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August 27, 2013; 81 (9) Article

Cognitive impairment and PD patients' capacity to consent to research

Jason Karlawish, Mark Cary, Stephen T. Moelter, Andrew Siderowf, Elizabeth Sullo, Sharon Xie, Daniel Weintraub
First published July 26, 2013, DOI: https://doi.org/10.1212/WNL.0b013e3182a05ba5
Jason Karlawish
From the University of Pennsylvania (J.K., M.C., E.S., S.X., D.W.), Department of Medicine (J.K., E.S.), Department of Medical Ethics and Health Policy (J.K.), Alzheimer's Disease Center (J.K.), Neurodegenerative Disease Ethics and Policy Program (J.K., E.S.), Leonard Davis Institute of Health Economics (J.K.), Center for Clinical Epidemiology and Biostatistics (M.C., S.X.), Department of Psychiatry (D.W.), Parkinson's Disease (D.W.) and Mental Illness (D.W.) Research, Education and Clinical Centers; University of the Sciences in Philadelphia (S.T.M.); and Avid Radiopharmaceuticals (A.S.), Philadelphia, PA.
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Mark Cary
From the University of Pennsylvania (J.K., M.C., E.S., S.X., D.W.), Department of Medicine (J.K., E.S.), Department of Medical Ethics and Health Policy (J.K.), Alzheimer's Disease Center (J.K.), Neurodegenerative Disease Ethics and Policy Program (J.K., E.S.), Leonard Davis Institute of Health Economics (J.K.), Center for Clinical Epidemiology and Biostatistics (M.C., S.X.), Department of Psychiatry (D.W.), Parkinson's Disease (D.W.) and Mental Illness (D.W.) Research, Education and Clinical Centers; University of the Sciences in Philadelphia (S.T.M.); and Avid Radiopharmaceuticals (A.S.), Philadelphia, PA.
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Stephen T. Moelter
From the University of Pennsylvania (J.K., M.C., E.S., S.X., D.W.), Department of Medicine (J.K., E.S.), Department of Medical Ethics and Health Policy (J.K.), Alzheimer's Disease Center (J.K.), Neurodegenerative Disease Ethics and Policy Program (J.K., E.S.), Leonard Davis Institute of Health Economics (J.K.), Center for Clinical Epidemiology and Biostatistics (M.C., S.X.), Department of Psychiatry (D.W.), Parkinson's Disease (D.W.) and Mental Illness (D.W.) Research, Education and Clinical Centers; University of the Sciences in Philadelphia (S.T.M.); and Avid Radiopharmaceuticals (A.S.), Philadelphia, PA.
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Andrew Siderowf
From the University of Pennsylvania (J.K., M.C., E.S., S.X., D.W.), Department of Medicine (J.K., E.S.), Department of Medical Ethics and Health Policy (J.K.), Alzheimer's Disease Center (J.K.), Neurodegenerative Disease Ethics and Policy Program (J.K., E.S.), Leonard Davis Institute of Health Economics (J.K.), Center for Clinical Epidemiology and Biostatistics (M.C., S.X.), Department of Psychiatry (D.W.), Parkinson's Disease (D.W.) and Mental Illness (D.W.) Research, Education and Clinical Centers; University of the Sciences in Philadelphia (S.T.M.); and Avid Radiopharmaceuticals (A.S.), Philadelphia, PA.
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Elizabeth Sullo
From the University of Pennsylvania (J.K., M.C., E.S., S.X., D.W.), Department of Medicine (J.K., E.S.), Department of Medical Ethics and Health Policy (J.K.), Alzheimer's Disease Center (J.K.), Neurodegenerative Disease Ethics and Policy Program (J.K., E.S.), Leonard Davis Institute of Health Economics (J.K.), Center for Clinical Epidemiology and Biostatistics (M.C., S.X.), Department of Psychiatry (D.W.), Parkinson's Disease (D.W.) and Mental Illness (D.W.) Research, Education and Clinical Centers; University of the Sciences in Philadelphia (S.T.M.); and Avid Radiopharmaceuticals (A.S.), Philadelphia, PA.
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Sharon Xie
From the University of Pennsylvania (J.K., M.C., E.S., S.X., D.W.), Department of Medicine (J.K., E.S.), Department of Medical Ethics and Health Policy (J.K.), Alzheimer's Disease Center (J.K.), Neurodegenerative Disease Ethics and Policy Program (J.K., E.S.), Leonard Davis Institute of Health Economics (J.K.), Center for Clinical Epidemiology and Biostatistics (M.C., S.X.), Department of Psychiatry (D.W.), Parkinson's Disease (D.W.) and Mental Illness (D.W.) Research, Education and Clinical Centers; University of the Sciences in Philadelphia (S.T.M.); and Avid Radiopharmaceuticals (A.S.), Philadelphia, PA.
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Daniel Weintraub
From the University of Pennsylvania (J.K., M.C., E.S., S.X., D.W.), Department of Medicine (J.K., E.S.), Department of Medical Ethics and Health Policy (J.K.), Alzheimer's Disease Center (J.K.), Neurodegenerative Disease Ethics and Policy Program (J.K., E.S.), Leonard Davis Institute of Health Economics (J.K.), Center for Clinical Epidemiology and Biostatistics (M.C., S.X.), Department of Psychiatry (D.W.), Parkinson's Disease (D.W.) and Mental Illness (D.W.) Research, Education and Clinical Centers; University of the Sciences in Philadelphia (S.T.M.); and Avid Radiopharmaceuticals (A.S.), Philadelphia, PA.
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Citation
Cognitive impairment and PD patients' capacity to consent to research
Jason Karlawish, Mark Cary, Stephen T. Moelter, Andrew Siderowf, Elizabeth Sullo, Sharon Xie, Daniel Weintraub
Neurology Aug 2013, 81 (9) 801-807; DOI: 10.1212/WNL.0b013e3182a05ba5

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Abstract

Objective: To examine how cognitive impairment affects Parkinson disease (PD) patients' research consent capacity.

Methods: A cross-sectional study of 90 patients with PD, divided using Mattis Dementia Rating Scale–2 scores into 3 groups of 30 (normal, borderline, and impaired), and 30 neurologically normal older adults completed 2 capacity interviews (an early-phase randomized and controlled drug trial and a sham-controlled surgical implantation of genetic tissue) using the MacArthur Competence Assessment Tool for Clinical Research. Expert clinicians used the interviews to classify the patients as either capable or not capable of providing their own informed consent. These judgments were compared with performance on the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE).

Results: Cognitively normal PD patients typically scored well on the capacity measures. In contrast, patients with impaired cognition were not capable of providing their own informed consent: 17% (5/30) on the drug trial and 3% (1/30) on the surgery trial were judged capable. Patients with borderline impairment showed adequate performance on measures of appreciation and reasoning, but impaired performance on understanding the drug trial compared with normal controls and normal PD patients, and on understanding the surgery trial compared with normal controls. Sixty-seven percent (20/30) on the drug trial and 57% (17/30) on the surgery trial were judged capable of consent. Receiver operating characteristic analyses showed that the MMSE and MoCA could detect the likelihood of impaired capacity, with the MoCA demonstrating greater sensitivity.

Conclusions: PD patients with borderline cognitive impairment have impairments in their decisional capacity. The MoCA may be useful to identify the patients at risk of impaired capacity.

GLOSSARY

AUC=
area under the receiver operating characteristic curve;
CI=
confidence interval;
DRS-2=
Dementia Rating Scale–2;
MacCAT-CR=
MacArthur Competence Assessment Tool for Clinical Research;
MCI=
mild cognitive impairment;
MMSE=
Mini-Mental State Examination;
MoCA=
Montreal Cognitive Assessment;
PD=
Parkinson disease;
ROC=
receiver operating characteristic

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Editorial, page 780

  • Received November 13, 2012.
  • Accepted in final form March 28, 2013.
  • © 2013 American Academy of Neurology
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