Release 4 5 Snapshot #1

This page is part of the FHIR Specification (v4.0.1: R4 - Mixed Normative and STU ) in it's permanent home (it will always be available at this URL). (v5.0.0-snapshot1: R5 Snapshot #1). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4

Clinical Decision Support Work Group Maturity Level : 0 1   Trial Use Security Category : Business Compartments : Not linked to any defined compartments

Detailed Descriptions for the elements in the EvidenceVariable resource.

To Do Note: This was added back in because this is a metadata resource and it's a required element for metadata resource searching. To Do Note: This was added back in because this is a metadata resource and it's a required element for metadata resource searching. Alternate Names To Do Consider how this applies to this resource. To Do Consider how this applies to this resource.
EvidenceVariable
Element Id EvidenceVariable
Definition

The EvidenceVariable resource describes a "PICO" an element that knowledge (evidence, assertion, recommendation) (Evidence) is about.

Cardinality 0..*
Type DomainResource MetadataResource
Requirements

Need to be able to define and reuse the definition of individual elements of a research question.

Summary false
Comments

PICO stands for Population (the population within which exposures are being compared), Intervention (the conditional state or The EvidenceVariable may be an exposure state being described for its effect on outcomes), Comparison (the alternative conditional state variable (intervention, condition, or alternative exposure state being compared against), and Outcome (the result state), a measured variable (outcome or effect of the intervention in the population). observed parameter), or other variable (such as confounding factor).

Invariants
Defined on this element
evv-0 cnl-0 Warning Name should be usable as an identifier for the module by machine processing applications such as code generation name.matches('[A-Z]([A-Za-z0-9_]){0,254}')
EvidenceVariable.url
Element Id EvidenceVariable.url
Definition

An absolute URI that is used to identify this evidence variable 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 evidence variable is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the evidence variable is stored on different servers.

Cardinality 0..1
Type uri
Requirements

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

Summary true
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.

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 .

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.

EvidenceVariable.identifier
Element Id EvidenceVariable.identifier
Definition

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

Note This is a business identifier, not a resource identifier (see discussion )
Cardinality 0..*
Type Identifier
Requirements

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

Summary true
Comments

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

EvidenceVariable.version
Element Id EvidenceVariable.version
Definition

The identifier that is used to identify this version of the evidence variable when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the evidence variable 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. To provide a version consistent with the Decision Support Service specification, use the format Major.Minor.Revision (e.g. 1.0.0). For more information on versioning knowledge assets, refer to the Decision Support Service specification. Note that a version is required for non-experimental active artifacts.

Note This is a business versionId, not a resource version id (see discussion )
Cardinality 0..1
Type string
Summary true
Comments

There may be different evidence variable instances that have the same identifier but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the evidence variable with the format [url]|[version].

EvidenceVariable.name
Element Id EvidenceVariable.name
Definition

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

Cardinality 0..1
Type string
Requirements

Support human navigation and code generation.

Summary true
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
inv-0 cnl-0 Warning Name should be usable as an identifier for the module by machine processing applications such as code generation name.matches('[A-Z]([A-Za-z0-9_]){0,254}')
EvidenceVariable.title
Element Id EvidenceVariable.title
Definition

A short, descriptive, user-friendly title for the evidence variable.

Cardinality 0..1
Type string
Summary true
Comments

This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

EvidenceVariable.shortTitle
Element Id EvidenceVariable.shortTitle
Definition

The short title provides an alternate title for use in informal descriptive contexts where the full, formal title is not necessary.

Cardinality 0..1
Type string
Requirements

Need to be able to reference the content by a short description, but still provide a longer, more formal title for the content.

Summary true
EvidenceVariable.subtitle
Element Id EvidenceVariable.subtitle
Definition

An explanatory or alternate title for the EvidenceVariable giving additional information about its content.

Cardinality 0..1
Type string
Summary false
EvidenceVariable.status
Element Id EvidenceVariable.status
Definition

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

Cardinality 1..1
Terminology Binding PublicationStatus ( Required )
Type code
Is Modifier true (Reason: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration)
Summary true
Comments

Allows filtering of evidence variables that are appropriate for use versus not.

EvidenceVariable.date
Element Id EvidenceVariable.date
Definition

The date (and optionally time) when the evidence variable 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 evidence variable changes.

Cardinality 0..1
Type dateTime
Alternate Names Revision Date
Summary true
Comments

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

EvidenceVariable.publisher Element Id EvidenceVariable.publisher Definition The name of the organization or individual that published the evidence variable. Cardinality 0..1 Type string Requirements Helps establish the "authority/credibility" of the evidence variable. May also allow for contact. Summary true Comments Usually an organization but may be an individual. The publisher (or steward) of the evidence variable is the organization or individual primarily responsible for the maintenance and upkeep of the evidence variable. 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 variable. This item SHOULD be populated unless the information is available from context. EvidenceVariable.contact Element Id EvidenceVariable.contact Definition Contact details to assist a user in finding and communicating with the publisher. Cardinality 0..* Type ContactDetail Summary true Comments May be a web site, an email address, a telephone number, etc. EvidenceVariable.description
Element Id EvidenceVariable.description
Definition

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

Cardinality 0..1
Type markdown
Summary true
Comments

This description can be used to capture details such as why the evidence variable 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 variable 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 variable is presumed to be the predominant language in the place the evidence variable was created).

EvidenceVariable.note
Element Id EvidenceVariable.note
Definition

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

Cardinality 0..*
Type Annotation
Summary false
EvidenceVariable.useContext
Element Id EvidenceVariable.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 variable instances.

Cardinality 0..*
Type UsageContext
Requirements

Assist in searching for appropriate content.

Summary true
Comments

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

EvidenceVariable.jurisdiction EvidenceVariable.publisher
Element Id EvidenceVariable.jurisdiction EvidenceVariable.publisher
Definition

A legal The name of the organization or geographic region in which individual that published the evidence variable is intended to be used. variable.

Cardinality 0..* 0..1
Terminology Binding Type Jurisdiction ( Extensible string )
Type Requirements CodeableConcept

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

Summary true
Comments

It Usually an organization but may be possible for an individual. The publisher (or steward) of the evidence variable to be used in jurisdictions other than those for which it was originally designed is the organization or intended. To Do Note: individual primarily responsible for the maintenance and upkeep of the evidence variable. This was added back in because this is a metadata resource not necessarily the same individual or organization that developed and it's a required element initially authored the content. The publisher is the primary point of contact for metadata resource searching. questions or issues with the evidence variable. This item SHOULD be populated unless the information is available from context.

EvidenceVariable.copyright EvidenceVariable.contact
Element Id EvidenceVariable.copyright EvidenceVariable.contact
Definition

A copyright statement relating Contact details to the evidence variable and/or its contents. Copyright statements are generally legal restrictions on the use assist a user in finding and publishing of communicating with the evidence variable. publisher.

Cardinality 0..1 0..*
Type markdown ContactDetail
Requirements Summary Consumers must be able to determine any legal restrictions on the use of the evidence variable and/or its content. true
Comments License; Restrictions

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

EvidenceVariable.approvalDate EvidenceVariable.author
Element Id EvidenceVariable.approvalDate EvidenceVariable.author
Definition

The date on which the resource content was approved by An individiual or organization primarily involved in the publisher. Approval happens once when creation and maintenance of the content is officially approved for usage. content.

Cardinality 0..1 0..*
Type date ContactDetail
Comments Summary The 'date' element may be more recent than the approval date because of minor changes or editorial corrections. false
To Do Comments Consider how this applies

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

EvidenceVariable.lastReviewDate EvidenceVariable.editor
Element Id EvidenceVariable.lastReviewDate EvidenceVariable.editor
Definition

The date on which the resource content was last reviewed. Review happens periodically after approval but does not change An individual or organization primarily responsible for internal coherence of the original approval date. content.

Cardinality 0..1 0..*
Type date ContactDetail
Requirements Summary 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. false
Comments

If specified, this date follows the original approval date. To Do Consider how this applies Extensions to this resource. ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

EvidenceVariable.effectivePeriod EvidenceVariable.reviewer
Element Id EvidenceVariable.effectivePeriod EvidenceVariable.reviewer
Definition

The period during which the evidence variable content was An individual or is planned to be in active use. organization primarily responsible for review of some aspect of the content.

Cardinality 0..1 0..*
Type Period ContactDetail
Requirements Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the evidence variable are or are expected to be used instead. Summary true false
Comments

The effective period for a evidence variable determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended Extensions to be used for the year 2016 might be published in 2015. ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

EvidenceVariable.topic EvidenceVariable.endorser
Element Id EvidenceVariable.topic EvidenceVariable.endorser
Definition

Descriptive topics related to An individual or organization responsible for officially endorsing the content of the EvidenceVariable. Topics provide a high-level categorization grouping types of EvidenceVariables that can be useful for filtering and searching. use in some setting.

Cardinality 0..*
Terminology Binding Type DefinitionTopic ( Example ContactDetail )
Type Summary CodeableConcept false
Requirements Comments

Repositories must be able to determine how Extensions to categorize the EvidenceVariable so that it can be found by topical searches. ContactDetail include: contactReference, contactAddress, and contributionTime (Details at: http://build.fhir.org/clinicalreasoning-module.html).

EvidenceVariable.author EvidenceVariable.relatedArtifact
Element Id EvidenceVariable.author EvidenceVariable.relatedArtifact
Definition

An individiual Related artifacts such as additional documentation, justification, or organization primarily involved in the creation and maintenance of the content. bibliographic references.

Cardinality 0..*
Type ContactDetail RelatedArtifact EvidenceVariable.editor Element Id EvidenceVariable.editor
Definition Requirements

An individual EvidenceVariables must be able to provide enough information for consumers of the content (and/or interventions or organization primarily responsible results produced by the content) to be able to determine and understand the justification for internal coherence and evidence in support of the content.

Cardinality Summary 0..* false
Type Comments ContactDetail

Each related artifact is either an attachment, or a reference to another resource, but not both.

EvidenceVariable.reviewer EvidenceVariable.actual
Element Id EvidenceVariable.reviewer EvidenceVariable.actual
Definition

An individual or organization primarily responsible for review of some aspect True if the actual variable measured, false if a conceptual representation of the content. intended variable.

Cardinality 0..* 0..1
Type ContactDetail boolean
Summary false
EvidenceVariable.endorser EvidenceVariable.characteristicCombination
Element Id EvidenceVariable.endorser EvidenceVariable.characteristicCombination
Definition

An individual Used to specify how two or organization responsible for officially endorsing the content for use in some setting. more characteristics are combined.

Cardinality 0..* 0..1
Type Summary ContactDetail false
EvidenceVariable.relatedArtifact EvidenceVariable.characteristicCombination.code
Element Id EvidenceVariable.relatedArtifact EvidenceVariable.characteristicCombination.code
Definition

Related artifacts such as additional documentation, justification, Used to specify if two or bibliographic references. more characteristics are combined with OR or AND.

Cardinality 0..* 1..1
Type Terminology Binding RelatedArtifact CharacteristicCombination ( Required )
Requirements Type EvidenceVariables must be able to provide enough information for consumers of the content (and/or interventions or results produced by the content) to be able to determine and understand the justification for and evidence in support of the content. code
Comments Requirements

Each related artifact If code is either an attachment, "at-least" or a reference to another resource, but not both. "at-most" then threshold SHALL be used. If code is neither "at-least" nor "at-most" then threshold SHALL NOT be used.

To Do Summary Consider how this applies to this resource. false
EvidenceVariable.type EvidenceVariable.characteristicCombination.threshold
Element Id EvidenceVariable.type EvidenceVariable.characteristicCombination.threshold
Definition

The type Provides the value of evidence element, a population, an exposure, "n" when "at-least" or an outcome. "at-most" codes are used.

Cardinality 0..1
Terminology Binding EvidenceVariableType ( Required ) Type code positiveInt
Summary true false
EvidenceVariable.characteristic
Element Id EvidenceVariable.characteristic
Definition

A characteristic that defines the members of the evidence element. Multiple characteristics are applied with "and" semantics.

Cardinality 1..* 0..*
Summary true
Comments

Characteristics can be defined flexibly to accommodate different use cases for membership criteria, ranging from simple codes, all the way to using an expression language to express the criteria.

EvidenceVariable.characteristic.description
Element Id EvidenceVariable.characteristic.description
Definition

A short, natural language description of the characteristic that could be used to communicate the criteria to an end-user.

Cardinality 0..1
Type string
Requirements

Need to be able to describe characteristics in natural language so that end users can understand the criteria.

Summary false
EvidenceVariable.characteristic.type
Element Id EvidenceVariable.characteristic.type
Definition

Used to expressing the type of characteristic.

Cardinality 0..1
Terminology Binding UsageContextType ( Example )
Type CodeableConcept
Summary false
EvidenceVariable.characteristic.definition[x]
Element Id EvidenceVariable.characteristic.definition[x]
Definition

Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).

Cardinality 1..1
Type Reference ( Group | EvidenceVariable )| canonical ( ActivityDefinition Any )| CodeableConcept | Expression | DataRequirement | TriggerDefinition
Patterns Reference(Group,EvidenceVariable): No common pattern
[x] Note See Choice of Data Types for further information about how to use [x]
Requirements

Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.

Summary true
EvidenceVariable.characteristic.usageContext EvidenceVariable.characteristic.method
Element Id EvidenceVariable.characteristic.usageContext EvidenceVariable.characteristic.method
Definition

Use UsageContext to define the members of the population, such as Age Ranges, Genders, Settings. Method used for describing characteristic.

Cardinality 0..* 0..1
Terminology Binding CharacteristicMethod ( Example )
Type UsageContext CodeableConcept
Requirements Summary false
EvidenceVariable.characteristic.device
Element Id EvidenceVariable.characteristic.device
Definition

Need to be able to define members more structurally when more information can be communicated such as age range. Device used for determining characteristic.

To Do Cardinality Define semantics when multiple definition types are present, or disallow mixtures. 0..1
Type Reference ( Device | DeviceMetric )
Patterns Reference(Device,DeviceMetric): No common pattern
Summary false
EvidenceVariable.characteristic.exclude
Element Id EvidenceVariable.characteristic.exclude
Definition

When true, members with this characteristic are excluded from the element.

Cardinality 0..1
Type boolean
Meaning if Missing False
Summary false
EvidenceVariable.characteristic.participantEffective[x] EvidenceVariable.characteristic.timeFromEvent
Element Id EvidenceVariable.characteristic.participantEffective[x] EvidenceVariable.characteristic.timeFromEvent
Definition

Indicates what effective period the Observation time from study covers. specified event.

Cardinality 0..*
Summary false
EvidenceVariable.characteristic.timeFromEvent.description
Element Id EvidenceVariable.characteristic.timeFromEvent.description
Definition

Human readable description.

Cardinality 0..1
Type dateTime string | Period
Summary | Duration false
| Timing EvidenceVariable.characteristic.timeFromEvent.event
Element Id EvidenceVariable.characteristic.timeFromEvent.event
Definition

The event used as a base point (reference point) in time.

Cardinality 0..1
[x] Note Terminology Binding See Choice of Data Types EvidenceVariableEvent for further information about how ( Example )
Type CodeableConcept
Summary false
EvidenceVariable.characteristic.timeFromEvent.quantity
Element Id EvidenceVariable.characteristic.timeFromEvent.quantity
Definition

Used to use [x] express the observation at a defined amount of time after the study start.

Cardinality 0..1
Type Quantity
Summary false
EvidenceVariable.characteristic.timeFromStart EvidenceVariable.characteristic.timeFromEvent.range
Element Id EvidenceVariable.characteristic.timeFromStart EvidenceVariable.characteristic.timeFromEvent.range
Definition

Indicates duration from Used to express the observation within a period after the participant's study entry. start.

Cardinality 0..1
Type Duration Range
Summary false
EvidenceVariable.characteristic.timeFromEvent.note
Element Id EvidenceVariable.characteristic.timeFromEvent.note
Definition

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

Cardinality 0..*
Type Annotation
Summary false
EvidenceVariable.characteristic.groupMeasure
Element Id EvidenceVariable.characteristic.groupMeasure
Definition

Indicates how elements are aggregated within Value or set of values that define the study effective period. grouping.

Cardinality 0..1
Terminology Binding GroupMeasure ( Required )
Type code
Summary false
EvidenceVariable.handling
Element Id EvidenceVariable.handling
Definition

continuous | dichotomous | ordinal | polychotomous.

Cardinality 0..1
Terminology Binding EvidenceVariableHandling ( Required )
Type code
Summary false
EvidenceVariable.category
Element Id EvidenceVariable.category
Definition

A grouping for ordinal or polychotomous variables.

Cardinality 0..*
Summary false
EvidenceVariable.category.name
Element Id EvidenceVariable.category.name
Definition

Description of the grouping.

Cardinality 0..1
Type string
Summary false
EvidenceVariable.category.value[x]
Element Id EvidenceVariable.category.value[x]
Definition

Definition of the grouping.

Cardinality 0..1
Type CodeableConcept | Quantity | Range
[x] Note See Choice of Data Types for further information about how to use [x]
Summary false