Release 4 4B

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

Detailed Descriptions for the elements in the ResearchElementDefinition resource.

Invariants Affect this element inv-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}')
ResearchElementDefinition
Element Id ResearchElementDefinition
Definition

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

Cardinality 0..*
Type DomainResource
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 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-0 Warning Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('[A-Z]([A-Za-z0-9_]){0,254}')
ResearchElementDefinition.url
Element Id ResearchElementDefinition.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.

Cardinality 0..1
Type uri
Requirements

Allows the research element definition 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.

ResearchElementDefinition.identifier
Element Id ResearchElementDefinition.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.

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 research element definition outside of FHIR, where it is not possible to use the logical URI.

ResearchElementDefinition.version
Element Id ResearchElementDefinition.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.

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 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 Id ResearchElementDefinition.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.

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.

ResearchElementDefinition.title
Element Id ResearchElementDefinition.title
Definition

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

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.

ResearchElementDefinition.shortTitle
Element Id ResearchElementDefinition.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
ResearchElementDefinition.subtitle
Element Id ResearchElementDefinition.subtitle
Definition

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

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

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

ResearchElementDefinition.experimental
Element Id ResearchElementDefinition.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.

Cardinality 0..1
Type boolean
Requirements

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

Summary true
Comments

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

ResearchElementDefinition.subject[x]
Element Id ResearchElementDefinition.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.

Cardinality 0..1
Terminology Binding Subject type ( Extensible )
Type CodeableConcept | Reference ( Group )
[x] Note See Choice of Data Types for further information about how to use [x]
Meaning if Missing Patient
Summary false
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 Id ResearchElementDefinition.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.

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 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 Id ResearchElementDefinition.publisher
Definition

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

Cardinality 0..1
Type string
Requirements

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

Summary true
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 Id ResearchElementDefinition.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.

ResearchElementDefinition.description
Element Id ResearchElementDefinition.description
Definition

A free text natural language description of the research element definition 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 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 Id ResearchElementDefinition.comment
Definition

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

Cardinality 0..*
Type string
Summary false
ResearchElementDefinition.useContext
Element Id ResearchElementDefinition.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.

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.

ResearchElementDefinition.jurisdiction
Element Id ResearchElementDefinition.jurisdiction
Definition

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

Cardinality 0..*
Terminology Binding Jurisdiction ( Extensible )
Type CodeableConcept
Summary true
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 Id ResearchElementDefinition.purpose
Definition

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

Cardinality 0..1
Type markdown
Summary false
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 Id ResearchElementDefinition.usage
Definition

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

Cardinality 0..1
Type string
Summary false
ResearchElementDefinition.copyright
Element Id ResearchElementDefinition.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.

Cardinality 0..1
Type markdown
Requirements

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

Alternate Names License; Restrictions
Summary false
ResearchElementDefinition.approvalDate
Element Id ResearchElementDefinition.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.

Cardinality 0..1
Type date
Summary false
Comments

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

To Do Consider how this applies to this resource.
ResearchElementDefinition.lastReviewDate
Element Id ResearchElementDefinition.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.

Cardinality 0..1
Type date
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.

Summary false
Comments

If specified, this date follows the original approval date.

To Do Consider how this applies to this resource.
ResearchElementDefinition.effectivePeriod
Element Id ResearchElementDefinition.effectivePeriod
Definition

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

Cardinality 0..1
Type Period
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.

Summary true
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 Do Consider how this applies to this resource.
ResearchElementDefinition.topic
Element Id ResearchElementDefinition.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.

Cardinality 0..*
Terminology Binding DefinitionTopic ( Example )
Type CodeableConcept
Requirements

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

Summary false
To Do Consider how this applies to this resource.
ResearchElementDefinition.author
Element Id ResearchElementDefinition.author
Definition

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

Cardinality 0..*
Type ContactDetail
Summary false
ResearchElementDefinition.editor
Element Id ResearchElementDefinition.editor
Definition

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

Cardinality 0..*
Type ContactDetail
Summary false
ResearchElementDefinition.reviewer
Element Id ResearchElementDefinition.reviewer
Definition

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

Cardinality 0..*
Type ContactDetail
Summary false
ResearchElementDefinition.endorser
Element Id ResearchElementDefinition.endorser
Definition

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

Cardinality 0..*
Type ContactDetail
Summary false
ResearchElementDefinition.relatedArtifact
Element Id ResearchElementDefinition.relatedArtifact
Definition

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

Cardinality 0..*
Type RelatedArtifact
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.

Summary false
Comments

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

To Do Consider how this applies to this resource.
ResearchElementDefinition.library
Element Id ResearchElementDefinition.library
Definition

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

Cardinality 0..*
Type canonical ( Library )
Summary false
To Do Consider how this applies to this resource.
ResearchElementDefinition.type
Element Id ResearchElementDefinition.type
Definition

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

Cardinality 1..1
Terminology Binding ResearchElementType ( Required )
Type code
Summary true
ResearchElementDefinition.variableType
Element Id ResearchElementDefinition.variableType
Definition

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

Cardinality 0..1
Terminology Binding VariableType ( Required )
Type code
Summary false
ResearchElementDefinition.characteristic
Element Id ResearchElementDefinition.characteristic
Definition

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

Cardinality 1..*
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.

ResearchElementDefinition.characteristic.definition[x]
Element Id ResearchElementDefinition.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).

Cardinality 1..1
Type CodeableConcept | canonical ( ValueSet )| Expression | DataRequirement
[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
ResearchElementDefinition.characteristic.usageContext
Element Id ResearchElementDefinition.characteristic.usageContext
Definition

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

Cardinality 0..*
Type UsageContext
Requirements

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

Summary false
To Do Define semantics when multiple definition types are present, or disallow mixtures.
ResearchElementDefinition.characteristic.exclude
Element Id ResearchElementDefinition.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
ResearchElementDefinition.characteristic.unitOfMeasure
Element Id ResearchElementDefinition.characteristic.unitOfMeasure
Definition

Specifies the UCUM unit for the outcome.

Cardinality 0..1
Terminology Binding UCUM Codes ( Required )
Type CodeableConcept
Summary false
ResearchElementDefinition.characteristic.studyEffectiveDescription
Element Id ResearchElementDefinition.characteristic.studyEffectiveDescription
Definition

A narrative description of the time period the study covers.

Cardinality 0..1
Type string
Summary false
ResearchElementDefinition.characteristic.studyEffective[x]
Element Id ResearchElementDefinition.characteristic.studyEffective[x]
Definition

Indicates what effective period the study covers.

Cardinality 0..1
Type dateTime | Period | Duration | Timing
[x] Note See Choice of Data Types for further information about how to use [x]
Summary false
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart
Element Id ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart
Definition

Indicates duration from the study initiation.

Cardinality 0..1
Type Duration
Summary false
ResearchElementDefinition.characteristic.studyEffectiveGroupMeasure
Element Id ResearchElementDefinition.characteristic.studyEffectiveGroupMeasure
Definition

Indicates how elements are aggregated within the study effective period.

Cardinality 0..1
Terminology Binding GroupMeasure ( Required )
Type code
Summary false
ResearchElementDefinition.characteristic.participantEffectiveDescription
Element Id ResearchElementDefinition.characteristic.participantEffectiveDescription
Definition

A narrative description of the time period the study covers.

Cardinality 0..1
Type string
Summary false
ResearchElementDefinition.characteristic.participantEffective[x]
Element Id ResearchElementDefinition.characteristic.participantEffective[x]
Definition

Indicates what effective period the study covers.

Cardinality 0..1
Type dateTime | Period | Duration | Timing
[x] Note See Choice of Data Types for further information about how to use [x]
Summary false
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart
Element Id ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart
Definition

Indicates duration from the participant's study entry.

Cardinality 0..1
Type Duration
Summary false
ResearchElementDefinition.characteristic.participantEffectiveGroupMeasure
Element Id ResearchElementDefinition.characteristic.participantEffectiveGroupMeasure
Definition

Indicates how elements are aggregated within the study effective period.

Cardinality 0..1
Terminology Binding GroupMeasure ( Required )
Type code
Summary false