2019 January CIC Agenda and Notes

• January 2019 San Antonio CIC Attendance Log

Dates: January 14-18, 2018

Tuesday Q3

Attendees:   Laura Heermann-Langford, Amy Nordo, Jay Lyle,  Steve Hufnagel, Avinash Shanbhag, Nancy Orvis

Agenda: Coordinated DAM Ballot Review

Presentation by Jay Lyle

     Review of ballot comments. Additional information on the ballot spreadsheet. (add link to spreadsheet)

See additional information on the motions in ballot spreadsheet on the reconciliation of negative comments

Vote #1

Moved: Jay Lyle

Seconded: Amy Nordo

              No (0) abstain

              No (0) negative

              5 affirmative

Vote #2

Moved: Steve Hufnagel

Seconded: Jay Lyle

           No (0) abstain

           No (0) negative

          5 affirmative

Vote #3

Moved: Jay Lyle

Seconded: Amy Nordo

        No (0) abstain

        No (0) negative

        5 affirmative

Vote #4

Moved: Jay Lyle

Seconded: Steve Hufnagel

        No (0) abstain

        No (0) negative

        5 affirmative

Vote #5

Moved: Jay Lyle

Seconded: Amy Nordo

        No (0) abstain

        No (0) negative

        5 affirmative

Vote #6

Moved: Jay Lyle

Seconded: Steve Hufnagel

        No (0) abstain

        No (0) negative

        5 affirmative

Vote #7

Moved: Jay Lyle

Seconded: Amy Nordo

        No (0) abstain

        No (0) negative

        5 affirmative

Vote to accept the disposition

Moved: Jay Lyle

Seconded: Steve Hufnagel

        No (0) abstain

        No (0) negative

        5 affirmative

Wednesday Q1

Attendees:   Laura Heermann-Langford, Amy Nordo, Anita Walden, Robinette Renner, Matt Elrod, Russ Leftwich, Crystal Price, Viet Nguyen

Agenda: Business Meeting

Presentation by Laura Heerman-Langford

•    Update agenda for Jan 2019 WG to include specific topics for discussion
•    CIC is invited to go to LHS Care Team Workgroup

   Doing a Write in for CIC Co-Chair Ballot : Lindsay Hoggle , Nutritionist by training but has been IT world for 15-20 years, In past she has implementer and consultant for NIH clinical center, Director of Informatics, Significant accomplishments in HL7 specifically with CIC reviewing DAMS. Currently works for IRIS.

•    Davinci Project at the Steering Level Meeting it was asked for Co-WG sponsorship
  • Laura shared that this might be appropriate for CIC to co-share
  • Viet shared more about the project  (slides can be found on the DaVinci Confluence page)
  • Ask for Primary Sponsor for eHRx which includes the eCDx (sponsor: Patient Care) and ePDx (sponsor: FM)
    • CIC is ask to coordinate this work as Sponsor for the umbrella of this work in the subset projects  
  • Davinci is putting facilitators dedicated to this work
  • Russ- there could be overlap with existing CIC work - specifically CCRF
  • Goal is implementation guides

Vote:  Motion for CIC to be Sponsor the project eHRx  (PSS eHRx in draft and available on Davinci Confluence page)

 Motion: Viet Nguyen

           Second : Russ Letwich

Discussion: Anita- question this needs for central location for projects and the US Realm . Response: The project has been talking to Us Realm on this and this was announced at Steering Committee.

                   Laura- conference call logistics

              1 Abstain

              0 Negative
•               6 Positives

eHRx is looking to "Ballot for Comments" in May so need to have PSS voted by Jan 27, 2019

NEED to add a meeting at Thursday at 10 am EST Jan 24th

     NEED to have final PSS for Vote by Jan 24th with email distribution for pre-read

Bio-polar publication

              Amy will help to facilitate the publication but as she has changed companies she will need updated access to the documents

              NEED to put out a notice that the role of publication facilitator role is open

•                Add to the agenda for Jan 24th Business Meeting- remind project teams that in the interim they are to identify a Publication Facilitator for their project
•                Add to the agenda for the Jan 24th Business Meeting that project documents should be stored on the Confluence page and NOT in Google docs or other external products

electronic and Services Tooling WG asks for Liasons

               Laura and Russ are Co-Chairs of multiple WGs and would make the most sense for economies of scale

Agenda for May 2019 WG

              Need a specific quarter dedicated as to Davinci project - because of the scope of this work we will most likely need two quarters - suggest that we have a joint session amongst all work groups involved in Davinci

                    Wed Q4 May 2019 (see May 2019 schedule)

              Davinci will also go to each individual WGs

              Number of expected participants : 50 attendees

              Added BR&R hosting CIC Tuesday Q2

               Laura is unable to attend in May. She will set up the agenda in the next two weeks and set up the Confluence pages which will include the digital attendance log.

              Digital attendance log will be used starting next quarter. Discussion of how to drive adoption and usability for first time users. This will be the 80/20 rule. Expectation that 80 percent will have confluence access and will continue to manually enter 20%

FIM Proposal

           No PSS prepared yet

•            Will discuss further in joint meeting with CIMI

           Discussion of whether this project is appropriate for CIC to sponsor or co-sponsor

WG Documents

      These are out of date - these we need to update

       Laura will send updated documents via email and add to Confluence. Please share comments on the Confluence site and NOT via email.

Tuesday Q2 Joint with CIMI

Attendees:   Please see digital attendance page

Agenda: Joint with CIMI see above for details of Agends

Presentation by Anita Walden CCRF project facilitator

• 
•    CIMI needs to look at high level procedure patterns and confirm that it conforms to US Core Procedure Codes

•    May need to clarify items with the team items such as "what is a drink"
•    Illicit Drug Use and Alcohol use new to CIMI
•     All others exist in either CIMI of FHIR
• Next Steps:
  • Need to take this list and work with the CIMI Co-Chairs and WG to discuss how the data elements in the spreadsheet will be added to CIMI
  • May need to rename illicit drug use because there are several states where some drugs or illegal
    • abuse of prescribed drugs is consider illicit?
    • Does illicit modify drug or use?
    • This will need clinician input
    • See additional notes on spreadsheet (link available above)  
  • For the four that need to be created new- Susan will investigate what is in LOINC as well as get SME input  (added to LOINC meeting - February 20, 2019). The agenda for this will be posted and is open.
  • CIMI will not be present at the CIC Tuesday Q3 meeting
  • Discussion on resources necessary on this type of work
    • Process for CIMI is to create the content- redirect to be specific to what resources are needed
    • Need funding or will be added to CIMI queue
    • If put into queue this work could be done this year  as it doesn't appear to be a lot of work
    • Illicit drug use and alcohol use may need to bring to larger group because of changes. Discussion on whether need to bring to ballot or just SME input.
  • Discussion on Tobacco
    • Anita attended a meeting yesterday with US Government (ONC) and shared this work
      •  ONC provided Anita with information on process but recommended taking this through HL7 US Core
      • Plan to schedule meetings with ONC to continue the discussion
      • Entire substance use needs to be addressed but recommended starting with Tobacco
    • Susan estimates about 40 hours of work
    • Laura- could the CCRF team work on creating spreadsheets like created for Tobacco for both illicit drug use and alcohol? Crystal- yes this would be a good idea for consistency
    • Goal of balloting in May the data elements in the DAM
    • No funding for this currently although the group is investigating options. Crystal - need a rough estimate of budget needed to help target correct funding sources. Susan- we can not tell you a budget at this time because she needs a clearer understanding of the content
  • Need to review PSS  and be ready for ballot
    • Anita need to have a discussion with the greater workgroup due to the extension of the scope  
    • Will share that information with CIMI when decided
  • Also discussion on sharing of PEW spreadsheet

Discussion on proposed project that will take the FIM to FHIR

Steve- trying to continue work for example: immunization . The analysis lead to three potential tracks, one of which was to the use the FIM. Goal is to come up with a standardized a DAM and harmonization across DAMS. Also question is the DAM a living document that is updated after implementation. Goal is to define the problems. Proposal is to continue on the path of FHIR. Can FIM assist to getting to path of FHIR?   Demonstrate how tooling could assist. 1- create existing profiles in an existing event 2- automate the process of creating a profile or extension where a new element is needed. Ask was for CIC to sponsor and the question was is this in conflict with CIMI? Steve feels there is no conflict.

Laura- this seems very different from what Jay presented Monday Q3 in CIC. Maybe the best course of action is to pause this discussion until we have a PSS to review.

Steve- there is a PSS in draft that he can share.

Laura- we would like to see this PSS for clarification. Discussion on whether the tooling should fall under CIMI. Clarification on the previous project that CIC sponsored.

Question what is being is asked is if the FIM could be helpful in the creation of new DAMs allowing for re-use of what already exists in the FIM. Last quarter PSS was to compare and contrast two DAMs that are related (immunizations and adverse events). Could the FIM be the uber DAM? The FIM will be sun-setted the end of this year and is looking for a new home. Thought was HL7 might be the correct place for the FIM to land. Felt that CIC would benefit the most from an uber DAM.

Laura- clarification of the definition of a DAM would be beneficial. Is this an information model or a DAM?  Unclear if CIC should take ownership of an informational model. This seems like a CIMI project. This almost appears that it crosses over multiple workgroups.

Amy- what is CIMI's thoughts across around the project?

Susan - I have been involved for 5 years and it is one of the best models out there and would not like to see this work go away.

Personal opinion- CIMI has long wanted to find a use for FIM as it is excellent work. Recent (last week) on the practical implementation of CIMI. Propose that CIMI review and bring back to CIC where this fits.

Anita- Typically focus on the content but sometime the content overlaps with another model and there is a need to have a centralized location for the content. This was also identified in yesterday's BR&R.

Suspect that FIM will need some work to be able to meet this need.

Susan- is the FIM something we can put in the repository ? This needs to be evaluated in more depth.

Stan- Thoughts are similar. FIM has tremendous content and value. It is used as one of the inputs for CIMI. Question is how is it technologically fit in? Further discussions on how to do that would be beneficial.

Laura- Is this an HL7 philosophy to direct projects to FIM similar to directing to V2? CIC is not against sponsoring but this a greater community project and will require direction.

Stan - Content is valuable but the concern is around two different representations. This requires more thought on how to handle.

Current DAMs are in UMLs

Laura- we need to see the PSS in writing. This will help to guide whether task force or ballot . CIC will review PSS and consult with others to include but not limited to CIMI, Pharmacy, patient care, emergency care WGs- we need to know who to invite. Suggested that we speak to Jay before talking to the larger group.

Steve- will share a draft of PSS with CIC and CIMI co-chairs . Timeline impacts the PSS

Susan- this may be appropriate to take escalate to HL7 leadership

Tuesday Q3 CCRF

Attendees:   Please see digital attendance page

Agenda: CCRF Update

Presentation by Chrystal Price and Anita Walden CCRF project facilitators

• Show of hands on who is new- Project Facilitators will provide a brief update
• Announcements: Robinette shared about her organization
• See slide deck  

Jimmy Tcheng, MD verbal presentation on Duke/PEW project

• 38 registry owners responded
•  Took the data model representations and eCRF for comparison in effort to determine commonalities and in the absences develop solutions.
• Goal to allow for native data interoperability
• Findings
  • No standardization of how data was collected amongst registries
  •  Using existing data standards developed best practices . This was published and is available on the Duke Clinical Research Institute's website : http://dcri.org/registry-data-standards/

Seth Blumenthal verbal addition to Jimmy's presentation

• Catalyst if we are successful with common data elements it will be extended to shared specialty data elements

Update on the meeting with CIMI- Wednesday Q2

• Reviewed all common data elements
• 
• Specifically tobacco and looked at illicit drug use and alcohol in a similar manner
• CIMI asked the project team to review the illicit drug use and alcohol. They have a strong preference to have the CCRF SME input before balloting.  Most of the data elements are available in FHIR or CIMI. The team needs to review some items and take back to the CIMI group and then the workload can be determined.
  • Discussion on the differentiation between medical marijuana and illicit drug use
  • CIMI is considering the appropriate use of balloting - potentially comment only ballot is most appropriate. This decision would impact whether this work needs to fit into a ballot cycle
  • Difference between USCDI and US Core - there is some difference but overlap. Anita attended a meeting to discuss this
    • Matt Rahn , ONC representative provided clarification- draft has been released but not finalized which includes CCDS and two additional items . There will be a process that is yet to be finalized on how to suggest revisions to existing data elements.
      • This would be a good time to identify value sets that are appropriate for revisions in harmonization with CDA.  
      • These can be sent to USCDI (via Matt Rahn)
      • Anita is arranging a call with Jimmy Tcheng, Matt Rahn and other interested party
    • US Core intended to develop FHIR profiles
    • It was recommended to Anita to take this project through the US Core .Smokin
  • Should this be included in the CCRF project?
    • Is this included in the items previously identified:  YES
      • CCRF PSS
  • Even without funding this work could be completed within the year 
• Review of data elements spreadsheet  

• Chrystal Price to share spreadsheet
   Question on the spreadsheet lab tab if a more clear on the notation of being more specific in laboratory test. Per Jimmy Tcheng: please refer to Mike Walters, FDA, work in development on lab data .

• Smoking
  • Does this include the cigar smokers? This has not included that because the registries do not collect this data and the science is nascent
  • Of not there is more science behind the quantity of marijuana and this may be something to consider in the future
  • This not a comprehensive list and is intended to be built upon in the future. This work is a starting point.
  • Discussion on the limitations for growth that this framework has. Recommend to drive this from the clinical perspective and not the business perspective
  • Many clinicians do not collect data on that we could potentially know - i.e number of marijuana cigarettes smoked daily. Concern is for clinician burden. This project is looking at minimum data sets
  • may need to look at including other tobacco types for details - and not just have cigarettes be the focus.  in addition - consider taking away qualifiers on start and end dates for cigarette smoking... 
  • consider separating the business logic from the information model - implementation can include the logic, on the user interface etc.  
  • issues with clinician burden are expressed - but it may be that we have contributed to the clinician burden by putting the business logic into the information model and not in the implementation of the model.  
  • what we have is a compendium of what is in the registries - now we need to look at how best to model what the registries are needing.  
  • Next steps:  
    • the group discussed and voted to continue the drug and alcohol use.  It makes sense to put this together as a package.  
    • group will connect with the work that has been done by CCDA (June refresh of the CCDA value sets if there is any contributions there)
    • unlikely to have a ballot in May - but will plan for one in September.  
  • Schedule this quarter for this topic in Montreal.  

Tuesday Q4 Cancer Interoperability

• Report out from team
  • Plan on going to the IHE Technical Connectathon next week.  
  • Lots of interest from the RSNA, ACR and others  - Project Gemini at RSNA/ACR...
  • Cancer Care Ontario - also interested party....
  • plan on taking the breast radiology models, review them, produce tooling, transformation tooling, to pull the information out of Richards tool, 
  • Robinette - has been involved in this project on and off, from the NCI point of view there is hesitation as they are not wanting to connect to CDEs.  There is a huge body of work that has been done at NCI - and it may not be connected with this work.  (the thesaurus and the CDEs are different.  The CDES are post coordinated. )
  • What Richard is showing on this screen with his tool are currently not connected to other previous work. He could get that data uploaded.  
  • Suggested made to harmonize with the NCI and CDISC work.    
  • Concern has been expressed about the level of curation in the thesaurus and perhaps the CDE
  • Ideally initial content would drive this work and not have it be all from SMEs    
  • Richard will work with Brahn to get the NCI CDEs the - standardized set... and upload that into his tool.  (Brahn is from the Thesaurus side of the work)
  • Motion made by May to approve the reconciled spreadsheet from teh September ballot, 2nd by Mark K.  abstain = 1 oppose = 0, approval = 5.  
  • Laura Heermann-Langford Current comments are all in GForge - we need to get these comments into the usual ballot spreadsheet and get that uploaded as resolved comments.        
• New Project Discussed
  • MCODE - ASCO project to look for the minimal clinical oncology data elements.  
  • This needs to be a new PSS - we will schedule one call to work on the PSS and then schedule further touch-bases further out as needed based on the PSS call.