Ethics and methods in surgical trials

Journal of Medical Ethics

Volumn 35, Issue 9, 2009, Pages 579-583

  Ashton, C M ^a   Wray, N P ^a   Jarman, A F ^a   Kolman, J M ^a   Wenner, D M ^a,c   Brody, B A ^b,c  

^a HOUSTON METHODIST HOSPITAL   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c RICE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ETHICS; HUMAN; METHODOLOGY; RANDOMIZED CONTROLLED TRIAL; STANDARD; STROKE; SURGERY;

HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; STROKE; SURGICAL PROCEDURES, OPERATIVE;

EID: 72549087718     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2008.028175     Document Type: Article

References (34)

1. MRC. Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. BMJ 1948;1:769-82.
2. Hill AB. The clinical trial. N Engl J Med 1952;247:113-19.
3. Freiman JA, Chalmers TC, Smith H Jr, et al. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials. N Engl J Med 1978;299:690-4.
4. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001;134:657-62.
5. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351:1250-1.
6. Brody BA. The ethics of biomedical research: an international perspective. New York: Oxford University Press, 1998:31-54.
7. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization. International ethical guidelines for biomedical research involving human subjects. Geneva: WHO, 2002.
8. Federal Policy for the Protection of Human Subjects (Common Rule). Washington, DC: US Department of Health and Human Services, 1991.
9. Council of Europe. Additional protocol to the Convention on Human Rights and Biomedicine, concerning biomedical research. Paris and Brussels: Council of Europe, 2005.
10. International Conference on Harmonisation. Technical requirements for registration of pharmaceuticals for human use. http://www.ich.org/cache/compo/276-254-1.html (accessed 5 May 2009).
11. Estol CJ. Dr C Miller Fisher and the history of carotid artery disease. Stroke 1996;27:559-66.
12. Winslow CM, Solomon DH, Chassin MR, et al. The appropriateness of carotid endarterectomy. N Engl J Med 1988;318:721-7.
13. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med 1991;325:445-53.
14. Barnett HJ, Taylor DW, Eliasziw M, et al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1998;339:1415-25.
15. Chaturvedi S, Bruno A, Feasby T, et al. Carotid endarterectomy-an evidence-based review: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2005;65:794-801.
16. Halm EA, Tuhrim S, Wang JJ, et al. Has evidence changed practice?: appropriateness of carotid endarterectomy after the clinical trials. Neurology 2007;68:187-94.
17. The EC/IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med 1985;313:1191-200.
18. Amin-Hanjani S, Butler WE, Ogilvy CS, et al. Extracranial-intracranial bypass in the treatment of occlusive cerebrovascular disease and intracranial aneurysms in the United States between 1992 and 2001: a population-based study. J Neurosurg 2005;103:794-804.
19. Endovascular, versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Lancet 2001;357:1729-37.
20. Coward LJ, Featherstone RL, Brown MM. Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence. Stroke 2005;36:905-11.
21. Ederle J, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. Cochrane Database Syst Rev 2007;(4):CD000515.
22. Jeng JS, Liu HM, Tu YK. Carotid angioplasty with or without stenting versus carotid endarterectomy for carotid artery stenosis: a meta-analysis. J Neurol Sci 2008;270:40-7.
23. Reitsma A, Moreno J. Ethics guidelines for innovative surgery: recommendations for national policy. In: Reitsma A, Moreno J, eds. Ethical guidelines for innovative surgery. Hagerstown, MD: University Publishing Group, 2006:199-212.
24. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5.
25. Weijer C, Shapiro SH, Cranley Glass K. For and against: clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial. BMJ 2000;321:756-8.
26. Brody BA. The ethics of biomedical research: an international perspective. New York: Oxford University Press, 1998:145-6.
27. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351:1493-501.
28. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 2006;296:2441-50.
29. Moher D, Jadad AR, Nichol G, et al. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials 1995;16:62-73.
30. Brody BA. The ethics of biomedical research: an international perspective. New York: Oxford University Press, 1998:35-7.
31. US Department of Health and Human Services, Office of Human Research Protections. International compilation of human subject research protections. http://www.hhs.gov/ohrp/international/index.html#NatlPol (accessed 5 May 2009).
32. United States National Library of Medicine. Medical subject headings (MeSH). http://www.nlm.nih.gov/pubs/factsheets/mesh.html (accessed 5 May 2009).
33. Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009;360:816-23.
34. Ang TW, ten Have H, Solbakk JH, et al. UNESCO Global Ethics Observatory: database on ethics related legislation and guidelines. J Med Ethics 2008;34:738-41.