FHIR IG analytics

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Source1

{
  "resourceType": "Evidence",
  "id": "367957",
  "meta": {
    "versionId": "26",
    "lastUpdated": "2025-08-18T13:22:42.074Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"
    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code": "active",
            "display": "Active"
          }
        ]
      }
    }
  ],
  "url": "https://fevir.net/resources/Evidence/367957",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "367957",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03640312-otherOutcomeMeasure-5-OutcomeAnalysis-16-BetweenGroupAnalysis-OG000-OG001",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "NCT03640312_otherOutcomeMeasure_5_OutcomeAnalysis_16_BetweenGroupAnalysis_OG000_OG001",
  "title": "Mean Change in Blood Urea Nitrogen at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312",
  "citeAs": "Mean Change in Blood Urea Nitrogen at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367957. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367957. Computable resource at: https://fevir.net/resources/Evidence/367957#json.",
  "status": "active",
  "author": [
    {
      "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
    }
  ],
  "publisher": "Computable Publishing LLC",
  "contact": [
    {
      "telecom": [
        {
          "system": "email",
          "value": "support@computablepublishing.com"
        }
      ]
    }
  ],
  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "description": "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
  "variableDefinition": [
    {
      "note": [
        {
          "text": "Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol."
        }
      ],
      "variableRole": "population",
      "intended": {
        "reference": "Group/367881",
        "type": "Group",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312 Eligibility Criteria",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      }
    },
    {
      "description": "Group Assignment: QUARTET LDQT vs. Candesartan",
      "variableRole": "exposure",
      "comparatorCategory": "Candesartan",
      "observed": {
        "display": "Group Assignment: Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
      }
    },
    {
      "variableRole": "outcome",
      "observed": {
        "reference": "EvidenceVariable/367901",
        "type": "EvidenceVariable",
        "identifier": {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-otherOutcome-5",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        },
        "display": "Mean Change in Blood Urea Nitrogen at 12 weeks (NCT03640312)"
      }
    }
  ],
  "statistic": [
    {
      "note": [
        {
          "text": "Outcome Analysis NonInferiority Type: Superiority"
        },
        {
          "text": "Outcome Analysis Estimate Comment: The model estimated mean differences, adjusted for covariates, will not be equal to the raw mean differences observed."
        }
      ],
      "statisticType": {
        "text": "Mean Difference (Net)"
      },
      "quantity": {
        "value": 0.08,
        "unit": "mg/dL"
      },
      "attributeEstimate": [
        {
          "type": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000037",
                "display": "standard error of the mean"
              }
            ]
          },
          "quantity": {
            "value": 0.95,
            "unit": "mg/dL"
          }
        },
        {
          "note": [
            {
              "text": "Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects."
            }
          ],
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
                "code": "C44185",
                "display": "P-value"
              }
            ]
          },
          "quantity": {
            "value": 0.94
          }
        },
        {
          "note": [
            {
              "text": "CI Number of Sides: 2-Sided"
            }
          ],
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
                "code": "C53324",
                "display": "Confidence interval"
              }
            ]
          },
          "level": 0.95,
          "range": {
            "low": {
              "value": -1.84,
              "unit": "mg/dL"
            },
            "high": {
              "value": 1.99,
              "unit": "mg/dL"
            }
          }
        }
      ],
      "modelCharacteristic": [
        {
          "code": {
            "text": "Mixed Models Analysis"
          }
        }
      ]
    }
  ]
}