Adverse Event Severity

Data Element

Description

Degree to which an an unfavorable or unintended disease, sign, or symptom that is temporally associated with the use of a medical treatment or procedure, affects the health and wellbeing of the subject. Usage Note: Adverse event may or may not be directly caused by the medical treatment or procedure. Severity may be represented by several scales or descriptions.

Submitted By: Vulcan / Vulcan
Data Element Information
Use Case Description(s)
Use Case Description	This data element is used in submission of adverse events to FDA, both in pre and post-market. "Mild", "Moderate", and "Severe", which are used to describe adverse event severity. In addition, NCI Common Terminology Criteria for Adverse Events (CTCAE) uses severity and grades it on a scale of 1 to 5, with 1 being mild and 5 being death related to the AE: Grade 1: Mild AE that doesn't interfere with routine activities Grade 2: Moderate AE that interferes with routine daily activities Grade 3: Severe AE that's not immediately life-threatening Grade 4: Life-threatening AE that requires urgent intervention Grade 5: Death related to the A
Estimate the breadth of applicability of the use case(s) for this data element	The maturity level for this data element is level 2 in FHIR R5. This data element has also been provided by FDA in previous uses. The use of severity has been represented in the Vulcan Adverse Event Clinical Research 1.0.1 - STU1 and CodeX Radiation Therapy 1.0.0 - STU 1.
Link to use case project page	https://hl7.org/fhir/uv/ae-research-ig/
ONC Priority	Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s)	The use of NCI CTCAE and SNOMED CT. The severity value sets of the adverse event are part of an existing FHIR CodeSystem: AdverseEventSeverity http://terminology.hl7.org/ValueSet/adverse-event-severity
Additional Specifications	The CodeX Radiation Therapy 1.0.0 - STU 1 references severity (see https://hl7.org/fhir/us/codexradiation-therapy/StructureDefinition-codexrt-radiotheraphy-adverse-event-severity-or-grade.html)
Current Use	(Level 0) Captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration
Extent of exchange	(Level 0) Limited environments, such as connectathons or pilots
Supporting Artifacts	The provided supporting link describes all relevant details on Connectathon testing for the proposed data element. https://confluence.hl7.org/display/VA/Project+Documentation
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)	None to described.
Restrictions on Use (e.g. licensing, user fees)	None to described.
Privacy and Security Concerns	None to described.
Estimate of Overall Burden	The requested data element simply adds detail to an existing one, so the estimated burden is minimal.
Other Implementation Challenges	No additional information available.

ASTP Evaluation Details Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1 Maturity - Current Standards	Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2 Maturity - Current Use	Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3 Maturity - Current Exchange	Level 1 - Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
Criterion #4 Use Case(s) - Breadth of Applicability	Level 1 - Use cases apply to several care settings or specialties.

Outcomes

Data Element

Comment