HL7 CIC – WGM
Location: Baltimore, MD / Date: 2012-09-11 Time: <Tuesday Q2 |
Time: am Pacific Time
Facilitator / Anita Walden / Note taker(s) / Dianne Reeves
Attendee / Name / Affiliation
See Attached Roster
Quorum Requirements Met:

·  Notice: There is an open co-lead position until Wednesday. Voting is allowed through Wednesday at the Registration desk.

Attendees: Anita Walden

Meredith Nahm

Dianne Reeves

Jackie Muroney

Becky Wilgus

·  Introduction of attendees

·  Only order of business is the reconciliation of the balloting of the Schizophrenia Model, presented by Meredith Nahm. Results of the balloting are:

Affirmative 7

Negative 23

Abstain 87

Non vote 10

Needed: 18 affirmative to pass

·  Class + Attribute + Value Domain discussion with group, reviewing how content is created in caDSR, and comparing that to items in the Schizophrenia model. The content originated from CRFs that have been reviewed primarily from a regulatory perspective. Extensive discussion of how to create a class + attribute administered item in caDSR that can be reused with various Value Domains.

·  Discussion of temporal qualifiers in some class: attribute pairs. Becky Wilgus and others suggested that all the temporal qualifiers be stripped out, and a normalized approach used instead.

·  Discussion of the reliability of certain data that goes back more than 2 years ago. The reviewer group felt that the reliability of data beyond two years should result in data elements not being used. The group felt strongly that should not be done – the elements should not be removed.

·  Use of the CGI-I and CGI-S.

HL7 CIC – WGM
Location: Baltimore, MD / Date: 2012-09-11 Time: <Tuesday Q3 |
Time: am Pacific Time
Facilitator / Anita Walden / Note taker(s) / Dianne Reeves
Attendee / Name / Affiliation
See Attached Roster
Quorum Requirements Met:

Attendees: Abdul-Malik Shakir

Meredith Nahm

Anita Walden

Dianne Reeves

Hugh Glover

The RFP did not get the response they wished, and no responses to the role of developer. There will need to be milestones on the deliverables. Email sent out looking for volunteers for a review group.

Meredith volunteered to be a reviewer. AMS is rewording the RFP and talking with John about the ability to reissue the RFP.

Part 2 – how are we approaching MAX? Max wants to take data out of EA UML tool, and put it into a spreadsheet. Reviewers can share it for editing and sharing.

Permissible values should be added as enumerations in literals. Some folks may want them added as tags.

Joined by Mike


– An xls is limited in terms of validation rule capability, lots of manual checking is needed.

HL7 CIC – WGM
Location: Baltimore, MD / Date: 2012-09-11 Time: <Tuesday Q4 |
Time: am Pacific Time
Facilitator / Anita Walden / Note taker(s) / Dianne Reeves
Attendee / Name / Affiliation
See Attached Roster
Quorum Requirements Met:

·  Agenda

·  Publication or R2

·  Timelines

·  Process

·  What to do with Concept Mapping

·  Measure when a data element is complete

·  Revised scope on Douglas R24

·  Metadata publication for R2 – lessons learned

Release 2 Project

ACTION: Becky Wilgus will check in two weeks to see if the R2 ballot has been published and will double check the text on the publishing website.

Imaging Project

Timelines: Ballot for R3 Imaging is behind, would like to move our ballot date from Jan 2013 to September 2013.

Need an approach to get data elements from work groups 3, 4 and 5. There are no data elements from those workgroups.

Approach –

Hand-off the 72 data elements to NCI review? Find a consistent format to handle the review of the data elements.

Or

Give the data elements with the definitions and PVs to the cardiologists to review. Let the cardiology clinicians to review them.

Group 4: is making progress on identifying the data elements they need to define for their group.

ACTION: Meredith will work with Group #4 to draft data elements.

Group 1: Dianne Reeves is reviewing data elements for group 1. She will provide feedback to Maria.

Group 5: Draft a set of data elements for Pam Woodard and Jimmy Tcheng to review with workgroup #5.

ACTION: Anita will work with workgroup #5

Fellow is doing workgroup 3

ACTION: ORISE Fellow define data elements for Work Group 4 along with Meredith.

Submit to EVS if you have new content.

Sept 13 – ballot for Imaging

ACTION- Becky will speak with Wayne Kubick of CDISC to discuss the SDTM terminology mapping work between Duke and CDISC

Endpoint Project

Will this a HL7 project? It was part of the R1 scope but wasn’t included in the ballot because this content wasn’t developed yet. Can be a separate project or it can be included in the Imaging ballot because there are only a few data elements.

ACTION: Becky will check with Brian if endpoints will be part of the Imaging Ballot.

Schizophrenia DAM Notes Wed Q4

Designating a data element as “Required” is recommended not to include because it could change over time. This is a modeling convention to capture.

ACTION: Capture that “Required” is not recommended on the data element level but as an implementation guide business level.

HL7 CIC – Patient Care Meeting
Location: Baltimore, MD / Date: 2012-09-12 Time: <Tuesday Q1 |
Time: am Pacific Time
Facilitator: William Goose Presiding / Note taker(s) / Dianne Reeves
Name / Affiliation
See Attached Roster
Quorum Requirements Met:

Agenda Topics

·  Update for Patient Care activities

o  Clinical statement review

o  DMIM balloted – comments from Patient Care group

o  Kevin talked about Allergies, adverse reactions for proclivity to have allergies, the context in which the allergy occurred and the risk of recurrence.

o  Health concern – any clinical issue that requires tracking over time.

§  Status code

§  ID

§  Activity time

·  Act relationship – name

o  The mood is ‘EVENT’ or ‘RISK’

o  This allows tracking of a concern over time

o  Can nest concerns

·  Update from CIC – Anita, Meredith update on projects

o  Kevin: how to go from a DCM that describes a specific condition to a DAM? Have not discussed this in great detail.

o  Kevin: said that the cardiology model should have been collaboratively done with the emergency care model

o  Collaborative aspects of the model development discussed.

·  PHER update from Rob

o  Successful ballot of v3 immunization message, based on Canada activities

o  Cross-paradigm immunization message ballot reconciliation open

o  Additional ballot reconciliations open

o  Joint meeting that PHER was invited to host with OASYS – which are the people who are in the ambulance during transport.

·  DAMs – Kevin: DAMs need to have standards called out. We need better traceability back to the standards incorporated. The functional profiles are critical.

·  DAMs – Laura about the inconsistency of the DAMs. What is the point and purpose, and what is their value? This is not working.

HL7 CIC – Public Health ER Meeting
Location: Baltimore, MD / Date: 2012-09-12 Time: <Tuesday Q2|
Time: am Pacific Time
Facilitator: Anita Walden / Note taker(s) / Dianne Reeves
Name / Affiliation
See Attached Roster
Quorum Requirements Met:

Agenda Topics

·  Functional profile for Public Health discussed.

·  Patient care: Allergy and Intolerances Project

o  PSS approved, a number of cosponsors (not including CIC)

o  RMIM balloted as DSTU, did not pass in 2007, withdrawn. Reworked now. Care Coordination Services topic. Collaborative project with HSSP SOA, to develop a set of service profiles to support. Will complete the DAM; collaborate with IHE and international groups. Want the work to align with the Functional profile.

o  Expectation is to have models that are agnostic and don’t have to require a lot of transformation.

·  CIC – update on projects, NCI presentation on tools and services. Schizophrenia project reviewed.

o  Follow-up by Mitra from the FDA, on the 55 (58) in 5 years

o  Paradigm problem for HL7 – people think of the trial information as completely different from data in an electronic system.

·  Patient Safety – Mead Walker update. PSUR project – Periodic Safety Update Report. This is the periodic pharmaceutical data to regulatory groups. This is being merged with a risk management plan to identify how product risks are resolved. Being driven by European legislation requiring them to get these plans from corporations annually and manage them centrally. Need a co-chair for this group.

·  Pharmacy – Jean Duteau. Three projects

o  Patient medication profile. Two phases of work. Is working on FHIR – no other workgroups are working on FHIR resources

o  Fast Healthcare Interoperability Resources – FHIR, a new set of standard objects, clinical representation for objects. One resource to rule all –no others.

HL7 CIC – Patient Care Meeting
Location: Baltimore, MD / Date: 2012-09-12 Time: <Tuesday Q3|
Time: am Pacific Time
Facilitator: Anita Walden / Note taker(s) / Dianne Reeves
Name / Affiliation
See Attached Roster
Quorum Requirements Met:

Agenda Topics

·  Discussion of FHIR – DAMs not included.

·  For a registry of DAMs there may be a need to put a listing on the wiki. The listing is incomplete at this point.

·  Anita – each artifact needs to be registered

·  Jane Curry discussed a registry need with CIC – there is an open source project that could be used to register the DAMs

·  William – we can start with a simple link and make it available to people. If it grows over the next few years, they will have a need.

o  DAM Name

o  Working group

o  Status

·  Vote: To create a shared wiki for the inventory of DAMs

·  HDF version 1.5 November 2009 – changes needed. Can we create a PSS and ask M*M to participate. HL7 Healthcare Development Framework Release 1, version 1.5 – on website; from Modeling and Methodology Work Group

·  Some of the things we have been using to create DAMs is in the HDF. What is missing is guidance on how to make data elements specifications. How do these things all fit together?

·  Point: The term ‘domain’ is overloaded, and the direction of how to do a DAM is ‘backward’ for our use.

·  One way to approach content is to use a smaller set of items than an entire DAM.

·  Models described in HDF are not very clear. The ability for clinicians to validate models is very limited.

HL7 CIC –DAM Lessons Learned
Location: Baltimore, MD / Date: 2012-09-12 Time: <Tuesday Lunch Discussion
Time: am Pacific Time
Facilitator: Anita Walden / Note taker(s) / Dianne Reeves
Name / Affiliation
See Attached Roster
Quorum Requirements Met:

What artifacts should be included in a DAM ballot?

-  UML model

-  List of data elements with definitions and concepts

-  Activity diagrams

-  Story boards/use cases

The primary purpose of the DAM is to get to the data elements. Funding can affect balloting. If funding is limited, a group is encouraged to ballot through HL7 for widest adoption of content.

We need an inclusive set of data elements, regardless of the domain.

Laura Heermann said that Emergency care has struggled with their DAMs. The level of granularity to use can be challenging. Therapeutic areas can supply great detail, while reusing groups typically need a higher level of details for use. Clinicians need a certain amount of differential information in their data elements.

Clinicians are intimidated and frustrated by models, and not able to confirm they are correct. There is a struggle between the model not being precise enough to create a system, and changing it so that a clinician cannot relate and confirm it. A DAM is sometimes done to illustrate an area, so that the SMEs can reach consensus.

We may need to have more than one model – for multiple purposes.

HL7 CIC – WG Meeting – Hosting RCRIM
Location: Vancouver, BC, Canada / Date: 2012-09-12 Time: <Tuesday Q4|
Time: am Pacific Time
Facilitator: Anita Walden / Note taker(s) / Diane Reeves
Name / Affiliation
See Attached Roster
Quorum Requirements Met:

Agenda Topics

Background on the model given by Meredith Nahm. Review of the votes was done, and reconciliation of the comments done during this session.

·  30 comments were based on activity diagrams that were created at a very high level.

·  Use case/storyboard comments were minimal.

·  The use of scales – including the source of data, use of scales, etc. Instead of creating multiple types of elements that imbed the source, included an additional element to capture the source of the information.

·  Should the use of data elements from scales be included? Whether an index or questionnaire or test – lots of validated tools used in mental health. Clinicians typically don’t need each individual item, but if so – we can use abbreviated question text. Multiple levels of granularity and concerns need to be resolved.

·  Resolution needed pertaining to copyright concerns!!

·  Need multiple levels of abstraction in all the scales.

·  How to model the optional or required designation of a data element.

·  When data elements are linked, the UID referenced now in the elements will be replaced by a derivation in the caDSR

·  The categorization of an element is based on its intended use.

There are about 4 items that need to go back to the clinical expert review committee.

·  The DSM class structures are based on diagnostic differentials. This is related to 5 or 6 of the comments on the ballot. Discussion on how a diagnosis is expressed – should the definition of the diagnosis be based on DSM diagnosis, the controlled terminology is the permissible value set. To gather the answer, an extra data element can be used to collect the method used to make the diagnosis.

Going through the comments:

·  Definition of episode- PC suggested items very close to what we have. Unable to find the term ‘episode of disease’ defined anywhere.

·  Permissible values will be concepts in EVS that will have definitions

·  Reason for definition – is this coded, enumerated, or a text field? This is a text field based on the expert review