Virtual Mentor. October 2004, Volume 6, Number 10.
Suggested Reading and Resources
Resources on Ethics in the Practice of Surgery
- Ethics in the Practice of Surgery
- 69 Federal Register 35650-35651 (2004).
- Agency for Healthcare Research and Quality. Making health care safer: a critical analysis of patient safety practices. Wachter RM (Project Director). Evidence Report/Technology Assessment #43. Publication 01-E058. Washington, DC; July, 2001.
- Agich GJ. Ethics and innovation in medicine. J Med Ethics. 2001;27:295-296.
- American Medical Association. Opinion 8.08 Informed consent. Code of Medical Ethics. Accessed August 19, 2004.
- American Medical Association. Opinion 8.12 Patient information. Code of Medical Ethics. Accessed August 19, 2004.
- Arya J, Wolford H, Harken AH. Evidence-based science. Arch Surg. 2002;137:1301-1303.
- Baum M. Reflections on randomized controlled trials in surgery. Lancet. 1999;353(s-I):6-8.
- Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgery volume and operative mortality in the United States. N Eng J Med. 2003;349: 2117-2127.
- Bunch WH, Dvonch VM. Moral decisions regarding innovation. The case method. Clin Orthop. 2000;378:44-49.
- Bunker JP, Hinkley D, McDermottWV. Surgical innovation and its evaluation. Science. 1978;200:937-941.
- Carey TS. Randomized controlled trials in surgery: an essential component of scientific progress. Spine. 1999;24:2553-2555.
- Casler JD. Clinical use of new technologies without scientific studies. Arch Otolaryngol Head Neck Surg. 2003;129:674-677.
- Centre for Evidence Based Medicine. Levels of evidence and grades of recommendation. Accessed September 27, 2004.
- Clark PA. Placebo surgery for Parkinson's disease: do the benefits outweigh the risks? J Law Med Ethics. 2002;30:58-68.
- Cook RC, Alscher KT, Hsiang YN. A debate on the value and necessity of clinical trials in surgery. Am Journal of Surg. 2003;185:305-310.
- Cronenwett JL, Seeger JM: Withdrawal of an article by the FDA after objection by Medtronic. J Vasc Surg. 2004;40:209-210.
- Cronin DC, II, Millis JM, Siegler M. Transplantation of liver grafts from living donors into adults—too much, too soon. N Engl J Med. 2001;344:1633-1637.
- Davis K. Reshaping the Female Body: The Dilemma of Cosmetic Surgery. New York: Routledge; 1995.
- Declaration of Helsinki, 2002. Accessed August 29, 2004.
- Deyo RA: Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice. J Am Board Fam Pract. 2004;17:142-149.
- Dingle v Belin, 749 A2d 157 (Md 2000).
- Elliott C. Better Than Well: American Medicine Meets the American Dream. New York: W.W. Norton & Company; 2003.
- Ericsson KA. The acquisition of expert performance: an introduction to some of the issues. In: Ericsson KA, ed. The Road to Excellence. The Acquisition of Expert Performance in the Arts and Sciences, Sports and Games. Mahwah, NJ: Lawrence Erlbaum Associates; 1996:1-50.
- FDA. Overview of what we do. Accessed September 3, 2004.
- Frader JE, Caniano DA. Research and innovation in surgery. In: McCullough LB, Jones JW, Brody BA, eds. Surgical Ethics. New York: Oxford University Press; 1998:216-241.
- Frader JE, Flanagan-Klygis E. Innovation and research in pediatric surgery. Semin Pediatr Surg. 2001;10:198-203.
- Freedman B, Glass KC, Weijer C. Placebo orthodoxy in clinical research II: ethical, legal, and regulatory myths. J Law Med Ethics. 1996;24:252-259.
- Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients' and physicians' attitudes regarding the disclosure of medical errors. JAMA. 2003;289:1001-1007.
- Gilman SL. Making the Body Beautiful: A Cultural History of Aesthetic Surgery. Princeton, NJ: Princeton University Press; 1999.
- Gross M. Innovations in surgery. J Bone Joint Surg Br. 1993;75:351-354.
- Guyatt G, Haynes RB, Jaeschke RZ, et al. User's guide to the medical literature XXV. Evidence-based medicine: principles for applying the user's guides for patient care. JAMA. 2000;284:1290-1296.
- Haiken E. Venus Envy: A History of Cosmetic Surgery. Baltimore: The Johns Hopkins University Press; 1997.
- JCAHO's Universal Protocol for Preventing Wrong Site, Wrong Person, Wrong Procedure Surgery. Accessed September 27, 2004.
- Jimenez RE, Guitierrez AR, Benitez IM. Methodological requirements for assessing surgical procedures in current medical literature. World J Surg. 2003;27:229-233.
- Jones JW. Ethics of rapid surgical technological advancement. Ann Thorac Surg. 2000;69:676-677.
- Jones JW. The surgeon's autonomy: defining limits in therapeutic decision-making. Commissioned paper for the Committee on Development of Ethical Guidelines for Innovative Surgery. March 2004. Charlottesville: University of Virginia Press. (In press).
- Jones RS, Richards K. Office of Evidence-Based Surgery charts course for improved system of care. Bull Amer Coll Surg. 88;4:11-21.
- Jones RS. Requiem and renewal. presidential address. Ann Surg. 2004;240:395-404.
- Josefson D. University must tell patients that they were research "guinea pigs." BMJ. 2000;321:1487A.
- Law S, Wong J. Use of controlled randomized trials to evaluate new technologies and new operative procedures in surgery. J Gastrointest Surg. 1998;2:494-495.
- Lilford RJ, Braunholz D, Harris J, Gill T: Trials in surgery. Br J Surg. 2004;91:6-16.
- Lombardo PA. The history of ethics in innovative surgery: a few stories, many questions. Commissioned paper for the Committee on Development of Ethical Guidelines for Innovative Surgery. March 2004. Charlottesville: University of Virginia Press. (In press).
- London AJ, Kadane JB. Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res. 2002;11:413-427.
- London AJ. Cutting surgical research at the joints: individuating and assessing surgical procedures. Commissioned paper for the Committee on Development of Ethical Guidelines for Innovative Surgery. March 2004. Charlottesville: University of Virginia Press. (In press).
- Love JW. Drugs and operations: some important differences. JAMA. 1975;232:37-38.
- Maddem GJ. Evidence-based medicine in practice—surgery. Med J Aust. 2001;174:528-529.
- Margo CE. When is surgery research? Towards an operational definition of human research. J Med Ethics. 2001;27:40-43.
- McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomized controlled trials in surgery: problems and possible solutions. BMJ. 2002;324:1448-1451.
- McCullough LB. Standard of care, innovation and research in surgery: a problem in research ethics or professional medical ethics? Commissioned paper for the Committee on Development of Ethical Guidelines for Innovative Surgery. March 2004. Charlottesville: University of Virginia Press. (In press).
- McKneally MF. A bypass for the Institutional Review Board: reflections on the Cleveland Clinic study of the Batista operation. J Thorac Cardiovasc Surg. 2001;121:837-839.
- McKneally MF. Ethical problems in surgery: innovation leading to unforeseen complications. World J Surg. 1999;23:786-788.
- McKneally MF. Surgical innovation. Panel presentation at American Society for Bioethics and Humanities. November 2003; Montreal, Canada.
- McKneally MF: Professional obligations of surgeons. In: McGrath M, ed. American College of Surgeons Ethics Curriculum for Surgical Residents. Chicago, IL (in press).
- McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999;23:1210-1214.
- McNeil BJ. Shattuck Lecture – Hidden barriers to the improvement of the quality of care. N Eng J Med. 2001;345:1612-1620.
- Meakins JL. Innovation in surgery: the rules of evidence. Am J Surg. 2002;183:399-405.
- Miller FG. Sham surgery: an ethical analysis. AJOB. 2003;3:41-48.
- Miller PB, Weijer C. Rehabilitating equipoise. Kennedy Inst Ethics J. 2003;13:93-118.
- Moore FD. Ethical problems special to surgery: surgical teaching, surgical innovation, and the surgeon in managed care. Arch Surg. 2000;135:14-16.
- Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347:81-88.
- Moss RL. The CONSORT Statement: progress in clinical research in pediatric surgery. J Ped Surg. 2001;36:1739-1742.
- Pisano GP, Bohmer RMJ, Edmondson AC. Organizational differences in rates of learning: evidence from the adoption of minimally invasive cardiac surgery. Manage Sci. 2001;47:752.
- Qualms about innovative surgery. Lancet. 1985;1:149.
- Rangel S, Efron B, Moss RL. Recent trends in National Institutes of Health funding of surgical research. Ann Surg. 2002;236:277-287.
- Reason JT. Human Error. Cambridge, UK: Cambridge University Press; 1990.
- Reeves B. Health-technology assessment in surgery. Lancet. 1999;353 Suppl 1: SI 3-5.
- Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg. 2002;194:792-801.
- Reitsma AM, Moreno JD. Surgical research, an elusive entity. AJOB. 2003:3:49-50.
- Reitsma AM, Moreno JD, Bosk CL, et al. Ethical guidelines for innovative surgery: recommendations for national policy. Position statement. J Am Coll of Surg. (Submitted for publication).
- Roy DL, Black P, McPeek B. "Ethical Principles in Research" In: Troidl H, Spitzer WO, McPeek B, et al, eds. Principles and Practice of Research: Strategies for Surgical Investigation. New York: Springer-Verlag; 1991:92.
- Rutan RL, Deitch EA, Waymack JP. Academic surgeons' knowledge of Food and Drug Administration regulations for clinical trials. Arch Surg. 1997;132:94-98.
- Shinebourne EA. Ethics of innovative cardiac surgery. Br Heart J. 1984;52: 597-601.
- Siegler M. Ethical issues in innovative surgery: should we attempt a cadaveric hand transplantation in a human subject? Transplant Proc. 1998;30:2779-2782.
- Spodick DH. Numerators without denominators. There is no FDA for the surgeon. JAMA. 1975;232:35-36.
- Starling RC, McCarthy PM, Buda T, et al. Results of partial left ventriculectomy for dilated cardiomyopathy: hemodynamic, clinical and echocardiographic observations. J Am Coll Cardiol. 2000;36:2098-2103.
- Strasberg SM, Ludbrook PA. Who oversees innovative practice? Is there a structure that meets the monitoring needs of new techniques? J Am Coll Surg. 2003;196:938-948.
- Swerdlow PS. Use of humans in biomedical experimentation. In: Macrina FL, ed. Scientific Integrity: An Introductory Text with Cases. Washington DC: ASM Press; 2000:73-99.
- Ward CM. Surgical research, experimentation and innovation. Br J Plast Surg. 1994;47:90-94.
- Waring GO III. A cautionary tale of innovation in refractive surgery. Arch Ophthalmol. 1999;117:1069-1073.
- Way LW, Stewart L, Gantert W, et al. Cause and prevention of laparoscopic bile duct injuries: analysis of 252 cases from a human factors and cognitive psychology perspective. Ann Surg. 2003;237:460-469.
- Weijer C. I need a placebo like I need a hole in the head. J Law Med Ethics. 2002;30:69-72.
- White J, Morrow M, Moughan J, et al. American College of Surgeons Commission on Cancer, American College of Radiology patterns of care study. Cancer. 2003;97:893-904.
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