type: exampleresource: ArtifactAssessmentexample: artifactassessment-example-risk-of-bias-assessment-of-parachute-trial
ArtifactAssessment Example: artifactassessment-example-risk-of-bias-assessment-of-parachute-trial
Example XML
<?xml version="1.0" encoding="UTF-8"?>
<ArtifactAssessment xmlns="http://hl7.org/fhir">
<id value="example-risk-of-bias-assessment-of-parachute-trial"/>
<meta>
<versionId value="4"/>
<lastUpdated value="2025-02-25T20:01:47.665Z"/>
<profile value="http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias"/>
</meta>
<!-- artifact-url is not allowed on ArtifactAssessment. Should it be? -->
<!--
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-url">
<valueUri value="https://fevir.net/resources/ArtifactAssessment/307449"/>
</extension>
-->
<!-- artifact-description is not allowed on ArtifactAssessment. Should it be? -->
<!--
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-description">
<valueMarkdown value="This is an example of the RiskOfBias Profile."/>
</extension>
-->
<identifier>
<type>
<text value="FEvIR Object Identifier"/>
</type>
<system value="urn:ietf:rfc:3986"/>
<value value="https://fevir.net/FOI/307449"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<title value="Risk of Bias Assessment of PARACHUTE trial"/>
<artifactReference>
<!-- <reference value="Citation/306957"/> -->
<type value="Citation"/>
<display value="30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial."/>
</artifactReference>
<copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
<content>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00001"/>
<display value="Bias"/>
</coding>
</type>
<freeToShare value="true"/>
<component>
<summary value="Assignment was done by order of enrollment. "/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00278"/>
<display value="Inadequate random sequence generation"/>
</coding>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00194"/>
<display value="Factor present"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00208"/>
<display value="Factor likely has potential to impact results"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00205"/>
<display value="Risk of bias direction unpredictable"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00187"/>
<display value="Moderate risk of bias"/>
</coding>
</classifier>
</component>
<component>
<summary value="The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant. "/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00031"/>
<display value="Inadequate allocation concealment"/>
</coding>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00194"/>
<display value="Factor present"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00208"/>
<display value="Factor likely has potential to impact results"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00205"/>
<display value="Risk of bias direction unpredictable"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00187"/>
<display value="Moderate risk of bias"/>
</coding>
</classifier>
</component>
<component>
<summary value="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. "/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00035"/>
<display value="Inadequate blinding of participants"/>
</coding>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00195"/>
<display value="Factor likely present"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00208"/>
<display value="Factor likely has potential to impact results"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00205"/>
<display value="Risk of bias direction unpredictable"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00187"/>
<display value="Moderate risk of bias"/>
</coding>
</classifier>
</component>
<component>
<summary value="Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome."/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00036"/>
<display value="Inadequate blinding of intervention deliverers"/>
</coding>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00195"/>
<display value="Factor likely present"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00209"/>
<display value="Factor likely does not have potential to impact results"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00205"/>
<display value="Risk of bias direction unpredictable"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00186"/>
<display value="Low risk of bias"/>
</coding>
</classifier>
</component>
<component>
<summary value="Although outcome determination was done with full knowledge of exposure status, it was not likely that this changed the determination of death or injury"/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00048"/>
<display value="Bias due to lack of masking for outcome determination"/>
</coding>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00195"/>
<display value="Factor likely present"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00209"/>
<display value="Factor likely does not have potential to impact results"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00205"/>
<display value="Risk of bias direction unpredictable"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00186"/>
<display value="Low risk of bias"/>
</coding>
</classifier>
</component>
<component>
<summary value="Attrition was much higher in the intervention group."/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00019"/>
<display value="Attrition Bias"/>
</coding>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00195"/>
<display value="Factor likely present"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00208"/>
<display value="Factor likely has potential to impact results"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00205"/>
<display value="Risk of bias direction unpredictable"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00187"/>
<display value="Moderate risk of bias"/>
</coding>
</classifier>
</component>
<component>
<summary value="Study was only published in a satirical journal issue."/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00023"/>
<display value="Reporting Bias"/>
</coding>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00194"/>
<display value="Factor present"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00208"/>
<display value="Factor likely has potential to impact results"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00205"/>
<display value="Risk of bias direction unpredictable"/>
</coding>
</classifier>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/27270"/>
<code value="SEVCO:00187"/>
<display value="Moderate risk of bias"/>
</coding>
</classifier>
</component>
</content>
<content>
<type>
<text value="Profile"/>
</type>
<classifier>
<text value="ROB1"/>
</classifier>
</content>
</ArtifactAssessment>