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Am J Geriatr Psychiatry. 2008 Jul;16(7):568-74. doi: 10.1097/JGP.0b013e318172b406. Epub 2008 Jun 12.

Interpreting the clinical significance of capacity scores for informed consent in Alzheimer disease clinical trials.

Author information

  • 1Department of Medicine, Alzheimer's Disease Center, Leonard Davis Institute for Health Economics, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, School of Medicine, PA, USA. Jason.karlawish@uphs.upenn.edu

Abstract

OBJECTIVE:

Among Alzheimer disease (AD) patients enrolled in a clinical trial, the authors assessed the ability of a standardized capacity assessment procedure to identify persons who are capable of giving their own informed consent.

DESIGN:

Cross-sectional interview.

SETTING:

Thirteen sites participating in a randomized and placebo controlled study of simvastatin for the treatment of mild to moderate AD.

PARTICIPANTS:

Persons with mild to moderate AD and their study partners enrolled in the simvastatin clinical trial.

MEASUREMENTS:

Interviews to assess decision-making capacity using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR).

RESULTS:

Judges blinded to the subject's clinical status had a high rate of agreement on patients capable of giving their own informed consent (kappa = 0.73). The understanding subscale had the best receiver operator characteristic and an analysis of positive and negative predictive values over a range of hypothetical prevalences of incapacity to consent demonstrated the value of a range of understanding cut-points.

CONCLUSION:

Among mild to moderate AD patients, enrolled in an actual clinical trial, these results suggest evidence based guidelines for using the MacCAT-CR understanding subscale to help guide judgments about whether a patient has the capacity to consent.

PMID:
18556397
[PubMed - indexed for MEDLINE]
PMCID:
PMC3936673
Free PMC Article
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