Abstract
There is a lack of validated instruments assessing the decision-making capacity to consent to clinical research of patients with schizophrenia spectrum disorders who speak Chinese. This study aimed to determine the validity and reliability of the Chinese version of MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). The MacCAT-CR using a hypothetical study, the Positive and Negative Syndrome Scale (PANSS), the Mini-Mental State Examination (MMSE) assessed 139 patients with schizophrenia or schizoaffective disorder. The Cronbach's alpha coefficient was 0.74. The intra-class coefficients for understanding, appreciation, and reasoning scores ranged from 0.53 to 0.81. Regarding validity, the understanding, appreciation and reasoning scores were negatively correlated with the PANSS (r ranged from −0.27 to −0.33), and the negative subscale score (r ranged from −0.31 to −0.37) as well as positively correlated with the MMSE (r ranged from 0.26 to 0.43). All pvalues were less than 0.01. The factor analysis explained 57.6 % of the total variance; specifically, Components 1 and 2 contributed 44.5% and 13.1 % of the variance respectively. These findings indicate that the Chinese version of the MacCAT-CR is a reliable and valid instrument to assess the decision-making capacity to consent to clinical research of patients with schizophrenia spectrum disorders.
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