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Large language models (LLMs) can improve text analysis efficiency in healthcare. This study explores the application of LLMs to analyze patient perspectives within the exception from informed consent (EFIC) process, which waives consent in emergency research. Our objective is to assess whether LLMs can analyze patient perspectives in EFIC interviews with performance comparable to human reviewers. We analyzed 102 EFIC community interviews from 9 sites, each with 46 questions, as part of the Pediatric Dose Optimization for Seizures in Emergency Medical Services study. We evaluated 5 LLMs, including GPT-4, to assess sentiment polarity on a 5-point scale and classify responses into predefined thematic classes. Three human reviewers conducted parallel analyses, with agreement measured by Cohen's Kappa and classification accuracy. Polarity scores between LLM and human reviewers showed substantial agreement (Cohen's kappa: 0.69, 95% CI 0.61-0.76), with major discrepancies in only 4.7% of responses. LLM achieved high thematic classification accuracy (0.868, 95% CI 0.853-0.881), comparable to inter-rater agreement among human reviewers (0.867, 95% CI 0.836-0.901). LLMs enabled large-scale visual analysis, comparing response statistics across sites, questions, and classes. LLMs efficiently analyzed patient perspectives in EFIC interviews, showing substantial sentiment assessment and thematic classification performance. However, occasional underperformance suggests LLMs should complement, not replace, human judgment. Future work should evaluate LLM integration in EFIC to enhance efficiency, reduce subjectivity, and support accurate patient perspective analysis.

BACKGROUND: Targeted temperature management (TTM) is a common therapeutic intervention, yet its cost-effectiveness remains uncertain. This study aimed to evaluate the real-world cost-effectiveness of TTM compared with that of conventional care in adult out-of-hospital cardiac arrest (OHCA) survivors using clinical patient-level data. METHODS: We conducted a retrospective cohort study at an academic medical center in the USA to assess the cost-effectiveness of TTM in adult non-traumatic OHCA survivors between 1 January, 2019 and 30 June, 2023. The primary outcome was survival to hospital discharge. Incremental cost-effectiveness ratios (ICERs) were calculated and compared with various decision makers willingness to pay. Cost-effectiveness acceptability curves were utilized to evaluate the economic attractiveness of TTM. Uncertainty about the incremental cost and effect was explored with a 95% confidence ellipse. RESULTS: Among 925 non-traumatic OHCA survivors, only 30 (3%) received TTM. After adjusting for potential confounders, the TTM group did not demonstrate a significantly lower cost (delta cost -$5,141, 95% confidence interval [95% CI]: $-35,347 to $25,065, P=0.79) and higher survival to hospital discharge (delta effect 6%, 95% CI: -11% to 23%, P=0.41). Additionally, a 95% confidence ellipse indicated uncertainty reflected by evidence that the true value of the ICER could be in any of the quadrants of the cost-effectiveness plane. CONCLUSION: Although TTM did not demonstrate a clear survival benefit in this study, its potential cost-effectiveness warrants further investigation with larger sample sizes. These findings highlight the need for additional research to optimize TTM use in OHCA care and inform resource allocation decisions.

ImportanceThe incidence of opioid-associated out-of-hospital cardiac arrest (OA-OHCA) has grown from less than 1% of OHCA in 2000 to between 7% and 14% of OHCA in recent years; American Heart Association (AHA) protocols suggest that emergency medical service (EMS) clinicians consider naloxone in OA-OHCA. However, it is unknown whether naloxone improves survival in these patients or in patients with undifferentiated OHCA.ObjectiveTo evaluate the association of naloxone with clinical outcomes in patients with undifferentiated OHCA.Design, setting, and participantsRetrospective cohort study of EMS-treated patients aged 18 or older who received EMS treatment for nontraumatic OHCA in 3 Northern California counties between 2015 and 2023. Data were analyzed using propensity score-based models from February to April 2024.ExposureEMS administration of naloxone.Main outcomes and measuresThe primary outcome was survival to hospital discharge; the secondary outcome was sustained return of spontaneous circulation (ROSC). Covariates included patient and cardiac arrest characteristics (eg, age, sex, nonshockable rhythm, any comorbidity, unwitnessed arrest, and EMS agency) and EMS clinician determination of OHCA cause as presumed drug-related.ResultsAmong 8195 patients (median [IQR] age, 65 [51-78] years; 5540 male [67.6%]; 1304 Asian, Native Hawaiian, or Pacific Islander [15.9%]; 1119 Black [13.7%]; 2538 White [31.0%]) with OHCA treated by 5 EMS agencies from 2015 to 2023, 715 (8.7%) were believed by treating clinicians to have drug-related OHCA. Naloxone was administered to 1165 patients (14.2%) and was associated with increased ROSC using both nearest neighbor propensity matching (absolute risk difference [ARD], 15.2%; 95% CI, 9.9%-20.6%) and inverse propensity-weighted regression adjustment (ARD, 11.8%; 95% CI, 7.3%-16.4%). Naloxone was also associated with increased survival to hospital discharge using both nearest neighbor propensity matching (ARD, 6.2%; 95% CI, 2.3%-10.0%) and inverse propensity-weighted regression adjustment (ARD, 3.9%; 95% CI, 1.1%-6.7%). The number needed to treat with naloxone was 9 for ROSC and 26 for survival to hospital discharge. In a regression model that assessed effect modification between naloxone and presumed drug-related OHCA, naloxone was associated with improved survival to hospital discharge in both the presumed drug-related OHCA (odds ratio [OR], 2.48; 95% CI, 1.34-4.58) and non-drug-related OHCA groups (OR, 1.35; 95% CI, 1.04-1.77).Conclusions and relevanceIn this retrospective cohort study, naloxone administration as part of EMS management of OHCA was associated with increased rates of ROSC and increased survival to hospital discharge when evaluated using propensity score-based models. Given the lack of clinical practice data on the efficacy of naloxone in OA-OHCA and OHCA in general, these findings support further evaluation of naloxone as part of cardiac arrest care.

Introduction: The objective of this study was to compare long-term neurological outcomes in low-risk patients with traumatic intracranial hemorrhage (tICH) admitted to the ICU (intensive care unit) versus patients admitted to the floor. Methods: This retrospective study was conducted at a Level 1 trauma center from October 1, 2008, to February 1, 2013. We defined low-risk patients as age less than 65 years, isolated head injury, normal admission mental status, and no shift or swelling on initial head CT (computed tomography). Clinical data were abstracted from a trauma registry and linked to a brain injury database. We compared the Extended Glasgow Outcome Scale (GOS-E) score at six months between patients admitted to the ICU and patients admitted to the floor. We did a risk-adjusted analysis of the influence of floor admission on a normal GOS-E. Results: We identified 151 patients; 45 (30%) were admitted to the floor and 106 (70%) to the ICU. Twenty-three (51%; 95% CI [36-66%]) patients admitted to the floor and 55 (52%; 95% CI [42-62%]) patients admitted to the ICU had a normal GOS-E. On adjusted analysis; the odds ratio for floor admission was 0.77 (95% CI [0.36-1.64]) for a normal GOS-E at six months. Conclusion: Long-term neurological outcomes in low-risk patients with tICH were not markedly different between patients admitted to the ICU and those admitted to the floor. However, we were unable to demonstrate non-inferiority on adjusted analysis. Future work aimed at a larger, prospective cohort may better evaluate the relative impacts of admission type on outcomes. [West J Emerg Med. 2015;16(2):284–290.]

BackgroundExtracorporeal cardiopulmonary resuscitation (ECPR) is commonly initiated for adults experiencing cardiac arrest within the cardiac catheterization lab or the intensive care unit. However, the potential benefit of ECPR for these patients in the emergency department (ED) remains undocumented. This study aims to assess the benefit of ECPR initiated in the ED for patients with out-of-hospital cardiac arrest (OHCA).MethodsWe conducted a systematic review and meta-analysis of studies comparing ECPR initiated in the ED versus conventional CPR. Relevant articles were identified by searching several databases including PubMed, EMBASE, Web of Science, and Cochrane collaborations up to July 31, 2022. Pooled estimates were calculated using the inverse variance heterogeneity method, while heterogeneity was evaluated using Q and I2 statistics. The risk of bias in included studies was evaluated using validated bias assessment tools. The primary outcome was a favorable neurological outcome at hospital discharge, and the secondary outcome was survival to hospital discharge or 30-day survival. Sensitivity analyses were performed to explore the benefits of ED-initiated ECPR in studies utilizing propensity score (PPS) analysis. Publication bias was assessed using Doi plots and the Luis Furuya-Kanamori (LFK) index.ResultsThe meta-analysis included a total of eight studies comprising 51,173 patients. ED-initiated ECPR may not be associated with a significant increase in favorable neurological outcomes (odds ratio [OR] 1.43, 95% confidence interval [CI] 0.30-6.70, I2 = 96%). However, this intervention may be linked to improved survival to hospital discharge (OR 3.34, 95% CI 2.23-5.01, I2 = 17%). Notably, when analyzing only PPS data, ED-initiated ECPR demonstrated efficacy for both favorable neurological outcomes (OR 1.89, 95% CI 1.26-2.83, I2 = 21%) and survival to hospital discharge (OR 3.37, 95% CI 1.52-7.49, I2 = 57%). Publication bias was detected for primary (LFK index 2.50) and secondary (LFK index 2.14) outcomes.ConclusionThe results of this study indicate that ED-initiated ECPR may not offer significant benefits in terms of favorable neurological outcomes for OHCA patients. However, it may be associated with increased survival to hospital discharge. Future studies should prioritize randomized trials with larger sample sizes and strive for homogeneity in patient populations to obtain more robust evidence in this area.

Current guidelines for treating cardiac arrest recommend administering 1 mg of epinephrine every 3−5 min. However, this interval is based solely on expert opinion. We aimed to investigate the impact of the epinephrine administration interval (EAI) on resuscitation outcomes in adults with cardiac arrest. We systematically reviewed the PubMed, EMBASE, and Scopus databases. We included studies comparing different EAIs in adult cardiac arrest patients with reported neurological outcomes. Pooled estimates were calculated using the IVhet meta-analysis, and the heterogeneities were assessed using Q and I2 statistics. We evaluated the study risk of bias and overall quality using validated bias assessment tools. Three studies were included. All were classified as “good quality” studies. Only two reported the primary outcome. Compared with a recommended EAI of 3−5 min, a favorable neurological outcome was not significantly different in patients with the other frequencies: for 5 min, OR 1.01 (95% CI: 0.55−1.87). For survival to hospital discharge, administering epinephrine for less than 3 min was not associated with a good outcome (OR 1.66, 95% CI: 0.89−3.10). Moreover, EAI of >5 min did not pose a benefit (OR 0.87, 95% CI: 0.68−1.11). Our review showed that EAI during CPR was not associated with better hospital outcomes. Further clinical trials are necessary to determine the optimal dosing interval for epinephrine in adults with cardiac arrest.

Study objectiveThe objective of this study was to conduct a systematic review and meta-analysis of the diagnostic accuracy of the clinical signs, symptoms, laboratory investigations, and imaging modalities commonly used in patients with clinically suspected renal colic.MethodsWe conducted this systematic review and meta-analysis according to an a priori, registered protocol (PROSPERO CRD42017055153). A literature search was performed using MEDLINE and EMBASE from inception to July 2, 2020. We assessed the risk of bias using Quality Assessment of Diagnostic Accuracy Studies-2, calculated likelihood ratios (LRs), and applied a random-effects model for meta-analysis.ResultsAmong 7641 references screened, 76 were included in the systematic review and 53 were included in the meta-analyis. The overall pooled prevalence for ureteral stones was 63% (95% confidence interval [CI], 58%-67%). No individual demographic feature, symptom, or sign when present had an LR+ ≥2.0 for identifying ureterolithiasis. A (Sex, Timing and Origin of pain, race, presence or absence of Nausea, and Erythrocytes) STONE score ≥10 increased (sensitivity 0.49, specificity 0.91, LR 5.3 [95% CI, 4.1-6.7]) and a STONE score

BackgroundThe antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We assessed the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.MethodsSeverely injured children (0 up to 18th birthday) were randomized into a double-blind randomized trial of (1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/h infusion over 8 h, (2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/h infusion over 8 h, or (3) normal saline placebo bolus and infusion. The trial was conducted at four pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month.ResultsA total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 h (SD 0.6 h). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (nine patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified.ConclusionBased on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.

AbstractA previous study demonstrated that the Pediatric Quality of Life Inventory, a health-related quality-of-life instrument consisting of physical and psychosocial domain scores, reliably differentiates between children with varying severities of traumatic brain injuries (N = 729) 3, 12, and 24 mos after injury. However, the Pediatric Quality of Life Inventory physical domain score alone may simplify evaluation outcomes in physical rehabilitation and clinical research when comparing different trauma interventions. Therefore, we performed a secondary analysis to evaluate and compare the discriminative capacity of traumatic brain injury severity for changes in the overall Pediatric Quality of Life Inventory or the Pediatric Quality of Life Inventory physical domain score alone. We used linear mixed models to assess the change of outcome scores from baseline compared with arm-injury controls. Somers' D was calculated to compare discriminatory capacity with injury severity as a predictor of change in Pediatric Quality of Life Inventory outcome scores. We found that traumatic brain injury severity in children can be differentiated by the Pediatric Quality of Life Inventory physical domain score alone. However, at all follow-up time points, traumatic brain injury severity had higher discriminatory capacity for changes in the overall Pediatric Quality of Life Inventory. Our results suggest that the overall Pediatric Quality of Life Inventory should be used preferentially in children with traumatic brain injuries, although further investigation of the physical domain is warranted in conditions where physical injuries may predominate.

ObjectivesCritically ill children frequently receive plasma and platelet transfusions. We sought to determine evidence-based recommendations, and when evidence was insufficient, we developed expert-based consensus statements about decision-making for plasma and platelet transfusions in critically ill pediatric patients.DesignSystematic review and consensus conference series involving multidisciplinary international experts in hemostasis, and plasma/platelet transfusion in critically ill infants and children (Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding [TAXI-CAB]).SettingNot applicable.PatientsChildren admitted to a PICU at risk of bleeding and receipt of plasma and/or platelet transfusions.InterventionsNone.Measurements and main resultsA panel of 29 experts in methodology, transfusion, and implementation science from five countries and nine pediatric subspecialties completed a systematic review and participated in a virtual consensus conference series to develop recommendations. The search included MEDLINE, EMBASE, and Cochrane Library databases, from inception to December 2020, using a combination of subject heading terms and text words for concepts of plasma and platelet transfusion in critically ill children. Four graded recommendations and 49 consensus expert statements were developed using modified Research and Development/UCLA and Grading of Recommendations, Assessment, Development, and Evaluation methodology. We focused on eight subpopulations of critical illness (1, severe trauma, intracranial hemorrhage, or traumatic brain injury; 2, cardiopulmonary bypass surgery; 3, extracorporeal membrane oxygenation; 4, oncologic diagnosis or hematopoietic stem cell transplantation; 5, acute liver failure or liver transplantation; 6, noncardiac surgery; 7, invasive procedures outside the operating room; 8, sepsis and/or disseminated intravascular coagulation) as well as laboratory assays and selection/processing of plasma and platelet components. In total, we came to consensus on four recommendations, five good practice statements, and 44 consensus-based statements. These results were further developed into consensus-based clinical decision trees for plasma and platelet transfusion in critically ill pediatric patients.ConclusionsThe TAXI-CAB program provides expert-based consensus for pediatric intensivists for the administration of plasma and/or platelet transfusions in critically ill pediatric patients. There is a pressing need for primary research to provide more evidence to guide practitioners.

ObjectivesTo present consensus statements and supporting literature for plasma and platelet transfusions in critically ill children with severe trauma, traumatic brain injury, and/or intracranial hemorrhage from the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding.DesignSystematic review and consensus conference of international, multidisciplinary experts in platelet and plasma transfusion management of critically ill children.SettingNot applicable.PatientsCritically ill neonates and children with severe trauma, traumatic brain injury, and/or intracranial hemorrhage.InterventionsNone.Measurements and main resultsA panel of eight experts developed expert-based statements for plasma and platelet transfusions in critically ill neonates and children with severe trauma, traumatic brain injury, and/or intracranial hemorrhage. These statements were reviewed and ratified by the 29 Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding experts. A systematic review was conducted using MEDLINE, EMBASE, and Cochrane Library databases, from inception to December 2020. Consensus was obtained using the Research and Development/University of California, Los Angeles Appropriateness Method. Results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method. We developed one good practice statement and six expert consensus statements.ConclusionsThe lack of evidence precludes proposing recommendations on monitoring of the coagulation system and on plasma and platelets transfusion in critically ill pediatric patients with severe trauma, severe traumatic brain injury, or nontraumatic intracranial hemorrhage.

BackgroundFederal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries.MethodsWe conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC.ResultsWe enrolled one of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, seven (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months.ConclusionsIn a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.

BackgroundTrauma is the leading cause of death and disability in children in the USA. Tranexamic acid (TXA) reduces the blood transfusion requirements in adults and children during surgery. Several studies have evaluated TXA in adults with hemorrhagic trauma, but no randomized controlled trials have occurred in children with trauma. We propose a Bayesian adaptive clinical trial to investigate TXA in children with brain and/or torso hemorrhagic trauma.Methods/designWe designed a double-blind, Bayesian adaptive clinical trial that will enroll up to 2000 patients. We extend the traditional Emax dose-response model to incorporate a hierarchical structure so multiple doses of TXA can be evaluated in different injury populations (isolated head injury, isolated torso injury, or both head and torso injury). Up to 3 doses of TXA (15 mg/kg, 30 mg/kg, and 45 mg/kg bolus doses) will be compared to placebo. Equal allocation between placebo, 15 mg/kg, and 30 mg/kg will be used for an initial period within each injury group. Depending on the dose-response curve, the 45 mg/kg arm may open in an injury group if there is a trend towards increasing efficacy based on the observed relationship using the data from the lower doses. Response-adaptive randomization allows each injury group to differ in allocation proportions of TXA so an optimal dose can be identified for each injury group. Frequent interim stopping periods are included to evaluate efficacy and futility. The statistical design is evaluated through extensive simulations to determine the operating characteristics in several plausible scenarios. This trial achieves adequate power in each injury group.DiscussionThis trial design evaluating TXA in pediatric hemorrhagic trauma allows for three separate injury populations to be analyzed and compared within a single study framework. Individual conclusions regarding optimal dosing of TXA can be made within each injury group. Identifying the optimal dose of TXA, if any, for various injury types in childhood may reduce death and disability.

ObjectiveWe evaluated the acceptability of the Pediatric Quality of Life Inventory (PedsQL) and other outcomes as the primary outcomes for a pediatric hemorrhagic trauma trial (TIC-TOC) among clinicians.MethodsWe conducted a mixed-methods study that included an electronic questionnaire followed by teleconference discussions. Participants confirmed or rejected the PedsQL as the primary outcome for the TIC-TOC trial and evaluated and proposed alternative primary outcomes. Responses were compiled and a list of themes and representative quotes was generated.Results73 of 91 (80%) participants completed the questionnaire. 61 (84%) participants agreed that the PedsQL is an appropriate primary outcome for children with hemorrhagic brain injuries. 32 (44%) participants agreed that the PedsQL is an acceptable primary outcome for children with hemorrhagic torso injuries, 27 (38%) participants were neutral, and 13 (18%) participants disagreed. Several themes were identified from responses, including that the PedsQL is an important and patient-centered outcome but may be affected by other factors, and that intracranial hemorrhage progression assessed by brain imaging (among patients with brain injuries) or blood product transfusion requirements (among patients with torso injuries) may be more objective outcomes than the PedsQL.ConclusionsThe PedsQL was a well-accepted proposed primary outcome for children with hemorrhagic brain injuries. Traumatic intracranial hemorrhage progression was favored by a subset of clinicians. A plurality of participants also considered the PedsQL an acceptable outcome for children with hemorrhagic torso injuries. Blood product transfusion requirement was favored by fewer participants.

BackgroundMcKesson's InterQual criteria are widely used in hospitals to determine if patients should be classified as observation or inpatient status, but the accuracy of the criteria is unknown.ObjectiveWe sought to determine whether InterQual criteria accurately predicted length of stay (LOS) in older patients with syncope.MethodsWe conducted a secondary analysis of a cohort study of adults ≥60 years of age who had syncope. We calculated InterQual criteria and classified the patient as observation or inpatient status. Outcomes were whether LOS were less than or greater than 2 midnights.ResultsWe analyzed 2361 patients; 1227 (52.0%) patients were male and 1945 (82.8%) were white, with a mean age of 73.2 ± 9.0 years. The median LOS was 32.6 h (interquartile range 24.2-71.8). The sensitivity of InterQual criteria for LOS was 60.8% (95% confidence interval 57.9-63.6%) and the specificity was 47.8% (95% confidence interval 45.0-50.5%).ConclusionsIn older adults with syncope, those who met InterQual criteria for inpatient status had longer LOS compared with those who did not; however, the accuracy of the criteria to predict length of stay over 2 days is poor, with a sensitivity of 60% and a specificity of 48%. Future research should identify criteria to improve LOS prediction.

STUDY OBJECTIVE:In the current era of frequent chest computed tomography (CT) for adult blunt trauma evaluation, many minor injuries are diagnosed, potentially rendering traditional teachings obsolete. We seek to update teachings in regard to thoracic spine fracture by determining how often such fractures are observed on CT only (ie, not visualized on preceding trauma chest radiograph), the admission rate, mortality, and hospital length of stay of thoracic spine fracture patients, and how often thoracic spine fractures are clinically significant. METHODS:This was a preplanned analysis of prospectively collected data from the NEXUS Chest CT study conducted from 2011 to 2014 at 9 Level I trauma centers. The inclusion criteria were older than 14 years, blunt trauma occurring within 6 hours of emergency department (ED) presentation, and chest imaging (radiography, CT, or both) during ED evaluation. RESULTS:Of 11,477 enrolled subjects, 217 (1.9%) had a thoracic spine fracture; 181 of the 198 thoracic spine fracture patients (91.4%) who had both chest radiograph and CT had their thoracic spine fracture observed on CT only. Half of patients (49.8%) had more than 1 level of thoracic spine fracture, with a mean of 2.1 levels (SD 1.6 levels) of thoracic spine involved. Most patients (62%) had associated thoracic injuries. Compared with patients without thoracic spine fracture, those with it had higher admission rates (88.5% versus 47.2%; difference 41.3%; 95% confidence interval 36.3% to 45%), higher mortality (6.3% versus 4.0%; difference 2.3%; 95% confidence interval 0 to 6.7%), and longer length of stay (median 9 versus 6 days; difference 3 days; P

OBJECTIVES:The CRASH-2 trial demonstrated that tranexamic acid (TXA) in adults with significant traumatic hemorrhage safely reduces mortality. Given that the CRASH-2 trial did not include U.S. sites, our objective was to evaluate patient characteristics, TXA dosing strategies, and the incidence of mortality and adverse events in adult trauma patients receiving TXA at a U.S. Level I trauma center in the post-CRASH-2 era. METHODS:We conducted a retrospective study that included patients aged 18 years or older who received TXA after an acute injury from July 2014 to June 2017. We excluded patients who received TXA orally, patients who received TXA for elective surgical procedures or nontrauma indications, patients who received it 8 hours or longer after the time of injury, and patients with cardiac arrest at time of emergency department arrival. Trained abstractors collected data from the trauma registry and hospital electronic medical records. Our primary outcome measures were in-hospital death and acute thromboembolic events within 28 days from injury. RESULTS:We included 273 patients with a mean (±SD) age of 43.8 (±18.7)  years. The mean (±SD) time of administration of TXA from time of injury was 1.55 (±1.2)  hours with 229 patients (83.9%) receiving TXA within 3 hours. The overall mortality within 28 days from injury was 12.8% (95% confidence interval [CI] = 8.9% to 16.7%), which was similar compared to that in the CRASH-2 trial (14.5%, 95% CI = 13.9% to 15.2%). The incidence of acute thromboembolic events was 6.6% (95% CI = 3.7% to 9.5%), which was higher than that in the CRASH-2 trial (2.0%, 95% CI = 1.73% to 2.27%). Patients in our cohort also received surgery (64.8% vs. 47.9%) and blood transfusions (74.0% vs. 50.4%) more frequently than those in the CRASH-2 cohort. CONCLUSIONS:Adult trauma patients receiving TXA had similar incidences of death but higher incidences of thromboembolic events compared to the CRASH-2 trial. Variation in patient characteristics, injury severity, TXA dosing, and surgery and transfusion rates could explain these observed differences. Further research is necessary to provide additional insight into the incidence and risk factors of thromboembolic events in TXA use.

BACKGROUND:In the era of frequent head-to-pelvis computed tomography (CT) for adult blunt trauma evaluation, we sought to update teachings regarding aortic injury by determining 1) the incidence of aortic injury; 2) the proportion of patients with isolated aortic injury (without other concomitant thoracic injury); 3) the clinical implications of aortic injury (hospital mortality, length of stay [LOS], and rate of surgical interventions); and 4) the screening value of traditional risk factors/markers (such as high-energy mechanism and widened mediastinum on chest x-ray [CXR]) for aortic injury, compared to newer criteria from the recently developed NEXUS Chest CT decision instrument (DI). METHODS:We conducted a preplanned analysis of patients prospectively enrolled in the NEXUS Chest studies at 10 Level I trauma centers with the following inclusion criteria: age > 14 years, blunt trauma within 6 hours of ED presentation, and receiving chest imaging during ED trauma evaluation. RESULTS:Of 24,010 enrolled subjects, 42 (0.17%, 95% confidence interval [CI] = 0.13% to 0.24%) had aortic injury. Most patients (79%, 95% CI = 64% to 88%) had an associated thoracic injury, with rib fractures, pneumothorax/hemothorax, and pulmonary contusion occurring most frequently. Compared to patients without aortic injury this cohort had similar mortality (9.5%, 95% CI = 3.8% to 22.1% vs. 5.8%, 95% CI = 5.4% to 6.3%), longer median hospital LOS (11 days vs. 3 days, p

Study objectiveOlder adults with syncope are commonly treated in the emergency department (ED). We seek to derive a novel risk-stratification tool to predict 30-day serious cardiac outcomes.MethodsWe performed a prospective, observational study of older adults (≥60 years) with unexplained syncope or near syncope who presented to 11 EDs in the United States. Patients with a serious diagnosis identified in the ED were excluded. We collected clinical and laboratory data on all patients. Our primary outcome was 30-day all-cause mortality or serious cardiac outcome.ResultsWe enrolled 3,177 older adults with unexplained syncope or near syncope between April 2013 and September 2016. Mean age was 73 years (SD 9.0 years). The incidence of the primary outcome was 5.7% (95% confidence interval [CI] 4.9% to 6.5%). Using Bayesian logistic regression, we derived the FAINT score: history of heart failure, history of cardiac arrhythmia, initial abnormal ECG result, elevated pro B-type natriuretic peptide, and elevated high-sensitivity troponin T. A FAINT score of 0 versus greater than or equal to 1 had sensitivity of 96.7% (95% CI 92.9% to 98.8%) and specificity 22.2% (95% CI 20.7% to 23.8%), respectively. The FAINT score tended to be more accurate than unstructured physician judgment: area under the curve 0.704 (95% CI 0.669 to 0.739) versus 0.630 (95% CI 0.589 to 0.670).ConclusionAmong older adults with syncope or near syncope of potential cardiac cause, a FAINT score of zero had a reasonably high sensitivity for excluding death and serious cardiac outcomes at 30 days. If externally validated, this tool could improve resource use for this common condition.

Objective: To evaluate the accuracy of emergency medical services (EMS) provider judgment for traumatic intracranial hemorrhage (tICH) in older patients following head trauma in the field. We also compared EMS provider judgment with other sets of field triage criteria. Methods: This was a prospective observational cohort study conducted with five EMS agencies and 11 hospitals in Northern California. Patients 55 years and older who experienced blunt head trauma were transported by EMS between August 1, 2015 and September 30, 2016, and received an initial cranial computed tomography (CT) imaging, were eligible. EMS providers were asked, "What is your suspicion for the patient having intracranial hemorrhage (bleeding in the brain)?" Responses were recorded as ordinal categories (5-10%, >10-50%, or >50%) and the incidences of tICH were recorded for each category. The accuracy of EMS provider judgment was compared to other sets of triage criteria, including current field triage criteria, current field triage criteria plus multivariate logistical regression risk factors, and actual transport. Results: Among the 673 patients enrolled, 319 (47.0%) were male and the median age was 75 years (interquartile range 64-85). Seventy-six (11.3%) patients had tICH on initial cranial CT imaging. The increase in EMS provider judgment correlated with an increase in the incidence of tICH. EMS provider judgment had a sensitivity of 77.6% (95% CI 67.1-85.5%) and a specificity of 41.5% (37.7-45.5%) when using a threshold of 1% or higher suspicion for tICH. Current field triage criteria (Steps 1-3) was poorly sensitive (26.3%, 95% CI 17.7-37.2%) in identifying tICH and current field trial criteria plus multivariate logistical regression risk factors was sensitive (97.4%, 95% CI 90.9-99.3%) but poorly specific (12.9%, 95% CI 10.4-15.8%). Actual transport was comparable to EMS provider judgment (sensitivity 71.1%, 95% CI 60.0-80.0%; specificity 35.3%, 95% CI 31.6-38.3%). Conclusions: As EMS provider judgment for tICH increased, the incidence for tICH also increased. EMS provider judgment, using a threshold of 1% or higher suspicion for tICH, was more accurate than current field triage criteria, with and without additional risk factors included.

BackgroundOlder adults with isolated rib fractures are often admitted to an intensive care unit (ICU) because of presumedly increased morbidity and mortality. However, evidence-based guidelines are limited. We sought to identify characteristics of these patients that predict the need for ICU care.Materials and methodsWe analyzed patients ≥50 y old at our center during 2013-2017 whose only indication for ICU admission, if any, was isolated rib fractures. The primary outcome was any critical care intervention (e.g., intubation) or adverse event (e.g., hypoxemia) (CCIE) based on accepted critical care guidelines. We used stepwise logistic regression to identify characteristics that predict CCIEs.ResultsAmong 401 patients, 251 (63%) were admitted to an ICU. Eighty-three patients (33%) admitted to an ICU and 7 (5%) admitted to the ward experienced a CCIE. The most common CCIEs were hypotension (10%), frequent respiratory therapy (9%), and oxygen desaturation (8%). Predictors of CCIEs included incentive spirometry

The surgical guidelines for male breast cancer (MBC) have been largely guided by female-predominant clinical trials. Because no clinical trial has been conducted to examine the surgical treatment of MBC, we performed a systematic review comparing the survival of patients with MBC who had undergone breast conserving surgery (BCS) and those who had undergone mastectomy and evaluated the patients' radiotherapy compliance after BCS. We performed a systematic search of electronic databases to find MBC cohort studies that had reported ≥ 1 survival outcome (disease-free survival [DFS], disease-specific survival [DSS], or overall survival [OS]) stratified by surgical treatment (BCS and/or mastectomy) and/or radiotherapy compliance with BCS. A total of 1 prospective and 9 retrospective cohort studies were included, with the number of patients ranging from 7 to 6039. Of the BCS patients, compliance with postoperative radiotherapy was low (range, 27%-46%), with the exception of 1 single-institution prospective study that reported 86% compliance (6 of 7 patients). The pooled estimate for all patients with MBC was 83% (95% confidence interval [CI], 78%-88%) for 5-year DSS and 66% (95% CI, 63%-70%) for 5-year OS. Most studies reported no differences in DFS, DSS, or OS for BCS and mastectomy. BCS is a reasonable treatment approach for MBC because it was associated with oncologic outcomes similar to those with mastectomy. However, the low rates of radiotherapy compliance among male patients who underwent BCS is concerning and highlights the importance of shared decision-making with patients with MBC when selecting a surgical treatment strategy.

BackgroundSyncope is a common chief complaint among older adults in the Emergency Department (ED), and orthostatic vital signs are often a part of their evaluation. We assessed whether abnormal orthostatic vital signs in the ED are associated with composite 30-day serious outcomes in older adults presenting with syncope.MethodsWe performed a secondary analysis of a prospective, observational study at 11 EDs in adults ≥ 60 years who presented with syncope or near syncope. We excluded patients lost to follow up. We used the standard definition of abnormal orthostatic vital signs or subjective symptoms of lightheadedness upon standing to define orthostasis. We determined the rate of composite 30-day serious outcomes, including those during the index ED visit, such as cardiac arrhythmias, myocardial infarction, cardiac intervention, new diagnosis of structural heart disease, stroke, pulmonary embolism, aortic dissection, subarachnoid hemorrhage, cardiopulmonary resuscitation, hemorrhage/anemia requiring transfusion, with major traumatic injury from fall, recurrent syncope, and death) between the groups with normal and abnormal orthostatic vital signs.ResultsThe study cohort included 1974 patients, of whom 51.2% were male and 725 patients (37.7%) had abnormal orthostatic vital signs. Comparing those with abnormal to those with normal orthostatic vital signs, we did not find a difference in composite 30-serious outcomes (111/725 (15.3%) vs 184/1249 (14.7%); unadjusted odds ratio, 1.05 [95%CI, 0.81-1.35], p = 0.73). After adjustment for gender, coronary artery disease, congestive heart failure (CHF), history of arrhythmia, dyspnea, hypotension, any abnormal ECG, physician risk assessment, medication classes and disposition, there was no association with composite 30-serious outcomes (adjusted odds ratio, 0.82 [95%CI, 0.62-1.09], p = 0.18).ConclusionsIn a cohort of older adult patients presenting with syncope who were able to have orthostatic vital signs evaluated, abnormal orthostatic vital signs did not independently predict composite 30-day serious outcomes.

BackgroundThere is wide variability of transfusion practices for children with hemorrhagic injuries across trauma centers. We are planning a multicenter, randomized clinical trial evaluating tranexamic acid in children with hemorrhage. Standardization of transfusion practices across sites is important to minimize confounding. Therefore, we sought to generate consensus-based transfusion guidelines for the trial.MethodsWe used a modified Delphi process utilizing a multi-site, multi-disciplinary panel of experts to develop our transfusion guidelines. A survey of 23 clinical categories on various aspects of transfusion practices was developed and distributed via SurveyMonkey®. Statements were graded on a 5-point Likert scale ("Strongly agree" to "This intervention may be harmful"). Statements were accepted if ≥ 80% of the panelists rated the statement as "Strongly agree" or "Agree". After each round, the responses were calculated and the results included on subsequent rounds.Results35 panelists from four pediatric trauma centers participated in the study, including 11 (31%) pediatric EM physicians, 8 (23%) pediatric trauma surgeons, 5 (14%) transfusionists, 5 (14%) pediatric anesthesiologists, and 6 (17%) pediatric critical care physicians (range of 8 to 10 from each clinical site). Four survey iterations were performed. In total 176 statements were rated and 39 were accepted by criteria across all 23 categories. An rational algorithm for transfusion in trauma was then developed.ConclusionsWe successfully developed transfusion guidelines for various aspects of the management of children with hemorrhagic injuries using a modified Delphi process with broad interdisciplinary participation. We anticipate implementation of these guidelines will help minimize heterogeneity of transfusion practices across clinical sites for the upcoming clinical trial evaluating tranexamic acid in children with hemorrhage.

ObjectivesCommunity consultation is required for clinical trials considering federal exception from informed consent (EFIC) procedures. Questions remain about the value of the community consult process and whether it adds intended protections to study subjects. Public deliberation methods that provide baseline participant education and elicit values and opinions about consent options is a novel approach for community consultation. This study evaluated the use of structured public deliberation methods to assess a community's values and opinions about informed consent procedures for a pediatric trauma trial.MethodsThis was a mixed-methods descriptive study of public deliberation sessions assessing participants' opinions about informed consent procedures for a pediatric trauma randomized controlled trial (RCT). Participants from communities with high rates of pediatric trauma were recruited via community-based organizations and social media. Deliberation focused on three consent options for a proposed RCT: 1) enrollment using EFIC procedures with no attempt to obtain informed consent, 2) enrollment using EFIC procedures after attempting to reach a parent, or 3) enrollment only with informed consent. Participant demographic data and their opinions about the proposed study and deliberative session were also collected.ResultsThere were 102 participants across eight sessions (range of nine to 15/session, mean of 13). Most participants were female (n = 78, 76%) and a plurality were black (n = 48, 47%). The majority of participants preferred enrollment using EFIC procedures only after an attempt was made to reach a parent and informed consent was not possible (n = 56, 55%), followed by enrollment using EFIC procedures with no attempt to obtain informed consent (n = 32, 32%), and enrollment only with written informed consent (n = 13, 13%). One participant declined all options. Eighty-four participants (82%) agreed or strongly agreed that the RCT was important to do, and 79 participants (77%) said that the sessions provided enough information to make an informed decision about the proposed RCT.ConclusionsStructured public deliberation is an effective approach when consulting communities for trials considering EFIC procedures. Future studies are needed to evaluate whether public deliberation methods provide participants with enhanced understanding of clinical trials compared to other community consultation methods.

Study objectiveMany adults with syncope are hospitalized solely for observation and testing. We seek to determine whether hospitalization versus outpatient management for older adults with unexplained syncope is associated with a reduction in postdisposition serious adverse events at 30 days.MethodsWe performed a propensity score analysis using data from a prospective, observational study of older adults with unexplained syncope or near syncope who presented to 11 emergency departments (EDs) in the United States. We enrolled adults (≥60 years) who presented with syncope or near syncope. We excluded patients with a serious diagnosis identified in the ED. Clinical and laboratory data were collected on all patients. The primary outcome was rate of post-ED serious adverse events at 30 days.ResultsWe enrolled 2,492 older adults with syncope and no serious ED diagnosis from April 2013 to September 2016. Mean age was 73 years (SD 8.9 years), and 51% were women. The incidence of serious adverse events within 30 days after the index visit was 7.4% for hospitalized patients and 3.19% for discharged patients, representing an unadjusted difference of 4.2% (95% confidence interval 2.38% to 6.02%). After propensity score matching on risk of hospitalization, there was no statistically significant difference in serious adverse events at 30 days between the hospitalized group (4.89%) and the discharged group (2.82%) (risk difference 2.07%; 95% confidence interval -0.24% to 4.38%).ConclusionIn our propensity-matched sample of older adults with unexplained syncope, for those with clinical characteristics similar to that of the discharged cohort, hospitalization was not associated with improvement in 30-day serious adverse event rates.

Almost 20% of patients with syncope will experience another event. It is unknown whether recurrent syncope is a marker for a higher or lower risk etiology of syncope. The goal of this study is to determine whether older adults with recurrent syncope have a higher likelihood of 30-day serious clinical events than patients experiencing their first episode.MethodsThis study is a pre-specified secondary analysis of a multicenter prospective, observational study conducted at 11 emergency departments in the US. Adults 60 years or older who presented with syncope or near syncope were enrolled. The primary outcome was occurrence of 30-day serious outcome. The secondary outcome was 30-day serious cardiac arrhythmia. In multivariate analysis, we assessed whether prior syncope was an independent predictor of 30-day serious events.ResultsThe study cohort included 3580 patients: 1281 (35.8%) had prior syncope and 2299 (64.2%) were presenting with first episode of syncope. 498 (13.9%) patients had 1 prior episode while 771 (21.5%) had >1 prior episode. Those with recurrent syncope were more likely to have congestive heart failure, coronary artery disease, previous diagnosis of arrhythmia, and an abnormal ECG. Overall, 657 (18.4%) of the cohort had a serious outcome by 30 days after index ED visit. In multivariate analysis, we found no significant difference in risk of events (adjusted odds ratio 1.09; 95% confidence interval 0.90-1.31; p = 0.387).ConclusionIn older adults with syncope, a prior history of syncope within the year does not increase the risk for serious 30-day events.

OBJECTIVES:An estimated 1.2 million annual emergency department (ED) visits for syncope/near syncope occur in the United States. Cardiac biomarkers are frequently obtained during the ED evaluation, but the prognostic value of index high-sensitivity troponin (hscTnT) and natriuretic peptide (NT-proBNP) are unclear. The objective of this study was to determine if hscTnT and NT-proBNP drawn in the ED are independently associated with 30-day death/serious cardiac outcomes in adult patients presenting with syncope. METHODS:A prespecified secondary analysis of a prospective, observational trial enrolling participants ≥ age 60 presenting with syncope, at 11 United States hospitals, was conducted between April 2013 and September 2016. Exclusions included seizure, stroke, transient ischemic attack, trauma, intoxication, hypoglycemia, persistent confusion, mechanical/electrical invention, prior enrollment, or predicted poor follow-up. Within 3 hours of consent, hscTnT and NT-proBNP were collected and later analyzed centrally using Roche Elecsys Gen 5 STAT and 2010 Cobas, respectively. Primary outcome was combined 30-day all-cause mortality and serious cardiac events. Adjusting for illness severity, using multivariate logistic regression analysis, variations between primary outcome and biomarkers were estimated, adjusting absolute risk associated with ranges of biomarkers using Bayesian Markov Chain Monte Carlo methods. RESULTS:The cohort included 3,392 patients; 367 (10.8%) experienced the primary outcome. Adjusted absolute risk for the primary outcome increased with hscTnT and NT-proBNP levels. HscTnT levels ≤ 5 ng/L were associated with a 4% (95% confidence interval [CI] = 3%-5%) outcome risk, and hscTnT > 50 ng/L, a 29% (95% CI = 26%-33%) risk. NT-proBNP levels ≤ 125 ng/L were associated with a 4% (95% CI = 4%-5%) risk, and NT-proBNP > 2,000 ng/L a 29% (95% CI = 25%-32%) risk. Likelihood ratios and predictive values demonstrated similar results. Sensitivity analyses excluding ED index serious outcomes demonstrated similar findings. CONCLUSIONS:hscTnT and NT-proBNP are independent predictors of 30-day death and serious outcomes in older ED patients presenting with syncope.

BACKGROUND: Targeted temperature management (TTM) is a common therapeutic intervention, yet its cost-effectiveness remains uncertain. This study aimed to evaluate the real-world cost-effectiveness of TTM compared with that of conventional care in adult out-of-hospital cardiac arrest (OHCA) survivors using clinical patient-level data. METHODS: We conducted a retrospective cohort study at an academic medical center in the USA to assess the cost-effectiveness of TTM in adult non-traumatic OHCA survivors between 1 January, 2019 and 30 June, 2023. The primary outcome was survival to hospital discharge. Incremental cost-effectiveness ratios (ICERs) were calculated and compared with various decision makers' willingness to pay. Cost-effectiveness acceptability curves were utilized to evaluate the economic attractiveness of TTM. Uncertainty about the incremental cost and effect was explored with a 95% confidence ellipse. RESULTS: Among 925 non-traumatic OHCA survivors, only 30 (3%) received TTM. After adjusting for potential confounders, the TTM group did not demonstrate a significantly lower cost (delta cost -$5,141, 95% confidence interval [95% CI]: $-35,347 to $25,065, P=0.79) and higher survival to hospital discharge (delta effect 6%, 95% CI: -11% to 23%, P=0.4l). Additionally, a 95% confidence ellipse indicated uncertainty reflected by evidence that the true value of the ICER could be in any of the quadrants of the cost-effectiveness plane. CONCLUSION: Although TTM did not demonstrate a clear survival benefit in this study, its potential cost-effectiveness warrants further investigation with larger sample sizes. These findings highlight the need for additional research to optimize TTM use in OHCA care and inform resource allocation decisions. [ABSTRACT FROM AUTHOR]

BackgroundApproximately 5% of emergency department (ED) patients with altered mental status (AMS) have non-convulsive seizures (NCS). Patients with NCS should be diagnosed with EEG as soon as possible to initiate antiepileptic treatment. Since ED physicians encounter such patients first in the ED, they should be familiar with general EEG principles as well as the EEG patterns of NCS/NCSE. We evaluated the utility of a brief training module in enhancing the ED physicians' ability to identify seizures on EEG.MethodsThis was a randomized controlled trial conducted in three academic institutions. A slide presentation was developed describing the basic principles of EEG including EEG recording techniques, followed by characteristics of normal and abnormal patterns, the goal of which was to familiarize the participants with EEG seizure patterns. We enrolled board-certified emergency medicine physicians into the trial. Subjects were randomized to control or intervention groups. Participants allocated to the intervention group received a self-learning training module and were asked to take a quiz of EEG snapshots after reviewing the presentation, while the control group took the quiz without the training.ResultsA total of 30 emergency physicians were enrolled (10 per site, with 15 controls and 15 interventions). Participants were 52% male with median years of practice of 9.5 years (3, 14). The percentage of correct answers in the intervention group (65%, 63% and 75%) was significantly different (p = 0.002) from that of control group (50%, 45% and 60%).ConclusionsA brief self-learning training module improved the ability of emergency physicians in identifying EEG seizure patterns.

Study objectiveControversy remains in regard to the risk of adverse events for patients presenting with syncope compared with near-syncope. The purpose of our study is to describe the difference in outcomes between these groups in a large multicenter cohort of older emergency department (ED) patients.MethodsFrom April 28, 2013, to September 21, 2016, we conducted a prospective, observational study across 11 EDs in adults (≥60 years) with syncope or near-syncope. A standardized data extraction tool was used to collect information during their index visit and at 30-day follow-up. Our primary outcome was the incidence of 30-day death or serious clinical events. Data were analyzed with descriptive statistics and multivariate logistic regression analysis adjusting for relevant demographic or historical variables.ResultsA total of 3,581 patients (mean age 72.8 years; 51.6% men) were enrolled in the study. There were 1,380 patients (39%) presenting with near-syncope and 2,201 (61%) presenting with syncope. Baseline characteristics revealed a greater incidence of congestive heart failure, coronary artery disease, previous arrhythmia, nonwhite race, and presenting dyspnea in the near-syncope compared with syncope cohort. There were no differences in the primary outcome between the groups (near-syncope 18.7% versus syncope 18.2%). A multivariate logistic regression analysis identified no difference in 30-day serious outcomes for patients with near-syncope (odds ratio 0.94; 95% confidence interval 0.78 to 1.14) compared with syncope.ConclusionNear-syncope confers risk to patients similar to that of syncope for the composite outcome of 30-day death or serious clinical event.

Introduction: The CRASH-2 trial demonstrated that tranexamic acid (TXA) reduced mortality with no increase in adverse events in severely injured adults. TXA has since been widely used in injured adults worldwide. Our objective was to estimate mortality and adverse events in adults with trauma receiving TXA in studies published after the CRASH-2 trial.Methods: We systematically searched PubMed, Embase, MicroMedex, and ClinicalTrials.gov for studies that included injured adults who received TXA and reported mortality and/or adverse events. Two reviewers independently assessed study eligibility, abstracted data, and assessed the risk of bias. We conducted meta-analyses using random effects models to estimate the incidence of mortality at 28 or 30 days and in-hospital thrombotic events.Results: We included 19 studies and 13 studies in the systematic review and meta-analyses, respectively. The pooled incidence of mortality at 28 or 30 days (five studies, 1538 patients) was 10.1% (95% confidence interval [CI], 7.8-12.4%) (vs 14.5% [95% CI, 13.9-15.2%] in the CRASH-2 trial), and the pooled incidence of in-hospital thrombotic events (nine studies, 1656 patients) was 5.9% (95% CI, 3.3-8.5%) (vs 2.0% [95% CI, 1.8-2.3%] in the CRASH-2 trial).Conclusion: Compared to the CRASH-2 trial, adult trauma patients receiving TXA identified in our systematic review had a lower incidence of mortality at 28 or 30 days, but a higher incidence of in-hospital thrombotic events. Our findings neither support nor refute the findings of the CRASH-2 trial but suggest that incidence rates in adults with trauma in settings outside of the CRASH-2 trial may be different than those observed in the CRASH-2 trial.

Study objectiveAlthough traditional teachings in regard to pneumothorax and hemothorax generally recommend chest tube placement and hospital admission, the increasing use of chest computed tomography (CT) in blunt trauma evaluation may detect more minor pneumothorax and hemothorax that might indicate a need to modify these traditional practices. We determine the incidence of pneumothorax and hemothorax observed on CT only and the incidence of isolated pneumothorax and hemothorax (pneumothorax and hemothorax occurring without other thoracic injuries), and describe the clinical implications of these injuries.MethodsThis was a planned secondary analysis of 2 prospective, observational studies of adult patients with blunt trauma, NEXUS Chest (January 2009 to December 2012) and NEXUS Chest CT (August 2011 to May 2014), set in 10 Level I US trauma centers. Participants' inclusion criteria were older than 14 years, presentation to the emergency department (ED) within 6 hours of blunt trauma, and receipt of chest imaging (chest radiograph, chest CT, or both) during their ED evaluation. Exposure(s) (for observational studies) were that patients had trauma and chest imaging. Primary measures and outcomes included the incidence of pneumothorax and hemothorax observed on CT only versus on both chest radiograph and chest CT, the incidence of isolated pneumothorax and hemothorax (pneumothorax and hemothorax occurring without other thoracic injuries), and admission rates, hospital length of stay, mortality, and frequency of chest tube placement for these injuries.ResultsOf 21,382 enrolled subjects, 1,064 (5%) had a pneumothorax and 384 (1.8%) had a hemothorax. Of the 8,661 patients who received both a chest radiograph and a chest CT, 910 (10.5%) had a pneumothorax, with 609 (67%) observed on CT only; 319 (3.7%) had a hemothorax, with 254 (80%) observed on CT only. Of 1,117 patients with pneumothorax, hemothorax, or both, 108 (10%) had isolated pneumothorax or hemothorax. Patients with pneumothorax observed on CT only had a lower chest tube placement rate (30% versus 65%; difference in proportions [Δ] -35%; 95% confidence interval [CI] -28% to 42%), admission rate (94% versus 99%; Δ 5%; 95% CI 3% to 8%), and median length of stay (5 versus 6 days; difference 1 day; 95% CI 0 to 2 days) but similar mortality compared with patients with pneumothorax observed on chest radiograph and CT. Patients with hemothorax observed on CT had only a lower chest tube placement rate (49% versus 68%; Δ -19%; 95% CI -31% to -5%) but similar admission rate, mortality, and median length of stay compared with patients with hemothorax observed on chest radiograph and CT. Compared with patients with other thoracic injury, those with isolated pneumothorax or hemothorax had a lower chest tube placement rate (20% versus 43%; Δ -22%; 95% CI -30% to -13%), median length of stay (4 versus 5 days; difference -1 day; 95% CI -3 to 1 days), and admission rate (44% versus 97%; Δ -53%; 95% CI -62% to -43%), with an admission rate comparable to that of patients without pneumothorax or hemothorax (49%).ConclusionUnder current imaging protocols for adult blunt trauma evaluation, most pneumothoraces and hemothoraces are observed on CT only and few occur as isolated thoracic injury. The clinical implications (admission rates and frequency of chest tube placement) of pneumothorax and hemothorax observed on CT only and isolated pneumothorax or hemothorax are lower than those of patients with pneumothorax and hemothorax observed on chest radiograph and CT and of those who have other thoracic injury, respectively.

BackgroundSyncope is a common reason for visiting the emergency department (ED) and is associated with significant healthcare resource utilization.ObjectiveTo develop a risk-stratification tool for clinically significant findings on echocardiography among older adults presenting to the ED with syncope or nearsyncope.DesignProspective, observational cohort study from April 2013 to September 2016.SettingEleven EDs in the United States.PatientsWe enrolled adults (=60 years) who presented to the ED with syncope or near-syncope who underwent transthoracic echocardiography (TTE).MeasurementsThe primary outcome was a clinically significant finding on TTE. Clinical, electrocardiogram, and laboratory variables were also collected. Multivariable logistic regression analysis was used to identify predictors of significant findings on echocardiography.ResultsA total of 3,686 patients were enrolled. Of these, 995 (27%) received echocardiography, and 215 (22%) had a significant finding on echocardiography. Regression analysis identified five predictors of significant finding: (1) history of congestive heart failure, (2) history of coronary artery disease, (3) abnormal electrocardiogram, (4) high-sensitivity troponin-T >14 pg/mL, and 5) N-terminal pro B-type natriuretic peptide >125 pg/mL. These five variables make up the ROMEO (Risk Of Major Echocardiography findings in Older adults with syncope) criteria. The sensitivity of a ROMEO score of zero for excluding significant findings on echocardiography was 99.5% (95% CI: 97.4%-99.9%) with a specificity of 15.4% (95% CI: 13.0%-18.1%).ConclusionsIf validated, this risk-stratification tool could help clinicians determine which syncope patients are at very low risk of having clinically significant findings on echocardiography.RegistrationClinicalTrials.gov Identifier NCT01802398.

BackgroundTrauma is the leading cause of morbidity and mortality in children in the United States. The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage, however, the drug has not been evaluated in a clinical trial in severely injured children. We designed the Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) trial to evaluate the feasibility of conducting a confirmatory clinical trial that evaluates the effects of TXA in children with severe trauma and hemorrhagic injuries.MethodsChildren with severe trauma and evidence of hemorrhagic torso or brain injuries will be randomized to one of three arms: (1) TXA dose A (15 mg/kg bolus dose over 20 min, followed by 2 mg/kg/hr infusion over 8 h), (2) TXA dose B (30 mg/kg bolus dose over 20 min, followed by 4 mg/kg/hr infusion over 8 h), or (3) placebo. We will use permuted-block randomization by injury type: hemorrhagic brain injury, hemorrhagic torso injury, and combined hemorrhagic brain and torso injury. The trial will be conducted at four pediatric Level I trauma centers. We will collect the following outcome measures: global functioning as measured by the Pediatric Quality of Life (PedsQL) and Pediatric Glasgow Outcome Scale Extended (GOS-E Peds), working memory (digit span test), total amount of blood products transfused in the initial 48 h, intracranial hemorrhage progression at 24 h, coagulation biomarkers, and adverse events (specifically thromboembolic events and seizures).DiscussionThis multicenter trial will provide important preliminary data and assess the feasibility of conducting a confirmatory clinical trial that evaluates the benefits of TXA in children with severe trauma and hemorrhagic injuries to the torso and/or brain.Trial registrationClinicalTrials.gov registration number: NCT02840097 . Registered on 14 July 2016.

ObjectivesSyncope and near-syncope are common in patients with dementia and a leading cause of emergency department (ED) evaluation and subsequent hospitalization. The objective of this study was to describe the clinical trajectory and short-term outcomes of patients who presented to the ED with syncope or near-syncope and were assessed by their ED provider to have dementia.MethodsThis multisite prospective cohort study included patients 60 years of age or older who presented to the ED with syncope or near-syncope between 2013 and 2016. We analyzed a subcohort of 279 patients who were identified by the treating ED provider to have baseline dementia. We collected comprehensive patient-level, utilization, and outcomes data through interviews, provider surveys, and chart abstraction. Outcome measures included serious conditions related to syncope and death.ResultsOverall, 221 patients (79%) were hospitalized with a median length of stay of 2.1 days. A total of 46 patients (16%) were diagnosed with a serious condition in the ED. Of the 179 hospitalized patients who did not have a serious condition identified in the ED, 14 (7.8%) were subsequently diagnosed with a serious condition during the hospitalization, and an additional 12 patients (6.7%) were diagnosed postdischarge within 30 days of the index ED visit. There were seven deaths (2.5%) overall, none of which were cardiac-related. No patients who were discharged from the ED died or had a serious condition in the subsequent 30 days.ConclusionsPatients with perceived dementia who presented to the ED with syncope or near-syncope were frequently hospitalized. The diagnosis of a serious condition was uncommon if not identified during the initial ED assessment. Given the known iatrogenic risks of hospitalization for patients with dementia, future investigation of the impact of goals of care discussions on reducing potentially preventable, futile, or unwanted hospitalizations while improving goal-concordant care is warranted.

Study objectiveCardiac arrhythmia is a life-threatening condition in older adults who present to the emergency department (ED) with syncope. Previous work suggests the initial ED ECG can predict arrhythmia risk; however, specific ECG predictors have been variably specified. Our objective is to identify specific ECG abnormalities predictive of 30-day serious cardiac arrhythmias in older adults presenting to the ED with syncope.MethodsWe conducted a prospective, observational study at 11 EDs in adults aged 60 years or older who presented with syncope or near syncope. We excluded patients with a serious cardiac arrhythmia diagnosed during the ED evaluation from the primary analysis. The outcome was occurrence of 30-day serous cardiac arrhythmia. The exposure variables were predefined ECG abnormalities. Independent predictors were identified through multivariate logistic regression. The sensitivities and specificities of any predefined ECG abnormality and any ECG abnormality identified on adjusted analysis to predict 30-day serious cardiac arrhythmia were also calculated.ResultsAfter exclusion of 197 patients (5.5%; 95% confidence interval [CI] 4.7% to 6.2%) with serious cardiac arrhythmias in the ED, the study cohort included 3,416 patients. Of these, 104 patients (3.0%; 95% CI 2.5% to 3.7%) had a serious cardiac arrhythmia within 30 days from the index ED visit (median time to diagnosis 2 days [interquartile range 1 to 5 days]). The presence of nonsinus rhythm, multiple premature ventricular conductions, short PR interval, first-degree atrioventricular block, complete left bundle branch block, and Q wave/T wave/ST-segment abnormalities consistent with acute or chronic ischemia on the initial ED ECG increased the risk for a 30-day serious cardiac arrhythmia. This combination of ECG abnormalities had a similar sensitivity in predicting 30-day serious cardiac arrhythmia compared with any ECG abnormality (76.9% [95% CI 67.6% to 84.6%] versus 77.9% [95% CI 68.7% to 85.4%]) and was more specific (55.1% [95% CI 53.4% to 56.8%] versus 46.6% [95% CI 44.9% to 48.3%]).ConclusionIn older ED adults with syncope, approximately 3% receive a diagnosis of a serious cardiac arrhythmia not recognized on initial ED evaluation. The presence of specific abnormalities on the initial ED ECG increased the risk for 30-day serious cardiac arrhythmias.

Field triage guidelines recommend transport of head-injured patients on anticoagulants or antiplatelets to a higher-level trauma center based on studies suggesting a high incidence of traumatic intracranial hemorrhage (tICH). We compared the incidence of tICH in older adults transported by emergency medical services (EMS) with and without anticoagulation or antiplatelet use and evaluated the accuracies of different sets of field triage criteria to identify tICH. This was a prospective, observational study at five EMS agencies and 11 hospitals. Older adults (≥55 years) with head trauma and transported by EMS from August 2015 to September 2016 were eligible. EMS providers completed standardized data forms and patients were followed through emergency department (ED) or hospital discharge. We enrolled 1304 patients; 1147 (88%) received a cranial computed tomography (CT) scan and were eligible for analysis. Four hundred thirty-four (33%) patients had anticoagulant or antiplatelet use and 112 (10%) had tICH. The incidence of tICH in patients with (11%, 95% confidence interval [CI] 8%-14%) and without (9%, 95% CI 7%-11%) anticoagulant or antiplatelet use was similar. Anticoagulant or antiplatelet use was not predictive of tICH on adjusted analysis. Steps 1-3 criteria alone were not sensitive in identifying tICH (27%), whereas the addition of anticoagulant or antiplatelet criterion improved sensitivity (63%). Other derived sets of triage criteria were highly sensitive (>98%) but poorly specific (

Study objectiveWith increased use of chest computed tomography (CT) in trauma evaluation, traditional teachings in regard to rib fracture morbidity and mortality may no longer be accurate. We seek to determine rates of rib fracture observed on chest CT only; admission and mortality of patients with isolated rib fractures, rib fractures observed on CT only, and first or second rib fractures; and first or second rib fracture-associated great vessel injury.MethodsWe conducted a planned secondary analysis of 2 prospectively enrolled cohorts of the National Emergency X-Radiography Utilization Study chest studies, which evaluated patients with blunt trauma who were older than 14 years and received chest imaging in the emergency department. We defined rib fractures and other thoracic injuries according to CT reports and followed patients through their hospital course to determine outcomes.ResultsOf 8,661 patients who had both chest radiograph and chest CT, 2,071 (23.9%) had rib fractures, and rib fractures were observed on chest CT only in 1,368 cases (66.1%). Rib fracture patients had higher admission rates (88.7% versus 45.8%; mean difference 42.9%; 95% confidence interval [CI] 41.4% to 44.4%) and mortality (5.6% versus 2.7%; mean difference 2.9%; 95% CI 1.8% to 4.0%) than patients without rib fracture. The mortality of patients with rib fracture observed on chest CT only was not statistically significantly different from that of patients with fractures also observed on chest radiograph (4.8% versus 5.7%; mean difference -0.9%; 95% CI -3.1% to 1.1%). Patients with first or second rib fractures had significantly higher mortality (7.4% versus 4.1%; mean difference 3.3%; 95% CI 0.2% to 7.1%) and prevalence of concomitant great vessel injury (2.8% versus 0.6%; mean difference 2.2%; 95% CI 0.6% to 4.9%) than patients with fractures of ribs 3 to 12, and the odds ratio of great vessel injury with first or second rib fracture was 4.4 (95% CI 1.8 to 10.4).ConclusionUnder trauma imaging protocols that commonly incorporate chest CT, two thirds of rib fractures were observed on chest CT only. Patients with rib fractures had higher admission rates and mortality than those without rib fractures. First or second rib fractures were associated with significantly higher mortality and great vessel injury.

Study objectiveField triage guidelines recommend that emergency medical services (EMS) providers consider transport of head-injured older adults with anticoagulation use to trauma centers. However, the triage patterns and the incidence of intracranial hemorrhage or neurosurgery in these patients are unknown. Our objective is to describe the characteristics and outcomes of older adults with head trauma who are transported by EMS, particularly for patients who do not meet physiologic, anatomic, or mechanism-of-injury (steps 1 to 3) field triage criteria but are receiving anticoagulant or antiplatelet medications.MethodsThis was a retrospective study at 5 EMS agencies and 11 hospitals (4 trauma centers, 7 nontrauma centers). Patients aged 55 years or older with head trauma who were transported by EMS were included. The primary outcome was the presence of intracranial hemorrhage. The secondary outcome was a composite measure of inhospital death or neurosurgery.ResultsOf the 2,110 patients included, 131 (6%) had intracranial hemorrhage and 41 (2%) had inhospital death or neurosurgery. There were 162 patients (8%) with steps 1 to 3 criteria. Of the remaining 1,948 patients without steps 1 to 3 criteria, 566 (29%) had anticoagulant or antiplatelet use. Of these patients, 52 (9%) had traumatic intracranial hemorrhage and 15 (3%) died or had neurosurgery. The sensitivity (adjusted for clustering by EMS agency) of steps 1 to 3 criteria was 19.8% (26/131; 95% confidence interval [CI] 5.5% to 51.2%) for identifying traumatic intracranial hemorrhage and 34.1% (14/41; 95% CI 9.9% to 70.1%) for death or neurosurgery. The additional criterion of anticoagulant or antiplatelet use improved the sensitivity for intracranial hemorrhage (78/131; 59.5%; 95% CI 42.9% to 74.2%) and death or neurosurgery (29/41; 70.7%; 95% CI 61.0% to 78.9%).ConclusionRelatively few patients met steps 1 to 3 triage criteria. For individuals who did not have steps 1 to 3 criteria, nearly 30% had anticoagulant or antiplatelet use. A relatively high proportion of these patients had intracranial hemorrhage, but a much smaller proportion died or had neurosurgery during hospitalization. Use of steps 1 to 3 triage criteria alone is not sufficient in identifying intracranial hemorrhage and death or neurosurgery in this patient population. The additional criterion of anticoagulant or antiplatelet use improves the sensitivity of the instrument, with only a modest decrease in specificity.

Loss to follow-up of enrolled patients (a.k.a. attrition) is a major threat to study validity and power. Minimizing attrition can be challenging even under ideal research conditions, including the presence of adequate funding, experienced study personnel, and a refined research infrastructure. Emergency care research is shifting toward enrollment through multisite networks, but there have been limited descriptions of approaches to minimize attrition for these multicenter emergency care studies. This concept paper describes a stepwise approach to minimize attrition, using a case example of a multisite emergency department prospective cohort of over 3,000 patients that has achieved a 30-day direct phone follow-up attrition rate of

The article focuses on identifying the factors influencing the redemption of incentives among participants in a multicenter prospective clinical study on syncope. It investigates how demographic variables such as age, gender, and socioeconomic factors impact the likelihood of participants redeeming their electronic gift card incentives.