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首页> 外文期刊>AIDS care. >Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.
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Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

机译：试点研究证明了有针对性的教育对改善艾滋病临床试验中知情同意理解的有效性。

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Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.
机译：评估和提高知情同意理解与在临床试验研究中获得参与者的同意同等重要，但是开发针对参与者知情同意理解中的差距的干预措施仍然是一个挑战。我们使用了一项随机对照研究设计来对教育干预措施进行试点测试，以提高对成人AIDS临床试验组（AACTG）中新入组者的实际知情同意的理解。对24名参与者进行问卷调查，以评估他们对与AIDS临床试验相关的知情同意的八个要素的基线理解。得分为18/21（85％）或更低的入选者被随机分配到面对面，有针对性的教育（干预）或延迟教育（对照）中。进行了两次随访评估。进行了重复测量方差分析（ANOVA），以确定随时间推移改善实际知情同意理解的干预效果。与干预组和延迟组相比，干预后的即时理解提高了实际理解，得分差异为2.5。此外，将基线与三个月的随访进行比较，两组的得分差异显着，为3.2，这表明统计学上具有统计学意义的干预效果，可改善对知情同意书基本要素的实际理解。研究结果表明，一次有针对性的教育可以在干预后一周改善对知情同意的理解，但是保留这些概念可能需要定期进行监测，以确保在整个临床试验过程中获得理解。

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