Rainbow Babies & Children's Hospital, Cleveland, Ohio, USA.
Pediatr Blood Cancer. 2010 Jul 15;55(1):113-8. doi: 10.1002/pbc.22411.
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.
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.
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).
Our study supports the feasibility and potential efficacy of a brief video intervention employing anticipatory guidance to prepare parents for future discussions about RCTs.
研究表明，父母对儿科随机临床试验（RCT）知情同意的理解存在弱点，主要表现在对知情同意的关键方面理解不足。本研究的目的是评估一种视频干预措施在提高儿科白血病 RCT 知情同意方面的可行性和父母满意度，并将本研究中父母在知情同意会议（ICCs）中的提问与历史对照数据进行比较。
制作了一个 20 分钟的视频。利用预期指导的原则，它包括护士和医生提供的有关白血病和知情同意关键方面的信息。鼓励父母积极参与 ICCs。参与者包括 12 名新诊断为儿科白血病的儿童的父母。在将视频提供给家庭之前，当地儿科肿瘤学家先观看了该视频。
92%的父母报告说，该视频使他们更容易理解孩子的医生后来提供的信息；83%的父母报告说，它帮助他们想到要问医生的问题；67%的父母表示，该视频使他们在向医生提问时感到更加舒适。对 ICC 期间提问进行 t 检验的结果显示，参与干预的父母比历史对照样本中的父母提出的问题更多（t=1.95，P=0.05）。
我们的研究支持使用预期指导来准备父母参与未来 RCT 讨论的简短视频干预措施的可行性和潜在效果。
