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The association of specific neuropsychological deficits with capacity to consent to research or treatment

Published online by Cambridge University Press:  18 October 2007

BARTON W. PALMER
Affiliation:
Department of Psychiatry, University of California, San Diego, La Jolla, California
GAURI N. SAVLA
Affiliation:
Department of Psychiatry, University of California, San Diego, La Jolla, California Joint Doctoral Program in Clinical Psychology, San Diego State University and University of California, San Diego, San Diego and La Jolla, California

Abstract

Informed consent is key to ethical clinical research and treatment, but partially rests on the ability of individual patients or research participants to use disclosed information to make a meaningful choice. Although the construct of decisional capacity emerged from legal and philosophical traditions, several investigators have begun examining the relationship of specific neuropsychological abilities to decisional capacity. This line of research may foster development of better consent procedures, as well as aid in refining the construct of decisional capacity toward a form that better reflects the underlying neurocognitive processes. We conducted a systematic search of the published literature and thereby identified and reviewed 16 published reports of empirical studies that examined the relationship between specific neuropsychological abilities and capacity to consent to research or treatment. Significant relationships between neuropsychological scores and decisional capacity were present across all the reviewed studies. The degree to which specific neuropsychological abilities have particular relevance to decisional capacity remains uncertain, but the existing studies provide a solid basis for a priori hypotheses for future investigations. These ongoing efforts represent an important conceptual and empirical bridge between bioethical, legal, and neuropsychological approaches to understanding meaningful decision-making processes. (JINS, 2007, 13, 1047–1059.)

Type
CRITICAL REVIEW
Copyright
© 2007 The International Neuropsychological Society

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References

REFERENCES

Appelbaum, P.S. & Grisso, T. (1988). Assessing patients' capacities to consent to treatment. New England Journal of Medicine, 319, 16351638.Google Scholar
Appelbaum, P.S. & Grisso, T. (2001). MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press.
Appelbaum, P.S. & Roth, L.H. (1982). Competency to consent to research: A psychiatric overview. Archives of General Psychiatry, 39, 951958.Google Scholar
Awad, N., Gagnon, M., & Messier, C. (2004). The relationship between impaired glucose tolerance, type 2 diabetes, and cognitive function. Journal of Clinical and Experimental Neuropsychology, 26, 10441080.Google Scholar
Bambara, J.K., Griffith, H.R., Martin, R.C., Faught, E., Wadley, V.G., & Marson, D.C. (2007). Medical decision-making abilities in older adults with chronic partial epilepsy. Epilepsy and Behavior, 10, 6368.CrossRefGoogle Scholar
Barton, C.D., Jr., Mallik, H.S., Orr, W.B., & Janofsky, J.S. (1996). Clinicians' judgement of capacity of nursing home patients to give informed consent. Psychiatric Services, 47, 956960.Google Scholar
Bishop, C.L., Temple, R.O., Tremont, G., Westervelt, H.J., & Stern, R.A. (2003). Utility of the neuropsychological evaluation in an acute medical hospital. Clinical Neuropsychology, 17, 468473.Google Scholar
Bowie, C.R., Reichenberg, A., Patterson, T.L., Heaton, R.K., & Harvey, P.D. (2006). Determinants of real-world functional performance in schizophrenia subjects: Correlations with cognition, functional capacity, and symptoms. American Journal of Psychiatry, 163, 418425.Google Scholar
Brewer, N.T., Chapman, G.B., Schwartz, J.A., & Bergus, G.R. (2007). The influence of irrelevant anchors on the judgments and choices of doctors and patients. Medical Decision Making, 27, 203211.Google Scholar
Carpenter, W.T., Gold, J.M., Lahti, A.C., Queern, C.A., Conley, R.R., Bartko, J.J., Kovnick, J., & Appelbaum, P.S. (2000). Decisional capacity for informed consent in schizophrenia research. Archives of General Psychiatry, 57, 533538.Google Scholar
Casarett, D.J., Karlawish, J.H., & Hirschman, K.B. (2003). Identifying ambulatory cancer patients at risk of impaired capacity to consent to research. Journal of Pain and Symptom Management, 26, 615624.Google Scholar
Chapman, L.J. & Chapman, J.P. (1978). The measurement of differential deficit. Journal of Psychiatric Research, 14, 303311.Google Scholar
Cohen, J. & Cohen, P. (1983). Applied Multiple Regression/Correlation Analysis for Behavioral Sciences (2nd ed., pp. 5657). Hillsdale, NJ: Lawrence Earlbaum Associates.
Collie, A. (2005). Cognition in liver disease. Liver International, 25, 18.Google Scholar
Delis, D., Kaplan, E., & Kramer, J. (2001). Delis-Kaplan Executive Function Scale (D-KEFS): Examiner's Manual. San Antonio, TX: The Psychological Corporation.
Dunn, L.B., Candilis, P.J., & Roberts, L.W. (2006a). Emerging empirical evidence on the ethics of schizophrenia research. Schizophrenia Bulletin, 32, 4768.Google Scholar
Dunn, L.B. & Jeste, D.V. (2001). Enhancing informed consent for research and treatment. Neuropsychopharmacology, 24, 595607.Google Scholar
Dunn, L.B., Nowrangi, M., Palmer, B.W., Jeste, D.V., & Saks, E. (2006b). Assessing capacity to consent to treatment and research: A review of instruments. American Journal of Psychiatry, 163, 13231334.Google Scholar
Dunn, L.B., Palmer, B.W., Appelbaum, P.S., Saks, E.R., Aarons, G.A., & Jeste, D.V. (2007a). Prevalence and correlates of adequate performance on a measure of abilities related to decisional capacity: Differences among three standards for the MacCAT-CR in patients with schizophrenia. Schizophrenia Research, 89, 110118.Google Scholar
Dunn, L.B., Palmer, B.W., & Karlawish, J.H. (2007b). Frontal dysfunction and capacity to consent to treatment or research: Conceptual considerations and empirical evidence. In B. Miller & J.L. Cummings (Eds.), The Human Frontal Lobes: Functions and Disorders (2nd ed., pp. 335344). New York: Guilford Press.
Dymek, M.P., Atchison, P., Harrell, L., & Marson, D.C. (2001). Competency to consent to medical treatment in cognitively impaired patients with Parkinson's disease. Neurology, 56, 1724.Google Scholar
Dymek, M.P., Marson, D.C., & Harrell, L. (1999). Factor structure of capacity to consent to medical treatment in patients with Alzheimer's disease: An exploratory study. Journal of Forensic Neuropsychology, 1, 2748.Google Scholar
Earnst, K.S., Marson, D.C., & Harrell, L.E. (2000). Cognitive models of physicians' legal standard and personal judgments of competency in patients with Alzheimer's disease. Journal of the American Geriatric Society, 48, 919927.Google Scholar
Etchells, E., Katz, M.R., Shuchman, M., Wong, G., Workman, S., Choudhry, N.K., Craven, J., & Singer, P.A. (1997). Accuracy of clinical impressions and Mini-Mental State Exam scores for assessing capacity to consent to major medical treatment. Comparison with criterion-standard psychiatric assessments. Psychosomatics, 38, 239245.Google Scholar
Eyler, L.T. & Jeste, D.V. (2006). Enhancing the informed consent process: A conceptual overview. Behavioral Sciences & The Law, 24, 553568.Google Scholar
Eyler, L.T., Olsen, R.K., Nayak, G.V., Mirzakhanian, H., Brown, G.G., & Jeste, D.V. (2007). Brain response correlates of decisional capacity in schizophrenia: A preliminary FMRI study. Journal of Neuropsychiatry and Clinical Neurosciences, 19, 137144.Google Scholar
Faden, R., Beauchamp, T., & King, N. (1986). A History and Theory of Informed Consent. New York: Oxford University Press.
Fagerlin, A., Wang, C., & Ubel, P.A. (2005). Reducing the influence of anecdotal reasoning on people's health care decisions: Is a picture worth a thousand statistics? Medical Decision Making, 25, 398405.Google Scholar
Fioravanti, M., Carlone, O., Vitale, B., Cinti, M.E., & Clare, L. (2005). A meta-analysis of cognitive deficits in adults with a diagnosis of schizophrenia. Neuropsychology Review, 15, 7395.Google Scholar
Fisher, C.B., Cea, C.D., Davidson, P.W., & Fried, A.L. (2006). Capacity of persons with mental retardation to consent to participate in randomized clinical trials. American Journal of Psychiatry, 163, 18131820.Google Scholar
Fitten, L.J. & Waite, M.S. (1990). Impact of medical hospitalization on treatment decision-making capacity in the elderly. Archives of Internal Medicine, 150, 17171721.Google Scholar
Flory, J. & Emanuel, E. (2004). Interventions to improve research participants' understanding in informed consent for research: A systematic review. Journal of the American Medical Association, 292, 15931601.Google Scholar
Ganzini, L., Volicer, L., Nelson, W.A., Fox, E., & Derse, A.R. (2005). Ten myths about decision-making capacity. Journal of the American Medical Directors Association, 6(Suppl.), S100S104.Google Scholar
Gladsjo, J.A., McAdams, L.A., Palmer, B.W., Moore, D.J., Jeste, D.V., & Heaton, R.K. (2004). A six-factor model of cognition in schizophrenia and related psychotic disorders: Relationships with clinical symptoms and functional capacity. Schizophrenia Bulletin, 30, 739754.Google Scholar
Green, M.F., Kern, R.S., Braff, D.L., & Mintz, J. (2000). Neurocognitive deficits and functional outcome in schizophrenia: Are we measuring the “right stuff”? Schizophrenia Bulletin, 26, 119136.Google Scholar
Grisso, T. & Appelbaum, P.S. (1995). The MacArthur Treatment Competence Study. III: Abilities of patients to consent to psychiatric and medical treatments. Law and Human Behavior, 19, 149174.Google Scholar
Grisso, T. & Appelbaum, P.S. (1998). Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health Professionals. New York: Oxford University Press.
Grisso, T., Appelbaum, P.S., & Hill-Fotouhi, C. (1997). The MacCAT-T: A clinical tool to assess patients' capacities to make treatment decisions. Psychiatric Services, 48, 14151419.Google Scholar
Gurrera, R.J., Karel, M.J., Azar, A.R., & Moye, J. (2007). Agreement between instruments for rating treatment decisional capacity. American Journal of Geriatric Psychiatry, 15, 168173.Google Scholar
Gurrera, R.J., Moye, J., Karel, M.J., Azar, A.R., & Armesto, J.C. (2006). Cognitive performance predicts treatment decisional abilities in mild to moderate dementia. Neurology, 66, 13671372.Google Scholar
Halpern, S.D. (2005). Towards evidence based bioethics. BMJ, 331, 901903.Google Scholar
Heinrichs, R.W. & Zakzanis, K.K. (1998). Neurocognitive deficit in schizophrenia: A quantitative review of the evidence. Neuropsychology, 12, 426445.Google Scholar
Hey, C.T., Hynes, S.M., Reese, R.L., Benjamin, M.L., Arndt, S., Schultz, S.K., Andreasen, N.C., & Moser, D.J. (2006). Cognitive and psychiatric factors associated with capacity for informed consent in schizophrenia research [abstract]. Journal of the International Neuropsychological Society, 12(Suppl. S1), 240.Google Scholar
Jefferson, A.L., Paul, R.H., Ozonoff, A., & Cohen, R.A. (2006). Evaluating elements of executive functioning as predictors of instrumental activities of daily living (IADLs). Archives of Clinical Neuropsychology, 21, 311320.Google Scholar
Kaplan, E. (1988). A process approach to neuropsychological assessment. In M. Dennis, E. Kaplan, M.I. Posner, D.G. Stein, & R.F. Thompson (Eds.), Clinical Neuropsychology and Brain Function: Research, Measurment, and Practice (pp. 129167). Washington, DC: American Psychological Association.
Karlawish, J.H., Casarett, D.J., James, B.D., Xie, S.X., & Kim, S.Y. (2005). The ability of persons with Alzheimer disease (AD) to make a decision about taking an AD treatment. Neurology, 64, 15141519.Google Scholar
Kim, S.Y. (2004). Evidence-based ethics for neurology and psychiatry research. NeuroRx, 1, 372377.Google Scholar
Kim, S.Y. & Caine, E.D. (2002). Utility and limits of the mini mental state examination in evaluating consent capacity in Alzheimer's disease. Psychiatric Services, 53, 13221324.Google Scholar
Kim, S.Y., Cox, C., & Caine, E.D. (2002). Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research. American Journal of Psychiatry, 159, 797802.Google Scholar
Knight, R.A. & Silverstein, S.M. (2001). A process-oriented approach for averting confounds resulting from general performance deficiencies in schizophrenia. Journal of Abnormal Psychology, 110, 1530.Google Scholar
Kovnick, J.A., Appelbaum, P.S., Hoge, S.K., & Leadbetter, R.A. (2003). Competence to consent to research among long-stay inpatients with chronic schizophrenia. Psychiatric Services, 54, 12471252.Google Scholar
Marson, D.C. (2001). Loss of competency in Alzheimer's disease: Conceptual and psychometric approaches. International Journal of Law and Psychiatry, 24, 267283.Google Scholar
Marson, D.C., Annis, S.M., McInturff, B., Bartolucci, A., & Harrell, L.E. (1999). Error behaviors associated with loss of competency in Alzheimer's disease. Neurology, 53, 19831992.Google Scholar
Marson, D.C., Chatterjee, A., Ingram, K.K., & Harrell, L.E. (1996). Toward a neurologic model of competency: Cognitive predictors of capacity to consent in Alzheimer's disease using three different legal standards. Neurology, 46, 666672.Google Scholar
Marson, D.C., Cody, H.A., Ingram, K.K., & Harrell, L.E. (1995a). Neuropsychologic predictors of competency in Alzheimer's disease using a rational reasons legal standard. Archives of Neurology, 52, 955959.Google Scholar
Marson, D.C. & Harrell, L. (1999). Executive dysfunction and loss of capacity to consent to medical treatment in patients with Alzheimer's disease. Seminars in Clinical Neuropsychiatry, 4, 4149.Google Scholar
Marson, D.C., Hawkins, L., McInturff, B., & Harrell, L.E. (1997). Cognitive models that predict physician judgments of capacity to consent in mild Alzheimer's disease. Journal of the American Geriatric Society, 45, 458464.Google Scholar
Marson, D.C. & Ingram, K.K. (1996). Competency to consent to treatment: A growing field of research: Commentary. Journal of Ethics, Law, and Aging, 2, 5963.Google Scholar
Marson, D.C., Ingram, K.K., Cody, H.A., & Harrell, L.E. (1995b). Assessing the competency of patients with Alzheimer's disease under different legal standards. A prototype instrument. Archives Neurology, 52, 949954.Google Scholar
Marson, D.C., Ingram, K.K., & Harrell, L. (1993). Neuropsychological correlates of competency loss in dementia using a simple legal standard [abstract]. Journal of the American Geriatric Society, 41, SA43.Google Scholar
Meisel, A., Roth, L.H., & Lidz, C.W. (1977). Toward a model of the legal doctrine of informed consent. American Journal of Psychiatry, 134, 285289.Google Scholar
Moser, D.J., Schultz, S.K., Arndt, S., Benjamin, M.L., Fleming, F.W., Brems, C.S., Paulsen, J.S., Appelbaum, P.S., & Andreasen, N.C. (2002). Capacity to provide informed consent for participation in schizophrenia and HIV research. American Journal of Psychiatry, 159, 12011207.Google Scholar
Moye, J. & Karel, M.J. (1999). Evaluating decisional capacities in older adults: Results of two clinical studies. Advances in Medical Psychotherapy, 10, 7184.Google Scholar
Moye, J., Karel, M.J., Azar, A.R., & Gurrera, R.J. (2004a). Capacity to consent to treatment: Empirical comparison of three instruments in older adults with and without dementia. Gerontologist, 44, 166175.Google Scholar
Moye, J., Karel, M.J., Azar, A.R., & Gurrera, R.J. (2004b). Hopes and cautions for instrument-based evaluation of consent capacity: Results of a construct validity study of three instruments. Journal of Ethics, Law, and Aging Review, 10, 3961.Google Scholar
Moye, J., Karel, M.J., Gurrera, R.J., & Azar, A.R. (2006). Neuropsychological predictors of decision-making capacity over 9 months in mild-to-moderate dementia. Journal of General Internal Medicine, 21, 7883.Google Scholar
Moye, J. & Marson, D.C. (2007). Assessment of decision-making capacity in older adults: An emerging area of practice and research. The Journals of Gerontology. Series B, Psychological Sciences and Social Sciences, 62B, P3P11.Google Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. Accessed May 24, 2007.
Newman, M.F., Kirchner, J.L., Phillips-Bute, B., Gaver, V., Grocott, H., Jones, R.H., Mark, D.B., Reves, J.G., & Blumenthal, J.A. (2001). Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. New England Journal of Medicine, 344, 395402.Google Scholar
Northoff, G. (2006). Neuroscience of decision making and informed consent: An investigation in neuroethics. Journal of Medical Ethics, 32, 7073.Google Scholar
Palmer, B.W. (2006). Informed consent for schizophrenia research: What is an investigator (or IRB) to do? Behavioral Sciences & The Law, 24, 447452.Google Scholar
Palmer, B.W., Dunn, L.B., Appelbaum, P.S., & Jeste, D.V. (2004). Correlates of treatment-related decision-making capacity among middle-aged and older patients with schizophrenia. Archives of General Psychiatry, 61, 230236.Google Scholar
Palmer, B.W., Dunn, L.B., Appelbaum, P.S., Mudaliar, S., Thal, L., Henry, R., Golshan, S., & Jeste, D.V. (2005). 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. Archives of General Psychiatry, 62, 726733.Google Scholar
Palmer, B.W., Dunn, L.B., Depp, C.A., Eyler, L.T., & Jeste, D.V. (2007). Decisional capacity to consent to research among patients with bipolar disorder: Comparison with schizophrenia patients and healthy subjects. The Journal of Clinical Psychiatry, 68, 689696.Google Scholar
Palmer, B.W. & Heaton, R. (2000). Executive dysfunction in schizophrenia. In T. Sharma & P. Harvey (Eds.), Cognition in Schizophrenia: Impairments, Importance and Treatment Strategies (pp. 5272). New York: Oxford University Press.
Palmer, B.W. & Jeste, D.V. (2006). Relationship of individual cognitive abilities to specific components of decisional capacity among middle-aged and older patients with schizophrenia. Schizophrenia Bulletin, 32, 98106.Google Scholar
Pucci, E., Belardinelli, N., Borsetti, G., Rodriguez, D., & Signorino, M. (2001). Information and competency for consent to pharmacologic clinical trials in Alzheimer disease: An empirical analysis in patients and family caregivers. Alzheimer Disease and Associated Disorders, 15, 146154.Google Scholar
Randolph, C. (1998). RBANS—Manual—Repeatable Battery for the Assessment of Neuropsychological Status. San Antonio, TX: The Psychological Corporation.
Raymont, V., Bingley, W., Buchanan, A., David, A.S., Hayward, P., Wessely, S., & Hotopf, M. (2004). Prevalence of mental incapacity in medical inpatients and associated risk factors: Cross-sectional study. Lancet, 364, 14211427.Google Scholar
Resnick, B., Gruber-Baldini, A.L., Pretzer-Aboff, I., Galik, E., Buie, V.C., Russ, K., & Zimmerman, S. (2007). Reliability and validity of the evaluation to sign consent measure. Gerontologist, 47, 6977.Google Scholar
Reynolds, C.F., III. (2007). Assessing the capacity to make everyday decisions about functional problems: Where does the field go from here? American Journal of Geriatric Psychiatry, 15, 8991.Google Scholar
Roth, L.H., Meisel, A., & Lidz, C.W. (1977). Tests of competency to consent to treatment. American Journal of Psychiatry, 134, 279284.Google Scholar
Royall, D.R. (2002). Back to the future of mental capacity assessment. Journal of the American Geriatric Society, 50, 18841885.Google Scholar
Salmon, D.P. & Bondi, M.W. (1999). Neuropsychology of Alzheimer disease. In D.P. Salmon & M.W. Bondi (Eds.), Alzheimer Disease (2nd ed., pp. 3956). Philadelphia: Lippincott Williams & Wilkins.
Salthouse, T.A. & Becker, J.T. (1998). Independent effects of Alzheimer's disease on neuropsychological functioning. Neuropsychology, 12, 242252.Google Scholar
Savla, G.N., Moore, D.J., & Palmer, B.W., (in press). Cognitive functioning in schizophrenia. In K.T. Mueser & D.V. Jeste (Eds.), Clinical Handbook of Schizophrenia. New York: Guilford Press.
Schillerstrom, J.E., Rickenbacker, D., Joshi, K.G., & Royall, D.R. (2007). Executive function and capacity to consent to a noninvasive research protocol. American Journal of Geriatric Psychiatry, 15, 159162.Google Scholar
Sedlmeier, P. & Jaeger, S. (2007). The impact of post-event information on study-related memories: An exploration of the roles of judgemental anchoring, specific expectations about change, and motivational influences. Memory, 15, 7092.Google Scholar
Smith, D.M., Schwarz, N., Roberts, T.R., & Ubel, P.A. (2006). Why are you calling me? How study introductions change response patterns. Quality of Life Research, 15, 621630.Google Scholar
Stroup, S., Appelbaum, P., Swartz, M., Patel, M., Davis, S., Jeste, D., Kim, S., Keefe, R., Manschreck, T., McEvoy, J., & Lieberman, J. (2005). Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial. Schizophrenia Research, 80, 18.Google Scholar
Tabachnick, B.G. & Fidell, L.S. (1996). Using Multivariate Statistics—Third Edition. New York: HarperCollins College Publishers.
The Psychological Corporation. (1997). WAIS-III/WMS-III Technical Manual. San Antonio, TX: The Psychological Corporation.
Thompson, B. (1995). Stepwise regression and stepwise discriminant analysis need not apply here: A guidelines editorial. Educational and Psychological Measurement, 55, 525534.Google Scholar
Tversky, A. & Kahneman, D. (1974). Judgment under uncertainty: Heuristics and biases. Science, 185, 11241131.Google Scholar
Waldstein, S.R., Manuck, S.B., Ryan, C.M., & Muldoon, M.F. (1991). Neuropsychological correlates of hypertension: Review and methodologic considerations. Psychology Bulletin, 110, 451468.Google Scholar
Wechsler, D. (1997). Wechsler Adult Intelligence Scale—Third Edition (WAIS-III). Administration and Scoring Manual. San Antonio, TX: The Psychological Corporation.