Ottawa Hospital Research Institute, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, Ontario, Canada.
Contemp Clin Trials. 2010 May;31(3):218-20. doi: 10.1016/j.cct.2010.02.002. Epub 2010 Feb 13.
This commentary argues that the existing approach towards obtaining informed consent for clinical research may be improved by using decision aids. Problems with the current approach include i) an emphasis on documentation to the detriment of good quality decision-making; ii) ad hoc rather than theory-based research studying how to improve informed consent; and iii) a lack of clarity around what is meant by 'comprehension' and how to measure it. Decision aids, which clearly improve patient treatment decisions but are new to decisions surrounding study participation, have strengths in precisely the areas where the informed consent literature is weak. Decision aids facilitate a process of decision-making, combining clear documentation, exercises to facilitate decision-making, and consultation. They are increasingly informed by theory and clear, empirically-derived standards. Furthermore, decision aid research has clearly defined and operationalized three indicators of good quality decision-making in situations where there is no objectively correct answer: demonstrable knowledge of key aspects of the decision, accurate perceptions of the probabilities of various outcomes, and a match between preferred outcomes and the choice made. We identify outstanding issues and propose a research approach that will determine whether the use of decision aids can improve the informed consent process.
这篇评论认为，使用决策辅助工具可以改进目前用于获取临床研究知情同意的方法。目前方法存在的问题包括：i）强调文件记录而不利于做出高质量的决策；ii）临时而非基于理论的研究，以研究如何改进知情同意；以及 iii）对于“理解”的含义以及如何衡量理解程度缺乏明确性。决策辅助工具在明确改善患者治疗决策方面具有优势，而这些优势正是知情同意文献薄弱的领域。决策辅助工具通过清晰的文件记录、促进决策的练习以及咨询，促进决策过程。它们越来越多地受到理论和明确的、经验衍生标准的指导。此外，决策辅助工具研究在没有客观正确答案的情况下，明确定义并操作化了三个良好决策质量的指标：对决策关键方面的明显了解、对各种结果概率的准确感知，以及首选结果与做出的选择之间的匹配。我们确定了未解决的问题，并提出了一种研究方法，以确定使用决策辅助工具是否可以改善知情同意过程。
