Professor of Epidemiology
Co-Director, Epidemiology Data Center
Department of Epidemiology
A525 Crabtree Hall
University of Pittsburgh
Pittsburgh, PA 15261

Phone: 412-624-5157
FAX: 412-383-5891

Email: Kelsey@edc.pitt.edu

Dr. Kelsey’s research interests are in the coordination of multicenter clinical trials and registries primarily in cardiology, but also in diabetes, women’s health, neurology, and ophthalmology. She has served as Principal Investigator for coordinating centers for a number of National Institutes of Health-sponsored multicenter clinical trials and registries. She has served on over thirty Data and Safety Monitoring Boards for the National Institutes of Health, the Veteran’s Administration and industry.



Education

Ph.D. Carnegie Mellon University, 1978, Statistics
Thesis: The measurement of air pollution emissions from coke oven doors
Thesis Advisor: Paul Shaman, Ph.D.

M.S. Carnegie Mellon University, 1973, Statistics

A.B. Mount Holyoke College, 1967, cum laude
Major: Mathematics Minor: Chemistry



Positions Held

1996-Present

Professor (with tenure), Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh

1985-Present

Deputy Director, Director, Co-Director, Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh

1977-1996

Research Associate, Assistant Professor, Associate Professor, Graduate School of Public Health, University of Pittsburgh

2005-Present

Cooperative Studies Scientific Merit Review Board (CSSMRB) Veterans Administration

1990-Present

Data and Safety Monitoring Boards for National Institutes of Health, (NHLBI, NINDS, NIDDK, NEI, NIDA, NIMH) Veterans Administration and Industry

1984-Present

NIH Ad hoc Reviewer (NHLBI, NINDS, NIDDK, NEI, NCCAM)

Honors

Pittsburgh Statistician of the Year (2009)
Fellow of the American Heart Association (elected 2001) Fellow of the American Statistical Association
(elected 1998) Delta Omega: Honor Society in Public Health (elected 1993) Teaching

Design of Clinical Trials, Epidemiology 2181, is offered in the Fall term. Both clinical and statistical aspects of design are addressed. Assignments include a critique of reports of clinical trials in the literature. Students work in groups to design a randomized clinical trial.


Current Projects

Bypass Angioplasty Revascularization Investigation (BARI 2D) in Diabetic Patients, Principal Investigator, NHLBI Grant 1-R01 HL61744-01A1. This multicenter, two by two factorial, randomized, clinical trial tests two treatment strategies for diabetes as well as tests maximal medical therapy versus revascularization for patients with existing diabetes and heart disease. Five-year mortality is the primary outcome.

Dynamic Evaluation of Percutaneous Coronary Intervention, NHLBI Grant HL33292, Principal Investigator. The NHLBI Dynamic Registry provides an objective assessment of the current practice of percutaneous coronary intervention. Reports from this multicenter, international registry provide the cardiology community with the fact s needed for selection of appropriate interventional therapies and for the design of clinical trials to evaluate competing devices in selected settings.

Women’s Ischemia Syndrome Evaluation (WISE) extension NHLBI Grant 1 U01 HL64829-0, Principal Investigator. This cooperative agreement extends the collaboration with the four WISE clinical centers, established to evaluate innovative methods to improve the diagnostic reliability of cardiovascular disease testing in women with suspected ischemic heart disease. To evaluate prognosis, women are undergoing five years of follow-up to measure symptoms, cardiovascular events and medical resource utilization.

Randomized Clinical Trial on Preventing Pressure Ulcers with Seat Cushions. NICHD 1 R01 HD041490-A1A, Co- Principal Investigator, In a nursing home population, patients are assigned at random to a standard foam wheelchair cushion or a specially fitted wheelchair cushion. Incidence of pressure ulcers is measured over a six month period.

Self Regulated Exercise in Cystic Fibrosis: A Randomized Trial, NIH/NIRS Grant NR009285-01A2, Co-Investigator, Coordinating Center Director.

Past Projects Include:

• International Registry of Enhanced External Counter Pulsation (IEPR), Vasomedical, Inc. Contract. Principal Investigator.
• Heart Failure Home Care Demonstration Project (HFHC) (Centers for Medicare and Medicaid Services (MCS), Coordinating Center, Principal Investigator.
• Women's Ischemia Syndrome Evaluation (WISE) NHLBI Contract 1HV68162, Coordinating Center, Principal Investigator.
• Bypass Angioplasty Revascularization Investigation (BARI) (Coordinating Center, Co Principal Investigator)
• Encophthalmitis Vitrectomy Study (EVS) (Coordinating Center, Principal Investigator)
• Brain Trauma Research Center (Biostatistics Core, Principal Investigator)
• Epidemiology of Diabetic Complications
• Epidemiology of Cardiovascular Risk Factors in Women
• Brain Resuscitation Clinical Trials (BRCT I, II, & III)
• NHLBI Type II Coronary Intervention Study
• Liver Transplantation Database, Pilot Phase (Co-Principal Investigator)
• NHLBI PTCA Registry (Co-Principal Investigator)
• Aerobic Exercise Intervention in Cystic Fibrosis
• Treatment of Pelvic Inflammatory Disease (PEACH)

Selected Publications:

Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, Hlatky MA, Jones TL, Molitch ME, Nesto RW, Sako EY, Sobel BE, the BARI 2D Study Group. A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease. N Engl J Med 2009;236(24):2503-15.

Hlatky MA, Boothroyd DB, Bravata DM, Boersma E, Booth J, Brooks MM, Carrie D, Clayton TC, Danchin N, Flather M, Hamm CW, Hueb WA, Kahler J, Kelsey SF, King SB, Kosinski AS, Lopes N, McDonald KM, Rodriguez A, Serruys P, Sigwart U, Stables RH, Owens DK, Pocock SJ. Lancet. 2009;376(9670):1190-7.

Venkitachalam L, Kip KE, Selzer F, Wilensky RL, Slater JN, Mulukutla SR, Marroquin OC, Block PC, Williams DO, Kelsey SF. Twenty-year evolution of Percutaneous coronary Intervention and its impact on clinical outcomes – A Report from the NHLBI-Sponsored 1985-86 PTCA and 1997-2006 Dynamic Registries. Circulation Cardiovasc Intervent 2009;2:6-13.

Soran OZ, Piña IL, Lamas GA, Kelsey SF, Selzer F, Pilotte J, Lave JR, Feldman AM. A Randomized Clinical Trial of the Clinical Effects of Enhanced Heart Failure Monitoring Using a Computer-based Telephonic Monitoring System in Older Minorities and Women. J Card Fail. 2008;14(9):711-717.

Marroquin OC, Selzer F, Mulukutla SR, Williams DO, Vlachos HA, Wilensky RL, Tanguay JF, Holper E, Abbott JD, Lee JS, Smith C, Anderson WD, Kelsey SF, Kip KE. A Comparison of Bare Metal and Drug-Eluting Stents for Off-Label Indications: Findings from the NHLBI Dynamic Registry. N Engl J Med. 2008;358:342-52.

Olson MB, Kelsey SF, Matthews KA, Bairey Merz CN, McGorray SP, Cornell CE, Vido D, Muldoon MF. Lipid-lowering Medication Use and Aggression Scores in Women: A Report from the NHLBI-sponsored WISE Study. Journal of Women’s Health, 2008;17(2):187-194.

The Final Ten-Year Follow-up Results from the Bypass Angioplasty Revascularization Investigation (BARI) Randomized Trial - The BARI Investigators. J Am Coll Cardiol. 2007;49(15):1600-6.

Brooks MM, Frye RL, Genuth S, Detre KM, Nesto R, Sobel BE, Kelsey SF, Orchard TJ, Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial Investigators. Hypotheses, Design, and Methods for the Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial. AM J Cardiol. 2006;97[suppl]:9G-19G.

Lawson WE, Silver MA, Hui JCK, Kennard ED, Kelsey SF, for the IEPR Investigators. Angina Patients with Diastolic Versus Systolic Heart Failure Demonstrated Comparable Immediate and One Year Benefit from Enhanced External Counterpulsation. J of Cardiac Failure. 2005;11(1):61-66.

Wessel TR, Arant CB, Olson MB, Johnson BD, Reis SE, Sharaf BL, Shaw LJ, Handberg E, Sopko G, Kelsey SF, Peopine CJ, Bairey Merz CN. Relationships of Physical Fitness versus Body Mass Index with Coronary Artery Disease and Cardiovascular Events in Women. JAMA. 2004;292(10)1179-1187.

Orenstein DM, Hovell MF, Mulvihill M, Keating KK, Hofstetter CR, Kelsey S, Morris K, Nixon PS. Strength Versus Aerobic Training in Children with Cystic Fibrosis: A Randomized, Controlled Trial. Chest. 2004;126:1204-1214

Johnson DB, Shaw LJ, Buchthal SD, Bairey Merz CN, Kim HW, Scott KN, Doyle M, Olson MB, Pepine CJ, Den Hollander J, Sharaf B, Rogers WJ, Mankad S, Forder JR, Kelsey SF, Pohost GM. Prognosis in Women with Myocardial Ischemia in the Absence of Obstructive Coronary Disease: Results from the NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE) Study. Circulation. 2004;109:2993-2999.

Kip KE, Marroquin OC, Kelley DE, Johnson BD, Kelsey SF, Shaw LJ, Rogers WJ, Reis SE. Clinical Importance of Obesity Versus the Metabolic Syndrome in Cardiovascular Risk in Women. A Report From the Women's Ischemia Syndrome Evaluation (WISE) Study. Circulation. 2004;109:706-713.

Reis SE, Holubkov R, Smith AJC, Kelsey SF, Sharaf BL, Reichek N, Rogers WJ, Bairey Merz CN, Sopko G, Pepine CJ for the WISE investigators, “Coronary Microvascular Dysfunction is Highly Prevalent in Women with Chest Pain in the Absence of Coronary Artery Disease: Results From the NHLBI WISE Study.” Am Heart J. 2001;141:735-41.

Barsness G, Feldman AM, Holmes DR, Holubkov R, Kelsey SF, Kennard ED, and the International EECP Patient Registry Investigators, “The International EECP Patient Registry (IEPR): Design, Methods, Baseline Characteristics, and Acute Results.” Clin Cardio. 2001;24:435-442.

Buchthal SD, den Hollander JA, Bairey Merz CN, Rogers WJ, Pepine CJ, Reichek N, Reis S, Kelsey SF, Pohost GM. “Metabolic Evidence of Myocardial Ischemia by 31P NMR Spectroscopy in Women with Chest Pain but No Significant Coronary Stenoses: Pilot Phase Results from NHLBI-sponsored WISE Study.” N Eng J Med. 2000:342;12;829-835.

Williams DO, Holubkov R, Yeh W, Bourassa MG, Al-Bassam M, Block PC, Cohen H, Cowley M, Dorros G, Faxon D, Holmes DR, Jacobs A, Kelsey SF, King SB, Myler R, Slater J, Stanek V, Vlachos HA, Detre KM, “Percutaneous Coronary Intervention in the Current Era Compared With 1985-1986: The NHLBI Registries.” Circulation. 2000;102:2945-2951.

Kelsey, SF, “Patients with diabetes did better with coronary bypass graft surgery than with percutaneous transluminal coronary angioplasty: Was this BARI finding real?” Am Heart J 1999;138:S387-S393.

Bairey-Merz CN, Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G, for the WISE Study Group, “The Women’s Ischemia Syndrome Evaluation (WISE) Study: Protocol Design, Methodology and Feasibility Report.” J Am Coll Cardiol. 1999;33:1453-61.

Jacobs AK, Kelsey SF, Brooks MM, Faxon DP, Chaitman BR, Bittner V, Mock MB, Weiner BH, Dean L, Winston C, Drew L, Sopko G. “A Better Outcome for Women as Compared to Men Undergoing Coronary Revascularization: A Report from the Bypass Angioplasty Revascularization Investigation (BARI).” Circulation. 1998;98:1279-1285.

Marion DW, Penrod LE, Kelsey SF, Obrist WD, Kochanek PM, Palmer AM, Wisniewski SP, DeKosky ST. "Improved Outcome After Traumatic Brain Injury WithThe Use of Moderate Hypothermia." N Eng J Med. 1997;336:540-546.

Detre K, Yeh W, Kelsey S, Williams D, Desvigne-Nickens P, Holmes Jr. D, Bourassa M, King III S, Faxon D, Kent K for the Investigators of the National Heart, Lung, and Blood Institute’s Percutaneous Transluminal Coronary Angioplasty Registry. "Has Improvement in PTCA Intervention Affected Long-Term Prognosis? The NHLBI PTCA Registry Experience." Circulation, 1995;91:2868-2875.

Endophthalmitis Vitrectomy Study Group. "Results of the Endophthalmitis Vitrectomy Study: A Randomized Trial of Immediate Vitrectomy and of Intravenous Antibiotics for the Treatment of Post-Operative Bacterial Endophthalmitis." Arch Ophthalmol.1995;113:1479-1496.

Kelsey SF, James M, Holubkov AL, Holubkov R, Cowley MJ, Detre KM, and Investigators from the NHLBI PTCA Registry. "Results of Percutaneous Transluminal Coronary Angioplasty in Women. (From the 1985-86 National Heart, Lung and Blood Institute's Coronary Angioplasty Registry)." Circulation. 1993;87:720-727.

Nixon PA, Orenstein DM, Kelsey SF, Doershuk CF. “The Prognostic Value of Exercise Testing in Patients with Cystic Fibrosis.” N Engl J Med. 1992;327:1785-8.

Kelsey SF for the BRCT Study Group. "A Randomized Clinical Trial of Calcium Entry Blocker Administration to Comatose Survivors of Cardiac Arrest: Design, Methods and Patient Characteristics." Controlled Clin Trials. 1991;12:525-545.

BRCT II Study Group. "Randomized clinical study of calcium entry blocker (Lidoflazine) therapy in comatose survivors of cardiac arrest." N Engl J Med, 3 1991;24:1225-31.

Kelsey, SF. "Strategies for Statistical Analysis of Angiographic Data: Individual Lesions Versus Individual Patients." In Workshop on the Patholobiology of the Human Atherosclerotic Plaque, Glagov S, Newman WP, Schaffer SA (eds.). Springer-Verlag, New York, NY, 1990; pp525-533.

Kelsey SF, Miller DP, Holubkov R, Lu AS, Cowley MJ, Faxon DP, Detre KM and Investigators from the NHLBI PTCA Registry: "Results of Percutaneous Transluminal Coronary Angioplasty in Patients >65 Years of Age (From the 1985-86 National Heart, Lung and Blood Institute Coronary Angioplasty Registry." Am J Cardiol. 1990;1033-1038.

Matthews KA, Meilahn E, Kuller LH, Kelsey SF, Caggiula AW, and Wing R. “Menopause and Cardiovascular Risk Factors in Women.” N Engl J Med. 1989; 321 (10):641-646.