"Entering a Clinical Trial: Is it Right for You?": a randomized study of The Clinical Trials Video and its impact on the informed consent process.
"Entering a Clinical Trial: Is it Right for You?": a randomized study of The Clinical Trials Video and its impact on the informed consent process.
复制标题
作者：
Hoffner B;Bauer-Wu S;Hitchcock-Bryan S;Powell M;Wolanski A;Joffe S
这项随机研究旨在评估教育视频在癌症患者准备参与临床试验决定方面的效用。该研究评估了视频对患者理解和感知临床试验的影响，其对决策和患者-提供者沟通的影响，以及患者对视频的满意度。90名考虑进行癌症临床试验的成年人被随机分配接受（n = 45）或不接受（n = 45）视频。使用经验证的知情同意质量（QuIC），评估了受访者对临床试验参与的了解。所有受试者都完成了关于视频满意度、决策和医患沟通的其他问题。使用Wilcoxon秩和检验、回归模型和描述性统计分析数据。尽管意向性治疗分析发现，随机观看或不观看视频的受试者在客观理解方面没有显著的组间差异，但大多数受试者报告了观看视频的良好体验：85%的受试者发现视频是有关临床试验的重要信息来源; 81%的受试者感觉更好地准备与医生讨论试验; 89%与家人一起观看视频的人表示，这有助于家人更好地了解临床试验; 73%表示这有助于家人接受他们参与的决定。虽然该视频并没有显著提高患者对临床试验的了解，但它是一个重要的信息来源，有助于教育家庭，并加强患者与肿瘤学提供者的沟通。
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.
登录
查看更多内容
影响因子：
158.5
作者：
Paasche-Orlow, MK;Taylor, HA;Brancati, FL
通讯作者：
Brancati, FL
DOI：
10.1093/jnci/93.2.139
发表时间：
2001-01-17
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
Joffe, S;Cook, EF;Weeks, JC
通讯作者：
Weeks, JC
影响因子：
3.6
作者：
Hack, Thomas F.;Whelan, Tim;Brady, Jane
通讯作者：
Brady, Jane
影响因子：
2.7
作者：
Bergenmar, Mia;Johansson, Hemming;Wilking, Nils
通讯作者：
Wilking, Nils
DOI：
10.1016/0021-9681(74)90015-0
发表时间：
1974-01-01
期刊：
JOURNAL OF CHRONIC DISEASES
影响因子：
--
作者：
ZELEN, M
通讯作者：
ZELEN, M