FACTORS AFFECTING QUALITY OF INFORMED CONSENT

FACTORS AFFECTING QUALITY OF INFORMED CONSENT
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DOI:
10.1136/bmj.306.6882.885
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发表时间:
1993-04-03
影响因子:
--
通讯作者:
CUSCHIERI, A
CUSCHIERI, A
中科院分区:
医学1区
文献类型:
--
作者:
LAVELLEJONES, C;BYRNE, DJ;CUSCHIERI, A

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目的:探讨影响知情同意质量的因素。设计-前瞻性研究包括患者访谈和患者填写标准问卷。设置-大型教学医院学术外科单位。患者-265例接受胸内、腹腔和血管外科手术的患者。在这些患者中,有192人随访了6个月。主要结果测量-患者在研究中不同时间点的信息回忆;这个分数通过年龄、提供书面信息、认知功能、智商、情绪状态和人格特征以及健康控制点进行比较。结果:签署知情同意书后立即告知患者信息的效果最好,此后患者对相关信息的回忆逐渐恶化。共有172/250(69%)患者承认在签署同意书之前没有阅读同意书。年龄对所有评估点的信息回忆都有不利影响。认知功能受损仅在住院期间减少了信息回忆。智商高于平均水平的患者处理信息的能力要强于智商较低的患者,除非他们刚刚签署了知情同意书。具有内部健康控制点的患者(即认为自己的健康掌握在自己手中的患者)比具有外部健康控制点的患者更了解情况。操作信息卡仅在出院当天提高了召回率。结论:老年患者及智商低于平均水平、认知功能受损、有外部控制点的患者信息回忆能力较差。如果在入院前提供书面资料,可能会更有用。
Objective-To examine the factors influencing quality of informed consent.Design-Prospective study comprising interviews with patients and patients' completing standard questionnaires.Setting-Academic surgical unit of large teaching hospital.Patients-265 patients undergoing intrathoracic, intraperitoneal, and vascular surgical procedures. Of these patients, 192 have been followed up for six months.Main outcome measures-Patients' recall of information at various points in the study; this score was compared by age, provision of written information, cognitive function, intelligence quotient (IQ), mood state and personality traits, and health locus of control.Results-The patients were best informed immediately after signing the consent form and from then on recall of information deteriorated. A total of 172/250 (69%) patients admitted to not reading the consent form before signing it. Old age adversely affected recall of information at all assessment points. Impaired cognitive function reduced information recall only during the stay in hospital. Patients with above average lQs handled information better than those with a lower IQ except immediately after the signing of consent forms. Patients with an internal locus of health control (that is, those who believed their health to be in their own control) were better informed than those with an external locus of health control. Operation information cards improved recall only on the day of discharge.Conclusion-Elderly patients and patients with below average IQ, impaired cognitive functions, and an external locus of control have poor information recall. Written information may be more useful if given before admission to hospital.