Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Resource Profile: EndpointAnalysisPlan - Detailed Descriptions

Page standards status: Draft Maturity Level: 1

Definitions for the endpoint-analysis-plan resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Evidence
2. Evidence.statistic
4. Evidence.statistic.modelCharacteristic
Control1..?
6. Evidence.statistic.modelCharacteristic.intended
Pattern Valuetrue

Guidance on how to interpret the contents of this table can be found here

0. Evidence
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.

ShortSingle evidence bit
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantscnl-0: 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_]){1,254}$'))
2. Evidence.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Evidence.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. Evidence.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Evidence.status
Definition

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

Shortdraft | active | retired | unknown
Comments

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

See guidance around (not) making local changes to elements here.


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

See guidance around (not) making local changes to elements here.

Control1..1
BindingThe codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2
(required to http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2)

The lifecycle status of an artifact.

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Evidence.variableDefinition
Definition

Evidence variable such as population, exposure, or outcome.

ShortEvidence variable such as population, exposure, or outcome
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Evidence.variableDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Evidence.variableDefinition.variableRole
Definition

Classification of the role of the variable.

Shortpopulation | exposure | outcome | covariate
Control1..1
BindingThe codes SHALL be taken from EvidenceVariableRolehttp://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2
(required to http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2)

The role that the variable plays.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. Evidence
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.

ShortSingle evidence bit
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantscnl-0: 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_]){1,254}$'))
2. Evidence.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

Control0..1
Typeid
Is Modifierfalse
Must Supportfalse
Summarytrue
4. Evidence.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Evidence.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Evidence.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2)

IETF language tag for a human language

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Evidence.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Evidence.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. Evidence.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Evidence.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Evidence.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 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.

ShortCanonical identifier for this evidence, represented as a globally unique URI
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.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

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

Invariantscnl-1: URL should not contain | or # - these characters make processing canonical references problematic (exists() implies matches('^[^|# ]+$'))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Evidence.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.

ShortAdditional identifier for the summary
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.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Evidence.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.

ShortBusiness version of this summary
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.

NoteThis is a business version Id, not a resource version Id (see discussion)
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Evidence.versionAlgorithm[x]
Definition

Indicates the mechanism used to compare versions to determine which is more current.

ShortHow to compare versions
Comments

If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 is newer, and a 0 if the version ordering can't successfully be determined.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from VersionAlgorithm
(extensible to http://hl7.org/fhir/ValueSet/version-algorithm)
TypeChoice of: string, Coding
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Evidence.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.

ShortName for this summary (machine friendly)
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.

Control0..1
This element is affected by the following invariants: cnl-0
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Evidence.title
Definition

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

ShortName for this summary (human friendly)
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Evidence.citeAs[x]
Definition

Citation Resource or display of suggested citation for this evidence.

ShortCitation for this evidence
Control0..1
TypeChoice of: Reference(Citation), markdown
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Evidence.status
Definition

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

Shortdraft | active | retired | unknown
Comments

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

See guidance around (not) making local changes to elements here.

Control1..1
BindingThe codes SHALL be taken from PublicationStatus
(required to http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2)

The lifecycle status of an artifact.

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Evidence.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.

ShortFor testing purposes, not real usage
Control0..1
Typeboolean
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Meaning if MissingIf absent, this resource is treated as though it is not experimental.
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Evidence.date
Definition

The date (and optionally time) when the summary was last significantly changed. 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.

ShortDate last changed
Comments

The date is often not tracked until the resource is published, but may be present on draft content. 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.

See guidance around (not) making local changes to elements here.

Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Alternate NamesRevision Date
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Evidence.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.

ShortWhen the summary was approved by publisher
Comments

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

See guidance around (not) making local changes to elements here.

Control0..1
Typedate
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Evidence.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.

ShortWhen the summary was last reviewed by the publisher
Comments

If specified, this date follows the original approval date.

See guidance around (not) making local changes to elements here.

Control0..1
Typedate
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Evidence.publisher
Definition

The name of the organization or individual responsible for the release and ongoing maintenance of the evidence.

ShortName of the publisher/steward (organization or individual)
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.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Evidence.contact
Definition

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

ShortContact details for the publisher
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (see Clinical Reasoning Module).

See guidance around (not) making local changes to elements here.

Control0..*
TypeContactDetail
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Evidence.author
Definition

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

ShortWho authored the content
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (see Clinical Reasoning Module).

Control0..*
TypeContactDetail
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Evidence.editor
Definition

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

ShortWho edited the content
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (see Clinical Reasoning Module).

Control0..*
TypeContactDetail
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Evidence.reviewer
Definition

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

ShortWho reviewed the content
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (see Clinical Reasoning Module).

See guidance around (not) making local changes to elements here.

Control0..*
TypeContactDetail
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Evidence.endorser
Definition

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

ShortWho endorsed the content
Comments

Extensions to ContactDetail include: contactReference, contactAddress, and contributionTime (see Clinical Reasoning Module).

See guidance around (not) making local changes to elements here.

Control0..*
TypeContactDetail
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Evidence.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.

ShortThe context that the content is intended to support
Comments

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

Control0..*
TypeUsageContext
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Assist in searching for appropriate content.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Evidence.purpose
Definition

Explanation of why this Evidence is needed and why it has been designed as it has.

ShortWhy this Evidence is defined
Comments

This element does not describe the usage of the Evidence. 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 Evidence.

Control0..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. Evidence.copyright
Definition

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

ShortUse and/or publishing restrictions
Comments

The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element.

Control0..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Requirements

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

Alternate NamesLicense, Restrictions
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Evidence.copyrightLabel
Definition

A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').

ShortCopyright holder and year(s)
Comments

The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Requirements

Defines the content expected to be rendered in all representations of the artifact.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Evidence.relatedArtifact
Definition

Link or citation to artifact associated with the summary.

ShortLink or citation to artifact associated with the summary
Comments

Use type value 'derived-from' to denote the source for the Evidence content. To express exact phrasing in the source material, use a classifier instance with a coding value of 'Quotation' and a text value of the quoted content. The coding value of 'Quotation' can be expressed with a system value of 'http://hl7.org/fhir/provenance-entity-role', a code value of 'quotation' and a display value of 'Quotation'.

Control0..*
TypeRelatedArtifact
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. Evidence.description
Definition

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

ShortDescription of the particular summary
Comments

This description can be used to capture details such as 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).

Control0..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. Evidence.assertion
Definition

Declarative description of the Evidence.

ShortDeclarative description of the Evidence
Control0..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Evidence.note
Definition

Footnotes and/or explanatory notes.

ShortFootnotes and/or explanatory notes
Control0..*
TypeAnnotation
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Evidence.variableDefinition
Definition

Evidence variable such as population, exposure, or outcome.

ShortEvidence variable such as population, exposure, or outcome
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Evidence.variableDefinition.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
74. Evidence.variableDefinition.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. Evidence.variableDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. Evidence.variableDefinition.description
Definition

A text description or summary of the variable.

ShortA text description or summary of the variable
Control0..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Evidence.variableDefinition.note
Definition

Footnotes and/or explanatory notes.

ShortFootnotes and/or explanatory notes
Control0..*
TypeAnnotation
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. Evidence.variableDefinition.variableRole
Definition

Classification of the role of the variable.

Shortpopulation | exposure | outcome | covariate
Control1..1
BindingThe codes SHALL be taken from EvidenceVariableRole
(required to http://hl7.org/fhir/ValueSet/variable-role|6.0.0-ballot2)

The role that the variable plays.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. Evidence.variableDefinition.roleSubtype
Definition

Sub-classification of the role of the variable.

Shortsubgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier
Control0..1
BindingUnless not suitable, these codes SHALL be taken from EvidenceVariableRoleSubtype
(extensible to http://hl7.org/fhir/ValueSet/variable-role-subtype)

The sub-role that the variable plays.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. Evidence.variableDefinition.comparatorCategory
Definition

The reference value used for comparison.

ShortThe reference value used for comparison
Comments

Value should match EvidenceVariable.category.name in the EvidenceVariable referenced in the observed or intended element.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Evidence.variableDefinition.observed
Definition

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

ShortDefinition of the actual variable related to the statistic(s)
Control0..1
TypeReference(Group, EvidenceVariable)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. Evidence.variableDefinition.intended
Definition

Definition of the intended variable related to the Evidence.

ShortDefinition of the intended variable related to the Evidence
Control0..1
TypeReference(Group, EvidenceVariable)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Evidence.variableDefinition.directnessMatch
Definition

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

Shortlow | moderate | high | exact
Control0..1
BindingUnless not suitable, these codes SHALL be taken from EvidenceDirectness
(extensible to http://terminology.hl7.org/ValueSet/directness)

The quality of how direct the match is.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Evidence.synthesisType
Definition

The method to combine studies.

ShortThe method to combine studies
Control0..1
BindingUnless not suitable, these codes SHALL be taken from StatisticSynthesisType
(extensible to http://terminology.hl7.org/ValueSet/synthesis-type)

Types of combining results from a body of evidence (e.g. summary data meta-analysis).

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. Evidence.studyDesign
Definition

The design of the study that produced this evidence. The design is described with any number of study design characteristics.

ShortThe design of the study that produced this evidence
Control0..*
BindingUnless not suitable, these codes SHALL be taken from StudyDesign
(extensible to http://hl7.org/fhir/ValueSet/study-design)

This is a set of terms for study design characteristics.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Evidence.statistic
Definition

Values and parameters for a single statistic.

ShortValues and parameters for a single statistic
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. Evidence.statistic.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
102. Evidence.statistic.extension
Definition

An Extension

ShortExtension
Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Evidence.statistic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 104. Evidence.statistic.extension:modelExpression
    Slice NamemodelExpression
    Definition

    The formula for analysis.

    ShortThe formula for analysis
    Control0..1
    TypeExtension(StatisticModelExpression) (Extension Type: Expression)
    Is Modifierfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    106. Evidence.statistic.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    108. Evidence.statistic.description
    Definition

    A description of the content value of the statistic.

    ShortDescription of content
    Control0..1
    Typemarkdown
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    110. Evidence.statistic.note
    Definition

    Footnotes and/or explanatory notes.

    ShortFootnotes and/or explanatory notes
    Control0..*
    TypeAnnotation
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    112. Evidence.statistic.statisticType
    Definition

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

    ShortType of statistic, e.g., relative risk
    Control0..1
    BindingUnless not suitable, these codes SHALL be taken from StatisticType
    (extensible to http://hl7.org/fhir/ValueSet/statistic-type)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    114. Evidence.statistic.category
    Definition

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

    ShortAssociated category for categorical variable
    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.

    Control0..1
    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    116. Evidence.statistic.quantity
    Definition

    Statistic value.

    ShortStatistic value
    Control0..1
    TypeQuantity
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    118. Evidence.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.

    ShortThe number of events associated with the statistic
    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.

    Control0..1
    TypeunsignedInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    120. Evidence.statistic.numberAffected
    Definition

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

    ShortThe number of participants affected
    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.

    Control0..1
    TypeunsignedInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    122. Evidence.statistic.sampleSize
    Definition

    Number of samples in the statistic.

    ShortNumber of samples in the statistic
    Control0..1
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    124. Evidence.statistic.sampleSize.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    This element is affected by the following invariants: ele-1
    Typestring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    126. Evidence.statistic.sampleSize.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    128. Evidence.statistic.sampleSize.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    130. Evidence.statistic.sampleSize.description
    Definition

    Human-readable summary of population sample size.

    ShortTextual description of sample size for statistic
    Control0..1
    Typemarkdown
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    132. Evidence.statistic.sampleSize.note
    Definition

    Footnote or explanatory note about the sample size.

    ShortFootnote or explanatory note about the sample size
    Control0..*
    TypeAnnotation
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    134. Evidence.statistic.sampleSize.numberOfStudies
    Definition

    Number of participants in the population.

    ShortNumber of contributing studies
    Control0..1
    TypeunsignedInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    136. Evidence.statistic.sampleSize.numberOfParticipants
    Definition

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

    ShortCumulative number of participants
    Control0..1
    TypeunsignedInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    138. Evidence.statistic.sampleSize.knownDataCount
    Definition

    Number of participants with known results for measured variables.

    ShortNumber of participants with known results for measured variables
    Control0..1
    TypeunsignedInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    140. Evidence.statistic.attributeEstimate
    Definition

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

    ShortAn attribute of the Statistic
    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    142. Evidence.statistic.attributeEstimate.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    This element is affected by the following invariants: ele-1
    Typestring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    144. Evidence.statistic.attributeEstimate.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    146. Evidence.statistic.attributeEstimate.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    148. Evidence.statistic.attributeEstimate.description
    Definition

    Human-readable summary of the estimate.

    ShortTextual description of the attribute estimate
    Control0..1
    Typemarkdown
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    150. Evidence.statistic.attributeEstimate.note
    Definition

    Footnote or explanatory note about the estimate.

    ShortFootnote or explanatory note about the estimate
    Control0..*
    TypeAnnotation
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    152. Evidence.statistic.attributeEstimate.type
    Definition

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

    ShortThe type of attribute estimate, e.g., confidence interval or p value
    Control0..1
    BindingUnless not suitable, these codes SHALL be taken from AttributeEstimateType
    (extensible to http://hl7.org/fhir/ValueSet/attribute-estimate-type)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    154. Evidence.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.

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

    Often the p value

    Control0..1
    TypeQuantity
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    156. Evidence.statistic.attributeEstimate.level
    Definition

    Use 95 for a 95% confidence interval.

    ShortLevel of confidence interval, e.g., 0.95 for 95% confidence interval
    Control0..1
    Typedecimal
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    158. Evidence.statistic.attributeEstimate.range
    Definition

    Lower bound of confidence interval.

    ShortLower and upper bound values of the attribute estimate
    Control0..1
    TypeRange
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    160. Evidence.statistic.attributeEstimate.attributeEstimate
    Definition

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

    ShortA nested attribute estimate; which is the attribute estimate of an attribute estimate
    Comments

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

    Control0..*
    TypeSeettp://hl7.org/fhir/StructureDefinition/Evidence#Evidence.statistic.attributeEstimate
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    162. Evidence.statistic.modelCharacteristic
    Definition

    A component of the method to generate the statistic.

    ShortAn aspect of the statistical model
    Control1..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    164. Evidence.statistic.modelCharacteristic.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    This element is affected by the following invariants: ele-1
    Typestring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    166. Evidence.statistic.modelCharacteristic.extension
    Definition

    An Extension

    ShortExtension
    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Evidence.statistic.modelCharacteristic.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 168. Evidence.statistic.modelCharacteristic.extension:includeIf
      Slice NameincludeIf
      Definition

      The condition upon which to include the variable or model characteristic in the analysis.

      ShortCondition upon which to include the variable or model characteristic in the analysis
      Control0..1
      TypeExtension(StatisticModelIncludeIf) (Complex Extension)
      Is Modifierfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      170. Evidence.statistic.modelCharacteristic.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      172. Evidence.statistic.modelCharacteristic.code
      Definition

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

      ShortModel specification
      Control1..1
      BindingUnless not suitable, these codes SHALL be taken from StatisticModelCode
      (extensible to http://hl7.org/fhir/ValueSet/statistic-model-code)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      174. Evidence.statistic.modelCharacteristic.value[x]
      Definition

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

      ShortThe specific value (when paired with code)
      Control0..1
      TypeChoice of: Quantity(SimpleQuantity), Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      176. Evidence.statistic.modelCharacteristic.intended
      Definition

      The plan for analysis.

      ShortThe plan for analysis
      Control0..1
      Typeboolean
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Pattern Valuetrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      178. Evidence.statistic.modelCharacteristic.applied
      Definition

      The analysis that was applied.

      ShortThe analysis that was applied
      Control0..1
      Typeboolean
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      180. Evidence.statistic.modelCharacteristic.variable
      Definition

      A variable adjusted for in the adjusted analysis.

      ShortA variable adjusted for in the adjusted analysis
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      182. Evidence.statistic.modelCharacteristic.variable.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      184. Evidence.statistic.modelCharacteristic.variable.extension
      Definition

      An Extension

      ShortExtension
      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Evidence.statistic.modelCharacteristic.variable.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 186. Evidence.statistic.modelCharacteristic.variable.extension:includeIf
        Slice NameincludeIf
        Definition

        The condition upon which to include the variable or model characteristic in the analysis.

        ShortCondition upon which to include the variable or model characteristic in the analysis
        Control0..1
        TypeExtension(StatisticModelIncludeIf) (Complex Extension)
        Is Modifierfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        188. Evidence.statistic.modelCharacteristic.variable.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        190. Evidence.statistic.modelCharacteristic.variable.variableDefinition
        Definition

        Description of the variable.

        ShortDescription of the variable
        Control1..1
        TypeReference(Group, EvidenceVariable)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        192. Evidence.statistic.modelCharacteristic.variable.handling
        Definition

        How the variable is classified for use in adjusted analysis.

        Shortcontinuous | dichotomous | ordinal | polychotomous
        Control0..1
        BindingThe codes SHALL be taken from EvidenceVariableHandling
        (required to http://hl7.org/fhir/ValueSet/variable-handling|6.0.0-ballot2)
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        194. Evidence.statistic.modelCharacteristic.variable.valueCategory
        Definition

        Description for grouping of ordinal or polychotomous variables.

        ShortDescription for grouping of ordinal or polychotomous variables
        Control0..*
        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        196. Evidence.statistic.modelCharacteristic.variable.valueQuantity
        Definition

        Discrete value for grouping of ordinal or polychotomous variables.

        ShortDiscrete value for grouping of ordinal or polychotomous variables
        Control0..*
        TypeQuantity
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        198. Evidence.statistic.modelCharacteristic.variable.valueRange
        Definition

        Range of values for grouping of ordinal or polychotomous variables.

        ShortRange of values for grouping of ordinal or polychotomous variables
        Control0..*
        TypeRange
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        200. Evidence.statistic.modelCharacteristic.attribute
        Definition

        An attribute of the statistic used as a model characteristic.

        ShortAn attribute of the statistic used as a model characteristic
        Control0..*
        TypeSeettp://hl7.org/fhir/StructureDefinition/Evidence#Evidence.statistic.attributeEstimate
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        202. Evidence.certainty
        Definition

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

        ShortCertainty or quality of the evidence
        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        204. Evidence.certainty.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        206. Evidence.certainty.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        208. Evidence.certainty.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        210. Evidence.certainty.description
        Definition

        Textual description of certainty.

        ShortTextual description of certainty
        Control0..1
        Typemarkdown
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        212. Evidence.certainty.note
        Definition

        Footnotes and/or explanatory notes.

        ShortFootnotes and/or explanatory notes
        Control0..*
        TypeAnnotation
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        214. Evidence.certainty.type
        Definition

        Aspect of certainty being rated.

        ShortAspect of certainty being rated
        Control0..1
        BindingUnless not suitable, these codes SHALL be taken from EvidenceCertaintyType
        (extensible to http://hl7.org/fhir/ValueSet/certainty-type)

        The aspect of quality, confidence, or certainty.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        216. Evidence.certainty.rating
        Definition

        Assessment or judgement of the aspect.

        ShortAssessment or judgement of the aspect
        Control0..1
        BindingUnless not suitable, these codes SHALL be taken from EvidenceCertaintyRating
        (extensible to http://hl7.org/fhir/ValueSet/certainty-rating)

        The assessment of quality, confidence, or certainty.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        218. Evidence.certainty.rater
        Definition

        Individual or group who did the rating.

        ShortIndividual or group who did the rating
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        220. Evidence.certainty.subcomponent
        Definition

        A domain or subdomain of certainty.

        ShortA domain or subdomain of certainty
        Control0..*
        TypeSeettp://hl7.org/fhir/StructureDefinition/Evidence#Evidence.certainty
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))