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| Clinical Decision Support Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
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Statistical analysis plan with different statistical test if non-normal distribution
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
<http://hl7.org/fhir/Evidence/example-statistic-model-include-if> a fhir:Evidence ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "example-statistic-model-include-if"] ; #
fhir:meta [
fhir:versionId [ fhir:v "9" ] ;
fhir:lastUpdated [ fhir:v "2025-03-10T14:59:32.227Z"^^xsd:dateTime ] ;
fhir:profile ( [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model>
] )
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "cds"
]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/Evidence/example-statistic-model-include-if"^^xsd:anyURI] ; #
fhir:identifier ( [
fhir:type [
fhir:text [ fhir:v "FEvIR Object Identifier" ]
] ;
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "https://fevir.net/FOI/346428" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]
]
] ) ; #
fhir:title [ fhir:v "Example of statistical analysis plan with different statistical test if non-normal distribution"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:author ( [
fhir:name [ fhir:v "Brian S. Alper, MD, MSPH" ]
] ) ; #
fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; #
fhir:contact ( [
fhir:telecom ( [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/dss" ]
] )
] ) ; #
fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; #
fhir:description [ fhir:v "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 >= 0.05) and a Wilcoxon Mann-Whitney test if not."] ; #
fhir:variableDefinition ( [
fhir:description [ fhir:v "Adults with hypertension" ] ;
fhir:variableRole [ fhir:v "population" ]
] [
fhir:description [ fhir:v "Reversitol vs. Placebo" ] ;
fhir:variableRole [ fhir:v "exposure" ]
] [
fhir:description [ fhir:v "Change in systolic blood pressure from baseline to 3 months" ] ;
fhir:variableRole [ fhir:v "outcome" ]
] ) ; #
fhir:studyDesign ( [
fhir:coding ( [
fhir:system [ fhir:v "https://fevir.net/sevco"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01003" ] ;
fhir:display [ fhir:v "randomized assignment" ]
] )
] ) ; #
fhir:statistic ( [
fhir:statisticType [
fhir:coding ( [
fhir:system [ fhir:v "https://fevir.net/sevco"^^xsd:anyURI ] ;
fhir:code [ fhir:v "STATO:0000457" ] ;
fhir:display [ fhir:v "difference in means" ]
] )
] ;
fhir:modelCharacteristic ( [
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/statistic-model-include-if"^^xsd:anyURI ] ;
fhir:extension ( [
fhir:url [ fhir:v "attribute"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "data distribution" ]
]
] [
fhir:url [ fhir:v "value"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "normal distribution (Shapiro-Wilk test with p-value >= 0.05)" ]
]
] )
] ) ;
fhir:code [
fhir:text [ fhir:v "Welch's 2-sample t-test" ]
] ;
fhir:intended [ fhir:v true ]
] [
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/statistic-model-include-if"^^xsd:anyURI ] ;
fhir:extension ( [
fhir:url [ fhir:v "attribute"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "data distribution" ]
]
] [
fhir:url [ fhir:v "value"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "not consistent with normal distribution (Shapiro-Wilk test with p-value < 0.05)" ]
]
] )
] ) ;
fhir:code [
fhir:text [ fhir:v "Wilcoxon Mann-Whitney test" ]
] ;
fhir:intended [ fhir:v true ]
] )
] ) . #
# -------------------------------------------------------------------------------------
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot3 generated on Sun, Oct 26, 2025 05:51+0000.
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