Using digital multimedia to improve parents' and children's understanding of clinical trials.
Using digital multimedia to improve parents' and children's understanding of clinical trials.
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DOI：
10.1136/archdischild-2014-308021
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发表时间：
2015-06
影响因子：
5.2
通讯作者：
Levine R
中科院分区：
文献类型：
--
作者：
Tait AR;Voepel-Lewis T;Levine R
数据显示，许多研究受试者难以使用传统的纸质知情同意书来理解研究信息。因此，本研究旨在评估互动式多媒体节目对提高家长和儿童对临床试验概念和参与的理解的影响。父母（n = 148）和儿童（n = 135）分别随机接受有关临床试验的信息，使用传统的纸质格式（TF）或交互式iPad程序（IP）与在线练习。参与者的信息的理解进行了评估，使用半结构化的访谈之前（前测试）和之后（后测试）收到的信息。与会者还完成了一项简短的调查，以评估他们对信息提供的看法和对这一进程的满意度。无论信息传递的模式如何，所有参与者都表现出对测试前到测试后的理解有所提高。虽然TF组和IP组的父母在测试后理解方面没有统计学差异，但IP组的儿童在测试后理解方面明显高于TF组（11.65（4.1）vs 8.85（4.1）[2.8，1.4，4.2] 0-18量表，其中18 =完全理解）。此外，研究发现，与TF相比，IP在提供信息方面明显“更容易遵循”和“更有效”。结果证明了向父母和儿童提供有关临床试验概念的信息的重要性。重要的是，交互式多媒体的能力，以提高对临床试验的概念和满意度的信息传递，特别是在儿童中，支持这种方法作为一种新的和有效的工具，以加强知情同意过程。
Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents’ and children’s understanding of clinical trial concepts and participation. Parents (n = 148) and children (n = 135) were each randomized to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with in-line exercises. Participants’ understanding of the information was assessed using semi-structured interviews prior to (pre-test) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of the information delivery and satisfaction with the process. Regardless of the mode of information delivery, all participants demonstrated improved pre- to post-test understanding. While there were no statistical differences in parents’ post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65(4.1) vs 8.85(4.1) [2.8, 1.4,4.2] 0–18 scale where 18 = complete understanding). Furthermore, the IP was found to be significantly “easier to follow” and “more effective” in presenting information compared with the TF. Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process.
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影响因子：
2
作者：
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通讯作者：
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