Measuring informed consent capacity in an Alzheimer's disease clinical trial

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• 作者：Peter D. Guarino^a ; ^b ; ¹ ; ^{pguarino@fredhutch.org} ; Julia E. Vertrees^c ; Sanjay Asthana^d ; ^e ; Mary Sano^f ; ^g ; Maria D. Llorente^h ; ⁱ ; Muralidhar Pallaki^j ; ^k ; Susan Love^l ; ^m ; Gerard D. Schellenbergⁿ ; Maurice W. Dysken^l
• 关键词：Informed consent ; Alzheimer's disease ; Consent forms ; Comprehension ; Mental competency ; Third-Party consent ; Clinical trials as topic
• 刊名：Alzheimer's & Dementia: Translational Research & Clinical Interventions
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：2
• 期：4
• 页码：258-266
• 全文大小：785 K
• 卷排序：2

文摘

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).MethodsUnderstanding 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.ResultsA 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.DiscussionWe found a significant association between capacity and disease severity level, caregiver time, race, and ICQ perceived understanding.