Bone Marrow Transplant and Hematologic Malignancies, University of Colorado School of Medicine, University of Colorado Hospital, Denver, Colorado, USA.
Cancer. 2012 Apr 1;118(7):1877-83. doi: 10.1002/cncr.26438. Epub 2011 Aug 25.
This randomized study was designed to assess the utility of an educational video in preparing cancer patients for decisions about clinical trial participation. The study assessed the effect of the video on patients' understanding and perceptions of clinical trials, its impact on decision making and patient-provider communication, and patients' satisfaction with the video.
Ninety adults considering cancer clinical trials were randomized to receive (n = 45) or not receive (n = 45) the video. Using the validated Quality of Informed Consent (QuIC), respondents' knowledge about clinical trial participation was assessed. All subjects completed additional questions about satisfaction with the video, decision making, and patient-provider communication. Data were analyzed using the Wilcoxon rank-sum test, regression model, and descriptive statistics.
Although intent-to-treat analysis found no significant group differences in objective understanding between those randomized to view or not view the video, the majority of participants reported favorable experiences with regard to watching the video: 85% found the video was an important source of information about clinical trials; 81% felt better prepared to discuss the trial with their physician; 89% of those who watched the video with family indicated that it helped family better understand clinical trials; and 73% indicated it helped family accept their decision about participation.
Although the video did not measurably improve patients' knowledge about clinical trials, it was an important source of information, helped educate families, and enhanced patient communication with their oncology providers.
本随机研究旨在评估教育视频在帮助癌症患者准备参与临床试验决策方面的效用。该研究评估了视频对患者对临床试验的理解和认知的影响、对决策和医患沟通的影响，以及患者对视频的满意度。
90 名考虑参加癌症临床试验的成年人被随机分为接受（n=45）或不接受（n=45）视频组。使用经过验证的知情同意质量评估工具（QuIC）评估受访者对临床试验参与的知识。所有受试者都完成了关于对视频的满意度、决策和医患沟通的附加问题。数据分析采用 Wilcoxon 秩和检验、回归模型和描述性统计。
尽管意向治疗分析发现，随机观看或不观看视频的组间在客观理解方面没有显著差异，但大多数参与者对观看视频的体验表示满意：85%的参与者认为视频是关于临床试验的重要信息来源；81%的参与者感到更有准备与医生讨论试验；89%的与家人一起观看视频的参与者表示，这有助于家人更好地理解临床试验；73%的参与者表示这有助于家人接受他们参与试验的决定。
虽然视频没有显著提高患者对临床试验的知识，但它是一个重要的信息来源，有助于教育家属，并增强患者与肿瘤学提供者的沟通。
