Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior

{
  "resourceType" : "Evidence",
  "id" : "example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n      <p>\n        &quot;Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior&quot; is a comparative effect estimate.\n      </p>\n\t</div>"
  },
  "url" : "http://hl7.org/fhir/Evidence/example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.10.5"
  }],
  "title" : "Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior",
  "status" : "draft",
  "relatedArtifact" : [{
    "type" : "citation",
    "label" : "Wardlaw 2014",
    "display" : "Analysis 1.16 from Wardlaw 2014",
    "citation" : "Wardlaw JM, Murray V, Berge E, del Zoppo GJ. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2014 Jul 29(7):CD000213. PMID 25072528",
    "document" : {
      "url" : "https://doi.org/10.1002/14651858.CD000213.pub3"
    }
  }],
  "description" : "mRS 3-6 at 90 days Odds Ratio 0.65 for Alteplase vs. No Alteplase in patients with acute ischemic stroke 0-3 hours prior",
  "variableDefinition" : [{
    "variableRole" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/variable-role",
        "code" : "population",
        "display" : "population"
      }]
    },
    "observed" : {
      "reference" : "EvidenceVariable/Wardlaw2014Analysis1.16.3EvidenceSet",
      "type" : "EvidenceVariable",
      "display" : "Wardlaw 2014 Analysis 1.16.3 Evidence set"
    },
    "intended" : {
      "reference" : "Group/AcuteIschemicStroke0-3Hours",
      "type" : "Group",
      "display" : "stroke at 0-3 hours"
    }
  },
  {
    "variableRole" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/variable-role",
        "code" : "measuredVariable",
        "display" : "measured variable"
      }]
    },
    "observed" : {
      "reference" : "EvidenceVariable/example-mRS3-6-at-90days",
      "type" : "EvidenceVariable",
      "display" : "mRS 3-6 at 90 days"
    },
    "intended" : {
      "reference" : "EvidenceVariable/example-dead-or-dependent-90day",
      "type" : "EvidenceVariable",
      "display" : "Dead or functionally dependent at 90 days"
    }
  },
  {
    "variableRole" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/variable-role",
        "code" : "exposure",
        "display" : "exposure"
      }]
    },
    "observed" : {
      "reference" : "EvidenceVariable/example-alteplase-for-stroke",
      "type" : "EvidenceVariable",
      "display" : "Alteplase for Stroke"
    },
    "intended" : {
      "reference" : "EvidenceVariable/example-alteplase-for-stroke",
      "type" : "EvidenceVariable",
      "display" : "Alteplase for Stroke"
    }
  },
  {
    "variableRole" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/variable-role",
        "code" : "referenceExposure",
        "display" : "reference exposure"
      }]
    },
    "observed" : {
      "reference" : "EvidenceVariable/example-no-alteplase",
      "type" : "EvidenceVariable",
      "display" : "no alteplase"
    },
    "intended" : {
      "reference" : "EvidenceVariable/example-no-alteplase",
      "type" : "EvidenceVariable",
      "display" : "no alteplase"
    }
  }],
  "synthesisType" : {
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/synthesis-type",
      "code" : "std-MA",
      "display" : "summary data meta-analysis"
    }]
  },
  "studyDesign" : [{
    "coding" : [{
      "system" : "http://hl7.org/fhir/research-study-classifiers",
      "code" : "SEVCO:01003",
      "display" : "randomized assignment"
    }]
  }],
  "statistic" : [{
    "statisticType" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/statistic-type",
        "code" : "C16932",
        "display" : "Odds Ratio"
      }]
    },
    "quantity" : {
      "value" : 0.65
    },
    "numberOfEvents" : 1137,
    "sampleSize" : {
      "numberOfStudies" : 6,
      "numberOfParticipants" : 1779
    },
    "attributeEstimate" : [{
      "description" : "95% CI 0.54 to 0.80",
      "type" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
          "code" : "C53324",
          "display" : "Confidence interval"
        }]
      },
      "level" : 0.95,
      "range" : {
        "low" : {
          "value" : 0.54
        },
        "high" : {
          "value" : 0.8
        }
      }
    },
    {
      "description" : "P-value = 0.000023",
      "type" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
          "code" : "C44185",
          "display" : "P-value"
        }]
      },
      "quantity" : {
        "value" : 0.000023
      }
    },
    {
      "description" : "Heterogeneity I-sq = 0.0%",
      "type" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
          "code" : "0000420",
          "display" : "I-squared"
        }]
      },
      "quantity" : {
        "value" : 0,
        "unit" : "%",
        "system" : "http://unitsofmeasure.org",
        "code" : "%"
      }
    }]
  }],
  "certainty" : [{
    "description" : "Moderate certainty due to risk of bias",
    "type" : {
      "coding" : [{
        "system" : "http://hl7.org/fhir/certainty-type",
        "code" : "Overall",
        "display" : "Overall quality"
      }]
    },
    "rating" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/certainty-rating",
        "code" : "moderate",
        "display" : "Moderate"
      }]
    },
    "subcomponent" : [{
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "PublicationBias",
          "display" : "Publication bias"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/certainty-rating",
          "code" : "no-concern",
          "display" : "no serious concern"
        }]
      }
    },
    {
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "Inconsistency",
          "display" : "Inconsistency"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/certainty-rating",
          "code" : "no-concern",
          "display" : "no serious concern"
        }]
      }
    },
    {
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "Imprecision",
          "display" : "Imprecision"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/certainty-rating",
          "code" : "no-concern",
          "display" : "no serious concern"
        }]
      }
    },
    {
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "Indirectness",
          "display" : "Indirectness"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/certainty-rating",
          "code" : "no-concern",
          "display" : "no serious concern"
        }]
      }
    },
    {
      "note" : [{
        "text" : "results largely influenced by IST-3 trial which was unblinded and NINDS trial which had allocation concealment not stated and baseline imbalances"
      }],
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "RiskOfBias",
          "display" : "Risk of bias"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/certainty-rating",
          "code" : "serious-concern",
          "display" : "serious concern"
        }]
      }
    }]
  }]
}