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Clinical Decision Support Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
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This is an example of the RiskOfBias Profile.
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- <http://hl7.org/fhir/ArtifactAssessment/example-risk-of-bias-assessment-of-parachute-trial> a fhir:ArtifactAssessment ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "example-risk-of-bias-assessment-of-parachute-trial"] ; # fhir:meta [ fhir:versionId [ fhir:v "4" ] ; fhir:lastUpdated [ fhir:v "2025-02-25T20:01:47.665Z"^^xsd:dateTime ] ; fhir:profile ( [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias> ] ) ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-url"^^xsd:anyURI ] ; fhir:value [ a fhir:uri ; fhir:v "https://fevir.net/resources/ArtifactAssessment/307449"^^xsd:anyURI ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-description"^^xsd:anyURI ] ; fhir:value [ a fhir:markdown ; fhir:v "This is an example of the RiskOfBias Profile." ] ] ) ; # fhir:identifier ( [ fhir:type [ fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ; fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "https://fevir.net/FOI/307449" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] ) ; # fhir:title [ fhir:v "Risk of Bias Assessment of PARACHUTE trial"] ; # fhir:artifact [ a fhir:Reference ; fhir:link <http://hl7.org/fhir/Citation/306957> ; fhir:reference [ fhir:v "Citation/306957" ] ; fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ; fhir:display [ fhir:v "30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial." ] ] ; # fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # fhir:content ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00001" ] ; fhir:display [ fhir:v "Bias" ] ] ) ] ; fhir:freeToShare [ fhir:v true ] ; fhir:component ( [ fhir:summary [ fhir:v "Assignment was done by order of enrollment. " ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00278" ] ; fhir:display [ fhir:v "Inadequate random sequence generation" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00194" ] ; fhir:display [ fhir:v "Factor present" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00208" ] ; fhir:display [ fhir:v "Factor likely has potential to impact results" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00205" ] ; fhir:display [ fhir:v "Risk of bias direction unpredictable" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00187" ] ; fhir:display [ fhir:v "Moderate risk of bias" ] ] ) ] ) ] [ fhir:summary [ fhir:v "The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant. " ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00031" ] ; fhir:display [ fhir:v "Inadequate allocation concealment" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00194" ] ; fhir:display [ fhir:v "Factor present" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00208" ] ; fhir:display [ fhir:v "Factor likely has potential to impact results" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00205" ] ; fhir:display [ fhir:v "Risk of bias direction unpredictable" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00187" ] ; fhir:display [ fhir:v "Moderate risk of bias" ] ] ) ] ) ] [ fhir:summary [ fhir:v "Participants could discern the difference between a parachute and an empty backpack. Knowing that they have only an empty backpack might change jumping behavior which would have an unpredictable effect on the outcome. " ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00035" ] ; fhir:display [ fhir:v "Inadequate blinding of participants" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00195" ] ; fhir:display [ fhir:v "Factor likely present" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00208" ] ; fhir:display [ fhir:v "Factor likely has potential to impact results" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00205" ] ; fhir:display [ fhir:v "Risk of bias direction unpredictable" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00187" ] ; fhir:display [ fhir:v "Moderate risk of bias" ] ] ) ] ) ] [ fhir:summary [ fhir:v "Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome." ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00036" ] ; fhir:display [ fhir:v "Inadequate blinding of intervention deliverers" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00195" ] ; fhir:display [ fhir:v "Factor likely present" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00209" ] ; fhir:display [ fhir:v "Factor likely does not have potential to impact results" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00205" ] ; fhir:display [ fhir:v "Risk of bias direction unpredictable" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00186" ] ; fhir:display [ fhir:v "Low risk of bias" ] ] ) ] ) ] [ fhir:summary [ fhir:v "Although outcome determination was done with full knowledge of exposure status, it was not likely that this changed the determination of death or injury" ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00048" ] ; fhir:display [ fhir:v "Bias due to lack of masking for outcome determination" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00195" ] ; fhir:display [ fhir:v "Factor likely present" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00209" ] ; fhir:display [ fhir:v "Factor likely does not have potential to impact results" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00205" ] ; fhir:display [ fhir:v "Risk of bias direction unpredictable" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00186" ] ; fhir:display [ fhir:v "Low risk of bias" ] ] ) ] ) ] [ fhir:summary [ fhir:v "Attrition was much higher in the intervention group." ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00019" ] ; fhir:display [ fhir:v "Attrition Bias" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00195" ] ; fhir:display [ fhir:v "Factor likely present" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00208" ] ; fhir:display [ fhir:v "Factor likely has potential to impact results" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00205" ] ; fhir:display [ fhir:v "Risk of bias direction unpredictable" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00187" ] ; fhir:display [ fhir:v "Moderate risk of bias" ] ] ) ] ) ] [ fhir:summary [ fhir:v "Study was only published in a satirical journal issue." ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00023" ] ; fhir:display [ fhir:v "Reporting Bias" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00194" ] ; fhir:display [ fhir:v "Factor present" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00208" ] ; fhir:display [ fhir:v "Factor likely has potential to impact results" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00205" ] ; fhir:display [ fhir:v "Risk of bias direction unpredictable" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/27270"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00187" ] ; fhir:display [ fhir:v "Moderate risk of bias" ] ] ) ] ) ] ) ] [ fhir:type [ fhir:text [ fhir:v "Profile" ] ] ; fhir:classifier ( [ fhir:text [ fhir:v "ROB1" ] ] ) ] ) . # <http://hl7.org/fhir/Citation/306957> a fhir:Citation . # -------------------------------------------------------------------------------------
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
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