A new brief instrument for assessing decisional capacity for clinical research.
BACKGROUND
There is a critical need for practical measures for screening and documenting decisional capacity in people participating in different types of clinical research. However, there are few reliable and validated brief tools that could be used routinely to evaluate individuals' capacity to consent to a research protocol.


OBJECTIVE
To describe the development, testing, and proposed use of a new practical instrument to assess decision-making capacity: the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). The UBACC is intended to help investigators identify research participants who warrant more thorough decisional capacity assessment and/or remediation efforts prior to enrollment.


METHODS
We developed the UBACC as a 10-item scale that included questions focusing on understanding and appreciation of the information concerning a research protocol. It was developed and tested among middle-aged and older outpatients with schizophrenia and healthy comparison subjects participating in research on informed consent. In an investigation of reliability and validity, we studied 127 outpatients with schizophrenia or schizoaffective disorder and 30 healthy comparison subjects who received information about a simulated clinical drug trial. Internal consistency, interrater reliability, and concurrent (criterion) validity (including correlations with an established instrument as well as sensitivity and specificity relative to 2 potential "gold standard" criteria) were measured.


METHODS
Reliability and validity of the UBACC.


RESULTS
The UBACC was found to have good internal consistency, interrater reliability, concurrent validity, high sensitivity, and acceptable specificity. It typically took less than 5 minutes to administer, was easy to use and reliably score, and could be used to identify subjects with questionable capacity to consent to the specific research project.


CONCLUSIONS
The UBACC is a potentially useful instrument for screening large numbers of subjects to identify those needing more comprehensive decisional capacity assessment and/or remediation efforts.
Department of Psychiatry, University of California, San Diego, Veterans Affairs San Diego Healthcare System, Bldg 13, Fourth Floor, 3350 La Jolla Village Dr, San Diego, CA 92161, USA. djeste@ucsd.edu
Dilip V
DV
Jeste
Barton W
BW
Palmer
Paul S
PS
Appelbaum
Shahrokh
S
Golshan
Danielle
D
Glorioso
Laura B
LB
Dunn
Kathleen
K
Kim
Thomas
T
Meeks
Helena C
HC
Kraemer
D000553:Ambulatory Care; D001675:Bioethics; D003072:Cognition Disorders / Q000175:diagnosis / Q000523:psychology; D003657:Decision Making / Q000941:ethics; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000523:psychology / Q000592:standards; D008297:Male; D008403:Mass Screening / Q000295:instrumentation* / Q000379:methods; D016743:Mental Competency / Q000523:psychology* / Q000592:standards; D008875:Middle Aged; D018579:Patient Selection / Q000941:ethics; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics / Q000295:instrumentation; D011618:Psychotic Disorders / Q000175:diagnosis; D012372:ROC Curve; D015203:Reproducibility of Results; D035842:Research Subjects / Q000523:psychology; D012559:Schizophrenia / Q000175:diagnosis; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires