. "5 Case Study of a Strategic-Investment Decision." A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press, 2011.
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration
Katz, B.P., D.A. Freund, D.A. Heck, R.S. Dittus, J.E. Paul, J. Wright, P. Coyte, E. Holleman, and G. Hawker. 1996. Demographic variation in the rate of knee replacement: A multi-year analysis. Health Serv. Res. 31(2):125-140.
Kirklin, J.K., D.C. Naftel, R.L. Kormos, L.W. Stevenson, F.D. Pagani, M.A. Miller, K.L. Ulisney, J.T. Baldwin, and J.B. Young. 2010. Second INTERMACS annual report: More than 1,000 primary left ventricular assist device implants. J. Heart Lung Transplant. 29(1):1-10.
Mahomed, N.N., J. Barrett, J.N. Katz, J.A. Baron, J. Wright, and E. Losina. 2005. Epidemiology of total knee replacement in the United States, Medicare population. J Bone Joint Surg Am. 87(6):1222-1228.
Moss, A.J., S. Hamburger, R.M. Moore, Jr., L.L. Jeng, and L.J. Howie. 1991. Use of Selected Medical Device Implants in the United States, 1988. Advance Data No. 191. DHHS (PHS) 91-1250. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Center for Health Statistics, Hyattsville, MD.
NCHS (National Center for Health Statistics). 2010. Deaths and Mortality. Centers for Disease Control, National Center for Health Statistics, Hyattsville, MD [online]. Available: http://www.cdc.gov/nchs/fastats/deaths.htm [accessed Nov. 8, 2010].
Parvizi, J., T.A. Sullivan, R.T. Trousdale, and D.G. Lewallen. 2001. Thirty-day mortality after total knee arthroplasty. J. Bone Joint Surg. Am. 83-A (8):1157-1161.
Paxton, E.W., R.S. Namba, G.B. Maletis, M. Khatod, E.J. Yue, M. Davies, R.B. Low Jr., R.W. Wyatt, M.C. Inacio, and T.T. Funahashi. 2010. A prospective study of 80,000 total joint and 5000 anterior cruciate ligament reconstruction procedures in a community-based registry in the United States. J. Bone Joint Surg. Am. Suppl 2:117-132.
Slaughter, M.S., J. Rogers, C.A. Milano, S.D. Russell, J.V. Conte, D. Feldman, B. Sun, A.J. Tatooles, R.M. Delgado III, J.W. Long, T.C. Wozniak, W. Ghumman, D.J. Farrar, and O.H. Frazier. 2009. Advanced heart failure treated with continuous-flow left ventricular assist device. N. Engl. J. Med. 361(23)2241-2251.
Taylor, H.D., D.A. Dennis, and H.S. Crane. 1997. Relationship between mortality rates and hospital patient volume for Medicare patients undergoing major orthopaedic surgery of the hip, knee, spine, and femur. J. Arthroplasty 12(3):235-242.
Terracciano, C.M., L.W. Miller, and M.H. Yacoub. 2010. Contemporary use of ventricular assist devices. Annu. Rev. Med. 61:255-270.
UAMS (University of Arkansas for Medical Sciences). 2010. Inpatient Mortality Rate for Knee Replacement. University of Arkansas for Medical Sciences [online]. Available: http://www.uamshealth.com/?id=1240&sid=1 [accessed Oct. 26, 2010].