FHIR IG analytics| Package | hl7.fhir.uv.ebm |
| Resource Type | ArtifactAssessment |
| Id | ArtifactAssessment-307449.json |
| FHIR Version | R6 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: ArtifactAssessment 307449
version: 10; Last updated: 2025-11-04 15:25:42+0000; Language: en
Profile: RiskOfBias
Artifact Description:
This is an example of the RiskOfBias Profile.
ArtifactPublicationStatus: Draft
Artifact Status: active
identifier: FEvIR Object Identifier/307449
title: Risk of Bias Assessment of PARACHUTE trial
citeAs:
Risk of Bias Assessment of PARACHUTE trial [Database Entry: FHIR ArtifactAssessment Resource]. Contributors: In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 307449. Revised 2025-11-04. Available at: https://fevir.net/resources/ArtifactAssessment/307449. Computable resource at: https://fevir.net/resources/ArtifactAssessment/307449#json.
copyright:
https://creativecommons.org/licenses/by-nc-sa/4.0/
content
type: Risk of bias
freeToShare: true
Components
Summary Type Classifier Assignment was done by order of enrollment.
Inadequate random sequence generation Factor present, some potential to influence research 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, some potential to influence research 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, some potential to influence research 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, limited potential to influence research 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, limited potential to influence research results, Risk of bias direction unpredictable, Low risk of bias Attrition was much higher in the intervention group.
Attrition Bias Factor likely present, some potential to influence research results, Risk of bias direction unpredictable, Moderate risk of bias Study was only published in a satirical journal issue.
Reporting Bias Factor present, some potential to influence research results, Risk of bias direction unpredictable, Moderate risk of bias
content
type: Rating System
classifier: ROB1
FHIR
FHIRsmith{
"resourceType": "ArtifactAssessment",
"id": "307449",
"meta": {
"versionId": "10",
"lastUpdated": "2025-11-04T15:25:42.461Z",
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias"
]
},
"language": "en",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-description",
"valueMarkdown": "This is an example of the RiskOfBias Profile."
},
{
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
"code": "draft",
"display": "Draft"
}
]
}
}
],
"modifierExtension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-status",
"valueCode": "active"
}
],
"identifier": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "ACSN",
"display": "Accession ID"
}
],
"text": "FEvIR Object Identifier"
},
"system": "https://fevir.net/FOI",
"value": "307449",
"assigner": {
"display": "Computable Publishing LLC"
}
}
],
"title": "Risk of Bias Assessment of PARACHUTE trial",
"citeAs": "Risk of Bias Assessment of PARACHUTE trial [Database Entry: FHIR ArtifactAssessment Resource]. Contributors: In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 307449. Revised 2025-11-04. Available at: https://fevir.net/resources/ArtifactAssessment/307449. Computable resource at: https://fevir.net/resources/ArtifactAssessment/307449#json.",
"artifactReference": {
"reference": "Citation/306957",
"type": "Citation",
"display": "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": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-type",
"code": "RiskOfBias",
"display": "Risk of bias"
}
]
},
"freeToShare": true,
"component": [
{
"summary": "Assignment was done by order of enrollment.",
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00278",
"display": "bias due to non-randomized allocation"
}
],
"text": "Inadequate random sequence generation"
},
"classifier": [
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00194",
"display": "Factor present"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00208",
"display": "some potential to influence research results"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00205",
"display": "Risk of bias direction unpredictable"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00187",
"display": "Moderate risk of bias"
}
]
}
]
},
{
"summary": "The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant.",
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00031",
"display": "Inadequate allocation concealment"
}
]
},
"classifier": [
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00194",
"display": "Factor present"
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]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00208",
"display": "some potential to influence research results"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00205",
"display": "Risk of bias direction unpredictable"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00187",
"display": "Moderate risk of bias"
}
]
}
]
},
{
"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": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00035",
"display": "Inadequate blinding of participants"
}
]
},
"classifier": [
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00195",
"display": "Factor likely present"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00208",
"display": "some potential to influence research results"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00205",
"display": "Risk of bias direction unpredictable"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00187",
"display": "Moderate risk of bias"
}
]
}
]
},
{
"summary": "Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome.",
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00036",
"display": "Inadequate blinding of intervention deliverers"
}
]
},
"classifier": [
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00195",
"display": "Factor likely present"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00209",
"display": "limited potential to influence research results"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00205",
"display": "Risk of bias direction unpredictable"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00186",
"display": "Low risk of bias"
}
]
}
]
},
{
"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": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00048",
"display": "Bias due to lack of masking for outcome determination"
}
]
},
"classifier": [
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00195",
"display": "Factor likely present"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00209",
"display": "limited potential to influence research results"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00205",
"display": "Risk of bias direction unpredictable"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00186",
"display": "Low risk of bias"
}
]
}
]
},
{
"summary": "Attrition was much higher in the intervention group.",
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00019",
"display": "Attrition Bias"
}
]
},
"classifier": [
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00195",
"display": "Factor likely present"
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},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00208",
"display": "some potential to influence research results"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00205",
"display": "Risk of bias direction unpredictable"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00187",
"display": "Moderate risk of bias"
}
]
}
]
},
{
"summary": "Study was only published in a satirical journal issue.",
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00023",
"display": "Reporting Bias"
}
]
},
"classifier": [
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00194",
"display": "Factor present"
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},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00208",
"display": "some potential to influence research results"
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},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00205",
"display": "Risk of bias direction unpredictable"
}
]
},
{
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "SEVCO:00187",
"display": "Moderate risk of bias"
}
]
}
]
}
]
},
{
"type": {
"coding": [
{
"system": "https://fevir.net/resources/CodeSystem/179423",
"code": "rating-system",
"display": "Rating System"
}
]
},
"classifier": [
{
"coding": [
{
"system": "http://hl7.org/fhir/uv/ebm/CodeSystem/evidence-rating-system-classifier-codesystem",
"code": "CochraneRoB",
"display": "Cochrane RoB"
}
],
"text": "ROB1"
}
]
}
]
}