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Cardiology Cardiology Special Interest Group Special Interest Group Presentation to Presentation to Technical Steering Committee Technical Steering Committee September 12, 2005

Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

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Page 1: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

CardiologyCardiologySpecial Interest GroupSpecial Interest Group

Presentation to Presentation to Technical Steering CommitteeTechnical Steering Committee

September 12, 2005

Page 2: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

NIH Roadmap contract: NIH Roadmap contract: BAA-RM-04-23BAA-RM-04-23

Re-engineering the Clinical Research Enterprise: Re-engineering the Clinical Research Enterprise: Feasibility of Integrating and Expanding Clinical Feasibility of Integrating and Expanding Clinical

Research NetworksResearch Networks

Recognition that therapeutic area standards development Recognition that therapeutic area standards development needs to be done in a public forum, formalized development needs to be done in a public forum, formalized development process and broad participation from experts and process and broad participation from experts and stakeholders representing a variety of domainsstakeholders representing a variety of domains

Focus on contributing to the public domain, not an specific Focus on contributing to the public domain, not an specific implementation effort. implementation effort.

BackgroundBackground

Page 3: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

Define the raw data and let it be the single Define the raw data and let it be the single source for all possible usessource for all possible uses

Patient carePatient care

ResearchResearch

QIQI

PaymentPayment

Patient safetyPatient safety

Decision SupportDecision Support

EMREMR

AdministrationAdministration

Clinical DocumentsClinical Documents

Public Health ReportingPublic Health Reporting

And more…And more…

Patient carePatient care

ResearchResearch

QIQI

PaymentPayment

Patient safetyPatient safety

Decision SupportDecision Support

EMREMR

AdministrationAdministration

Clinical DocumentsClinical Documents

Public Health ReportingPublic Health Reporting

And more…And more…

Data SystemsData SystemsData SystemsData Systems Analyses & Analyses & ReportingReportingAnalyses & Analyses & ReportingReporting

SourceSourceSourceSource

Page 4: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

MissionMission

Page 5: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

CharterCharter

Page 6: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

Operational DesignOperational Design

HL7 Standards Development Infrastructure

HL7 Standards Development Infrastructure

Proposed Cardiology SIGProposed Cardiology SIG

Stakeholder Working GroupsStakeholder Working Groups

FDA

CDC

CMS

NIH(NHLBI / NIAID)

American College of Cardiology

Society of Thoracic Surgeons

American Heart Association

Industry

Working GroupsEuropean Society of Cardiology

Page 7: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

Groundwork and Formal SupportGroundwork and Formal Support

American College of Cardiology Meeting, March 2005, with AHA/ACC/STS/VA/NIHAmerican College of Cardiology Meeting, March 2005, with AHA/ACC/STS/VA/NIH Ongoing engagement and support receivedOngoing engagement and support received Discussion started on role of ACC/AHA Task Force on Data StandardsDiscussion started on role of ACC/AHA Task Force on Data Standards

Stakeholder Kickoff Meeting, May 2005Stakeholder Kickoff Meeting, May 2005 34 Attendees representing 29 organizations34 Attendees representing 29 organizations

Participation in NIH Roadmap ‘Interoperability Working Group’Participation in NIH Roadmap ‘Interoperability Working Group’ HL7 EffortsHL7 Efforts

Experience from ECG Waveform standard developmentExperience from ECG Waveform standard development WGM Jan 2005 – RCRIM DiscussionWGM Jan 2005 – RCRIM Discussion WGM May 2005 – Participation and ad hoc discussionsWGM May 2005 – Participation and ad hoc discussions WGM Sept 2005 – SIG Application ReviewWGM Sept 2005 – SIG Application Review

Supported by Patient Care Technical CommitteeSupported by Patient Care Technical CommitteeApproved by the HL7 Architectural Review BoardApproved by the HL7 Architectural Review BoardRCRIM Follow-up discussionRCRIM Follow-up discussion

Page 8: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

UpcomingUpcoming

Stakeholder Follow-up Meeting, September Stakeholder Follow-up Meeting, September 23, 200523, 2005 ‘‘Call for data elements’Call for data elements’

American Heart Association meeting, American Heart Association meeting, November 2005, with AHA/ACC/STS/VA/NIHNovember 2005, with AHA/ACC/STS/VA/NIH

Page 9: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

Planned ActivitiesPlanned Activities

Activity diagramActivity diagram Draft in clinical reviewDraft in clinical review

Master set of data elements, including clinical definitionsMaster set of data elements, including clinical definitions Attribute sets reviewed (ISO 11179, caDSR, RIM, CDISC Attribute sets reviewed (ISO 11179, caDSR, RIM, CDISC

SDTM)SDTM) DCRI cardiology trial set and CDISC SDTM used to pilot DCRI cardiology trial set and CDISC SDTM used to pilot

attributes & formatattributes & format Data element relationship to terminology sets exploredData element relationship to terminology sets explored Further discussion with ACC/AHA Task Force on Data Further discussion with ACC/AHA Task Force on Data

Standards on clinical definitions and stewardship roleStandards on clinical definitions and stewardship role Mapping data elements to Activity DiagramMapping data elements to Activity Diagram Pilot studyPilot study

Cardiology and Psychology cross-therapeutic area datasetCardiology and Psychology cross-therapeutic area dataset Single source to supply patient care, administrative reporting, Single source to supply patient care, administrative reporting,

research and QI purposesresearch and QI purposes CTN Best Practices clinical sites and/or others to participate.CTN Best Practices clinical sites and/or others to participate. Storyboards supporting pilot study to be pursued firstStoryboards supporting pilot study to be pursued first Standards needed for pilot study implementation to be pursued Standards needed for pilot study implementation to be pursued

firstfirst Ongoing Rendering of data elements in content & structure Ongoing Rendering of data elements in content & structure

formatsformats

Page 10: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

draft draft

ActivityActivityDiagramDiagram

Page 11: Cardiology Special Interest Group Presentation to Technical Steering Committee September 12, 2005

Thank you for your consideration.Thank you for your consideration.