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Scott Y.H. Kim, and Robert G. Holloway

Burdens and Benefits of Placebos in Antidepressant Clinical Trials: A Decision and Cost-Effectiveness Analysis
Am J Psychiatry 160: 1272-1276.

Scott Y. H. Kim, and Eric D. Caine

Utility and Limits of the Mini Mental State Examination in Evaluating Consent Capacity in Alzheimer's Disease
Psychiatr Serv 53: 1322-1324.

Scott Y.H. Kim, Christopher Cox, and Eric D. Caine

Impaired Decision-Making Ability in Subjects With Alzheimer’s Disease and Willingness to Participate in Research
Am J Psychiatry 159: 797-802.

Scott Y. H. Kim, Eric D. Caine, Glenn W. Currier, Adrian Leibovici, and J. Michael Ryan

Assessing the Competence of Persons With Alzheimer’s Disease in Providing Informed Consent for Participation in Research
Am J Psychiatry 158: 712-717.

Abstract 1 of 4

Burdens and Benefits of Placebos in Antidepressant Clinical Trials: A Decision and Cost-Effectiveness Analysis

OBJECTIVE: The use of placebos is a necessary, if controversial, part of determining the efficacy of new antidepressants in randomized clinical trials. Such studies need to convey accurate and useful risk-benefit information to subjects since effective treatments are withheld. The authors assessed the cost-effectiveness of entering such a trial from the perspective of potential subjects. METHOD: The choice between individualized psychiatric treatment and an 8-week placebo-controlled, randomized clinical trial was modeled by using a static model. The analysis was conducted from the perspective of a potential subject who has moderate depression, is at low risk for suicide, has no comorbid conditions, and lacks adequate insurance to pay for mental health services. The trial was assumed to be free for subjects, except for indirect costs. Model outcomes included the probability of treatment response at 8 weeks and "decremental" cost-effectiveness. Data were based on reviews of published and some unpublished clinical trials of novel antidepressants that were eventually shown to be efficacious. RESULTS: A participant in a typical antidepressant efficacy trial has a chance of treatment response almost 25% less than that with individualized treatment. An uninsured participant can expect to save just over $164 for every 10% chance of response sacrificed by entering the placebo-controlled trial. CONCLUSIONS: For placebo-controlled antidepressant trials, it is possible to derive systematic and evidence-based estimates of the burdens and potential benefits to subjects. Such information may be more useful for institutional review boards and potential subjects than an unstructured enumeration of risks and benefits.

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Abstract 2 of 4

Utility and Limits of the Mini Mental State Examination in Evaluating Consent Capacity in Alzheimer's Disease

The call for formal capacity assessments of potential research participants with impairments due to illnesses such as Alzheimer's disease is increasing. Because such an evaluation of every potential subject requires significant resources, clinicians and researchers may want to know the utility and the limits of a familiar cognitive screening test, the Mini Mental State Examination (MMSE), in capacity evaluations. In this study of 37 patients with mild to moderate Alzheimer's disease, a fairly wide range of MMSE scores (21 to 25, which includes an often used cutoff for "normal") did not discriminate capacity status well. Nevertheless, there may still be approaches that enhance the practical utility of the MMSE in capacity assessment.

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Abstract 3 of 4

Impaired Decision-Making Ability in Subjects With Alzheimer’s Disease and Willingness to Participate in Research

OBJECTIVE: Ethical concerns persist over research participation of decisionally impaired persons, such as those suffering from Alzheimer’s disease. Such persons may be poor judges of the burdens and risks of specific research protocols. Since even decisionally incapacitated persons cannot be enrolled in studies against their objection, their preferences convey important ethical information. The authors examined the effects of cognitive and decisional impairment on willingness to participate in research among persons with Alzheimer’s disease. METHOD: Cognitive status, decision-making ability, and willingness to participate in four hypothetical research protocols of varying risk/benefit profiles were measured in 34 subjects with mild to mild/moderate Alzheimer’s disease and 14 healthy elderly comparison subjects. Univariate and multivariate methods were used to analyze the effects of impairment in cognitive and decision-making abilities on willingness to participate in research. RESULTS: There were no differences in willingness to participate found between the Alzheimer’s and the healthy comparison subjects for three of the four hypothetical protocols. In both groups, willingness declined as risk increased. Within the Alzheimer’s disease group, the presence of greater decisional impairment tended to predict less willingness to participate in research, even after adjusting for cognitive impairment, gender, and education. CONCLUSIONS: Persons with decisional impairment due to Alzheimer’s disease are as a group able to distinguish between research protocols of varying risk/benefit profiles. Because declining decision-making abilities may predict declining willingness to participate in research, informed consent procedures for Alzheimer’s disease research should be sensitive to this possibility.

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Abstract 4 of 4

Assessing the Competence of Persons With Alzheimer’s Disease in Providing Informed Consent for Participation in Research

OBJECTIVE: The capacity of persons with Alzheimer’s disease or other neuropsychiatric disorders for giving consent to participate in research has come under increasing scrutiny. While instruments for measuring abilities related to capacity have been developed, how they should be used to categorize subjects as capable or incapable is not clear. A criterion validation study was carried out to help address this question. METHOD: The authors measured the ability of 37 subjects with mild-to-moderate Alzheimer’s disease and 15 elderly comparison subjects to provide consent for participation in a hypothetical clinical trial. Using the judgment of three experts as the criterion standard, the authors performed a receiver operator characteristic analysis for the capacity ability measures from the MacArthur Competence Assessment Tool—Clinical Research Version. The results were compared with categorizations of capacity status that were based on normative values. RESULTS: While most comparison subjects scored perfectly on all measures of the competence assessment tool, the majority of the group with Alzheimer’s disease showed significant decision-making impairment. Thresholds based on normative values resulted in 84% (N=31) of the Alzheimer’s disease subjects being rated as incapable on at least one ability; thresholds based on expert judgment resulted in 62% (N=23) failing to meet cutoff scores on at least one ability. CONCLUSIONS: Even relatively mild Alzheimer’s disease significantly impairs consent-giving capacity. But differentiating capable from incapable subjects remains an issue despite the aid of standardized tools. More research is needed to understand the relationship between subject factors (performance on ability measures) and categorical judgments about their capacity.

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