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עמוד בית
Tue, 25.06.24

Original Articles

IMAJ | volume 14

Journal 8, August 2012
pages: 470-474

Evaluation of the Capacity of Inpatients with Chronic Schizophrenia to provide Informed Consent for Participation in Clinical Trials Using the Hebrew Version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)

    Summary

    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.

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