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AttendeeNameAffiliation


XStephen ChuThe Australian Digital Health Agency (ADHA)

Irina Connelly Georgia Tech Research Institute 
XGeorge Dixon Allscripts 

Evelyn GallegoEMI Advisors LLC

Eric HaasHealth eData Inc

Rob HausamHausam Consulting LLC
XLaura Heermann-LangfordIntermountain Healthcare

Yanyan HuJoint Commission  
XEmma JonesAllscripts
XThom Kuhn 
XRuss LeftwichInterSystems
XTony LittleOptum 360

Jay LyleOckham Information Services LLC, VA

Chris Melo Philips
XMichelle M MillerCerner

Lisa NelsonMax MD
XMike PadulaThe Children's Hospital of Philadelphia

Joe QuinnOptum

Nick Radov United Healthcare 

Stefan RothGeorgia Tech Research Institute  
XCasey Thompson  Clinovation

Jack Wallace Georgia Tech Research Institute  
XChristi Denney 
XHugh Glover  

Wayne Kubick
XAmy Nordo   

John Stamm

Mead Walker 

Barbee Whitaker  
XTom Yosick 
XLynn Perrine
XAndi Maddela
XRobinette Renner

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  1. Agenda Review
  2. Approve previous meeting minutes 2019-03-28 Patient Care FHIR Conference Call
    1. Motion:  Emma/Mike
  3. gForge change requests

AdverseEvent

Stephen updated Adverse Event Project based on 2019-03-14 Patient Care FHIR Conference Call

Hugh suggested a few AdverseEvent changes, Revisions to FHIR Definition, so we got that logged as GF#20676

AdverseEvent Scope

Per Russ, in clinical trials, adverse reaction or injury are recorded - regardless of workflow or cause.  No near misses.

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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?

Stephen asked Amy Nordoto send Stephen Chua summary to add to the  Adverse Event Project.

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.


gForge Discussed

gForge Backlog

AdverseEvent - April 4

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