European Journal of Vascular & Endovascular Surgery
Volume 36, Issue 3 , Pages 253-257 , September 2008

When Does the ‘Learning Curve’ of Innovative Interventions Become Questionable Practice?

  • P. Healey

      Affiliations

    • Corresponding Author InformationCorresponding author. P. Healey, Senior Lecturer in Law, Department of Law, De Montfort University, Elfed Thomas Building, The Gateway, Leicester LE1 9BH, UK. Tel.: +44 116 2577225.
  • ,
  • J. Samanta

Received 23 May 2008 ,Accepted 23 May 2008.

References 

  1. American college of surgeons statement on emerging technologies and the evaluation of crudentials. Am Coll Surg Bull. 1994;79:40–41
  2. Price D. Remodelling the regulation of postmodern innovation in medicine. International Journal of Law in Context I, 2:121–141.
  3. Royal College of Physicians (1996, para. 6.4).
  4. Price D. Remodelling the regulation of postmodern innovation in medicine. International Journal of Law in Context I, 2:130.
  5. Price D. Remodelling the regulation of postmodern innovation in medicine. International Journal of Law in Context I, 2:134.
  6. Scott LD. Innovative endoscopy – research or patient care?. J. Am Coll Surg. 2007;102:2617–2619
  7. The report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary. 1984–1995.
  8. Price D. Remodelling the regulation of postmodern innovation in medicine. International Journal of Law in Context I, 2:123.
  9. British Medical Association Ethics Department . Medical Ethics Today. 2nd ed.. BMJ Publishing Group; 2004;p. 496
  10. British Medical Association Ethics Department . Medical Ethics Today. 2nd ed.. BMJ Publishing Group; 2004;p. 497
  11. Margo CE. When is surgery research? Toward an operational definition of human research. J Med Ethics. 2001;27:40–43
  12. Rock JA, Warshaw JR. The history and future of operative laparoscopy. Am J Obstet Gynaecol. 1994;170:7–11
  13. The Southern Surgeons Club . A prospective analysis of 1518 laparoscopic cholecystectomies. N Engl J Med. 1991;324:1073–1078
  14. Dent TL. Training, credentialing and granting clinical privileges for laparoscopic general surgery. Am J Surg. 1991;161:399–403
  15. Lin PH, Bush RL, Peden E, Zhou W, Kougias P, Henao E, et al. What is the learning curve for carotid artery stenting with neuroprotection? Analysis of 200 consecutive cases at an academic institution. Perspect Vasc Surg Endovasc Ther. 2005;17:113–123
  16. Michel LA, Johnson P. Is surgical mystiques a myth and double standard in reality? 2002;28:66–70.
  17. Simms v Simms [2003] 1 All ER 669.
  18. Mason JK, McCall RA. Law and Medical Ethics. London Butterworths. p. 218–229.
  19. Liddell K, Bion J, Chamberlain D, Drumi C, Kompanje E, Lemaire F, et al. Medical research involving incapacitated adults: implications of the EU clinical trials directive 2001/20/EC. Med L Rev. 2006;384
  20. Soot SJ, Eshraghi N, Farahmand M, Sheppard BC, Deveney CW. Transition from open laparoscopic fundoplication: the learning curve. Arch Surg. 1999;134:278–281
  21. Chalmers TC. Randomisation of the first patient. Med Clin North Am. 1975;59:1035–1038
  22. Corbett v Corbett [1971] 83,para99.
  23. Chester v Afshar [2004] 3 WLR 927.
  24. Sidaway v Board of Governors of the Bethlehem hospital and the Maudsley hospital [1984] AC 871.
  25. Helsinki Declaration 6th version (2000).
  26. Sidaway v Board of Governors of the Bethlehem hospital and the Maudsley hospital [1984] AC 871: Pearce v United Bristol Healthcare NHS Trust (1999) 48, CA BMLR 118.
  27. Reitsma AM, Moreno JD. Ethical regulations in innovative surgery: the last frontier?. J Am Coll Surg. 2002;194:792–801
  28. Karp v Cooley, Anderson v George H Lanier Memorial Hospital (1974) 493 F 2d 408 (US CA, 5th Cir): Estrada v Jaques 321 S.E. 2d 240 (N.C. Ct App 1984).

 One of a series of articles edited by Prof. A. Ross Naylor, Leicester, UK.

PII: S1078-5884(08)00279-7

doi: 10.1016/j.ejvs.2008.05.006

European Journal of Vascular & Endovascular Surgery
Volume 36, Issue 3 , Pages 253-257 , September 2008