Document Detail

Informed consent for innovative surgery: a survey of patients and surgeons.
MedLine Citation:
PMID:  23218878     Owner:  NLM     Status:  MEDLINE    
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.
Susan J Lee Char; Nancy K Hills; Bernard Lo; Kimberly S Kirkwood
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-12-04
Journal Detail:
Title:  Surgery     Volume:  153     ISSN:  1532-7361     ISO Abbreviation:  Surgery     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-18     Completed Date:  2013-05-02     Revised Date:  2014-04-02    
Medline Journal Info:
Nlm Unique ID:  0417347     Medline TA:  Surgery     Country:  United States    
Other Details:
Languages:  eng     Pagination:  473-80     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 Mosby, Inc. All rights reserved.
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MeSH Terms
Attitude of Health Personnel*
Clinical Competence
Consent Forms*
Data Collection
General Surgery
Middle Aged
Patients / psychology*
Personal Autonomy*
Surgical Procedures, Operative*
Grant Support
1 UL1 RR024131-01/RR/NCRR NIH HHS; R03 MH062214/MH/NIMH NIH HHS

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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