Release 4B Ballot #1

This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. 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: R4B R4

Clinical Decision Support Work GroupMaturity Level: 0 Trial UseSecurity Category: Business Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the ResearchElementDefinition resource.

ResearchElementDefinition
Element IdResearchElementDefinition
Definition

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

Cardinality0..*
TypeDomainResource
Requirements

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

Summaryfalse
Comments

PICO stands for Population (the population within which exposures are being compared), Intervention (the conditional state or exposure state being described for its effect on outcomes), Comparison (the alternative conditional state or alternative exposure state being compared against), and Outcome (the result or effect of the intervention in the population).

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

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

Cardinality0..1
Typeuri
Requirements

Allows the research element definition 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.

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.

ResearchElementDefinition.identifier
Element IdResearchElementDefinition.identifier
Definition

A formal identifier that is used to identify this research element definition 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 research element definition outside of FHIR, where it is not possible to use the logical URI.

ResearchElementDefinition.version
Element IdResearchElementDefinition.version
Definition

The identifier that is used to identify this version of the research element definition when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the research element definition 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.

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

There may be different research element definition 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 research element definition with the format [url]|[version].

ResearchElementDefinition.name
Element IdResearchElementDefinition.name
Definition

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

Cardinality0..1
Typestring
Requirements

Support human navigation and code generation.

Summarytrue
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.

ResearchElementDefinition.title
Element IdResearchElementDefinition.title
Definition

A short, descriptive, user-friendly title for the research element definition.

Cardinality0..1
Typestring
Summarytrue
Comments

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

ResearchElementDefinition.shortTitle
Element IdResearchElementDefinition.shortTitle
Definition

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

Cardinality0..1
Typestring
Requirements

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

Summarytrue
ResearchElementDefinition.subtitle
Element IdResearchElementDefinition.subtitle
Definition

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

Cardinality0..1
Typestring
Summaryfalse
ResearchElementDefinition.status
Element IdResearchElementDefinition.status
Definition

The status of this research element definition. 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 research element definitions that are appropriate for use versus not.

ResearchElementDefinition.experimental
Element IdResearchElementDefinition.experimental
Definition

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

Cardinality0..1
Typeboolean
Requirements

Enables experimental content to be developed following the same lifecycle that would be used for a production-level research element definition.

Summarytrue
Comments

Allows filtering of research element definitions that are appropriate for use versus not.

ResearchElementDefinition.subject[x]
Element IdResearchElementDefinition.subject[x]
Definition

The intended subjects for the ResearchElementDefinition. If this element is not provided, a Patient subject is assumed, but the subject of the ResearchElementDefinition can be anything.

Cardinality0..1
Terminology BindingSubject type (Extensible)
TypeCodeableConcept|Reference(Group)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Meaning if MissingPatient
Summaryfalse
Comments

The subject of the ResearchElementDefinition is critical in interpreting the criteria definitions, as the logic in the ResearchElementDefinitions is evaluated with respect to a particular subject. This corresponds roughly to the notion of a Compartment in that it limits what content is available based on its relationship to the subject. In CQL, this corresponds to the context declaration.

ResearchElementDefinition.date
Element IdResearchElementDefinition.date
Definition

The date (and optionally time) when the research element definition 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 research element definition 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 research element definition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

ResearchElementDefinition.publisher
Element IdResearchElementDefinition.publisher
Definition

The name of the organization or individual that published the research element definition.

Cardinality0..1
Typestring
Requirements

Helps establish the "authority/credibility" of the research element definition. May also allow for contact.

Summarytrue
Comments

Usually an organization but may be an individual. The publisher (or steward) of the research element definition is the organization or individual primarily responsible for the maintenance and upkeep of the research element definition. 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 research element definition. This item SHOULD be populated unless the information is available from context.

ResearchElementDefinition.contact
Element IdResearchElementDefinition.contact
Definition

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

Cardinality0..*
TypeContactDetail
Summarytrue
Comments

May be a web site, an email address, a telephone number, etc.

ResearchElementDefinition.description
Element IdResearchElementDefinition.description
Definition

A free text natural language description of the research element definition from a consumer's perspective.

Cardinality0..1
Typemarkdown
Summarytrue
Comments

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

ResearchElementDefinition.comment
Element IdResearchElementDefinition.comment
Definition

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

Cardinality0..*
Typestring
Summaryfalse
ResearchElementDefinition.useContext
Element IdResearchElementDefinition.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 research element definition 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.

ResearchElementDefinition.jurisdiction
Element IdResearchElementDefinition.jurisdiction
Definition

A legal or geographic region in which the research element definition is intended to be used.

Cardinality0..*
Terminology BindingJurisdiction (Extensible)
TypeCodeableConcept
Summarytrue
Comments

It may be possible for the research element definition to be used in jurisdictions other than those for which it was originally designed or intended.

ResearchElementDefinition.purpose
Element IdResearchElementDefinition.purpose
Definition

Explanation of why this research element definition is needed and why it has been designed as it has.

Cardinality0..1
Typemarkdown
Summaryfalse
Comments

This element does not describe the usage of the research element definition. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this research element definition.

ResearchElementDefinition.usage
Element IdResearchElementDefinition.usage
Definition

A detailed description, from a clinical perspective, of how the ResearchElementDefinition is used.

Cardinality0..1
Typestring
Summaryfalse
ResearchElementDefinition.copyright
Element IdResearchElementDefinition.copyright
Definition

A copyright statement relating to the research element definition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the research element definition.

Cardinality0..1
Typemarkdown
Requirements

Consumers must be able to determine any legal restrictions on the use of the research element definition and/or its content.

Alternate NamesLicense; Restrictions
Summaryfalse
ResearchElementDefinition.approvalDate
Element IdResearchElementDefinition.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.

To DoConsider how this applies to this resource.
ResearchElementDefinition.lastReviewDate
Element IdResearchElementDefinition.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.

To DoConsider how this applies to this resource.
ResearchElementDefinition.effectivePeriod
Element IdResearchElementDefinition.effectivePeriod
Definition

The period during which the research element definition content was or is planned to be in active use.

Cardinality0..1
TypePeriod
Requirements

Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the research element definition are or are expected to be used instead.

Summarytrue
Comments

The effective period for a research element definition determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 might be published in 2015.

To DoConsider how this applies to this resource.
ResearchElementDefinition.topic
Element IdResearchElementDefinition.topic
Definition

Descriptive topics related to the content of the ResearchElementDefinition. Topics provide a high-level categorization grouping types of ResearchElementDefinitions that can be useful for filtering and searching.

Cardinality0..*
Terminology BindingDefinitionTopic (Example)
TypeCodeableConcept
Requirements

Repositories must be able to determine how to categorize the ResearchElementDefinition so that it can be found by topical searches.

Summaryfalse
To DoConsider how this applies to this resource.
ResearchElementDefinition.author
Element IdResearchElementDefinition.author
Definition

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

Cardinality0..*
TypeContactDetail
Summaryfalse
ResearchElementDefinition.editor
Element IdResearchElementDefinition.editor
Definition

An individual or organization primarily responsible for internal coherence of the content.

Cardinality0..*
TypeContactDetail
Summaryfalse
ResearchElementDefinition.reviewer
Element IdResearchElementDefinition.reviewer
Definition

An individual or organization primarily responsible for review of some aspect of the content.

Cardinality0..*
TypeContactDetail
Summaryfalse
ResearchElementDefinition.endorser
Element IdResearchElementDefinition.endorser
Definition

An individual or organization responsible for officially endorsing the content for use in some setting.

Cardinality0..*
TypeContactDetail
Summaryfalse
ResearchElementDefinition.relatedArtifact
Element IdResearchElementDefinition.relatedArtifact
Definition

Related artifacts such as additional documentation, justification, or bibliographic references.

Cardinality0..*
TypeRelatedArtifact
Requirements

ResearchElementDefinitions 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.

Summaryfalse
Comments

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

To DoConsider how this applies to this resource.
ResearchElementDefinition.library
Element IdResearchElementDefinition.library
Definition

A reference to a Library resource containing the formal logic used by the ResearchElementDefinition.

Cardinality0..*
Typecanonical(Library)
Summaryfalse
To DoConsider how this applies to this resource.
ResearchElementDefinition.type
Element IdResearchElementDefinition.type
Definition

The type of research element, a population, an exposure, or an outcome.

Cardinality1..1
Terminology BindingResearchElementType (Required)
Typecode
Summarytrue
ResearchElementDefinition.variableType
Element IdResearchElementDefinition.variableType
Definition

The type of the outcome (e.g. Dichotomous, Continuous, or Descriptive).

Cardinality0..1
Terminology BindingVariableType (Required)
Typecode
Summaryfalse
ResearchElementDefinition.characteristic
Element IdResearchElementDefinition.characteristic
Definition

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

Cardinality1..*
Summarytrue
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.

ResearchElementDefinition.characteristic.definition[x]
Element IdResearchElementDefinition.characteristic.definition[x]
Definition

Define members of the research 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).

Cardinality1..1
TypeCodeableConcept|canonical(ValueSet)|Expression|DataRequirement
[x] NoteSee 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.

Summarytrue
ResearchElementDefinition.characteristic.usageContext
Element IdResearchElementDefinition.characteristic.usageContext
Definition

Use UsageContext to define the members of the population, such as Age Ranges, Genders, Settings.

Cardinality0..*
TypeUsageContext
Requirements

Need to be able to define members more structurally when more information can be communicated such as age range.

Summaryfalse
To DoDefine semantics when multiple definition types are present, or disallow mixtures.
ResearchElementDefinition.characteristic.exclude
Element IdResearchElementDefinition.characteristic.exclude
Definition

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

Cardinality0..1
Typeboolean
Meaning if MissingFalse
Summaryfalse
ResearchElementDefinition.characteristic.unitOfMeasure
Element IdResearchElementDefinition.characteristic.unitOfMeasure
Definition

Specifies the UCUM unit for the outcome.

Cardinality0..1
Terminology BindingUCUM Codes (Required)
TypeCodeableConcept
Summaryfalse
ResearchElementDefinition.characteristic.studyEffectiveDescription
Element IdResearchElementDefinition.characteristic.studyEffectiveDescription
Definition

A narrative description of the time period the study covers.

Cardinality0..1
Typestring
Summaryfalse
ResearchElementDefinition.characteristic.studyEffective[x]
Element IdResearchElementDefinition.characteristic.studyEffective[x]
Definition

Indicates what effective period the study covers.

Cardinality0..1
TypedateTime|Period|Duration|Timing
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart
Element IdResearchElementDefinition.characteristic.studyEffectiveTimeFromStart
Definition

Indicates duration from the study initiation.

Cardinality0..1
TypeDuration
Summaryfalse
ResearchElementDefinition.characteristic.studyEffectiveGroupMeasure
Element IdResearchElementDefinition.characteristic.studyEffectiveGroupMeasure
Definition

Indicates how elements are aggregated within the study effective period.

Cardinality0..1
Terminology BindingGroupMeasure (Required)
Typecode
Summaryfalse
ResearchElementDefinition.characteristic.participantEffectiveDescription
Element IdResearchElementDefinition.characteristic.participantEffectiveDescription
Definition

A narrative description of the time period the study covers.

Cardinality0..1
Typestring
Summaryfalse
ResearchElementDefinition.characteristic.participantEffective[x]
Element IdResearchElementDefinition.characteristic.participantEffective[x]
Definition

Indicates what effective period the study covers.

Cardinality0..1
TypedateTime|Period|Duration|Timing
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart
Element IdResearchElementDefinition.characteristic.participantEffectiveTimeFromStart
Definition

Indicates duration from the participant's study entry.

Cardinality0..1
TypeDuration
Summaryfalse
ResearchElementDefinition.characteristic.participantEffectiveGroupMeasure
Element IdResearchElementDefinition.characteristic.participantEffectiveGroupMeasure
Definition

Indicates how elements are aggregated within the study effective period.

Cardinality0..1
Terminology BindingGroupMeasure (Required)
Typecode
Summaryfalse