Evaluation of the capacity of inpatients with chronic schizophrenia to provide informed consent for participation in clinical trials; use of the Hebrew version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)

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. To evaluate the ut...

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Bibliographic Details
Published inThe Israel Medical Association journal Vol. 14; no. 8; pp. 470 - 474
Main Authors Linder, Mull, Lev-Ari, Lilac, Kurs, Rena, Melamed, Yuval
Format Journal Article
LanguageEnglish
Published Israel 01.08.2012
Subjects
Adult
Chronic Disease
Clinical Trials as Topic
Female
Humans
Informed Consent
Inpatients
Israel
Male
Mental Competency
Middle Aged
Neuropsychological Tests
Research Subjects
Schizophrenia
Translating
Israel
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Summary: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. To evaluate the utility of the Hebrew translation of the MacCAT-CR for assessing the capacity of patients with chronic schizophrenia to provide informed consent to participate in clinical trials. We evaluated the translated MacCAT-CR by comparingthe 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. Twenty-one patients participated. Mean MacCAT-CR score was 12 +/- 10.57 (range 0-32), mean FAB score 9.9 +/- 4.77 (range 1-18), mean ACE 59.14 +/- 16.6 (range 27-86) and mean doctor's assessment 5.24 +/- 1.18 (range 3-7). 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 > or = 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 > or = 12 on the FAB.
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ISSN:1565-1088