Berman Loren, Dardik Alan, Bradley Elizabeth H, Gusberg Richard J, Fraenkel Liana
Yale University School of Medicine, New Haven, CT 06520, USA.
J Vasc Surg. 2008 Feb;47(2):287-295. doi: 10.1016/j.jvs.2007.10.050.
Informed consent discussions for elective abdominal aortic aneurysm (AAA) repair should reflect appropriate risks of the open or endovascular repair (EVAR), but few guidelines exist describing what surgeons should discuss. This study examines expert opinion regarding what constitutes informed consent.
Design. We conducted an anonymous, web-based, national survey of vascular surgeons. Associations between surgeon characteristics and opinions regarding informed consent were measured using bivariate statistics; multivariable logistic regression was performed to estimate effects adjusted for covariates. Setting. Academic and private practice surgeons were surveyed. Subjects. United States members of the International Society for Vascular Surgery membership. Main Outcome Measure. Surgeons' self-reported opinions regarding the content of informed consent for AAA repair.
A total of 199 surgeons completed the survey (response rate 51%). More than 90% of respondents reported that it was essential to discuss mortality risk for both procedures. However, only 60% and 30% of respondents reported that it was essential to discuss the risk of myocardial infarction and stroke, respectively. Opinions varied by procedure regarding the risks of impotence (32% vs 62%; EVAR vs open repair), reintervention (78% vs 17%), and rupture during long-term follow-up (57% vs 17%). Younger and private practice surgeons were more likely to discuss complications compared with older surgeons and those in academic practice. Surgeons who perform predominantly EVAR were more likely to quote higher mortality rates for open repair (odds ration [OR] = 3.1, 95% confidence interval [CI] = 1.4-6.4) and lower reintervention rates for EVAR (OR = 0.3, 95% CI = 0.1-0.7) compared with other surgeons.
This is the first study of the practice of informed consent for AAA repair. The only risk that the vast majority of surgeons agreed should be included in informed consent for AAA repair was mortality. Significant variation exists regarding whether other complications should be discussed and what complication rates should be quoted. Surgeon characteristics may influence how risks are presented to patients. Further efforts are needed to develop guidelines to ensure consistent communication of appropriate risk during informed consent for AAA repair.
对于择期腹主动脉瘤(AAA)修复术的知情同意讨论应反映开放手术或血管腔内修复术(EVAR)的适当风险,但描述外科医生应讨论内容的指南很少。本研究探讨了关于构成知情同意的专家意见。
设计。我们对血管外科医生进行了一项基于网络的全国性匿名调查。使用双变量统计方法测量外科医生特征与关于知情同意的意见之间的关联;进行多变量逻辑回归以估计经协变量调整后的效应。背景。对学术和私人执业外科医生进行了调查。研究对象。国际血管外科学会美国会员。主要观察指标。外科医生对AAA修复术知情同意内容的自我报告意见。
共有199名外科医生完成了调查(回复率51%)。超过90%的受访者表示,讨论两种手术的死亡风险至关重要。然而,分别只有60%和30%的受访者表示讨论心肌梗死和中风风险至关重要。对于阳痿风险(32%对62%;EVAR对开放手术)、再次干预风险(78%对17%)以及长期随访期间破裂风险(57%对17%),不同手术的意见存在差异。与年长外科医生和学术执业外科医生相比,年轻和私人执业外科医生更有可能讨论并发症。与其他外科医生相比,主要进行EVAR手术的外科医生更有可能报出开放手术更高的死亡率(优势比[OR]=3.1,95%置信区间[CI]=1.4 - 6.4)和EVAR更低的再次干预率(OR = 0.3,95%CI = 0.1 - 0.7)。
这是第一项关于AAA修复术知情同意实践的研究。绝大多数外科医生一致认为应纳入AAA修复术知情同意的唯一风险是死亡率。对于是否应讨论其他并发症以及应报出何种并发症发生率存在显著差异。外科医生特征可能会影响向患者呈现风险的方式。需要进一步努力制定指南,以确保在AAA修复术知情同意过程中一致地传达适当风险。