Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.
Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.
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DOI：
10.1080/09540121.2011.565031
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发表时间：
2011-11
期刊：
影响因子：
1.7
通讯作者：
Gifford AL
中科院分区：
文献类型：
--
作者：
Sengupta S;Lo B;Strauss RP;Eron J;Gifford AL
评估和改善知情同意理解与获得临床试验研究参与者的同意同等重要，但制定干预措施以弥补参与者知情同意理解方面的差距仍然是一项挑战。我们使用随机对照研究设计来试行教育干预，以提高成人艾滋病临床试验组(AACTG)新参与者的实际知情同意理解。对24名参与者进行问卷调查，以评估他们对与艾滋病临床试验相关的知情同意的八个要素的基线理解。得分在18/21(85%)或以下的参与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)。进行了两次随访评估。重复测量采用方差分析，以确定随时间推移在改善实际知情同意理解方面的干预有效性。在干预后即刻时间点，实际理解能力有所提高，干预组和延迟组的得分差异显著，达到2.5分。此外，两组在基线和3个月随访时的得分差异显著，达到3.2分，这表明在提高对知情同意基本要素的实际理解方面，干预效果具有统计学意义。研究结果表明，一次性定向教育可以在干预一周后提高对知情同意的实际理解，但保留这些概念可能需要定期监测，以确保在整个临床试验过程中理解。
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 3-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.
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DOI：
10.1097/01.qai.0000229998.59869.05
发表时间：
2006-08-15
影响因子：
3.6
作者：
Joseph, Patrice;Schackman, Bruce R.;Fitzgerald, Daniel W.
通讯作者：
Fitzgerald, Daniel W.
影响因子：
51.1
作者：
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通讯作者：
Moore, Rosemary
影响因子：
2.7
作者：
Sarkar, Rajiv;Sowmyanarayanan, Thuppal V.;Kang, Gagandeep
通讯作者：
Kang, Gagandeep
影响因子：
1.6
作者：
Wray, Ricardo J.;Stryker, Jo Ellen;Demetri, George
通讯作者：
Demetri, George
影响因子：
3.5
作者：
Campbell, FA;Goldman, BD;Skinner, M
通讯作者：
Skinner, M