AEOCCUR and FAORRES maps to actuality

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    • Type: Change Request
    • Resolution: Not Persuasive
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Adverse Events
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      The concepts are different.

      1a. AEOCCUR - "Is did [prespecified] happen?" Y/N 

           There is no ability in FHIR to answer this question.  It is either present or not in the EHR.

      1b. FAORRES - is still dealing with distinction of results that might not have occurred.  FHIR only captures when something happens.  The only way this would be collected would be in Questionnaire/Response. 

      2.  AdverseEventActuality - only happens if it happened.  It answers answer if this happens or is it a "near miss."  The context here for this value is hospital quality and safety.  These are different concepts.  This element does not reflect checklist approach as SDTM.

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      The concepts are different. 1a. AEOCCUR - "Is did  [prespecified] happen?" Y/N       There is no ability in FHIR to answer this question.  It is either present or not in the EHR. 1b. FAORRES - is still dealing with distinction of results that might not have occurred.  FHIR only captures when something happens.  The only way this would be collected would be in Questionnaire/Response.  2.  AdverseEventActuality - only happens if it happened.  It answers answer if this happens or is it a "near miss."  The context here for this value is hospital quality and safety.  These are different concepts.  This element does not reflect checklist approach as SDTM.
    • Clarification

      The mapping table describes the CDISC variables AEOCCUR and FAORRES, both are not mappable for the reason "FHIR only captures AdverseEventd that have actually occurred." But it seems the FHIR element AdverseEvent.Actuality can be mapped into these two CDISC variables.

      (Comment 18 - imported by: Lloyd McKenzie)

            Assignee:
            Unassigned
            Reporter:
            mrocca
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              Created:
              Updated:
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