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Example Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2 (JSON)

Clinical Decision Support Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

Raw JSON (canonical form + also see JSON Format Specification)

Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior

{
  "resourceType" : "Evidence",
  "id" : "example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n      \n      <p>\n        &quot;Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior&quot; is a comparative effect estimate.\n      </p>\n\t\n    </div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "cds"
  }],
  "url" : "http://hl7.org/fhir/Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.10.3"
  }],
  "name" : "EffectOfAlteplaseVsNoAlteplaseOnMRS02At90DaysInStroke345HoursPrior",
  "title" : "Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior",
  "status" : "draft",
  "publisher" : "HL7 International / Clinical Decision Support",
  "contact" : [{
    "telecom" : [{
      "system" : "url"
    }]
  }],
  "relatedArtifact" : [{
    "type" : "citation",
    "label" : "Lees 2016",
    "display" : "Figure 2 Lees 2016",
    "citation" : "Lees KR, Emberson J, Blackwell L, Bluhmki E, Davis SM, Donnan GA, et al; Stroke Thrombolysis Trialists’ Collaborators Group. Effects of alteplase for acute stroke on the distribution of functional outcomes: a pooled analysis of 9 trials. Stroke. 2016;47:2373-2379. PMID 27507856",
    "document" : {
      "url" : "https://doi.org/10.1161/STROKEAHA.116.013644"
    }
  }],
  "description" : "mRS 0-2 at 90 days Odds Ratio 1.2 for Alteplase vs. No Alteplase in patients with acute ischemic stroke 3-4.5 hours prior",
  "variableDefinition" : [{
    "variableRole" : "population",
    "observed" : {
      "reference" : "EvidenceVariable/Stroke-Thrombolysis-Trialists-2014-2016-IPD-MA-Cohort",
      "type" : "EvidenceVariable",
      "display" : "Stroke Thrombolysis Trialists’ 2014-2016 IPD-MA Cohort"
    },
    "intended" : {
      "reference" : "Group/AcuteIschemicStroke3-4halfHours",
      "type" : "Group",
      "display" : "stroke at 3-4.5 hours"
    },
    "directnessMatch" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/directness",
        "code" : "moderate",
        "display" : "Moderate quality match between observed and intended variable"
      }]
    }
  },
  {
    "variableRole" : "outcome",
    "observed" : {
      "reference" : "EvidenceVariable/example-mRS0-2-at-90days",
      "type" : "EvidenceVariable",
      "display" : "mRS 0-2 at 90 days"
    },
    "intended" : {
      "reference" : "EvidenceVariable/example-alive-independent-90day",
      "type" : "EvidenceVariable",
      "display" : "Alive and not functionally dependent at 90 days"
    }
  },
  {
    "variableRole" : "exposure",
    "comparatorCategory" : "No Alteplase",
    "observed" : {
      "reference" : "EvidenceVariable/example-group-assignment-alteplase-for-stroke-vs-no-alteplase",
      "type" : "EvidenceVariable",
      "display" : "Group Assignment: Alteplase for Stroke vs No Alteplase"
    }
  }],
  "synthesisType" : {
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/synthesis-type",
      "code" : "IPD-MA",
      "display" : "individual patient data meta-analysis"
    }]
  },
  "studyDesign" : [{
    "coding" : [{
      "system" : "http://hl7.org/fhir/study-design",
      "code" : "SEVCO:01003",
      "display" : "randomized assignment"
    }]
  }],
  "statistic" : [{
    "statisticType" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/statistic-type",
        "code" : "C16932",
        "display" : "Odds Ratio"
      }]
    },
    "quantity" : {
      "value" : 1.2
    },
    "sampleSize" : {
      "numberOfStudies" : 9
    },
    "attributeEstimate" : [{
      "description" : "95% CI 1.06 to 1.3",
      "type" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
          "code" : "C53324",
          "display" : "Confidence interval"
        }]
      },
      "level" : 0.95,
      "range" : {
        "low" : {
          "value" : 1.06
        },
        "high" : {
          "value" : 1.3
        }
      }
    }]
  }],
  "certainty" : [{
    "description" : "Very low certainty due to risk of bias, inconsistency, imprecision, and indirectness",
    "type" : {
      "coding" : [{
        "system" : "http://hl7.org/fhir/certainty-type",
        "code" : "Overall",
        "display" : "Overall certainty"
      }]
    },
    "rating" : {
      "coding" : [{
        "system" : "http://hl7.org/fhir/certainty-rating",
        "code" : "very-low",
        "display" : "Very low quality"
      }]
    },
    "subcomponent" : [{
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "PublicationBias",
          "display" : "Publication bias"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-rating",
          "code" : "no-concern",
          "display" : "no serious concern"
        }]
      }
    },
    {
      "note" : [{
        "text" : "IST-3 had inconsistent results and contributed large proportion of data"
      }],
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "Inconsistency",
          "display" : "Inconsistency"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-rating",
          "code" : "serious-concern",
          "display" : "serious concern"
        }]
      }
    },
    {
      "note" : [{
        "text" : "results derived from figure with limited data reported to support the specific effect estimate; derived odds ratio in figure does not match results from rates of mRS 0-2 reported in Supplementary Figure 3b"
      }],
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "Imprecision",
          "display" : "Imprecision"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-rating",
          "code" : "serious-concern",
          "display" : "serious concern"
        }]
      }
    },
    {
      "note" : [{
        "text" : "resuts derived for 3 - 4.5 hours assume data from 0 - 6 hours is informative"
      }],
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "Indirectness",
          "display" : "Indirectness"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-rating",
          "code" : "serious-concern",
          "display" : "serious concern"
        }]
      }
    },
    {
      "note" : [{
        "text" : "results largely influenced by IST-3 trial which was unblinded and ECASS III which had baseline imbalances"
      }],
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-type",
          "code" : "RiskOfBias",
          "display" : "Risk of bias"
        }]
      },
      "rating" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/certainty-rating",
          "code" : "serious-concern",
          "display" : "serious concern"
        }]
      }
    }]
  }]
}

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.