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"]
  },
  "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."
  }],
  "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"
    }]
  }]
}