Standardized Collection and Submission of Cardiovascular Endpoint Data



Rebecca Wilgus

by Rebecca Wilgus

Building on an FDA writing group chaired by Karen A. Hicks, MD a multidisciplinary expert panel convened in 2011 to standardize cardiovascular endpoints (such as death and MI) to achieve computational interoperability. Representatives from the DCRI, ACC, and CDISC partnered to harmonize clinical definitions, represent the terms in UML and the CDISC Study Data Tabulation Model, and create a demonstration test dataset. Sponsored by FDA grant 1R24FD004411-01, James E. Tcheng, MD (PI) and David Kong, MD (Co-PI) led this project. Robert Anderson, James Topping, Rebecca Wilgus, and Brian McCourt (DCRI), Maria Isler (ACC), and Steve Kopko and Amy Palmer (CDISC) completed the project team.

Next steps include publication of a CDISC Cardiovascular Therapeutic Area User Guide and an ACC-AHA Task Force on Clinical Data Standards manuscript. Future goals include publication as a controlled terminology in the NCI Thesaurus and balloting through HL7 in a future version of the CV Domain Analysis Model.

Cardiovascular Imaging Data Standards



by Rebecca Wilgus and Anita Walden

In 2011, the Cardiovascular Imaging Data Standards initiative was chartered to extend the development of informative standards that support semantic and technical interoperability of cardiovascular data. Sponsored by two grants from the FDA, this project is led jointly by Principal Investigators Drs. Pamela Douglas and Meredith Nahm Zozus, along with co- investigators Drs. James Tcheng and David Kong of Duke.  Other Duke team members are Anita Walden and Claire Miller from the DTMI and Brian McCourt, Mary Williams, and Rebecca Wilgus from the DCRI.

Led by a steering committee chaired by Dr. Douglas of Duke and Karen A. Hicks, MD, Medical Officer with the FDA, clinical working groups with members from more than 21 professional societies, government, and industry were convened to review existing standards and harmonize the definitions of core cardiovascular imaging data elements. The data elements were submitted to HL7’s Clinical Interoperability Council for a Comment Ballot in 2013. Over 700 data elements were reviewed; of these, roughly 250 related to transthoracic echocardiography (TTE) were prioritized for further development to support a regulatory decision-making use case. Future goals include representation in CDISC’s Study Data Tabulation Model (SDTM), publication in the NCI’s caDSR, and balloting through HL7 in a future version of the CV Domain Analysis Model.

University-Based Training: A Look at Duke

HealthITBuzz, August 8, 2011

The Program of Assistance for University-Based Training (UBT), which is part of the Office of the National Coordinator for Health Information Technology’s (ONC) Workforce Development Program, is designed to rapidly and sustainably increase the availability of individuals qualified to serve in specific health IT professional roles requiring university-level training.

The nine colleges and universities that received a grant under this program are charged with promptly establishing new and/or expanded training programs, many of which can be completed in a year or less.

This blog post will focus on Duke’s unique approach and experience with training the health IT professionals of tomorrow through its UBT program.


About Our Programs


Duke University has a rich history in health informatics. Our long standing strengths in computer-based medical records, integrated advanced information management systems, and medical instrumentation have Duke uniquely poised to address the challenges faced by the changing health care landscape. To meet the growing needs and challenges faced in health care today, the Duke Center for Health Informatics (DCHI) was created to provide a campus focus and academic home for health informatics at Duke. The informatics programs being offered through the Duke School of Nursing and the Fuqua School of Business draw on these strengths.

For more information

Walden to present at the Information Technology and Communications in Health conference

January 11, 2011

In February, DCHI’s Anita Walden, the manager for clinical data operations, will present a paper on “Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies” at the Information Technology and Communications in Health (ITCH) conference in Victoria, BC, Canada.

Tcheng to serve as faculty at HIT CME Event before HIMSS 2011



Dr. James Tcheng, MD, FACC, FSCAI, FESC will serve as faculty at the HIT Outcome Solutions: Certificate Series #1-Accredited Symposium / Workshop before HIMSS 2011 on February 19  from 1:00pm – 6:00pm at the Buena Vista Suites, 8203 World Center Dr., Orlando. This CME event will focus on the key issues to utilize data analytics of healthcare information technology (HIT) with electronic medical records (EMR) to rapidly improve clinical and financial outcomes in practice services during the healthcare reform. Dr. Tcheng will present–How to do more (quality and effectiveness) with less (time and effort) using EMR analytics: Experience from the Duke Data Bank.

Seven stories to watch in 2011 Journal of American Health Information Management

“7 for 11: Health Information Management and Technology Stories to Watch in 2011” by Chris Dimick, Journal of AHIMA 82, no. 1 (January 2011): 20-24.

Seven stories unfolding in 2011 illustrate the sweeping changes under way in health information management. To view the feature article:

*Dr. Chris Roth accepts Director of Imaging IT Strategy position for Duke Health Technology Solutions



Dr. Chris Roth has accepted the Director of Imaging IT Strategy position for Duke Health Technology Solutions.  Dr. Roth graduated from the University of Michigan Medical School in 2004 and did both his Residency and a Fellowship at Duke University Medical Center.  Most recently, he completed the Fuqua School of Business’ Master’s of Management Clinical Informatics program.

When announcing Dr. Roth’s new position, Dr. Jeffrey Ferranti, Chief Medical Information Officer for DHTS said “Moving forward, Chris will play a central role in the office of the CMIO in providing strategic leadership and vision for the imaging informatics needs of Duke Medicine.  He will partner with clinical and IT stakeholders to devise a comprehensive strategy to evaluate, develop, and deploy novel imaging modalities and informatics tools to enhance decision support within Duke Medicine care settings.  He will also create a strategy to deploy a vendor neutral image archive system enterprise wide.”

The DCHI congratulates Dr. Roth!

Hammond keynote speaker at the Greater China eHealth Forum: October 7-8, 2011

Dr. Ed Hammond will be presenting “From Molecules to Population” at the Greater China eHealth Forum being held October 7-8, 2011 at the Kowloonbay International Trade & Exhibition Centre (KITEC), Kowloon, Hong Kong.

The Greater China eHealth Forum is a joint effort among Mainland China, Hong Kong, Macau and Taiwan initiated by CHIMA and eHC, aimed at: raising the awareness of ehealth and health informatics; promoting ehealth development, project collaboration and experience sharing among Mainland China, Hong Kong, Macau and Taiwan; introducing new technologies and international standards; encouraging cooperation between domestic and foreign regions on medical informatics and internationalization of standards.

For more information

Hammond to serve as a panelist for the Council for Allied Health in North Carolina 2011 meeting.

March 2, 2011

Dr. W. Ed Hammond, PhD and Director, Duke Center for Health Informatics will serve a panelist for the Council for Allied Health in North Carolina meeting, on Wednesday, March 2, 2011. The focus of the presentation is Health Information Management and it’s impact on the healthcare workforce. Dr. Hammond will be discussing the training grants on HIM and workforce management at Duke.

The meeting will be held from 9:30 a.m. – 12:00 p.m. at UNC-Chapel Hill in the C.D. Spangler, Jr. Building (General Administration Building), located on 910 Raleigh Rd. Chapel Hill.

Health IT Training Creates New Careers

The Recovery Act at Work

Sherri Stuart has been a physician assistant for the last 30 years. She didn’t expect her career to dramatically change, but this spring she got a new job with substantial increases in pay and responsibility, thanks to her enrollment in a new health information technology (IT) training program.

The practice where she worked began using an electronic health record (EHR) system six years ago, and Stuart was impressed by the system’s potential to improve quality, reduce redundancy, and increase access to care. Through a contact at her local Regional Extension Center (REC), Stuart heard about a scholarship opportunity to learn more about health informatics at the University of Colorado Denver’s Health Information Technology program, and after one semester of classes, she was recruited for a new position managing the clinical applications and workflow of four outpatient hospital clinics’ EHR implementation.

“This new job is absolutely a new direction for me, and a new chapter in my life,” Stuart said. “It’s the culmination of my health care experience and my new training in health IT, management, and leadership.”

Stuart’s scholarship is part of a $32 million federal investment designed to rapidly develop a professional health IT workforce to serve in roles that require university-level training.This financial assistance is available to students and professionals nationwide, and was included in the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009.

The HITECH Act’s funding also supports training programs at 82 community colleges, curriculum development for use in community colleges and other institutions of higher education, and the development of competency examinations. Totaling $118 million, this investment in workforce training aims to supply health care providers across the country with the highly skilled experts needed to support the adoption and meaningful use of EHR.

Over the next three years, about 1,700 graduate-level students will receive tuition assistance for enrollment in nine university programs nationwide. To date, nearly 650 students have been enrolled in the programs, and more than 400 students will graduate between May-August 2011.

“I don’t think I would have embarked on this without the scholarship, at my own cost,” Stuart said. “This is a new field, and the future is relatively unknown. But my new position is a direct result of this opportunity.”


Building Real-World Skills, Virtually


The university programs receiving HITECH funds are intended for students like Stuart, who are mid-career and who already have backgrounds in either health care or IT, but need to develop specific health IT capabilities. The programs can also assist Bachelor-level graduates who want to enter the new and growing career field of health IT.

At the University of Colorado Denver, project director Diane J. Skiba has cultivated a diverse student body and developed a program designed to build expertise with a heavy emphasis on teamwork and leadership.

“When you want to implement a new system in a health care setting, it is very important to consider how the people there work as a team,” Dr. Skiba said. “For example, in a practice, you have the nurses, the doctors, the business side of the practice, the schedulers. Collaboration is critical in this environment.”

Kellyn Pearson, RN, MSN, another University of Colorado Denver student, says she, too, is already benefiting from her continued education. After beginning classes in fall 2010, Pearson began working with HealthTeamWorks, one of the nonprofit organizations contracting with the Colorado Regional Health Information Organization, the HITECH-funded REC working in Colorado to help primary care clinicians use EHRs. Pearson’s role is to work hands-on with medical practices to help them select EHR systems, integrate the new technology into their daily practice, and meaningfully use the systems.

“The program fills in the big theoretical picture, and helps you understand how all the different parts work together,” Pearson said. “In one class, we learned how an EHR works, how it can be used in the office, how implementing an EHR can affect workflow, and how you can get an office to change from paper records to electronic. These are the tools that I can take back into my work every day.”

Living 40 miles from Denver, Pearson takes advantage of the program’s distance learning initiatives, such as online chat and computer simulations in Second Life, a virtual, online world. Using these tools, Pearson is able to connect with her peers living and working across Colorado and other states for real-time discussions and team projects.

Pearson says that working closely with her peers has been valuable, since the varied backgrounds that students bring to their team projects add to the educational experience. “For one project on systems lifecycle, our group went through the whole process of selecting and designing a bar code medication administration system for a hospital setting. A couple of people in the group had worked in a hospital setting implementing such a system, so their input was grounded in real life.”


Cultivating Leaders in Rural Areas


Emily Burns, MD, MSPH, lives in Durango, CO, and also capitalizes on the University of Colorado Denver’s distance learning opportunities. Between her roles as executive director of Southwestern Colorado Area Health Education Center (AHEC) and as an assistant professor of epidemiology, Dr. Burns is not in the market for additional employment. However, she is passionate about developing expertise in health IT and applying her skills and knowledge to her rural community.

According to Dr. Burns, rural areas like her community are the most in need of health IT experts. “When I’m out talking to rural providers, I often find that there is little awareness of health IT. In some cases, they don’t have accurate information, and in many cases, they do not know what to do about health IT. Aside from the vendors who come into the area, there’s not a lot of expertise,” she said. “Furthermore, offices are fairly small in rural areas, so there is little extra capacity to take on a project like implementing an EHR.”

Dr. Burns applied for the university program in order to help her local providers stay abreast of developments in the national movement toward adoption of health IT.

“I figured that if I built my own expertise through this program, then I could provide timely leadership to rural providers. Part of the AHEC mission is to provide continuing education to rural providers, and health IT is currently an area of great need,” Dr. Burns said. “I don’t want them to miss out on opportunities.”

The Colorado Regional Extension Center (CO-REC) and other RECs across the country often look to community leaders like Dr. Burns for help in motivating health care providers to implement EHR systems in their daily practices. According to Elizabeth Brooks at Health TeamWorks, a partner organization of CO-REC, “It’s important that we have physician champions who are engaged and interested in health IT. Their clinical knowledge and experience coupled with a health IT background provides physician leadership for their community and fosters adoption.”

Brooks cites two rationales often mentioned by physicians as reasons to abstain from implementing EHRs: the technology is too expensive and implementations often fail. “The importance of having physician champions in a community to inform about the pros and cons of electronic health records cannot be overstated,” she said. “The health IT scholarships and education are essential in developing this leadership.”