{
  "resourceType": "Evidence",
  "id": "example-statistic-model-include-if",
  "meta": {
    "versionId": "9",
    "lastUpdated": "2025-03-10T14:59:32.227Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model"
    ]
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "cds"
    }
  ],
  "url": "http://hl7.org/fhir/Evidence/example-statistic-model-include-if",
  "identifier": [
    {
      "type": {
        "text": "FEvIR Object Identifier"
      },
      "system": "urn:ietf:rfc:3986",
      "value": "https://fevir.net/FOI/346428",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "title": "Example of statistical analysis plan with different statistical test if non-normal distribution",
  "status": "active",
  "author": [
    {
      "name": "Brian S. Alper, MD, MSPH"
    }
  ],
  "publisher": "HL7 International / Clinical Decision Support",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/dss"
        }
      ]
    }
  ],
  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "description": "This example uses the StatisticModelIncludeIf extension to represent the model characteristic of Welch\u0027s 2-sample t-test if the data is consistent with a normal distribution (based on Shapiro-Wilk test with p-value \u003e\u003d 0.05) and a Wilcoxon Mann-Whitney test if not.",
  "variableDefinition": [
    {
      "description": "Adults with hypertension",
      "variableRole": "population"
    },
    {
      "description": "Reversitol vs. Placebo",
      "variableRole": "exposure"
    },
    {
      "description": "Change in systolic blood pressure from baseline to 3 months",
      "variableRole": "outcome"
    }
  ],
  "studyDesign": [
    {
      "coding": [
        {
          "system": "https://fevir.net/sevco",
          "code": "SEVCO:01003",
          "display": "randomized assignment"
        }
      ]
    }
  ],
  "statistic": [
    {
      "statisticType": {
        "coding": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000457",
            "display": "difference in means"
          }
        ]
      },
      "modelCharacteristic": [
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/statistic-model-include-if",
              "extension": [
                {
                  "url": "attribute",
                  "valueCodeableConcept": {
                    "text": "data distribution"
                  }
                },
                {
                  "url": "value",
                  "valueCodeableConcept": {
                    "text": "normal distribution (Shapiro-Wilk test with p-value \u003e\u003d 0.05)"
                  }
                }
              ]
            }
          ],
          "code": {
            "text": "Welch\u0027s 2-sample t-test"
          },
          "intended": true
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/statistic-model-include-if",
              "extension": [
                {
                  "url": "attribute",
                  "valueCodeableConcept": {
                    "text": "data distribution"
                  }
                },
                {
                  "url": "value",
                  "valueCodeableConcept": {
                    "text": "not consistent with normal distribution (Shapiro-Wilk test with p-value \u003c 0.05)"
                  }
                }
              ]
            }
          ],
          "code": {
            "text": "Wilcoxon Mann-Whitney test"
          },
          "intended": true
        }
      ]
    }
  ]
}