Assessment of an electronic system for research ethics committees document management: An observational study.

Since 1 January 2020, the Central Research Ethics Committee of the Health Ministry implemented PRIISA.BA, an in-house developed electronic system for online submission of health research applications to the 63 public and private research ethics committees (RECs) of Buenos Aires City, Argentina. This study though to compare the times to first review and the time to approval among applications submitted prior to PRIISA.BA and thereafter, across public RECs. All public RECs of the city were invited to participate. Overall, 453 applications from 10 RECs (242 pre- and 211 post-PRIISA.BA) were available for the analyses. There was a decrease in the time to first review and an increase in the time to approval after PRIISA.BA implementation. The increase in time to approval was transient and limited to the first three months. The results were consistent with analyses limited to non-COVID applications. Our results show an increase in the times to approval after the implementation of an electronic system for online submission of health research applications that, although transient, was significant. These data could be relevant to other RECs implementing this technology since it emphasizes the need of monitoring potential unnecessary delays in reviews during the critical initial period.

Mortality due to Respiratory Syncytial Virus. Burden and Risk Factors.

RATIONALE: Respiratory syncytial virus (RSV) is the most frequent cause of hospitalization and an important cause of death in infants in the developing world. The relative contribution of social, biologic, and clinical risk factors to RSV mortality in low-income regions is unclear. OBJECTIVES: To determine the burden and risk factors for mortality due to RSV in a low-income population of 84,840 infants. METHODS: This was a prospective, population-based, cross-sectional, multicenter study conducted between 2011 and 2013. Hospitalizations and deaths due to severe lower respiratory tract illness (LRTI) were recorded during the RSV season. All-cause hospital deaths and community deaths were monitored. Risk factors for respiratory failure (RF) and mortality due to RSV were assessed using a hierarchical, logistic regression model. MEASUREMENTS AND MAIN RESULTS: A total of 2,588 (65.5%) infants with severe LRTI were infected with RSV. A total of 157 infants (148 postneonatal) experienced RF or died with RSV. RSV LRTI accounted for 57% fatal LRTI tested for the virus. A diagnosis of sepsis (odds ratio [OR], 17.03; 95% confidence interval [CI], 13.14-21.16 for RF) (OR, 119.39; 95% CI, 50.98-273.34 for death) and pneumothorax (OR, 17.15; 95% CI, 13.07-21.01 for RF) (OR, 65.49; 95% CI, 28.90-139.17 for death) were the main determinants of poor outcomes. CONCLUSIONS: RSV was the most frequent cause of mortality in low-income postneonatal infants. RF and death due to RSV LRTI, almost exclusively associated with prematurity and cardiopulmonary diseases in industrialized countries, primarily affect term infants in a developing world environment. Poor outcomes at hospitals are frequent and associated with the cooccurrence of bacterial sepsis and clinically significant pneumothoraxes.

Evaluación de la producción científica del Hospital General de Niños Pedro de Elizalde, 2000-2011 / Assessment of the scientific output of Hospital de Niños Pedro de Elizalde, 2000-2011

Introducción. El monitoreo de las presentaciones y publicaciones de una institución es una medida idónea para valorar su producción científica. Objetivos. Estimar la proporción de proyectos de investigación de un hospital pediátrico que fueron finalizados y sus resultados presentados/ publicados; describir sus diseños y características; describir las condiciones limitantes para el desarrollo o la difusión de las investigaciones. Métodos. Estudio descriptivo y analítico que incluyó los trabajos científicos autorizados para desarrollar entre 2000 y 2011. Se contactó a cada investigador y se le solicitó que participara en una encuesta que indagaba sobre el desarrollo de la investigación, la difusión de los resultados y las posibles causas de su no finalización/no difusión. Resultados. Respondieron la encuesta los autores de 197 proyectos (60,9% finalizados, 16,2% en curso, 12,7% cancelados y 10,2% suspendidos). Los ensayos con fármacos tuvieron más riesgo de no completarse. De los finalizados (n= 120), 45,8% correspondieron a investigación clínica, 43,3% a epidemiológica y 10% a servicios de salud. Por diseño, 77,5% fueron observacionales y 22,5% experimentales. Por alcance, 69,1% fueron limitados al hospital, 16,6% multicéntricos internacionales y 14,1% multicéntricos nacionales. Solo 36,6% recibieron financiamiento. La falta de tiempo (20%) y el tamaño muestral insuficiente (10%) fueron las razones más referidas como responsables de la no difusión. El 78,3% fue presentado en congresos y 37,5% publicado. Solo la presencia de financiación fue un predictor independiente de publicación. Conclusiones. De los proyectos aprobados, 60,9% fueron finalizados y de ellos, 78,3% fueron presentados en congresos y 37,5% publicados. Los ensayos con fármacos tuvieron más riesgo de no completarse y aquellos con financiamiento tuvieron más probabilidades de ser publicados.

Introduction. Monitoring article submissions and publications developed by an institution is a suitable measure to assess its scientific output. Objectives. To estimate the proportion of research projects that were completed and had results submitted/published by a pediatric hospital; to describe research project design and characteristics; to outline limitations on research development or dissemination. Methods. Descriptive and analytical study including scientific studies approved to be developed between 2000 and 2011. Each investigator was contacted and asked to participate in a survey on research development, result dissemination and possible reasons for not completing or disseminating a study. Results. The survey was completed by the authors of 197 projects (60.9% completed, 16.2% ongoing, 12.7% cancelled, and 10.2% put off). Drug trials were most likely not to be completed. Of all completed projects (n = 120), 45.8% were clinical research studies, 43.3% were epidemiological studies, and 10% were related to health services. When analyzed by design, 77.5% were observational studies while 22.5% were experimental ones. In terms of scope, 69.1% were restricted to the hospital, 16.6% were international multicenter studies, and 14.1% were national multicenter studies. Only 36.6% of projects received funding. Lack of time (20%) and insufficient sample size (10%) were the most commonly indicated reasons for non dissemination. A total of 78.3% of projects were presented in conferences and 37.5% were published. The presence of funding was the only independent predictor of publication. Conclusions. Of all approved projects, 60.9% were completed; of them, 78.3% were presented in conferences and 37.5% were published. Drug trials were most likely not to be completed, and funded studies had more chances of being published.

Assessment of the scientific output of Hospital de Niños Pedro de Elizalde, 2000-2011.

INTRODUCTION: Monitoring article submissions and publications developed by an institution is a suitable measure to assess its scientific output. OBJECTIVES: To estimate the proportion of research projects that were completed and had results submitted/published by a pediatric hospital; to describe research project design and characteristics; to outline limitations on research development or dissemination. METHODS: Descriptive and analytical study including scientific studies approved to be developed between 2000 and 2011. Each investigator was contacted and asked to participate in a survey on research development, result dissemination and possible reasons for not completing or disseminating a study. RESULTS: The survey was completed by the authors of 197 projects (60.9% completed, 16.2% ongoing, 12.7% cancelled, and 10.2% put off). Drug trials were most likely not to be completed. Of all completed projects (n = 120), 45.8% were clinical research studies, 43.3% were epidemiological studies, and 10% were related to health services. When analyzed by design, 77.5% were observational studies while 22.5% were experimental ones. In terms of scope, 69.1% were restricted to the hospital, 16.6% were international multicenter studies, and 14.1% were national multicenter studies. Only 36.6% of projects received funding. Lack of time (20%) and insufficient sample size (10%) were the most commonly indicated reasons for non dissemination. A total of 78.3% of projects were presented in conferences and 37.5% were published. The presence of funding was the only independent predictor of publication. CONCLUSIONS: Of all approved projects, 60.9% were completed; of them, 78.3% were presented in conferences and 37.5% were published. Drug trials were most likely not to be completed, and funded studies had more chances of being published.

Impact assessment of a decision rule for using antibiotics in pneumonia: a randomized trial.

BACKGROUND: Although more than half of the cases of pneumonia in children can be due to virus, most of them receive antibiotic treatment. A previously published clinical prediction rule bacterial pneumonia score (BPS) allows the identification of children with pneumonia who do not require antibiotics, but its impact has not been evaluated. We assessed whether the use of the BPS for the initial management of patients with pneumonia results in decreasing the use of antibiotics than under standard management of this condition without increasing patients' risks. METHODS: This was a randomized, parallel-group, observer-blind, controlled clinical trial comparing the use of antibiotics in children aged 3-60 months treated for pneumonia in an outpatient setting, according to two methods of initial management. Patients were assigned randomly to management according to the BPS (antibiotic indication with a BPS ≥ 4 points) or routine management (antibiotic indication based on the institutional guidelines). We calculated the proportion of the use of antibiotics in each group and evaluated each patient's clinical outcome. RESULTS: We included 120 patients (60 BPS and 60 controls) with a mean age of 24.2 ± 14.1 months. The use of antibiotics was significantly lower in the BPS group (46.6% vs. 86.6; OR 0.13; 95% CI: 0.05-0.35; P < 0.001). We observed an unfavorable outcome in 10 patients (8.3%), 5 in each group (P = 1.0; OR: 1.0 95% CI: 0.2-3.6). CONCLUSION: The use of antibiotics was significantly lower in the group managed according to the BPS compared to the conventionally treated group, without increasing the rate of treatment failure.