determining capacity and protecting subjects who have lost capacity jason karlawish, md university...
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Determining capacity and Determining capacity and protecting subjects who have lost protecting subjects who have lost
capacitycapacity
Jason Karlawish, MD
University of Pennsylvania
The problem
• Proxy decision whether to enroll their relative who lived in a nursing home in research that presented no direct benefit. – 60% of the proxies who declined to allow their
relative to participate in the study reported an important reason was their reluctance to decide for the patient.
Warren. NEJM. 1986.
The problem
• Proxy decision whether to enroll their relative who lived in a nursing home in research that presented no direct benefit. – One-third (17/55) enrolled their relative even
though they thought their relative would not want to enroll.
Warren. NEJM. 1986.
Issues to discuss
• How do we know someone cannot provide informed consent?
• Do people agree with proxy consent?
• Who, ethically, should be the proxy?
• How should the proxy make the decision?
Core concepts
• The decision making abilities: choice, The decision making abilities: choice, understanding, appreciation, reasoningunderstanding, appreciation, reasoning
• Capacity and competency Capacity and competency – Capacity is the continuum of decision Capacity is the continuum of decision
making abilitiesmaking abilities– ““Being competent” or “having adequate Being competent” or “having adequate
capacity” is a judgment of a person’s capacity” is a judgment of a person’s decision making abilitiesdecision making abilities
• Assessments of capacity are used to Assessments of capacity are used to make make judgments judgments of competencyof competency
Comparison of AD patient and caregiver performance on ability to express a choice
AD patients (N = 59)* Caregivers (N = 60)
Ability to Express a Choice
1.9+0.3 2.0+0.0
2 55 (93%) 60 (100%)
1 3 (5%) 0 (0%)
0 1 (3%) 0 (0%)
*Very mild 31% (N =18) Very mild 31% (N =18) Mild Mild 32% (N =19) 32% (N =19) Moderate 37% (N =22)Moderate 37% (N =22)
Comparison of AD patient and caregiver performance on ability to reason
AD patients (N = 59)* Caregivers (N = 60)
Ability to Reason 5.9+1.8 7.7+0.6
7-8 27 (46%) 55 (92%)
5-6 22 (37%) 5 (8%)
0-3 10 (17%) 0 (0%)
*Very mild 31% (N =18) Very mild 31% (N =18) Mild Mild 32% (N =19) 32% (N =19) Moderate 37% (N =22)Moderate 37% (N =22)
Comparison of AD patient and caregiver performance on ability to understand
AD patients (N = 59)* Caregivers (N = 60)
Ability to Understand
17.3+6.6 25.4+1.1
25-26 9 (15%) 51 (85%)
23-24 6 (10%) 7 (12%)
21-22 10 (17%) 2 (3%)
13-20 21 (35%) 0 (0%)
0-12 13 (22%) 0 (0%)
*Very mild 31% (N =18) Very mild 31% (N =18) Mild Mild 32% (N =19) 32% (N =19) Moderate 37% (N =22)Moderate 37% (N =22)
Comparison of AD patient and caregiver performance on ability to appreciate
AD patients (N = 59)* Caregivers (N = 60)
Ability to Appreciate
3.4+2.0 5.6+0.8
5-6 17 (29%) 54 (90%)
3-4 21 (36%) 5 (8%)
1-2 15 (25%) 1 (2%)
0 6 (10%) 0 (0%)
*Very mild 31% (N =18) Very mild 31% (N =18) Mild Mild 32% (N =19) 32% (N =19) Moderate 37% (N =22)Moderate 37% (N =22)
Summary points
• Have some reasonable way to assess decision making ability– a quiz, a questionnaire– especially the ability to understand
• “Can you tell me in your own words, what are the [factual element under assessment] of this study?”
– select key facts you think a person needs to understand
– the rigor and detail of this assessment should be proportionate to the risks of the research
Issues to discuss
• How do we know someone cannot provide informed consent?
• Do people agree with proxy consent?• Who, ethically, should be the proxy?• How should the proxy make the decision?
Preferences for proxy decisionmaking
• Survey of 226 persons with a family history of Alzheimers disease– the vast majority willing to execute a RAD, but when
offered the opportunity to execute one few did (~10%)• Interviews with 538 older adults about their
preferences for research advance planning– all but 20 (4%) willing to have a proxy
• National population weighted survey of 1,515 older adults found general support for proxy consent for research that involves persons with AD.
Wendler et al. Am J Psych. 2002.Karlawish et al. Am J Psych. 2008.Kim et al. Neurology. 2009.
Issues to discuss
• How do we know someone cannot provide informed consent?
• Do people agree with proxy consent?
• Who, ethically, should be the proxy?
• How should the proxy make the decision?
Who should be the proxy – people who share the risks and benefits
• “What do you see as the study’s benefits for you?”
Having a husband that won’t get any worse, that’s a benefit to me because right now, I don’t know what my future is, you know, if he gets any worse. Anything that I feel could help him, I’m willing to do [A453, ll. 537-40].
The better condition of my wife is a benefit to me. That’s all. The improvement in any way that we would have – it would affect our entire lives [A531, ll. 767-8].
• What do you see as the study’s risks to you?
The study’s risks to me are that it might exacerbate my mother’s stress levels and make it more difficult for me and my Dad to maintain her care [C137, ll. 550-51].
Karlawish et al. Neurology. 2001.
Issues to discuss
• How should the proxy make the decision?
LP Willingness to Participate
Advance Consent
Proxy No Proxy Total
No Leeway Leeway
No 115
(21.4%)
145
(27.0%)
19
(3.5%)
279
(51.9%)
Yes 27
(5.0%)
230
(42.7%)
2
(0.4%)
259
(48.1%)
Total 142
(26.4%)
375
(69.7%)
21
(3.9%)
538
(100%)
Karlawish et al. Am J Psych. 2009
How would study partner make decision for patient if patient could not choose?
n (%)
Choose what patient, if competent, would decide
14 (24%)
Choose what will maximize patient’s well-being.
35 (59%)
Other 10 (17%)
Can’t answer 1 (0%)
Total 60
Karlawish et al. Am J Psych. 2008.
Summary points
• Designating a proxy (study partner) is potentially useful within a protocol where loss of capacity is anticipated
Summary points
• As the risks and hassles of the research increase or the subject population becomes more vulnerable (not able to provide informed consent) the proxy/study partner needs to be someone who fulfills roles you specify in the protocol– decisionmaker for the patient, assists with activities of daily
living, reports on disease progression and response to therapies– is available during the study
• Document that the proxy knows they are a proxy– watch the law -- “family” hierarchy rules
Summary points
• A requirement for a substituted judgment should focus on not simply the “yes” or “no” choice for enrollment, but the factors that subjects say should guide decisionmaking– risk, trust (in science, in person), benefit
Contact Information
Jason Karlawish, MD
University of Pennsylvania
3615 Chestnut Street
Philadelphia, PA 19104
References
Review of capacity assessment• Appelbaum P. Assessment of patients’ competence
to consent to treatment. N Engl J Med. 357(18); 2007:1834.
Review of assent/dissent and suggested steps to operationalize it
• Black B.S. et al. Seeking assent and respecting dissent in dementia research. Am J Geriatric Psych. 18;2010:77-85.
Why do people enroll?
You just get involved in something and you go for it. You don’t separate one thing from the other in minute detail and say well I like this but I don’t like that, or this is an invasion of privacy but this isn’t. We don’t care. What we’re just looking for is the answer to our prayers, that’s all [C064, lines 741-748].
Karlawish et al. Neurology. 2001.
Why do people enroll?
Essentially, I'm going in based on if [principal investigator] is in it, and the clinic is in it, and other people at the university and other patients at the university are in it, then it looks like a pretty good bet [A883, lines 655-57].
Karlawish et al. Neurology. 2001.