Regular ArticleThe California Scale of Appreciation: A New Instrument to Measure the Appreciation Component of Capacity to Consent to Research
Section snippets
METHODS
The CSA was developed in several stages. We used as our guide the standard elements of informed consent—presentation of the nature, risks and benefits, and alternatives to a procedure. We included research-specific items, such as randomization and use of a placebo. Also included were potential PFBs (defined below) that might motivate a decision, such as a subject's belief that his doctor is all-powerful. Once satisfied that the instrument covered the critical issues relevant to research
RESULTS
Demographic and clinical characteristics, as well as CSA ratings of the patients and normal-comparison subjects, are presented in Table 2. At the time of assessment, the patients had mild-to-moderate levels of psychotic symptoms, as indicated by their scores on the PANSS.
The CSA showed good interrater agreement on individual items as well as on total CSA score (Table 3). Overall Cronbach alpha values for internal consistency of the CSA scores for all the subjects ranged from 0.83 to 0.88; for
DISCUSSION
We have described a new instrument designed to measure the appreciation component of capacity to consent to psychiatric research. In a preliminary assessment of the instrument, we found that it had good interrater reliability, internal consistency, and face validity. Operationalizing the concept of a PFB in a semistructured interview with detailed scoring instructions appeared to allow raters to evaluate subjects in a consistent way. The mean total CSA score was significantly lower in the
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We acknowledge helpful advice from Paul Appelbaum, M.D., who critiqued an early draft of this manuscript.
This work was supported, in part, by a grant from the Greenwall Foundation and by NIMH grants MH-43693, MH-49671, MH-59101, and by the Department of Veterans Affairs.