1. All Rights Reserved, Duke Medicine 2007 Cardiovascular Data Analysis Model HL7 Balloting (September 22, 2011) Salvatore Mungal Duke Bioinformatics Shared Resources (DBSR) Duke Cancer Institute (DCI)

2. All Rights Reserved, Duke Medicine 2007 Agenda Background: –Stakeholders –Harmonization of the data elements HL7 Balloting –Converting to the RIM (RIM mapping) –HL7 Balloting Future Plans –Including CDISC terminology –Update model from balloting comments –Loading the CV DAM to caDSR Acknowledgements Questions

3. All Rights Reserved, Duke Medicine 2007 Stakeholders Duke Clinical Research Institute (DCRI) American College of Cardiology (ACC) Clinical Data Interchange Standard Consortium (CDISC) Federal Drug Agency (FDA) NCI CBIIT (EVS and caDSR) HL7 (RIM) v3 messaging - (CCHIT certification for EHR)

4. All Rights Reserved, Duke Medicine 2007 Harmonization of Data Elements Harmonization of the Data elements was coordinated by the ACC and DCRI via a governance group that consisted of practicing cardiologists Data was collected from all over the USA DCRI also has international clinical studies The focus of the harmonization effort was from the following registries (from 23,000 hospitals across the country) using >10.5 million records (data several years old): –Cath PCI (CAD) –Action(STEMI) –ICD (Devices) –ACC top 100 data elements

5. All Rights Reserved, Duke Medicine 2007 High Level View of the CV DAM

6. All Rights Reserved, Duke Medicine 2007 RIM Mapping Published with permission

7. All Rights Reserved, Duke Medicine 2007 HL7 Balloting Story Board/Use Case(s) Activity Diagram Data elements EA file Class Models Description of Project May 2009 Ballot site http://www.hl7.org/ctl.cfm?action=ballots.home&ballot_c ycle_id=520&ballot_voter_id=5082 http://www.hl7.org/ctl.cfm?action=ballots.home&ballot_c ycle_id=520&ballot_voter_id=5082 Published with permission

8. All Rights Reserved, Duke Medicine 2007 HL7 Balloting We needed 27 affirmative votes to pass ballot and we received 35 We received very constructive comments from several voters. At the HL7 working group meeting in San Diego, the team reviewed the comments and determined they would add considerable value to the model. Our team in collaboration with members of the HL7 Clinical Interoperability Council, decided to incorporate the revisions into an updated version of the DAM and submit it as CV DAM version V2.1 for review later this fall. A follow-up review or ballot cycle is customary when structural changes to the model and/or changes to the clinical content of the model are made. This cycle will give all stakeholders an opportunity to review and accept the updates before the model is published as an informative standard. Published with permission

9. All Rights Reserved, Duke Medicine 2007 Future Plans CDISC terminology Loading the CV DAM to caDSR –Currently working on Semantics Creation of a Cardiovascular ontology Published with permission

10. All Rights Reserved, Duke Medicine 2007 Acknowledgements CDISC DBSR William Barry, Director Chris Tolk, Director Terminologies ACC Dana Pinchotti Arsalan Khalid Ganesan Srinivasan DCRI Brian McCourt, Assoc. Director David Kong Rebecca Wilgus HL7 (CIC) Mead Walker Dianne Reeves Anita Walden NCI CBIIT Sherri De Coronado, Director Semantic Services Margaret Haber Dianne Reeves

11. All Rights Reserved, Duke Medicine 2007 Q & A