Ives N J, Troop M, Waters A, Davies S, Higgs C, Easterbrook P J
Academic Department of HIV/GU Medicine, The Guy's, King's and St Thomas's School of Medicine, and St Stephen's Centre, Chelsea and Westminster Hospital, London, UK.
HIV Med. 2001 Oct;2(4):241-9. doi: 10.1046/j.1464-2662.2001.00084.x.
To evaluate the impact of an information booklet on HIV clinical trials, Clinical Trials in HIV and AIDS: Information For People Who Are Thinking About Joining a Trial, in addition to the standard trial information (SI) on patients' knowledge; understanding and attitudes about clinical trials; and to investigate patients' motivations and reasons for enrolling or not enrolling in a clinical trial.
Fifty HIV-1 positive patients who attended the HIV clinic at a west London hospital were randomized to receive either SI alone (n = 27) or SI and a 16 page information booklet explaining the principles and procedures of HIV clinical trials (n = 23). A self-administered questionnaire was used at baseline to assess past experience and attitudes to clinical trials (10 questions), knowledge and understanding of HIV treatments (8 questions) and clinical trials (11 questions). At 2-6 months after randomization, a second interviewer-administered questionnaire addressed the patient's assessment of the usefulness and comprehensiveness of the information provided by the SI and information booklet, whether or not the patient had enrolled in a clinical trial and reasons for enrolling/not enrolling, knowledge of specific aspects of the trial protocol the patient was eligible to join (13 questions) and general knowledge of clinical trial procedures (repeat of 11 baseline questions). Changes in the attitudes and scores on knowledge and understanding of clinical trials were compared for the two groups.
In both groups, patient knowledge of clinical trial procedures improved significantly over the study period. The median score increased from 30 at baseline to 35/44 at follow-up (SI only) vs. 24-31/44 (SI plus booklet), but this did not differ significantly between the two groups. However, knowledge of the specific trial protocol was poor [median score 13/25, interquartile range (IQR) 8-14], and there was no difference in the scores for the two groups. The prime motivations for joining a clinical trial were to benefit personal health and to gain access to new treatments. Potential side-effects were the main concern of prospective trial participants.
This small trial shows that, while the patients' general knowledge and understanding of clinical trials improved over time, this was not improved by the information booklet and recollection of the details of the relevant trial protocol remained poor.
评估一本关于艾滋病临床试验的信息手册《艾滋病与艾滋病临床试验：有意参与试验者须知》对患者知识的影响，该手册是除标准试验信息（SI）之外的内容；了解患者对临床试验的理解和态度；并调查患者参与或不参与临床试验的动机及原因。
选取五十名在伦敦西部一家医院的艾滋病诊所就诊的HIV-1阳性患者，随机分为两组，一组仅接受标准试验信息（n = 27），另一组接受标准试验信息及一本16页的信息手册，该手册解释了艾滋病临床试验的原则和程序（n = 23）。在基线时使用一份自填式问卷来评估患者过去对临床试验的经验和态度（10个问题）、对艾滋病治疗的知识和理解（8个问题）以及对临床试验的知识和理解（11个问题）。在随机分组后2至6个月，由访谈者再次发放问卷，内容包括患者对标准试验信息和信息手册所提供信息的有用性和全面性的评估、患者是否参与了临床试验及参与/未参与的原因、患者对其符合条件的特定试验方案具体方面的了解（13个问题）以及对临床试验程序的一般知识（重复11个基线问题）。比较两组在态度以及对临床试验的知识和理解得分方面的变化。
在研究期间，两组患者对临床试验程序的知识均有显著提高。中位数得分从基线时的30分提高到随访时的35/44分（仅标准试验信息组）与24 - 31/44分（标准试验信息加手册组），但两组之间差异不显著。然而，对特定试验方案的了解较差[中位数得分13/25，四分位间距（IQR）8 - 14]，两组得分无差异。参与临床试验的主要动机是使个人健康受益并获得新的治疗方法。潜在的副作用是未来试验参与者主要关注的问题。
这项小型试验表明，虽然随着时间推移患者对临床试验的一般知识和理解有所提高，但信息手册并未使其得到改善，且对相关试验方案细节的记忆仍然较差。
