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  1. FHIR Specification Feedback
  2. FHIR-37746

Make AdverseEvent.code semantically consistent

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    • Icon: Change Request Change Request
    • Resolution: Unresolved
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R5
    • Patient Care
    • AdverseEvent

    Description

      Proposal from [Tuesday|https://confluence.hl7.org/pages/viewpage.action?pageId=90341474#id-2022MayWGMPatientCareAgendaandMinutes-TuesdayQ2 : To use 'code' for the thing prompting the report, and to only use the condition or suspect entity (or contributing factor) for the ancillary things

      E.g., To use 'code' for the fall if there is no harm, and to use 'code' for the bruise if there is harm (and put the fall in 'contributing factor').

      It seems counterintuitive to me to put the fall in different places under different circumstances. I'd like to always know where to find the act (if any), the intermediate event (if any), & the harm (if any).

      Option 1: 'code' could be used to classify the AE as
                    A pharmacovigiliance representation of a symptom in a patient in a study following a suspect act
                                   for an AE containing a study, act, and symptom
                    A pharmacovigiliance representation of a symptom in a patient in a study not following a suspect act
                                   for an AE containing a study and symptom
                    A patient safety representation of a symptom in a patient following a suspect act
                                   for an AE containing an act & a symptom (& possibly event)
                    A patient safety representation of a symptom in a patient not following a suspect act
                                   for an AE containing a symptom (& possibly event)
                    A patient safety representation of a risky act with no harm (near miss)
                                   for an AE containing an act (& possibly event)
                    A patient safety representation of an event with no identified act and no harm (near miss)
                                   for an AE containing an event only

      This classification might even be automated based on content. I'd be more comfortable if the elements of the resource had consistent semantics. There's a place for the fall (or whatever else prompted the judgment of AE).

      Option 2: OK, put the fall in code, but the semantics of code are "this is the item of interest"; it would also be recorded in its semantically appropriate location. Redundant, so not my favorite, but better than switching it out.

      Some tweaks:
      A. Change "Suspect Entity" to "Suspect Activity" or "Suspect Activity or Event". From a Pharma perspective it may look like an entity, but it's not always a thing. Even for a drug, it's equally accurate to blame the exposure.
      B1. Either change "Contributing Factor" to "Contributing Factor or Intermediate Event", or
      B2. Add "Intermediate Event"
      I think the element "contributing factor" name was the objection to putting the fall in this place. But we need a consistent place.

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            jlyle Jay Lyle
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              Created:
              Updated: