Informed consent in pediatric cardiology and cardiac surgery

Background: A multidisciplinary study group was established to review and approve the informed consent forms in Pediatric Cardiology and Cardiac Surgery. Methods: The work was carried out in several stages, starting with an analysis of what was already in use in several Italian Centers. Subsequently, shared forms for pediatric cardiac surgery and interventional catheter-ization procedures were developed, pointing to clarity of information, prediction of therapeutic options, quantification for verbal categories of risk associated with cardiac surgery procedures, and provision of information also to young patients. Results: Two versions of informed consent for pediatric cardiac surgery and pediatric interventional catheterization procedures were developed. Conclusions: The work performed by the multidisciplinary study group, under the supervision of the Italian Society of Pediatric Cardiology and the Section of Surgery for Congenital Heart Disease of the Italian Society for Cardiac Surgery, resulted in a clear and evolutionary summary of the relationship between available therapeutic options and the patient needs to understand and share the healthcare pathway in terms of risk and perspectives