A Feasibility Trial of a Video Intervention to Improve Informed Consent for Parents of Children With Leukemia
A Feasibility Trial of a Video Intervention to Improve Informed Consent for Parents of Children With Leukemia
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DOI：
10.1002/pbc.22411
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发表时间：
2010-07-15
影响因子：
3.2
通讯作者：
Noll, Robert B.
中科院分区：
文献类型：
--
作者：
Hazen, Rebecca A.;Eder, Michelle;Noll, Robert B.
背景。关于儿科随机临床试验（RCT）中家长对知情同意的理解的研究突显了对知情同意关键方面理解的弱点。本研究的目标是评估视频干预的可行性和家长对儿童白血病随机对照试验知情同意的满意度，并将本研究中家长在知情同意会议 (ICC) 期间提出的问题与历史对照数据进行比较。程序。制作了一段20分钟的视频。它利用预期指导原则，包括护士和医生提供的有关白血病和知情同意的关键方面的信息。我们鼓励家长积极参与 ICC。参与者包括 12 名新诊断出患有小儿白血病的儿童的家长。在与家人一起使用之前，当地儿科肿瘤学家观看了该视频。结果。 92% 的家长表示，该视频让他们更容易理解孩子的医生后来提供的信息； 83% 的家长表示，这有助于他们思考要问医生的问题； 67% 的家长表示，该视频让他们更愿意向医生提问。比较 ICC 期间提问的 t 检验结果显示，参与干预的家长提出问题的比例高于历史对照样本的家长（t=1.95，P=0.05）。讨论。我们的研究支持采用预期指导的简短视频干预的可行性和潜在功效，为家长未来讨论随机对照试验做好准备。 Pecliatr 血癌 2010；55：113-118。 (C) 2010 Wiley-Liss, Inc.
Background. Research on parental understanding of informed consent for pediatric randomized clinical trials (RCTs) has highlighted weaknesses in understanding of key aspects of informed consent. The goals of the current study were to assess the feasibility of and parental satisfaction with a video intervention to improve informed consent for pediatric leukemia RCTs and to compare parental question asking during informed consent conferences (ICCs) for parents in the current study with historical control data. Procedure. A 20-min video was produced. Utilizing the principles of anticipatory guidance, it included information delivered by nurses and physicians about leukemia and key aspects of informed consent. Parents were encouraged to be active participants in ICCs. Participants included 12 parents of children newly diagnosed with pediatric leukemia. The video was viewed by local pediatric oncologists prior to utilization with families. Results. Ninety-two percent of parents reported that the video made it easier to understand information that their child's physician later provided; 83% of parents reported that it helped them to think of questions to ask the physician; and 67% of parents indicated that the video made them feel more comfortable with asking questions of the physician. Results of a t-test comparing question asking during ICCs revealed that parents who participated in the intervention asked a higher rate of questions than parents from a historical control sample (t=1.95, P=0.05). Discussion. Our study supports the feasibility and potential efficacy of a brief video intervention employing anticipatory guidance to prepare parents for future discussions about RCTs. Pecliatr Blood Cancer 2010;55:113-118. (C) 2010 Wiley-Liss, Inc.