M. Linder, L. Lev Ari, R. Kurs and Y. Melamed
Background: Patient protection requires the provision of informed consent for participation in medical research. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) is frequently used for screening the capacity of research subjects to consent to participate in research.
Objectives: To evaluate the utility of the Hebrew translation of the MacCAT-CR for the assessment of capacity of patients with chronic schizophrenia to provide informed consent to participate in clinical trials.
Methods: We evaluated the translated MacCAT-CR by comparing the capacity of patients with chronic schizophrenia to provide informed consent to participate in clinical trials. The following standardized neurocognitive assessment tools were used: Addenbrooke’s Cognitive Examination (ACE) and Frontal Assessment Battery (FAB), as well as the attending doctor’s assessment.
Results: Twenty-one patients participated. Mean MacCAT-CR score was12 ¡À 10.57 (range 0¨C32), mean FAB score was 9.9 ¡À 4.77 (range 1¨C18), mean ACE was 59.14 ¡À 16.6 (range 27¨C86) and mean doctor’s assessment was 5.24 ¡À 1.18 (range 3¨C7).
Conclusions: The Hebrew-version of the MacCAT-CR helped identify patients with the capacity to provide informed consent for participation in research. Patients with FAB scores ¡Ý 12 tended to score higher on the Hebrew-version of the MacCAT-CR, thus confirming the utility of the Hebrew version of the MacCAT-CR. During the screening process for clinical trials it may be practical to administer the concise FAB questionnaire, and then administer the MacCAT-CR only to those who scored ¡Ý 12 on the FAB.