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Tuberculosis & Cardiology Projects. Anita Walden & Brian McCourt RCRIM Presentation HL7 WGM January 2007 (San Diego). Topics. Background, Objectives, Methodology Project specific details Tuberculosis Project Cardiology Project Questions & Discussion. Background & Project Objectives.

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tuberculosis cardiology projects

Tuberculosis & Cardiology Projects

Anita Walden & Brian McCourt

RCRIM Presentation

HL7 WGM January 2007 (San Diego)

  • Background, Objectives, Methodology
  • Project specific details
    • Tuberculosis Project
    • Cardiology Project
  • Questions & Discussion
background project objectives
Background & Project Objectives
  • Funded by two independent NIH Roadmap contracts
  • Focus on methodology for developing therapeutic area data standards
  • Produce real, useful products along the way
  • Report on experience, process, best practices back to the larger community
  • Develop and/or contribute to data exchange standards within SDOs (HL7, CDISC…)
    • Implementation Guide
  • Publish consensus set of Common Data Elements (CDE’s)
  • Generate a Domain Analysis Model
    • including storyboards, use cases and activity diagram artifacts
  • Data collected for patient care must support multiple re-uses, including research
    • Clinical data for patient care and research are the same.
  • Stakeholders need to represent as many of the uses of the data as possible
    • Clinicians, researchers, standards organizations, industry, international…
  • Engage stakeholders in objectives
  • Select a use case from stakeholder contributions to define specific project scope and objectives
  • Develop a consensus set of CDE’s used in use case
  • Use case and CDE’s guide DAM development
  • Incorporate interchange standards under the DAM
cde process
CDE Process
  • Collect & aggregate data elements from stakeholders current databases
  • Convene 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…
    • Biweekly conference calls
  • Release for public comment
  • Publish via NCI EVS/caDSR
dam process
DAM Process
  • Start with pretty good understanding of storyboards, activity diagrams, use cases and CDE’s to set scope
  • Work with experienced modeler
  • Vetted by stakeholders
  • A use of DAM, provide context (associations) for Data Elements that will be provided to NCI’s caDSR.
data element contributors
World Health Organization

Stop TB Partnership


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

Data Element Contributors
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

single source for data reuse and interoperability patient enrollment aggregated data research
Single Source for Data Reuse and InteroperabilityPatient Enrollment/Aggregated Data Research

Local Health Dept

Query (message V2.5)

Query (message V 2.5)



State Health Dept

Query (message V 2.5)

Federal Health Dept






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)

Expert GroupRepresented Organizations
  • 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
  • WHO’s Stop TB Partnership
  • Pharmaceutical Companies
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



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

TB Specifics
creating implementing and sharing best practices for clinical trials networks
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."

data element contributors1
American Heart Association Get With the Guidelines

Society of Thoracic Surgeons




Data Element Contributors
  • American College of Cardiology National Cardiovascular Data Registry (NCDR)
  • Duke Databank
  • Eli Lilly
  • European Society of Cardiology Cardiac Registry and Registration Standards (CARDS)
expert group represented organizations1
Professional Societies & Clinical Organizations

Am. College of Cardiology (ACC)

Am. Heart Assoc.

ACC/AHA Task Force on Data Standards

Assoc. of Italian Hospital Cardiologists

European Soc. Cardiology

Soc. Cardiovascular Angiography & Intervention

Society of Thoracic Surgeons





Expert Group - Represented Organizations
  • Standards Organizations
    • HL7 & HL7 Cardiology SIG
    • CDISC (incl. pharma)
    • Integrating the Healthcare Enterprise
  • Industry & Academia
    • AstraZeneca
    • GE
    • Leuven Coordinating Centre
    • Mortara
    • UCLA
  • Clinical focus
    • Acute ischemic heart disease/Acute Coronary Syndromes (ACS)
  • Use Cases
    • A clinical site reporting data to a quality improvement registry (also IHE RFD use case)
      • HL7 CDA
    • A research study sending data to another organization or for regulatory submission
      • CDISC SDTM
status of related standards work
Status of related standards work
  • HL7 CDA
    • 1st draft mapping of ACC NCDR to HL7 CDA completed
    • To do – 1st draft Implementation Guide
    • Get feedback on work from HL7 groups
    • 1st draft in development mapping of ACC NCDR to SDTM
    • Need to understand relationship to BRIDG and HL7 efforts
  • ‘Multiple data re-use’ pilot for future
    • Implement the draft HL7 CV CDA for reporting data to the ACC’s NCDR registry and to SDTM model
  • ‘Single Source’ clinical trial
    • Use existing HL7 messaging to report data directly to a large international phase III trial electronic data capture system.
  • All feedback & comments welcome
  • 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?
  • SDTM & HL7 v3: Work related to the cardiology SDTM-CDA piece to know about?
  • CDE’s & EVS/caDSR: Work related to TB standard CRFs to know about?
  • Other?