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A new brief instrument for assessing decisional capacity for clinical research.

A new brief instrument for assessing decisional capacity for clinical research. Research Abstract Details 

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  • A new brief instrument for assessing decisional capacity for clinical research. Abstract Text:

    dilip v jesteDilip V Jeste,barton w palmerBarton W Palmer,paul s appelbaumPaul S Appelbaum,shahrokh golshanShahrokh Golshan,danielle gloriosoDanielle Glorioso,laura b dunnLaura B Dunn,kathleen kimKathleen Kim,thomas meeksThomas Meeks,helena c kraemerHelena C Kraemer,

    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.

    A new brief instrument for assessing decisional capacity for clinical research. Publishing Authors By Initials

    dv jesteDV Jeste,bw palmerBW Palmer,ps appelbaumPS Appelbaum,s golshanS Golshan,d gloriosoD Glorioso,lb dunnLB Dunn,k kimK Kim,t meeksT Meeks,hc kraemerHC Kraemer,

    For similar investigative techniques: epidemiologic methods: statistics as topic: sensitivity and specificity research abstracts see: investigative techniques: epidemiologic methods: statistics as topic: sensitivity and specificity research

    PUBMED ID PMID:

    MEDLINE DATE:

    A new brief instrument for assessing decisional capacity for clinical research. Journal Published:

    PUBLICATION TYPE: Research Support, U.S. Gov't,

    Journal: Archives of general psychiatry

    VOLUME: 64

    Page Numbers: 966-74

    Journal Abbreviation: Arch. Gen. Psychiatry

    ISSN: 0003-990X

    DAY: 3

    MONTH: Aug

    YEAR: 2007

    A new brief instrument for assessing decisional capacity for clinical research. Information

    Number of References:

    LANGUAGE: eng

    NlmUniqueID: 372435

    A new brief instrument for assessing decisional capacity for clinical research. Keywords Mesh Terms:

    KEYWORDS: Sensitivity and Specificity

    MESH TERMS: diagnosis

    Chemical & Substance for Abstract: A new brief instrument for assessing decisional capacity for clinical research. Information

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    Grant and Affiliation Information for A new brief instrument for assessing decisional capacity for clinical research.

    AFFILIATION: 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

    Country: United States

    United States Research PublicationUnited States Research Publication

    AGENCY: United States NIMH

    GRANT: R01 MH67002

    ACRONYM: MH

    MEDLINETA: Arch Gen Psychiatry

    REFSOURCE:

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