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Tuberculosis therapeutic and CDISC data standards: A pilot projectCharles M. Heilig, PhD1; Jane Diefenbach2; Erin Bliven-Sizemore, MPH1; Craig M. Hales, MD, MPH1; Bron Kisler3; Anita Walden4
1U.S. Centers for Disease Control and Prevention, Atlanta, Georgia; 2PharmaStat, Washington, DC; 3Clinical Data Interchange Standards Consortium, Austin, TX; 4Duke Translational Medicine Institute, Durham, NC
Duke Translational Medicine Institute
Abstract
The Tuberculosis (TB) Data Standards project, funded by the National
Institutes of Health, produced Health Level 7 (HL7) and Clinical Data
Interchange Standards Consortium (CDISC) standards to facilitate semantic
interoperability between health care and research. A pilot project was
established to test the application of these standards when coupled with
the Standard Data Tabulation Model (SDTM). Preliminary experience
demonstrates that implementing standards requires expert knowledge of
both the data and the application of the standard.
DCRI Communications • November 2010
Introduction and background
While standard data elements exist for tuberculosis (TB) in the field of public
health [1], no such standards exist for clinical care or research. For example,
data from TB clinical trials are submitted to the FDA in various proprietary,
nonstandard formats—a scenario common in academic research as well.
In the arena of TB research, the capacity to easily pool data from multiple
studies could yield substantial benefits. While there are many challenges
to creating and adopting such standards, this effort also holds significant
promise.
In 2005, the NIH funded a TB-oriented Roadmap project. In 2008, the TB
data standards aim of this project developed and balloted an HL7 standard
at the informative level for data elements supporting TB diagnosis and
treatment. These standards were vetted through the CDISC community.
A pilot project was developed 1) to implement the balloted TB standards
in research use with the CDISC SDTM model and 2) to develop a common
method for implementation to increase consistency in standards application.
Acknowledgments
Funded in part by HHSN268200425214C from the National Center for
Research Resources (NCRR), a component of the National Institutes of Health.
We thank the U.S. Food and Drug Administration, the Centers for Disease
Control and Prevention, CDISC, and Quintiles for sharing their domain
expertise and technical knowledge.
Reference
[1] U.S. Centers for Disease Control and Prevention; Report of Verified Case
of Tuberculosis, 2009
Conclusions
Pending verification and review of the conversion, preliminary results
indicate that 1) significant time is required for the conversion and validation
of data to SDTM if standards were not considered at the beginning of study
design, and 2) appropriate application of a standard requires adoption
and implementation by persons expert in its use. Consistent application
of a standard is necessary to realize its full potential for supporting
interoperability and data aggregation, and individual variation in experience
with the standard can affect its application. Inconsistent application can lead
to additional effort and remodeling, reducing the potential benefits of the
standard.
Application of standards (CDISC SDTM and TB Data Elements): CDC-TBTC legacy study as pilot project
Design projectplan approach
CDISC Modeler(PharmaStat); TBTC atCDC; Duke
10 hrs
Prepare data• Sort and identify data• Code data events and medications• Anonymize data• Convert and derive dates
CDC; Quintiles; CDISC Modeler; Duke
Coding 458 hrs by Quintiles South Africaand India teams
Convert to SDTM• Build system to perform modeling• Convert data to SDTM• Test conversion
CDISC Modeler
CDISC Modeler 500 hrs
Conformance• Build system to perform conformance• Render the define.xml to HTML and PDF for ease of viewing and printing
PharmaStat LLC;Phase Forward;Octagon Research Solutions; Formedix; OpenCDISC.
Verification
PharmaStat;CDISC
Full implementationof TB and SDTM
standards
In Progress
SDTM application method
TB data standards application method
Project leadership: PharmaStat (CDISC Modeler)Project facilitation support: Duke
F_AMIA_walden_p_05nov10.indd 1 11/5/10 4:04 PM
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