Tindall B, Forde S, Ross M W, Goldstein D, Barker S, Cooper D A
Patient Educ Couns. 1994 Dec;24(3):261-6. doi: 10.1016/0738-3991(94)90069-8.
To determine subjects' perception of the purpose of informed consent, 113 subjects were recruited from a dose-controlled clinical trial of didanosine (ddI). Subjects were surveyed regarding how they made decisions regarding their medical care in general, about how they obtained information about this trial in particular, and several aspects of the informed consent procedure. Subjects were then randomly allocated to receive information about the trial by either a written only format or a written and verbal format 1 week before commencement of the trial. An eight-item instrument assessed knowledge of ddI prior to and subsequent to receiving information. Most subjects obtained information about HIV-related issues from their specialist (70%) or general (51%) medical practitioner. A large proportion of subjects (88%) reported that they believed their specialist medical practitioner always acted in their best interest. The majority of subjects (79%) believed that subjects should be allowed the choice between participating in the clinical trial and receiving the drug outside the trial mechanism. Of the subjects, 96% believed that informed consent was necessary in clinical trials; however, their opinions of the purpose of informed consent varied widely. Although they signed the informed consent, 44% of the subjects stated that they did not understand 'all' of the information that was provided. We found that the provision of information by written mode alone, or written and verbal modes were both associated with significant increases in knowledge levels and that there was a significant interaction in the degree of change between the two methods, with the written plus verbal method showing the most improvement over time. There was an interaction between degree of improvement in knowledge of didanosine in subjects who received written information versus those who received written and verbal knowledge and time (pre- versus post-consent) and a significant main effect for time. All subjects were relatively well-informed about the drug and stated that specialist and general medical practitioners were their major source of knowledge for all aspects of their HIV health care.
为了确定受试者对知情同意目的的认知，从一项去羟肌苷（ddI）剂量对照临床试验中招募了113名受试者。就他们一般如何做出医疗护理决策、特别是如何获取有关该试验的信息以及知情同意程序的几个方面，对受试者进行了调查。然后在试验开始前1周，将受试者随机分配为仅通过书面形式或书面加口头形式接收有关试验的信息。一个包含8个条目的工具评估了受试者在接收信息前后对ddI的了解情况。大多数受试者从其专科医生（70%）或全科医生（51%）那里获取有关艾滋病毒相关问题的信息。很大一部分受试者（88%）报告称，他们认为其专科医生总是为他们的最大利益行事。大多数受试者（79%）认为应该允许受试者在参与临床试验和在试验机制之外接受药物之间进行选择。在这些受试者中，96%认为知情同意在临床试验中是必要的；然而，他们对知情同意目的的看法差异很大。尽管他们签署了知情同意书，但44%的受试者表示他们并不理解所提供的“所有”信息。我们发现，仅通过书面方式或书面加口头方式提供信息均与知识水平的显著提高相关，并且这两种方法在变化程度上存在显著交互作用，书面加口头方法随着时间推移显示出最大的改善。在接收书面信息的受试者与接收书面加口头信息的受试者之间，去羟肌苷知识改善程度与时间（同意前与同意后）之间存在交互作用，并且时间有显著的主效应。所有受试者对该药物都有相对充分的了解，并表示专科医生和全科医生是他们艾滋病毒医疗保健各方面知识的主要来源。
