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Elyn R Saks

Publications and source records attributed to Elyn R Saks.

8 recordsLinked to original sources
PubMed2006

Prevalence and correlates of adequate performance on a measure of abilities related to decisional capacity: differences among three standards for the MacCAT-CR in patients with schizophrenia.

Despite the availability of structured decision-making capacity assessment tools, insufficient guidance exists for applying their results. Investigators often use cutpoints on these instruments to identify potential subjects in need of further assessment or education. Yet, information is lacking regarding the effects of different cutpoints on the proportion and characteristics of individuals categorized as possessing adequate or impaired decisional abilities for consent to research. To demonstrate the potential impact of different standards, we informed 91 individuals, aged 50 or older with a diagnosis of schizophrenia or schizoaffective disorder, about a hypothetical clinical trial, and assessed their decisional abilities with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Three published MacCAT-CR-based standards were applied to participants' scores to examine the rates and correlates of categorical determinations of adequate performance. The three standards ranged in stringency: the most stringent incorporated cutpoints on all three of the major MacCAT-CR subscales (Understanding, Appreciation, and Reasoning); the other two standards required threshold performance only on the Understanding subscale. The most stringent standard resulted in a 57% rate of impaired performance; the intermediate standard, 19%; and the least stringent standard, 8%. Nearly half of the participants (n=45) were classified as having performed adequately by the least stringent standard yet inadequately by the most stringent. The majority of these 45 were impaired on the Appreciation subscale (n=9), Reasoning (n=15), or both (n=18). Cognitive functioning was correlated with performance status for the more stringent standards. These findings underscore the need for refinement of capacity assessment procedures and for improvements in the use of capacity assessment tools for screening purposes and to assist in categorical capacity determinations.

Aged↗
PubMed2006

Capacity to consent to or refuse treatment and/or research: theoretical considerations.

This article discusses theoretical dimensions of competency to consent to or refuse treatment and/or research. We will consider a number of issues. Our first subject is the nature of assessments of competency-their empirical, normative, and conceptual aspects. We then discuss how we should divide up the components of capacity-understanding, appreciation, reasoning, and evidencing a choice; how we should understand these different components; and whether all are indeed necessary. We discuss where to draw the line between capacity and incapacity on each of the four elements of capacity. We ask whether we should have a variable competency standard, either in general or in different contexts (e.g. treatment versus research). Finally we consider the role of mental illness in competency assessments.

Humans↗
PubMed2006

Assessing decisional capacity for clinical research or treatment: a review of instruments.

OBJECTIVE: The need to evaluate decisional capacity among patients in treatment settings as well as subjects in clinical research settings has increasingly gained attention. Decisional capacity is generally conceptualized to include not only an understanding of disclosed information but also an appreciation of its significance, the ability to use the information in reasoning, and the ability to express a clear choice. The authors critically reviewed existing measures of decisional capacity for research and treatment. METHOD: Electronic medical and legal databases were searched for articles published from 1980 to 2004 describing structured assessments of adults' capacity to consent to clinical treatment or research protocols. The authors identified 23 decisional capacity assessment instruments and evaluated each in terms of format, content, administration features, and psychometric properties. RESULTS: Six instruments focused solely on understanding of disclosed information, and 11 tested for understanding, appreciation, reasoning, and expression of a choice. The instruments varied substantially in format, degree of standardization of disclosures, flexibility of item content, and scoring procedures. Reliability and validity also varied widely. All instruments have limitations, ranging from lack of supporting psychometric data to lack of generalizability across contexts. CONCLUSIONS: Of the instruments reviewed, the MacArthur Competence Assessment Tools for Clinical Research and for Treatment have the most empirical support, although other instruments may be equally or better suited to certain situations. Contextual factors are important but understudied. Capacity assessment tools should undergo further empirically based development and refinement as well as testing with a variety of populations.

Adult↗
PubMed2005

Meta-consent in research on decisional capacity: a "Catch-22"?

Empirical studies of ethical issues, which have increased in number and scope in recent years, may themselves raise both practical and ethical issues. One example of such an issue is the question of who may be legitimately enrolled in studies of decision-making capacity; must all participants in studies of consent capacity have capacity to consent? This question may pose a "Catch-22": For example, if some of the participants in a study of consent capacity are deemed by a particular standard to be incapable of consent. In weighing the risks and benefits of studies of consent capacity, how should reviewers consider the context of actual versus hypothetical trials for which the participant's consent is being sought? Here, we explore these "meta-consent" issues by describing the dimensions of the issue and potential solutions, centering around the concept of "active assent" (requiring expressed understanding of the purpose of the study and its voluntary nature, as well as expression of a choice to participate).

Biomedical Research↗
PubMedDate not supplied

Involuntary outpatient commitment.

This article offers a novel approach to outpatient commitment (OPC). After distinguishing 4 varieties of OPC, the article shows how 3 are easy to justify, whereas "preventive outpatient commitment" (POC) requires more careful scrutiny. The article argues that, as a general matter, POC is not justified, except for on a "one free shot" basis. The hope is that patients will come to appreciate the benefits of treatment in the community and will become voluntarily compliant; after one free shot, they are in a much better position to decide. The consequences of noncompliance are also explored.

Advance Directives↗
PubMedDate not supplied

The California Scale of Appreciation: a new instrument to measure the appreciation component of capacity to consent to research.

Capacity to consent is one of the linchpins of the ethical conduct of clinical care and research, and it needs to be reliably measured. The authors describe the development of a new measure of the "appreciation" component of capacity, the California Scale of Appreciation (CSA), 18 items rated according to the concept of "patently false belief" (a belief that is grossly improbable); 39 patients with schizophrenia or a related psychotic disorder (27 outpatients and 12 inpatients) and 15 normal-comparison subjects participated. Each subject's audiotaped interview was rated by three evaluators. Answers to each item were scored as "capable," "incapable," or "uncertain capacity." Also, each subject was given an overall rating of one of these three categories by each rater. Total scores on the CSA were calculated and correlated with scores on standardized instruments for assessing psychopathology and cognitive impairment. The mean total CSA score was significantly lower in the patients than in the normal-comparison subjects; however, a majority of the patients were found to be fully "capable" on the CSA. The CSA is a potentially useful instrument for measuring the appreciation component of capacity in persons with psychotic disorders. Its generalizability to other patient populations and to other types of protocols needs to be determined.

Aged↗