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Background: The aim of this protocol is to describe the study protocol changes made and subsequently implemented to the Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina randomized controlled trial (RCT) for care of children with severe traumatic brain injuries (TBI) imposed by the COVID-19 pandemic. The PEGASUS study group met in spring 2020 to evaluate available literature review guidance and the study design change or pausing options due to the potential interruption of research., Methods: As a parallel cluster RCT, pediatric patients with severe TBIs are admitted to 8 control (usual care) and 8 intervention (PEGASUS program) hospitals in Argentina, Chile, and Paraguay. PEGASUS is an intervention that aims to increase guideline adherence and best practice care for improving patient outcomes using multi-level implementation science-based approaches. Strengths and weaknesses of proposed options were assessed and resulted in a decision to revert from a stepped wedge to a parallel cluster RCT but to not delay planned implementation., Discussion: The parallel cluster design was considered more robust and flexible to secular interruptions and acceptable and feasible to the local study sites in this situation. Due to the early stage of the study, the team had flexibility to redesign and implement a design more compatible with the conditions of the research landscape in 2020 while balancing analytical methods and power, logistical and implementation feasibility, and acceptability. As of fall 2022, the PEGASUS RCT has been active for nearly 2 years of implementation and data collection, scheduled to be completed in in fall 2023. The experience of navigating research during this period will influence decisions about future research design, strategies, and contingencies., Trial Registration: Pediatric Guideline Adherence and Outcomes-Argentina. Registered with ClinicalTrials.gov Identifier NCT03896789 on April 1, 2019., (© 2022. The Author(s).)

Introduction: Trauma quality improvement (QI) programs improve care and outcomes for injured patients. Information about QI programs for pediatric traumatic brain injury (TBI) is sparse in Latin America., Methods: We gathered data on the status of QI programs and activities that encompass pediatric TBI at 15 Argentine hospitals. Data were gathered during 2019 and included hospital characteristics, QI practices, presence of a queryable registry, and use of protocols for TBI care. Level of QI activities was compared between hospital types using Fisher's exact test., Results: Most hospitals had guidelines for pediatric TBI care, including management and/or prevention of intracranial pressure (100%) and central-line-associated infections (87%). Morbidity and mortality meetings or other types of case discussions in which quality of pediatric TBI care was discussed were held by all hospitals, with most (53%) having weekly-monthly meetings, but 27% having rare or annual meetings. Sixty percent of hospitals had adequate data for case reviews (fewer than 25% of cases with essential information missing). Fifty-three percent documented discussions that occurred at these meetings and 53% utilized computerized trauma registries. Larger hospitals (> 200 beds) more frequently had adequate data (88%) for case reviews than smaller hospitals (29%, P = 0.046). Hospital size did not affect other QI activities., Conclusions: Most hospitals had guidelines for pediatric TBI care. Adequacy of care was discussed at reasonably frequent case conferences. Opportunities for improvement include increasing documentation of case reviews and improving adequacy of data for case reviews, especially at smaller hospitals. Greater use of computerized trauma registries could provide such data., (Copyright © 2021. Published by Elsevier Inc.)

Background: : Previous studies indicate that age, Glasgow Coma Scale score (GCS), arterial hypotension, computed tomography (CT) findings, and pupillary reactivity are strong predictors of outcome for patients with severe traumatic brain injury (TBI). However, the predictive validity of these variables has never been rigorously tested in patients from the developing world. The objective of this study was to evaluate the prognostic value of these variables in a resource-limited setting and to test their predictive power by using them to create an outcome model., Methods: : The study was conducted at Hospital Emergencias "Dr. Clemente Alvarez" in Rosario, Argentina. All patients with severe TBI meeting criteria between August 2000 and February 2003 were included. Outcome at 6 months postinjury was measured by mortality and by the Extended Glasgow Outcome Scale score. Two logistic regression models were created for predicting mortality and outcome., Results: : Outcome measures were acquired for 100% of the sample (N = 148). There was 58% mortality; 30% had moderate to good recovery, and 12% were severely disabled. The model accurately predicted 83.9% of mortality, and 81.1% of outcome. Because of variation in timing of CT scans, the models were recalculated without the CT variable. The accuracy of prediction was 79.7% and 79% for mortality and Extended Glasgow Outcome Scale, respectively., Conclusions: : This study provides rigorous, prospective data that (1) validates the generalizability of the five World Health Organization/Organization Mondiale de la Santé TBI prognostic predictors outside of the developed world, and (2) provides outcome benchmarks for mortality and morbidity from severe TBI in developing countries.

Unlabelled: After adopting the Guidelines for the Management of Severe Head Injury, critical care physicians in Argentina reduced the mortality rate of patients with traumatic brain injury (TBI). However, there is no in-hospital or postdischarge rehabilitation services for persons with TBI in Argentina. Thus, severely disabled survivors were being discharged to home without follow-up or long-term care., Objectives: The objectives of this project were to establish a structure for conducting research about TBI in Argentina, and to conduct a prospective, observational study of outcomes from TBI in hospitals that had adopted the acute care guidelines. The goal was to document outcomes for people treated in a medical system that does not provide TBI rehabilitation. The focus of this report is mortality and morbidity during the acute care and hospital ward treatment of TBI in Argentina., Methods: We established a data-collection system in 5 hospitals in Argentina, using instruments and protocols developed by the NIDRR-funded TBI Model System program. Data-collection intervals were established to be comparable with intervals used in the TBI Model System program. The Argentine team consists of 11 neurocritical care physicians and 1 project manager/translator. All patient evaluation, data collection and entry, quality control, and local administration were conducted by this group., Results: Over 31 months, 278 patients were entered into the study. Approximately 61% were discharged from acute care directly to home. The in-hospital mortality rate was 31%. Seventy-six percent of expired patients died from secondary complications such as sepsis and pneumonia, and 93% while in the hospital., Discussion: TBI is a major public health concern in Argentina. However, rehabilitation for TBI is not a part of this country's medical system. The greatest proportion of expired patients in the Argentine sample died of secondary complications such as pneumonia or sepsis, which may have been avoided employing basic medical rehabilitation. The next research questions to be addressed in this population should be designed to identify solutions to the immediate need for rehabilitation, including treatment efficacy questions as well as questions about systems for delivering treatments.