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Background: Identifying correlates of capacity to provide informed consent among individuals with bipolar disorder is essential for patient protection. As part of a clinical trial involving approved, standard treatments, we investigated relationships between clinical characteristics and capacity to provide informed consent in adults with bipolar disorder using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). After administering the MacCAT-CR, continuing participants in the trial were capable of and provided informed consent.Methods: Trained, board-certified psychiatrists administered the MacCAT-CR to potential study participants (N = 50) after they provided informed consent, but prior to initiation of study procedures.Results: Higher Schedule for Assessment of Positive Symptoms (SAPS) scores were significantly correlated with worse MacCAT-CR Understanding and Appreciation (p < 0.04) subscale scores; lower Hamilton Depression Rating Scale (HDRS) scores and higher Clinical Global Impression-Severity (CGI-S) scores were significantly correlated with worse Reasoning and Understanding subscale scores (p < 0.03); and patients with comorbid substance use disorders (SUD) had better Appreciation and Reasoning subscale scores (p < 0.05).Limitations: The MacCAT-CR identifies areas where participants need explanation. However, there is not a predetermined score to indicate understanding of study procedures and therefore input from a trained clinician is needed to determine capacity to provide informed consent.Conclusions: Our findings suggest that certain measures of illness severity are associated with lower levels of capacity to provide informed consent among adults with bipolar disorder. This study provides important information for clinicians and researchers to consider when obtaining informed consent in this population. [ABSTRACT FROM AUTHOR]

Background: The process of assessing the decision-making capacity of potential subjects before their inclusion in clinical trials is a legal requirement and a moral obligation, as it is essential for respecting their autonomy. This issue is especially important in psychiatry patients (such as those diagnosed with schizophrenia). The primary purpose of this article was to evaluate the degree of impairment in each dimension of decision-making capacity in schizophrenia patients compared to non-mentally-ill controls, as quantified by the (MacCAT-CR) instrument. Secondary objectives were (1) to see whether enhanced consent forms are associated with a significant increase in decision-making capacity in schizophrenia patients, and (2) if decision-making capacity in schizophrenia subjects is dependent on the age, gender, or the inpatient status of the subjects. Methods: We systematically reviewed the results obtained from three databases: ISI Web of Science, Pubmed, Scopus. Each database was scrutinised using the following keywords: "MacCAT-CR + schizophrenia", "decision-making capacity + schizophrenia", and "informed consent + schizophrenia." Results: We included 13 studies in the analysis. The effect size between the schizophrenia and the control group was significant, with a difference in means of -4.43 (-5.76; -3.1, p < 0.001) for understanding, -1.17 (-1.49, -0.84, p < 0.001) for appreciation, -1.29 (-1.79, -0.79, p < 0.001) for reasoning, and -0.05 (-0.9, -0.01, p = 0.022) for expressing a choice. Conclusions: Even if schizophrenia patients have a significantly decreased decision-making capacity compared to non-mentally-ill controls, they should be considered as competent unless very severe changes are identifiable during clinical examination. Enhanced informed consent forms decrease the differences between schizophrenia patients and non-mentally-ill controls (except for the reasoning dimension) and should be used whenever the investigators want to include more ill patients in their clinical trials. Increased age, men gender and an increased percentage of inpatients might increase the differential of decision-making incompetence compared to nonmentally- ill subjects in various dimensions of the decision-making competence as analysed by the MacCAT-CR scale, but the small number of subjects did not allow us (except for one instance) to reach statistical significance. [ABSTRACT FROM AUTHOR]