在阿尔茨海默病临床试验中测量知情同意能力。
Measuring informed consent capacity in an Alzheimer's disease clinical trial.
作者信息
Guarino Peter D, Vertrees Julia E, Asthana Sanjay, Sano Mary, Llorente Maria D, Pallaki Muralidhar, Love Susan, Schellenberg Gerard D, Dysken Maurice W
机构信息
Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.
Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
出版信息
Alzheimers Dement (N Y). 2016 Sep 20;2(4):258-266. doi: 10.1016/j.trci.2016.09.001. eCollection 2016 Nov.
INTRODUCTION
Accurately and efficiently determining a participant's capacity to consent to research is critically important to protect the rights of patients with Alzheimer's disease (AD).
METHODS
Understanding of the informed consent document was assessed in 613 community-dwelling patients with mild-to-moderate AD enrolled in a randomized, placebo-controlled trial. Associations were examined between clinically determined capacity to consent and (1) patient demographics and clinical characteristics and (2) the Informed Consent Questionnaire (ICQ), an objective measurement of a participant's factual understanding and perceived understanding.
RESULTS
A total of 453 (74%) participants were determined to have capacity to consent by clinical judgment. ICQ perceived understanding, race, measures of cognitive function, and caregiver time were all significantly associated with the determination of capacity in multivariate analyses.
DISCUSSION
We found a significant association between capacity and disease severity level, caregiver time, race, and ICQ perceived understanding.
引言
准确且高效地确定参与者同意参与研究的能力对于保护阿尔茨海默病（AD）患者的权利至关重要。
方法
在一项随机、安慰剂对照试验中，对613名社区居住的轻至中度AD患者对知情同意文件的理解情况进行了评估。研究了临床确定的同意能力与以下因素之间的关联：（1）患者的人口统计学和临床特征；（2）知情同意问卷（ICQ），这是一种对参与者事实理解和感知理解的客观测量。
结果
通过临床判断，共有453名（74%）参与者被确定有同意能力。在多变量分析中，ICQ感知理解、种族、认知功能指标和照顾者时间均与同意能力的确定显著相关。
讨论
我们发现同意能力与疾病严重程度、照顾者时间、种族和ICQ感知理解之间存在显著关联。
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