|X||Stephen Chu||The Australian Digital Health Agency (ADHA)|
|Irina Connelly||Georgia Tech Research Institute|
|Evelyn Gallego||EMI Advisors LLC|
|Eric Haas||Health eData Inc|
|Rob Hausam||Hausam Consulting LLC|
|X||Laura Heermann-Langford||Intermountain Healthcare|
|Yanyan Hu||Joint Commission|
|X||Tony Little||Optum 360|
|Jay Lyle||Ockham Information Services LLC, VA|
|X||Michelle M Miller||Cerner|
|Lisa Nelson||Max MD|
|X||Mike Padula||The Children's Hospital of Philadelphia|
|Nick Radov||United Healthcare|
|Stefan Roth||Georgia Tech Research Institute|
|Jack Wallace||Georgia Tech Research Institute|
- Agenda Review
- Approve previous meeting minutes 2019-03-28 Patient Care FHIR Conference Call
- Motion: Emma/Mike
- gForge change requests
Per Russ, in clinical trials, adverse reaction or injury are recorded - regardless of workflow or cause. No near misses.
Hugh said that V3 would specify responsibilities on each side of message, but that is more complex than what FHIR requires. FHIR doesn't force recording of what isn't needed. No more conflict between clinical care vs clinical trials since that can be pushed to the implementation guide.
Per Amy, on clinical care side, adverse event is negative, but pharma doesn't always consider it negative. Amy suggested that EHRs are using forms to capture any change (positive or negative) in the patient for clinical trials.
Russ doesn't think any AdverseEvent is positive.
Stephen has suggested separation between reaction vs incident. For example, in context of a clinical trial, if patient falls in the middle of the night. In clinical trial world, it would be an incident. The fall has a number of consequences. If patient is not in clinical trial, but patient gets med and has reactions.
Amy agrees an incident is any change to the patient (good or bad). Does that change meet the criteria of adverse event? Is it a serious adverse event? Related to study interventions
Russ would like to focus on what AdverseEvent contains. In clinical care, a clinician (or patient) asserts a cause/effect for a reaction whereas in a clinical trial, it is based on a protocol. For example, vomiting might be an adverse event in clinical trial, but vomiting wouldn't be an adverse event when patient has stomach flu. Why do we need to use the same resource for both clinical trial and clinical care?
Russ asked if we need an AdverseReaction resource?
Hugh countered if we need an Incident resource with two profiles (one that is focused on clinical care and the other is focused on clinical trials). Russ is concerned that "incident" is a loaded term. Russ prefers AdverseEvent and AdverseReaction. Amy doesn't think it is an incident (negative connotation). Amy thinks it is a change that happened after patient is enrolled in study. PI needs to determine if related to study drug. In a trial, a headache is an AdverseEvent (not an incident). Hugh reminded everyone that only developers see the name of the resource – need to focus on the data items.
Stephen summarized that Amy will send Stephen her feedback. Offline discussion on the name of the resource.
AdverseEvent - April 4