Robert A. Wynbrandt, Executive Director & General Counsel
Cynthia M. Shewan, PhD, Director of Research & Scientific Affairs
STS News, Fall 2012 -- Continuing our series of guest columns from other members of the STS management team, Cynthia Shewan takes an in-depth look at the STS Research Center, which already is well into its second year of operation. Cynthia joined our staff in 2004 as Director of Quality, Research, and Patient Safety, overseeing enormous growth in the STS National Database, the advent of the STS public reporting initiative, expansion of our clinical practice guideline series, and numerous other advances in this mushrooming area of Society activity. With the establishment of the STS Research Center last year and all of the associated projects that it has spawned, she has transitioned to a new and challenging role on the team as our first Director of Research and Scientific Affairs.
The story of the STS Research Center began in 2010 when the STS Board of Directors and selected invited guests were establishing a five-year Strategic Plan for the Society. The consensus expressed was that the Society, its members, and the profession would benefit from greater concentration on research, which was articulated by the establishment of a Research Center. The Board supported this new endeavor by authorizing funds to support the Center in its developmental years.
The Society’s first, and perhaps most important, activity in establishing the STS Research Center was the retention of Fred H. Edwards, MD as its first Director, effective April 1, 2011. Dr. Edwards was well known to STS and the cardiothoracic surgery community with his numerous contributions to the STS National Database and to the research literature. Dr. Edwards and other members of the STS management team developed a business plan, which would serve as the blueprint for the Center with its stated mission to:
1. Independently procure, manage, and coordinate funded clinical research grants that are based largely on STS National Database data and that are designed to optimize cardiothoracic patient care;
2. Provide the scientific basis for these grants through data aggregation and statistical analysis; and
3. Provide advanced educational opportunities based on the use of the STS National Database data and analytic resources.
As the premier database for cardiothoracic surgery, the STS National Database serves not only as a quality improvement tool but also as a key data resource for several types of observational studies, such as comparative effectiveness, which was the emphasis of the recent ASCERT study, a collaboration between STS and the ACC to compare coronary artery bypass grafting surgery and percutaneous coronary intervention. ASCERT was funded through a grant from the National Heart, Lung, and Blood Institute.
The early months of the Research Center’s operations included efforts to hire sufficient staff at STS headquarters in Chicago to carry out the day-to-day operations of developing, submitting, and conducting research grants and contracts. Research Center activities were integrated into the Society’s governance structure through the Workforce on Research Development, chaired by Dr. Edwards.
Operationally, studies from the Research Center could emanate from sources such as the Access and Publications Task Force, requests from industry and health care organizations, and STS members with research grants, as well as external researchers wanting to involve STS and the Database.
Recently, STS linked its clinical data with administrative claims data, including CMS MedPAR data, thereby affording the Society the ability to study long-term outcomes such as survival status and resource utilization. At present, each study requires a separate request to use CMS data; however, the goal is to develop an ongoing link between these data sources and create a research infrastructure that would be available for a wide variety of research studies. Such a “research engine” would allow STS to conduct research more efficiently and less expensively. This research engine would be an important national resource that could be used to study long-term outcomes of medical devices and other treatment outcomes.
STS has developed strong relationships with several federal agencies to increase awareness of and cultivate support for the Society’s priority research. Dr. Edwards has made presentations to the leaderships of CMS, the CMS Innovation Center, and the Agency for Healthcare Research and Quality, among others. Currently, the Research Center has four active grants/contracts with federal agencies—AHRQ, CMS, FDA, and NIH.
In the fall of 2011, STS and ACC, with input from FDA and CMS, developed and launched a novel clinical data collection tool to conduct postmarket surveillance studies for cardiac devices. The new STS/ACC TVT Registry sought to acquire data on a new technology—transcatheter valve replacement—using a web-based tool, and now has well over 100 participating institutions along with their respective heart teams. When a sufficient amount of data has been collected, the registry will be a rich resource for research projects as well as for fulfilling its role in postmarket surveillance.
Now in its second year of operation, the STS Research Center has already made some substantial accomplishments and will continue to grow and contribute to the cardiothoracic surgery community as it undertakes additional research projects, attracts more funding, helps develop new registries, and provides the insights needed for improved patient care.