Enhancing Consent for Alzheimer Research

增强阿尔茨海默病研究的共识

• 批准号: 7883283
• 负责人: Barton W. Palmer
• 金额: $ 26.88万
• 依托单位: VETERANS MEDICAL RESEARCH FDN/SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2012-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7883283
• 关键词: Address; Affect; Age; Alzheimer' s Disease; Amyloid; Area; Binding; Cause of Death; Characteristics; Cholinomimetics; Clinical; Clinical Research; Clip; Cognitive; Cognitive deficits; Comprehension; Computers; Consent; Dementia; Diagnostic; Dimensions; Disclosure; Dissent; Education; Effectiveness; Empirical Research; Ensure; Ethical Issues; Ethics; Evaluation; Fostering; Funding; Future; Goals; Human; Immunotherapy; Individual; Informed Consent; Learning; Literature; Manuals; Medical; Memory; Memory impairment; Methods; Modification; Multimedia; National Institute on Aging; Nature; Participant; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Procedures; Process; Protocols documentation; Publishing; Randomized; Randomized Controlled Trials; Relative (related person); Research; Research Personnel; Severities; Symptoms; Testing; Text; United States National Institutes of Health; Visual; Work; base; cognitive function; design; disability; effective therapy; grasp; impaired capacity; improved; interest; neuropsychiatry; patient population; programs; research study; satisfaction; symposium; tool; willingness

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.

描述（由申请人提供）：阿尔茨海默氏病（AD）可能会损害患者给予知情同意以进行研究参与的能力。涉及其他患者人群的知情同意的研究表明，可以通过修改同意交付过程中更好地了解与同意相关的信息，包括将多媒体学习工具纳入同意讨论。该项目的目标是评估对轻度至中度AD的患者增强同意程序的功效，并确定因素和患者特征，以预测增强同意的程度比常规同意程序更有益。这些目标将通过对136名轻度适度AD患者和136名相处年龄相比的正常比较受试者（NCS）的患者（NCS）进行随机比较来解决这些目标。决策能力将参考两个（随机分配）假设方案中的任何一个，并将评估参与意愿。参与者将通过认知测试电池进行评估；还将管理神经精神症状的评级量表和对同意过程的满意度。随着应用设置中的容量评估最终需要二分法决定，参与者将被归类为对提出的协议的决策能力或无能为力，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决策能力，更大的意愿参加介绍的研究，对同意程序的更大满意度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，尤其是记忆力，将降低增强同意的有效性，而在极端的人（非常轻度的认知缺陷或更严重的认知缺陷）中，其益处比中间距离的效果较小。该项目解决了与知情同意有关的重要问题，该问题适合NIH PA＃02-103的目标，并寻求支持对“知情同意程序的特征如何影响参与者参与研究的理解和/或愿意的研究”。这项研究的相关性来自于以下观点：加强同意可能会促进理解，因为要求AD患者提供同意或同意参加临床研究。

项目成果

Sensitive and Specific Preclinical Identification of Alzheimer Disease: A Key to Novel Intervention Development.

阿尔茨海默病的灵敏和特异性临床前鉴定：新型干预开发的关键。

• DOI: 10.1016/j.jagp.2016.07.010
• 发表时间: 2016
• 期刊: The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry
• 作者: Palmer,BartonW

Neuropsychological correlates of capacity determinations in Alzheimer disease: implications for assessment.

• DOI: 10.1016/j.jagp.2012.11.008
• 发表时间: 2013-04
• 期刊: AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
• 影响因子: 7.2
• 作者: Palmer, Barton W.;Ryan, Kerry A.;Kim, H. Myra;Karlawish, Jason H.;Appelbaum, Paul S.;Kim, Scott Y. H.
• 通讯作者: Kim, Scott Y. H.