The adequacy of consent forms for informing patients entering oncological clinical trials
The adequacy of consent forms for informing patients entering oncological clinical trials
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DOI：
10.1093/oxfordjournals.annonc.a059352
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发表时间：
1995-11-01
影响因子：
50.5
通讯作者：
Poulton, G
中科院分区：
文献类型：
--
作者：
Buchanan, L;Laidlaw, C;Poulton, G
在随后的访视中通过调查评估了100例患者在医学肿瘤学临床试验前签署的信息和知情同意书的影响。只有40名患者认为该表格的目的是解释治疗，12名患者将该表格列为主要信息来源，52名患者列出了医生和26名护士。虽然21名患者认为表格使他们不那么焦虑，但19名患者认为它使他们更加焦虑。尽管有80名患者阅读了所有的表格，60名声称理解了所有的表格，68名声称表格包含了足够的信息，但在回忆测试中，只有52名患者能说出所有的药物，只有4名患者能说出所有的副作用。药物的数量与患者阅读同意书的程度（p = 0.003）和患者达到的最高教育水平（p = 0.0003）相关。55岁以下的患者记忆力明显更好。ECOG体能状态较好的患者更有可能发现该表格非常有用。这些表格可能无法确保满足知情同意的要求。
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 made 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 it 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.