Evidence Example: evidence-example-statistic-model-include-if

Example XML

<?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"/>
    </meta>
    <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="Computable Publishing LLC"/>
    <contact>
        <telecom>
            <system value="email"/>
            <value value="support@computablepublishing.com"/>
        </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&apos;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&apos;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>