Stanley B M, Walters D J, Maddern G J
Department of Surgery, Queen Elizabeth Hospital, Woodville, South Australia, Australia.
Aust N Z J Surg. 1998 Nov;68(11):788-91. doi: 10.1111/j.1445-2197.1998.tb04678.x.
Recent judicial decisions involving informed consent have led to some medical practitioners altering the way they obtain consent. The aim of this study was to determine the degree to which patients understood the risks associated with a surgical procedure after giving routine consent and whether providing additional detailed verbal and/or written information improved their understanding. It was further determined whether the provision of more extensive information altered patients' anxiety levels.
Patients undergoing femoral popliteal bypass or carotid surgery were randomized to obtain either routine consent only or routine consent with verbal or written or verbal and written consent. Patients undertook a pre-operative risk and complication questionnaire, a pre- and postoperative anxiety and depression evaluation and a follow-up questionnaire 6 weeks after discharge.
Thirty-two patients were included in the trial. The comprehension questionnaire resulted in a correct percentage response of 48% for the routine information only, 59% with added verbal information, 59% with added written information and 55% with added written and verbal information. Twenty-five per cent of patients stated that they had a poor understanding of the risks and complications of the procedure.
Additional written or verbal information did not improve a patient's understanding of risks and complications of the procedure. It also did not improve patients' perceived understanding of the operation or its complications. Patients' anxiety levels were unaltered by the increase in the information they were given. The information provided to patients should be simple, easy to understand and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure.
近期涉及知情同意的司法判决导致一些执业医生改变了获取同意的方式。本研究的目的是确定患者在给予常规同意后对手术相关风险的理解程度，以及提供额外的详细口头和/或书面信息是否能提高他们的理解。还进一步确定提供更广泛的信息是否会改变患者的焦虑水平。
接受股腘动脉搭桥术或颈动脉手术的患者被随机分为仅获得常规同意组，或获得常规同意并伴有口头或书面或口头加书面同意组。患者在术前进行风险和并发症问卷调查、术前和术后焦虑及抑郁评估，并在出院后6周进行随访问卷调查。
32名患者纳入试验。理解问卷结果显示，仅常规信息的正确回答百分比为48%，增加口头信息后为59%，增加书面信息后为59%，增加书面和口头信息后为55%。25%的患者表示对手术的风险和并发症理解较差。
额外的书面或口头信息并未提高患者对手术风险和并发症的理解。也未改善患者对手术及其并发症的认知理解。提供给患者的信息增加并未改变患者的焦虑水平。提供给患者的信息应简单易懂，并列出任何可能的主要并发症，以使患者能够决定是否接受或拒绝手术。
