Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
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
| Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/systematic-review | Version: 2.0.0-ballot | |||
| Standards status: Draft | Maturity Level: 1 | Computable Name: SystematicReview | ||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.110 | ||||
Profile of ResearchStudy for Evidence Based Medicine IG. The SystematicReview Profile is used for a scientific study based on a protocol that includes search and selection of eligible studies, study quality assessment, data extraction, and synthesis.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
| Path | Conformance | ValueSet | URI |
| ResearchStudy.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|
  ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
  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 | |||||
  Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
   author |
0..* | ContactDetail | Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author | |||||
| searchStrategy |
0..* | Reference(SearchStrategy) | Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy | |||||
| systematicReviewEligibilityCriteria |
0..1 | Reference(SystematicReviewEligibilityCriteria) | Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria | |||||
| numberOfStudiesIdentified |
0..1 | unsignedInt | Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified | |||||
| numberOfStudiesIncluded |
0..1 | unsignedInt | Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included | |||||
| includedStudy |
0..* | Reference(Citation | Composition | ResearchStudy) | Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study | |||||
| excludedStudy |
0..* | Reference(Citation | Composition | ResearchStudy) | Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study | |||||
| resultAsComposition |
0..* | Reference(Composition) | Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition | |||||
 studyRegistration |
0..* | base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta | Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration | |||||
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| url |
0..1 | uri | Canonical identifier for this study resource | |||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for study | ||||
| version |
0..1 | string | The business version for the study record | |||||
| name |
0..1 | string | Name for this study (computer friendly) | |||||
| title |
Σ | 0..1 | string | Human readable name of the study | ||||
| label |
0..* | BackboneElement | Additional names for the study | |||||
| 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 | ||||
| type |
0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: TitleType (extensible): desc. | |||||
 value |
0..1 | string | The name | |||||
 protocol |
Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| relatedArtifact |
0..* | RelatedArtifact | References, URLs, and attachments | |||||
| date |
0..1 | dateTime | Date the resource last changed | |||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | ||||
| primaryPurposeType |
Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study. | ||||
| studyDesign |
Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Binding: StudyDesign (preferred): This is a set of terms for study design characteristics. | ||||
| focus |
0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Common codes of research study focus | |||||
| condition |
Σ | 0..* | CodeableConcept | Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery. | ||||
| region |
Σ | 0..* | CodeableConcept | Geographic area for the study Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| descriptionSummary |
0..1 | markdown | Brief text explaining the study | |||||
| description |
0..1 | markdown | Detailed narrative of the study | |||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| site |
Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted | ||||
| note |
0..* | Annotation | Comments made about the study | |||||
| classifier |
0..* | CodeableConcept | Classification for the study Binding: ResearchStudyClassifiers (example): desc. | |||||
| associatedParty |
0..* | BackboneElement | Sponsors, collaborators, and other parties | |||||
| 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 | ||||
| name |
0..1 | string | Name of associated party | |||||
| role |
1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc. | |||||
| period |
0..* | Period | When active in the role | |||||
| classifier |
0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity. | |||||
| party |
0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation) | |||||
| progressStatus |
0..* | BackboneElement | Status of study with time for that status | |||||
| 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 | ||||
| state |
1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: ResearchStudyStatus (extensible): defn. | |||||
| actual |
0..1 | boolean | Actual if true else anticipated | |||||
| period |
0..1 | Period | Date range | |||||
| whyStopped |
Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
| comparisonGroup |
0..* | BackboneElement | Defined path through the study for a subject | |||||
| 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 | ||||
| linkId |
0..1 | id | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily | |||||
| name |
1..1 | string | Label for study comparisonGroup | |||||
| type |
0..1 | CodeableConcept | Categorization of study comparisonGroup Binding: ResearchStudyArmType (extensible): desc. | |||||
| description |
0..1 | markdown | Short explanation of study path | |||||
| intendedExposure |
0..* | Reference(EvidenceVariable) | Interventions or exposures in this comparisonGroup or cohort | |||||
| observedGroup |
0..1 | Reference(Group) | Group of participants who were enrolled in study comparisonGroup | |||||
| objective |
0..* | BackboneElement | A goal for the study | |||||
| 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 | ||||
| name |
0..1 | string | Label for the objective | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
| description |
0..1 | markdown | Description of the objective | |||||
| outcomeMeasure |
0..* | BackboneElement | A variable measured during the study | |||||
| 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 | ||||
| name |
0..1 | string | Label for the outcome | |||||
| type |
0..* | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn. | |||||
| description |
0..1 | markdown | Description of the outcome | |||||
| reference |
0..1 | Reference(EvidenceVariable) | Structured outcome definition | |||||
| result |
Σ | 0..* | Reference(Citation | Composition | DiagnosticReport) | Link to results generated during the study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| ResearchStudy.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2from the FHIR Standard | |
| ResearchStudy.label.type | extensible | TitleTypehttp://hl7.org/fhir/ValueSet/title-typefrom the FHIR Standard | |
| ResearchStudy.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2from the FHIR Standard | |
| ResearchStudy.primaryPurposeType | preferred | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-typefrom the FHIR Standard | |
| ResearchStudy.studyDesign | preferred | StudyDesignhttp://hl7.org/fhir/ValueSet/study-designfrom the FHIR Standard | |
| ResearchStudy.focus | example | ResearchStudyFocusTypehttp://hl7.org/fhir/ValueSet/research-study-focus-typefrom the FHIR Standard | |
| ResearchStudy.condition | example | ConditionProblemDiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard | |
| ResearchStudy.keyword | example | ||
| ResearchStudy.region | extensible | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| ResearchStudy.classifier | example | ResearchStudyClassifiershttp://hl7.org/fhir/ValueSet/research-study-classifiersfrom the FHIR Standard | |
| ResearchStudy.associatedParty.role | extensible | ResearchStudyPartyRolehttp://hl7.org/fhir/ValueSet/research-study-party-rolefrom the FHIR Standard | |
| ResearchStudy.associatedParty.classifier | example | ResearchStudyPartyOrgTypehttp://hl7.org/fhir/ValueSet/research-study-party-organization-typefrom the FHIR Standard | |
| ResearchStudy.progressStatus.state | extensible | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-statusfrom the FHIR Standard | |
| ResearchStudy.whyStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stoppedfrom the FHIR Standard | |
| ResearchStudy.comparisonGroup.type | extensible | ResearchStudyArmTypehttp://hl7.org/fhir/ValueSet/research-study-arm-typefrom the FHIR Standard | |
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard | |
| ResearchStudy.outcomeMeasure.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 ResearchStudy
Summary
Prohibited: 2 elements
Extensions
This structure refers to these extensions:
Maturity: 1
Differential View
This structure is derived from ResearchStudy
Key Elements View
| Path | Conformance | ValueSet | URI |
| ResearchStudy.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
| 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 | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| author |
0..* | ContactDetail | Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author | |||||
| searchStrategy |
0..* | Reference(SearchStrategy) | Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy | |||||
| systematicReviewEligibilityCriteria |
0..1 | Reference(SystematicReviewEligibilityCriteria) | Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria | |||||
| numberOfStudiesIdentified |
0..1 | unsignedInt | Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified | |||||
| numberOfStudiesIncluded |
0..1 | unsignedInt | Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included | |||||
| includedStudy |
0..* | Reference(Citation | Composition | ResearchStudy) | Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study | |||||
| excludedStudy |
0..* | Reference(Citation | Composition | ResearchStudy) | Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study | |||||
| resultAsComposition |
0..* | Reference(Composition) | Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition | |||||
| studyRegistration |
0..* | base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta | Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| url |
0..1 | uri | Canonical identifier for this study resource | |||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for study | ||||
| version |
0..1 | string | The business version for the study record | |||||
| name |
0..1 | string | Name for this study (computer friendly) | |||||
| title |
Σ | 0..1 | string | Human readable name of the study | ||||
| label |
0..* | BackboneElement | Additional names for the study | |||||
| 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 | ||||
| type |
0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: TitleType (extensible): desc. | |||||
| value |
0..1 | string | The name | |||||
| protocol |
Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| relatedArtifact |
0..* | RelatedArtifact | References, URLs, and attachments | |||||
| date |
0..1 | dateTime | Date the resource last changed | |||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | ||||
| primaryPurposeType |
Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study. | ||||
| studyDesign |
Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Binding: StudyDesign (preferred): This is a set of terms for study design characteristics. | ||||
| focus |
0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Common codes of research study focus | |||||
| condition |
Σ | 0..* | CodeableConcept | Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery. | ||||
| region |
Σ | 0..* | CodeableConcept | Geographic area for the study Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| descriptionSummary |
0..1 | markdown | Brief text explaining the study | |||||
| description |
0..1 | markdown | Detailed narrative of the study | |||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| site |
Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted | ||||
| note |
0..* | Annotation | Comments made about the study | |||||
| classifier |
0..* | CodeableConcept | Classification for the study Binding: ResearchStudyClassifiers (example): desc. | |||||
| associatedParty |
0..* | BackboneElement | Sponsors, collaborators, and other parties | |||||
| 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 | ||||
| name |
0..1 | string | Name of associated party | |||||
| role |
1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc. | |||||
| period |
0..* | Period | When active in the role | |||||
| classifier |
0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity. | |||||
| party |
0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation) | |||||
| progressStatus |
0..* | BackboneElement | Status of study with time for that status | |||||
| 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 | ||||
| state |
1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: ResearchStudyStatus (extensible): defn. | |||||
| actual |
0..1 | boolean | Actual if true else anticipated | |||||
| period |
0..1 | Period | Date range | |||||
| whyStopped |
Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
| comparisonGroup |
0..* | BackboneElement | Defined path through the study for a subject | |||||
| 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 | ||||
| linkId |
0..1 | id | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily | |||||
| name |
1..1 | string | Label for study comparisonGroup | |||||
| type |
0..1 | CodeableConcept | Categorization of study comparisonGroup Binding: ResearchStudyArmType (extensible): desc. | |||||
| description |
0..1 | markdown | Short explanation of study path | |||||
| intendedExposure |
0..* | Reference(EvidenceVariable) | Interventions or exposures in this comparisonGroup or cohort | |||||
| observedGroup |
0..1 | Reference(Group) | Group of participants who were enrolled in study comparisonGroup | |||||
| objective |
0..* | BackboneElement | A goal for the study | |||||
| 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 | ||||
| name |
0..1 | string | Label for the objective | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
| description |
0..1 | markdown | Description of the objective | |||||
| outcomeMeasure |
0..* | BackboneElement | A variable measured during the study | |||||
| 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 | ||||
| name |
0..1 | string | Label for the outcome | |||||
| type |
0..* | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn. | |||||
| description |
0..1 | markdown | Description of the outcome | |||||
| reference |
0..1 | Reference(EvidenceVariable) | Structured outcome definition | |||||
| result |
Σ | 0..* | Reference(Citation | Composition | DiagnosticReport) | Link to results generated during the study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| ResearchStudy.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2from the FHIR Standard | |
| ResearchStudy.label.type | extensible | TitleTypehttp://hl7.org/fhir/ValueSet/title-typefrom the FHIR Standard | |
| ResearchStudy.status | required | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2from the FHIR Standard | |
| ResearchStudy.primaryPurposeType | preferred | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-typefrom the FHIR Standard | |
| ResearchStudy.studyDesign | preferred | StudyDesignhttp://hl7.org/fhir/ValueSet/study-designfrom the FHIR Standard | |
| ResearchStudy.focus | example | ResearchStudyFocusTypehttp://hl7.org/fhir/ValueSet/research-study-focus-typefrom the FHIR Standard | |
| ResearchStudy.condition | example | ConditionProblemDiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard | |
| ResearchStudy.keyword | example | ||
| ResearchStudy.region | extensible | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| ResearchStudy.classifier | example | ResearchStudyClassifiershttp://hl7.org/fhir/ValueSet/research-study-classifiersfrom the FHIR Standard | |
| ResearchStudy.associatedParty.role | extensible | ResearchStudyPartyRolehttp://hl7.org/fhir/ValueSet/research-study-party-rolefrom the FHIR Standard | |
| ResearchStudy.associatedParty.classifier | example | ResearchStudyPartyOrgTypehttp://hl7.org/fhir/ValueSet/research-study-party-organization-typefrom the FHIR Standard | |
| ResearchStudy.progressStatus.state | extensible | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-statusfrom the FHIR Standard | |
| ResearchStudy.whyStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stoppedfrom the FHIR Standard | |
| ResearchStudy.comparisonGroup.type | extensible | ResearchStudyArmTypehttp://hl7.org/fhir/ValueSet/research-study-arm-typefrom the FHIR Standard | |
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard | |
| ResearchStudy.outcomeMeasure.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
| 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 ResearchStudy
Summary
Prohibited: 2 elements
Extensions
This structure refers to these extensions:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-21
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change
