Surgery
Volume 145, Issue 6 , Pages 581-587 , June 2009

Randomized trials in surgery

  • Annetine C. Gelijns, PhD

      Affiliations

    • Department of Health Policy, Mount Sinai School of Medicine, New York, NY
    • Corresponding Author InformationReprint requests: Annetine C. Gelijns, PhD, Department of Health Policy, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1077, New York, NY 10029
    • ,
  • Deborah D. Ascheim, MD

      Affiliations

    • Department of Health Policy, Mount Sinai School of Medicine, New York, NY
    • ,
  • Michael K. Parides, PhD

      Affiliations

    • Department of Health Policy, Mount Sinai School of Medicine, New York, NY
    • ,
  • K. Craig Kent, MD

      Affiliations

    • Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI
    • ,
  • Alan J. Moskowitz, MD

      Affiliations

    • Department of Health Policy, Mount Sinai School of Medicine, New York, NY

,Accepted 6 April 2009.

References 

  1. Horton R. Surgical research or comic opera. Lancet. 1996;347:984–985
  2. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141–145
  3. Rettig RA, Jacobsen PD, Farquhar CM, Aubry WM. False hope: bone marrow transplantation for breast cancer. New York (NY): Oxford University Press; 2007;
  4. Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis. 1976;29:175–188
  5. Begg CB, Pilote A. A model for incorporating historical controls into a meta-analysis. Biometrics. 1991;47:899–906
  6. Serruys PW, Morice MC, Kappetein AD, et al. Percutaneous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360:961–972
  7. Lange RA, Hillis RD. Coronary revascularization in context. N Engl J Med. 2009;360:1024–1026
  8. Gelijns AC, Killelea B, Vitale M, Mankad V, Moskowitz AJ. Appendix: C. The dynamics of pediatric device innovation: putting evidence in context. In: Institute of Medicine Committee on Postmarket Surveillance of Pediatric Medical Devices. Board on Health Sciences Policy. In:  Field MJ,  Tilson H editor. Safe medical devices for children. Washington (DC): The National Academies Press; 2005;p. 302–326
  9. Parides MK, Moskowitz AJ, Ascheim DD, Rose EA, Gelijns AC. Progress versus precision: challenges in clinical trial design for left ventricular assist devices. Ann Thorac Surg. 2006;82:1140–1146
  10. Moore MJ, Bennett CL. The learning curve for laparoscopic cholecystectomy. The Southern Surgeons Club. Am J Surg. 1995;170:55–59
  11. Egorova N, Giacovelli J, Gelijns A, Mureebe L, Greco G, Morrissey N, et al. Defining high risk patients for endovascular aneurysm repair: a national analysis. Circulation. Accepted for publication.
  12. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. 2001;345:1435–1443
  13. Park SJ, Gelijns AC, Moskowitz AJ, Frazier OH, Piccioni W, Raines E, et al. LVADs as destination therapy: a new look at survival. J Thorac Cardiovasc Surg. 2005;129:9–17
  14. Tu JV, Hannan EL, Anderson GM, et al. The fall and rise of carotid endarterectomy in the United States and Canada. N Engl J Med. 1998;339:1441–1447
  15. Hlatky MA, Lee KL, Harrell FE, Califf RM, Pryor DB, Mark DB, et al. Tying clinical research to patient care by use of an observational database. Stat Med. 1984;3:375–387
  16. Hannan EL, Racz MJ, Walford G, et al. Long-term outcomes of coronary-artery bypass grafting versus stent implantation. N Engl J Med. 2005;352:2174–2183
  17. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–1632

 Supported in part by grants HL088942 and HL77096 from the National Heart Lung and Blood Institute and by grant NF051566 from the National Institute of Neurological Disease and Stroke of the National Institutes of Health.

PII: S0039-6060(09)00195-0

doi: 10.1016/j.surg.2009.04.003

Surgery
Volume 145, Issue 6 , Pages 581-587 , June 2009

Article Tools

* Image Usage & Resolution