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

Autor: Ernesto J. Verdura-Vizcaíno, Ignacio Álvarez-Marrodán, Tirso Ventura-Faci, Beatriz S. Baón-Pérez, Mercedes Navío-Acosta
Rok vydání: 2017
Předmět:
Zdroj: Journal of Empirical Research on Human Research Ethics. 12:343-351
ISSN: 1556-2654
1556-2646
DOI: 10.1177/1556264617720755
Popis: 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.
Databáze: OpenAIRE