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  1. FHIR Specification Feedback
  2. FHIR-39099

Adverse event definition is definative and does not cover the research use case

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Details

    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Highest Highest
    • FHIR Core (FHIR)
    • R5
    • Patient Care
    • AdverseEvent
    • Element Id = AdverseEvent
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      Update AdverseEvent (resource) short display to be "An event that may be related to unintended effects on a patient or research subject" (which is the first sentence of the long description)

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      Update AdverseEvent (resource) short display to be "An event that may be related to unintended effects on a patient or research subject" (which is the first sentence of the long description)
    • Emma Jones / Stephen Chu : 5-0-2
    • Clarification
    • Non-substantive
    • R5

    Description

      The long definition is okay.

       

      The current short definition, for Adverse Event covers healthcare adverse events and not research adverse events: "Medical care, research study or other healthcare event causing physical injury".

       

      In clinical research, after the study drug is administered, any new condition is considered an "adverse event" regardless of the relationship of the study drug.  The drug is not unblinded to the patient or the research staff in some cases in large randomized blinded clinical trials.

       

       

      Consider a broader definition: "An unfavorable event that occurred or may have potentially occurred that may or may not be related to medical treatment or procedure."

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            Unassigned Unassigned
            rbaker@acc.org Rebecca Baker
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              Created:
              Updated:
              Resolved: