title: 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).
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  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 > 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.
authors.affiliation: Lev Hasharon Mental Health Center, Netanya, Israel. mulil@lev-hasharon.co.il
authors.forename: Mull
authors.initials: M
authors.lastname: Linder
authors.forename: Lilac
authors.initials: L
authors.lastname: Lev-Ari
authors.forename: Rena
authors.initials: R
authors.lastname: Kurs
authors.forename: Yuval
authors.initials: Y
authors.lastname: Melamed
mesh_terms: D000328:Adult; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007258:Informed Consent; D007297:Inpatients; D007557:Israel; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D009483:Neuropsychological Tests; D035842:Research Subjects; D012559:Schizophrenia; D014175:Translating