{
  "resourceType": "Evidence",
  "id": "example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2",
  "text": {
    "status": "generated",
    "div": "\u003cdiv xmlns\u003d\"http://www.w3.org/1999/xhtml\"\u003e\n      \n      \u003cp\u003e\n        \u0026quot;Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior\u0026quot; is a comparative effect estimate.\n      \u003c/p\u003e\n\t\n    \u003c/div\u003e"
  },
  "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",
          "value": "http://www.hl7.org/Special/committees/dss"
        }
      ]
    }
  ],
  "relatesTo": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/artifact-relationship-type",
            "code": "cites",
            "display": "Cites"
          }
        ]
      },
      "targetMarkdown": "Figure 2 Lees 2016 \u003cb\u003eCitation:\u003c/b\u003e 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 \u003cb\u003eURL:\u003c/b\u003e 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": "https://fevir.net/sevco",
          "code": "SEVCO:01003",
          "display": "randomized assignment"
        }
      ]
    }
  ],
  "statistic": [
    {
      "statisticType": {
        "coding": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000182",
            "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 certainty"
          }
        ]
      },
      "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"
              }
            ]
          }
        }
      ]
    }
  ]
}