<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><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><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>