Pleat J M, Dunkin C S J, Davies C E, Ripley R M, Tyler M P H
Department of Plastic Surgery, Stoke Mandeville Hospital, Aylesbury, UK.
Br J Surg. 2004 Oct;91(10):1377-80. doi: 10.1002/bjs.4590.
The Department of Health in the UK has developed new consent guidance but without clear recommendations on how the incidence and severity of a given risk should influence its discussion during the process of obtaining informed consent. Plastic surgery is a litigation-prone specialty that offers a paradigm for assessing attitudes to consent.
A questionnaire was sent to all surgeons at six plastic and reconstructive surgery units within the UK. It enquired what incidence of a relatively frequent minor severity risk such as wound infection, or an extremely rare but major risk such as stroke, would merit its discussion when obtaining informed consent for elective surgery.
Sixty of 85 questionnaires were returned. For a minor risk, there was a consensus that an incidence threshold of 5 per cent or greater would necessitate its discussion. For a major risk, the modal threshold was 0.1 per cent, but there was a greater variability of response.
There was a wide variation of opinion as to how frequently a major risk must occur before it is likely to be conveyed to a patient during the process of consent. The findings suggest that recent change in case law has yet to disseminate fully in one surgical specialty, with the potential for the challenge that consent is not 'informed'.
英国卫生部制定了新的同意书指南,但对于在获取知情同意过程中,特定风险的发生率和严重程度应如何影响对此风险的讨论,却没有给出明确建议。整形手术是一个易引发诉讼的专业领域,为评估对同意书的态度提供了一个范例。
向英国六个整形与重建外科科室的所有外科医生发放了一份调查问卷。问卷询问,在为择期手术获取知情同意时,诸如伤口感染这类相对常见的轻度风险,或诸如中风这类极为罕见但严重的风险,其发生率达到多少时才值得进行讨论。
共收回85份问卷中的60份。对于轻度风险,大家一致认为发生率阈值达到或超过5%时就需要进行讨论。对于严重风险,众数阈值为0.1%,但回答的差异更大。
对于在同意过程中,严重风险在多大频率发生时才有可能告知患者,意见存在很大差异。研究结果表明,近期判例法的变化在一个外科专业领域尚未完全传播开来,这可能导致同意书并非“知情”的质疑。