Tait Alan R, Voepel-Lewis Terri, Levine Robert
Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA Center for Bioethics and Social Sciences in Medicine, University of Michigan.
Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA.
Arch Dis Child. 2015 Jun;100(6):589-93. doi: 10.1136/archdischild-2014-308021. Epub 2015 Mar 31.
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 randomised to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with inline exercises. Participants' understanding of the information was assessed using semistructured interviews prior to (pretest) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process.
Regardless of the mode of information delivery, all participants demonstrated improved pretest 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.
数据显示，许多研究对象在使用传统纸质同意书理解研究信息时存在困难。因此，本研究旨在评估交互式多媒体程序对提高家长和儿童对临床试验概念的理解及参与度的效果。
将148名家长和135名儿童分别随机分组，使其接受关于临床试验的信息，信息提供方式分别为传统纸质形式（TF）或带有嵌入式练习的交互式iPad程序（IP）。在接受信息之前（预测试）和之后（后测试），通过半结构化访谈评估参与者对信息的理解。参与者还完成了一项简短调查，以评估他们对信息传递的看法以及对该过程的满意度。
无论信息传递方式如何，所有参与者从预测试到后测试的理解都有提高。虽然TF组和IP组家长在后测试中的理解没有统计学差异，但IP组儿童在后测试中的理解明显高于TF组儿童（11.65（4.1）对8.85（4.1）（2.8, 1.4, 4.2），0至18分制，18分表示完全理解）。此外，与TF相比，发现IP在呈现信息方面明显“更易于理解”且“更有效”。
结果证明了向家长和儿童提供关于临床试验概念信息的重要性。重要的是，交互式多媒体能够提高对临床试验概念的理解以及对信息传递的满意度，尤其是在儿童中，这支持了将其作为加强知情同意过程的一种新颖且有效的手段。
