Assessing the decisional capacity of potential subjects before their inclusion in clinical research is essential in order to respect their right to self-determination. Decisional capacity is best described as a four-dimensional concept, including (1) the understanding of the disclosed information, (2) the appreciation of the disclosed information in relation to the particular circumstance to which it must apply, (3) reasoning applied to that information and (4) the aptitude to express a choice1. If for adult, healthy persons the presence of decisional capacity is assumed, this is not the case for other groups of potential research subjects including children, elderly, persons with psychiatric or neurological disorders2-4. To assess …show more content…
The mean score for each dimension and the differential score between the subgroups was variable. For example Candilis et al found a mean score for understanding in schizophrenia subjects of 22.4218 while Carpenter et al found a score of 20.2 in the control group19. Kim et al found a mean score for reasoning in schizophrenia subjects of 5.221 while Moser et al found, for the same dimension, a score of 4.93 in normal subjects13. Palmer et al found a differential in the understanding dimension of less than 2 points between the two groups23 while Harmell et showed an almost 10 points difference20. Possible explanations for these results are the differences in testing the results of the instrument, the characteristics of the subjects enrolled (age, gender, severity of the psychiatric symptoms, in- or outpatient status), or a low number of enrolled subjects.
The main purpose of this article is to test the impairment in each dimension of decisional capacity in schizophrenia patients compared to non-psychiatric controls, as appraised by the MacCAT-CR instrument. Secondary objectives are (1) to see whether enhanced consent forms are associated with a significant increase in decisional capacity in schizophrenia patients, and (2) if decisional capacity in schizophrenia subjects depends on the age, gender, or the inpatient status of the