1. Tuberculosis & Cardiology Projects Anita Walden & Brian McCourt RCRIM Presentation HL7 WGM January 2007 (San Diego)

2. Topics Background, Objectives, Methodology Project specific details Tuberculosis Project Cardiology Project Questions & Discussion

3. Background & Project Objectives Funded by two independent NIH Roadmap contractsFunded by two independent NIH Roadmap contracts Focus on methodology for developing therapeutic area data standardsFocus on methodology for developing therapeutic area data standards Produce real, useful products along the wayProduce real, useful products along the way Report on experience, process, best practices back to the larger communityReport on experience, process, best practices back to the larger community

4. Products Develop and/or contribute to data exchange standards within SDOs (HL7, CDISC…)Develop and/or contribute to data exchange standards within SDOs (HL7, CDISC…) Implementation GuideImplementation Guide Publish consensus set of Common Data Elements (CDEs)Publish consensus set of Common Data Elements (CDEs) Generate a Domain Analysis ModelGenerate a Domain Analysis Model including storyboards, use cases and activity diagram artifactsincluding storyboards, use cases and activity diagram artifacts

5. Assumptions Data collected for patient care must support multiple re-uses, including researchData collected for patient care must support multiple re-uses, including research Clinical data for patient care and research are the same.Clinical data for patient care and research are the same. Stakeholders need to represent as many of the uses of the data as possibleStakeholders need to represent as many of the uses of the data as possible Clinicians, researchers, standards organizations, industry, international…Clinicians, researchers, standards organizations, industry, international…

6. Methodology Engage stakeholders in objectivesEngage stakeholders in objectives Select a use case from stakeholder contributions to define specific project scope and objectivesSelect a use case from stakeholder contributions to define specific project scope and objectives Develop a consensus set of CDEs used in use caseDevelop a consensus set of CDEs used in use case Use case and CDEs guide DAM developmentUse case and CDEs guide DAM development Incorporate interchange standards under the DAMIncorporate interchange standards under the DAM

7. CDE Process Collect & aggregate data elements from stakeholders current databasesCollect & aggregate data elements from stakeholders current databases Convene expert group to select Package 1 and focus on terminology, definitions, value listsConvene expert group to select Package 1 and focus on terminology, definitions, value lists Clinical leadership at core of group, supported by experts from CDISC, NCI, HL7…Clinical leadership at core of group, supported by experts from CDISC, NCI, HL7… Biweekly conference callsBiweekly conference calls Release for public commentRelease for public comment Publish via NCI EVS/caDSRPublish via NCI EVS/caDSR

8. DAM Process Start with pretty good understanding of storyboards, activity diagrams, use cases and CDEs to set scopeStart with pretty good understanding of storyboards, activity diagrams, use cases and CDEs to set scope Work with experienced modelerWork with experienced modeler Vetted by stakeholdersVetted by stakeholders A use of DAM, provide context (associations) for Data Elements that will be provided to NCIs caDSR.A use of DAM, provide context (associations) for Data Elements that will be provided to NCIs caDSR.

9. Timelines Engage Stakeholders Summer 05 Call for Data Elements Fall 05 Aggregate CDEs January 06 Convene expert group May-Aug 06 DAM initiated December 06 Package 1 CDEs out for public comment February 07 Start Package 2 February 07 DAM v1 Summer 07 CDEs Pkg 1 published Aug/Sept 07

11. 11 Data Element Contributors –World Health Organization Stop TB Partnership DOT DOT Plus –Center for Disease Control and Prevention (CDC) TIMS – Meta data NEDSS – Meta data RVCT - forms –MOXI Brazil CRF forms –TB Alliance TBESC - forms TBTC Study 26 – Meta data TBTC Study 27 – forms

12. 12 Scope Clinical focus –Pulmonary Tuberculosis Use Case –Use data from EHR and public health reporting to trigger notification to researcher of potential study candidate –Development of standard CRF modules for tuberculosis research projects

13. 13 Single Source for Data Reuse and Interoperability Patient Enrollment/Aggregated Data Research Treatment/SurveillanceTreatment/Surveillance Enrollment Enrollment Data Data Aggregation Aggregation Enrollment Enrollment Data Data Aggregation Aggregation PatientPatient Hosp. EHR State Health Dept Federal Health Dept Researcher Query (message V 2.5) Local Health Dept Query (message V2.5)

14. 14 Expert Group Represented Organizations Aereas Global TB Vaccine Foundation Center for Disease Control and Prevention (CDC) Clinical Data Interchange Standards Consortium (CDISC) Clinical research experts Duke University Medical Center Foundation for Innovative New Diagnostics (FIND) Global Alliance for TB Drug Development KNCV Health Level 7 (HL7) National Cancer Institute National Heart, Lung & Blood Institute (NHLBI) National Institutes of Health (NIH) National TB Controllers Association WHOs Stop TB Partnership Pharmaceutical Companies

15. 15 TB Specifics Draft of CRF modules using current TB package #1 data elements. WHO is aware of the initiative TBTN needs to engage pharmaceutical companies in the process Continue to engage the global communities Challenges –Languages –Time Zones –Country Resources –TB not high priority in US –Much of the work is International –Technology is limited in many countries –Additional Funding to continue

16. Creating, Implementing, and Sharing Best Practices for Clinical Trials Networks This project has been funded in whole or in part with federal funds from the National Institutes of Health, under contract No. HHSN268200425212C, "Re-Engineering the Clinical Research Enterprise."

17. Data Element Contributors American Heart Association Get With the GuidelinesAmerican Heart Association Get With the Guidelines Society of Thoracic SurgeonsSociety of Thoracic Surgeons NIH (NHLBI)NIH (NHLBI) GlaxoSmithKlineGlaxoSmithKline MerckMerck American College of Cardiology National Cardiovascular Data Registry (NCDR)American College of Cardiology National Cardiovascular Data Registry (NCDR) CRUSADECRUSADE Duke DatabankDuke Databank Eli LillyEli Lilly European Society of Cardiology Cardiac Registry and Registration Standards (CARDS)European Society of Cardiology Cardiac Registry and Registration Standards (CARDS)

18. Expert Group - Represented Organizations Professional Societies & Clinical OrganizationsProfessional Societies & Clinical Organizations Am. College of Cardiology (ACC)Am. College of Cardiology (ACC) Am. Heart Assoc.Am. Heart Assoc. ACC/AHA Task Force on Data StandardsACC/AHA Task Force on Data Standards Assoc. of Italian Hospital CardiologistsAssoc. of Italian Hospital Cardiologists European Soc. CardiologyEuropean Soc. Cardiology Soc. Cardiovascular Angiography & InterventionSoc. Cardiovascular Angiography & Intervention Society of Thoracic SurgeonsSociety of Thoracic Surgeons GovernmentGovernment FDAFDA NIH (NCI, NCRR, NHLBI)NIH (NCI, NCRR, NHLBI) VHAVHA Standards OrganizationsStandards Organizations HL7 & HL7 Cardiology SIGHL7 & HL7 Cardiology SIG CDISC (incl. pharma)CDISC (incl. pharma) Integrating the Healthcare EnterpriseIntegrating the Healthcare Enterprise Industry & AcademiaIndustry & Academia AstraZenecaAstraZeneca GEGE Leuven Coordinating CentreLeuven Coordinating Centre MortaraMortara UCLAUCLA

19. Scope Clinical focusClinical focus Acute ischemic heart disease/Acute Coronary Syndromes (ACS)Acute ischemic heart disease/Acute Coronary Syndromes (ACS) Use CasesUse Cases A clinical site reporting data to a quality improvement registry (also IHE RFD use case)A clinical site reporting data to a quality improvement registry (also IHE RFD use case) HL7 CDA HL7 CDA A research study sending data to another organization or for regulatory submissionA research study sending data to another organization or for regulatory submission CDISC SDTM CDISC SDTM

20. Status of related standards work HL7 CDAHL7 CDA 1 st draft mapping of ACC NCDR to HL7 CDA completed1 st draft mapping of ACC NCDR to HL7 CDA completed To do – 1 st draft Implementation GuideTo do – 1 st draft Implementation Guide Get feedback on work from HL7 groupsGet feedback on work from HL7 groups CDISC SDTMCDISC SDTM 1 st draft in development mapping of ACC NCDR to SDTM1 st draft in development mapping of ACC NCDR to SDTM Need to understand relationship to BRIDG and HL7 effortsNeed to understand relationship to BRIDG and HL7 efforts

21. Pilots Multiple data re-use pilot for futureMultiple data re-use pilot for future Implement the draft HL7 CV CDA for reporting data to the ACCs NCDR registry and to SDTM modelImplement the draft HL7 CV CDA for reporting data to the ACCs NCDR registry and to SDTM model Single Source clinical trialSingle Source clinical trial Use existing HL7 messaging to report data directly to a large international phase III trial electronic data capture system.Use existing HL7 messaging to report data directly to a large international phase III trial electronic data capture system.

22. Discussion All feedback & comments welcomeAll feedback & comments welcome Domain Analysis Model: How should a clinical domain DAM relate to other models (i.e. BRIDG, Detailed Clinical Models (DCM)?Domain Analysis Model: How should a clinical domain DAM relate to other models (i.e. BRIDG, Detailed Clinical Models (DCM)? eDCI Message: What should we know in relation to these projects?eDCI Message: What should we know in relation to these projects? SDTM & HL7 v3: Work related to the cardiology SDTM-CDA piece to know about?SDTM & HL7 v3: Work related to the cardiology SDTM-CDA piece to know about? CDEs & EVS/caDSR: Work related to TB standard CRFs to know about?CDEs & EVS/caDSR: Work related to TB standard CRFs to know about? Other?Other?