Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Clinical Decision Support Work GroupMaturity Level: 1 Trial UseSecurity Category: Business Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the Evidence resource.

Evidence
Element IdEvidence
Definition

The Evidence Resource provides a machine-interpretable expression of an evidence concept including the evidence variables (e.g., population, exposures/interventions, comparators, outcomes, measured variables, confounding variables), the statistics, and the certainty of this evidence.

Cardinality0..*
TypeMetadataResource
Summaryfalse
Invariants
Defined on this element
cnl-0Warning Name should be usable as an identifier for the module by machine processing applications such as code generationname.exists() implies name.matches('[A-Z]([A-Za-z0-9_]){0,254}')
Evidence.url
Element IdEvidence.url
Definition

An absolute URI that is used to identify this evidence when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which at which an authoritative instance of this summary is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the summary is stored on different servers.

Cardinality0..1
Typeuri
Requirements

Allows the evidence to be referenced by a single globally unique identifier.

Summarytrue
Comments

Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.

Evidence.identifier
Element IdEvidence.identifier
Definition

A formal identifier that is used to identify this summary when it is represented in other formats, or referenced in a specification, model, design or an instance.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Requirements

Allows externally provided and/or usable business identifiers to be easily associated with the module.

Summarytrue
Comments

Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this summary outside of FHIR, where it is not possible to use the logical URI.

Evidence.version
Element IdEvidence.version
Definition

The identifier that is used to identify this version of the summary when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the summary author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions can be placed in a lexicographical sequence.

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summarytrue
Comments

The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in Technical and Business Versions.

Evidence.name
Element IdEvidence.name
Definition

A natural language name identifying the evidence. This name should be usable as an identifier for the module by machine processing applications such as code generation.

Cardinality0..1
Typestring
Summaryfalse
Comments

The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.

Invariants
Affect this element
cnl-0Warning Name should be usable as an identifier for the module by machine processing applications such as code generationname.exists() implies name.matches('[A-Z]([A-Za-z0-9_]){0,254}')
Evidence.title
Element IdEvidence.title
Definition

A short, descriptive, user-friendly title for the summary.

Cardinality0..1
Typestring
Summarytrue
Comments

In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the meta.source element to indicate where the current master source of the resource can be found.

Evidence.citeAs[x]
Element IdEvidence.citeAs[x]
Definition

Citation Resource or display of suggested citation for this evidence.

Cardinality0..1
TypeReference(Citation)|markdown
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
Evidence.status
Element IdEvidence.status
Definition

The status of this summary. Enables tracking the life-cycle of the content.

Cardinality1..1
Terminology BindingPublicationStatus (Required)
Typecode
Is Modifiertrue (Reason: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration)
Summarytrue
Comments

Allows filtering of summarys s that are appropriate for use versus not.

Evidence.experimental
Element IdEvidence.experimental
Definition

A Boolean value to indicate that this resource is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage.

Cardinality0..1
Typeboolean
Meaning if MissingFalse
Summaryfalse
Evidence.date
Element IdEvidence.date
Definition

The date (and optionally time) when the summary was published. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the summary changes.

Cardinality0..1
TypedateTime
Alternate NamesRevision Date
Summarytrue
Comments

Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the summary. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

Evidence.useContext
Element IdEvidence.useContext
Definition

The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate evidence instances.

Cardinality0..*
TypeUsageContext
Requirements

Assist in searching for appropriate content.

Summarytrue
Comments

When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.

Evidence.approvalDate
Element IdEvidence.approvalDate
Definition

The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.

Cardinality0..1
Typedate
Summaryfalse
Comments

The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.

Evidence.lastReviewDate
Element IdEvidence.lastReviewDate
Definition

The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.

Cardinality0..1
Typedate
Requirements

Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.

Summaryfalse
Comments

If specified, this date follows the original approval date.

Evidence.publisher
Element IdEvidence.publisher
Definition

The name of the organization or individual that published the evidence.

Cardinality0..1
Typestring
Requirements

Helps establish the "authority/credibility" of the evidence. May also allow for contact.

Summarytrue
Comments

Usually an organization but may be an individual. The publisher (or steward) of the evidence is the organization or individual primarily responsible for the maintenance and upkeep of the evidence. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the evidence. This item SHOULD be populated unless the information is available from context.

Evidence.contact
Element IdEvidence.contact
Definition

Contact details to assist a user in finding and communicating with the publisher.

Cardinality0..*
TypeContactDetail
Summarytrue
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

Evidence.author
Element IdEvidence.author
Definition

An individiual, organization, or device primarily involved in the creation and maintenance of the content.

Cardinality0..*
TypeContactDetail
Summarytrue
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

Evidence.editor
Element IdEvidence.editor
Definition

An individiual, organization, or device primarily responsible for internal coherence of the content.

Cardinality0..*
TypeContactDetail
Summaryfalse
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

Evidence.reviewer
Element IdEvidence.reviewer
Definition

An individiual, organization, or device primarily responsible for review of some aspect of the content.

Cardinality0..*
TypeContactDetail
Summaryfalse
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

Evidence.endorser
Element IdEvidence.endorser
Definition

An individiual, organization, or device responsible for officially endorsing the content for use in some setting.

Cardinality0..*
TypeContactDetail
Summarytrue
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

Evidence.relatedArtifact
Element IdEvidence.relatedArtifact
Definition

Link or citation to artifact associated with the summary.

Cardinality0..*
TypeRelatedArtifact
Summaryfalse
Evidence.description
Element IdEvidence.description
Definition

A free text natural language description of the evidence from a consumer's perspective.

Cardinality0..1
Typemarkdown
Summaryfalse
Comments

This description can be used to capture details such as why the evidence was built, comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the evidence as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the evidence is presumed to be the predominant language in the place the evidence was created).

Evidence.assertion
Element IdEvidence.assertion
Definition

Declarative description of the Evidence.

Cardinality0..1
Typemarkdown
Summaryfalse
Evidence.note
Element IdEvidence.note
Definition

Footnotes and/or explanatory notes.

Cardinality0..*
TypeAnnotation
Summaryfalse
Evidence.variableDefinition
Element IdEvidence.variableDefinition
Definition

Evidence variable such as population, exposure, or outcome.

Cardinality1..*
Summaryfalse
Evidence.variableDefinition.description
Element IdEvidence.variableDefinition.description
Definition

A text description or summary of the variable.

Cardinality0..1
Typemarkdown
Summaryfalse
Evidence.variableDefinition.note
Element IdEvidence.variableDefinition.note
Definition

Footnotes and/or explanatory notes.

Cardinality0..*
TypeAnnotation
Summaryfalse
Evidence.variableDefinition.variableRole
Element IdEvidence.variableDefinition.variableRole
Definition

population | subpopulation | exposure | referenceExposure | measuredVariable | confounder.

Cardinality1..1
Terminology BindingEvidenceVariableRole (Extensible)
TypeCodeableConcept
Summarytrue
Evidence.variableDefinition.observed
Element IdEvidence.variableDefinition.observed
Definition

Definition of the actual variable related to the statistic(s).

Cardinality0..1
TypeReference(Group | EvidenceVariable)
Summarytrue
Evidence.variableDefinition.intended
Element IdEvidence.variableDefinition.intended
Definition

Definition of the intended variable related to the Evidence.

Cardinality0..1
TypeReference(Group | EvidenceVariable)
Summaryfalse
Evidence.variableDefinition.directnessMatch
Element IdEvidence.variableDefinition.directnessMatch
Definition

Indication of quality of match between intended variable to actual variable.

Cardinality0..1
Terminology BindingEvidenceDirectness (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.synthesisType
Element IdEvidence.synthesisType
Definition

The method to combine studies.

Cardinality0..1
Terminology BindingSynthesisType (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.studyDesign
Element IdEvidence.studyDesign
Definition

The type of study that produced this evidence.

Cardinality0..*
Terminology BindingStudyType (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.statistic
Element IdEvidence.statistic
Definition

Values and parameters for a single statistic.

Cardinality0..*
Summaryfalse
Evidence.statistic.description
Element IdEvidence.statistic.description
Definition

A description of the content value of the statistic.

Cardinality0..1
Typestring
Summaryfalse
Evidence.statistic.note
Element IdEvidence.statistic.note
Definition

Footnotes and/or explanatory notes.

Cardinality0..*
TypeAnnotation
Summaryfalse
Evidence.statistic.statisticType
Element IdEvidence.statistic.statisticType
Definition

Type of statistic, e.g., relative risk.

Cardinality0..1
Terminology BindingStatisticType (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.statistic.category
Element IdEvidence.statistic.category
Definition

When the measured variable is handled categorically, the category element is used to define which category the statistic is reporting.

Cardinality0..1
TypeCodeableConcept
Summaryfalse
Comments

Simple strings can be used for descriptive purposes. Exact matching to EvidenceVariable.category.name for the Evidence.variableDefinition[variableRole=measuredVariable].observed=Reference(EvidenceVariable) could facilitate validation within datasets.

Evidence.statistic.quantity
Element IdEvidence.statistic.quantity
Definition

Statistic value.

Cardinality0..1
TypeQuantity
Summaryfalse
Evidence.statistic.numberOfEvents
Element IdEvidence.statistic.numberOfEvents
Definition

The number of events associated with the statistic, where the unit of analysis is different from numberAffected, sampleSize.knownDataCount and sampleSize.numberOfParticipants.

Cardinality0..1
TypeunsignedInt
Summaryfalse
Comments

When the number of events is the statistic, use Evidence.statistic.quantity and set Evidence.statistic.type.coding.code=C25463 and Evidence.statistic.type.coding.display=Count. When the statistic is an Event Rate (where individual participants may have 2 or more events), use Evidence.statistic.numberOfEvents to record the total number of events rather than the number of participants with events.

Evidence.statistic.numberAffected
Element IdEvidence.statistic.numberAffected
Definition

The number of participants affected where the unit of analysis is the same as sampleSize.knownDataCount and sampleSize.numberOfParticipants.

Cardinality0..1
TypeunsignedInt
Summaryfalse
Comments

When the number affected is the statistic, use Evidence.statistic.quantity and set Evidence.statistic.type.coding.code=C25463 and Evidence.statistic.type.coding.display=Count. When the statistic is a Proportion, use Evidence.statistic.numberAffected and enter an integer as the value. When the statistic is an Event Rate (where individual participants may have 2 or more events), use Evidence.statistic.numberAffected to record the number of participants with events rather than the total number of events.

Evidence.statistic.sampleSize
Element IdEvidence.statistic.sampleSize
Definition

Number of samples in the statistic.

Cardinality0..1
Summaryfalse
Evidence.statistic.sampleSize.description
Element IdEvidence.statistic.sampleSize.description
Definition

Human-readable summary of population sample size.

Cardinality0..1
Typestring
Summaryfalse
Evidence.statistic.sampleSize.note
Element IdEvidence.statistic.sampleSize.note
Definition

Footnote or explanatory note about the sample size.

Cardinality0..*
TypeAnnotation
Summaryfalse
Evidence.statistic.sampleSize.numberOfStudies
Element IdEvidence.statistic.sampleSize.numberOfStudies
Definition

Number of participants in the population.

Cardinality0..1
TypeunsignedInt
Summaryfalse
Evidence.statistic.sampleSize.numberOfParticipants
Element IdEvidence.statistic.sampleSize.numberOfParticipants
Definition

A human-readable string to clarify or explain concepts about the sample size.

Cardinality0..1
TypeunsignedInt
Summaryfalse
Evidence.statistic.sampleSize.knownDataCount
Element IdEvidence.statistic.sampleSize.knownDataCount
Definition

Number of participants with known results for measured variables.

Cardinality0..1
TypeunsignedInt
Summaryfalse
Evidence.statistic.attributeEstimate
Element IdEvidence.statistic.attributeEstimate
Definition

A statistical attribute of the statistic such as a measure of heterogeneity.

Cardinality0..*
Summaryfalse
Evidence.statistic.attributeEstimate.description
Element IdEvidence.statistic.attributeEstimate.description
Definition

Human-readable summary of the estimate.

Cardinality0..1
Typestring
Summaryfalse
Evidence.statistic.attributeEstimate.note
Element IdEvidence.statistic.attributeEstimate.note
Definition

Footnote or explanatory note about the estimate.

Cardinality0..*
TypeAnnotation
Summaryfalse
Evidence.statistic.attributeEstimate.type
Element IdEvidence.statistic.attributeEstimate.type
Definition

The type of attribute estimate, e.g., confidence interval or p value.

Cardinality0..1
Terminology BindingAttributeEstimateType (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.statistic.attributeEstimate.quantity
Element IdEvidence.statistic.attributeEstimate.quantity
Definition

The singular quantity of the attribute estimate, for attribute estimates represented as single values; also used to report unit of measure.

Cardinality0..1
TypeQuantity
Summaryfalse
Comments

Often the p value

Evidence.statistic.attributeEstimate.level
Element IdEvidence.statistic.attributeEstimate.level
Definition

Use 95 for a 95% confidence interval.

Cardinality0..1
Typedecimal
Summaryfalse
Evidence.statistic.attributeEstimate.range
Element IdEvidence.statistic.attributeEstimate.range
Definition

Lower bound of confidence interval.

Cardinality0..1
TypeRange
Summaryfalse
Evidence.statistic.attributeEstimate.attributeEstimate
Element IdEvidence.statistic.attributeEstimate.attributeEstimate
Definition

A nested attribute estimate; which is the attribute estimate of an attribute estimate.

Cardinality0..*
TypeSee Evidence.statistic.attributeEstimate
Summaryfalse
Comments

A nested attribute estimate; which is the attribute estimate of an attribute estimate

Evidence.statistic.modelCharacteristic
Element IdEvidence.statistic.modelCharacteristic
Definition

A component of the method to generate the statistic.

Cardinality0..*
Summaryfalse
Evidence.statistic.modelCharacteristic.code
Element IdEvidence.statistic.modelCharacteristic.code
Definition

Description of a component of the method to generate the statistic.

Cardinality1..1
Terminology BindingStatisticModelCode (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.statistic.modelCharacteristic.value
Element IdEvidence.statistic.modelCharacteristic.value
Definition

Further specification of the quantified value of the component of the method to generate the statistic.

Cardinality0..1
TypeSimpleQuantity
Summaryfalse
Evidence.statistic.modelCharacteristic.variable
Element IdEvidence.statistic.modelCharacteristic.variable
Definition

A variable adjusted for in the adjusted analysis.

Cardinality0..*
Summaryfalse
Evidence.statistic.modelCharacteristic.variable.variableDefinition
Element IdEvidence.statistic.modelCharacteristic.variable.variableDefinition
Definition

Description of the variable.

Cardinality1..1
TypeReference(Group | EvidenceVariable)
Summaryfalse
Evidence.statistic.modelCharacteristic.variable.handling
Element IdEvidence.statistic.modelCharacteristic.variable.handling
Definition

How the variable is classified for use in adjusted analysis.

Cardinality0..1
Terminology BindingEvidenceVariableHandling (Required)
Typecode
Summaryfalse
Evidence.statistic.modelCharacteristic.variable.valueCategory
Element IdEvidence.statistic.modelCharacteristic.variable.valueCategory
Definition

Description for grouping of ordinal or polychotomous variables.

Cardinality0..*
TypeCodeableConcept
Summaryfalse
Evidence.statistic.modelCharacteristic.variable.valueQuantity
Element IdEvidence.statistic.modelCharacteristic.variable.valueQuantity
Definition

Discrete value for grouping of ordinal or polychotomous variables.

Cardinality0..*
TypeQuantity
Summaryfalse
Evidence.statistic.modelCharacteristic.variable.valueRange
Element IdEvidence.statistic.modelCharacteristic.variable.valueRange
Definition

Range of values for grouping of ordinal or polychotomous variables.

Cardinality0..*
TypeRange
Summaryfalse
Evidence.statistic.modelCharacteristic.attributeEstimate
Element IdEvidence.statistic.modelCharacteristic.attributeEstimate
Definition

An attribute of the statistic used as a model characteristic.

Cardinality0..*
TypeSee Evidence.statistic.attributeEstimate
Summaryfalse
Evidence.certainty
Element IdEvidence.certainty
Definition

Assessment of certainty, confidence in the estimates, or quality of the evidence.

Cardinality0..*
Summaryfalse
Evidence.certainty.description
Element IdEvidence.certainty.description
Definition

Textual description of certainty.

Cardinality0..1
Typestring
Summaryfalse
Evidence.certainty.note
Element IdEvidence.certainty.note
Definition

Footnotes and/or explanatory notes.

Cardinality0..*
TypeAnnotation
Summaryfalse
Evidence.certainty.type
Element IdEvidence.certainty.type
Definition

Aspect of certainty being rated.

Cardinality0..1
Terminology BindingEvidenceCertaintyType (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.certainty.rating
Element IdEvidence.certainty.rating
Definition

Assessment or judgement of the aspect.

Cardinality0..1
Terminology BindingEvidenceCertaintyRating (Extensible)
TypeCodeableConcept
Summaryfalse
Evidence.certainty.rater
Element IdEvidence.certainty.rater
Definition

Individual or group who did the rating.

Cardinality0..1
Typestring
Summaryfalse
Evidence.certainty.subcomponent
Element IdEvidence.certainty.subcomponent
Definition

A domain or subdomain of certainty.

Cardinality0..*
TypeSee Evidence.certainty
Summaryfalse