Abstract

To perform a meta-analysis of clinical studies on the differences in treatment or research decision-making capacity among patients with Mild Cognitive Impairment (MCI), Alzheimer's disease (AD), and healthy comparisons (HCs). A systematic search was conducted on Medline/Pubmed, CINAHL, PsycINFO, Web of Science, and Scopus. Standardized mean differences and random-effects model were used in all cases. The United States, France, Japan, and China. Four hundred and ten patients with MCI, 149 with AD, and 368 HCs were included. The studies we included in the analysis assessed decisional capacity to consent by the MacArthur Competence Assessment Tool for Treatment (MAcCAT-T), MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), Capacity to Consent to Treatment Instrument (CCTI), and University of California Brief Assessment of Capacity to Consent (UBACC). We identified 109 potentially eligible studies from 1672 records, and 7 papers were included in the meta-analysis. The meta-analysis showed that there was significant impairment in a decision-making capacity in MCI patients compared to the HCs group in terms of Understanding (SMD = -1.04, 95% CI: -1.31 to -0.77, P < 0.001; I2 = 52%, P = 0.07), Appreciation (SMD = -0.51, 95% CI: -0.66 to -0.36, P < 0.001; I2 = 0%, P = 0.97), and Reasoning (SMD = -0.62, 95% CI: -0.77, -0.47, P < 0.001; I2=0%, P =0.46). MCI patients scored significantly higher in Understanding (SMD = 1.50, 95% CI: 0.91, 2.09, P = 0.01, I2 = 78%, P = 0.00001) compared to patients affected by AD. Patients affected by MCI are at higher risk of impaired capacity to consent to treatment and research compared to HCs, despite being at lower risk compared to patients affected by AD. Clinicians and researchers need to carefully evaluate decisional capacity in MCI patients providing informed consent.

Highlights

  • Mild Cognitive Impairment (MCI) is a syndrome characterized by a decline in cognitive functions greater than expected for age and education, but that does not interfere notably with daily life activities (Gauthier et al, 2006)

  • The meta-analysis showed that there was significant impairment in a decision-making capacity in MCI patients compared to the healthy comparisons (HCs) group in terms of Understanding (SMD = − 1.04, 95% confidence intervals (CIs): − 1.31 to − 0.77, P < 0.001; I2 = 52%, P = 0.07), Appreciation (SMD = − 0.51, 95% CI: − 0.66 to − 0.36, P < 0.001; I2 = 0%, P = 0.97), and Reasoning (SMD = − 0.62, 95% CI: − 0.77, − 0.47, P < 0.001; I2=0%, P =0.46)

  • MCI patients scored significantly higher in Understanding (SMD = 1.50, 95% CI: 0.91, 2.09, P = 0.01, I2 = 78%, P = 0.00001) compared to patients affected by Alzheimer’s disease (AD)

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Summary

Introduction

Mild Cognitive Impairment (MCI) is a syndrome characterized by a decline in cognitive functions greater than expected for age and education, but that does not interfere notably with daily life activities (Gauthier et al, 2006). Patients with MCI can be considered as a risk state for dementia and represents a strategic intervention point Patients affected by MCI are increasingly involved in clinical trials aimed at testing new anti-dementia treatments and interventions and often receive dementia-related medication (Ilhan Algin et al, 2017; Ma et al, 2017; Petersen et al, 2005). Patients with MCI are a clinical population at risk of decisional incapacity, whose treatment requires clinicians to carefully find the proper balance between respecting the right of capable patients to make choices (even if clinicians do not approve) about their treatment or participation in clinical trials and the right of incapable patients to be protected from the possible harmful consequences of their improper decisions

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