Enhancing Consent for Alzheimer Research

描述（由申请人提供）：阿尔茨海默病（AD）会损害患者对参与研究给予知情同意的能力。涉及其他患者群体的知情同意研究表明，可以通过修改同意交付过程，包括将多媒体学习工具纳入同意讨论，来更好地理解与同意相关的信息。该项目的目标是评估增强同意程序对轻度至中度AD患者的疗效，并确定预测增强同意程序比常规同意程序更有益的程度的因素和患者特征。这些目标将通过对136名轻度至中度AD患者和136名年龄相当的正常对照受试者（nc）进行增强与常规同意程序的随机比较来解决。将参考两种（随机分配的）假设方案中的任何一种来评估决策能力，并评估参与意愿。参与者将接受认知测试；还将对神经精神症状和同意过程满意度进行评定。由于应用环境中的能力评估最终需要一个二分决策，参与者将被分类为决策能力或不能同意所提出的协议，我们将评估同意条件对这些分类率的影响。我们假设，增强的同意程序将导致更好的明确决策能力，更愿意参与所提出的研究，更满意的同意程序，更有可能被归类为“有能力同意”。我们还假设，认知能力，特别是记忆能力，会缓和增强同意的有效性，那些处于极端状态（非常轻微的认知缺陷或更严重的认知缺陷）的人比处于中等水平的人表现出更少的好处。该项目解决了与研究知情同意相关的重要问题，符合NIH PA # 02-103的目标，旨在支持“知情同意过程的特征如何影响参与者的理解和/或参与研究的意愿”的研究。这项研究的相关性源于这样一种观点，即当AD患者被要求提供同意或同意参与临床研究时，增强同意可能会促进理解。

DESCRIPTION (provided by applicant): Alzheimer disease (AD) can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion. The goals of this project are to evaluate the efficacy of an enhanced consent procedure for patients with mild-to-moderate AD, and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures. These goals will be addressed through a randomized comparison of enhanced versus routine consent procedures administered to 136 patients with mild-to- moderate AD patients and 136 age-comparable normal comparison subjects (NCs). Decisional capacity will be evaluated in reference to either of two (randomly assigned) hypothetical protocols, and willingness to participate will be assessed. Participants will be evaluated with a cognitive test battery; rating scales of neuropsychiatric symptoms and satisfaction with the consent process will also be administered. As capacity evaluations in applied settings ultimately require a dichotomous decision, participants will be categorized as decisionally capable or incapable of consent for the presented protocol, and we will evaluate the effects of consent condition on these categorization rates. We hypothesize that the enhanced consent procedure will result in better manifest decisional capacity, greater willingness to participate in the presented study, greater satisfaction with the consent procedure, and greater likelihood of being categorized as "capable of consent". We also hypothesize that cognitive abilities, particularly memory, will moderate the effectiveness of enhanced consent, with those in the extreme ends (very mild cognitive deficits or more severe cognitive deficits) showing less benefit than those in the mid-range. This project addresses important issues relating to informed consent for research, fitting within the goals of NIH PA # 02-103, seeking to support studies of "how features of the informed consent process affect participants' comprehension and/or willingness to participate in research." This study's relevance derives from the idea that enhanced consent may foster comprehension as AD patients are asked to provide consent or assent to participate in clinical research.