KERRY L. LEE RESIDENCE: OFFICE: 215 Stratford Drive Chapel Hill, N.C. 27516 Duke Clinical Research Institute Duke University Medical Center 2400 Pratt Street Durham, NC 27705 TELEPHONE: (919) 929-1635 (residence) (919) 668-8725 (office) EDUCATION: B.S. Mathematics M.S. Statistics Ph.D. Biostatistics University of Utah (Magna Cum Laude) Stanford University University of North Carolina PROFESSIONAL EXPERIENCE: December 2007 – present Professor of Biostatistics Department of Biostatistics and Bioinformatics Duke University, Durham, North Carolina July 2000 – December 2007 Associate Professor of Biostatistics Department of Biostatistics and Bioinformatics Duke University, Durham, North Carolina July 1980 – June 2000 Associate Professor of Biostatistics, Division of Biometry, Department of Community and Family Medicine Duke University, Durham, North Carolina July 1981 – present Adjunct Associate Professor, Department of Biostatistics University of North Carolina, Chapel Hill, North Carolina December 1974 – June 1980 Assistant Professor of Biostatistics, Division of Biometry, Department of Community and Family Medicine Duke University, Durham, North Carolina June 1965 June 1966 August 1975 November 1975 – June 1981 Adjunct Assistant Professor, Department of Biostatistics University of North Carolina, Chapel Hill, North Carolina June 1966 – September 1971 Member of Technical Staff, Bell Telephone Laboratories Whippany and Murray Hill, New Jersey OTHER RELATED EXPERIENCE: January 1976 – July 1978 Member, Editorial Board of CIRCULATION, (an Official Journal of the American Heart Association) 1984 – 1994 Participant, Visiting Lecturer Program in Statistics, Sponsored by the Committee of Presidents of Statistical Societies 1985 – 1986 President, North Carolina Chapter of the American Statistical Association. 1987 ASA Council Representative, North Carolina Chapter of the American Statistical Association. 1989 – 1993 Member, Health Services Developmental Grants Study Section, Agency for Health Care Policy and Research 1995 – 1999 Member, Clinical Trials Review Committee (Study Section), National Heart, Lung, and Blood Institute 1997 – 2000 Associate Editor, American Heart Journal 2000 – present Member, Editorial Board of the American Heart Journal 1997 Chair-elect, Biometrics Section, American Statistical Association 1998 Chair, Biometrics Section, American Statistical Association 1999 Past Chair and Member of Executive Committee, Biometrics Section, American Statistical Association 2 PROFESSIONAL MEMBERSHIPS: American Statistical Association Biometric Society Society for Clinical Trials American Heart Association American Association for the Advancement of Science HONORS: Sigma Xi, Phi Kappa Phi U.S. Public Health Traineeship 1971-74 NIH Research Career Development Award 1979-84 Outstanding Member, North Carolina Chapter, American Statistical Association 1989 REFEREED PUBLICATIONS 1. Starmer CF, Lee KL. A mathematical approach to medical decisions: application of Bayes' rule to a mixture of continuous and discrete clinical variables. Comput Biomed Res 1976;9:531-541. 2. Rosati RA, Lee KL, Mittler BS, McNeer JF, Behar VS, Margolis JR. Does coronary surgery prolong life in comparison with medical management. Postgrad Med J 1976;52:749-756. 3. Whalen RE, Wallace AG, McNeer JF, Rosati RA, Lee KL. The natural history of coronary artery disease: an update on surgical and medical management. Trans Am Clin Climatol Assoc 1977;89:19-35. 4. Mendell NR, Lee KL, Reinsmoen N, Yunis E, Amos DB, Emme L. Statistical methods for evaluating responses in HLA-D typing. Transplant Proc 1977;9:99-106. 5. Conley MJ, McNeer JF, Lee KL, Wagner GS, Rosati RA. Cardiac arrest complicating acute myocardial infarction: predictability and prognosis. Am J Cardiol 1977;39:7-12. 6. Wenger TL, Masterton CE, Abou-Donia MB, Lee KL, Bache RJ, Strauss HC. Relationship between regional myocardial procainamide concentration and regional myocardial blood flow during ischemia in the dog. Circ Res 1978;42:846-851. 7. McNeer JF, Margolis JR, Lee KL, Kisslo JA, Peter RH, Kong Y, Behar VS, Wallace AG, McCants CB, Rosati RA. The role of the exercise test in the evaluation of patients for ischemic heart disease. Circulation 1978;57:64-70. 8. Ideker RE, Behar VS, Wagner GS, Starr JW, Starmer CF, Lee KL, Hackel DB. Evaluation of asynergy as an indicator of myocardial fibrosis. Circulation 1978;57:715725. 3 9. Conley MJ, Ely RL, Kisslo JA, Lee KL, McNeer JF, Rosati RA. The prognostic spectrum of left main stenosis. Circulation 1978;57:947-952. 10. Lee KL. Multivariate tests for clusters. J Am Statist Assn 1979;74:708-714. 11. Harris PJ, Harrell FE Jr, Lee KL, Behar VS, Rosati RA. Survival in medically treated coronary artery disease. Circulation 1979;60:1259-1269. 12. Hammond CB, Jelovsek FR, Lee KL, Creasman WT, Parker RT. Effects of long-term estrogen replacement therapy. I. Metabolic effects. Am J Obstet Gynecol 1979;133:525536. 13. Hammond CB, Jelovsek FR, Lee KL, Creasman WT, Parker RT. Effects of long-term estrogen replacement therapy. II. Neoplasia. Am J Obstet Gynecol 1979;133:537-547. 14. Williams RB Jr, Haney TL, Lee KL, Kong Y, Blumenthal JA, Whalen RE. Type A behavior, hostility, and coronary atherosclerosis. Psychosom Med 1980;42:539-549. 15. Harris PJ, Lee KL, Harrell FE Jr, Behar VS, Rosati RA. Outcome in medically treated coronary artery disease. Ischemic events: nonfatal infarction and death. Circulation 1980;62:718-726. 16. Harris PJ, Behar VS, Conley MJ, Harrell FE Jr, Lee KL, Peter RH, Kong Y, Rosati RA. The prognostic significance of 50% coronary stenosis in medically treated patients with coronary artery disease. Circulation 1980;62:240-248. 17. Starmer CF, Lee KL, Harrell FE Jr, Rosati RA. On the complexity of investigating chronic illness. Biometrics 1980;36:333-335. 18. Lee KL, McNeer JF, Starmer CF, Harris PJ, Rosati RA. Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease. Circulation 1980;61:508-515. 19. Jelovsek FR, Hammond CB, Woodard BH, Draffin R, Lee KL, Creasman WT, Parker RT. Risk of exogenous estrogen therapy and endometrial cancer. Am J Obstet Gynecol 1980;137:85-91. 20. Harris PJ, Harrell FE Jr, Lee KL, Rosati RA. Nonfatal myocardial infarction in medically treated patients with coronary artery disease. Am J Cardiol 1980;46:937-942. 21. Olsen CO, Attarian DE, Jones RN, Hill RC, Sink JD, Lee KL, Wechsler AS. The coronary pressure-flow determinants of left ventricular compliance in dogs. Circ Res 1981;49:856-865. 22. Gibbons RJ, Lee KL, Cobb F, Jones RH. Ejection fraction response to exercise in patients with chest pain and normal coronary arteriograms. Circulation 1981;64:952-957. 4 23. Whalen RE, Harrell FE Jr, Lee KL, Rosati RA. Survival of coronary artery disease patients with stable pain and normal left ventricular function treated medically or surgically at Duke University. Circulation 1982;65(II):49-52. 24. Starmer CF, Lee KL. A data-based approach to assessing clinical interventions in the setting of chronic disease. Cancer Treat Rep 1982;66:1077-1082. 25. Rosati RA, Lee KL, Califf RM, Pryor DB, Harrell FE Jr. Problems and advantages of an observational data base approach to evaluating the effect of therapy on outcome. Circulation 1982;65 (Suppl II):27-32. 26. Phillips HR III, Stack RS, Davis DD, Morris KG, Lee KL, Shand DG, Pritchett ELC. Hemodynamic effects of the antiarrhythmic drug pirmenol. Clin Pharmacol Ther 1982;32:235-239. 27. Harrell FE Jr, Califf RM, Pryor DB, Lee KL, Rosati RA. Evaluating the yield of medical tests. JAMA 1982;247:2543-2546. 28. Goldman L, Cook EF, Mitchell N, Flatley M, Sherman H, Rosati R, Harrell FE Jr, Lee KL, Cohn PF. Incremental value of the exercise test for diagnosing the presence or absence of coronary artery disease. Circulation 1982;66:945-953. 29. Gibbons RJ, Lee KL, Cobb FR, Coleman RE, Jones RH. Ejection fraction response to exercise in patients with chest pain, coronary artery disease and normal resting ventricular function. Circulation 1982;66:643-648. 30. Califf RM, McKinnis RA, Burks J, Lee KL, Harrell FE Jr, Behar VS, Pryor DB, Wagner GS, Rosati RA. Prognostic implications of ventricular arrhythmias during 24 hour ambulatory monitoring in patients undergoing cardiac catheterization for coronary artery disease. Am J Cardiol 1982;50:23-31. 31. Califf RM, Lee KL, Harrell FE Jr, Kimm SYS, Grufferman S, Rosati RA. Assessment of the use of the age- and sex-specific United States population as a control group for analysis of survival in coronary artery disease. Am J Cardiol 1982;50:1279-1282. 32. Buckley CE III, Lee KL, Burdick DS. Methacholine-induced cutaneous flare response: bivariate analysis of responsiveness and sensitivity. J Allergy Clin Immunol 1982;69:2534. 33. Roberts KB, Califf RM, Harrell FE Jr, Lee KL, Pryor DB, Rosati RA. The prognosis for patients with new-onset angina who have undergone cardiac catheterization. Circulation 1983;68:970-978. 34. Pryor DB, Harrell FE Jr, Lee KL, Califf RM, Rosati RA. Estimating the likelihood of significant coronary artery disease. Am J Med 1983;75:771-780. 35. Pryor DB, Harrell FE Jr, Lee KL, Califf RM, Rosati RA. An improving prognosis over time in medically treated patients with coronary artery disease. Am J Cardiol 1983;52:444448. 5 36. Pritchett ELC, Hammill SC, Reiter MJ, Lee KL, McCarthy EA, Zimmerman JM, Shand DG. Life-table methods for evaluating antiarrhythmic drug efficacy in patients with paroxysmal atrial tachycardia. Am J Cardiol 1983;52:1007-1012. 37. Lee KL, Harrell FE Jr, Tolley HD, Rosati RA. A comparison of test statistics for assessing the effects of concomitant variables in survival analysis. Biometrics 1983;39:341-350. 38. Hlatky MA, Lee KL, Botvinick EH, Brundage BH. Diagnostic test use in different practice settings. A controlled comparison. Arch Intern Med 1983;143:1886-1889. 39. Gibbons RJ, Lee KL, Pryor DB, Harrell FE Jr, Coleman RE, Cobb FR, Rosati RA, Jones RH. The use of radionuclide angiography in the diagnosis of coronary artery disease--a logistic regression analysis. Circulation 1983;68:740-746. 40. Floyd RD, Sabiston DC Jr, Lee KL, Jones RH. The effect of duration of hypothermic cardioplegia on ventricular function. J Thorac Cardiovasc Surg 1983;85:606-611. 41. Califf RM, McKinnis RA, McNeer JF, Harrell FE Jr, Lee KL, Pryor DB, Waugh RA, Harris PJ, Rosati RA, Wagner GS. Prognostic value of ventricular arrhythmias associated with treadmill exercise testing in patients studied with cardiac catheterization for suspected ischemic heart disease. J Am Coll Cardiol 1983;2:1060-1067. 42. Califf RM, Tomabechi Y, Lee KL, Phillips HR III, Pryor DB, Harrell FE Jr, Harris PJ, Peter RH, Behar VS, Kong Y, Rosati RA. Outcome in one-vessel coronary artery disease. Circulation 1983;67:283-290. 43. Trask N, Califf RM, Conley MJ, Kong Y, Peter RH, Lee KL, Hackel DB, Wagner GS. Accuracy and interobserver variability of coronary cineangiography: a comparison with postmortem evaluation. J Am Coll Cardiol 1984;3:1145-1154. 44. Pryor DB, Lee KL, Harris PJ, Harrell FE Jr, Rosati RA. The effect of crossovers on estimates of survival in medically treated patients with coronary artery disease. J Chronic Dis 1984;37:521-529. 45. Pryor DB, Harrell FE , Lee KL, Rosati RA, Coleman RE, Cobb FR, Califf RM, Jones RH. Prognostic indicators from radionuclide angiography in medically treated patients with coronary artery disease. Am J Cardiol 1984;53:18-22. 46. Pritchett ELC, Smith MS, McCarthy EA, Lee KL. The spontaneous occurrence of paroxysmal supraventricular tachycardia. Circulation 1984;70:1-6. 47. Mark DB, Califf RM, Morris KG, Harrell FE Jr, Pryor DB, Hlatky MA, Lee KL, Rosati RA. Clinical characteristics and long-term survival of patients with variant angina. Circulation 1984;69:880-888. 48. Hlatky MA, Lee KL, Harrell FE Jr, Califf RM, Pryor DB, Mark DB, Rosati RA. Tying clinical research to patient care by use of an observational database. Statistics in Medicine 1984;3:375-384. 6 49. Harrell FE Jr, Lee KL, Califf RM, Pryor DB, Rosati RA. Regression modelling strategies for improved prognostic prediction. Statistics in Medicine 1984;3:143-152. 50. Gibbons RJ, Morris KG, Lee KL, Coleman RE, Cobb FR. Assessment of regional left ventricular function using gated radionuclide angiography. Am J Cardiol 1984;54:294300. 51. Califf RM, Conley MJ, Behar VS, Harrell FE Jr, Lee KL, Pryor DB, McKinnis RA, Rosati RA. "Left main equivalent" coronary artery disease: its clinical presentation and prognostic significance with nonsurgical therapy. Am J Cardiol 1984;53:1489-1495. 52. Pryor DB, Califf RM, Harrell FE Jr, Hlatky MA, Lee KL, Mark DB, Rosati RA. Clinical data bases: accomplishments and unrealized potential. Medical Care 1985;23:623-647. 53. Hlatky MA, Califf RM, Lee KL, Pryor DB, Wagner GS, Rosati RA. Prognostic significance of precordial ST-segment depression during inferior acute myocardial infarction. Am J Cardiol 1985;55:325-329. 54. Harrell FE Jr, Lee KL, Matchar DB, Reichert TA. Regression models for prognostic prediction: advantages, problems, and suggested solutions. Cancer Treat Rep 1985;69:1071-1077. 55. Califf RM, Hlatky MA, Mark DB, Lee KL, Harrell FE Jr, Rosati RA, Pryor DB. Randomized trials of coronary artery bypass surgery: impact on clinical practice at Duke University Medical Center. Circulation 1985;72(V):V136-V144. 56. Califf RM, Phillips HR III, Hindman MC, Mark DB, Lee KL, Behar VS, Johnson RA, Pryor DB, Rosati RA, Wagner GS, Harrell FE Jr. Prognostic value of a coronary artery jeopardy score. J Am Coll Cardiol 1985;5:1055-1063. 57. Williams RB Jr, Haney TL, McKinnis RA, Harrell FE Jr, Lee KL, Pryor DB, Califf RM, Kong Y, Rosati RA, Blumenthal JA. Psychosocial and physical predictors of anginal pain relief with medical management. Psychosom Med 1986;48:200-210. 58. Sintetos AL, Roark SF, Smith MS, McCarthy EA, Lee KL, Pritchett ELC. Incidence of symptomatic tachycardia in untreated patients with paroxysmal supraventricular tachycardia. Arch Intern Med 1986;146:2205-2209. 59. Roark SF, McCarthy EA, Lee KL, Pritchett ELC. Observations on the occurrence of atrial fibrillation in paroxysmal supraventricular tachycardia. Am J Cardiol 1986;57:571-575. 60. Papanicolaou MN, Califf RM, Hlatky MA, McKinnis RA, Harrell FE Jr, Mark DB, McCants CB, Rosati RA, Lee KL, Pryor DB. Prognostic implications of angiographically normal and insignificantly narrowed coronary arteries. Am J Cardiol 1986;58:1181-1187. 61. Olive DL, Lee KL. Analysis of sequential treatment protocols for endometriosis-associated infertility. Am J Obstet Gynecol 1986;154:613-619. 7 62. Lee KL, Pryor DB, Harrell FE Jr, Califf RM, Behar VS, Floyd WL, Morris JJ, Waugh RA, Whalen RE, Rosati RA. Predicting outcome in coronary disease. Statistical models versus expert clinicians. Am J Med 1986;80:553-560. 63. Goldman L, Mushlin AI, Lee KL. Using medical databases for clinical research. J Gen Intern Med 1986;1:S25-S30. 64. Topol EJ, Califf RM, George BS, Kereiakes DJ, Abbottsmith CW, Candela RJ, Lee KL, Pitt B, Stack RS, O'Neill WW and the TAMI Study Group. A randomized trial of immediate versus delayed elective angioplasty after intravenous tissue plasminogen activator in acute myocardial infarction. N Engl J Med 1987;317:581-588. 65. Pryor DB, Harrell FE Jr, Rankin JS, Lee KL, Muhlbaier LH, Oldham HN Jr, Hlatky MA, Mark DB, Reves JG, Califf RM. The changing survival benefits of coronary revascularization over time. Circulation 1987;76(V):V13-V21. 66. Mark DB, Hlatky MA, Lee KL, Harrell FE Jr, Califf RM, Pryor DB. Localizing coronary artery obstructions with the exercise treadmill test. Ann Intern Med 1987;106:53-55. 67. Mark DB, Hlatky MA, Harrell FE Jr, Lee KL, Califf RM, Pryor DB. Exercise treadmill score for predicting prognosis in coronary artery disease. Ann Intern Med 1987;106:793800. 68. Kay GN, Pryor DB, Lee KL, Harrell FE Jr, Pressley JC, Gilbert MR, German LD. Comparison of survival of amiodarone-treated patients with coronary artery disease and malignant ventricular arrhythmias with that of a control group with coronary artery disease. J Am Coll Cardiol 1987;9:877-881. 69. Hlatky MA, Mark DB, Harrell FE Jr, Lee KL, Califf RM, Pryor DB. Rethinking sensitivity and specificity. Am J Cardiol 1987;59:1195-1198. 70. Chu A, Califf RM, Pryor DB, McKinnis RA, Harrell FE Jr, Lee KL, Curtis SE, Oldham HN Jr, Wagner GS. Prognostic effect of bundle branch block related to coronary artery bypass grafting. Am J Cardiol 1987;59:798-803. 71. Aldrich HR, Hindman NB, Hinohara T, Jones MG, Boswick JM, Lee KL, Bride W, Califf RM, Wagner GS. Identification of the optimal electrocardiographic leads for detecting acute epicardial injury in acute myocardial infarction. Am J Cardiol 1987;59:2023. 72. Wagner NB, Sevilla DC, Krucoff MW, Lee KL, Pieper KS, Kent KK, Bottner RK, Selvester RH, Wagner GS. Transient alterations of the QRS complex and ST segment during percutaneous transluminal balloon angioplasty of the left anterior descending coronary artery. Am J Cardiol 1988;62:1038-1042. 8 73. Topol EJ, Califf RM, George BS, Kereiakes DJ, Rothbaum D, Candela RJ, Abbottsmith CW, Pinkerton CA, Stump DC, Collen D, Lee KL, Pitt B, Kline EM, Boswick JM, O'Neill WW, Stack RS, and the TAMI Study Group. Coronary arterial thrombolysis with combined infusion of recombinant tissue-type plasminogen activator and urokinase in patients with acute myocardial infarction. Circulation 1988;77:1100-1107. 74. Pritchett ELC, McCarthy EA, Lee KL. Clinical behavior of paroxysmal atrial tachycardia. Am J Cardiol 1988;62(Suppl.6):3D-9D. 75. Hlatky MA, Califf RM, Harrell FE Jr, Lee KL, Mark DB, Pryor DB. Comparison of predictions based on observational data with the results of randomized controlled clinical trials of coronary artery bypass surgery. J Am Coll Cardiol 1988;11:237-245. 76. Harrell FE Jr, Lee KL, Pollock BG. Regression models in clinical studies: determining relationships between predictors and response. J Nat Cancer Inst 1988;80:1198-1202. 77. Bounous EP Jr, Mark DB, Pollock BG, Hlatky MA, Harrell FE Jr, Lee KL, Rankin JS, Wechsler AS, Pryor DB, Califf RM. Surgical survival benefits for coronary disease patients with left ventricular dysfunction. Circulation 1988;78 (Suppl I):I151-I157. 78. Califf RM, Mark DB, Harrell FE Jr, Hlatky MA, Lee KL, Rosati RA, Pryor DB. Importance of clinical measures of ischemia in the prognosis of patients with documented coronary artery disease. J Am Coll Cardiol 1988;11:20-26. 79. Califf RM, Harrell FE Jr, Lee KL, Rankin JS, Mark DB, Hlatky MA, Muhlbaier LH, Wechsler AS, Jones RH, Oldham HN Jr, Pryor DB. Changing efficacy of coronary revascularization: implications for patient selection. Circulation 1988;78 (Suppl I):185191. 80. Califf RM, Topol EJ, George BS, Boswick JM, Lee KL, Stump D, Dillon J, Abbottsmith CW, Candela RJ, Kereiakes DJ, O'Neill WW, Stack RS, and the TAMI Study Group. Characteristics and outcome of patients in whom reperfusion with intravenous tissue-type plasminogen activator fails: results of the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) I trial. Circulation 1988;77:1090-1099. 81. Anderson WD, Wagner NB, Lee KL, White RD, Yuschak J, Behar VS, Selvester RH, Ideker RE, Wagner GS. Evaluation of a QRS scoring system for estimating myocardial infarct size. VI: Identification of screening criteria for non-acute myocardial infarcts. Am J Cardiol 1988;61:729-733. 82. Aldrich HR, Wagner NB, Boswick JM, Corsa AT, Jones MG, Grande P, Lee KL, Wagner GS. Use of initial ST-segment deviation for prediction of final electrocardiographic size of acute myocardial infarcts. Am J Cardiol 1988;61:749-753. 83. Pritchett ELC, Lee KL. Designing clinical trials for paroxysmal atrial tachycardia and other paroxysmal arrhythmias. J Clin Epidemiol 1988;41:851-858. 9 84. Topol EJ, Califf RM, George BS, Kereiakes DJ, Lee KL and the TAMI Study Group. Insights derived from the thrombolysis and angioplasty in myocardial infarction (TAMI) trials. J Am Coll Cardiol 1988;12(Suppl.A):24A-31A. 85. Califf RM, Harrell FE Jr, Lee KL, Rankin JS, Hlatky MA, Mark DB, Jones RH, Muhlbaier LH, Oldham HN Jr, Pryor DB. The evolution of medical and surgical therapy for coronary artery disease: a 15-year perspective. JAMA 1989;261:2077-2086. 86. Kong DF, Lee KL, Harrell FE Jr, Boswick JM, Mark DB, Hlatky MA, Califf RM, Pryor DB. Clinical experience and predicting survival in coronary disease. Arch Intern Med 1989;149:1177-1181. 87. Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol 1989;64:651-654. 88. Mark DB, Hlatky, MA, Califf RM, Morris JJ, Sisson S, McCants CB, Lee KL, Harrell FE, Pryor DB. Painless exercise ST deviation on the treadmill: long-term prognosis. J Am Coll Cardiol 1989;14:885-892. 89. Topol EJ, George BS, Kereiakes DJ, Stump DC, Candela RJ, Abbottsmith CW, Aronson LG, Pickel A, Boswick JM, Lee KL, Ellis SG, Califf RM and the TAMI Study Group. A randomized controlled trial of intravenous tissue plasminogen activator and early intravenous heparin in acute myocardial infarction. Circulation 1989;79:281-286. 90. Ellis SG, Topol EJ, George BS, Kereiakes DJ, Debowey D, Sigmon KN, Pickel A, Lee KL, Califf RM. Recurrent ischemia without warning. Analysis of risk factors for in-hospital ischemic events following successful thrombolysis with intravenous tissue plasminogen activator. Circulation 1989;80:1159-1165. 91. Topol EJ, Ellis SG, Califf RM, George BS, Stump DC, Bates ER, Nabel EG, Walton JA, Candela RJ, Lee KL, Kline EM, Pitt B and the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) 4 Study Group. Combined tissue-type plasminogen activator and prostacyclin therapy for acute myocardial infarction. J Am Coll Cardiol 1989;14:877-884. 92. Wagner NB, Sevilla DC, Krucoff MW, Pieper KS, Lee KL, White RD, Kent KM, Renzi R, Selvester RH, Wagner GS. Transient alterations of the QRS complex and ST segment during percutaneous transluminal balloon angioplasty of the right and left circumflex coronary arteries. Am J Cardiol 1989;63:1208-1213. 93. Bengston JR, Mark DB, Honan MB, Rendall DS, Hinohara T, Stack RS, Hlatky MA, Califf RM, Lee KL, Pryor DB. Detection of restenosis after elective percutaneous transluminal coronary angioplasty using the exercise treadmill test. Am J Cardiol 1990;65:28-34. 94. Hlatky MA, Califf RM, Harrell FE Jr., Lee KL, Mark DB, Muhlbaier LH, Pryor DB. Clinical judgment and therapeutic decision making. J Am Coll Cardiol 1990;15:1-14. 10 95. Lee KL, Pryor DB, Pieper KS, Harrell FE Jr, Califf RM, Mark DB, Hlatky MA, Coleman RE, Cobb FR, Jones RH. Prognostic value of radionuclide angiography in medically treated patients with coronary artery disease: a comparison with clinical and catheterization variables. Circulation 1990;82:1705-1717. 96. Califf RM, Topol EJ, George BS, Kereiakes DJ, Aronson LG, Lee KL, Martin L, Candela R, Abbottsmith C, O'Neill WW, Pryor DB, Stack RS, and the TAMI Study Group. Oneyear outcome after therapy with tissue plasminogen activator: Report from the Thrombolysis and Angioplasty in Myocardial Infarction trial. Am Heart J 1990;119:777785. 97. Muller DWM, Topol EJ, Califf RM, Sigmon KN, Gorman L, George BS, Kereiakes DJ, Lee KL, Ellis SG, and the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) Study Group. Relationship between antecedent angina pectoris and short-term prognosis after thrombolytic therapy for acute myocardial infarction. Am Heart J 1990;119:224-231. 98. Muller DWM, Topol EJ, George BS, Kereiakes DJ, Aronson LG, Lee KL, Abbottsmith CW, Ellis SG, Califf RM, and the TAMI Study Group. Two year outcome after angiographically documented myocardial reperfusion for acute coronary occlusion. Am J Cardiol 1990;66:796-801. 99. Clemmensen P, Ohman EM, Sevilla DC, Peck S, Wagner NB, Quigley PS, Grande P, Lee KL, Wagner GS. Changes in standard electrocardiographic ST-segment elevation predictive of successful reperfusion therapy in acute myocardial infarction. Am J Cardiol 1990;66:1407-1411. 100. Krucoff MW, Croll M, Pope JE, Granger C, Pieper K, Sigmon K, Lee KL, Califf RM. Heuristic and logistic principles of ST segment interpretation in the time domain: evolution in the context of the TAMI 7 trial design. J Electrocard 1990;23:6-10. 101. Clemmensen P, Bates ER, Califf RM, Hlatky MA, Aronson L, George BS, Lee KL, Kereiakes DJ, Gacioch G, Berrios E, Topol EJ and the TAMI Study Group. Complete atrioventricular block complicating inferior wall acute myocardial infarction treated with reperfusion therapy. Am J Cardiol 1991;67:225-230. 102. Califf RM, Topol EJ, Stack RS, Ellis SG, George BS, Kereiakes DJ, Samaha JK, Worley SJ, Anderson JL, Woodlief LH, Wall TC, Phillips HR, Abbottsmith CW, Candela RJ, Flanagan WH, Sasahara AA, Mantell SJ, Lee KL. Evaluation of combination thrombolytic therapy and timing of cardiac catheterization in acute myocardial infarction: Results of Thrombolysis and Angioplasty in Myocardial Infarction - Phase 5 randomized trial. Circulation 1991;83:1543-1556. 103. Muller DWM, Topol EJ, Ellis SG, Sigmon KN, Lee KL, Califf RM, and the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) Study Group. Multivessel coronary artery disease: A key predictor of short-term prognosis after reperfusion therapy for acute myocardial infarction. Am Heart J 1991;121:1042-1049. 104. Pryor DB, Lee KL. Methods for the analysis and assessment of clinical databases: The clinician's perspective. Statistics in Medicine 1991;10:617-628. 11 105. Johnson SH, Bigelow C, Lee KL, Pryor DB, Jones RH. Prediction of death and myocardial infarction by radionuclide angiocardiography in patients with suspected coronary artery disease. Am J Cardiol 1991;67:919-926. 106. Pryor DB, Shaw L, Harrell FE Jr, Lee KL, Hlatky MA, Mark DB, Muhlbaier LH, Califf RM. Estimating the likelihood of severe coronary artery disease. Am J Med 1991;90:553562. 107. Brazer SR, Pancotto FS, Long TT III, Harrell FE Jr., Lee KL, Tyor MP. Using ordinal logistic regression to estimate the likelihood of colorectal neoplasia. J Clin Epidemiol 1991;44:1263-1270. 108. Olsen CO, Glower DD, Lee KL, McHale, PA, Rankin JS. Diastolic anisotropic properties of the left ventricle in the conscious dog. Circulation Res 1991;69:765-778. 109. Mark DB, Shaw L, Harrell FE, Hlatky MA, Lee KL, Bengtson JR, McCants CB, Califf RM, Pryor DB. Prognostic value of a treadmill exercise test score in outpatients with suspected coronary artery disease. N Engl J Med 1991;325:849-853. 110. Jones RH, Lee KL, Johnson SH, Bigelow C, Pieper KS, Coleman E, Cobb FR, Pryor DB. Exercise radionuclide angiocardiography predicts cardiac death in patients with coronary artery disease. Circulation 1991;84(I):52-58. 111. Smith LR, Harrell FE, Rankin SJ, Califf RM, Pryor DB, Muhlbaier LH, Lee KL, Mark DB, Jones RH, Oldham HN, Glower DD, Reves JG, Sabiston DC Jr. Determinants of early versus late cardiac death in patients undergoing coronary artery bypass surgery. Circulation 1991;84(III)245-253. 112. Bickell NA, Pieper KS, Lee KL, Mark DB, Glower DD, Pryor DB, Califf RM. Referral patterns for coronary artery disease treatment: gender bias or good clinical judgment? Ann Intern Med 1992;116:791-797. 113. Califf RM, Pieper KS, Harlan WR, Lee KL, Serum cholesterol in patients undergoing cardiac catheterization for suspected coronary artery disease: Diagnostic and prognostic implications. Annals of Epidemiol 1992;2:137-145. 114. Muller DWM, Topol EJ, Harrelson-Woodlief LG, Ellis SG, Dereiakes DJ, George BS, Worley SJ, Samaha JK, Lee KL, Califf RM, and the TAMI 5 Study Group. Determinants of the need for early acute intervention in patients treated conservatively following thrombolytic therapy for acute myocardial infarction. J Am Coll Cardiol 1991;18:15941601. 115. Topol EJ, Califf RM, Vandormael M, Grines CL, George BS, Sanz ML, Wall T, O'Brien M, Schwaiger M, Aguirre FV, Young S, Sigmon K, Popma JJ, Lee KL, Ellis SG and the TAMI 6 Study Group. A randomized trial of late reperfusion therapy for acute myocardial infarction. Circulation 1992;85:2090-2099. 12 116. Muhlbaier LH, Pryor DB, Rankin JS, Smith LR, Mark DB, Jones RH, Glower DD, Harrell FE Jr., Lee KL, Califf RM, Sabiston Jr. Observational comparison of event-free survival with medical and surgical therapy in patients with coronary artery disease: 20 years of follow-up. Circulation 1992;86(II):198-204. 117. Mark DB, Lam LC, Lee KL, Clapp-Channing N, Williams RB, Pryor DB, Califf RM, Hlatky MA. Identification of patients with coronary disease at high risk for loss of employment: a prospective validation study. Circulation 1992;86:1485-1494. 118. Topol EJ, Armstrong P, Van de Werf F, Kleiman N, Lee KL, Morris D, Simoons M, Barbash G, White H, Califf RM on behalf of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) Steering Committee. Confronting the issues of patient safety and investigator conflict of interest in an international clinical trial of myocardial reperfusion. J Am Coll Cardiol 1992;19:11231128. 119. Pryor DB, Shaw L, McCants CB, Lee KL, Mark DB, Harrell FE Jr., Muhlbaier LH, Califf RM. Value of the history and physical examination in identifying patients at increased risk for coronary artery disease. Ann Intern Med 1993;118:81-90. 120. Krucoff MW, Croll MA, Pope JE, Granger CB, O'Connor CM, Sigmon KN, Wagner BL, Ryan JA, Lee KL, Kereiakes DJ, Samaha JK, Worley SJ, Ellis SG, Wall TC, Topol EJ, Califf RM for the TAMI 7 Study Group. Continuous 12-lead ST segment recovery analysis in the TAMI 7 Study: performance of a noninvasive method for real time detection of failed myocardial reperfusion. Circulation 1993;88:437-446. 121. Topol EJ, Leya F, Pinkerton CA, Whitlow PL, Hofling B, Simonton CA, Masden RR, Serruys PW, Leon MB, Williams DO, King SB, Mark DB, Isner JM, Holmes DR, Ellis SG, Lee KL, Keeler G, Berdan LG, Hinohara T, Califf RM for the CAVEAT Study Group. A comparison of directional atherectomy with coronary angioplasty in patients with coronary artery disease. N Engl J Med 1993;329:221-227. 122. Harrison JK, Califf RM, Woodlief L, Kereiakes D, George BS, Stack RS, Ellis SG, Lee KL. O'Neill WW. Topol EJ and the TAMI Study Group. Systolic left ventricular function after reperfusion therapy for acute myocardial infarction: an analysis of determinants of improvement. Circulation 1993;87:1531-1541. 123. Ohman EM, Christenson RH, Califf RM, George BS, Samaha JK, Kereiakes DJ, Worley SJ, Wall TC, Berrios E, Sigmon KN, Lee KL, Topol EJ, and the TAMI 7 Study Group. Noninvasive detection of reperfusion after thrombolysis based on serum creatine kinase MB changes and clinical variables. Am Heart J 1993;126:819-826. 124. Lincoff AM, Califf RM, Ellis SG, Sigmon KN, Lee KL, Leimberger JD, Topol EJ, for the Thrombolysis and Angioplasty in Myocardial Infarction Study Group. Thrombolytic therapy for women with myocardial infarction: is there a gender gap? J Am Coll Cardiol 1993;22:1780-1787. 13 125. Buxton AE, Fisher JD, Josephson ME, Lee KL, Pryor DB, Prystowsky EN, Simson MB, DeCarlo L, Echt DS, Packer D, Greer GS, Talajic M and the MUSTT Investigators. Prevention of sudden death in patients with coronary artery disease: the multicenter unsustained tachycardia trial (MUSTT). Prog Cardiovasc Dis 1993;215-226. 126. The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993;329:673-682. 127. The GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med 1993;329:1615-1622. 128. O'Connor CM, Meese R, Carney R, Smith J, Conn E, Burks J, Hartman C, Roark S, Shadoff N, Heard M III, Mittler B, Collins G, Navetta F, Lee K, Califf RM. A randomized trial of intravenous heparin in conjunction with Anistreplase (APSAC) in acute myocardial infarction: The DUCCS 1 Study. J Am Coll Cardiol 1994;23:11-18. 129. Mark DB, Lam LC, Lee KL, Jones RH, Pryor DB, Stack RS, Williams RB, ClappChanning NE, Califf RM, Hlatky MA. Effects of coronary angioplasty, coronary bypass surgery and medical therapy on employment in patients with coronary artery disease. Ann Intern Med 1994;120:111-117 130. Harrington RA, Sane DC, Califf RM, Sigmon KN, Abbottsmith CW, Candela RJ, Lee KL, Topol EJ, for the Thrombolysis and Angioplasty in Myocardial Infarction Study Group. Clinical importance of thrombocytopenia occurring in the hospital phase after administration of thrombolytic therapy for acute myocardial infarction. J Am Coll Cardiol 1994;23:891-898. 131. Topol EJ, Califf RM, Weisman HF, Ellis SG, Tcheng JE, Worley S, Ivanhoe R, George BS, Fintel D, Weston M, Sigmon K, Anderson KM, Lee KL, Willerson JT, for the EPIC Investigators. Randomised trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months. Lancet 1994;343:881-886. 132. Selker HP, Beshansky JR, Schmid CH, Griffith JL, Longstreth WT, O'Connor CM, Caplan LR, Massey EQ, D'Agostino RB, Laks MM, Maynard C, Wagner GS, Weaver WD, Califf RM. Presenting pulse pressure predicts thrombolytic therapy-related intracranial hemorrhage: thrombolytic predictive instrument (TPI) project results. Circulation 1994;90:1657-1661. 133. Ohman EM, Marques J-F, Ricci DR, Brown R, Knudtson ML, Kereiakes DJ, Samaha JK, Margolis JR, Niederman AL, Dean LS, Gurbel PA, Sketch MH, Wildermann NM, Lee KL, Califf RM, for the Balloon Catheter Study Group. A randomized comparison of the effects of gradual prolonged versus standard primary balloon inflation on early and late outcome: results of a multicenter clinical trial. Circulation 1994;89:1118-1125. 134. The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high risk coronary angioplasty. N Engl J Med 1994;330:956-961. 14 135. Lee KL, Califf RM, Simes J, Van de Werf F, Topol EJ, for the GUSTO Investigators. Holding GUSTO up to the light. Ann Intern Med 1994;120:876-881. 136. Mark DB, Nelson CL, Califf RM, Harrell FE Jr., Lee KL, Jones RH, Fortin DF, Stack RS, Glower DD, Smith LR, DeLong ER, Smith PK, Reves JG, Jollis JG, Tcheng JE, Muhlbaier LH, Lowe JE, Phillips HR, Pryor DB. Continuing evolution of therapy for coronary artery disease: initial results from the era of coronary angioplasty. Circulation 1994;89:20152025. 137. Mark DB, Naylor CD, Hlatky MA, Califf RM, Topol EJ, Granger CB, Knight JD, Nelson CL, Lee KL, Clapp-Channing NE, Sutherland W, Pilote L, Armstrong PW. Use of medical resources and quality of life after acute myocardial infarction in Canada and the United States. N Engl J Med 1994;331:1130-1135. 138. Ohman EM, George BS, White CJ, Kern MJ, Gurbel PA, Freedman RJ, Lundergan C, Hartmann JR, Talley JD, Frey MJ, Taylor G, Leimberger JD, Owens PM, Lee KL, Stack RS, Califf RM, for the Randomized IABP Study Group. Use of aortic counterpulsation to improve sustained coronary artery patency during acute myocardial infarction: results of a randomized trial. Circulation 1994;90:792-799. 139. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIa Investigators. Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. Circulation 1994;90:1631-1637. 140. Maynard C, Selker HP, Beshansky JR, Griffith JL, Schmid CH, Califf RM, D’Agostino RB, Laks MM, Lee, KL, Wagner GS, Weaver WD. The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database. Med Decis Making 1995;15:38-43. 141. Lee KL, Woodlief LH, Topol EJ, Weaver WD, Betriu A. Col J, Simoons M, Aylward P, Van de Werf F, Califf RM. Predictors of 30-day mortality in the era of reperfusion for acute myocardial infarction: results from an international trial of 41,021 patients. Circulation 1995;91:1659-1668. 142. Mark, DB, Hlatky MA, Califf RM, Naylor CD, Phil D, Lee KL, Armstrong PW, Barbash G, White H, Simoons ML, Nelson CL, Clapp-Channing N, Knight D, Harrell FE Jr, Simes J, Topol EJ. Cost effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction. N Engl J Med 1995;332:1418-1424. 143. Lipscomb J, Kilpatrick KE, Lee KL, Pieper KS. Determining VA physician requirements through empirically based models. Health Serv Res 1995;29:697-717. 144. Harlan WR, Sandler SA, Lee KL, Lam LE, Mark DB. Importance of baseline functional and socioeconomic factors for participation in cardiac rehabilitation. Am J Cardiol 1995;76:36-39. 15 145. Van de Werf F, Topol EJ, Lee KL, Woodlief LH, Granger CB, Armstrong PW, Barbash GI, Hampton JR, Guerci A, Simes RJ et al. Variations in patient management and outcomes for acute myocardial infarction in the United States and other countries. Results from the GUSTO trial. Global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries. JAMA 1995;273-1586-1591. 146. Lincoff AM, Topol EJ, Califf RM, Sigmon KN, Lee KL, Ohman EM, Rosenchein U, Ellis SG, for the Thrombolysis and Angioplasty in Myocardial infarction Study Group. Significance of a coronary artery with thrombolysis in myocardial infarction grade 2 flow “patency” (outcome in the thrombolysis and angioplasty in myocardial infarction trials). Am J Cardiol 1995;75:871-876. 147. Holmes DR, Topol EJ, Califf RM, Berdan LG, Leya F, Berger PB, Whitlow PL, Safian RD, Adelman AG, Kellett MA Jr, Talley JD, Shani J, Gottlieb RS, Pinkerton CA, Lee KL, Keeler GP, Ellis SG, the CAVEAT-II Investigators. A Multicenter, Randomized Trial of Coronary Angioplasty Versus Directional Atherectomy for Patients With Saphenous Vein Bypass Graft Lesions. Circulation 1995;91:1966-1974. 148. Hlatky MA, Lam LC, Lee KL, Clapp-Channing NE, Williams RB, Pryor DB, Califf RM, Mark DB. Job strain and the prevalance and outcome of coronary artery disease. Circulation 1995;92(3)327-333. 149. Harrell FE Jr., Lee KL, Mark DB. Tutorial in biostatistics. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med 1996;15:361-387. 150. Granger CB, Hirsch J, Califf RM, Col J, White HD, Betriu A, Woodlief LH, Lee KL, Bovill EG, Simes RJ, Topol EJ for the GUSTO-I Investigators. Activated partial thromboplastin time and outcome after thrombolytic therapy for acute myocardial infarction. Results from the GUSTO-I trial. Circulation 1996;93:870-878. 151. Buxton AE, Lee KL, DiCarlo L, Echt DS, Fisher JD, Greer S, Josephson ME, Packer D, Prystowsky EN, Talajic M, for the MUSTT Investigators. Nonsustained ventricular tachycardia in coronary artery disease: relation to inducible sustained ventricular tachycardia. Ann Intern Med 1996;125:35-39. 152. Newby LK, Rutsch WG, Califf, RM, Simoons ML, Aylward PE, Armstrong PW, Woodlief LH, Lee KL, Topol EJ, Van de Werf F for the GUSTO-I Investigators. Time from symptom onset to treatment and outcomes after thrombolytic therapy. J Am Coll Cardiol 1996;27:1646-1655. 153. Mark DB, Talley JD, Topol EJ, Bowman L, Lam LC, Anderson KM, Jollis JG, Cleman MW, Lee KL, Aversano T, Untereker WJ, Davidson-Ray L, Califf RM for the EPIC Investigators. Economic assessment of platelet glycoprotein IIb/IIIa inhibition for prevention of ischemic complications of high-risk coronary angioplasty. Circulation 1996;94:629-635. 16 154. White HD, Barbash GI, Califf, RM, Simes, RJ, Granger CB, Weaver WD, Kleiman NS, Aylward PE, Gore JM, Vahanian JA, Lee KL, Ross AM, Topol EJ for the GUSTO-I Investigators. Age and outcome with contemporary thrombolytic therapy: results from the GUSTO-I trial. Circulation 1996;94:1826-1833. 155. Califf RM, White HD, Van de Werf F, Sandowski Z, Armstrong PW, Vahanian A, Simoons ML, Simes J, Lee KL, Topol EJ for the GUSTO-I Investigators. One-year results from the global utilization of streptokinase and TPA for occluded coronary arteries (GUSTO-I) Trial. Circulation 1996;94:1233-1238. 156. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb Investigators. A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes. N Engl J Med 1996;335:775-782. 157. Topol EJ, Califf RM, Van de Werf F, Simoons M, Hampton J., Lee KL, White H, Simes J, Armstrong PW, for the Virtual Coordinating Center for Global Collaborative Cardiovascular Research (VIGOUR) Group. Perspectives on large scale cardiovascular clinical trials in the new millennium. Circulation 1997;95:1072-1082. 158. Califf RM, Woodlief LH, Harrell FE Jr., Lee KL, White HD, Guerci A, Barbash GI, Simes RJ, Weaver WD, Simoons ML, Topol EJ, for the GUSTO-I Investigators. Selection of thrombolytic therapy for individual patients: development of a clinical model. Am Heart J 1997;133(6):630-639. 159. Wilkins ML, Maynard C, Elias WJ, Turner J, Lee KL, Anderson ST, Annex B, Clemmensen P, Gibson RS, Pryor AD, Wagner GS. Admission prediction of expected final myocardial infarct size using weighted ST-segment, Q wave, and T wave measurements. J Electrocard 1997;30:1-7. 160. Tardiff BE, Califf RM, Morris D, Bates E, Woodlief LH, Lee KL, Green C, Rutsch Betriu A, Ayward PE, Topol EJ, for the GUSTO Investigators. Coronary revascularization surgery after myocardial infarction: impact of bypass surgery on survival after thrombolysis GUSTO investigators. Global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries. J Am Coll Cardiol 1997;29(2):240249. 161. Selker HP, Griffith JL, Beshansky JR, Schmid CH, Califf RM, D’Agostino RB, Laks Lee KL, Maynard C, Selvester RH, Wagner GS, Weaver WD. Patient-specific predictions of outcomes in myocardial infarction for real-time emergency use: a thrombolytic predictive instrument. Ann Intern Med 1997;127(7):538-556. 162. Berkowitz SD, Granger CB, Pieper KS, Lee KL, Gore JM, Simoons M, Armstrong Topol EJ, Califf RM. Incidence and predictors of bleeding after contemporary thrombolytic therapy for myocardial infarction. The Global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-I) investigators. Circulation 1997;95(11):2508-2516. 17 163. Califf RM, Lee KL, Granger CB, Ohman EM. Predictors of outcome of reperfusion therapy. Eur Heart J 1997;18(5):728-735. 164. Bart BA, Shaw LK, McCants CB Jr., Fortin DF, Lee KL, Califf RM, O’Connor CM. Clinical determinants of mortality in patients with angiographically diagnosed ischemic or nonischemic cardiomyopathy. J Am Coll Cardiol 1997;30(4):1002-1008. 165. Tsang TS, Califf RM, Stebbins AL, Lee KL, Cho S, Ross AM, Armstrong PW. Incidence and impact on outcome of streptokinase allergy in the GUSTO-I trial. Global utilization of streptokinase and t-PA in occluded coronary arteries. Am J Cardiol 1997;79(9):1232-1235. 166. The Global use of strategies to open occluded coronary arteries in acute coronary syndromes (GUSTO IIb) angioplasty substudy investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. N Engl J Med 1997;336:1621-1628. 167. The GUSTO-III Investigtators. A comparison of reteplase with alteplase for acute myocardial infarction. N Engl J Med 1997;337:1118-1123. 168. The IMPACT II Investigators. Randomized placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention: IMPACT II. Lancet 1997;349:1422-1428. 169. Pracyk JB, Wall TC, Longabaugh JP, Tice FD, Hochrein J, Green C, Cox G, Lee KL, Stach RS, Tcheng JE. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol 1998;81(8):970-976. 170. The PURSUIT Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. N Engl J Med 1998;339:436-443. 171. Hochrein J, Sun FC, Pieper KS, Lee KL, Gates KB, Armstrong PW, Weaver WD, Goodman SG, Topol EJ, Califf RM, Granger CB, Wagner GS. Higher T-wave amplitude associated with better prognosis in patients receiving thrombolytic therapy for acute myocardial infarction (a GUSTO-I substudy). Am J Cardiol 1998;81(9):1078-1084. 172. Pfisterer M, Cox JL, Granger CB, Brener SJ, Naylor CD, Califf RM, Van de Werf F, Stebbins AL, Lee KL, Topol EJ, Armstrong PW, for the GUSTO-I Investigators. Atenolol use and clinical outcomes after thrombolysis for acute myocardial infarction: the GUSTO-I experience. J Am Coll Cardiol 1998;32(3):634-640. 173. Newby LK, Christenson RH, Ohman EM, Armstrong PW, Thompson TD, Lee KL, Hamm CW, Katus HA, Cianciolo C, Granger CB, Topol EJ, Califf RM. Value of serial troponin T measures for early and late risk stratification in patients with acute coronary syndromes. The GUSTO-IIa Investigators. Circulation 1998;98(18):1853-1859. 174. Armstrong PW, Fu Y, Chang WC, Topol EJ, Granger CB, Betriu A, Van de Werf F, Lee KL, Califf RM. Acute coronary syndromes in the GUSTO-IIb trial: prognostic insights and impact of recurrent ischemia. The GUSTO-IIb Investigators. Circulation 1998;98(18):1860-1868. 18 175. The PARAGON Investigators. International, randomized, controlled trial of lamifiban (a platelet glycoprotein IIb/IIIa inhibitor), heparin, or both in unstable angina. Circulation 1998;97:2386-2395. 176. Buxton AE, Hafley GE, Lehmann MH, Gold M, O’Toole M, Tang A, Coromilas J, Hook B, Stamato NJ, Lee KL. Prediction of sustained ventricular tachycardia inducible by programmed stimulation in patients with coronary artery disease. Utility of clinical variables. Circulation 1999;99(14):1843-1850. 177. Buxton, AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley GE for the Multicenter Unsustained Tachycardia Trial Investigators. A randomized, controlled trial of the prevention of sudden death in patients with coronary artery disease. N Engl J Med 1999;341:1882-1889. 178. Steyerberg EW, Bossuyt PM, Lee KL. Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics? AM Heart J 2000;139:745-751. 179. Steyerberg EW, Eijkemans MJC, Van Houwelingen JC, Lee KL, Habbema JDF. Prognostic models based on literature and individual patient data in logistic regression analysis. Statistics in Medicine 2000;19:141-160. 180. Califf RM, Pieper KS, Lee KL, Van de Werf F, Simes RJ, Armstrong PW, Topol EJ. Prediction of 1-year survival after thrombolysis for acute myocardial infarction in the global utilization of streptokinase and TPA for occluded coronary arteries trial. Circulation 2000;101:2231-2238. 181. Boersma E, Pieper KS, Steyerberg EW, Wilcox RG, Chang WC, Lee KL, Akkerhuis KM, Harrington RA, Deckers JW, Armstrong PW, Lincoff AM, Califf RM, Topot EJ, Simoons ML. Predictors of outcome in patients with acute coronary syndromes without persistent ST-segment elevation. Results from an international trial of 9,461 patients. The PURSUIT Investigators. Circulation 2000;101:2557-2567. 182. The SYMPHONY Investigators. Comparison of sibrafiban with aspirin for prevention of cardiovascular events after acute coronary syndromes: a randomized trial. Lancet 2000;355:337-345. 183. Buxton AE, Lee KL, DiCarlo L, Gold MR, Greer GS, Prystowsky EN, O’Toole MF, Tang A, Fisher JD, Coromilas J, Talajic M, Hafley G for the Multicenter Unsustained Tachycardia Trial Investigators. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death. N Engl J Med 2000;342:19371945. 184. Lamas GA, Lee KL, Sweeney M, Leon A, Yee R, Ellenbogen K, Greer S, Wilber D, Silverman R, Marinchak R, Bernstein R, Mittleman RS, Lieberman EH, Sullivan C, Zorn L, Flaker G, Schron E, Orav EJ, Goldman L. The Mode Selection Trial (MOST) in sinus node dysfunction: design, rationale, and baseline characteristics of the first 1000 patients. Am Heart J 2000;140(4):541-551. 19 185. Singh SN, Karasik P, Hafley GE, Pieper KS, Lee KL, Wyse G, Burton AE for the MUSTT Investigators. Electrophysiologic and Clinical Effects of Angiotensin-Coverting Enzyme Inhibitors in Patients With Prior Myocardial Infarction, Nonsustained Ventricular Tachycardia, and Depressed Left Ventricular Function. Am J Cardiol 2001;87:716-720. 186. Gomes JA, Cain ME, Buxton AE, Josephson ME, Lee KL, Hafley GE. Prediction of LongTerm Outcomes by Signal-Averaged Electrocardiography in Patients With Unsustained Vertricular Tachycardia, Coronary Artery Disease, and Left Ventricular Dysfunction. Circulation 2001;104:436-441. 187. Second SYMPHONY Investigators. Randomized trial of aspirin, sibrafiban, or both for secondary prevention after acute coronary syndromes. Circulation 2001;103:1727-1733. 188. DeLong ER, Nelson CL, Wong JB, Pryor DB, Peterson ED, Lee KL, Mark DB, Califf RM, Pauker SG. Tutorial in Biostatistics – Using Observational Data to Estimate Prognosis: An Example Using a Coronary Artery Disease Registry. Statistics in Medicine 2001;20:2505-2532. 189. Pires LA, Lehmann MH, Buxton AE, Hafley GE, Lee KL, and the Multicenter Unsustained Tachycardia Trial Investigators. Differences in Inducibility and Prognosis of In-Hospital Versus Out-of Hospital Identified Nonsustained Ventricular Tachycardia in Patients With Coronary Artery Disease: Clinical and Trial Design Implications. JACC 2001;38(4):115662. 190. Al-Khatib SM, Pieper KS, Lee KL, Mahaffey KW, Hochman JS, Pepine CJ, Kopecky SL, Akkerhuis M, Stepinska J, Simoons ML, Topol EJ, Califf RM, Harrington RA. Atrial fibrillation and mortality among patients with acute coronary syndromes without STsegment elevation: Results from the PURSUIT trial. Am J Cardiol 2001;88:76-9. 191. Mahaffey KW, Harrington RA, Akkerhuis M, Kleiman NS, Berdan LG, Crenshaw BS, Tardiff BE, Granger CB, DeJong I, Bhapkar M, Widimsky P, Corbalan R, Lee KL, Deckers JW, Simoons ML, Topol EJ, Califf RM. Systematic adjudication of myocardial infarction endpoints in an international clinical trial. Curr Control Trials Cardiovasc Med 2001; 2:180-186. 192. Mahaffey KW, Harrington RA, Akkerhuis M, Kleiman NS, Berdan LG, Crenshaw BS, Tardiff BE, Granger CB, DeJong I, Bhapkar M, Widimsky P, Corbalan R, Lee KL, Deckers JW, Simoons ML, Topol EJ, Califf RM. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study. Curr Control Trials Cardiovasc Med 2001; 2:187-194. 193. The Platelet IIb/IIIa Antagonist for the Reduction of Acute coronary syndrome events in a Global Organization Network (PARAGON)-B Investigators. Randomized, placebocontrolled trial of titrated intravenous lamifiban for acute coronary syndromes. Circulation 2002;105:316-321. 20 194. Mahaffey KW, Roe MT, Dyke CK, Newby LK, Kleiman NS, Connolly P, Berdan LG, Sparapani R, Lee KL, Armstrong PW, Topol EJ, Califf RM, Harrington RA. Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second platelet IIb/IIIa antagonist for the reduction of acute coronary syndrome events in a global organization network trial. Am Heart J 2002;143:242-8. 195. Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Goldman L for the MOST Investigators. A randomized trial of ventricular pacing or dual-chamber pacing for sinus node dysfunction. N Engl J Med 2002;346:1854-1862. 196. O’Connor CM, Velazquez EJ, Gardner LH, Smith PK, Newman MF, Landolfo KP, Lee KL, Califf RM, Jones RH. Comparison of coronary artery bypass grafting versus medical therapy on long-term outcome in patients with ischemic cardiomyopathy (a 25-year experience from the Duke cardiovascular disease databank). Am J Cardiol 2002;90:101107. 197. Lee KL, Hafley G, Fisher JD, Gold MR, Prystowsky EN, Talajic M, Josephson ME, Packer DL, Buxton AE, for the multicenter unsustained tachycardial trial investigators. The effects of implantable defibrillators on arrhythmic events and mortality in the Multicenter Unsustained Tachycardia Trial. Circulation 2002;106:233-238. 198. Page RL, Kerber RE, Russell JK, Trouton T, Waktare J, Gallik D, Olgin JE, Ricard P, Dalzell GW, Reddy R, Lazzara R, Lee KL, Carlson M, Halperin B, Bardy GH, for the BiCard Investigators. Biphasic versus monophasic shock waveform for conversion of atrial fibrillation: the results of an international randomized, double-blind multicenter trial. J Am Coll Cardiol 2002;39:1958-1963. 199. Al-Khatib SM, Granger CB, Huang Y, Lee KL, Califf RM, Simoons ML, Armstrong PW, Van de Werf F, White HD, Simes RJ, Moliterno DJ, Topol EJ, Harrington RA. Sustained ventricular arrhythmias among patients with acute coronary syndromes with no STsegment elevation: incidence, predictors, and outcomes. Circulation 2002;106:309-312. 200. Buxton AE, Lee KL, Hafley GE, Wyse DG, Fisher JD, Lehmann, MH, Pires LA Gold MR, Packer DL, Josephson ME, Prystowsky EN, Talajic MR for the MUSTT Investigators. Relation of ejection fraction and inducible ventricular tachycardia to mode of death in patients with coronary artery disease. An analysis of patients enrolled in the Multicenter Unsustained Tachycardia Trial. Circulation 2002;106:2466-2472. 201. Ellison KE, Hafley GE, Hickey K, Kellen J, Coromilas J, Stein KM, Lee KL, Buxton AE for the MUSTT Investigators. Effect of beta-blocking therapy on outcome in the Multicenter Unsustained Tachycardia Trial (MUSTT). Circulation 2002;106:2694-2699. 202. Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA, for the MOde Selection Trial (MOST) Investigators. Adverse Effect of Ventriculat Pacing on Heart Failure and Atrial Fibrillation Among Patients With Normal Baseline QRS Duration in a Clinical Trial of Pacemaker Therapy for Sinus Node Dysfunction. Circulation 2003;107:2932-2937. 21 203. Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA, for the MOST Investigators. Atrial High Rate Episodes Detected by Pacemaker Diagnostics Predict Death and Stroke: Report of the Atrial Diagnostics Ancillary Study of the Mode Selection Trial (MOST). Circulation 2003;107:1614-1619. 204. Russo AM, Hafley GE, Lee KL, Stamato NJ, Lehmann MH, Page RL, Kus T, Buxton AE, for the Multicenter UnSustained Tachycardia Trial Investigators. Racial differences in dutcome in the Multicenter UnSustained Tachycardia Trial (MUSTT): a comparison of whites versus blacks. Circulation 2003;108:67-72. 205. Al-Khatib SM, Stebbins AL, Califf RM, Lee KL, Granger CB, White HD, Armstrong PW, Topol EJ, Ohman EM, for the GUSTO-III Trial Investigators. Sustained ventricular arrhythmias and mortality among patients with acute myocardial infarction: results from the GUSTO-III trial. Am Heart J 2003;145:515-521. 206. Ellenbogen KA, Hellkamp AS, Wilkoff BL, Camunas JL, Love JC, Hadjis TA, Lee KL, Lamas GA. Complications arising after implantation of DDD pacemakers: the MOST experience. Am Heart J 2003;92:740-749. 207. Flaker G, Greenspon A, Tardiff B, Schron E, Goldman L, Hellkamp A, Lee KL, Lamas G, for the Mode Selection Trial (MOST) Investigators. Death in patients with permanent pacemakers for sick sinus syndrome. Am Heart J 2003;146:887-893. 208. Kramer JM, Newby LK, Chang W, Simes RJ, Van de werf F, Granger CB, Lee KL, White HD, Piegas LS, Topol EJ, Califf RM, Armstrong PW for the SYMPHONY and 2 nd SYMPHONY Investigators. International variation in the use of evidence-based medicines for acute coronary syndromes. Eur Heart J 2003;24:2133-2141. 209. Kandazari DE, Granger CB, Simoons ML, White HD, Simes J, Mahaffey KW, Gore J, Weaver WD, Longstreth WT Jr., Stebbins A, Lee KL, Califf RM, Topol EJ for the Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries-I Investigators. Risk factors for intracranial hemorrhage and nonhemorrhagic stroke after fibrinolytic therapy (from the GUSTO-I trial). Am J Cardiol 2004;93:458-461. 210. Greenspon AJ, Hart RG, Dawson D, Hellkamp AS, Silver M, Flaker GC, Schron E, Goldman L, Lee KL, Lamas GA. Predictors of stroke in patients paced for sick sinus syndrome. J Am Coll Cardiol 2004;43:1617-1622. 211. Link MS, Hellkamp AS, Estes NA 3rd, Orav EJ, Ellenbogen KA, Ibrahim B, Greenspon A, Rizo-Patron C, Goldman L, Lee KL, Lamas GA. High incidence of pacemaker syndrome in patients with sinus node dysfunction treated with ventricular-based pacing in the Mode Selection Trial (MOST). J Am Coll Cardiol 2004;43:2066-2071. 212. Sweeney MO, Hellkamp AS, Ellenbogen KA, Glotzer TV, Silverman R, Yee R, Lee KL, Lamas GA. Prospective randomized study of mode switching in a clinical trial of pacemaker therapy for sinus node dysfunction. J Cardiovas Electrophysiology 2004;15:153-160. 22 213. Kaul P, Armstrong PW, Chang WC, Naylor CD, Granger CB, Lee KL, Peterson ED, Califf RM, Topol EJ, Mark DB. Long-term mortality of patients with acute myocardial infarction in the United States and Canada: a comparison of patients enrolled in GUSTO-I. Circulation 2004;110:1754-1760. 214. Armstrong PW, Newby LK, Granger CB, Lee KL, Simes RJ, van de Werf F, White HD, Califf RM, for the Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (VIGOUR) Group. Lessons learned from a clinical trial. Circulation 2004;110:3610-3614. 215. Alkhatib SM, Shaw LK, Lee KL, O’Connor C, Califf RM. Is rhythm control superior to rate control in patients with atrial fibrillation and congestive heart failure? Am J Cardiol 2004; 94:797-800. 216. Russo AM, Stamato NJ, Lehmann MH, Hafley GE, Lee KL, Pieper K, Buxton AE, MUSTT Investigators. Influence of gender on arrhythmia characteristics and outcome in the Multicenter UnSustained Tachycardia Trial. J Cardiovasc Electrophysiol 2004;15:993998. 217. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH, for the Sudden Cardiac Death in Heart Failure Trial (SCDHeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225-237. 218. Rinfret S, Cohen DJ, Lamas GA, Fleischmann KE, Weinstein MC, Orav J, Schron E, Lee KL, Goldman L. Cost-effectiveness of dual-chamber pacing compared with ventricular pacing for sinus node dysfunction. Circulation 2005;111:165-172. 219. Ohman EM, Nanas J, Stomel RJ, Leesar MA, Nielsen DW, O’Dea D, Rogers FJ, Harber D, Hudson MP, Fraula E, Shaw LK, Lee KL. Thrombolysis and counterpulsation to improve survival in myocardial infarction complicated by hypotension and suspected cardiogenic shock or heart failure: results of the TACTICS Trial. J Thromb Thrombolysis 2005;91:33-39. 220. Shukla HH, Hellkamp AS, James EA, Flaker GC, Lee KL, Sweeney MO, Lamas GA, for the Mode Selection Trial (MOST) Investigators. Heart failure hospitalization is more common in pacemaker patients with sinus node dysfunction and a prolonged paced QRS duration. Heart Rhythm 2005;2:245-251. 221. Liao L, Kong DF, Shaw LK, Sketch MH Jr, Milano CA, Lee KL, Mark DB. A new anatomic score for prognosis after cardiac catheterization in patients with previous bypass surgery. J Am Coll Cardiol 2005;46:1684-1692. 222. Sweeney MO, Hellkamp AS, Lee KL, Lamas GA, for the MODE Selection Trial (MOST) Investigators. Association of prolonged QRS duration with death in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation 2005;111;2418-2123. 23 223. Alexander JH, Ferguson TB Jr, Joseph DM, Mack MJ, Wolf RK, Gibson CM, Gennevois D, Lorenz TJ, Harrington RA, Peterson ED, Lee KL, Califf RM, Kouchoukos NT, PREVENT IV Investigators. The project of ex-vivo vein graft engineering via transfection iv (PREVENT IV) trial: study rationale, design, and baseline patient characteristics. Am Heart J 2005;150:643-649. 224. Al-Khatib SM, Sanders GD, Mark DB, Lee KL, Bardy GH, Bigger JT, Buxton AE, Connolly S, Kadish A, Moss A, Feldman AM, Ellenbogen KA, Singh S, Calliff RM. Implantable cardioverter defibrillators and cardiac resynchronization therapy in patients with left ventricular dysfunction: randomized trial evidence through 2004. Am Heart J 2005;149:1020-1034. 225. Krucoff MW, Crater SW, Gallup D, Blankenship JC, Cuffe M, Guarneri M, Krieger RA, Kshettry VR, Morris K, Oz M, Pichard A, Sketch MH Jr, Koenig HG, Mark D, Lee KL. Music, imagery, touch, and prayer as adjuncts to interventional cardiac care: the Monitoring and Actualization of Noetic Trainings (MANTRA) II randomized study. Lancet 2005;366:211-217. 226. Lewis EF, Hellkamp AS, Pfeffer MA, Greenspon AJ, Machado C, Singh S, Schron E, Lee KL, Lamas GA. The association of the heart failure score with mortality and heart failure hospitalizations in elderly patients: insights from the Mode Selection Trial (MOST). Am Heart J 2006; 151:699-705. 227. Hellkamp AS, Lee KL, Sweeney MO, Link MS, Lamas GA for the MOST Investigators. Treatment crossovers did not affect randomized treatment comparisons in the Mode Selection Trial (MOST). J Am Coll Cardiol 2006;47:2260-2266. 228. Healey JS, Toff WD, Lamas GA, Andersen HR, Thorpe KE, Ellenbogen KA, Lee KL, Skene AM, Schron EB, Skehan JD, Goldman L, Roberts RS, Camm AJ, Yusuf S, Connolly SJ. Cardiovascular outcomes with atrial-based pacing compared with ventricular pacing: meta-analysis of randomized trials, using individual patient data. Circulation 2006;114:1117. 229. Petersen JL, Haque G, Hellkamp AS, Flaker GC, Mark EN, III, Marchlinski FE, McAnulty JH, Greenspon AJ, Marinchak RA, Lee KL, Lamas GA, Mahaffey KW. Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials 2006;27:260-268. 230. Fleischmann KE, Orav EJ, Lamas GA, Mangione CM, Schron E, Lee KL, Goldman L. Pacemaker implantation and quality of life in the Mode Selection Trial (MOST). Heart Rhythm 2006;3:653-659. 231. Smith PK, Califf RM, Tuttle RH, Shaw LK, Lee KL, Delong ER, Lilly RE, Sketch MH Jr., Peterson ED, Jones RH. Selection of surgical or percutaneous coronary intervention provides differential longevity benefit. Ann Thorac Surg 2006;82:1420-1429. 24 232. Mark DB, Nelson CL, Anstrom KJ, Al-Khatib SM, Tsiatis AA, Cowper PA, ClappChanning NE, Davidson-Ray L, Poole JE, Johnson G, Anderson J, Lee KL, Bardy GH, for the SCD-HeFT Investigators. Cost-effectiveness of defibrillator therapy or amiodarone in chronic stable heart failure: results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Circulation 2006;114:135-142. 233. Singh SN, Poole J, Anderson J, Hellkamp AS, Karasik P, Mark DB, Lee KL, Bardy GH and the SCD-HeFT Investigators. Role of amiodarone or implantable cardioverter/defibrillator in patients with atrial fibrillation and heart failure. Am Heart J 2006;152:974.e7-974.e11. 234. Whellan DJ, O’Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Pina IL, on behalf of the HF-ACTION Trial Investigators. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J 2007;153:201-211. 235. Bensimhon DR, Adams GL, Whellan DJ, Pagnanelli RA, Trimble M, Lee BA, Lee KL, Ellis SJ, Kraus WE, Rendall DS, Iskandrian AE, O'Connor CM, Borges-Neto S, HFACTION Trial Investigators. Effect of exercise training on ventricular function, dyssynchrony, resting myocardial perfusion, and clinical outcomes in patients with heart failure: a nuclear ancillary study of Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION); design and rationale. Am Heart J 2007;154:46-53. 236. Dickinson MG, Ip JH, Olshanky B, Hellkamp AS, Anderson J, Poole JE, Mark DB, Lee KL, Bardy GH. Statin use was associated with reduced mortality in both ischemic and nonischemic cardiomyopathy and in patients with implantable defibrillators: mortality data and mechanistic insights from SCD-HeFT. Am Heart J 2007;153:573-578. 237. Mindel JS, Anderson J, Johnson G, Hellkamp A, Poole JE, Mark DB, Lee KL, Bardy GH, SCD-HeFT Investigators. Absence of bilateral vision loss from amiodarone: a randomized trial. Am Heart J 2007;153:837-842. 238. Fisher JD, Buxton AE, Lee KL, Packer DL, Echt DS, Denes P, Lehmann MH, DiMarco JP, Roy D, Hafley GE, MUSTT Events Committee. Designation and distribution of events in the Multicenter UnSustained Tachycardia Trial (MUSTT). Am J Cardiol 2007;100:76-83. 239. Olshansky B, Wood F, Hellkamp AS, Poole JE, Anderson J, Johnson GW, Boineau R, Domanski MJ, Mark DB, Lee KL, Bardy GH, SCD-HeFT Investigators. Where patients with mild to moderate heart failure die: results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Am Heart J 2007;153:1089-94. 240. Freudenberger RS, Hellkamp AS, Halperin JL, Poole J, Anderson J, Johnson G, Mark DB, Lee KL, Bardy GH, SCD-HeFT Investigators. Risk of thromboembolism in heart failure: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Circulation. 2007;115:2637-41. 25 241. Sanders GD, Al-Khatib SM, Berliner E, Bigger JT, Buxton AE, Califf RM, Carlson M, Curtis AB, Curtis JP, Domanski M, Fain E, Gersh BJ, Gold MR, Goldberger J, HaghighiMood A, Hammill SC, Harder J, Healey J, Hlatky MA, Hohnloser SH, Lee KL, Mark DB, Mitchell B, Phurrough S, Prystowsky E, Smith JM, Stockbridge N, Temple R, Expert panel participating in a Duke Center for the Prevention of Sudden Cardiac Death-sponsored conference. Preventing tomorrow's sudden cardiac death today: part II: Translating sudden cardiac death risk assessment strategies into practice and policy. Am Heart J 2007;153:951959. 242. Buxton AE, Lee KL, Hafley GE, Pires LA, Fisher JD, Gold MR, Josephson ME, Lehmann MH, Prystowsky EN, for the MUSTT Investigators. Limitations of ejection fraction for prediction of sudden death risk in patients with coronary artery disease: lessons from the MUSTT study. J Am Coll Cardiol 2007;50:1150-1157. 243. Lamas GA, Knight JD, Sweeney MO, Mianulli M, Jorapur V, Khalighi K, Cook JR, Silverman R, Rosenthal L, Clapp-Channing N, Lee KL, Mark DB. Impact of ratemodulated pacing on quality of life and exercise capacity—evidence from the Advanced Elements of Pacing Randomized Controlled Trial (ADEPT). Heart Rhythm 2007;4:11251132. 244. Velazquez EJ, Lee KL, O’Connor CM, Oh JK, Bonnow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH, for the STICH Investigators. The rationale and design of the surgical treatment for ischemic heart failure (STICH) Trial. J Thorac Cardiovasc Surg 2007;134:1540-1547. NON-REFEREED PUBLICATIONS 1. Lee KL. Some statistical test for clusters. Institute of Statistics Mimeo Series No. 1036. University of NC at Chapel Hill, 1975. 1. Tolley HD, Lee KL. Partitioning the effects of concomitant variables in survival analysis. Institute of Statistics Mimeo Series No. 1048. University of NC at Chapel Hill, 1975. 2. Starmer CF, Lee KL, Harrell FE Jr, Rosati RA. A database approach for stabilizing clinical decisions in the setting of chronic illness. Comp App Med Care 1979;777-786. 3. Harrell FE Jr, Lee KL, McKinnis RA. Procedures for large regression problems requiring maximum likelihood estimation. Proc 4th Annual Conference, SAS Users Group International 1980;4:199-202. 4. Harrell FE Jr, Lee KL, McKinnis RA. Enhancements in logistic and proportional hazard regression procedures. Proc 5th Annual Conference, SAS Users Group International 1981;5:166-168. 5. Harrell FE Jr, Lee KL, Grizzle JE. Additional comments on "some statistical methods useful in circulation research" [letter]. Circ Res 1981;48:592-594. 26 6. Pryor DB, Harrell FE Jr, Lee KL, Califf RM, Rosati RA. Using experience to improve clinical decision making. Proc 7th Symposium on Computer Applications in Medical Care 1983:936-939. 7. McKinnis RA, Harrell FE Jr, Lee KL. Discriminant function analysis using thallium-201 scintiscans and exercise stress variables to predict coronary heart disease [letter]. Am J Cardiol 1983;51:1565-1565. 8. Harrell FE Jr, Lee KL. The practical value of logistic regression. Proc 9th Annual Conference, SAS Users Group International 1985;9:1031-1036. 9. Harrell FE Jr, Lee KL, McKinnis RA, Hlatky MA, Mark DB, Califf RM, Pryor DB. Analysis of risk factors for sudden death after acute myocardial infarction [letter]. Am J Cardiol 1985;55:621-622. 10. Harrell FE Jr, Lee KL. Verifying assumptions of the Cox proportional hazards model. Proc 11th Annual Conference, SAS Users Group International 1986;10:823-828. 11. Harrell FE Jr, Pollock BG, Lee KL. Graphical methods for the analysis of survival data. Proc 12th Annual Conference, SAS Users Group International 1987;12:1107-1115. 12. Harrell FE Jr, Lee KL. Simple tests of global association in the logistic model. Am Stat 1987;41:87. 13. Boswick JM, Lee KL, Aronson LG, O'Connor CM, Honan MB, Califf RM, Pryor DB. Use of computerized statistical models to educate medical housestaff in estimating clinical outcomes. Proceedings of 11th Annual Symposium of Computer Applications in Medical Care 1987;1:162-165. 14. Mark DB, Hlatky MA, Harrell FE Jr, Lee KL, Califf RM, Pryor DB. Reply: Treadmill score for predicting prognosis in coronary artery disease [letter]. Ann Intern Med 1987;107:595-596. 15. Simpson EV, Ideker RE, Lee KL, Smith WM. Computing ROC curve confidence intervals for cardiac activation detectors. Proc 11th Annual International Conference, IEEE Engineering in Medicine & Biology 1989;226-227. 16. Topol EJ, Califf RM, Lee KL. The irony of biased editors who write editorials. GUSTO Investigators [editorial]. Br J Clin Pract 1993;47(6)283-284. 17. Lee KL, Califf RM, Topol EJ. The last word on GUSTO for now [letter; comment] [see comments]. Ann Intern Med 1994;120(11):970. 18. Topol EJ, Califf RM, Lee KL. More on the GUSTO trial [letter; comment]. N Engl J Med 1994;331(10):687 and 10;331(19):1323. 19. Bardy GH, Fishbein DP, Poole JE, Mark D, Lee KL. A proposed trial for the prevention of sudden cardiac death in patients with congestive heart failure. Proceedings of 12th International Congress “The New Frontiers of Arrhythmias.” 1996;342-352. 27 20. Ohman EM, Granger CB, Harrington RA, Lee KL. Risk stratification and therapeutic decision making in acute coronary syndromes [editorial]. JSMS 2000;284:876-878. 21. Lee KL, Sample size and interim analysis issues for dose selection. Am Heart J 2000;139(4):S161-5. 22. Califf RM, Lee KL. Data and safety monitoring committees: Philosophy and practice. Am Heart J 2001;141:154-155. 23. Krucoff MW, Crater SW, Lee KL. From efficacy to safety concerns: a step forward or a step back for clinical research and intercessory prayer?: The Study of Therapeutic Effects of Intercessory Prayer (STEP) [editorial]. Am Heart J 2006:151;762-764. 25. Krucoff MW, Crater SW, Lee KL. From efficacy to safety concerns: a STEP forward or a step back for clinical research and intercessory prayer? The Study of Therapeutic Effects of Intercessory Prayer (STEP). Am Heart J 2006; 151:762-764. 26. Al-Khatib SM, Sanders GD, Bigger JT, Buxton AE, Califf RM, Carlson M, Curtis A, Curtis J, Fair E, Gersh BJ, Gold MR, Haghighi-Mood A, Hammill SC, Healey J, Hlatky MA, Hohnloser S, Kim RJ, Lee K, Mark DB, Mianulli M, Mitchell B, Prystowsky EN, Smith J, Steinhaus D, Zareba W. Preventing tomorrow’s sudden cardiac death today part I: current data on risk stratification for sudden cardiac death. Am Heart J 2007;153:941-950. 27. Sanders GD, Al-Khatib SM, Berliner E, Bigger JT, Buxton AE, Califf RM, Carlson M, Curtis AB, Curtis JP, Domanski M, Fain E, Gersh BJ, Gold MR, Goldberger J, HaghighiMood A, Hammill SC, Harder J, Healey J, Hlatky MA, Hohnloser SH, Lee K, Mark DB, Mitchell B, Phurrough S, Prystowsky E, Smith JM, Stockbridge N, Temple R. Preventing tomorrow’s sudden cardiac death today: part II: translating sudden cardiac death risk assessment strategies into practice and policy. Am Heart J 2007;153:951-959. BOOK CHAPTERS 1. Wagner GS, Rosati RA, Mittler BS, Lee KL. A computerized textbook for determining optimal management of patients with coronary artery disease. In: Davila JC, ed. Second Henry Ford Hospital International Symposium on Cardiac Surgery. New York: AppletonCentury-Crofts, 1977:625-631. 2. Califf RM, Bounous EP Jr, Harrell FE Jr, McCants CB, Lee KL, McKinnis RA, Rosati RA. The prognosis in the presence of coronary artery disease. In: Braunwald E, ed. Congestive Heart Failure: Current Research and Clinical Application. New York: Grune and Stratton, 1982:31-40. 3. Lee KL, Harrell FE Jr, Califf RM, Pryor DB, Hlatky MA, Rosati RA. Secondary prevention trials in post-myocardial infarction patients: methodologic issues. In: Kulbertus HE, Wellens HJJ, eds. The First Year after a Myocardial Infarction. New York: Futura Publishing, 1983:407-419. 28 4. Harrell FE Jr, Lee KL. A comparison of the discrimination of discriminant analysis and logistic regression under multivariate normality. In: Sen PK, ed. Biostatistics: Statistics in Biomedical, Public Health and Environmental Sciences - The Bernard G. Greenberg Volume. New York: North-Holland, 1985:333-343. 5. Pryor DB, Harrell FE Jr, Rankin JS, Lee KL, Muhlbaier LH, Hlatky MA, Mark DB, Oldham HN Jr, Reves JG, Califf RM. Trends in the presentation, management and survival of patients with coronary artery disease - the Duke Data Base for Cardiovascular Disease. In: Higgins MW, Luepker RV, eds. Trends in Coronary Heart Disease Mortality: The Influence of Medical Care. New York: Oxford University Press, 1988:76-87. 6. Pritchett ELC, McCarthy EA, Lee KL, Wilkinson WE. The clinical presentation of paroxysmal supraventricular tachycardia in untreated patients. In: Zipes DP, Jalife J, eds. Cardiac Electrophysiology: From Cell to Bedside. Philadelphia: W.B. Saunders, 1990:703707. 7. Hlatky MA, Califf RM, Harrell FE, Lee KL, Mark DB, Muhlbaier LH, Pryor DB. Clinical judgment and therapeutic decision making. In: Knoebel SB, Dack S, eds. An Era in Cardiovascular Medicine. New York: Elsevier, 1991:303-315. 8. Selker HP, Griffith JL, Beshansky JR, Califf RM, D'Agostino RB, Laks MM, Lee KL, Maynard C, Wagner GS, Weaver WD. The thrombolytic predictive instrumet project: combining clinical study data bases to take medical effectiveness research to the streets. Grady ML, Schwartz HA, eds. Summary Report: Medical Effectiveness Research Data Methods. Rockville, MD: Agency for Health Care Policy and Research, 1992:9-37. 9. Topol EJ, Califf RM, Sigmon KN, Lee KL. Thrombolytic therapy for women with acute myocardial infarction: is there a gender gap? In: Wenger NK, Speroff L, Packard B, eds. Proceedings of an NHLBI Conference: Cardiovascular Health and Disease in Women. Greenwich, CT, Le Jacq Communications, Inc., 1993:109-112. 10. Buxton AE, Lee KL. The Multicenter Usustained Tachycardia Trial (MUSTT): A randomized, controlled trial of the primary prevention of sudden death in patients with coronary artery disease. In: Woosley RL, Singh SN, eds. Arrhythmia Treatment and Therapy: Evaluation of Clinical Trial Evidence. New York: Marcel Dekker, Inc., 2000:301-315. 29