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Clinical ReasoningThis is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
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| Clinical Decision Support Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
This is an example of the RiskOfBias Profile.
{
"resourceType" : "ArtifactAssessment",
"id" : "example-risk-of-bias-assessment-of-parachute-trial",
"meta" : {
"versionId" : "4",
"lastUpdated" : "2025-02-25T20:01:47.665Z",
"profile" : ["http://hl7.org/fhir/uv/ebm/StructureDefinition/risk-of-bias"]
},
"identifier" : [{
"type" : {
"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",
"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" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00001",
"display" : "Bias"
}]
},
"freeToShare" : true,
"component" : [{
"summary" : "Assignment was done by order of enrollment. ",
"type" : {
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00278",
"display" : "Inadequate random sequence generation"
}]
},
"classifier" : [{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00194",
"display" : "Factor present"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact results"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00205",
"display" : "Risk of bias direction unpredictable"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"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/resources/CodeSystem/27270",
"code" : "SEVCO:00031",
"display" : "Inadequate allocation concealment"
}]
},
"classifier" : [{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00194",
"display" : "Factor present"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact results"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00205",
"display" : "Risk of bias direction unpredictable"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"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/resources/CodeSystem/27270",
"code" : "SEVCO:00035",
"display" : "Inadequate blinding of participants"
}]
},
"classifier" : [{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00195",
"display" : "Factor likely present"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact results"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00205",
"display" : "Risk of bias direction unpredictable"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"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/resources/CodeSystem/27270",
"code" : "SEVCO:00036",
"display" : "Inadequate blinding of intervention deliverers"
}]
},
"classifier" : [{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00195",
"display" : "Factor likely present"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00209",
"display" : "Factor likely does not have potential to impact results"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00205",
"display" : "Risk of bias direction unpredictable"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"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/resources/CodeSystem/27270",
"code" : "SEVCO:00048",
"display" : "Bias due to lack of masking for outcome determination"
}]
},
"classifier" : [{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00195",
"display" : "Factor likely present"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00209",
"display" : "Factor likely does not have potential to impact results"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00205",
"display" : "Risk of bias direction unpredictable"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00186",
"display" : "Low risk of bias"
}]
}]
},
{
"summary" : "Attrition was much higher in the intervention group.",
"type" : {
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00019",
"display" : "Attrition Bias"
}]
},
"classifier" : [{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00195",
"display" : "Factor likely present"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact results"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00205",
"display" : "Risk of bias direction unpredictable"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00187",
"display" : "Moderate risk of bias"
}]
}]
},
{
"summary" : "Study was only published in a satirical journal issue.",
"type" : {
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00023",
"display" : "Reporting Bias"
}]
},
"classifier" : [{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00194",
"display" : "Factor present"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00208",
"display" : "Factor likely has potential to impact results"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00205",
"display" : "Risk of bias direction unpredictable"
}]
},
{
"coding" : [{
"system" : "https://fevir.net/resources/CodeSystem/27270",
"code" : "SEVCO:00187",
"display" : "Moderate risk of bias"
}]
}]
}]
},
{
"type" : {
"text" : "Profile"
},
"classifier" : [{
"text" : "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.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot3 generated on Tue, Oct 28, 2025 04:41+0000.
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