Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India
Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India
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DOI：
10.1093/inthealth/ihs009
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发表时间：
2013-03-01
影响因子：
2.5
通讯作者：
Mehendale, Sanjay M.
中科院分区：
文献类型：
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作者：
Joglekar, Neelam S.;Deshpande, Swapna S.;Mehendale, Sanjay M.
研究参与者对知情同意的最佳理解至关重要，但也具有挑战性。本研究探讨了一项队列研究的 1334 名参与者对知情同意理解程度较低的相关性，该研究旨在估计印度浦那的艾滋病毒发病率。作为知情同意过程的一部分，向研究参与者使用了结构化理解工具。得分为 90 分的参与者被分为“最佳理解组”，而得分为 8089 分的参与者被分为“较低理解组”。对数据进行分析，以确定较低同意理解力的社会人口统计学和行为相关性。平均 SD 理解力得分为 94.4 ± 5.00。 61.7 的参与者不理解与研究相关的风险相关的信息。 HIV 阴性男性（调整后 OR [AOR] 4.36，95 CI 1.7111.05）或 HIV 阴性女性（AOR 13.54，95 CI 6.4228.55）、文盲（AOR 1.65，95 CI 1.192.30）、有多个伴侣史的人（AOR 1.73，95 CI 1.122.66）和那些从不使用安全套的人（AOR 1.35，95 CI 1.011.82）更有可能具有较低的同意理解力。我们建议使用经过验证的同意理解工具探索较低同意理解力的领域。改善这些特定领域的教育将优化研究参与者的同意理解。
Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India.As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring epsilon 90 were categorised into the ooptimal comprehension group', whilst those scoring 8089 were categorised into the olower comprehension group'. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension.The mean SD comprehension score was 94.4 5.00. Information pertaining to study-related risks was not comprehended by 61.7 of participants. HIV-negative men (adjusted OR [AOR] 4.36, 95 CI 1.7111.05) or HIV-negative women (AOR 13.54, 95 CI 6.4228.55), illiteracy (AOR 1.65, 95 CI 1.192.30), those with a history of multiple partners (AOR 1.73, 95 CI 1.122.66) and those never using condoms (AOR 1.35, 95 CI 1.011.82) were more likely to have lower consent comprehension.We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.