{"artifactReference":{"display":"30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.","type":"Citation"},"content":[{"component":[{"classifier":[{"coding":[{"code":"SEVCO:00194","display":"Factor present","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00208","display":"Factor likely has potential to impact results","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00205","display":"Risk of bias direction unpredictable","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00187","display":"Moderate risk of bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}],"summary":"Assignment was done by order of enrollment. ","type":{"coding":[{"code":"SEVCO:00278","display":"Inadequate random sequence generation","system":"https://fevir.net/resources/CodeSystem/27270"}]}},{"classifier":[{"coding":[{"code":"SEVCO:00194","display":"Factor present","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00208","display":"Factor likely has potential to impact results","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00205","display":"Risk of bias direction unpredictable","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00187","display":"Moderate risk of bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}],"summary":"The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant. ","type":{"coding":[{"code":"SEVCO:00031","display":"Inadequate allocation concealment","system":"https://fevir.net/resources/CodeSystem/27270"}]}},{"classifier":[{"coding":[{"code":"SEVCO:00195","display":"Factor likely present","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00208","display":"Factor likely has potential to impact results","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00205","display":"Risk of bias direction unpredictable","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00187","display":"Moderate risk of bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}],"summary":"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":[{"code":"SEVCO:00035","display":"Inadequate blinding of participants","system":"https://fevir.net/resources/CodeSystem/27270"}]}},{"classifier":[{"coding":[{"code":"SEVCO:00195","display":"Factor likely present","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00209","display":"Factor likely does not have potential to impact results","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00205","display":"Risk of bias direction unpredictable","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00186","display":"Low risk of bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}],"summary":"Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome.","type":{"coding":[{"code":"SEVCO:00036","display":"Inadequate blinding of intervention deliverers","system":"https://fevir.net/resources/CodeSystem/27270"}]}},{"classifier":[{"coding":[{"code":"SEVCO:00195","display":"Factor likely present","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00209","display":"Factor likely does not have potential to impact results","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00205","display":"Risk of bias direction unpredictable","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00186","display":"Low risk of bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}],"summary":"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":[{"code":"SEVCO:00048","display":"Bias due to lack of masking for outcome determination","system":"https://fevir.net/resources/CodeSystem/27270"}]}},{"classifier":[{"coding":[{"code":"SEVCO:00195","display":"Factor likely present","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00208","display":"Factor likely has potential to impact results","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00205","display":"Risk of bias direction unpredictable","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00187","display":"Moderate risk of bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}],"summary":"Attrition was much higher in the intervention group.","type":{"coding":[{"code":"SEVCO:00019","display":"Attrition Bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}},{"classifier":[{"coding":[{"code":"SEVCO:00194","display":"Factor present","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00208","display":"Factor likely has potential to impact results","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00205","display":"Risk of bias direction unpredictable","system":"https://fevir.net/resources/CodeSystem/27270"}]},{"coding":[{"code":"SEVCO:00187","display":"Moderate risk of bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}],"summary":"Study was only published in a satirical journal issue.","type":{"coding":[{"code":"SEVCO:00023","display":"Reporting Bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}}],"freeToShare":true,"type":{"coding":[{"code":"SEVCO:00001","display":"Bias","system":"https://fevir.net/resources/CodeSystem/27270"}]}},{"classifier":[{"text":"ROB1"}],"type":{"text":"Profile"}}],"copyright":"https://creativecommons.org/licenses/by-nc-sa/4.0/","id":"example-risk-of-bias-assessment-of-parachute-trial","identifier":[{"assigner":{"display":"Computable Publishing LLC"},"system":"urn:ietf:rfc:3986","type":{"text":"FEvIR Object Identifier"},"value":"https://fevir.net/FOI/307449"}],"meta":{"lastUpdated":"2025-02-25T20:01:47.665Z","profile":["http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias"],"versionId":"4"},"resourceType":"ArtifactAssessment","title":"Risk of Bias Assessment of PARACHUTE trial"}