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.