A New Brief Instrument for Assessing Decisional Capacity for Clinical Research

Datos Bibliográficos

ID23340752
AutoresDilip V Jeste (0000-0002-1161-7351, University of California San Diego), BARTON W PALMER (0000-0002-7618-3144, University of California San Diego), Paul S Appelbaum, Peter Appelbaum (0000-0002-1940-0042, University of California San Diego), Shahrokh Golshan (University of California San Diego), Danielle Glorioso (0000-0003-1644-5031, University of California San Diego), Laura B Dunn (0000-0001-5669-6244, University of California San Diego), Kathleen Kim (0000-0002-4214-7778, University of California San Diego), Thomas W Meeks (University of California San Diego), Thomas Meeks, Helena C Kraemer (0000-0003-3843-2637, University of California San Diego)
Año2007
Volumen64
Número8
Páginas966
Fecha de publicación2007-08-01
Peer ReviewedSí
Open AccessNo
TipoARTICLE
RevistaArchives of General Psychiatry (JOURNAL)
Identificadores de la revistaISSN: 0003-990X • E-ISSN: 1538-3636
EditorialAmerican Medical Association (AMA) (PUBLISHER)
DOI10.1001/archpsyc.64.8.966
PMID17679641
OpenAlexW2127025881
IdiomaEN
Citas recibidas54
Referencias citadas2

CONTEXT: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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. CONCLUSION: 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.

Alternative medicine · Clinical trial · Concurrent validity · Construct validity · Criterion validity · Developmental psychology · External validity · Gold standard (test) · Informed consent · Inter-rater reliability · Internal consistency · Internal validity · Protocol (science) · Psychiatry · Psychometrics · Psychosis · Rating scale · Reliability (semiconductor) · Scale (ratio) · Schizoaffective disorder · Test validity · Applied Psychology · Clinical Psychology · Ethics in Clinical Research · Healthcare Decision-Making and Restraints · Medicine · Mental Health and Patient Involvement · Psychology · Social Psychology