Disclosure, Consent, and the Exercise of Patient Autonomy in Surgical Innovation: A Systematic Content Analysis of the Conceptual Literature

References

• Agich, G. J. (2001). Ethics and innovation in medicine. Journal of Medical Ethics, 27:295–296.
   PubMed Web of Science ®Google Scholar
• Angelos, P. (2010). The ethical challenges of surgical innovation for patient care. Lancet, 376:1046–1047.
   PubMed Web of Science ®Google Scholar
• Barkun, J. S., Aronson, J. K., Feldman, L. S., Maddern, G. J., Strasberg, S. M., Altman, D. G., Blazeby, J. M., Boutron, I. C., Campbell, W. B., Clavien, P. A., Cook, J. A., Ergina, P. L., Flum, D. R., Glasziou, P., Marshall, J. C., McCulloch, P., Nicholl, J., Reeves, B. C., Seiler, C. M., Meakins, J. L., Ashby, D., Black, N., Bunker, J., Burton, M., Campbell, M., Chalkidou, K., Chalmers, I., de Leval, M., Deeks, J., Grant, A., Gray, M., Greenhalgh, R., Jenicek, M., Kehoe, S., Lilford, R., Littlejohns, P., Loke, Y., Madhock, R., McPherson, K., Rothwell, P., Summerskill, B., Taggart, D., Tekkis, P., Thompson, M., Treasure, T., Trohler, U., and Vandenbroucke, J. (2009). Evaluation and stages of surgical innovations. Lancet, 374:1089–1096.
   PubMed Web of Science ®Google Scholar
• Bernstein, M. and Bampoe, J. (2004). Surgical innovation or surgical evolution: An ethical and practical guide to handling novel neurosurgical procedures. Journal of Neurosurgery, 100:2–7.
   PubMed Web of Science ®Google Scholar
• Biffl, W., Spain, D., Reitsma, A., Minter, R., Upperman, J., Wilson, M., Adams, R., Goldman, E., Angelos, P., Krummel, T., and Greenfield, L. (2008). Responsible development and application of surgical innovations: A position statement of the Society of University Surgeons. Journal of the American College of Surgeons, 206:1204–1209.
   PubMed Web of Science ®Google Scholar
• Brower, V. (2003). The ethics of innovation. Should innovative surgery be exempt from clinical trials and regulations? EMBO Reports, 4:338–340.
   PubMed Web of Science ®Google Scholar
• De Ville, K. (2010). Bariatric surgery, ethical obligation, and the life cycle of medical innovation. The American Journal of Bioethics, 10:22–24.
   PubMed Web of Science ®Google Scholar
• Ehrich, K., Cowie, L., and Sandall, J. (2013). Expect the unexpected: Patients’ and families’ expectations and experiences of new clinical procedures. Health Expectations.
   Google Scholar
• Evans, D. (2002). Ethical review of innovative treatment. HEC Forum, 14:53–63.
   PubMedGoogle Scholar
• Fins, J. (2008). Surgical innovation and ethical dilemmas: Precautions and proximity. Cleveland Clinic Journal of Medicine, 75:S7–S12.
   PubMedGoogle Scholar
• Ford, P. J. (2009). Vulnerable brains: Research ethics and neurosurgical patients. Journal of Law and Medical Ethics, 37:73–82.
   PubMed Web of Science ®Google Scholar
• Gillett, G. (2001). Ethics of surgical innovation. British Journal of Surgery, 88:897–898.
   PubMed Web of Science ®Google Scholar
• Gillett, G. R. (1998). Innovative treatments: Ethical requirements for evaluation. Journal of Clinical Neuroscience, 5:378–381.
   PubMed Web of Science ®Google Scholar
• Grimmett, M. R. and Sulmasy, D. P. (1998). The call of the sirens: Ethically navigating the sea of nonvalidated therapies. Journal of Refractive Surgery, 14:559–566.
   PubMed Web of Science ®Google Scholar
• Healey, P. and Samanta, J. (2008). When does the ‘learning curve’ of innovative interventions become questionable practice? European Journal of Vascular and Endovascular Surgery, 36:253–257.
   PubMed Web of Science ®Google Scholar
• Hsieh, H.-F. and Shannon, S. E. (2005). Three approaches to qualitative content analysis. Qualitative Health Research, 15:1277–1288.
   PubMed Web of Science ®Google Scholar
• Johnson, J. and Rogers, W. (2011). Innovative surgery: The ethical challenges. Journal of Medical Ethics, 38:9–12.
   PubMed Web of Science ®Google Scholar
• Johnson, J., Rogers, W., Lotz, M., Townley, C., Meyerson, D., and Tomossy, G. (2010). Ethical challenges of innovative surgery: A response to the IDEAL recommendations. Lancet, 376:1113–1115.
   PubMed Web of Science ®Google Scholar
• Jones, J. W., McCullough, L. B., and Richman, B. W. (2004a). The ethics of innovative surgical approaches for well-established procedures. Journal of Vascular Surgery, 40:199–201.
   PubMed Web of Science ®Google Scholar
• Jones, J. W., McCullough, L. B., Richman, B. W. (2004b). Ethics of surgical innovation to treat rare diseases. Journal of Vascular Surgery, 39:918–919.
   PubMed Web of Science ®Google Scholar
• Krummel, T. M. and Ziegler, M. M. (2006). IPEG panel on challenges of medical innovation: Introduction. Journal of Laparoendoscopic and Advanced Surgical Techniques, Part A, 16:634–638.
   PubMed Web of Science ®Google Scholar
• Lee Char, S. J., Hills, N. K., Lo, B., and Kirkwood, K. S. (2013). Informed consent for innovative surgery: A survey of patients and surgeons. Surgery, 153:473–480.
   PubMed Web of Science ®Google Scholar
• Levin, A. V. (2002). IOLs, innovation, and ethics in pediatric ophthalmology: Let’s be honest. Journal of American Association for Pediatric Ophthalmology and Strabismus, 6:133–135.
   Web of Science ®Google Scholar
• Levin, A. V. (2005). The ethics of surgical innovation: More than one answer? Canadian Journal of Ophthalmology, 40:685–688.
   PubMedGoogle Scholar
• Lieberman, I., Herndon, J., Hahn, J., Fins, J. J., and Rezai, A. (2008). Surgical innovation and ethical dilemmas: A panel discussion. Cleveland Clinic Journal of Medicine, 75:S13–S21.
   PubMedGoogle Scholar
• Lieberman, J. R. and Wenger, N. (2004). New technology and the orthopaedic surgeon: Are you protecting your patients? Clinical Orthopaedics and Related Research, 429:338–341.
   PubMed Web of Science ®Google Scholar
• Margo, C. E. (2001). When is surgery research? Towards an operational definition of human research. Journal of Medical Ethics, 27:40–43.
   PubMed Web of Science ®Google Scholar
• Marron, J. M. and Siegler, M. (2005). Ethical issues in innovative colorectal surgery. Diseases of the Colon and Rectum, 48:1109–1113.
   PubMed Web of Science ®Google Scholar
• Mavroudis, C., Mavroudis, C. D., Jacobs, M. L., and Jacobs, J. P. (2009). Ethics of innovation in surgery for congenital cardiac diseases. Cardiology in the Young, 19:100–105.
   PubMed Web of Science ®Google Scholar
• McCulloch, P., Altman, D. G., Campbell, W. B., Flum, D. R., Glasziou, P., Marshall, J. C., Nicholl, J., Aronson, J. K., Barkun, J. S., Blazeby, J. M., Boutron, I. C., Clavien,P. A., Cook, J. A., Ergina, P. L., Feldman, L. S., Maddern, G. J., Reeves, B. C., Seiler, C. M., Strasberg, S. M., Meakins, J. L., Ashby, D., Black, N., Bunker, J., Burton, M., Campbell, M., Chalkidou, K., Chalmers, I., de Leval, M., Deeks, J., Grant, A., Gray, M., Greenhalgh, R., Jenicek, M., Kehoe, S., Lilford, R., Littlejohns, P., Loke, Y., Madhock, R., McPherson, K., Meakins, J., Rothwell, P., Summerskill, B., Taggart, D., Tekkis, P., Thompson, M., Treasure, T., Trohler, U., and Vandenbroucke, J. (2009). No surgical innovation without evaluation: The IDEAL recommendations. Lancet, 374:1105–1112.
   PubMed Web of Science ®Google Scholar
• McCullough, L., Coverdale, J., and Chervenak, F. (2007). Constructing a systematic review for argument-based clinical ethics literature: The example of concealed medications. Journal of Medicine and Philosophy, 32:65–76.
   PubMed Web of Science ®Google Scholar
• McCullough, L. B., Coverdale, J. H., and Chervenak, F. A. (2004). Argument-based medical ethics: A formal tool for critically appraising the normative medical ethics literature. American Journal of Obstetrics and Gynecology, 191:1097–1102.
   PubMed Web of Science ®Google Scholar
• McKneally, M. F. (1999). Ethical problems in surgery: Innovation leading to unforeseen complications. World Journal of Surgery, 23:786–788.
   PubMedGoogle Scholar
• McKneally, M. F. (2011). The ethics of innovation: Columbus and others try something new. Journal of Thoracic and Cardiovascular Surgery, 141:863–866.
   PubMed Web of Science ®Google Scholar
• McKneally, M. F. and Daar, A. S. (2003). Introducing new technologies: Protecting subjects of surgical innovation and research. World Journal of Surgery, 27:930–934; discussion 934–935.
   PubMed Web of Science ®Google Scholar
• Moore, F. D. (2000). Ethical problems special to surgery: Surgical teaching, surgical innovation, and the surgeon in managed care. Archives of Surgery, 135:14–16.
   PubMed Web of Science ®Google Scholar
• Morgenstern, L. (2005). Warning! Dangerous curve ahead: The learning curve. Surgical Innovation, 12:101–103.
   PubMedGoogle Scholar
• Morgenstern, L. (2006). Innovative surgery’s dilemma. Surgical Innovation, 13:73–74.
   PubMed Web of Science ®Google Scholar
• Morreim, H., Mack, M. J., and Sade, R. M. (2006). Surgical innovation: Too risky to remain unregulated? Annals of Thoracic Surgery, 82:1957–1965.
   PubMed Web of Science ®Google Scholar
• Neugebauer, E. A., Becker, M., Buess, G. F., Cuschieri, A., Dauben, H. P., Fingerhut, A., Fuchs, K. H., Habermalz, B., Lantsberg, L., Morino, M., Reiter-Theil, S., Soskuty, G., Wayand, W., and Welsch, T. (2010). EAES recommendations on methodology of innovation management in endoscopic surgery. Surgical Endoscopy, 24:1594–1615.
   PubMed Web of Science ®Google Scholar
• Nwomeh, B. C. and Caniano, D. A. (2011). Emerging ethical issues in pediatric surgery. Pediatr. Surgery International, 27:555–562.
   PubMed Web of Science ®Google Scholar
• Pretz, J. L., Magnus, D., and Spain, D. A. (2009). Emergency innovation: Implications for the trauma surgeon. Journal of Trauma, 67:1443–1447.
   PubMed Web of Science ®Google Scholar
• Reitsma, A. and Moreno, J. (2002). Ethical regulations for innovative surgery: The last frontier? Journal of the American College of Surgeons, 194:792–801.
   PubMed Web of Science ®Google Scholar
• Reitsma, A. M. and Moreno, J. D. (2003). Surgical research, an elusive entity. The American Journal of Bioethics, 3:49–50.
   PubMed Web of Science ®Google Scholar
• Riskin, D., Mongaker, M., Gertner, M., and Krummel, T. (2006). Innovation in surgery: A historical perspective. Annals of Surgery, 244:686–693.
   PubMed Web of Science ®Google Scholar
• Shaul, R. Z., McDonald, M., and Langer, J. C. (2009). Facilitating innovation in the clinical setting: a pathway for operationalizing accountability. Healthcare Quarterly, 12:60–65.
   PubMedGoogle Scholar
• Sofaer, N. and Strech, D. (2012). The need for systematic reviews of reasons. Bioethics, 26:315–328.
   PubMed Web of Science ®Google Scholar
• Steiger, H. J. (2001). How to control the risk of novel surgical procedures. Acta Neurochirurgica Supplement, 78:179–184.
   PubMedGoogle Scholar
• Strasberg, S. M. and Ludbrook, P. A. (2003). Who oversees innovative practice? Is there a structure that meets the monitoring needs of new techniques? Journal of the American College of Surgeons, 196:938–948.
   PubMed Web of Science ®Google Scholar
• Strech, D. and Sofaer, N. (2012). How to write a systematic review of reasons. Journal of Medical Ethics, 38:121–126.
   PubMed Web of Science ®Google Scholar
• Tan, V. K. and Chow, P. K. (2011). An approach to the ethical evaluation of innovative surgical procedures. Annals of the Academy of Medicine, Singapore, 40:26–29.
   PubMed Web of Science ®Google Scholar
• Wall, L. L. (2001). Innovation in surgery: Caveat emptor. International Urogynecology Journal and Pelvic Floor Dysfunction, 12:353–354.
   PubMed Web of Science ®Google Scholar
• Wheeler, R. (2000). One person’s innovation is another’s experiment. British Medical Journal, 320:1548.
   Web of Science ®Google Scholar