Informed consent for innovative surgery: A survey of patients and surgeons
ABSTRACT BACKGROUND: Unlike new drugs and medical devices, most surgical procedures are developed outside clinical trials and without regulatory oversight. Surgical professional organizations have discussed how new procedures should be introduced into practice without agreement on what topics informed consent discussions must include. To provide surgeons with more specific guidance, we wanted to determine what information patients and surgeons consider essential to disclose before an innovative surgical procedure. METHODS: Of those approached, 85 of 113 attending surgeons and 383 of 541 adult postoperative patients completed surveys; responses to the surveys were 75% and 71%, respectively. Using a 6-point Likert scale, participants rated the importance of discussing 16 types of information preoperatively for 3 techniques (standard open, laparoscopic, robotic) offered for a hypothetic partial hepatectomy. RESULTS: Compared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, approximately 80% of patients indicated that they could not decide on surgery without being told whether it would be the surgeon's first time doing the procedure. When considering an innovative robotic surgery, a clear majority of both patients and surgeons agreed that it was essential to disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether it would be the surgeon's first time performing the procedure. CONCLUSION: To promote informed decision-making and autonomy among patients considering innovative surgery, surgeons should disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether the surgeon would be performing the procedure for the first time. When accurate volumes and outcomes data are available, surgeons should also discuss these with patients.
- Annals of Surgery 05/2014; 261(1). DOI:10.1097/SLA.0000000000000748 · 7.19 Impact Factor
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ABSTRACT: The classification of surgical innovation as clinical care, research, or as third distinct type of activity creates ambiguity which impacts standards for disclosure and informed consent. We conducted a systematic review of the conceptual literature to identify positions expressed about consent and disclosure, as well as major tension points associated with this issue. Literature overwhelmingly favors special consent and disclosure. Four major tension points were identified: the use of biasing/biased terminology to characterize innovation; patient vulnerability; the relationship between surgeon-innovator and patient; and practices and associated gaps related to consent and disclosure. Recommendations often focused on the informed consent process.Accountability in Research Policies and Quality Assurance 05/2014; 21(6):331-352. DOI:10.1080/08989621.2013.866045 · 0.72 Impact Factor
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ABSTRACT: Based on literature and personal experience, this paper address the question of how much information patients want or need prior to surgery. It underlines the importance of not only answering patients' questions but also making them aware of information available, to help them go through this difficult process. Aspects such as obtaining a second opinion and use of the Internet are also covered.World Journal of Surgery 05/2014; 38(7). DOI:10.1007/s00268-014-2599-7 · 2.35 Impact Factor