Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Trials. 2019 Jul 5;20(1):401. doi: 10.1186/s13063-019-3489-y.
Ethical requirements of informed consent stipulate that patients approached to participate in a clinical trial be provided with written information that must cover key aspects of the trial. For consent to be deemed "informed", potential participants should be provided with a range of information about the trials (e.g., the trial aims, the anticipated benefits and potential risks of the trial, and their right to withdraw consent at any time). However, it is well documented that simple provision of this information does not ensure that participants make truly informed decisions. Decision aids, tools that have been shown in a treatment and screening context to support better-quality decisions, are emerging as a possible vehicle to support decision making about trial participation. However, information on how they should best be developed and evaluated in a clinical trial context is lacking. Therefore, this article, drawing on theoretical and empirical insights, outlines a framework for the development and evaluation of decision aids for people considering taking part in a clinical trial.
知情同意的伦理要求规定，拟参与临床试验的患者应提供书面信息，该信息必须涵盖试验的关键方面。为了使同意被视为“知情”，潜在参与者应提供有关试验的一系列信息（例如，试验目的、试验的预期益处和潜在风险，以及他们随时撤回同意的权利）。然而，有充分的文献记载表明，简单地提供这些信息并不能确保参与者做出真正知情的决策。决策辅助工具是一种在治疗和筛查背景下已被证明可以支持更好决策的工具，它们作为支持试验参与决策的一种可能手段正在出现。然而，在临床试验背景下，关于如何最好地开发和评估它们的信息却缺乏。因此，本文借鉴理论和实证见解，概述了一个用于开发和评估考虑参加临床试验的人员的决策辅助工具的框架。
