J# 41379 Evidence.statistic.modelCharacteristic changes

[Khalid-Shahin]

The EBMonFHIR project, through multiple meetings with statisticians and informaticists developed models and examples for expressing an endpoint analysis plan (a statistical model commonly expressed in clinical study protocols) in a FHIR Resource. The approach with the smallest number of changes to the FHIR specification involves 5 changes to the Evidence.statistic.modelCharacteristic element, namely:

1. Add condition[x] 0..1 CodeableConcept | Expression short="When this characteristic is used"
2. Change value element to value[x] 0..1 Quantity | Range | CodeableConcept  short="The specific value (when paired with code)"
3. Add intended 0..1 boolean  short="The plan for analysis"
4. Add applied 0..1 boolean   short="The analysis that was applied"
5. Add modelCharacteristic 0..* see modelCharacteristic  short="model component"