Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow | Version: 1.0.0-ballot | |||
| Standards status: Draft | Maturity Level: 1 | Computable Name: ParticipantFlow | ||
Profile of Evidence for Evidence Based Medicine IG. The ParticipantFlow Profile is used for counts of completion and reasons for non-completion of participation in a research study.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from NonComparativeEvidence
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Evidence | NonComparativeEvidence | |||
  variableDefinition | 2..* | BackboneElement | Evidence variable such as population, exposure, or outcome | |
  intended | 0..0 | |||
 directnessMatch | 0..0 | |||
 variableDefinition:population | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | |
 intended | 0..0 | |||
 directnessMatch | 0..0 | |||
| variableDefinition:outcome | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | |
 observed | 0..1 | Reference(ParticipantFlowMeasure) | Definition of the actual variable related to the statistic(s) | |
| intended | 0..0 | |||
| directnessMatch | 0..0 | |||
 statistic | ||||
 numberAffected | 0..0 | |||
| modelCharacteristic | 0..0 | |||
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Evidence | C | 0..* | NonComparativeEvidence | Single evidence bit |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
 Slices for variableDefinition | 2..* | BackboneElement | Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:note.text | |
 variableDefinition:All Slices | Content/Rules for all slices | |||
   Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
  variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. |
| variableDefinition:population | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
 variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |
 extension | 0..0 | |||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. |
 variableDefinition:outcome | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |
| extension | 0..0 | |||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. |
| observed | Σ | 0..1 | Reference(ParticipantFlowMeasure) | Definition of the actual variable related to the statistic(s) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Evidence.status | required | PublicationStatus |
| Evidence.variableDefinition.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:population.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:outcome.variableRole | extensible | EvidenceVariableRole |
| Id | Grade | Path(s) | Details | Requirements |
| cnl-0 | warning | Evidence | 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}$') | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Evidence | C | 0..* | NonComparativeEvidence | Single evidence bit | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| url | ΣC | 0..1 | uri | Canonical identifier for this evidence, represented as a globally unique URI | ||||
| identifier | Σ | 0..* | Identifier | Additional identifier for the summary | ||||
| version | Σ | 0..1 | string | Business version of this summary | ||||
 versionAlgorithm[x] | Σ | 0..1 | How to compare versions Binding: VersionAlgorithm (extensible) | |||||
| versionAlgorithmString | string | |||||||
| versionAlgorithmCoding | Coding | |||||||
| name | C | 0..1 | string | Name for this summary (machine friendly) | ||||
| title | Σ | 0..1 | string | Name for this summary (human friendly) | ||||
| citeAs[x] | 0..1 | Citation for this evidence | ||||||
| citeAsReference | Reference(Citation) | |||||||
| citeAsMarkdown | markdown | |||||||
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| experimental | 0..1 | boolean | For testing purposes, not real usage | |||||
| date | Σ | 0..1 | dateTime | Date last changed | ||||
| approvalDate | 0..1 | date | When the summary was approved by publisher | |||||
| lastReviewDate | 0..1 | date | When the summary was last reviewed by the publisher | |||||
| publisher | Σ | 0..1 | string | Name of the publisher/steward (organization or individual) | ||||
| contact | Σ | 0..* | ContactDetail | Contact details for the publisher | ||||
| author | Σ | 0..* | ContactDetail | Who authored the content | ||||
| editor | 0..* | ContactDetail | Who edited the content | |||||
| reviewer | 0..* | ContactDetail | Who reviewed the content | |||||
| endorser | Σ | 0..* | ContactDetail | Who endorsed the content | ||||
| useContext | Σ | 0..* | UsageContext | The context that the content is intended to support | ||||
| purpose | 0..1 | markdown | Why this Evidence is defined | |||||
| copyright | 0..1 | markdown | Use and/or publishing restrictions | |||||
| copyrightLabel | 0..1 | string | Copyright holder and year(s) | |||||
| relatedArtifact | 0..* | RelatedArtifact | Link or citation to artifact associated with the summary | |||||
| description | 0..1 | markdown | Description of the particular summary | |||||
| assertion | 0..1 | markdown | Declarative description of the Evidence | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| Slices for variableDefinition | 2..* | BackboneElement | Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:note.text | |||||
| variableDefinition:All Slices | Content/Rules for all slices | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |||||
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |||||
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | A text description or summary of the variable | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept Required Pattern: Use extension:variableRoleCode instead. | ||||
| observed | Σ | 0..1 | Reference(Group | EvidenceVariable) | Definition of the actual variable related to the statistic(s) | ||||
| variableDefinition:population | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..0 | |||||||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |||||
| value[x] | 0..1 | code | Value of extension Required Pattern: population | |||||
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |||||
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | A text description or summary of the variable | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| author[x] | Σ | 0..1 | Individual responsible for the annotation | |||||
| authorReference | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | Organization) | |||||||
| authorString | string | |||||||
| time | Σ | 0..1 | dateTime | When the annotation was made | ||||
| text | Σ | 1..1 | markdown | The annotation - text content (as markdown) Required Pattern: population | ||||
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept Required Pattern: Use extension:variableRoleCode instead. | ||||
| observed | Σ | 0..1 | Reference(StudyGroup | ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup) | Definition of the actual variable related to the statistic(s) | ||||
| variableDefinition:outcome | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..0 | |||||||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |||||
| value[x] | 0..1 | code | Value of extension Required Pattern: outcome | |||||
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |||||
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | A text description or summary of the variable | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| author[x] | Σ | 0..1 | Individual responsible for the annotation | |||||
| authorReference | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | Organization) | |||||||
| authorString | string | |||||||
| time | Σ | 0..1 | dateTime | When the annotation was made | ||||
| text | Σ | 1..1 | markdown | The annotation - text content (as markdown) Required Pattern: outcome | ||||
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept Required Pattern: Use extension:variableRoleCode instead. | ||||
| observed | Σ | 0..1 | Reference(ParticipantFlowMeasure) | Definition of the actual variable related to the statistic(s) | ||||
| synthesisType | 0..1 | CodeableConcept | The method to combine studies Binding: StatisticSynthesisType (extensible): Types of combining results from a body of evidence (e.g. summary data meta-analysis). | |||||
| studyDesign | 0..* | CodeableConcept | The design of the study that produced this evidence Binding: StudyDesign (extensible): This is a set of terms for study design characteristics. | |||||
| statistic | 0..* | BackboneElement | Values and parameters for a single statistic | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| modelExpression | 0..1 | Expression | The formula for analysis URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-expression | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Description of content | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| statisticType | 0..1 | CodeableConcept | Type of statistic, e.g., relative risk Binding: StatisticType (extensible) | |||||
| category | 0..1 | CodeableConcept | Associated category for categorical variable | |||||
| quantity | 0..1 | Quantity | Statistic value | |||||
| numberOfEvents | 0..1 | unsignedInt | The number of events associated with the statistic | |||||
| sampleSize | 0..1 | BackboneElement | Number of samples in the statistic | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Textual description of sample size for statistic | |||||
| note | 0..* | Annotation | Footnote or explanatory note about the sample size | |||||
| numberOfStudies | 0..1 | unsignedInt | Number of contributing studies | |||||
| numberOfParticipants | 0..1 | unsignedInt | Cumulative number of participants | |||||
| knownDataCount | 0..1 | unsignedInt | Number of participants with known results for measured variables | |||||
| attributeEstimate | 0..* | BackboneElement | An attribute of the Statistic | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Textual description of the attribute estimate | |||||
| note | 0..* | Annotation | Footnote or explanatory note about the estimate | |||||
| type | 0..1 | CodeableConcept | The type of attribute estimate, e.g., confidence interval or p value Binding: AttributeEstimateType (extensible) | |||||
| quantity | 0..1 | Quantity | The singular quantity of the attribute estimate, for attribute estimates represented as single values; also used to report unit of measure | |||||
| level | 0..1 | decimal | Level of confidence interval, e.g., 0.95 for 95% confidence interval | |||||
| range | 0..1 | Range | Lower and upper bound values of the attribute estimate | |||||
| attributeEstimate | 0..* | See attributeEstimate (Evidence) | A nested attribute estimate; which is the attribute estimate of an attribute estimate | |||||
| certainty | 0..* | BackboneElement | Certainty or quality of the evidence | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Textual description of certainty | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| type | 0..1 | CodeableConcept | Aspect of certainty being rated Binding: EvidenceCertaintyType (extensible): The aspect of quality, confidence, or certainty. | |||||
| rating | 0..1 | CodeableConcept | Assessment or judgement of the aspect Binding: EvidenceCertaintyRating (extensible): The assessment of quality, confidence, or certainty. | |||||
| rater | 0..1 | string | Individual or group who did the rating | |||||
| subcomponent | 0..* | See certainty (Evidence) | A domain or subdomain of certainty | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet |
| Evidence.language | required | AllLanguages |
| Evidence.versionAlgorithm[x] | extensible | VersionAlgorithm |
| Evidence.status | required | PublicationStatus |
| Evidence.variableDefinition.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:population.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:outcome.variableRole | extensible | EvidenceVariableRole |
| Evidence.synthesisType | extensible | StatisticSynthesisType |
| Evidence.studyDesign | extensible | StudyDesign |
| Evidence.statistic.statisticType | extensible | StatisticType |
| Evidence.statistic.attributeEstimate.type | extensible | AttributeEstimateType |
| Evidence.statistic.modelCharacteristic.code | extensible | StatisticModelCode |
| Evidence.statistic.modelCharacteristic.variable.handling | required | EvidenceVariableHandling |
| Evidence.certainty.type | extensible | EvidenceCertaintyType |
| Evidence.certainty.rating | extensible | EvidenceCertaintyRating |
| Id | Grade | Path(s) | Details | Requirements |
| cnl-0 | warning | Evidence | 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}$') | |
| cnl-1 | warning | Evidence.url | URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$') | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from NonComparativeEvidence
Summary
Prohibited: 8 elements
Structures
This structure refers to these other structures:
Maturity: 1
Differential View
This structure is derived from NonComparativeEvidence
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Evidence | NonComparativeEvidence | |||
| variableDefinition | 2..* | BackboneElement | Evidence variable such as population, exposure, or outcome | |
| intended | 0..0 | |||
| directnessMatch | 0..0 | |||
| variableDefinition:population | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | |
| intended | 0..0 | |||
| directnessMatch | 0..0 | |||
| variableDefinition:outcome | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | |
| observed | 0..1 | Reference(ParticipantFlowMeasure) | Definition of the actual variable related to the statistic(s) | |
| intended | 0..0 | |||
| directnessMatch | 0..0 | |||
| statistic | ||||
| numberAffected | 0..0 | |||
| modelCharacteristic | 0..0 | |||
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Evidence | C | 0..* | NonComparativeEvidence | Single evidence bit |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
| Slices for variableDefinition | 2..* | BackboneElement | Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:note.text | |
| variableDefinition:All Slices | Content/Rules for all slices | |||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. |
| variableDefinition:population | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |
| extension | 0..0 | |||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. |
| variableDefinition:outcome | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |
| extension | 0..0 | |||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. |
| observed | Σ | 0..1 | Reference(ParticipantFlowMeasure) | Definition of the actual variable related to the statistic(s) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Evidence.status | required | PublicationStatus |
| Evidence.variableDefinition.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:population.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:outcome.variableRole | extensible | EvidenceVariableRole |
| Id | Grade | Path(s) | Details | Requirements |
| cnl-0 | warning | Evidence | 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}$') | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Evidence | C | 0..* | NonComparativeEvidence | Single evidence bit | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| url | ΣC | 0..1 | uri | Canonical identifier for this evidence, represented as a globally unique URI | ||||
| identifier | Σ | 0..* | Identifier | Additional identifier for the summary | ||||
| version | Σ | 0..1 | string | Business version of this summary | ||||
| versionAlgorithm[x] | Σ | 0..1 | How to compare versions Binding: VersionAlgorithm (extensible) | |||||
| versionAlgorithmString | string | |||||||
| versionAlgorithmCoding | Coding | |||||||
| name | C | 0..1 | string | Name for this summary (machine friendly) | ||||
| title | Σ | 0..1 | string | Name for this summary (human friendly) | ||||
| citeAs[x] | 0..1 | Citation for this evidence | ||||||
| citeAsReference | Reference(Citation) | |||||||
| citeAsMarkdown | markdown | |||||||
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. | ||||
| experimental | 0..1 | boolean | For testing purposes, not real usage | |||||
| date | Σ | 0..1 | dateTime | Date last changed | ||||
| approvalDate | 0..1 | date | When the summary was approved by publisher | |||||
| lastReviewDate | 0..1 | date | When the summary was last reviewed by the publisher | |||||
| publisher | Σ | 0..1 | string | Name of the publisher/steward (organization or individual) | ||||
| contact | Σ | 0..* | ContactDetail | Contact details for the publisher | ||||
| author | Σ | 0..* | ContactDetail | Who authored the content | ||||
| editor | 0..* | ContactDetail | Who edited the content | |||||
| reviewer | 0..* | ContactDetail | Who reviewed the content | |||||
| endorser | Σ | 0..* | ContactDetail | Who endorsed the content | ||||
| useContext | Σ | 0..* | UsageContext | The context that the content is intended to support | ||||
| purpose | 0..1 | markdown | Why this Evidence is defined | |||||
| copyright | 0..1 | markdown | Use and/or publishing restrictions | |||||
| copyrightLabel | 0..1 | string | Copyright holder and year(s) | |||||
| relatedArtifact | 0..* | RelatedArtifact | Link or citation to artifact associated with the summary | |||||
| description | 0..1 | markdown | Description of the particular summary | |||||
| assertion | 0..1 | markdown | Declarative description of the Evidence | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| Slices for variableDefinition | 2..* | BackboneElement | Evidence variable such as population, exposure, or outcome Slice: Unordered, Open by value:note.text | |||||
| variableDefinition:All Slices | Content/Rules for all slices | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |||||
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |||||
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | A text description or summary of the variable | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept Required Pattern: Use extension:variableRoleCode instead. | ||||
| observed | Σ | 0..1 | Reference(Group | EvidenceVariable) | Definition of the actual variable related to the statistic(s) | ||||
| variableDefinition:population | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..0 | |||||||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |||||
| value[x] | 0..1 | code | Value of extension Required Pattern: population | |||||
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |||||
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | A text description or summary of the variable | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| author[x] | Σ | 0..1 | Individual responsible for the annotation | |||||
| authorReference | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | Organization) | |||||||
| authorString | string | |||||||
| time | Σ | 0..1 | dateTime | When the annotation was made | ||||
| text | Σ | 1..1 | markdown | The annotation - text content (as markdown) Required Pattern: population | ||||
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept Required Pattern: Use extension:variableRoleCode instead. | ||||
| observed | Σ | 0..1 | Reference(StudyGroup | ExposureGroup | ComparatorGroup | MetaanalysisStudyGroup) | Definition of the actual variable related to the statistic(s) | ||||
| variableDefinition:outcome | S | 1..* | BackboneElement | Evidence variable such as population, exposure, or outcome | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| variableRoleCode | 1..1 | code | population | exposure | outcome | covariate URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..0 | |||||||
| url | 1..1 | uri | "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code" | |||||
| value[x] | 0..1 | code | Value of extension Required Pattern: outcome | |||||
| roleSubtype | 0..1 | CodeableConcept | subgroup | variable-A | variable-B | variable-AB | confounder | collider | mediator | effect-modifier URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-role-subtype Binding: EvidenceVariableRoleSubtype Value Set (extensible) | |||||
| comparatorCategory | 0..1 | string | The reference value used for comparison URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | A text description or summary of the variable | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| author[x] | Σ | 0..1 | Individual responsible for the annotation | |||||
| authorReference | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | Organization) | |||||||
| authorString | string | |||||||
| time | Σ | 0..1 | dateTime | When the annotation was made | ||||
| text | Σ | 1..1 | markdown | The annotation - text content (as markdown) Required Pattern: outcome | ||||
| variableRole | Σ | 1..1 | CodeableConcept | population | subpopulation | exposure | referenceExposure | measuredVariable | confounder Binding: EvidenceVariableRole (extensible): The role that the assertion variable plays. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept Required Pattern: Use extension:variableRoleCode instead. | ||||
| observed | Σ | 0..1 | Reference(ParticipantFlowMeasure) | Definition of the actual variable related to the statistic(s) | ||||
| synthesisType | 0..1 | CodeableConcept | The method to combine studies Binding: StatisticSynthesisType (extensible): Types of combining results from a body of evidence (e.g. summary data meta-analysis). | |||||
| studyDesign | 0..* | CodeableConcept | The design of the study that produced this evidence Binding: StudyDesign (extensible): This is a set of terms for study design characteristics. | |||||
| statistic | 0..* | BackboneElement | Values and parameters for a single statistic | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| modelExpression | 0..1 | Expression | The formula for analysis URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-expression | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Description of content | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| statisticType | 0..1 | CodeableConcept | Type of statistic, e.g., relative risk Binding: StatisticType (extensible) | |||||
| category | 0..1 | CodeableConcept | Associated category for categorical variable | |||||
| quantity | 0..1 | Quantity | Statistic value | |||||
| numberOfEvents | 0..1 | unsignedInt | The number of events associated with the statistic | |||||
| sampleSize | 0..1 | BackboneElement | Number of samples in the statistic | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Textual description of sample size for statistic | |||||
| note | 0..* | Annotation | Footnote or explanatory note about the sample size | |||||
| numberOfStudies | 0..1 | unsignedInt | Number of contributing studies | |||||
| numberOfParticipants | 0..1 | unsignedInt | Cumulative number of participants | |||||
| knownDataCount | 0..1 | unsignedInt | Number of participants with known results for measured variables | |||||
| attributeEstimate | 0..* | BackboneElement | An attribute of the Statistic | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Textual description of the attribute estimate | |||||
| note | 0..* | Annotation | Footnote or explanatory note about the estimate | |||||
| type | 0..1 | CodeableConcept | The type of attribute estimate, e.g., confidence interval or p value Binding: AttributeEstimateType (extensible) | |||||
| quantity | 0..1 | Quantity | The singular quantity of the attribute estimate, for attribute estimates represented as single values; also used to report unit of measure | |||||
| level | 0..1 | decimal | Level of confidence interval, e.g., 0.95 for 95% confidence interval | |||||
| range | 0..1 | Range | Lower and upper bound values of the attribute estimate | |||||
| attributeEstimate | 0..* | See attributeEstimate (Evidence) | A nested attribute estimate; which is the attribute estimate of an attribute estimate | |||||
| certainty | 0..* | BackboneElement | Certainty or quality of the evidence | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| description | 0..1 | markdown | Textual description of certainty | |||||
| note | 0..* | Annotation | Footnotes and/or explanatory notes | |||||
| type | 0..1 | CodeableConcept | Aspect of certainty being rated Binding: EvidenceCertaintyType (extensible): The aspect of quality, confidence, or certainty. | |||||
| rating | 0..1 | CodeableConcept | Assessment or judgement of the aspect Binding: EvidenceCertaintyRating (extensible): The assessment of quality, confidence, or certainty. | |||||
| rater | 0..1 | string | Individual or group who did the rating | |||||
| subcomponent | 0..* | See certainty (Evidence) | A domain or subdomain of certainty | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet |
| Evidence.language | required | AllLanguages |
| Evidence.versionAlgorithm[x] | extensible | VersionAlgorithm |
| Evidence.status | required | PublicationStatus |
| Evidence.variableDefinition.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:population.variableRole | extensible | EvidenceVariableRole |
| Evidence.variableDefinition:outcome.variableRole | extensible | EvidenceVariableRole |
| Evidence.synthesisType | extensible | StatisticSynthesisType |
| Evidence.studyDesign | extensible | StudyDesign |
| Evidence.statistic.statisticType | extensible | StatisticType |
| Evidence.statistic.attributeEstimate.type | extensible | AttributeEstimateType |
| Evidence.statistic.modelCharacteristic.code | extensible | StatisticModelCode |
| Evidence.statistic.modelCharacteristic.variable.handling | required | EvidenceVariableHandling |
| Evidence.certainty.type | extensible | EvidenceCertaintyType |
| Evidence.certainty.rating | extensible | EvidenceCertaintyRating |
| Id | Grade | Path(s) | Details | Requirements |
| cnl-0 | warning | Evidence | 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}$') | |
| cnl-1 | warning | Evidence.url | URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$') | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from NonComparativeEvidence
Summary
Prohibited: 8 elements
Structures
This structure refers to these other structures:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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