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CardiologyCardiologySpecial Interest GroupSpecial Interest Group
Presentation to Presentation to Technical Steering CommitteeTechnical 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
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
MissionMission
CharterCharter
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
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
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
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
draft draft
ActivityActivityDiagramDiagram
Thank you for your consideration.Thank you for your consideration.