Barton W Palmer1, Alexandrea L Harmell2, Luz L Pinto3, Laura B Dunn4, Scott Y H Kim5, Shahrokh Golshan6, Dilip V Jeste3. 1. Department of Psychiatry, University of California, San Diego ; Veterans Medical Research Foundation, San Diego, CA ; Veterans Affairs San Diego Healthcare System ; Center for Healthy Aging/Stein Institute for Research on Aging, University of California, San Diego. 2. Department of Psychiatry, University of California, San Diego ; Center for Healthy Aging/Stein Institute for Research on Aging, University of California, San Diego ; San Diego State University/University of California San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA. 3. Department of Psychiatry, University of California, San Diego ; Center for Healthy Aging/Stein Institute for Research on Aging, University of California, San Diego. 4. Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA. 5. Department of Bioethics, National Institute of Health, Bethesda, MD. 6. Department of Psychiatry, University of California, San Diego ; Veterans Affairs San Diego Healthcare System.
Abstract
OBJECTIVE: Investigators conducting Alzheimer's disease (AD) research need to consider participants' capacity to consent. Cognitive functioning is a significant predictor of decisional capacity, but there is a dearth of information on the influence of neuropsychiatric symptoms in AD on decisional capacity. We examined the rates of decisional capacity associated with two types of research protocols, and the association of capacity with neuropsychiatric symptoms and other participant characteristics. METHODS: We comprehensively evaluated decisional capacity among 64 patients with mild-to-moderate AD and 70 healthy comparison (HC) subjects randomized to consider either a medium risk or higher risk hypothetical research protocol. Additional measures included sociodemographics, cognitive deficits, and neuropsychiatric symptoms. RESULTS: Twenty AD patients (31.3%) and 67 HCs (95.7%) were deemed capable; 44 AD patients (68.8%) and 3 HCs (4.3%) incapable of consent. Age, education, and severity of cognitive deficits were associated with incapable status; there were no significant associations with severity of neuropsychiatric symptoms or protocol risk level. CONCLUSIONS: Findings highlight the importance of understanding of capacity and its assessment among people with AD, rather than treating AD diagnosis as synonymous with impaired capacity. As novel treatments move from bench to bedside, methods of assessing and addressing capacity impairment must similarly advance. CLINICAL IMPLICATIONS: In assessing research consent capacity, use structured assessments with population specific cut scores interpreted in the context of the person's background including education, culture, and language. Individuals should be encouraged to execute research proxy documents when able.
OBJECTIVE: Investigators conducting Alzheimer's disease (AD) research need to consider participants' capacity to consent. Cognitive functioning is a significant predictor of decisional capacity, but there is a dearth of information on the influence of neuropsychiatric symptoms in AD on decisional capacity. We examined the rates of decisional capacity associated with two types of research protocols, and the association of capacity with neuropsychiatric symptoms and other participant characteristics. METHODS: We comprehensively evaluated decisional capacity among 64 patients with mild-to-moderate AD and 70 healthy comparison (HC) subjects randomized to consider either a medium risk or higher risk hypothetical research protocol. Additional measures included sociodemographics, cognitive deficits, and neuropsychiatric symptoms. RESULTS: Twenty ADpatients (31.3%) and 67 HCs (95.7%) were deemed capable; 44 ADpatients (68.8%) and 3 HCs (4.3%) incapable of consent. Age, education, and severity of cognitive deficits were associated with incapable status; there were no significant associations with severity of neuropsychiatric symptoms or protocol risk level. CONCLUSIONS: Findings highlight the importance of understanding of capacity and its assessment among people with AD, rather than treating AD diagnosis as synonymous with impaired capacity. As novel treatments move from bench to bedside, methods of assessing and addressing capacity impairment must similarly advance. CLINICAL IMPLICATIONS: In assessing research consent capacity, use structured assessments with population specific cut scores interpreted in the context of the person's background including education, culture, and language. Individuals should be encouraged to execute research proxy documents when able.
Authors: Dilip V Jeste; Barton W Palmer; Paul S Appelbaum; Shahrokh Golshan; Danielle Glorioso; Laura B Dunn; Kathleen Kim; Thomas Meeks; Helena C Kraemer Journal: Arch Gen Psychiatry Date: 2007-08
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Authors: Barton W Palmer; Laura B Dunn; Paul S Appelbaum; Sunder Mudaliar; Leon Thal; Robert Henry; Shahrokh Golshan; Dilip V Jeste Journal: Arch Gen Psychiatry Date: 2005-07
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Authors: D V Sheehan; Y Lecrubier; K H Sheehan; P Amorim; J Janavs; E Weiller; T Hergueta; R Baker; G C Dunbar Journal: J Clin Psychiatry Date: 1998 Impact factor: 4.384
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Authors: Andrea Pace; Johan A F Koekkoek; Martin J van den Bent; Helen J Bulbeck; Jane Fleming; Robin Grant; Heidrun Golla; Roger Henriksson; Simon Kerrigan; Christine Marosi; Ingela Oberg; Stefan Oberndorfer; Kathy Oliver; H Roeline W Pasman; Emilie Le Rhun; Alasdair G Rooney; Roberta Rudà; Simone Veronese; Tobias Walbert; Michael Weller; Wolfgang Wick; Martin J B Taphoorn; Linda Dirven Journal: Neurooncol Pract Date: 2020-07-16
Authors: Megan M Campbell; Ezra Susser; Sumaya Mall; Sibonile G Mqulwana; Michael M Mndini; Odwa A Ntola; Mohamed Nagdee; Zukiswa Zingela; Stephanus Van Wyk; Dan J Stein Journal: PLoS One Date: 2017-11-29 Impact factor: 3.240