Yates Bernice C, Dodendorf Diane, Lane Judy, LaFramboise Louise, Pozehl Bunny, Duncan Kathleen, Knodel Kendra
College of Nursing, University of Nebraska Medical Center, 985330 Nebraska Medical Center, Omaha, NE 68198-5330, USA.
Nurs Res. 2009 Mar-Apr;58(2):135-9. doi: 10.1097/NNR.0b013e31818c3df5.
One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions.
The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial.
An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process.
Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study.
Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.
开展临床试验的主要问题之一是参与率低，这是由于潜在参与者对临床试验的基本原理存在误解，或者认为在治疗决策上失去了控制权。
本研究的目的是在心脏康复参与者中测试一种替代的知情同意程序，该程序使用多媒体活页图表来描述未来的随机临床试验，然后假设性地询问他们是否会参与未来的试验。
以23页活页图表的形式创建了一个具有吸引力且引人入胜的研究视觉展示，其中包括24张彩色照片，展示了研究目的、两个治疗组之间的异同以及数据收集过程。我们在35名心脏康复参与者中测试了该活页图表。在两个时间点询问参与者是否会参与这项未来研究：在活页图表描述之后立即询问，以及在24小时后，即阅读完知情同意文件之后询问。还询问了参与者对活页图表和同意程序的看法。
在接受调查的35名参与者中，19名（54%）表示他们会参与未来的研究。在阅读完整的同意书后，没有参与者在24小时后改变其决定。参与率比早期可行性研究提高了145%，早期可行性研究的招募率为22%。大多数参与者表示活页图表很有帮助且信息丰富，照片有效地传达了研究目的。
通过使用视觉展示来解释和描述研究作为知情同意程序的一部分，未来临床试验的参与率可能会提高。需要更多研究来测试获取知情同意的替代方法。
