<?xml version="1.0" encoding="UTF-8"?><Evidence xmlns="http://hl7.org/fhir">
  <id value="example-statistic-model-include-if"/>
  <meta>
    <versionId value="9"/>
    <lastUpdated value="2025-03-10T14:59:32.227Z"/>
    <profile value="http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model"/>
  
    <security>
      <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
      <code value="HTEST"/>
      <display value="test health data"/>
    </security>
  </meta>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="cds"/>
  </extension>
  <url value="http://hl7.org/fhir/Evidence/example-statistic-model-include-if"/>
  <identifier>
    <type>
      <text value="FEvIR Object Identifier"/>
    </type>
    <system value="urn:ietf:rfc:3986"/>
    <value value="https://fevir.net/FOI/346428"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <title value="Example of statistical analysis plan with different statistical test if non-normal distribution"/>
  <status value="active"/>
  <author>
    <name value="Brian S. Alper, MD, MSPH"/>
  </author>
  <publisher value="HL7 International / Clinical Decision Support"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/dss"/>
    </telecom>
  </contact>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <description value="This example uses the StatisticModelIncludeIf extension to represent the model characteristic of Welch's 2-sample t-test if the data is consistent with a normal distribution (based on Shapiro-Wilk test with p-value &gt;= 0.05) and a Wilcoxon Mann-Whitney test if not."/>
  <variableDefinition>
    <description value="Adults with hypertension"/>
    <variableRole value="population"/>
  </variableDefinition>
  <variableDefinition>
    <description value="Reversitol vs. Placebo"/>
    <variableRole value="exposure"/>
  </variableDefinition>
  <variableDefinition>
    <description value="Change in systolic blood pressure from baseline to 3 months"/>
    <variableRole value="outcome"/>
  </variableDefinition>
  <studyDesign>
    <coding>
      <system value="https://fevir.net/sevco"/>
      <code value="SEVCO:01003"/>
      <display value="randomized assignment"/>
    </coding>
  </studyDesign>
  <statistic>
    <statisticType>
      <coding>
        <system value="https://fevir.net/sevco"/>
        <code value="STATO:0000457"/>
        <display value="difference in means"/>
      </coding>
    </statisticType>
    <modelCharacteristic>
      <extension url="http://hl7.org/fhir/StructureDefinition/statistic-model-include-if">
        <extension url="attribute">
          <valueCodeableConcept>
            <text value="data distribution"/>
          </valueCodeableConcept>
        </extension>
        <extension url="value">
          <valueCodeableConcept>
            <text value="normal distribution (Shapiro-Wilk test with p-value &gt;= 0.05)"/>
          </valueCodeableConcept>
        </extension>
      </extension>
      <code>
        <text value="Welch's 2-sample t-test"/>
      </code>
      <intended value="true"/>
    </modelCharacteristic>
    <modelCharacteristic>
      <extension url="http://hl7.org/fhir/StructureDefinition/statistic-model-include-if">
        <extension url="attribute">
          <valueCodeableConcept>
            <text value="data distribution"/>
          </valueCodeableConcept>
        </extension>
        <extension url="value">
          <valueCodeableConcept>
            <text value="not consistent with normal distribution (Shapiro-Wilk test with p-value &lt; 0.05)"/>
          </valueCodeableConcept>
        </extension>
      </extension>
      <code>
        <text value="Wilcoxon Mann-Whitney test"/>
      </code>
      <intended value="true"/>
    </modelCharacteristic>
  </statistic>
</Evidence>