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Example ArtifactAssessment/example-risk-of-bias-assessment-of-parachute-trial (Narrative)

Clinical Decision Support Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

This is the narrative for the resource. See also the XML, JSON or Turtle format. This example conforms to the profile ArtifactAssessment.


Generated Narrative: ArtifactAssessment example-risk-of-bias-assessment-of-parachute-trial

version: 4; Last updated: 2025-02-25T20:01:47.665Z

Profile: http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias

Artifact URL: https://fevir.net/resources/ArtifactAssessment/307449

Artifact Description:

This is an example of the RiskOfBias Profile.

identifier: FEvIR Object Identifier/https://fevir.net/FOI/307449

title: Risk of Bias Assessment of PARACHUTE trial

artifact: 30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

content

type: Bias

freeToShare: true

Components

-SummaryTypeClassifier
*

Assignment was done by order of enrollment.

Inadequate random sequence generation Factor present, Factor likely has potential to impact results, Risk of bias direction unpredictable, Moderate risk of bias
*

The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant.

Inadequate allocation concealment Factor present, Factor likely has potential to impact results, Risk of bias direction unpredictable, Moderate risk of bias
*

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.

Inadequate blinding of participants Factor likely present, Factor likely has potential to impact results, Risk of bias direction unpredictable, Moderate risk of bias
*

Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome.

Inadequate blinding of intervention deliverers Factor likely present, Factor likely does not have potential to impact results, Risk of bias direction unpredictable, Low risk of bias
*

Although outcome determination was done with full knowledge of exposure status, it was not likely that this changed the determination of death or injury

Bias due to lack of masking for outcome determination Factor likely present, Factor likely does not have potential to impact results, Risk of bias direction unpredictable, Low risk of bias
*

Attrition was much higher in the intervention group.

Attrition Bias Factor likely present, Factor likely has potential to impact results, Risk of bias direction unpredictable, Moderate risk of bias
*

Study was only published in a satirical journal issue.

Reporting Bias Factor present, Factor likely has potential to impact results, Risk of bias direction unpredictable, Moderate risk of bias

content

type: Profile

classifier: ROB1


 

 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.