RESUMO

Many different animal models are in use for drug development for leishmaniasis, but a universal model does not exist. There is a plethora of models, and this review assesses their design, quality, and limitations, including the attention paid to animal welfare in the study design and execution. A systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines of available literature after the year 2000 describing animal models for leishmaniasis. The risk of bias was determined using the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias assessment tool. A total of 10,980 records were initially identified after searching the databases PubMed, EMBASE, LILACS, and SciELO. Based on the application of predetermined exclusion and inclusion criteria, a total of 203 papers describing 216 animal experiments were available for full analysis. Major reasons for exclusion were a lack of essential study information or appropriate ethical review and approval. Mice (82.8%; an average of 35.9 animals per study) and hamsters (17.1%; an average of 7.4 animals per study) were the most frequently used animals, mostly commercially sourced, in the included studies. All studies lacked a formal sample size analysis. The promastigote stages of L. amazonensis or L. major were most frequently used to establish experimental infections (single inoculum). Animal welfare was poorly addressed in all included studies, as the definition of a human end-point or consideration of the 3Rs (Replacement, Reduction, Refinement) was hardly addressed. Most animals were euthanized at the termination of the experiment. The majority of the studies had an unknown or high risk of bias. Animal experiments for drug development for leishmaniasis mainly poorly designed and of low quality, lack appropriate ethical review, and are deficient in essential information needed to replicate and interpret the study. Importantly, aspects of animal welfare are hardly considered. This underpins the need to better consider and record the details of the study design and animal welfare.

RESUMO

Objective: The real burden of (congenital heart defects [CHD]) and the improvement after surgical correction or palliation is both reflected in the quality of life (QoL). There are few studies in Latin-America that evaluate QoL in the CHD population. The purpose of this study was to measure the QoL after corrective or palliative surgery for CHD. Materials and methods: An observational, cross-sectional, and comparative study was carried out at the Miguel Hidalgo Centennial Hospital. Patients from 8 to 18 years old who underwent surgery for CHD were included during a period of 8 months. A total of 40 patients were included, together with a group of 80 healthy controls. From all participants, a KIDSCREEN-52 questionnaire was taken. A comparative analysis of the results was performed. Results: Overall, patients with cardiac surgery had better QoL indexes than healthy controls (p < 0.0001). The difference was greatest in moods and emotions, autonomy, and parent relations. Conclusions: Self-perception of QoL in post-operative patients for congenital heart disease is similar and in certain dimensions higher than the healthy population, possibly due to socioeconomic differences, parental care, and styles of coping with their disease. Higher complexity studies that include psychosocial variables and parental perception are required, and a better understanding of the QoL determinants will improve the attention provided to the patient and their families. Objetivo: Los efectos de las cardiopatías congénitas en los pacientes, así como la mejoría después de la paliación o la corrección quirúrgica, se reflejan en la calidad de vida (CV). Hay pocos estudios en Latinoamérica que evalúen la CV en esta población. El objetivo de este artículo es notificar la CV posterior a la operación paliativa o correctiva para defectos cardíacos congénitos. Material y métodos: Se llevó a cabo un estudio observacional, transversal y comparativo en el Centenario Hospital Miguel Hidalgo. Durante un período de ocho meses se incluyó a pacientes de 8 a 18 años sometidos a una intervención para cardiopatías congénitas. Se reunió a dos grupos de 40 pacientes y 80 controles sanos, pareados por edad y sexo. A cada participante se le aplicó el cuestionario KIDSCREEN-52 y se realizó un análisis comparativo de los resultados. Resultados: Los pacientes sometidos a operación cardíaca tuvieron mejores índices de CV que los controles sanos (p < 0.0001). La mayor diferencia se obtuvo en los aspectos de estado de ánimo y emociones, autonomía y relación con los padres. Conclusiones: La autopercepción de la CV después de una intervención para cardiopatías congénitas es similar y, en ciertas dimensiones, mejor que la de la población sana, tal vez por diferencias socioeconómicas, atención de los padres y modelos de adaptación a la enfermedad. Se requieren estudios más extensos que incluyan variables psicosociales y percepción parental. Una mayor comprensión de los determinantes de la CV podría mejorar la atención ofrecida al paciente y su familia.

Assuntos

RESUMO

Abstract Objective: The real burden of (congenital heart defects [CHD]) and the improvement after surgical correction or palliation is both reflected in the quality of life (QoL). There are few studies in Latin-America that evaluate QoL in the CHD population. The purpose of this study was to measure the QoL after corrective or palliative surgery for CHD. Materials and methods: An observational, cross-sectional, and comparative study was carried out at the Miguel Hidalgo Centennial Hospital. Patients from 8 to 18 years old who underwent surgery for CHD were included during a period of 8 months. A total of 40 patients were included, together with a group of 80 healthy controls. From all participants, a KIDSCREEN-52 questionnaire was taken. A comparative analysis of the results was performed. Results: Overall, patients with cardiac surgery had better QoL indexes than healthy controls (p < 0.0001). The difference was greatest in moods and emotions, autonomy, and parent relations. Conclusions: Self-perception of QoL in post-operative patients for congenital heart disease is similar and in certain dimensions higher than the healthy population, possibly due to socioeconomic differences, parental care, and styles of coping with their disease. Higher complexity studies that include psychosocial variables and parental perception are required, and a better understanding of the QoL determinants will improve the attention provided to the patient and their families.

Resumen Objetivo: Los efectos de las cardiopatías congénitas en los pacientes, así como la mejoría después de la paliación o la corrección quirúrgica, se reflejan en la calidad de vida (CV). Hay pocos estudios en Latinoamérica que evalúen la CV en esta población. El objetivo de este artículo es notificar la CV posterior a la operación paliativa o correctiva para defectos cardíacos congénitos. Material y métodos: Se llevó a cabo un estudio observacional, transversal y comparativo en el Centenario Hospital Miguel Hidalgo. Durante un período de ocho meses se incluyó a pacientes de 8 a 18 años sometidos a una intervención para cardiopatías congénitas. Se reunió a dos grupos de 40 pacientes y 80 controles sanos, pareados por edad y sexo. A cada participante se le aplicó el cuestionario KIDSCREEN-52 y se realizó un análisis comparativo de los resultados. Resultados: Los pacientes sometidos a operación cardíaca tuvieron mejores índices de CV que los controles sanos (p < 0.0001). La mayor diferencia se obtuvo en los aspectos de estado de ánimo y emociones, autonomía y relación con los padres. Conclusiones: La autopercepción de la CV después de una intervención para cardiopatías congénitas es similar y, en ciertas dimensiones, mejor que la de la población sana, tal vez por diferencias socioeconómicas, atención de los padres y modelos de adaptación a la enfermedad. Se requieren estudios más extensos que incluyan variables psicosociales y percepción parental. Una mayor comprensión de los determinantes de la CV podría mejorar la atención ofrecida al paciente y su familia.

Assuntos