Control Clin Trials. 1989 Mar;10(1):83-96. doi: 10.1016/0197-2456(89)90020-2.
The Diabetes Control and Complications Trial (DCCT) is a multicenter, randomized clinical trial studying the effects of two different diabetes treatment regimens on the development and progression of early vascular complications in persons with insulin-dependent diabetes mellitus. A multicomponent program that utilized audiovisual and written material as well as behavioral practice was developed to educate prospective volunteers so that they could make an enlightened decision about participation in this complex and demanding long-term trial. The efficacy of this multicomponent approach was evaluated by administering a standardized test of knowledge about the trial and its requirements following the intensive educational process and again after 1 year's participation in the study. A mean score of 97% was achieved on the first test. The mean score of 91% 1 year after randomization indicated excellent retention of information. Moreover, the high degree of adherence during the first year of the trial suggests that the informed consent process provided the subjects with a realistic portrayal of the trial demands. The multicomponent informed consent process developed for the DCCT may serve as a model for other complex and demanding clinical trials where prospective subjects must be highly educated about the trial in order to participate effectively.
糖尿病控制与并发症试验（DCCT）是一项多中心随机临床试验，旨在研究两种不同糖尿病治疗方案对胰岛素依赖型糖尿病患者早期血管并发症发生和发展的影响。制定了一个多组成部分的项目，利用视听材料、书面材料以及行为实践来教育潜在志愿者，以便他们能够就是否参与这项复杂且要求严格的长期试验做出明智的决定。在强化教育过程之后以及参与研究1年后，通过对关于试验及其要求的知识进行标准化测试，来评估这种多组成部分方法的效果。第一次测试的平均得分达到了97%。随机分组1年后的平均得分91%表明信息保留情况良好。此外，试验第一年的高依从率表明，知情同意过程向受试者如实描述了试验要求。为糖尿病控制与并发症试验制定的多组成部分知情同意过程，可能为其他复杂且要求严格的临床试验提供一个模式，在这些试验中，潜在受试者必须接受关于试验的充分教育才能有效参与。
