Matching early arterial oxygenation to long-term outcome in severe traumatic brain injury: target values.

OBJECTIVE: The aim of this study was to examine the relationship between early arterial oxygenation thresholds and long-term outcome after severe traumatic brain injury (TBI). METHODS: In a post hoc analysis of a randomized trial, adults with severe TBI were classified based on exposure to different levels of arterial oxygenation as measured using the average of arterial partial pressure of oxygen (PaO2) values obtained within 24 hours of admission. Potentially important PaO2 thresholds were defined a priori. The primary outcome was Glasgow Outcome Scale-Extended (GOSE) score at 6 months. Secondary outcomes were cognitive outcomes measured using a battery of 9 neuropsychological tests administered at 6 months, and 6-month mortality. RESULTS: In adjusted analyses, oxygenation thresholds of 150 and 200 mm Hg were associated with better functional outcome at 6 months (adjusted OR for better functional outcome on GOSE 1.82 [95% CI 1.12-2.94] and 1.59 [95% CI 1.06-2.37], respectively) and improved cognitive outcome at 6 months (adjusted beta coefficients for better cognitive percentile across 9 neuropsychological tests: 6.9 [95% CI 1.3-12.5] and 6.8 [95% CI 2.4-11.3], respectively). There was no significant association between oxygenation level and 6-month mortality except at a PaO2 threshold of 200 mm Hg (OR for death 0.36, 95% CI 0.18-0.71). Higher or lower oxygenation thresholds were not associated with functional or cognitive outcome. CONCLUSIONS: In this observational study, the relationship between early arterial oxygenation and long-term functional and cognitive TBI outcomes appears to be U-shaped. Mild levels of hyperoxemia within the first 24 hours after injury were associated with better long-term functional and cognitive outcomes. These findings highlight the importance of examining balanced oxygen supplementation as a potential strategy to improve TBI outcomes in future research.

Computed tomography rates and estimated radiation-associated cancer risk among injured children treated at different trauma center types.

BACKGROUND: Trauma is a common indication for computed tomography (CT) in children. However, children are particularly vulnerable to CT radiation and its associated cancer risk. Identifying differences in CT usage across trauma centers and among specific populations of injured children is needed to identify where quality improvement initiatives could be implemented in order to reduce excess radiation exposure to children. We evaluated computed tomography (CT) rates among injured children treated at pediatric (PTC), mixed (MTC), or adult trauma centers (ATC) and estimated the resulting differential in potential cancer risk. METHODS: We identified children age ≤18 years with blunt injury AIS ≥2 treated from 2010 to 2013 at 130 U.S trauma centers participating in the Trauma Quality Improvement Program. CT rates were compared across center types using Chi-square analysis. Stratified analyses in children with varying injury severity, mechanism, and age were performed. We estimated the impact of differential rates of CT scans on cancer risk using published attributable risks. RESULTS: Among 59,010 children identified, CT rates were higher among injured children treated at ATC and MTC versus PTC. Findings were consistent after stratified analyses and were most striking in children with chest and abdomen/pelvis CT, adolescent age, low injury severity and fall injury mechanism. We estimated that for every 100,000 injured children, imaging practices in ATC and MTC would lead to an additional 17 and 16 lifetime cancers, respectively, when compared to PTC. CONCLUSION: CT use among injured children is higher at ATC and MTC compared to PTC. Children with low injury severity, fall injury mechanism, and adolescent age are most vulnerable to differential imaging practices across centers. Quality improvement initiatives aimed at reducing heterogeneity in CT usage across trauma centers are required to mitigate pediatric radiation exposure and cancer risk.

A clinical decision rule to predict intracranial hypertension in severe traumatic brain injury.

OBJECTIVE: While existing guidelines support the treatment of intracranial hypertension in severe traumatic brain injury (TBI), it is unclear when to suspect and initiate treatment for high intracranial pressure (ICP). The objective of this study was to derive a clinical decision rule that accurately predicts intracranial hypertension. METHODS: Using Delphi methods, the authors identified a set of potential predictors of intracranial hypertension and a clinical decision rule a priori by consensus among a group of 43 neurosurgeons and intensivists who have extensive experience managing severe TBI without ICP monitoring. To validate these predictors, the authors used data from a Latin American trial (n = 150; BEST TRIP). To report on the performance of the rule, they calculated sensitivity, specificity, and positive and negative predictive values with 95% confidence intervals. In a secondary analysis, the rule was validated using data from a North American trial (n = 131; COBRIT). RESULTS: The final predictors and the clinical decision rule were approved by 97% of participants in the consensus working group. The predictors are divided into major and minor criteria. High ICP would be considered suspected in the presence of 1 major or ≥ 2 minor criteria. Major criteria are: compressed cisterns (CT classification of Marshall diffuse injury [DI] III), midline shift > 5 mm (Marshall DI IV), or nonevacuated mass lesion. Minor criteria are: Glasgow Coma Scale (GCS) motor score ≤ 4, pupillary asymmetry, abnormal pupillary reactivity, or Marshall DI II. The area under the curve for the logistic regression model that contains all the predictors was 0.86. When high ICP was defined as > 22 mm Hg, the decision rule performed with a sensitivity of 93.9% (95% CI 85.0%-98.3%), a specificity of 42.3% (95% CI 31.7%-53.6%), a positive predictive value of 55.5% (95% CI 50.7%-60.2%), and a negative predictive value of 90% (95% CI 77.1%-96.0%). The sensitivity of the clinical decision rule improved with higher ICP cutoffs up to a sensitivity of 100% when intracranial hypertension was defined as ICP > 30 mm Hg. Similar results were found in the North American cohort. CONCLUSIONS: A simple clinical decision rule based on a combination of clinical and imaging findings was found to be highly sensitive in distinguishing patients with severe TBI who would suffer intracranial hypertension. It could be used to identify patients who require ICP monitoring in high-resource settings or start ICP-lowering treatment in environments where resource limitations preclude invasive monitoring.Clinical trial registration no.: NCT02059941 (clinicaltrials.gov).

Impact of ICU Structure and Processes of Care on Outcomes After Severe Traumatic Brain Injury: A Multicenter Cohort Study.

OBJECTIVES: It is uncertain whether dedicated neurocritical care units are associated with improved outcomes for critically ill neurologically injured patients in the era of collaborative protocol-driven care. We examined the association between dedicated neurocritical care units and mortality and the effects of standardized management protocols for severe traumatic brain injury. DESIGN: We surveyed trauma medical directors from centers participating in the American College of Surgeons Trauma Quality Improvement Program to obtain information about ICU structure and processes of care. Survey data were then linked to the Trauma Quality Improvement Program registry, and random-intercept hierarchical multivariable modeling was used to evaluate the association between dedicated neurocritical care units, the presence of standardized management protocols and mortality. SETTING: Trauma centers in North America participating in Trauma Quality Improvement Program. PATIENTS: Data were analyzed from 9,773 adult patients with isolated severe traumatic brain injury admitted to 134 Trauma Quality Improvement Program centers between 2011 and 2013. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Only 50 ICUs (37%) were dedicated neurocritical care units, whereas 84 (63%) were general ICUs. Rates of standardized management protocols were similar comparing dedicated neurocritical care units and general ICUs. Among severe TBI patients admitted to trauma centers enrolled in Trauma Quality Improvement Program, care in a dedicated neurocritical care unit did not improve risk-adjusted in-hospital survival (odds ratio, 0.97; 95% CI, 0.80-1.19; p = 0.79). However, the presence of a standardized management protocol for these patients was associated with lower risk-adjusted in-hospital mortality (odds ratio, 0.77; 95% CI, 0.63-0.93; p = 0.009). CONCLUSIONS: Compared with dedicated neurocritical care models, standardized management protocols for severe traumatic brain injured patients are process-targeted intervention strategies that may improve clinical outcomes.

Risk of intracranial hemorrhage after carotid artery stenting versus endarterectomy: a population-based study.

OBJECTIVEIntracranial hemorrhage (ICH) associated with cerebral hyperperfusion syndrome is a rare but major complication of carotid artery revascularization. The objective of this study was to compare the rate of ICH after carotid artery stenting (CAS) with that after endarterectomy (CEA).METHODSThe authors performed a retrospective population-based cohort study of patients who underwent carotid artery revascularization in the province of Ontario, Canada, between 2002 and 2015. The primary outcome was the rate of ICH that occurred within 90 days after carotid artery intervention among patients who underwent CAS versus that of those who underwent CEA. The authors used inverse probability of treatment weighting and propensity scores to account for selection bias. In sensitivity analyses, patients who had postprocedure ischemic stroke were excluded, and the following subgroups were examined: patients with symptomatic and asymptomatic carotid artery stenosis, patients treated between 2010 and 2015, and patients aged ≥ 66 years (to account for antiplatelet and anticoagulant use).RESULTSA total of 16,688 patients underwent carotid artery revascularization (14% CAS, 86% CEA). Patients with more comorbid illnesses, symptomatic carotid artery stenosis, or cardiac disease and those who were taking antiplatelet agents or warfarin before surgery were more likely to undergo CAS. Among the overall cohort, 80 (0.48%) patients developed ICH within 90 days (0.85% after CAS, 0.42% after CEA). The 180-day mortality rate after ICH in the overall cohort was 2.7%, whereas the 180-day mortality rate among patients who suffered ICH was 42.5% (40% for CAS-treated patients, 43.3% for CEA-treated patients). In the adjusted analysis, patients who underwent CAS were significantly more likely to have ICH than those who underwent CEA (adjusted OR 1.77; 95% CI 1.32-2.36; p < 0.001). These results were consistent after excluding patients who developed postprocedure ischemic stroke (adjusted OR 1.90; 95% CI 1.41-2.56) and consistent among symptomatic (adjusted OR 1.74; 95% CI 1.16-2.63) and asymptomatic (adjusted OR 1.75; 95% CI 1.16-2.63) patients with carotid artery stenosis, among patients treated between 2010 and 2015 (adjusted OR 2.21; 95% CI 1.45-3.38), and among the subgroup of patients aged ≥ 66 years (adjusted OR 1.53; 95% CI 1.05-2.24) after adjusting for medication use.CONCLUSIONSCAS is associated with a rare but higher risk of ICH relative to CEA. Future research is needed to devise strategies that minimize the risk of this serious complication after carotid artery revascularization.

Inclusion of Highest Glasgow Coma Scale Motor Component Score in Mortality Risk Adjustment for Benchmarking of Trauma Center Performance.

BACKGROUND: The Glasgow Coma Scale (GCS) is the most widely used measure of traumatic brain injury (TBI) severity. Currently, the arrival GCS motor component (mGCS) score is used in risk-adjustment models for external benchmarking of mortality. However, there is evidence that the highest mGCS score in the first 24 hours after injury might be a better predictor of death. Our objective was to evaluate the impact of including the highest mGCS score on the performance of risk-adjustment models and subsequent external benchmarking results. STUDY DESIGN: Data were derived from the Trauma Quality Improvement Program analytic dataset (January 2014 through March 2015) and were limited to the severe TBI cohort (16 years or older, isolated head injury, GCS ≤8). Risk-adjustment models were created that varied in the mGCS covariates only (initial score, highest score, or both initial and highest mGCS scores). Model performance and fit, as well as external benchmarking results, were compared. RESULTS: There were 6,553 patients with severe TBI across 231 trauma centers included. Initial and highest mGCS scores were different in 47% of patients (n = 3,097). Model performance and fit improved when both initial and highest mGCS scores were included, as evidenced by improved C-statistic, Akaike Information Criterion, and adjusted R-squared values. Three-quarters of centers changed their adjusted odds ratio decile, 2.6% of centers changed outlier status, and 45% of centers exhibited a ≥0.5-SD change in the odds ratio of death after including highest mGCS score in the model. CONCLUSIONS: This study supports the concept that additional clinical information has the potential to not only improve the performance of current risk-adjustment models, but can also have a meaningful impact on external benchmarking strategies. Highest mGCS score is a good potential candidate for inclusion in additional models.

Beta-blockers and Traumatic Brain Injury: A Systematic Review, Meta-analysis, and Eastern Association for the Surgery of Trauma Guideline.

OBJECTIVE: To determine if beta-(ß)-blockers improve outcomes after acute traumatic brain injury (TBI). BACKGROUND: There have been no new inpatient pharmacologic therapies to improve TBI outcomes in a half-century. Treatment of TBI patients with ß-blockers offers a potentially beneficial approach. METHODS: Using MEDLINE, EMBASE, and CENTRAL databases, eligible articles for our systematic review and meta-analysis (PROSPERO CRD42016048547) included adult (age ≥ 16 years) blunt trauma patients admitted with TBI. The exposure of interest was ß-blocker administration initiated during the hospitalization. Outcomes were mortality, functional measures, quality of life, cardiopulmonary morbidity (e.g., hypotension, bradycardia, bronchospasm, and/or congestive heart failure). Data were analyzed using a random-effects model, and represented by pooled odds ratio (OR) with 95% confidence intervals (CI) and statistical heterogeneity (I). RESULTS: Data were extracted from 9 included studies encompassing 2005 unique TBI patients with ß-blocker treatment and 6240 unique controls. Exposure to ß-blockers after TBI was associated with a reduction of in-hospital mortality (pooled OR 0.39, 95% CI: 0.27-0.56; I = 65%, P < 0.00001). None of the included studies examined functional outcome or quality of life measures, and cardiopulmonary adverse events were rarely reported. No clear evidence of reporting bias was identified. CONCLUSIONS: In adults with acute TBI, observational studies reveal a significant mortality advantage with ß-blockers; however, quality of evidence is very low. We conditionally recommend the use of in-hospital ß-blockers. However, we recommend further high-quality trials to answer questions about the mechanisms of action, effectiveness on subgroups, dose-response, length of therapy, functional outcome, and quality of life after ß-blocker use for TBI.

Structure, Process, and Culture of Intensive Care Units Treating Patients with Severe Traumatic Brain Injury: Survey of Centers Participating in the American College of Surgeons Trauma Quality Improvement Program.

Outcome after severe traumatic brain injury (TBI) differs substantially between hospitals. Explaining this variation begins with understanding the differences in structures and processes of care, particularly at intensive care units (ICUs) where acute TBI care takes place. We invited trauma medical directors (TMDs) from 187 centers participating in the American College of Surgeons Trauma Quality Improvement Program (ACS TQIP) to complete a survey. The survey domains included ICU model, type, availability of specialized units, staff, training programs, standard protocols and order sets, approach to withdrawal of life support, and perceived level of neurosurgeons' engagement in the ICU management of TBI. One hundred forty-two TMDs (76%) completed the survey. Severe TBI patients are admitted to dedicated neurocritical care units in 52 hospitals (37%), trauma ICUs in 44 hospitals (31%), general ICUs in 34 hospitals (24%), and surgical ICUs in 11 hospitals (8%). Fifty-seven percent are closed units. Board-certified intensivists directed 89% of ICUs, whereas 17% were led by neurointensivists. Sixty percent of ICU directors were general surgeons. Thirty-nine percent of hospitals had critical care fellowships and 11% had neurocritical care fellowships. Fifty-nine percent of ICUs had standard order sets and 61% had standard protocols specific for TBI, with the most common protocol relating to intracranial pressure management (53%). Only 43% of TMDs were satisfied with the current level of neurosurgeons' engagement in the ICU management of TBI; 46% believed that neurosurgeons should be more engaged; 11% believed they should be less engaged. In the largest survey of North American ICUs caring for TBI patients, there is substantial variation in the current approaches to ICU care for TBI, highlighting multiple opportunities for comparative effectiveness research.

Understanding Hospital Volume-Outcome Relationship in Severe Traumatic Brain Injury.

BACKGROUND: The hospital volume-outcome relationship in severe traumatic brain injury (TBI) population remains unclear. OBJECTIVE: To examine the relationship between volume of patients with severe TBI per hospital and in-hospital mortality, major complications, and mortality following a major complication (ie, failure to rescue). METHODS: In a multicenter cohort study, data on 9255 adults with severe TBI were derived from 111 hospitals participating in the American College of Surgeons Trauma Quality Improvement Program over 2009-2011. Hospitals were ranked into quartiles based on their volume of severe TBI during the study period. Random-intercept multilevel models were used to examine the association between hospital quartile of severe TBI volume and in-hospital mortality, major complications, and mortality following a major complication after adjusting for patient and hospital characteristics. In sensitivity analyses, we examined these associations after excluding transferred cases. RESULTS: Overall mortality was 37.2% (n = 3447). Two thousand ninety-eight patients (22.7%) suffered from 1 or more major complication. Among patients with major complications, 27.8% (n = 583) died. Higher-volume hospitals were associated with lower mortality; the adjusted odds ratio of death was 0.50 (95% confidence interval: 0.29-0.85) in the highest volume quartile compared to the lowest. There was no significant association between hospital-volume quartile and the odds of a major complication or the odds of death following a major complication. After excluding transferred cases, similar results were found. CONCLUSION: High-volume hospitals might be associated with lower in-hospital mortality following severe TBI. However, this mortality reduction was not associated with lower risk of major complications or death following a major complication.

Effect of Early Versus Late Tracheostomy or Prolonged Intubation in Critically Ill Patients with Acute Brain Injury: A Systematic Review and Meta-Analysis.

BACKGROUND: The optimal timing of tracheostomy placement in acutely brain-injured patients, who generally require endotracheal intubation for airway protection rather than respiratory failure, remains uncertain. We systematically reviewed trials comparing early tracheostomy to late tracheostomy or prolonged intubation in these patients. METHODS: We searched 5 databases (from inception to April 2015) to identify randomized controlled trials comparing early tracheostomy (≤10 days of intubation) with late tracheostomy (>10 days) or prolonged intubation in acutely brain-injured patients. We contacted the principal authors of included trials to obtain subgroup data. Two reviewers extracted data and assessed risk of bias. Outcomes included long-term mortality (primary), short-term mortality, duration of mechanical ventilation, complications, and liberation from ventilation without a tracheostomy. Meta-analyses used random-effects models. RESULTS: Ten trials (503 patients) met selection criteria; overall study quality was moderate to good. Early tracheostomy reduced long-term mortality (risk ratio [RR] 0.57. 95 % confidence interval (CI), 0.36-0.90; p = 0.02; n = 135), although in a sensitivity analysis excluding one trial, with an unclear risk of bias, the significant finding was attenuated (RR 0.61, 95 % CI, 0.32-1.16; p = 0.13; n = 95). Early tracheostomy reduced duration of mechanical ventilation (mean difference [MD] -2.72 days, 95 % CI, -1.29 to -4.15; p = 0.0002; n = 412) and ICU length of stay (MD -2.55 days, 95 % CI, -0.50 to -4.59; p = 0.01; n = 326). However, early tracheostomy did not reduce short-term mortality (RR 1.25; 95 % CI, 0.68-2.30; p = 0.47 n = 301) and increased the probability of ever receiving a tracheostomy (RR 1.58, 95 % CI, 1.24-2.02; 0 < 0.001; n = 377). CONCLUSIONS: Performing an early tracheostomy in acutely brain-injured patients may reduce long-term mortality, duration of mechanical ventilation, and ICU length of stay. However, waiting longer leads to fewer tracheostomy procedures and similar short-term mortality. Future research to explore the optimal timing of tracheostomy in this patient population should focus on patient-centered outcomes including patient comfort, functional outcomes, and long-term mortality.

A novel methodology to characterize interfacility transfer strategies in a trauma transfer network.

BACKGROUND: More than half of severely injured patients are initially transported from the scene of injury to nontrauma centers (NTCs), with many requiring subsequent transfer to trauma center (TC) care. Definitive care in the setting of severe injury is time sensitive. However, transferring severely injured patients from an NTC is a complex process often fraught with delays. Selection of the receiving TC and the mode of interfacility transport both strongly influence total transfer time and are highly amenable to quality improvement initiatives. METHODS: We analyzed transfer strategies, defined as the pairing of a destination and mode of transport (land vs. rotary wing vs. fixed wing), for severely injured adult patients. Existing transfer strategies at each NTC were derived from trauma registry data. Geographic Information Systems network analysis was used to identify the strategy that minimized transfer times the most as well as alternate strategies (+15 or +30 minutes) for each NTC. Transfer network efficiency was characterized based on optimality and stability. RESULTS: We identified 7,702 severely injured adult patients transferred from 146 NTCs to 9 TCs. Nontrauma centers transferred severely injured patients to a median of 3 (interquartile range, 1-4) different TCs and utilized a median of 4 (interquartile range, 2-6) different transfer strategies. After allowing for the use of alternate transfer strategies, 73.1% of severely injured patients were transported using optimal/alternate strategies, and only 40.4% of NTCs transferred more than 90% of patients using an optimal/alternate transfer strategy. Three quarters (75.5%) of transfers occurred between NTCs and their most common receiving TC. CONCLUSION: More than a quarter of patients with severe traumatic injuries undergoing interfacility transport to a TC in Ontario are consistently transported using a nonoptimal combination of destination and mode of transport. Our novel analytic approach can be easily adapted to different system configurations and provides actionable data that can be provided to NTCs and other stakeholders. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Early Cholecystectomy for Acute Cholecystitis Offers the Best Outcomes at the Least Cost: A Model-Based Cost-Utility Analysis.

BACKGROUND: The application of early cholecystectomy for acute cholecystitis remains inconsistent across hospitals worldwide. Given the constrained nature of health care spending, careful consideration of costs relative to the clinical consequences of alternative treatments should support decision making. We present a cost-utility analysis comparing alternative time frames of cholecystectomy for acute cholecystitis. STUDY DESIGN: A Markov model with a 5-year time horizon was developed to compare costs and quality-adjusted life-years (QALY) gained from 3 alternative management strategies for the treatment of acute cholecystitis: early cholecystectomy (within 7 days of presentation), delayed elective cholecystectomy (8 to 12 weeks from presentation), and watchful waiting, where cholecystectomy is performed urgently only if recurrent symptoms arise. Model inputs were selected to reflect patients with uncomplicated acute cholecystitis-without concurrent common bile duct obstruction, pancreatitis, or severe sepsis. Real-world outcome probability and cost estimates included in the model were derived from analysis of population-based administrative databases for the province of Ontario, Canada. The QALY values were derived from utilities identified in published literature. Parameter uncertainty was evaluated through probabilistic sensitivity analyses. RESULTS: Early cholecystectomy was less costly (C$6,905 per person) and more effective (4.20 QALYs per person) than delayed cholecystectomy (C$8,511; 4.18 QALYs per person) or watchful waiting (C$7,274; 3.99 QALYs per person). Probabilistic sensitivity analysis showed early cholecystectomy was the preferred management in 72% of model iterations, given a cost-effectiveness threshold of C$50,000 per QALY. CONCLUSIONS: This cost-utility analysis suggests early cholecystectomy is the optimal management of uncomplicated acute cholecystitis. Furthermore, deferring surgery until recurrent symptoms arise is associated with the worst clinical outcomes.

Timing of withdrawal of life-sustaining therapies in severe traumatic brain injury: Impact on overall mortality.

BACKGROUND: The care of patients with severe traumatic brain injury (TBI) is complex and confounded by uncertainty in prognoses. Studies have demonstrated significant unexplained variation in mortality between centers. Possible explanations include differences in the quality and intensity of care across centers, including the appropriateness and timing of withdrawal of life-sustaining therapies. We postulated that centers with a preponderance of early deaths might have a more pessimistic approach to the TBI patient, which would be reflected in an increased hospital TBI-related mortality. METHODS: This is a retrospective cohort study. Time to death was used as a proxy for time to withdrawal of life-sustaining therapies. Centers were classified as early or late based on when the majority (75th percentile) of their TBI-related deaths occurred. We evaluated the association between adjusted mortality and center classification using a hierarchical multivariable model. Two hundred trauma centers contributing data to the American College of Surgeons Trauma Quality Improvement Program from 2010 through 2013 were involved. The cohort included 17,505 patients with severe isolated TBI. RESULTS: One hundred eight centers were classified as early centers. The 75th percentile for time to death was 4 days among early centers versus 7 days in late centers. Mortality was 34% and 33%, respectively. After adjustment for case mix, care in an early center was not associated with increased odds of death (adjusted odds ratio, 0.95; 95% confidence interval, 0.83-1.09). Higher odds of death were independently associated with age, Glasgow Coma Scale (GCS) score, head Abbreviated Injury Scale (AIS) score, multiple comorbidities, traumatic subarachnoid hemorrhage, intracerebral mass lesions, brainstem lesions, and signs of compressed or absent basal cisterns. CONCLUSION: Centers rendering early decisions related to withdrawal of life-sustaining therapies in TBI patients, as measured by time until death, do not have worse outcomes than those making later decisions. How and when these decisions are made requires further exploration to balance an opportunity for clinical improvement with appropriate resource use. LEVEL OF EVIDENCE: Prognostic and epidemiologic study, level III.

Economic Evaluations in the Diagnosis and Management of Traumatic Brain Injury: A Systematic Review and Analysis of Quality.

BACKGROUND: Economic evaluations provide a unique opportunity to identify the optimal strategies for the diagnosis and management of traumatic brain injury (TBI), for which uncertainty is common and the economic burden is substantial. OBJECTIVE: The objective of this study was to systematically review and examine the quality of contemporary economic evaluations in the diagnosis and management of TBI. METHODS: Two reviewers independently searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, NHS Economic Evaluation Database, Health Technology Assessment Database, EconLit, and the Tufts CEA Registry for comparative economic evaluations published from 2000 onward (last updated on August 30, 2013). Data on methods, results, and quality were abstracted in duplicate. The results were summarized quantitatively and qualitatively. RESULTS: Of 3539 citations, 24 economic evaluations met our inclusion criteria. Nine were cost-utility, five were cost-effectiveness, three were cost-minimization, and seven were cost-consequences analyses. Only six studies were of high quality. Current evidence from high-quality studies suggests the economic attractiveness of the following strategies: a low medical threshold for computed tomography (CT) scanning of asymptomatic infants with possible inflicted TBI, selective CT scanning of adults with mild TBI as per the Canadian CT Head Rule, management of severe TBI according to the Brain Trauma Foundation guidelines, management of TBI in dedicated neurocritical care units, and early transfer of patients with TBI with nonsurgical lesions to neuroscience centers. CONCLUSIONS: Threshold-guided CT scanning, adherence to Brain Trauma Foundation guidelines, and care for patients with TBI, including those with nonsurgical lesions, in specialized settings appear to be economically attractive strategies.

Intracranial pressure monitoring among children with severe traumatic brain injury.

OBJECT Well-designed studies linking intracranial pressure (ICP) monitoring with improved outcomes among children with severe traumatic brain injury (TBI) are lacking. The main objective of this study was to examine the relationship between ICP monitoring in children and in-hospital mortality following severe TBI. METHODS An observational study was conducted using data derived from 153 adult or mixed (adult and pediatric) trauma centers participating in the American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP) and 29 pediatric trauma centers participating in the pediatric pilot TQIP between 2010 and 2012. Random-intercept multilevel modeling was used to examine the association between ICP monitoring and in-hospital mortality among children with severe TBI ≤16 years of age after adjusting for important confounders. This association was evaluated at the patient level and at the hospital level. In a sensitivity analysis, this association was reexamined in a propensity-matched cohort. RESULTS A total of 1705 children with severe TBI were included in the study cohort. The overall in-hospital mortality was 14.3% of patients (n = 243), whereas the mortality of the 273 patients (16%) who underwent invasive ICP monitoring was 11% (n = 30). After adjusting for patient- and hospital-level characteristics, ICP monitoring was associated with lower in-hospital mortality (adjusted OR 0.50; 95% CI 0.30-0.85; p = 0.01). It is possible that patients who were managed with ICP monitoring were selected because of an anticipated favorable or unfavorable outcome. To further address this potential selection bias, the analysis was repeated with the hospital-specific rate of ICP monitoring use as the exposure. The adjusted OR for death of children treated at high ICP-use hospitals was 0.49 compared with those treated at low ICP-use hospitals (95% CI 0.31-0.78; p = 0.003). Variations in ICP monitoring use accounted for 15.9% of the interhospital variation in mortality among children with severe TBI. Similar results were obtained after analyzing the data using propensity score-matching methods. CONCLUSIONS In this observational study, ICP monitoring use was associated with lower hospital mortality at both the patient and hospital levels. However, the contribution of variable ICP monitoring rates to interhospital variation in pediatric TBI mortality was modest.

Mortality Among Injured Children Treated at Different Trauma Center Types.

IMPORTANCE: Trauma is the leading cause of death among US children. Whether pediatric trauma centers (PTCs), mixed trauma centers (MTCs), or adult trauma centers (ATCs) offer a survival benefit compared with one another when treating injured children is controversial. Ascertaining the optimal care environment will better inform quality improvement initiatives and accreditation standards. OBJECTIVE: To evaluate the association between type of trauma center (PTC, MTC, or ATC) and in-hospital mortality among young children (5 years and younger), older children (aged 6-11 years), and adolescents (aged 12-18 years). DESIGN, SETTING, AND PARTICIPANTS: In this retrospective cohort study, injured children aged 18 years or younger who were hospitalized in the United States from January 1, 2010, to December 31, 2013, were observed for the duration of their admission until discharge or death. We included patients with an Abbreviated Injury Score of 2 or greater in at least 1 body region. Random-intercept multilevel regression was used to evaluate the association between center type and in-hospital mortality after adjusting for confounders. Stratified analyses in young children, older children, and adolescents were performed. We conducted secondary analyses limited to patients with severe injuries (Injury Severity Score ≥25). Both analyses were performed between January 1 and August 31, 2014. Data were derived from 252 US level I and II trauma centers voluntarily participating in the American College of Surgeons adult or pediatric Trauma Quality Improvement Program. MAIN OUTCOME AND MEASURE: In-hospital mortality. RESULTS: We identified 175 585 injured children. Crude mortality rates were 2.3% for children treated at ATCs, 1.8% for children treated at MTCs, and 0.6% for children treated at PTCs. After adjustment, children had higher odds of dying when treated at ATCs (odds ratio [OR], 1.57; 95% CI, 1.15-2.14) and MTCs (OR, 1.45; 95% CI, 1.05-2.01) compared with those treated at PTCs. In stratified analyses, young children had higher odds of death when treated at ATCs vs PTCs (OR, 1.78; 95% CI, 1.05-3.40), but there was no association between center type and mortality among older children (OR, 1.17; 95% CI, 0.65-2.11) and adolescents (OR, 1.23; 95% CI, 0.82-1.85). Results were similar in analyses of severely injured children: those treated at ATCs (OR, 1.75; 95% CI, 1.25-2.44) and MTCs (OR, 1.62; 95% CI, 1.15-2.29) had higher odds of death when compared with those treated at PTCs. CONCLUSIONS AND RELEVANCE: Injured children treated at ATCs and MTCs had higher in-hospital mortality compared with those treated at PTCs. This association was most evident in younger children and remained significant in severely injured children. Quality improvement initiatives geared toward ATCs and MTCs are required to provide optimal care to injured children.

Definitive care in level 3 trauma centres after severe injury: A comparison of clinical characteristics and outcomes.

BACKGROUND: The role of level 3 trauma centres (TC) in inclusive trauma systems has not been well defined. The absence of nationally recognised inter-facility transfer criteria for inclusive systems has often left individual level 3 TCs to decide upon their own what their spectrum of care is and particularly which severely injured patients to admit for definitive care. METHODS: Retrospective cohort study in which the principal objective was to compare the characteristics and outcomes of severely injured (injury severity score>15) adult patients (≥18 years) who received definitive care at level 3 centres with severely injured adult patients who were transferred to level 1-2 TCs during the same time period. Data were derived from the National Trauma Data Bank (2010-2011). First, we utilised hierarchical logistic regression models to evaluate the risk-adjusted mortality of patients admitted at level 3 TCs compared to those who were transferred to level 1-2 TCs. Subgroup analysis was carried out for patients with isolated traumatic brain injury (iTBI). Finally, we explored the extent of variation in risk-adjusted mortality across level 3 TCs. RESULTS: We identified 6433 severely injured patients who received definitive care across 150 level 3 TCs and 41,165 severely injured patients transferred to level 1-2 centres. Patients who received definitive care at level 3 TCs had a lower comorbidity burden and different injury profiles compared to those transferred to level 1-2 centres. There was no difference in crude mortality (10% vs. 11%, standardised difference 0.04); however, after risk-adjustment, the odds of death for patients who received definitive care at level 3 TCs were 1.24-fold higher (95%CI 1.08-1.43) when compared to those transferred to level 1-2 centres. A trend towards a higher likelihood of death at level 3 centres was observed when analysis was limited to patients with iTBI. Risk-adjusted mortality across level 3 TCs was with few exceptions, homogeneous (<10% of level 3 TCs were outliers with higher/lower mortality). CONCLUSIONS: Level 3 trauma centres are providing definitive care for a subset of severely injured patients. Our findings suggest that the outcomes of severely injured patients admitted at level 3 centres might be worse compared to those transferred to level 1-2 centres; a finding independent of performance outliers. Further work is required to elucidate the determinants of admission after severe injury at level 3 trauma centres.

Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

Temporal trends and differences in mortality at trauma centres across Ontario from 2005 to 2011: a retrospective cohort study.

BACKGROUND: Care in a trauma centre is associated with significant reductions in mortality after severe injury. However, emerging evidence suggests that outcomes across similarly accredited trauma centres are not equivalent, even after adjusting for case-mix. The primary objective of this analysis was to evaluate secular trends in overall mortality at trauma centres. Secondarily, we explored trauma centre-specific mortality to determine the extent of variation between centres. METHODS: Data on 26 421 adults (≥□18 yr) admitted to a trauma centre between 2005 and 2011 were derived from the Ontario Trauma Registry. We used generalized estimating equations to calculate in-hospital mortality over time and hierarchical models to estimate trauma-centre-specific mortality. To quantify variability between centres, we calculated median odds ratios. Adjusted odds of death were calculated for each trauma centre to identify those with higher than expected, average and lower than expected mortality. RESULTS: Overall mortality at trauma centres decreased from 13.2% in 2005 to 11.2% in 2009. After adjusting for case mix, the odds of death decreased by approximately 3% a year (95% confidence interval 0%-5%). Trauma centre-specific mortality ranged from 11.4% to 13.1%. After adjusting for case mix, differences in trauma centre-specific mortality were observed (median odds ratio = 1.25), suggesting that the odds of dying could be 1.25-fold greater if the same patient was admitted to 1 randomly selected trauma centre as opposed to another. Differences were most pronounced for patients with isolated head injuries and among older patients as evidenced by higher median odds ratios and the number of outliers. INTERPRETATION: We observed a significant improvement over time in the mortality of severely injured patients cared for at Ontario's trauma centres. However, considerable differences in trauma centre-specific mortality were observed. Differences were most pronounced among older injured patients and those with isolated traumatic brain injury. System-wide performance improvement initiatives should target these subgroups.