Am J Psychiatry 158:712-717, May 2001
© 2001 American Psychiatric Association
Assessing the Competence of Persons With Alzheimer’s Disease in Providing Informed Consent for Participation in Research
Scott Y. H. Kim, M.D., Ph.D.,
Eric D. Caine, M.D.,
Glenn W. Currier, M.D.,
Adrian Leibovici, M.D., and
J. Michael Ryan, M.D.
OBJECTIVE: The capacity of persons with Alzheimer’s disease or other neuropsychiatric disorders for giving consent to participate in research has come under increasing scrutiny. While instruments for measuring abilities related to capacity have been developed, how they should be used to categorize subjects as capable or incapable is not clear. A criterion validation study was carried out to help address this question. METHOD: The authors measured the ability of 37 subjects with mild-to-moderate Alzheimer’s disease and 15 elderly comparison subjects to provide consent for participation in a hypothetical clinical trial. Using the judgment of three experts as the criterion standard, the authors performed a receiver operator characteristic analysis for the capacity ability measures from the MacArthur Competence Assessment Tool—Clinical Research Version. The results were compared with categorizations of capacity status that were based on normative values. RESULTS: While most comparison subjects scored perfectly on all measures of the competence assessment tool, the majority of the group with Alzheimer’s disease showed significant decision-making impairment. Thresholds based on normative values resulted in 84% (N=31) of the Alzheimer’s disease subjects being rated as incapable on at least one ability; thresholds based on expert judgment resulted in 62% (N=23) failing to meet cutoff scores on at least one ability. CONCLUSIONS: Even relatively mild Alzheimer’s disease significantly impairs consent-giving capacity. But differentiating capable from incapable subjects remains an issue despite the aid of standardized tools. More research is needed to understand the relationship between subject factors (performance on ability measures) and categorical judgments about their capacity.
This article has been cited by other articles:
|
|
|
|
 
J Warner, R McCarney, M Griffin, K Hill, and P Fisher
Participation in dementia research: rates and correlates of capacity to give informed consent
J. Med. Ethics,
March 1, 2008;
34(3):
167 - 170.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. S. Black, J. Brandt, P. V. Rabins, Q. M. Samus, C. D. Steele, C. G. Lyketsos, and A. Rosenblatt
Predictors of Providing Informed Consent or Assent for Research Participation in Assisted Living Residents
Am J Geriatr Psychiatry,
January 1, 2008;
16(1):
83 - 91.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. V. Jeste, B. W. Palmer, P. S. Appelbaum, S. Golshan, D. Glorioso, L. B. Dunn, K. Kim, T. Meeks, and H. C. Kraemer
A New Brief Instrument for Assessing Decisional Capacity for Clinical Research
Arch Gen Psychiatry,
August 1, 2007;
64(8):
966 - 974.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y. H. Kim, P. S. Appelbaum, J. Swan, T. S. Stroup, J. P. McEvoy, D. C. Goff, D. V. Jeste, J. S. Lamberti, A. Leibovici, and E. D. Caine
Determining when impairment constitutes incapacity for informed consent in schizophrenia research
The British Journal of Psychiatry,
July 1, 2007;
191(1):
38 - 43.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. M. Lai and J. Karlawish
Assessing the Capacity to Make Everyday Decisions: A Guide for Clinicians and an Agenda for Future Research
Am J Geriatr Psychiatry,
February 1, 2007;
15(2):
101 - 111.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. Mittal, B. W. Palmer, L. B. Dunn, R. Landes, C. Ghormley, C. Beck, S. Golshan, D. Blevins, and D. V. Jeste
Comparison of Two Enhanced Consent Procedures for Patients With Mild Alzheimer Disease or Mild Cognitive Impairment
Am J Geriatr Psychiatry,
February 1, 2007;
15(2):
163 - 167.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Resnick, A. L. Gruber-Baldini, I. Pretzer-Aboff, E. Galik, V. C. Buie, K. Russ, and S. Zimmerman
Reliability and Validity of the Evaluation to Sign Consent Measure
Gerontologist,
February 1, 2007;
47(1):
69 - 77.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Moye and D. C. Marson
Assessment of Decision-Making Capacity in Older Adults: An Emerging Area of Practice and Research
J. Gerontol. B. Psychol. Sci. Soc. Sci.,
January 1, 2007;
62(1):
P3 - P11.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. S. Srebnik and S. Y. Kim
Competency for Creation, Use, and Revocation of Psychiatric Advance Directives
J Am Acad Psychiatry Law,
December 1, 2006;
34(4):
501 - 510.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. B. Fisher, C. D. Cea, P. W. Davidson, and A. L. Fried
Capacity of Persons With Mental Retardation to Consent to Participate in Randomized Clinical Trials
Am J Psychiatry,
October 1, 2006;
163(10):
1813 - 1820.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y.H. Kim, E. D. Caine, J. G. Swan, and P. S. Appelbaum
Do Clinicians Follow a Risk-Sensitive Model of Capacity-Determination? An Experimental Video Survey
Psychosomatics,
August 1, 2006;
47(4):
325 - 329.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. B. Dunn, M. A. Nowrangi, B. W. Palmer, D. V. Jeste, and E. R. Saks
Assessing Decisional Capacity for Clinical Research or Treatment: A Review of Instruments
Am J Psychiatry,
August 1, 2006;
163(8):
1323 - 1334.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. B. Dunn, B. W. Palmer, M. Keehan, D. V. Jeste, and P. S. Appelbaum
Assessment of Therapeutic Misconception in Older Schizophrenia Patients With a Brief Instrument
Am J Psychiatry,
March 1, 2006;
163(3):
500 - 506.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y H Kim
When Does Decisional Impairment Become Decisional Incompetence? Ethical and Methodological Issues in Capacity Research in Schizophrenia
Schizophr Bull,
January 1, 2006;
32(1):
92 - 97.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. W Palmer and D. V Jeste
Relationship of Individual Cognitive Abilities to Specific Components of Decisional Capacity Among Middle-Aged and Older Patients With Schizophrenia
Schizophr Bull,
January 1, 2006;
32(1):
98 - 106.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. R Saks, L. B Dunn, and B. W Palmer
Meta-Consent in Research on Decisional Capacity: A "Catch-22"?
Schizophr Bull,
January 1, 2006;
32(1):
42 - 46.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. C Marson, R. Savage, and J. Phillips
Financial Capacity in Persons with Schizophrenia and Serious Mental Illness: Clinical and Research Ethics Aspects
Schizophr Bull,
January 1, 2006;
32(1):
81 - 91.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y.H. Kim, H. M. Kim, C. McCallum, and P. N. Tariot
What do people at risk for Alzheimer disease think about surrogate consent for research?
Neurology,
November 8, 2005;
65(9):
1395 - 1401.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. C Holen, I. Saltvedt, P. M Fayers, M. Bjornnes, G. Stenseth, B. Hval, M. Filbet, J. H. Loge, and S. Kaasa
The Norwegian Doloplus-2, a tool for behavioural pain assessment: translation and pilot-validation in nursing home patients with cognitive impairment
Palliative Medicine,
July 1, 2005;
19(5):
411 - 417.
[Abstract]
[PDF]
|
|
|
|
|
|
|
B. W. Palmer, L. B. Dunn, P. S. Appelbaum, S. Mudaliar, L. Thal, R. Henry, S. Golshan, and D. V. Jeste
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,
July 1, 2005;
62(7):
726 - 733.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y.H. Kim, P. S. Appelbaum, D. V. Jeste, and J. T. Olin
Proxy and Surrogate Consent in Geriatric Neuropsychiatric Research: Update and Recommendations
Am J Psychiatry,
May 1, 2004;
161(5):
797 - 806.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. I. Lapid, T. A. Rummans, V. S. Pankratz, and P. S. Appelbaum
Decisional Capacity of Depressed Elderly to Consent to Electroconvulsive Therapy
J Geriatr Psychiatry Neurol,
March 1, 2004;
17(1):
42 - 46.
[Abstract]
[PDF]
|
|
|
|
|
|
|
V. D. Buckles, K. K. Powlishta, J. L. Palmer, M. Coats, T. Hosto, A. Buckley, and J. C. Morris
Understanding of informed consent by demented individuals
Neurology,
December 23, 2003;
61(12):
1662 - 1666.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. A. Kovnick, P. S. Appelbaum, S. K. Hoge, and R. A. Leadbetter
Competence to Consent to Research Among Long-Stay Inpatients With Chronic Schizophrenia
Psychiatr Serv,
September 1, 2003;
54(9):
1247 - 1252.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. H.T. Karlawish
Research Involving Cognitively Impaired Adults
N. Engl. J. Med.,
April 3, 2003;
348(14):
1389 - 1392.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. C. Colenda
Patient Choice and End-of-Life Decisions
Am J Geriatr Psychiatry,
February 1, 2003;
11(1):
113 - 114.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y. H. Kim and E. D. Caine
Utility and Limits of the Mini Mental State Examination in Evaluating Consent Capacity in Alzheimer's Disease
Psychiatr Serv,
October 1, 2002;
53(10):
1322 - 1324.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y.H. Kim, C. Cox, and E. D. Caine
Impaired Decision-Making Ability in Subjects With Alzheimer's Disease and Willingness to Participate in Research
Am J Psychiatry,
May 1, 2002;
159(5):
797 - 802.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. S. Appelbaum
Involving Decisionally Impaired Subjects in Research: The Need for Legislation
Am J Geriatr Psychiatry,
April 1, 2002;
10(2):
120 - 124.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Y.H. Kim, J. H.T. Karlawish, and E. D. Caine
Current State of Research on Decision-Making Competence of Cognitively Impaired Elderly Persons
Am J Geriatr Psychiatry,
April 1, 2002;
10(2):
151 - 165.
[Abstract]
[Full Text]
[PDF]
|
|
|
Get information about faster international access.
Privacy Policy
Copyright © 2001
American Psychiatric Association.
All rights reserved.
Home
| Search
| Current Issue
| Past Issues
| Subscribe
| All APPI Journals
| Help
| Contact Us
|
