Enhancing Consent for Alzheimer Research

描述(由申请人提供)：阿尔茨海默病(AD)可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，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，可以更好地理解与同意相关的信息。该项目的目标是评估加强同意程序对轻中度AD患者的疗效，并确定预测加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)进行增强同意程序和常规同意程序的随机比较来实现。将参照两个(随机分配的)假设方案之一来评估决策能力，并将评估参与意愿。参与者将接受认知测试组合的评估；还将实施神经精神症状评定表和对同意过程的满意度。由于应用环境中的能力评估最终需要做出两种决定，参与者将被归类为对所提出的议定书具有决定能力或不具有同意能力，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显的决策能力，更愿意参与所提出的研究，对同意程序更满意，以及更大的可能性被归类为“能够同意”。我们还假设，认知能力，特别是记忆力，将缓和增强同意的有效性，极端能力(非常轻微的认知缺陷或更严重的认知缺陷)比中等水平的人受益更少。该项目解决了与研究的知情同意有关的重要问题，符合NIH PA#02-103的目标，试图支持“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个想法，即当AD患者被要求提供同意或同意参与临床研究时，加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.