Phone Number: +1 563-999-2090
Participant Passcode: 792564
Chair: Michelle Miller
Scribe: Michelle Miller
|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|
Quorum (chair + 3) met? Yes
- 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.
- GF#20593 Description missing – discussed, no vote.
AdverseEvent - April 4
- GF#20593 Description missing
- GF#20537 Change AdverseEvent.identifier cardinality to 0-*
GF#20535 Add attribute to indicate if patient or SDM notified of incident/adverse event
GF#20534 Add concepts in AdverseEventSeverity value set
GF#19310 AdverseEvent.subjectMedicalHistory definition missing
- GF#18854 SuspectedEntity doesn't work for "certain" - STU #203 (2018-Sep Core STU)
- GF#18853 The short description is significantly different in meaning to the Definition. - STU #202 (2018-Sep Core STU)
GF#18852 AdverseEvent.resultingCondition - inadequate and inappropriate for documenting adverse reactions associated with AdverseEvent incidents - STU #201 (2018-Sep Core STU)
- GF#17397 Add ameliorating actions in AdverseEvent
GF#17238 Add attribute to capture future strategies/recommendations
GF#17237 Request to add attribute for actions or circumstances that prevented harm
GF#16092 Add contributing factors to AdverseEvent
GF#16038 Add interventions required in AdverseEvent
GF#16037 Add attribute to capture likelihood of recurrence - Christi will look into a possible value set / code system to use
GF#11021 Increase cardinality of substance and make certainty relation to substance not reaction - 2016-09 core #40
GF#20566 Update the value set binding on participant.role
- GF#20606 highlight that intent is an immutable element.
- GF#13903 CarePlan should allow tracking of past activities (i.e. past interventions)
- GF#11332 - Acknowledge Advance Directives as type of Care Plan - 2016-09 core #490 (2016-Sept Core)
- GF#11173 CarePlan needs support for reviews - 2016-09 core #327 (2016-Sept Core)
- GF#10028 Careplan: Provide ability to specify patient and/or provider preferences
SD / SOAP Notes
- GF#12676 Guidance request for GP SOAP in FHIR
- GF#14720 Add Guidance for Exchanging Notes - 2018-Jan Core #42
GF#20483 Add Encounter.diagnoses elements to Condition
- GF#17736 Need guidance on representation of Concern
- GF#14872 Not sufficient support for Concern - 2018-Jan Core #213
Condition/Encounter borderline duplicates
- GF#16147 Condition.category - can be used to specify granular type code? 2018-May Core - In Person Claude
- GF#20483 Add Encounter.diagnoses elements to Condition In Person
- GF#16148 Encounter.reason and Encounter.diagnosis (PA) In Person
- GF#20190 Deprecate Clinical Impression Resource
- GF#18859 Definition/description at odds with what clinical impression is - STU #208
- GF#10635 Michelle Miller logged it and is ok deferring due to ClinicalImpression maturity (2016-Sept Core:2018-Sep Core STU)
- GF#13047 Add DosageInstructions to Procedure
- GF#12993 Please Create a NonMedicationAdministration object or an Administration object
Waiting for Input
- GF#11026 - 2016-Sept Core Ballot - Jay Lyle was thinking about how to decompose - Relationship between Condition and Observation
- GF#8458 Is a blood transfusion closer to a medication administration or a procedure or something else?
- GF#13389 Clarify Communication Scope and Usage
- GF#13046 Add relevantHistory 0..* Provance to Procedure
- GF#17592 FHIRPath expression of search parameter "onset" on AllergyIntolerance is wrong
- GF#17902 Description for Communication resource may need to be updated
- GF#17946 Confusion regarding 'status' and 'outcome' metadata elements of "Procedure" resource - In Person (Floyd)
Adjourned at 6:32pm Eastern
Preliminary Agenda Items
- Agenda Review
- Approve previous meeting minutes
- gForge change requests