RESUMO
BACKGROUND: Severe traumatic brain injury (TBI) is a leading cause of pediatric mortality, with a disproportionate burden on low- and middle-income countries. The impact of concomitant extracranial injury (ECI) on these patients remains unclear. This study is the first to characterize the epidemiology and clinical course of severe pediatric TBI with extracranial injuries in any South American country. METHODS: We conducted a secondary analysis of baseline data collected prior to implementation of a clinical trial on TBI care in Argentina, Paraguay, and Chile from September 2019 to July 2020. Patients ≤18 years with CT evidence of TBI, and a Glasgow coma scale (GCS) score ≤8 were recruited. Patients were initially stratified by highest non-head abbreviated injury scale (AIS): isolated TBI (AIS=0), minor extracranial injury (MEI; AIS=1-2), and serious extracranial injury (SEI; AIS≥3). Patients were subsequently stratified by mechanism of injury. Intergroup differences were compared using ANOVA, two-tailed unpaired t-tests, and chi-square tests. RESULTS: Among the 116 children included, 33 % (n = 38) had an isolated TBI, 34 % (n = 39) had MEI, and 34 % (n = 39) had SEI. Facial (n = 53), thoracic (n = 44), and abdominal (n = 31) injuries were the most common ECIs. At discharge, there were no significant differences in median GCS, GOS, or GOS-extended between groups. Patients with SEI had a longer hospital LOS than those with isolated TBI (median 28.0 (IQR 10.6-40.1) vs 11.9 (IQR 8.7-20.7) days, p = 0.013). The most common mechanisms of injury were road traffic injuries (RTIs) (n = 50, 43 %) and falls (n = 35, 30 %). Patients with RTI-associated TBIs were more likely to be older (median 11.0 (IQR 3.0-14.0) vs 2.0 (IQR 0.8-7.0) years, p<0.001) and more likely to have an ECI (86% vs 54 %, respectively; p = 0.003). ICU and Hospital LOS for RTI patients (median 10.5 (IQR 6.1-21.1) and 24.1 (IQR 11.5-40.4) days) were longer than those of fall patients (median 6.1 (IQR 2.6-8.9) and 13.7 (IQR 7.7-24.5) days). CONCLUSIONS: Extracranial injuries are common in South American patients with severe TBI. Severe ECI is more frequently associated with RTIs and can result in a higher rate of surgical procedures and LOS. Further strategies are needed to characterize the prevention and treatment of severe pediatric TBI in the South American context.
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Lesões Encefálicas Traumáticas , Humanos , Criança , Lesões Encefálicas Traumáticas/terapia , Alta do Paciente , Escala de Coma de Glasgow , Hospitais , ChileRESUMO
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.
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Lesões Encefálicas Traumáticas , COVID-19 , Criança , Humanos , Fidelidade a Diretrizes , Argentina/epidemiologia , Lesões Encefálicas Traumáticas/diagnóstico , Lesões Encefálicas Traumáticas/terapia , Ciência da Implementação , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: To understand provider perceptions of the COVID-19 pandemic on priorities of severe pediatric traumatic brain injury (TBI) care across hospitals in South America. METHODS: Site principal investigators (PIs) from 17 hospitals in South America enrolled in the PEGASUS-Argentina randomized controlled trial completed questionnaires regarding order of tasks performed in the care of a typical pediatric patient with severe TBI before (2019) and during (2021) the COVID-19 pandemic. Acute care processes were examined by quintiles to identify early, mid, and late actions and were categorized and compared. Associations of hospital volume and subspecialty resource availability with prioritization of key process actions were examined. FINDING: Site PIs from 15 and 16 hospitals completed the surveys in 2019 and 2021, respectively, including 14 who completed both. Action category order was stable between 2019 and 2021 and were ranked in priorities as: initial encounter, primary survey, interventions and invasive monitors, diagnostics, medications, staff communication, then disposition (in 2019) or nutrition (in 2021). There was variation in specific action order between hospitals at both timepoints, with only a few initial encounter and disposition actions limited to a single quintile. There was no reported association between hospital volume or subspecialty resource availability with prioritization of key process actions. INTERPRETATION: Despite novel healthcare challenges presented by the COVID-19 pandemic, providers in South America perceived maintaining standard severe pediatric TBI care consistent with BTF guidelines. There was large variability in specific action order between individual hospitals reported.
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Lesões Encefálicas Traumáticas , COVID-19 , Lesões Encefálicas Traumáticas/epidemiologia , Lesões Encefálicas Traumáticas/terapia , COVID-19/epidemiologia , Criança , Hospitais , Humanos , Pandemias , América do Sul/epidemiologiaRESUMO
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.
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Lesões Encefálicas Traumáticas/terapia , Hospitais/estatística & dados numéricos , Pediatria/normas , Melhoria de Qualidade/organização & administração , Argentina , Criança , HumanosRESUMO
BACKGROUND: Traumatic brain injury (TBI) disproportionately affects lower- and middle-income countries (LMIC). The factors influencing outcomes in LMIC have not been examined as rigorously as in higher-income countries. METHODS: This study was conducted to examine clinical and demographic factors influencing TBI outcomes in Latin American LMIC. Data were prospectively collected during a randomized trial of intracranial pressure monitoring in severe TBI and a companion observational study. Participants were aged ≥13 years and admitted to study hospitals with Glasgow Coma Scale score ≤8. The primary outcome was Glasgow Outcome Scale, Extended (GOS-E) score at 6 months. Predictors were analyzed using a multivariable proportional odds model created by forward stepwise selection. RESULTS: A total of 550 patients were identified. Six-month outcomes were available for 88%, of whom 37% had died and 44% had achieved a GOS-E score of 5-8. In multivariable proportional odds modeling, higher Glasgow Coma Scale motor score (odds ratio [OR], 1.41 per point; 95% confidence interval [CI], 1.23-1.61) and epidural hematoma (OR, 1.83; 95% CI, 1.17-2.86) were significant predictors of higher GOS-E score, whereas advanced age (OR, 0.65 per 10 years; 95% CI, 0.57-0.73) and cisternal effacement (P < 0.001) were associated with lower GOS-E score. Study site (P < 0.001) and race (P = 0.004) significantly predicted outcome, outweighing clinical variables such as hypotension and pupillary examination. CONCLUSIONS: Mortality from severe TBI is high in Latin American LMIC, although the rate of favorable recovery is similar to that of high-income countries. Demographic factors such as race and study site played an outsized role in predicting outcome; further research is required to understand these associations.
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Lesões Encefálicas Traumáticas/terapia , Adulto , Lesões Encefálicas Traumáticas/mortalidade , Lesões Encefálicas Traumáticas/fisiopatologia , Feminino , Escala de Coma de Glasgow , Escala de Resultado de Glasgow , Humanos , Pressão Intracraniana , América Latina/epidemiologia , Masculino , Análise Multivariada , Razão de Chances , Estudos Prospectivos , América do Sul/epidemiologia , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: Little is known about the critical care management of children with traumatic brain injury (TBI) in low middle income countries. We aimed to identify indicators of intensive care unit (ICU) treatments associated with favorable outcomes in Argentine children with severe TBI. METHODS: We conducted a secondary analysis of data from patients previously enrolled in a prospective seven center study of children with severe TBI who were admitted to an ICU in one of the seven study centers. Severe TBI was defined by head AIS ≥ 3, head CT with traumatic lesion, and admission GCS < 9. Seven indicators of best practice TBI care were examined. The primary outcome was discharge Pediatric Cerebral Performance Category Scale [PCPC] and Pediatric Overall Performance category Scale [POPC]. We also examined variation in ICU care and in-patient mortality. RESULTS: Of the 117 children, 67% were male and 7.5 (4.3) years on average, 92% had isolated TBI. Hypotension (54%) was more common than hypoxia (28%) and clinical or radiographic signs of high intracranial pressure (ICP) were observed in 92%. Yet, ICP monitoring occurred in 60% and hyperosmolar therapy was used in only 36%. Adherence to indicators of best TBI practice ranged from 55.6% to 83.7% across the seven centers and adherence was associated with favorable discharge PCPC (aRR 0.98; 95% CI [0.96, 0.99]), and POPC (aRR 0.98; 95% CI [0.96, 0.99]). Compared to patients whose adherence rates were below 65%, patients whose adherence rates were higher between 75%-100% had better discharge PCPC (aRR 0.28; 95% CI [0.10, 0.83]) and POPC (aRR 0.32; 95% CI [0.15, 0.73]. Two indicators were associated with favorable discharge PCPC: Avoidance of hypoxia (aRR 0.46; 95% CI [0.23, 0.93]), and Nutrition started in 72 hours (aRR 0.45; 95% CI [0.21, 0.99]). Avoiding hypoxia was also associated with favorable discharge POPC (aRR 0.47; 95% CI [0.22, 0.99]). CONCLUSION: There is variation in Argentine ICU practice in the care of children with severe TBI. Second insults are common and hyperosmolar therapy use is uncommon. Adherence to best practice TBI care by avoiding hypoxia and providing timely nutrition were associated with significantly favorable discharge outcomes. Implementing strategies that prevent hypoxia and facilitate early nutrition in the ICUs are urgently needed to improve pediatric TBI outcomes.
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Lesões Encefálicas Traumáticas/terapia , Cuidados Críticos , Argentina , Lesões Encefálicas Traumáticas/patologia , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Alta do Paciente , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: There is little information on the type of early care provided to children with traumatic brain injury (TBI) in low middle income countries. We benchmarked early prehospital [PH] and emergency department [ED] pediatric TBI care in Argentina. METHODS: We conducted a secondary analysis of data from patients previously enrolled in a prospective seven center study of children with TBI. Eligible participants were patients 0-18 years, and had diagnosis of TBI (admission Glasgow Coma scale score [GCS] < 13 or with GCS 14-15 and abnormal head CT scan within 48 hours of admission, and head AIS > 0). Outcomes were transport type, transport time, PH and ED adherence to best practice, and discharge Pediatric Cerebral Performance Category Scale (PCPC) and Pediatric Overall Performance category Scale (POPC). RESULTS: Of the 366 children, mean age was 8.7 (5.0) years, 58% were male, 90% had isolated TBI and 45.4% were transported by private vehicle. 50 (34.7%) of the 144 children with severe TBI (39.3% of all TBI patients) were transported by private vehicle. Most (267; 73%) patients received initial TBI care at an index hospital prior to study center admission, including children with severe (81.9%) TBI. Transport times were shorter for those patients who were directly transported by ambulance to study center than for the whole cohort (1.4 vs.5.5 hours). Ambulance blood pressure data were recorded in 30.9%. ED guideline adherence rate was higher than PH guideline adherence rate (84.8% vs. 26.4%). For patients directly transferred from scene to study trauma centers, longer transport time was associated with worse discharge outcome (PCPC aOR 1.10 [1.04, 1.18] and (POPC aOR 1.10 [1.04, 1.18]). There was no relationship between PH or ED TBI guideline adherence rate and discharge POPC and PCPC. CONCLUSION: This study benchmarks early pediatric TBI care in Argentina and shows that many critically injured children with TBI do not receive timely or best practice PH care, that PH guideline adherence rate is low and that longer transport time was associated with poor discharge outcomes for patients with direct transfer status. There is an urgent need to improve the early care of children with TBI in Argentina, especially timely transportation to a hospital.
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Lesões Encefálicas Traumáticas/diagnóstico , Serviços Médicos de Emergência , Fidelidade a Diretrizes , Adolescente , Argentina , Benchmarking , Criança , Pré-Escolar , Serviço Hospitalar de Emergência , Feminino , Escala de Coma de Glasgow , Hospitais Públicos , Humanos , Lactente , Recém-Nascido , Masculino , Estudos Prospectivos , Fatores de Tempo , Tomografia Computadorizada por Raios X , Transporte de PacientesRESUMO
OBJECTIVE: To develop, in partnership with families of children with traumatic brain injury, a postdischarge intervention that is effective, simple, and sustainable. DESIGN: Randomized Controlled Trial. SETTING: Seven Level 1 Pediatric Trauma Centers in Argentina. PATIENTS: Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild traumatic brain injury and were discharged alive. INTERVENTIONS: Patients were randomly assigned to either the intervention or standard care group. A specially trained Community Resource Coordinator was assigned to each family in the intervention group. We hypothesized that children with severe, moderate, and complicated mild traumatic brain injury who received the intervention would have significantly better functional outcomes at 6 months post discharge than those who received standard care. We further hypothesized that there would be a direct correlation between patient outcome and measures of family function. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was a composite measured at 6 months post injury. There were 308 patients included in the study (61% men). Forty-four percent sustained a complicated mild traumatic brain injury, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and the scores on the Family Impact Module of the Pediatric Quality of Life Inventory (ρ = 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6 months post injury. CONCLUSIONS: Although no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with traumatic brain injury spanning hospital transport through hospital care and into the postdischarge setting.
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Lesões Encefálicas Traumáticas/reabilitação , Adolescente , Argentina , Criança , Pré-Escolar , Continuidade da Assistência ao Paciente/organização & administração , Feminino , Seguimentos , Indicadores Básicos de Saúde , Humanos , Lactente , Recém-Nascido , Masculino , Avaliação de Resultados em Cuidados de Saúde , Alta do Paciente , Qualidade de Vida , Método Simples-Cego , Centros de Traumatologia/organização & administração , Resultado do Tratamento , Adulto JovemRESUMO
In patients with severe traumatic brain injury (TBI), the influence on important outcomes of the use of information from intracranial pressure (ICP) monitoring to direct treatment has never been tested in a randomized controlled trial (RCT). We are conducting an RCT in six trauma centers in Latin America to test this question. We hypothesize that patients randomized to ICP monitoring will have lower mortality and better outcomes at 6-months post-trauma than patients treated without ICP monitoring. We selected three centers in Bolivia to participate in the trial, based on (1) the absence of ICP monitoring, (2) adequate patient accession and data collection during the pilot phase, (3) preliminary institutional review board approval, and (4) the presence of equipoise about the value of ICP monitoring. We conducted extensive training of site personnel, and initiated the trial on September 1, 2008. Subsequently, we included three additional centers. A total of 176 patients were entered into the trial as of August 31, 2010. Current enrollment is 81% of that expected. The trial is expected to reach its enrollment goal of 324 patients by September of 2011. We are conducting a high-quality RCT to answer a question that is important globally. In addition, we are establishing the capacity to conduct strong research in Latin America, where TBI is a serious epidemic. Finally, we are demonstrating the feasibility and utility of international collaborations that share resources and unique patient populations to conduct strong research about global public health concerns.
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Lesões Encefálicas/complicações , Hipertensão Intracraniana/diagnóstico , Hipertensão Intracraniana/etiologia , Monitorização Fisiológica , Bolívia , Humanos , Hipertensão Intracraniana/terapia , Pressão Intracraniana/fisiologia , Recuperação de Função Fisiológica , Projetos de PesquisaRESUMO
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.