Barton W Palmer1,2,3,4, Alexandrea L Harmell3,4,5,6, Laura B Dunn7, Scott Y Kim8, Luz L Pinto2,3,4, Shahrokh Golshan2,3, Dilip V Jeste3,4. 1. a Veterans Affairs San Diego Healthcare System , San Diego , California , USA. 2. b Veterans Medical Research Foundation , San Diego , California , USA. 3. c Department of Psychiatry , University of California, San Diego , La Jolla , California , USA. 4. d Center for Healthy Aging/Stein Institute for Research on Aging , University of California, San Diego , La Jolla , California , USA. 5. e San Diego State University/University of California San Diego Joint Doctoral Program in Clinical Psychology , San Diego , California , USA. 6. f Mental Health Service , San Francisco VA Healthcare System , San Francisco , California , USA. 7. g Department of Psychiatry and Behavioral Sciences , Stanford University , Stanford , California , USA. 8. h Department of Bioethics , National Institute of Health , Bethesda , Maryland , USA.
Abstract
OBJECTIVES: Optimizing the research consent process simultaneously fosters respect for autonomy and protection of those with diminished capacity for autonomy. This study evaluated the effectiveness of an enhanced research consent procedure, employing multimedia disclosure and corrective feedback, in improving decisional capacity among 114 people with mild-to-moderate Alzheimer's disease (AD) and 134 non-psychiatric comparison (NC) subjects. METHODS: Participants were randomized to consent type (routine versus enhanced) and protocol type (lower versus higher risk). Outcomes included a 5-item questionnaire assessing immediate comprehension, MacArthur Competence Assessment Tool for Clinical Research assessing four components of decision-making capacity, and categorical decisional capacity (based on a cut-score established in reference to expert judgments for a subset of participants). RESULTS: There was no significant effect of the enhanced consent procedure, relative to routine consent, on immediate comprehension or decisional capacity. CONCLUSIONS: Multimedia tools do not appear to be the solution to better consent for AD research. CLINICAL IMPLICATIONS: Given the ethical primacy of informed consent and issues of justice for impaired populations who might be harmed by an absence of research-based treatment advances, continued search for ways to more meaningfully engage people with AD in the consent or assent process is warranted.
RCT Entities:
OBJECTIVES: Optimizing the research consent process simultaneously fosters respect for autonomy and protection of those with diminished capacity for autonomy. This study evaluated the effectiveness of an enhanced research consent procedure, employing multimedia disclosure and corrective feedback, in improving decisional capacity among 114 people with mild-to-moderate Alzheimer's disease (AD) and 134 non-psychiatric comparison (NC) subjects. METHODS:Participants were randomized to consent type (routine versus enhanced) and protocol type (lower versus higher risk). Outcomes included a 5-item questionnaire assessing immediate comprehension, MacArthur Competence Assessment Tool for Clinical Research assessing four components of decision-making capacity, and categorical decisional capacity (based on a cut-score established in reference to expert judgments for a subset of participants). RESULTS: There was no significant effect of the enhanced consent procedure, relative to routine consent, on immediate comprehension or decisional capacity. CONCLUSIONS: Multimedia tools do not appear to be the solution to better consent for AD research. CLINICAL IMPLICATIONS: Given the ethical primacy of informed consent and issues of justice for impaired populations who might be harmed by an absence of research-based treatment advances, continued search for ways to more meaningfully engage people with AD in the consent or assent process is warranted.
Authors: Dinesh Mittal; Barton W Palmer; Laura B Dunn; Reid Landes; Courtney Ghormley; Cornelia Beck; Shah Golshan; Dean Blevins; Dilip V Jeste Journal: Am J Geriatr Psychiatry Date: 2007-02 Impact factor: 4.105
Authors: A I Tröster; N Butters; D P Salmon; C M Cullum; D Jacobs; J Brandt; R F White Journal: J Clin Exp Neuropsychol Date: 1993-09 Impact factor: 2.475
Authors: Barton W Palmer; Kerry A Ryan; H Myra Kim; Jason H Karlawish; Paul S Appelbaum; Scott Y H Kim Journal: Am J Geriatr Psychiatry Date: 2013-01-11 Impact factor: 4.105
Authors: O Okonkwo; H R Griffith; K Belue; S Lanza; E Y Zamrini; L E Harrell; J C Brockington; D Clark; R Raman; D C Marson Journal: Neurology Date: 2007-10-09 Impact factor: 9.910
Authors: C J Evans; E Yorganci; P Lewis; J Koffman; K Stone; I Tunnard; B Wee; W Bernal; M Hotopf; I J Higginson Journal: BMC Med Date: 2020-07-22 Impact factor: 8.775
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