Spanish Validation of the MacArthur Competence Assessment Tool for Clinical Research Interview for Assessing Patients' Mental Capacity to Consent to Clinical Research.

The aim of the study was to assess a Spanish adaptation of a method that determines the categorical capacity status of potential participants in research projects. The sample consisted of 120 subjects (40 general medicine inpatients, 40 psychiatric inpatients, and 40 healthy controls). The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview and Mini-Mental State Examination (MMSE) were used. A feasibility study was carried out and reliability and validity calculations were made against the expert-judgment gold standard. The mean duration of the MacCAT-CR was 13 min. For the MacCAT-CR understanding, appreciation, reasoning, and expressing a choice subscales, the intraclass coefficient correlation (interrater reliability) was .93, .88, .90, and .50, respectively, and internal consistency (Cronbach's alpha) was .96, .94, and .95, respectively. Patients considered to be incompetent for expert-judgment obtained lower scores in the MacCAT-CR interview. The Spanish version of the MacCAT-CR is feasible, reliable, and valid for assessing the capacity of patients to give consent in research.

[Spanish validation of the MacArthur Competence Assessment Tool for Treatment interview to assess patients competence to consent treatment]. / Validación española de la entrevista MacArthur Competence Assessment Tool for Treatment para evaluar la capacidad de los pacientes para consentir tratamiento.

BACKGROUND AND OBJECTIVE: To validate the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) Spanish version, which assesses the mental capacity of patients to consent treatment, by examining 4 areas (Understanding, Appreciation, Reasoning and Expressing a choice). SAMPLE: 160 subjects (80 Internal Medicine inpatients, 40 Psychiatric inpatients and 40 healthy controls). INSTRUMENTS: MacCAT-T, Mini-Mental Status Examination (MMSE). PROCEDURE: Feasibility study, reliability and validity calculations (against to gold standard of clinical expert). RESULTS: Mean duration of the MacCAT-T interview was 18min. Inter-rater reliability: Intraclass correlation coefficient for Understanding=0.98, Appreciation=0.97, Reasoning=0.98, Expressing a choice=0.91. Internal consistency (Cronbach's alpha): Understanding=0.87, for Appreciation=0.76, for Reasoning=0.86. Patients considered to be incapable (gold standard) scored lower in all the MacCAT-T areas. Poor performance on the MacCAT-T was related to cognitive impairment assessed by MMSE. CONCLUSIONS: Spanish version of the MacCAT-T is feasible, reliable, and valid for assessing the capacity of patients to consent treatment.