Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Example ArtifactAssessment: Risk of Bias Assessment of PARACHUTE trial

Page standards status: Informative

Generated Narrative: ArtifactAssessment 307449

version: 5; Last updated: 2025-03-01 19:14:10+0000

Profile: RiskOfBias

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

Artifact Description:

This is an example of the RiskOfBias Profile.

Artifact Status: draft

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

title: Risk of Bias Assessment of PARACHUTE trial

copyright:

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

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

content

type: Bias

freeToShare: true

Components

-SummaryTypeClassifier
*

Assignment was done by order of enrollment.

Inadequate random sequence generationFactor 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 concealmentFactor 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 participantsFactor 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 deliverersFactor 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 determinationFactor 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 BiasFactor 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 BiasFactor present, Factor likely has potential to impact results, Risk of bias direction unpredictable, Moderate risk of bias

content

type: Profile

classifier: ROB1