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Interpreting the Clinical Significance of Capacity Scores for Informed Consent in Alzheimer Disease Clinical Trials

From the Department of Medicine, Alzheimer’s Disease Center, Leonard Davis Institute for Health Economics, Center for Clinical Epidemiology and Biostatistics, Center for Bioethics, University of Pennsylvania, School of Medicine, PA (JK); Center for Behavioral and Decision Sciences in Medicine, Department of Psychiatry and the Bioethics Program, University of Michigan Medical School (SYHK); Department of Neurology, Mayo Clinic Rochester, (DK); Department of Psychiatry, Yale University (CHvD); Department of Epidemiology, Johns Hopkins University, Bloomberg School of Public Health (BDJ); Department of Neurology, University of Alabama at Birmingham (DM).

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 ( = 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.

Key Words: Informed consent • decision making capacity • Alzheimer disease