A new brief instrument for assessing decisional capacity for clinical research

Archives of General Psychiatry

Volumn 64, Issue 8, 2007, Pages 966-974

  Jeste, Dilip V ^a,b,e   Palmer, Barton W ^a   Appelbaum, Paul S ^c   Golshan, Shahrokh ^a   Glorioso, Danielle ^a   Dunn, Laura B ^a   Kim, Kathleen ^a,b   Meeks, Thomas ^a   Kraemer, Helena C ^d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

^c Columbia University College of Physicians and Surgeons ^*  (United States)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CLINICAL RESEARCH; CONTROLLED STUDY; FEMALE; HEALTH CARE UTILIZATION; HUMAN; INFORMED CONSENT; INTERNAL CONSISTENCY; INTERRATER RELIABILITY; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; MEDICAL DECISION MAKING; MEDICAL INFORMATION; MEDICAL INSTRUMENTATION; MEDICAL RESEARCH; OUTPATIENT CARE; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SENSITIVITY AND SPECIFICITY;

AMBULATORY CARE; BIOETHICS; COGNITION DISORDERS; DECISION MAKING; FEMALE; HUMANS; INFORMED CONSENT; MALE; MASS SCREENING; MENTAL COMPETENCY; MIDDLE AGED; PATIENT SELECTION; PSYCHIATRIC STATUS RATING SCALES; PSYCHOMETRICS; PSYCHOTIC DISORDERS; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; RESEARCH SUBJECTS; ROC CURVE; SCHIZOPHRENIA; SENSITIVITY AND SPECIFICITY;

EID: 34547787224     PISSN: 0003990X     EISSN: 15383636     Source Type: Journal    
DOI: 10.1001/archpsyc.64.8.966     Document Type: Article

References (35)

1. Marson DC, McInturff B, Hawkins L, Bartolucci A, Harrell LE. Consistency of physician judgments of capacity to consent in mild Alzheimer's disease. J Am Geriatr Soc. 1997;45(4):453-457.
2. Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, Saks ER. Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry. 2006;163(8):1323-1334.
3. Sturman ED. The capacity to consent to treatment and research: a review of standardized assessment tools. Clin Psychol Rev. 2005;25(7):954-974.
4. Appelbaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press; 2001.
5. Karlawish JH, Lantos J. Community equipoise and the architecture of clinical research. Camb Q Healthc Ethics. 1997;6(4):385-396.
6. Jeste DV, Dunn LB, Palmer BW, Saks E, Halpain M, Cook A, Appelbaum P, Schneiderman L. A collaborative model for research on decision capacity and informed consent in older patients with schizophrenia: bioethics unit of a geriatric psychiatry intervention research center. Psychopharmacology (Berl). 2003;171(1):68-74.
7. Jeste DV, Depp CA, Palmer BW. Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: an overview. Schizophr Bull. 2006;32(1):121-128.
8. Dunn LB, Candilis PJ, Roberts LW. Emerging empirical evidence on the ethics of schizophrenia research. Schizophr Bull. 2006;32(1):47-68.
9. Dunn LB, Jeste DV. Problem areas in the understanding of informed consent: study of middle-aged and older patients with psychotic disorders. Psychopharmacology (Berl). 2003;171(1):81-85.
10. Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-276.
11. Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967;6(4):278-296.
12. Randolph C. RBANS Manual: Repeatable Battery for the Assessment of Neuropsychological Status. San Antonio, TX: Psychological Corp; 1998.
13. Anastasi A, Urbina S. Psychological Testing. 7th ed. Upper Saddle River, NJ: Prentice Hall; 1997.
14. Delis DC, Jacobson M, Bondi MW, Hamilton JM, Salmon DP. The myth of testing construct validity using factor analysis or correlations with normal or mixed clinical populations: lessons from memory assessment. J Int Neuropsychol Soc. 2003;9(6):936-946.
15. Larrabee GJ. Lessons on measuring construct validity: a commentary on Delis, Jacobson, Bondi, Hamilton, and Salmon. J Int Neuropsychol Soc. 2003;9(6):947-953.
16. Carpenter WT, Gold JM, Lahti AC, Queern CA, Conley RR, Bartko JJ, Kovnick J, Appelbaum PS. Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry. 2000;57(6):533-538.
17. Moser DJ, Schultz SK, Arndt S, Benjamin ML, Fleming FW, Brems CS, Paulsen JS, Appelbaum PS, Andreasen NC. Capacity to provide informed consent for participation in schizophrenia and HIV research. Am J Psychiatry. 2002;159(7):1201-1207.
18. Palmer BW, Dunn LB, Appelbaum PS, Jeste DV. Correlates of treatment-related decision-making capacity among middle-aged and older patients with schizophrenia. Arch Gen Psychiatry. 2004;61(3):230-236.
19. Palmer BW, Jeste DV. Relationship of individual cognitive abilities to specific components of decisional capacity among middle-aged and older patients with schizophrenia. Schizophr Bull. 2006;32(1):98-106.
20. Stroup S, Appelbaum P, Swartz M, Patel M, Davis S, Jeste DV, Kim S, Keefe R, Manschreck T, McEvoy J, Lieberman J. Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial. Schizophr Res. 2005;80(1):1-8.
21. Stroup TS, McEvoy JP, Swartz MS, Byerly MJ, Glick ID, Canive JM, McGee MF, Simpson GM, Stevens MC, Lieberman JA. The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development. Schizophr Bull. 2003;29(1):15-31.
22. Palmer BW, Dunn LB, Appelbaum PS, Mudaliar S, Thal L, Henry R, Golshan S, Jeste DV. 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. 2005;62(7):726-733.
23. Saks ER, Dunn LB, Marshall BJ, Nayak GV, Golshan S, Jeste DV. The California Scale of Appreciation: a new instrument to measure the appreciation component of capacity to consent to research. Am J Geriatr Psychiatry. 2002;10(2):166-174.
24. Dunn LB, Palmer BW, Keehan M. Understanding of placebo controls among older people with schizophrenia. Schizophr Bull. 2006;32(1):137-146.
25. Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry. 2001;158(5):712-717.
26. Kim SYH, Cox C, Caine ED. Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research. Am J Psychiatry. 2002;159(5):797-802.
27. Moser DJ, Reese RL, Hey CT, Schultz SK, Arndt S, Beglinger LJ, Duff KM, Andreasen NC. Using a brief intervention to improve decisional capacity in schizophrenia research. Schizophr Bull. 2006;32(1):116-120.
28. Karlawish JH, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc. 2002;50(12):2019-2024.
29. Schmand B, Gouwenberg B, Smit JH, Jonker C. Assessment of mental competency in community-dwelling elderly. Alzheimer Dis Assoc Disord. 1999;13(2):80-87.
30. Lidz CW, Appelbaum PS. The therapeutic misconception: problems and solutions. Med Care. 2002;40(9)(suppl):V55-V63.
31. Candilis PJ, Geppert CM, Fletcher KE, Lidz CW, Appelbaum PS. Willingness of subjects with thought disorder to participate in research. Schizophr Bull. 2006;32(1):159-165.
32. Dunn LB, Palmer BW, Keehan M, Jeste DV, Appelbaum PS. Assessment of therapeutic misconception in older schizophrenia patients with a brief instrument. Am J Psychiatry. 2006;163(3):500-506.
33. Appelbaum PS, Roth LH. Competency to consent to research: a psychiatric overview. Arch Gen Psychiatry. 1982;39(8):951-958.
34. Grisso T, Appelbaum PS. Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health Professionals. New York, NY: Oxford University Press; 1988.
35. Roberts LW, Hammond KA, Warner TD, Lewis R. Influence of ethical safeguards on research participation: comparison of perspectives of people with schizophrenia and psychiatrists. Am J Psychiatry. 2004;161(12):2309-2311.