Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
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
| Page standards status: Informative |
{
"resourceType" : "ArtifactAssessment",
"id" : "307449",
"meta" : {
"versionId" : "5",
"lastUpdated" : "2025-03-01T19:14:10.582Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ArtifactAssessment 307449</b></p><a name=\"307449\"> </a><a name=\"hc307449\"> </a><a name=\"307449-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 5; Last updated: 2025-03-01 19:14:10+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-risk-of-bias.html\">RiskOfBias</a></p></div><p><b>Artifact URL</b>: <a href=\"https://fevir.net/resources/ArtifactAssessment/307449\">https://fevir.net/resources/ArtifactAssessment/307449</a></p><p><b>Artifact Description</b>: </p><div><p>This is an example of the RiskOfBias Profile.</p>\n</div><p><b>Artifact Status</b>: draft</p><p><b>identifier</b>: FEvIR Object Identifier/https://fevir.net/FOI/307449</p><p><b>title</b>: Risk of Bias Assessment of PARACHUTE trial</p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><p><b>artifact</b>: <a href=\"Citation-306957.html\">30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.</a></p><blockquote><p><b>content</b></p><p><b>type</b>: <span title=\"Codes:{https://fevir.net/sevco SEVCO:00001}\">Bias</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Summary</b></td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style=\"display: none\">*</td><td><div><p>Assignment was done by order of enrollment.</p>\n</div></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00278}\">Inadequate random sequence generation</span></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00194}\">Factor present</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00208}\">Factor likely has potential to impact results</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00205}\">Risk of bias direction unpredictable</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00187}\">Moderate risk of bias</span></td></tr><tr><td style=\"display: none\">*</td><td><div><p>The investigator who assigned the treatment was aware of the assignment which was reported verbally to the participant.</p>\n</div></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00031}\">Inadequate allocation concealment</span></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00194}\">Factor present</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00208}\">Factor likely has potential to impact results</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00205}\">Risk of bias direction unpredictable</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00187}\">Moderate risk of bias</span></td></tr><tr><td style=\"display: none\">*</td><td><div><p>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.</p>\n</div></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00035}\">Inadequate blinding of participants</span></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00195}\">Factor likely present</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00208}\">Factor likely has potential to impact results</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00205}\">Risk of bias direction unpredictable</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00187}\">Moderate risk of bias</span></td></tr><tr><td style=\"display: none\">*</td><td><div><p>Intervention deliverers could discern the difference between the parachute and the empty backback. This likely made no difference in the outcome.</p>\n</div></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00036}\">Inadequate blinding of intervention deliverers</span></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00195}\">Factor likely present</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00209}\">Factor likely does not have potential to impact results</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00205}\">Risk of bias direction unpredictable</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00186}\">Low risk of bias</span></td></tr><tr><td style=\"display: none\">*</td><td><div><p>Although outcome determination was done with full knowledge of exposure status, it was not likely that this changed the determination of death or injury</p>\n</div></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00048}\">Bias due to lack of masking for outcome determination</span></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00195}\">Factor likely present</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00209}\">Factor likely does not have potential to impact results</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00205}\">Risk of bias direction unpredictable</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00186}\">Low risk of bias</span></td></tr><tr><td style=\"display: none\">*</td><td><div><p>Attrition was much higher in the intervention group.</p>\n</div></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00019}\">Attrition Bias</span></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00195}\">Factor likely present</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00208}\">Factor likely has potential to impact results</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00205}\">Risk of bias direction unpredictable</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00187}\">Moderate risk of bias</span></td></tr><tr><td style=\"display: none\">*</td><td><div><p>Study was only published in a satirical journal issue.</p>\n</div></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00023}\">Reporting Bias</span></td><td><span title=\"Codes:{https://fevir.net/sevco SEVCO:00194}\">Factor present</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00208}\">Factor likely has potential to impact results</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00205}\">Risk of bias direction unpredictable</span>, <span title=\"Codes:{https://fevir.net/sevco SEVCO:00187}\">Moderate risk of bias</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title=\"Codes:\">Profile</span></p><p><b>classifier</b>: <span title=\"Codes:\">ROB1</span></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/artifact-url",
"valueUri" : "https://fevir.net/resources/ArtifactAssessment/307449"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/artifact-description",
"valueMarkdown" : "This is an example of the RiskOfBias Profile."
}
],
"modifierExtension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/artifact-status",
"valueCode" : "draft"
}
],
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "ACSN",
"display" : "Accession ID"
}
],
"text" : "FEvIR Object Identifier"
},
"system" : "urn:ietf:rfc:3986",
"value" : "https://fevir.net/FOI/307449",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
],
"title" : "Risk of Bias Assessment of PARACHUTE trial",
"copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"artifactReference" : {
🔗 "reference" : "Citation/306957",
"type" : "Citation",
"display" : "30545967 Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial."
},
"content" : [
{
"type" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "SEVCO:00001",
"display" : "Bias"
}
]
},
"freeToShare" : true,
"component" : [
{
"summary" : "Assignment was done by order of enrollment.",
"type" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "SEVCO:00278",
"display" : "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" : "Factor likely has potential to impact 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"
}
]
},
{
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact 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" : "Factor likely has potential to impact 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" : "Factor likely does not have potential to impact 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" : "Factor likely does not have potential to impact 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"
}
]
},
{
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact 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"
}
]
},
{
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact 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"
}
]
}
]
}
]
},
{
"type" : {
"text" : "Profile"
},
"classifier" : [
{
"text" : "ROB1"
}
]
}
]
}
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot2. Generated 2025-03-27
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change