<?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"/>
  
    <security>
      <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
      <code value="HTEST"/>
      <display value="test health data"/>
    </security>
  </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>