Olver I N, Buchanan L, Laidlaw C, Poulton G
Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia.
Ann Oncol. 1995 Nov;6(9):867-70. doi: 10.1093/oxfordjournals.annonc.a059352.
The impact on 100 patients of information and consent forms signed prior to medical oncology clinical trials was evaluated by a survey at a subsequent visit. Only 40 patients believed that the purpose of the form was to explain the treatment. The form was listed as the major source of information by 12 patients while 52 listed a doctor and 26 a nurse. Although 21 patients believed that the form mad them less anxious, 19 patients believed that it made them more anxious. Despite 80 patients reading all of the form, 60 claiming to understand all of it and 68 claiming that in contained adequate information, in tests of recall only 52 patients could name all of their drugs and only 4 all of the side effects. The number of drugs named correlated with how much of the consent form had been read (p = 0.003) and the highest education level achieved by the patient (p = 0.0003). Patients under 55 years had significantly better recall. Patients with a better ECOG performance status were more likely to find the form very helpful. Such forms may not ensure that the requirements for informed consent are satisfied.
通过在后续访视时进行的一项调查，评估了肿瘤内科临床试验前签署的信息和同意书对100名患者的影响。只有40名患者认为该表格的目的是解释治疗方案。12名患者将该表格列为主要信息来源，而52名患者列出的是医生，26名患者列出的是护士。尽管21名患者认为该表格使他们焦虑减轻，但19名患者认为它使他们更加焦虑。尽管80名患者阅读了全部表格，60名声称理解了全部内容，68名声称其中包含足够信息，但在记忆测试中，只有52名患者能说出所有服用的药物，只有4名能说出所有副作用。说出的药物数量与阅读同意书的篇幅相关（p = 0.003），也与患者所达到的最高教育水平相关（p = 0.0003）。55岁以下的患者记忆力明显更好。东部肿瘤协作组（ECOG）体能状态较好的患者更有可能觉得该表格非常有用。此类表格可能无法确保满足知情同意的要求。
