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Informed consent for innovative surgery: a survey of patients and surgeons.

ABSTRACT: 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.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.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.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.

SUBMITTER: Lee Char SJ

PROVIDER: S-EPMC3602241 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Informed consent for innovative surgery: a survey of patients and surgeons.

Lee Char Susan J SJ Hills Nancy K NK Lo Bernard B Kirkwood Kimberly S KS

Surgery 20121204 4

<h4>Background</h4>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 su ...[more]

PMID: 23218878

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Project description:UnlabelledAdditional non-English language abstract (in Dutch)BackgroundA properly conducted surgical informed consent process (SIC) allows patients to authorize an invasive procedure with full comprehension of relevant information including involved risks. Current practice of SIC may differ from the ideal situation. The aim of this study is to evaluate whether SIC practiced by Dutch general surgeons and residents is adequate with involvement of all required elements.MethodsAll members of the Dutch Society of Surgery received an online multiple choice questionnaire evaluating various aspects of SIC.ResultsA total of 453 questionnaires obtained from surgeons and residents representing >95% of all Dutch hospitals were eligible for analysis (response rate 30%). Knowledge on SIC was limited as only 55% was familiar with all three basic elements ('assessment of preconditions', 'provision of information' and 'stage of consent'). Residents performance was inferior compared to surgeons regarding most aspects of daily practice of SIC. One in 6 surgeons (17%) had faced a SIC-related complaint in the previous five years possibly illustrating suboptimal SIC implementation in daily surgical practice.ConclusionsThe quality of the current SIC process is far from optimal in the Netherlands. Surgical residents require training aimed at improving awareness and skills. The SIC process is ideally supported using modern tools including web-based interactive programs. Improvement of the SIC process may enhance patient satisfaction and may possibly reduce the number of complaints.AchtergrondHet doel van het preoperatieve informed consent proces (surgical informed consent, SIC) is om patiënten een weloverwogen en welgeïnformeerde keuze te laten maken over hun operatieve ingreep. De hedendaagse praktijk betreffende SIC staat mogelijk ver van de ideale situatie af. Doel van deze studie is om de dagelijkse praktijk van chirurgen en chirurgen in opleiding betreffende SIC te evalueren en te zien of deze voldoet aan de daarvoor gestelde eisen. METHODE: Alle chirurgen en andere leden van de Nederlandse Vereniging voor Heelkunde ontvingen een online multiple-choice vragenlijst betreffende de belangrijkste aspecten van SIC. RESULTATEN: In totaal waren er 453 bruikbare reacties uit meer dan 95% van alle Nederlandse ziekenhuizen (respons 30%). De kennis over SIC blijkt zeer beperkt. Slechts 55% van de chirurgen bleek bekend met de drie basiselementen van SIC ('beoordelen van de competentie van een patiënt', 'verstrekken van informatie' and 'adequaat vastleggen van de toestemming van de patiënt'). De dagelijkse praktijk liet behoorlijke verschillen tussen alle respondenten zien, maar chirurgen in opleiding scoorden significant slechter vergeleken met chirurgen. 17% van alle chirurgen kreeg de afgelopen vijf jaar te maken met een klacht betreffende SIC, wat zou kunnen wijzen op een suboptimale implementatie van SIC in de dagelijkse praktijk.ConclusieDe kwaliteit van het preoperatieve informed consent proces is in Nederland verre van goed. Chirurgen in opleiding scoorden minder goed dan chirurgen en dienen beter geschoold te worden. Het hele SIC proces zou geformaliseerd moeten worden in protocollen. Moderne hulpmiddelen zoals interactieve softwareprogramma's kunnen hierbij mogelijk helpen. Door het verbeteren van het SIC proces kan de patiëntentevredenheid verhoogd worden terwijl het aantal klachten mogelijk wordt verminderd.

Project description:BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

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Informed consent for innovative surgery: a survey of patients and surgeons.

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Informed consent for innovative surgery: a survey of patients and surgeons.

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