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