<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>