Progress Report
RCIOR
Dennis L. Fowler, MD, MPH
Director, Reemtsma Center for Innovation and Outcomes Research (RCIOR)
Over the past decade, a number of academic medical centers have created units for clinical outcomes research. RCIOR would fit within that world—with one huge difference. RCIOR is the only U.S. center to focus on surgical outcomes and related issues.
Our mission is threefold. The first is clinical outcomes research. In addition to traditional clinical end points, such as mortality, we focus on patient preferences, quality of life and cost-effectiveness. Our second mission is to devise quality improvement programs on the basis of the data, and the third is to develop policy analysis of issues surrounding the development, introduction and use of medical technology. Many people think of outcomes research in terms of large data sets, and we, too, use them. However, our definition includes clinical evaluative research, meaning that we do clinical trials as well as other risk-adjusted studies of outcomes.
Since inception, we have had a very strong link with the Division of Health Policy Management of the Columbia University School of Public Health. Our staff numbers 15, and includes economists, health policy analysts, epidemiologists, computer programmers, auditors, statisticians and decision analysts.
Our clinical trials and other studies stem from interaction with the Department's faculty. We may suggest inquiries based on current clinical work, or the surgeons may raise issues. The REMATCH trial got started in just that way.
REMATCH (Randomized Evaluation of Mechanical Assistance for Treatment of Congestive Heart Failure) is a recently closed trial with Eric A. Rose, MD, and Mehmet C. Oz, MD, to compare LVADs with medical management in patients who are not candidates for transplantation. The preliminary end points for this $25 million trial, which was funded by the NIH in April 1997, are survival, quality of life and cost-effectiveness. A unique dimension to the program is that it marks the first time the FDA accepted quality-adjusted life years as the end point for a study. Researchers found that patients with left ventricular assist devices had a 52 percent chance of surviving a year, compared with a 25 percent survival rate for medically monitored patients.
The Department's participation in the NIH's lung reduction surgery study was modeled on the LVAD experience, considering quality of life as well as survival. The inclusion of cost-effectiveness analysis is relatively new to an NIH-sponsored trial.
RCIOR is involved in nearly 25 projects embracing cardiac, thoracic, vascular and orthopedic surgery, as well as health policy analyses. Going forward, we hope to support our new liver transplantation program and to study the cost-effectiveness of endoscopic surgery. In the policy area, we are beginning a study of the future of academic medical centers in today's rapidly changing medical environment. Columbia and five other major research universities are collaborating on the project.
To add an additional dimension to surgical training, the Department is establishing a fellowship named for Keith Reemtsma, MD, who preceded Dr. Rose as Department Chairman. This fellowship will train young surgeons to set up clinical studies and to integrate economics and medical care.
Reemtsma Center for Innovation and Outcomes Research
http://www.columbiasurgery.org/rcior/
