Clinical Practice Guidelines (CPG) on EBMonFHIR
1.0.2 - qa-preview

This page is part of the CPG-on-EBMonFHIR Implementation Guide (1.0.2).

Resource Profile: Study Outcome Evidence

Defining URL:https://www.netzwerk-universitaetsmedizin.de/fhir/cpg-on-ebm-on-fhir/StructureDefinition/study-outcome-evidence
Version:0.1.0
Name:StudyOutcomeEvidence
Title:Study Outcome Evidence
Status:Draft as of 2022-05-10
Definition:

A single evidence for an outcome from a primary study.

Publisher:Netzwerk Universitätsmedizin (NUM),
Source Resource:XML / JSON / Turtle

The official URL for this profile is: 

https://www.netzwerk-universitaetsmedizin.de/fhir/cpg-on-ebm-on-fhir/StructureDefinition/study-outcome-evidence

Guidance

This profile of a FHIR Evidence is derived from the outcome-evidence FHIR resource.

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. Evidence C 0..* OutcomeEvidence 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 BindingsPurpose
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 1..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)
... Slices for relatedArtifact S 1..* RelatedArtifact Link or citation to artifact associated with the summary
Slice: Unordered, Open by pattern:type
.... relatedArtifact:studyCitation S 1..* RelatedArtifact Link or citation to artifact associated with the summary
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... type Σ 1..1 code 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: citation
..... classifier Σ 0..* CodeableConcept Additional classifiers
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.


..... label Σ 0..1 string Short label
..... display Σ 0..1 string Brief description of the related artifact
..... citation Σ 0..1 markdown Bibliographic citation for the artifact
..... document Σ 0..1 Attachment What document is being referenced
..... resource Σ 0..1 canonical(Resource) What artifact is being referenced
..... resourceReference SΣ 1..1 Reference(Study Citation) What artifact, if not a conformance resource
..... publicationStatus Σ 0..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Publication status of an artifact being referred to.

..... publicationDate Σ 0..1 date Date of publication of the artifact being referred to
... 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 CodeableConcept population | subpopulation | exposure | referenceExposure | measuredVariable | confounder
Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays.

..... 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..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 CodeableConcept population | subpopulation | exposure | referenceExposure | measuredVariable | confounder
Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/variable-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: population
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... observed SΣ 1..1 Reference(Study Cohort) Definition of the actual variable related to the statistic(s)
..... intended 0..1 Reference(Study Eligibility Criteria) 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..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 CodeableConcept population | subpopulation | exposure | referenceExposure | measuredVariable | confounder
Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/variable-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: measuredVariable
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... observed SΣ 1..1 Reference(Outcome Definition) Definition of the actual variable related to the statistic(s)
..... directnessMatch 0..1 CodeableConcept low | moderate | high | exact
Binding: EvidenceDirectness (extensible): The quality of how direct the match is.

.... variableDefinition:intervention 0..* 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 CodeableConcept population | subpopulation | exposure | referenceExposure | measuredVariable | confounder
Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/variable-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: exposure
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... observed SΣ 1..1 Reference(Intervention Definition) Definition of the actual variable related to the statistic(s)
..... directnessMatch 0..1 CodeableConcept low | moderate | high | exact
Binding: EvidenceDirectness (extensible): The quality of how direct the match is.

.... variableDefinition:comparator 0..* 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 CodeableConcept population | subpopulation | exposure | referenceExposure | measuredVariable | confounder
Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/variable-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: referenceExposure
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... observed SΣ 1..1 Reference(Intervention Definition) Definition of the actual variable related to the statistic(s)
..... directnessMatch 0..1 CodeableConcept low | moderate | high | exact
Binding: EvidenceDirectness (extensible): The quality of how direct the match is.

... synthesisType S 1..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.


... Slices for statistic S 0..* BackboneElement Values and parameters for a single statistic
Slice: Unordered, Open by value:statisticType
.... statistic: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 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 0..1 SimpleQuantity Numerical value to complete model specification
...... 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
...... attributeEstimate 0..* See attributeEstimate (Evidence) An attribute of the statistic used as a model characteristic
.... statistic:relativeEffect S 0..1 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 1..1 markdown Description of content
Required Pattern: Relative effect of intervention vs. comparator
..... note 0..* Annotation Footnotes and/or explanatory notes
..... statisticType S 1..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: Relative Effect Type (required)
..... category 0..1 CodeableConcept Associated category for categorical variable
..... quantity S 1..1 Quantity Relative Effect of the presented evidence (intervention vs. comparator) for dichotomous outcomes
..... numberOfEvents 0..1 unsignedInt The number of events associated with the statistic
..... numberAffected 0..1 unsignedInt The number of participants affected
..... sampleSize 1..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 1..1 unsignedInt Number of contributing studies
...... numberOfParticipants 1..1 unsignedInt Cumulative number of participants
...... knownDataCount 0..1 unsignedInt Number of participants with known results for measured variables
..... Slices for attributeEstimate S 1..* BackboneElement An attribute of the Statistic
Slice: Unordered, Open by value:type
...... attributeEstimate: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 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
...... attributeEstimate:confidenceInterval S 1..1 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 1..1 CodeableConcept The type of attribute estimate, e.g., confidence interval or p value
Binding: AttributeEstimateType (extensible)
Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/attribute-estimate-type
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C53324
......... display 1..1 string Representation defined by the system
Fixed Value: Confidence interval
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding Σ 0..* Coding Code defined by a terminology system
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
......... system Σ 1..1 uri Identity of the terminology system
......... version Σ 0..1 string Version of the system - if relevant
......... code ΣC 1..1 code Symbol in syntax defined by the system
......... display ΣC 1..1 string Representation defined by the system
......... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
........ text Σ 0..1 string Plain text representation of the concept
....... 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 S 1..1 decimal Level of confidence interval, e.g., 0.95 for 95% confidence interval
Required Pattern: 0.95
....... range S 1..1 Range Confidence interval of the relative effect
....... 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 0..1 SimpleQuantity Numerical value to complete model specification
...... 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
...... attributeEstimate 0..* See attributeEstimate (Evidence) An attribute of the statistic used as a model characteristic
.... statistic:baselineRisk S 0..1 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 1..1 markdown Description of content
Required Pattern: Baseline risk/result in the comparison group
..... note 0..* Annotation Footnotes and/or explanatory notes
..... statisticType S 1..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: StatisticType (extensible)
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/statistic-type
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C16726
....... display 1..1 string Representation defined by the system
Fixed Value: Incidence
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... category 0..1 CodeableConcept Associated category for categorical variable
..... quantity S 1..1 Quantity Baseline risk of the presented evidence (intervention vs. comparator) for dichotomous outcomes
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 0..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ 0..1 string Unit representation
...... system ΣC 1..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
...... code ΣC 1..1 code Coded form of the unit
Required Pattern: 1/1000
..... 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 0..1 SimpleQuantity Numerical value to complete model specification
...... 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
...... attributeEstimate 0..* See attributeEstimate (Evidence) An attribute of the statistic used as a model characteristic
.... statistic:meanDifference S 0..1 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 1..1 markdown Description of content
Required Pattern: Difference intervention vs. comparator
..... note 0..* Annotation Footnotes and/or explanatory notes
..... statisticType S 1..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: Mean Difference Type (required)
..... category 0..1 CodeableConcept Associated category for categorical variable
..... quantity S 1..1 Quantity Difference intervention vs. comparator for continous outcomes
..... 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
..... Slices for attributeEstimate S 1..* BackboneElement An attribute of the Statistic
Slice: Unordered, Open by value:type
...... attributeEstimate: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 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
...... attributeEstimate:confidenceInterval S 1..1 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 1..1 CodeableConcept The type of attribute estimate, e.g., confidence interval or p value
Binding: AttributeEstimateType (extensible)
Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/attribute-estimate-type
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C53324
......... display 1..1 string Representation defined by the system
Fixed Value: Confidence interval
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding Σ 0..* Coding Code defined by a terminology system
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
......... system Σ 1..1 uri Identity of the terminology system
......... version Σ 0..1 string Version of the system - if relevant
......... code ΣC 1..1 code Symbol in syntax defined by the system
......... display ΣC 1..1 string Representation defined by the system
......... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
........ text Σ 0..1 string Plain text representation of the concept
....... 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 S 1..1 decimal Level of confidence interval, e.g., 0.95 for 95% confidence interval
Required Pattern: 0.95
....... range S 1..1 Range Confidence interval of the relative effect
....... 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 0..1 SimpleQuantity Numerical value to complete model specification
...... 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
...... attributeEstimate 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

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Evidence 0..* OutcomeEvidence Single evidence bit
... Slices for relatedArtifact 1..* RelatedArtifact Link or citation to artifact associated with the summary
Slice: Unordered, Open by pattern:type
.... relatedArtifact:studyCitation 1..* RelatedArtifact Link or citation to artifact associated with the summary
..... resourceReference Σ 1..1 Reference(Study Citation) What artifact, if not a conformance resource
... Slices for variableDefinition Content/Rules for all slices
.... variableDefinition:population 1..1 BackboneElement Evidence variable such as population, exposure, or outcome
..... observed Σ 1..1 Reference(Study Cohort) Definition of the actual variable related to the statistic(s)
.... variableDefinition:outcome 1..1 BackboneElement Evidence variable such as population, exposure, or outcome
..... observed Σ 1..1 Reference(Outcome Definition) Definition of the actual variable related to the statistic(s)
.... variableDefinition:intervention 0..* BackboneElement Evidence variable such as population, exposure, or outcome
..... observed Σ 1..1 Reference(Intervention Definition) Definition of the actual variable related to the statistic(s)
.... variableDefinition:comparator 0..* BackboneElement Evidence variable such as population, exposure, or outcome
..... observed Σ 1..1 Reference(Intervention Definition) Definition of the actual variable related to the statistic(s)
... synthesisType 1..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).

.... statistic:relativeEffect 0..1 BackboneElement Values and parameters for a single statistic
..... statisticType 1..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: Relative Effect Type (required)
..... quantity 1..1 Quantity Relative Effect of the presented evidence (intervention vs. comparator) for dichotomous outcomes
..... Slices for attributeEstimate 1..* BackboneElement An attribute of the Statistic
Slice: Unordered, Open by value:type
...... attributeEstimate:confidenceInterval 1..1 BackboneElement An attribute of the Statistic
....... level 1..1 decimal Level of confidence interval, e.g., 0.95 for 95% confidence interval
Required Pattern: 0.95
....... range 1..1 Range Confidence interval of the relative effect
.... statistic:baselineRisk 0..1 BackboneElement Values and parameters for a single statistic
..... statisticType 1..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: StatisticType (extensible)
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/statistic-type
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C16726
....... display 1..1 string Representation defined by the system
Fixed Value: Incidence
..... quantity 1..1 Quantity Baseline risk of the presented evidence (intervention vs. comparator) for dichotomous outcomes
.... statistic:meanDifference 0..1 BackboneElement Values and parameters for a single statistic
..... statisticType 1..1 CodeableConcept Type of statistic, e.g., relative risk
Binding: Mean Difference Type (required)
..... quantity 1..1 Quantity Difference intervention vs. comparator for continous outcomes
..... Slices for attributeEstimate 1..* BackboneElement An attribute of the Statistic
Slice: Unordered, Open by value:type
...... attributeEstimate:confidenceInterval 1..1 BackboneElement An attribute of the Statistic
....... level 1..1 decimal Level of confidence interval, e.g., 0.95 for 95% confidence interval
Required Pattern: 0.95
....... range 1..1 Range Confidence interval of the relative effect

doco Documentation for this format

This structure is derived from OutcomeEvidence

NameFlagsCard.TypeDescription & Constraintsdoco
.. Evidence OutcomeEvidence
... Slices for variableDefinition Content/Rules for all slices
.... variableDefinition:population 1..1 BackboneElement Evidence variable such as population, exposure, or outcome
..... observed 1..1 Reference(Study Cohort) Definition of the actual variable related to the statistic(s)
.... variableDefinition:outcome 1..1 BackboneElement Evidence variable such as population, exposure, or outcome
..... observed 1..1 Reference(Outcome Definition) Definition of the actual variable related to the statistic(s)

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet / CodeURI
Evidence.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Evidence.versionAlgorithm[x]extensibleVersionAlgorithm
http://hl7.org/fhir/ValueSet/version-algorithm
from the FHIR Standard
Evidence.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Evidence.relatedArtifact:studyCitation.typerequiredPattern: citation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
Evidence.relatedArtifact:studyCitation.classifierexampleCitationArtifactClassifier
http://hl7.org/fhir/ValueSet/citation-artifact-classifier
from the FHIR Standard
Evidence.relatedArtifact:studyCitation.publicationStatusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Evidence.variableDefinition.variableRoleextensibleEvidenceVariableRole
http://hl7.org/fhir/ValueSet/variable-role
from the FHIR Standard
Evidence.variableDefinition.directnessMatchextensibleEvidenceDirectness
http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:population.variableRoleextensiblePattern: population
http://hl7.org/fhir/ValueSet/variable-role
from the FHIR Standard
Evidence.variableDefinition:population.directnessMatchextensibleEvidenceDirectness
http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:outcome.variableRoleextensiblePattern: measuredVariable
http://hl7.org/fhir/ValueSet/variable-role
from the FHIR Standard
Evidence.variableDefinition:outcome.directnessMatchextensibleEvidenceDirectness
http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:intervention.variableRoleextensiblePattern: exposure
http://hl7.org/fhir/ValueSet/variable-role
from the FHIR Standard
Evidence.variableDefinition:intervention.directnessMatchextensibleEvidenceDirectness
http://terminology.hl7.org/ValueSet/directness
Evidence.variableDefinition:comparator.variableRoleextensiblePattern: referenceExposure
http://hl7.org/fhir/ValueSet/variable-role
from the FHIR Standard
Evidence.variableDefinition:comparator.directnessMatchextensibleEvidenceDirectness
http://terminology.hl7.org/ValueSet/directness
Evidence.synthesisTypeextensibleStatisticSynthesisType (a valid code from SynthesisType)
http://terminology.hl7.org/ValueSet/synthesis-type
Evidence.studyDesignextensibleStudyDesign
http://hl7.org/fhir/ValueSet/study-design
from the FHIR Standard
Evidence.statistic.statisticTypeextensibleStatisticType
http://hl7.org/fhir/ValueSet/statistic-type
from the FHIR Standard
Evidence.statistic.attributeEstimate.typeextensibleAttributeEstimateType
http://hl7.org/fhir/ValueSet/attribute-estimate-type
from the FHIR Standard
Evidence.statistic.modelCharacteristic.codeextensibleStatisticModelCode
http://hl7.org/fhir/ValueSet/statistic-model-code
from the FHIR Standard
Evidence.statistic.modelCharacteristic.variable.handlingrequiredEvidenceVariableHandling
http://hl7.org/fhir/ValueSet/variable-handling|5.0.0
from the FHIR Standard
Evidence.statistic:relativeEffect.statisticTyperequiredRelativeEffectType
https://www.netzwerk-universitaetsmedizin.de/fhir/cpg-on-ebm-on-fhir/ValueSet/vs-relative-effect-type
from this IG
Evidence.statistic:relativeEffect.attributeEstimate.typeextensibleAttributeEstimateType
http://hl7.org/fhir/ValueSet/attribute-estimate-type
from the FHIR Standard
Evidence.statistic:relativeEffect.attributeEstimate:confidenceInterval.typeextensiblePattern: C53324("Confidence interval")
http://hl7.org/fhir/ValueSet/attribute-estimate-type
from the FHIR Standard
Evidence.statistic:relativeEffect.modelCharacteristic.codeextensibleStatisticModelCode
http://hl7.org/fhir/ValueSet/statistic-model-code
from the FHIR Standard
Evidence.statistic:relativeEffect.modelCharacteristic.variable.handlingrequiredEvidenceVariableHandling
http://hl7.org/fhir/ValueSet/variable-handling|5.0.0
from the FHIR Standard
Evidence.statistic:baselineRisk.statisticTypeextensiblePattern: C16726("Incidence")
http://hl7.org/fhir/ValueSet/statistic-type
from the FHIR Standard
Evidence.statistic:baselineRisk.quantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Evidence.statistic:baselineRisk.attributeEstimate.typeextensibleAttributeEstimateType
http://hl7.org/fhir/ValueSet/attribute-estimate-type
from the FHIR Standard
Evidence.statistic:baselineRisk.modelCharacteristic.codeextensibleStatisticModelCode
http://hl7.org/fhir/ValueSet/statistic-model-code
from the FHIR Standard
Evidence.statistic:baselineRisk.modelCharacteristic.variable.handlingrequiredEvidenceVariableHandling
http://hl7.org/fhir/ValueSet/variable-handling|5.0.0
from the FHIR Standard
Evidence.statistic:meanDifference.statisticTyperequiredMeanDifferenceType
https://www.netzwerk-universitaetsmedizin.de/fhir/cpg-on-ebm-on-fhir/ValueSet/vs-mean-difference-type
from this IG
Evidence.statistic:meanDifference.attributeEstimate.typeextensibleAttributeEstimateType
http://hl7.org/fhir/ValueSet/attribute-estimate-type
from the FHIR Standard
Evidence.statistic:meanDifference.attributeEstimate:confidenceInterval.typeextensiblePattern: C53324("Confidence interval")
http://hl7.org/fhir/ValueSet/attribute-estimate-type
from the FHIR Standard
Evidence.statistic:meanDifference.modelCharacteristic.codeextensibleStatisticModelCode
http://hl7.org/fhir/ValueSet/statistic-model-code
from the FHIR Standard
Evidence.statistic:meanDifference.modelCharacteristic.variable.handlingrequiredEvidenceVariableHandling
http://hl7.org/fhir/ValueSet/variable-handling|5.0.0
from the FHIR Standard
Evidence.certainty.typeextensibleEvidenceCertaintyType
http://hl7.org/fhir/ValueSet/certainty-type
from the FHIR Standard
Evidence.certainty.ratingextensibleEvidenceCertaintyRating (a valid code from Evidence Certainty Rating)
http://hl7.org/fhir/ValueSet/certainty-rating
from the FHIR Standard