ABSTRACT
BACKGROUND: An informed consent is mandatory to obtain any clinical audiovisual material from patients. Although there are some documents created for this purpose, there are some barriers for their application, such as the context in which they were created, the language and download availability. AIM: To create a proposal for an informed consent form (ICF) for the capture and different uses for audiovisual material from patients. MATERIAL AND METHODS: A bibliographic search was carried out to obtain different ICFs in Spanish and English, which were subjected to a process of translation, counter-translation and fragmentation. Subsequently, a panel of experts was formed by members of the Chilean Society of Plastic Surgery with extensive experience in social networks. Delphi methodology was applied to reach a consensus about the definitive content of the ICF based on the previously selected fragments. RESULTS: ICFs available for download were identified. The panel was made up of seven Plastic Surgeons and two Delphi rounds were carried out through electronic surveys. At the end of the process, an ICF proposal was obtained for therapeutic, academic or scientific purposes and another for dissemination or education in the mass media. CONCLUSIONS: The proposed ICFs were liberated for their use among health care professionals in Chile, who could use them, provided that they are approved by the local healthcare ethics committees.
Subject(s)
Humans , Consent Forms , Informed Consent , Translations , Surveys and Questionnaires , LanguageABSTRACT
El trasplante cardiaco pediátrico es una terapia efectiva para tratar la insuficiencia cardiaca avanzada. Objetivos: Analizar los resultados inmediatos y a mediano plazo de niños enlistados para trasplante cardiaco. Pacientes y Método: Se analizó el registro de pacientes enlistados para trasplante, entre octubre de 2001 y julio de 2016, analizando datos demográficos, diagnósticos, status de enlistamiento, tiempo de espera, datos de donantes, uso de asistencia ventricular, complicaciones y mortalidad. Resultados: La serie abarca 30 pacientes con edad promedio de 9,4 años (1 mes a 15 años). El diagnóstico principal fue miocardiopatía dilatada en 24 pacientes (80%). El status de ingreso fue I (urgencia) en 19 casos y II (no urgencia) en 11. Fallecieron 10 en la lista de espera (33,3%) en un promedio de 52 días (13 a 139 días). Catorce pacientes fueron trasplantados (46.7%), con un tiempo de espera de 199,6 días (4 a 586 días). Requirieron asistencia ventricular 9 pacientes (30%). Todos recibieron inmunosupresión tri asociada. Un paciente falleció a los 16 días por falla primaria del injerto (7,1%). El seguimiento promedio fue de 43 meses (0,5 a 159 meses). Dos pacientes fallecieron alejadamente (55 y 82 meses) por rechazo secundario al abandono de tratamiento inmunosupresor. La supervivencia a 1 y 5 años fue 93% y 74%, respectivamente. Conclusiones: Nuestro programa ha trasplantado al 50% de los pacientes enlistados con buena supervivencia a mediano plazo. Una proporción significativa de pacientes se enlistó con carácter de urgencia y un 34.5% de los pacientes fallecieron en la lista de espera.
Pediatric heart transplantation is an effective therapy to treat advanced heart failure in children. Objectives: To analyze the immediate and mid-term results of pediatric patients listed for heart transplantation. Patients and Methods: Registration of patients admitted to our transplant protocol between October 2001 and July 2016 were reviewed, analyzing demographic data, diagnosis, status at the time of listing, waiting time until transplantation, donor data, use of ventricular assist device, hemodynamic data, complications and global mortality. Results: Thirthy patients where included with a mean age of 9.4 years (1 month to 15 years). The most frequent diagnosis was dilated cardiomyopathy in 24 patients (80%). The status was I (urgency) in 19 cases and II in 11 cases. Ten patients died on the waiting list (33.3%) at an average of 52 days (13-139 days). Fourteen were transplanted (46.7%), with a waiting time of 199.6 days (4-586 days). Nine patients required mechanical support (30%). All patients received triple association of immunosuppression. One patient died 16 days post transplant due to primary graft failure (7.1%). The average follow-up was 43 months (0.5-159 months). Two patients died later on (82 and 55 months), both due to secondary rejection because of voluntary cessation of immunosuppressive therapy. Survival at 1 and 5 years was 93% and 74%, respectively. Conclusions: Our program has successfully transplanted 50% of patients enrolled, with good medium-term survival. A significant proportion of patients were listed as a medical emergency and 34.5% died on the waiting list.