A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial (original) (raw)
2010, The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry
Early and progressive cognitive impairments of patients with Alzheimer disease (AD) hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, the authors tested whether a memory and organizational aid improves the performance of patients with AD on measures of capacity and competency to give informed consent. Patients with AD randomly assigned to standard consent or standard plus a memory and organizational aid. Memory and organizational aid summarized the content of information mandated under the informed consent disclosure requirements of the Common Rule at a sixth grade reading level. Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of the three experts defined a par...
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The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry, 2008
Among Alzheimer disease (AD) patients enrolled in a clinical trial, the authors assessed the ability of a standardized capacity assessment procedure to identify persons who are capable of giving their own informed consent. Cross-sectional interview. Thirteen sites participating in a randomized and placebo controlled study of simvastatin for the treatment of mild to moderate AD. Persons with mild to moderate AD and their study partners enrolled in the simvastatin clinical trial. Interviews to assess decision-making capacity using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR). Judges blinded to the subject's clinical status had a high rate of agreement on patients capable of giving their own informed consent (kappa = 0.73). The understanding subscale had the best receiver operator characteristic and an analysis of positive and negative predictive values over a range of hypothetical prevalences of incapacity to consent demonstrated the value of a range ...
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Clinical research on Alzheimer disease (AD) is much needed but requires the participation of patients with substantial cognitive impairment who have difficulty providing informed consent. Despite decades of debate, policies regulating such research are not well-defined. Although numerous studies have underscored the difficulties of obtaining informed consent for clinical research from patients compromised by AD, there is also increasing evidence that such individuals and their surrogates can make decisions about research participation that are consistent with the patients' values. Policy discussions and future research should consider how the ethical reservations about enrolling incapacitated patients in research could be mitigated by developing ways to promote the congruence between surrogates' decisions and patients' values.
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