Informed consent for innovative surgery: A survey of patients and surgeons

BackgroundUnlike 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.MethodsOf 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.ResultsCompared 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.ConclusionTo 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

A Randomized Trial of Two Methods to Disclose Prognosis to Surrogate Decision Makers in Intensive Care Units

Rationale: Surrogate decision makers and clinicians often have discordant perceptions about a patient's prognosis. There is a paucity of empirical data to guide communication about prognosis

Informed consent for innovative surgery: A survey of patients and surgeons

BACKGROUND: Unlike new drugs and medical devices, most surgical procedures are developed outside clinical trials, 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: 85 attending surgeons and 383 adult postoperative patients completed surveys. 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 hypothetical partial hepatectomy. RESULTS: Compared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, around 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 procedure’s novel nature, potentially unknown risks and benefits, and whether it would be the surgeon’s first time performing the procedure. CONCLUSIONS: To promote informed decision making and autonomy among patients considering innovative surgery, surgeons should disclose the procedure’s novel nature, 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