Release 5 Preview #3

Evidence-example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2.json

Clinical Decision Support Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any 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      <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</div>"
  },
  "url": "Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2",
  "title": "Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior",
  "status": "draft",
  "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",
      "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": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/variable-role",
            "code": "population",
            "display": "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"
          }
        ]
      }
    },
    {
      "variableRole": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/variable-role",
            "code": "measuredVariable",
            "display": "measured variable"
          }
        ]
      },
      "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": {
        "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": "IPD-MA",
        "display": "individual patient data meta-analysis"
      }
    ]
  },
  "studyType": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/study-type",
        "code": "RCT",
        "display": "randomized trial"
      }
    ]
  },
  "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://terminology.hl7.org/CodeSystem/certainty-type",
            "code": "Overall",
            "display": "Overall quality"
          }
        ]
      },
      "rating": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/certainty-rating",
            "code": "very-low",
            "display": "Very low quality"
          }
        ]
      },
      "subcomponent": [
        {
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/certainty-type",
                "code": "PublicationBias",
                "display": "Publication bias"
              }
            ]
          },
          "rating": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/certainty-type",
                "code": "Inconsistency",
                "display": "Inconsistency"
              }
            ]
          },
          "rating": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/certainty-type",
                "code": "Imprecision",
                "display": "Imprecision"
              }
            ]
          },
          "rating": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/certainty-type",
                "code": "Indirectness",
                "display": "Indirectness"
              }
            ]
          },
          "rating": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/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://terminology.hl7.org/CodeSystem/certainty-type",
                "code": "RiskOfBias",
                "display": "Risk of bias"
              }
            ]
          },
          "rating": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/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.