Kondziolka Douglas S, Pirris Stephen M, Lunsford L Dade
Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Neurosurgery. 2006 Jun;58(6):1184-9; discussion 1184-9. doi: 10.1227/01.NEU.0000215958.26175.EA.
Obtaining and documenting informed consent is of vital importance to physicians. We developed a procedure-based consent form that facilitates patient discussion and validated this process by surveying the patient regarding elements of the consent process, using an independent evaluator.
One hundred and twenty consecutive outpatients were evaluated before different neurosurgery procedures. The consent form listed specific diagnoses, procedures, alternatives (eight listed), and risks (22 listed), and each point discussed was checked off by the surgeon. Between 10 and 20 minutes later, each element was questioned by one lay-member of the office staff. A group of patients not at risk for cognitive decline were resurveyed months later.
One hundred and twenty (100%) of 120 of patients answered correctly regarding their diagnosis and the planned procedure. Four hundred and twenty-eight alternative treatments were discussed, and 420 (98.1%) of the 428 were recalled correctly. Of 1207 risks that were discussed, 1176 (97.4%) were recalled correctly. When a subset of the patients were reevaluated at a mean of 4.5 months later, all 20 patients correctly recalled their procedure and diagnosis. Of 79 alternatives discussed with patients before surgery, 73 (92.4%) were subsequently recalled. Of 217 risks discussed before surgery, 199 (91.7%) were recalled. Although the immediate or delayed recall rates were high (> 90%), there was a reduction in the recall rate over time (alternatives, P = .007; risks, P < 0.0001).
A consent process designed for an individual surgeon's practice was validated and showed high rates of patient recall in the postprocedural period. We think that this method to obtain and document informed consent should be considered for use by physicians.
获取并记录知情同意书对医生至关重要。我们制定了一种基于流程的同意书，以促进与患者的讨论，并通过使用独立评估员就同意流程的各项内容对患者进行调查来验证这一过程。
对120例连续的门诊患者在接受不同神经外科手术前进行评估。同意书列出了具体诊断、手术、替代方案（列出8种）和风险（列出22种），外科医生会勾选讨论过的每一项内容。在10至20分钟后，办公室工作人员中的一名非专业人员会就各项内容进行询问。一组无认知能力下降风险的患者在数月后接受再次调查。
120例患者中有120例（100%）正确回答了他们的诊断和计划进行的手术。共讨论了428种替代治疗方案，其中420种（98.1%）被正确回忆。在讨论的1207项风险中，1176项（97.4%）被正确回忆。当对一部分患者在平均4.5个月后进行重新评估时，所有20例患者都正确回忆了他们的手术和诊断。在手术前与患者讨论的79种替代方案中，73种（92.4%）随后被回忆起来。在手术前讨论的217项风险中，199项（91.7%）被回忆起来。尽管即时或延迟回忆率很高（>90%），但随着时间推移回忆率有所下降（替代方案，P = 0.007；风险，P < 0.0001）。
为个体外科医生的实践设计的同意流程得到了验证，并且在术后阶段患者回忆率很高。我们认为这种获取并记录知情同意书的方法值得医生考虑采用。
