: Medical devices have been associated with some of the most significant therapeutic advances in medicine in the last decades, leading to many improvements in life expectancy and quality of life for patients with musculoskeletal, cardiac, and other diseases. However, there are enormous cost implications for Medicare and for other government and private health insurers. To address the need for clinical and economic studies to help clinicians, regulators, and payers make decisions about how best to use these devices, we propose a Center for Education and Research on Therapeutics with a focus on therapeutic medical devices. Our proposal combines the research experience and resources of the Department of Public Health at Weill Medical College of Cornell University with the Hospital for Special Surgery (HSS), the largest and one of the most well-respected orthopedic institutions in the country. The proposed CERT will have particular strength and focus in prosthetic orthopedic devices through HSS, and will add geographic diversity through a partnership with The Methodist Hospital in Houston, Texas. Additionally, the New York Presbyterian Healthcare System, which includes hospitals in highly diverse communities in the NY Metro region, provides a ready laboratory for conducting multi-center studies on therapeutic medical devices, for inclusion of disadvantaged populations, and for dissemination of research findings. Additionally, a number of clinical disciplines within the Cornell community have pledged interest in evaluating medical devices outside of the orthopedic arena in collaboration with the proposed CERT. The CERT will be organized into five cores: outcomes, clinical, health economics, dissemination and education, and data management and biostatistics in order to support the mission of the CERT. A strong focus on dissemination to patients, providers, and policy-makers is included in the proposal, with a particular emphasis on ensuring that culturally appropriate educational materials are developed. Two initial studies are included in this proposal: one evaluating predictors of total hip replacement failure (between 8 -18% of hip replacements require revision due to failure) and a second study evaluating the impact on patients of proposals to regionalize total joint replacement surgeries. Funding for pilot studies of other medical devices is included in the CERT, with several pilots described. Evaluating the clinical and economic impact of therapeutic medical devices will improve the use of devices. As the population ages, and as new technologies develop, patients, physicians, and policy-makers require information on how these devices impact the health of the public in order to make informed decisions.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
5U18HS016075-05
Application #
7799208
Study Section
Special Emphasis Panel (ZHS1-HSR-O (01))
Program Officer
Kelly, Carmen
Project Start
2006-04-14
Project End
2011-09-30
Budget Start
2010-04-01
Budget End
2011-09-30
Support Year
5
Fiscal Year
2010
Total Cost
Indirect Cost
Name
Weill Medical College of Cornell University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
060217502
City
New York
State
NY
Country
United States
Zip Code
10065
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