 code population | exposure | outcome | covariate
Required Pattern: outcome
..... comparatorCategory 0..0 The reference value used for comparison
..... observed 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

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Evidence C 0..* Evidence Single evidence bit
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... 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 BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... url ΣC 0..1 uri Canonical identifier for this evidence, represented as a globally unique URI
Constraints: cnl-1
... 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 0..1 markdown Display of how to cite this Evidence
... status ?!Σ 0..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... experimental 0..1 boolean For testing only - never for 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
... author Σ 0..* ContactDetail Who authored the content
... publisher Σ 0..1 string Name of the publisher/steward (organization or individual)
... contact Σ 0..* ContactDetail Contact details for the publisher
... recorder 0..* ContactDetail Who entered the data for the evidence
... editor 0..* ContactDetail Who edited the content
... reviewer 0..* ContactDetail Who reviewed the content
... endorser 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 Intellectual property ownership, may include restrictions on use
... copyrightLabel 0..1 string Copyright holder and year(s)
... relatesTo 0..* BackboneElement Relationships to other Resources
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:quotation 0..1 markdown Quoted portion from related artifact
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
..... extension:classifier 0..1 CodeableConcept A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... type 1..1 CodeableConcept documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes
Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact.
.... target[x] 1..1 The artifact that is related to this Evidence
..... targetUri uri
..... targetAttachment Attachment
..... targetCanonical canonical(Resource)
..... targetReference Reference(Resource)
..... targetMarkdown markdown
... description Σ 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
... classification Σ 0..* BackboneElement The assignment to an organizing scheme
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... type 0..1 CodeableConcept The kind of classifier (e.g. population, intervention)
Binding: EvidenceClassifierTypeExample (example)
.... classifier 0..* CodeableReference(Resource) The specific classification value
Binding: ConditionProblemDiagnosisCodes (example)
... Slices for variableDefinition 3..* BackboneElement Description, classification, and definition of a single variable
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
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): 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 (example): The quality of how direct the match is.
.... variableDefinition:population 1..* BackboneElement Description, classification, and definition of a single variable
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): The sub-role that the variable plays.
..... comparatorCategory 0..1 string The reference value used for comparison
..... observed Σ 0..1 Reference(StudyGroup | 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 (example): The quality of how direct the match is.
.... variableDefinition:exposure 1..1 BackboneElement Description, classification, and definition of a single variable
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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: exposure
..... roleSubtype 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): The sub-role that the variable plays.
..... comparatorCategory 1..1 string The reference value used for comparison
..... observed Σ 0..1 Reference(GroupAssignment) Definition of the actual variable related to the statistic(s)
..... intended 0..1 Reference(VariableDefinition) Definition of the intended variable related to the Evidence
..... directnessMatch 0..1 CodeableConcept low | moderate | high | exact
Binding: EvidenceDirectness (example): The quality of how direct the match is.
.... variableDefinition:outcome S 1..* BackboneElement Description, classification, and definition of a single variable
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 0..1 CodeableConcept Sub-classification of the role of the variable
Binding: EvidenceVariableRoleSubtype (example): The sub-role that the variable plays.
..... 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 (example): The quality of how direct the match is.
... synthesisType 0..* CodeableConcept The design of the synthesis (combination of studies) that produced this evidence
Binding: StatisticSynthesisType (example): 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: Study Design (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
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... description 0..1 markdown A natural language summary of the statistic
.... note 0..* Annotation Footnotes and/or explanatory notes
.... statisticType Σ 0..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: Statistic Type (extensible)
.... category 0..1 CodeableConcept Associated category for categorical variable
.... quantity Σ 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 Count of participants in the study sample
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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 Total number of participants
..... knownDataCount 0..1 unsignedInt Number of participants with known results for measured variables
..... numberAnalyzed 0..1 unsignedInt Total number of participants who were analayzed
.... 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
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... 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: StatisticAttributeEstimateType (extensible)
..... quantity 0..1 Quantity The singular quantity of the attribute estimate, for attribute estimates represented as single values, which may include a 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
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
..... code 1..1 CodeableConcept Model specification
Binding: Statistic Model Code (example)
..... 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 This model characteristic is part of the analysis that was applied, whether or not the analysis followed the plan
..... 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
Slice: Unordered, Open by value:url
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
...... variableDefinition 1..1 Reference(Group | EvidenceVariable) Description and definition of the variable
...... handling 0..1 CodeableConcept boolean | continuous | dichotomous | ordinal | polychotomous | time-to-event | not-specified
Binding: Evidence Variable Handling (extensible)
...... valueCategory 0..* CodeableConcept Qualitative label used for grouping values of a dichotomous, ordinal, or polychotomous variable
...... valueQuantity 0..* Quantity Quantitative label used for grouping values of a dichotomous, ordinal, or polychotomous variable
...... valueRange 0..* Range Range of quantitative labels used for grouping values of a dichotomous, ordinal, or polychotomous variable
..... attribute 0..* See attributeEstimate (Evidence) An attribute of the 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
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url
.... 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: Evidence Certainty Type (example): The aspect of quality, confidence, or certainty.
.... rating 0..1 CodeableConcept Assessment or judgement of the aspect
Binding: StatisticCertaintyRating (example): The assessment of quality, confidence, or certainty.
.... rater 0..* string Individual or group who did the rating
.... subcomponent 0..* See certainty (Evidence) A domain or subdomain of certainty

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Evidence.language Base required All Languages 📍6.0.0-ballot5 FHIR Std.
Evidence.versionAlgorithm[x] Base extensible Version Algorithm 📍6.0.0-ballot5 FHIR Std.
Evidence.status Base required PublicationStatus 📍6.0.0-ballot5 FHIR Std.
Evidence.relatesTo.type Base extensible Artifact Relationship Type 📦1.0.0 THO v7.3
Evidence.classification.​type Base example Evidence Classifier Type Example 📍6.0.0-ballot5 FHIR Std.
Evidence.classification.​classifier Base example Condition/Problem/Diagnosis Codes 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.variableDefinition:population.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:population.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition:population.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.variableDefinition:exposure.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:exposure.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition:exposure.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.variableDefinition:outcome.​variableRole Base required Evidence Variable Role 📍6.0.0-ballot5 FHIR Std.
Evidence.variableDefinition:outcome.​roleSubtype Base example EvidenceVariableRoleSubtype 📦1.0.1 THO v7.3
Evidence.variableDefinition:outcome.​directnessMatch Base example EvidenceDirectness 📦2.0.0 THO v7.3
Evidence.synthesisType Base example StatisticSynthesisType 📦2.0.0 THO v7.3
Evidence.studyDesign Base extensible Study Design 📦1.0.0 THO v7.3
Evidence.statistic.statisticType Base extensible Statistic Type 📦2.0.0 THO v7.3
Evidence.statistic.attributeEstimate.​type Base extensible StatisticAttributeEstimateType 📦2.0.0 THO v7.3
Evidence.statistic.modelCharacteristic.​code Base example Statistic Model Code 📦1.0.0 THO v7.3
Evidence.statistic.modelCharacteristic.​variable.handling Base extensible Evidence Variable Handling 📦1.0.0 THO v7.3
Evidence.certainty.type Base example Evidence Certainty Type 📦1.0.0 THO v7.3
Evidence.certainty.rating Base example StatisticCertaintyRating 📦2.0.0 THO v7.3

Constraints

Id Grade Path(s) Description Expression
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())

 

Other representations of profile: CSV, Excel, Schematron

Notes:

See Understanding the Evidence Resource for additional information.

An example from the QUARTET USA trial will be described here and can be viewed at Evidence for Results for Medication Adherence at 12 weeks in GroupAssignment: Quadpill vs. Candesartan.

The concepts needed to describe this evidence include:

  1. The study sample observed for this statistical analysis was the Enrolled Group for QUARTET USA Trial.
  2. The comparison evaluated is a group assignment to either Quadpill or Candesartan.
  3. The outcome measured for this statistical analysis was Medication Adherence at 12 weeks.
  4. There were 62 people in the Enrolled Group for QUARTET USA Trial.
  5. Only 53 people had data regarding their medication adherence at 12 weeks. Data were missing for 9 people.
  6. The summary statistic for this evidence is odds ratio 0.37.
  7. This odds ratio has a 95% confidence interval of 0.19 to 2.08.
  8. This odds ratio is estimated with a p-value of 0.444.

The Evidence.variableDefinition element provides a space for reporting what the evidence is about in the form of Group and EvidenceVariable Resources. For a ComparativeEvidence Profile, there is an expectation to report a Group Resource to represent the sample observed, an EvidenceVariable Resource (GroupAssignment Profile) to report the groups being compared, and an EvidenceVariable Resource to represent the outcome that was measured in the sample. The EvidenceVariable.variableDefinition.variableRole element is a required code for each instance, using a ‘population’, 'exposure', and an ‘outcome’ code in this case. The corresponding JSON is:

"variableDefinition" : [
    {
      "variableRole" : "population",
      "observed" : {
        "reference" : "Group/372797",
        "type" : "Group",
        "display" : "Enrolled Group for QUARTET USA Trial"
      }
    },
    {
      "variableRole" : "exposure",
      "comparatorCategory": "Candesartan 8 mg once daily",
      "observed" : {
        "reference" : "EvidenceVariable/375183",
        "type" : "EvidenceVariable",
        "display" : "GroupAssignment: Quadpill vs. Candesartan"
      }
    },
    {
      "variableRole" : "outcome",
      "observed" : {
        "reference" : "EvidenceVariable/375201",
        "type" : "EvidenceVariable",
        "display" : "Medication Adherence at 12 weeks"
      }
    }
  ]

The sample size can be represented with multiple elements in case there is a need to distinguish between the number in the sample and the number with known data. In this case, the Evidence.statistic.sampleSize element looks like:

"sampleSize" : {
      "numberOfParticipants" : 62,
      "knownDataCount" : 53
    }

The statistical measure of odds ratio 0.37 is reported in highly structured form including a codeable concept to denote the statistic type as an odds ratio and a quantity which in this case has a value of 0.37 without units. The corresponding JSON with Evidence.statistic.statisticType and Evidence.statistic.quantity looks like:

"statisticType" : {
    "coding" : [
      {
        "system" : "https://fevir.net/sevco",
        "code" : "STATO:0000182",
        "display" : "odds ratio"
      }
    ]
  },
"quantity" : {
    "value" : 0.37
  }

The associated statistics related to the odds ratio (95% confidence interval and p-value in this example) are considered attribute estimates as they are estimates of attributes of the primary statistic. The Evidence.statistic.attributeEstimate element is structured for such attribute estimates:

"attributeEstimate": [
    {
      "type": {
        "coding": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000196",
            "display": "confidence interval"
          }
        ]
      },
      "level": 0.95,
      "range": {
        "low": {
          "value": 0.19
        },
        "high": {
          "value": 2.08
        }
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000700",
            "display": "p-value"
          }
        ]
      },
      "quantity": {
        "value": 0.444
      }
    }
  ]