This is an example of the RiskOfBias Profile. (id = "example-risk-of-bias-assessment-of-parachute-trial")

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<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> 
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-url">
    <valueUri value="https://fevir.net/resources/ArtifactAssessment/307449"/> 
  </extension> 
  <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>