Assessment of the informed consent related to healthcare decisions for medically fragile child in italy: a pilot study.

ABSTRACT

Background: In Italy, the law n. 219/2017 regarding informed consent states that "Communication time between doctor and patient constitutes treatment time". Legal guardian is designated as a proxy to consent on the child's behalf. The issue of proxy informed consent should be approached with a model for parent-child decision-making that is participatory, collaborative, respects and supports the autonomy of child by recognizing their evolving capacities. We aim to assess the informed consent related to healthcare decisions for medically fragile child, using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T). Materials and Methods: An observational study has been conducted at a Child Neuropsychiatry Service, administering a semi-structured interview with customized questionnaire to examine their capacities in four areas of the MacCAT-T. Results were evaluated with the Pearson correlation coefficient for the cognitive and adaptive levels of the Wechsler-Intelligence-Scale-for-Children (WISC-IV) and the Vineland-Adaptive-Behavior-Scales-II (VABS-II). Conclusions: The MacCAT-T domains Understanding, Appreciation, Reasoning, Expressing a Choice were correlated with the cognitive and adaptive levels of the WISC-IV and the VABS-II. Understanding, Appreciation and Expressing a choice have positive correlation with the Communication and Socialization scores of VABS-II; Reasoning has positive correlation with the Working-Memory-Index scores of the WISC-IV. The study enabled to assess the informed consent processes in vulnerable children and although demonstrating how they participate in their care process in a mostly unconscious way, making the frail children more involved in their own care process was possible. Future studies should assess the impact of incorporating MacCAT-T into standard informed consent in other settings.