Ethical issues in evidence-based surgery

Surgical Clinics of North America

Volumn 86, Issue 1, 2006, Pages 151-168

  Burger, Ingrid ^a   Sugarman, Jeremy ^a,b,c   Goodman, Steven N ^a,b,c,d  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BOLDENONE UNDECENOATE;

ARTERY LIGATION; CLINICAL TRIAL; CORONARY ARTERY BYPASS GRAFT; EVIDENCE BASED MEDICINE; EXTRAINTRACRANIAL ANASTOMOSIS; GENERAL SURGERY; HUMAN; INFORMED CONSENT; KNEE SURGERY; LUNG RESECTION; MEDICAL DECISION MAKING; MEDICAL ETHICS; METHODOLOGY; NEUROSURGERY; PRIORITY JOURNAL; REVIEW; SURGICAL TECHNIQUE;

CLINICAL TRIALS; DIFFUSION OF INNOVATION; ETHICS, MEDICAL; EVIDENCE-BASED MEDICINE; HUMANS; INFORMED CONSENT; RESEARCH DESIGN; SURGERY; UNITED STATES;

EID: 31344438136     PISSN: 00396109     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.suc.2005.10.003     Document Type: Review

References (65)

1. R.B. Haynes, P.J. Devereaux, and G.H. Guyatt Clinical expertise in the era of evidence-based medicine and patient choice ACP J Club 136 2 2002 A11 A14
2. W.R. Dunn, S. Lyman, and R.G. Marx Small area variation in orthopedics J Knee Surg 18 1 2005 51 56
3. J. Wennberg, and A. Gittelsohn Small area variations in health care delivery Science 182 117 1973 1102 1108
4. J.D. Birkmeyer, S.M. Sharp, and S.R. Finlayson Variation profiles of common surgical procedures Surgery 124 5 1998 917 923
5. G. Lu-Yao, D. McLerran, and J.H. Wasson Team TPPOR. Assessment of radical prostatectomy. Time trends, geographic variation and outcomes JAMA 269 1993 2633 2636
6. Beauchamp T, Childress J. Principles of biomedical ethics. New York: Oxford University Press; 2001 5th edition. 2000.
7. R.R. Faden, and T.L. Beauchamp A history and theory of informed consent 1986 Oxford University Press New York
8. P.S. Appelbaum, C.W. Lidz, and A. Meisel Informed consent: legal theory and clinical practice 1987 Oxford University Press New York
9. E.J. Emanuel, and L.L. Emanuel Four models of the physician-patient relationship JAMA 267 16 1992 2221 2226
10. N. Daniels Just health care 1985 Cambridge University Press Cambridge (UK)
11. N. Daniels, and J. Sabin Setting limits fairly 2002 Oxford University Press New York
12. H. Sox Annals of internal medicine's Harold Sox, MD, discusses physician charter of professionalism. Interview by Brian Vastag JAMA 286 24 2001 3065 3066
13. R.E. Ashcroft Current epistemological problems in evidence based medicine J Med Ethics 30 2 2004 131 135
14. H.M. Marks The progress of experiment 1997 Cambridge University Press New York
15. D. Mainland The modern method of clinical trial Methods Med Res 6 1954 152 158
16. P.M. Wax Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act Ann Intern Med 122 6 1995 456 461
17. J. Botting The history of thalidomide Drug News Perspect 15 9 2002 604 611
18. S.B. Foote Managing the medical arms race; innovation and public policy in the medical device industry 1992 University of California Press, Ltd. Oxford (UK)
19. R. Merrill Regulation of drugs and devices: an evolution Health Aff (Millwood) 13 1994 47 69
20. H. Beecher Surgery as placebo, a quantitative study of bias JAMA 176 1961 1102 1107
21. D. Spodick Numerators without denominators: there is no FDA for the surgeon JAMA 232 1975 1 32
22. A.M. Reitsma, and J.D. Moreno Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg 194 6 2002 792 801
23. Surgeons ACo Statement on emerging surgical technologies and the evaluation of credentials Bull Am Coll Surg 79 1994 40 41
24. Surgeons ACo Statement on issues to be considered before new surgical technology is applied to the care of patients Bull Am Coll Surg 80 1995 46 47
25. L. Cobb, G. Thomas, and D. Dillard An evaluation of internal-mammary- artery ligation by a double-blind technic N Engl J Med 260 1959 1115 1118
26. E.G. Dimond, F. Kittle, and J. Crockett Comparison of internal mammary artery ligation and sham operations for angina pectoris Am J Cardiol 5 1960 483 486
27. Group TEIBS Failure of extravranial-intracranial arterial bypass to reduce the risk of ischemic stroke: results of an internaitional randomized trial N Engl J Med 313 1985 1191 1200
28. J.M. Ruffin, J.E. Grizzle, and N.C. Hightower A co-operative double-blind evaluation of gastric "freezing" in the treatment of duodenal ulcer N Engl J Med 281 1 1969 16 19
29. J.B. Moseley, K. O'Malley, and N.J. Petersen A controlled trial of arthroscopic surgery for osteoarthritis of the knee N Engl J Med 347 2 2002 81 88
30. The National Emphysema Treatment Trial Research Group A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema N Engl J Med 348 21 2003 2092 2102
31. R.L. Rutan, E.A. Deitch, and J.P. Waymack Academic surgeons' knowledge of Food and Drug Administration regulations for clinical trials Arch Surg 132 1 1997 94 98
32. C. Ramsay, A. Grant, and S. Wallace Statistical assessment of the learning curves of health technologies Health Technol Assess (Rockv) 5 2001 1 79
33. T. Carino, S. Scheingold, and S. Tunis Using clinical trials as a condition of coverage: lessons from the National Emphysema Treatment Trial Clin Trials 1 2004 108 121
34. D. Jones Visions of a cure: visualization, clinical trials, and controversies in cardiac therapeutics, 1968-1998 Isis 91 3 2000 504 541
35. T.C. Chalmers Randomize the first patient N Engl J Med 296 2 1977 107
36. J.L. Meakins Innovation in surgery: the rules of evidence Am J Surg 183 4 2002 399 405
37. R. Lilford, D. Braunholtz, and J. Harris Trials in surgery Br J Surg 91 1 2004 6 16
38. M.J. Solomon, A. Laxamana, and L. Devore Randomized controlled trials in surgery Surgery 115 6 1994 707 712
39. M.J. Solomon, and R.S. McLeod Surgery and the randomized controlled trial: past, present, and future Med J Aust 169 1998 380 383
40. D. Benjamin The efficacy of surgical treatment of cancer Med Hypotheses 40 1993 129 138
41. S. Haines Randomized clinical trials in the evaluation of surgical innovation J Neurosurg 51 1979 5 11
42. J. Gilbert, B. McPeek, and F. Mosteller Statistics and ethics in surgery and anethesia Science 198 1977 684 689
43. T. Sorenson Effects of treatments in clinical trials: surgery J Surg Oncol Suppl 3 1993 186 188
44. W.D. Hardin Jr., S. Stylianos, and K.P. Lally Evidence-based practice in pediatric surgery J Pediatr Surg 34 5 1999 908 912 [discussion: 912-13]
45. R.L. Moss, M.C. Henry, and R.A. Dimmitt The role of prospective randomized clinical trials in pediatric surgery: state of the art? J Pediatr Surg 36 8 2001 1182 1186
46. R.B. Haynes What kind of evidence is it that evidence-based medicine advocates want health care providers and consumers to pay attention to? BMC Health Serv Res 2 1 2002 3
47. N. Black Evidence-based surgery: a passing fad? World J Surg 23 1999 789 793
48. A.M. Cohen, P.Z. Stavri, and W.R. Hersh A categorization and analysis of the criticisms of evidence-based medicine Int J Med Inform 73 1 2004 35 43
49. L. Bonchek Are randomized trials appropriate for evaluating new operations? N Engl J Med 301 1977 44 45
50. J. Frader, and D. Caniano Research and innovation in surgery L.B. McCoullough J.W. Jones B.A. Brody Surgical ethics 1998 Oxford University Press New York 216 241
51. N. Kadar The operative laparoscopy debate: technology assessment or statistical Jezebel? Biomed Pharmacother 47 5 1993 201 206
52. W. Dekkers, and G. Boer Sham neurosurgery in patients with Parkinson's disease: is it morally acceptable? J Med Ethics 27 3 2001 151 156
53. R.L. Albin Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson's disease and proposed criteria for use of sham surgery controls J Med Ethics 28 5 2002 322 325
54. R. Macklin The ethical problems with sham surgery in clinical research N Engl J Med 341 13 1999 992 996
55. S. Horng, and F.G. Miller Ethical framework for the use of sham procedures in clinical trials Crit Care Med 31 Suppl 3 2003 S126 S130
56. S. Horng, and F.G. Miller Is placebo surgery unethical? N Engl J Med 347 2 2002 137 139
57. C. Fried Medical experiementation: personal integrity and social policy 1974 North Holland Amsterdam
58. B. Freedman Equipoise and the ethics of clinical research N Engl J Med 317 1987 141 145
59. P.B. Miller, and C. Weijer Rehabilitating equipoise Kennedy Inst Ethics J 13 2 2003 93 118
60. J.E. Tcheng, M. Madan, and J.C. O'Shea Ethics and equipoise: rationale for a placebo-controlled study design of platelet glycoprotein IIb/IIIa inhibition in coronary intervention J Interv Cardiol 16 2 2003 97 105
61. Schloendorff v Society of New York Hospital, Court of Appeals of New York; 211 NY 125 (1914).
62. Salgo v Leland Stanford Jr, University Board of Trustees, P2d 170 (1957).
63. P.S. Appelbaum, L. Rothe, and C. Lidz False hopes and best data Hastings Cent Rep 17 2 1987 20 24
64. N.J. Meropol, K.P. Weinfurt, and C.B. Burnett Perceptions of patients and physicians regarding Phase I cancer clinical trials: implications for physician-patient communication J Clin Oncol 21 13 2003 2589 2596
65. K.P. Weinfurt, D.P. Sulmasy, and K.A. Schulman Patient expectations of benefit from Phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception Theor Med Bioeth 24 4 2003 329 344