{
  "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"
    ],
    "tag": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
        "code": "HTEST",
        "display": "test health data"
      }
    ]
  },
  "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": {
    "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"
        }
      ]
    }
  ]
}