의사결정능력 도구인 University of California, SanDiego Brief Assessment of Capacity to Consent (UBACC)의 타당도와 신뢰도 평가
Validation of University of California’s Brief Assessment of Capacity to Consent (UBACC)
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
This study aimed to validate one of the tools for assessing decision-making capacity: the University of California at San Diego’s Brief Assessment of Capacity to Consent (UBACC), which is composed of a 10-item scale that includes questions focusing on the understanding and appreciation of information concerning research protocol. The subjects in the study were 30 inpatients and 30 outpatients with schizophrenia or schizoaffective disorder and, for comparison, 30 healthy subjects, all of whom received information about a simulated clinical drug trial. Using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) as a gold standard, inter-rater reliability with intra-class correlation coefficient (ICC) was measured. The ICC for inter-rater reliability ranged from 0.987 to 0.994. The UBACC was found to be a useful and valid instrument for the screening of decision-making capacity before obtaining informed consent. We recommend that it be used not only for schizophrenia patients but also for various vulnerable groups including the elderly or cognitively impaired subjects.
Abstract
This study aimed to validate one of the tools for assessing decision-making capacity: the University of California at San Diego’s Brief Assessment of Capacity to Consent (UBACC), which is composed of a 10-item scale that includes questions focusing on the understanding and appreciation of information concerning research protocol. The subjects in the study were 30 inpatients and 30 outpatients with schizophrenia or schizoaffective disorder and, for comparison, 30 healthy subjects, all of whom received information about a simulated clinical drug trial. Using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) as a gold standard, inter-rater reliability with intra-class correlation coefficient (ICC) was measured. The ICC for inter-rater reliability ranged from 0.987 to 0.994. The UBACC was found to be a useful and valid instrument for the screening of decision-making capacity before obtaining informed consent. We recommend that it be used not only for schizophrenia patients but also for various vulnerable groups including the elderly or cognitively impaired subjects.
참고문헌 (21)
- Appelbacum PS, "MacArthur competence assessment tool for clinical research (MacCAT-CR)" (2001), Professional Resource Press
- Dunn G, "Statistical evaluation of measurement errors: Design and analysis of reliability studies" (2004), Arnold
- Dunn LB, "Assessing decisional capacity for clinical research or treatment: a review of instruments", Am J Psychiatry, 163(8), pp.1323~1334 (2006)
- Dunn LB, "Understanding of placebo controls among older people with schizophrenia", Schizophr Bull, 32(1), pp.137~146 (2006)
- Jeste DV, "A new brief instrument for assessing decisional capacity for clinical research", Arch Gen Psychiatry, 64(8), pp.966~974 (2007)
- Marson DC, "Consistency of physician judgments of capacity to consent in mild Alzheimer's disease", J Am Geriatr Soc, 45(4), pp.453~457 (1997)
- Moser DJ, "Using a brief intervention to improve decisional capacity in schizophrenia research", Schizophr Bull, 32(1), pp.116~120 (2006)
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report : Ethical principles and guidelines for the protection of human subjects of research, , ~ (1979)
- Nunnally JC, "Psychometric theory" (1994), McGraw-Hill
- Palmer BW, "Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument", Arch Gen Psychiatry, 62(7), pp.726~733 (2005)
- Paris A, "French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research", Fundam Clin Pharmacol, 20, pp.97~104 (2006)
- Pellegrino E, "For patient's good", pp.149~ (1988), Oxford University Press
- Polit DF, "Nursing research: Generating and assessing evidence for nursing practice" (2008), Lippincott Williams & Wilkins
- Stroup S, "Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial", Schizophr Res, 80(1), pp.1~8 (2005)
- Sturman ED, "The capacity to consent to treatment and research: a review of standardized assessment tools", Clin Psychol Rev, 25(7), pp.954~974 (2005)
- Sugarman J, "The Nuremberg Code, in Ethics of research with human subjects", pp.12~13 (1998), University Publishing Group
- "The World Medical Association. Declaration of Helsinki", ~ (1964)
- U.S. Department of Health and Human Services, "45 Code of Federal Regulations 46", Fed Reg, 56, pp.28012~ (1991)
- 의약품 임상시험 관리기준. 식품의약품안전청 고시, "식품의약품안전청", ~, pp.제2009-211호 (2009)
- 정인숙, "임상연구코디네이터 근무특성, 직무만족도와 이직의도", 한국임상연구코디네이터회지, 3, pp.14~21 (2009)
- 홍소연, "충분한 설명에 근거한 동의에서 환자의 의사결정능력 판단의 기준", 한국의료윤리학회지, 8(1), pp.44~59 (2005), 한국의료윤리학회
