Details
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Change Request
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Resolution: Persuasive with Modification
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Medium
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FHIR Core (FHIR)
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STU3
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Patient Care
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AdverseEvent
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Stephen/Rob: 10-0-0
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Enhancement
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Non-compatible
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R5
Description
Seriousness of an adverse event serves as a guide for determining/defining regulatory reporting obligations (and the clinical gravity/gravenness of the event.
The value set is a adaptation of the FDA criteria for determining what consituties a serious adverse event (SAE), which is based on the potential outcome. But the way the value set is defined results in confusion with adverse event outcome:
Lvl Code Display Definition:
0 - Non-serious
0 - Serious
1 - SeriousResultsInDeath
1 - SeriousIsLifeThreatening
1 - SeriousResultsInHospitalization
1 - SeriousResultsInDisability
1 - SeriousIsBirthDefect
1 - SeriousRequiresPreventImpairmen
The FDA criteria of seriousness are intended for assessing whether the Adverse Event can be considered serious. They way that the AdverseEvent.seriousness value set is defined using the FDA criteria causes confusion with outcome of the event.
Suggest modification to value set to avoid confusion with AdverseEvent.outcome:
Not serious: low potential for long term complications or grave consequences, but requires intervention to prevent permanent impairment or damage\\Serious:
medium seriousness: requires hospitalization
high seriousness: potentially organ and body function threatening, i.e. potential to result in significant,
persistent or permanent change, impairment, diamage; or congenital
very high seriousness: life-threatening / potentially fatal