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BACKGROUND: Changes with aging make older patients vulnerable to blunt head trauma and alter the potential for injury and the injury patterns seen among this expanding cohort. High-quality care requires a clear understanding of the factors associated with blunt head injuries in the elderly. Our objective was to develop a detailed assessment of the injury mechanisms, presentations, injury patterns, and outcomes among older blunt head trauma patients. METHODS: We conducted a planned secondary analysis of patients aged 65 or greater who were enrolled in the National Emergency X-Radiography Utilization Study (NEXUS) Head Computed Tomography validation study. We performed a detailed assessment of the demographics, mechanisms, presentations, injuries, interventions, and outcomes among older patients. RESULTS: We identified 3,659 patients aged 65 years or greater, among the 11,770 patients enrolled in the NEXUS validation study. Of these older patients, 325 (8.9%) sustained significant injuries, as compared with significant injuries in 442 (5.4%) of the 8,111 younger patients. Older females (1,900; 51.9%) outnumbered older males (1,753; 47.9%), and occult presentations (exhibiting no high-risk clinical criteria beyond age) occurred in 48 (14.8%; 95% confidence interval (CI) 11.1 to 19.1) patients with significant injuries. Subdural hematomas (377 discreet lesions in 299 patients) and subarachnoid hemorrhages (333 discreet instances in 256 patients) were the most frequent types of injuries occurring in our elderly population. A ground-level fall was the most frequent mechanism of injury among all patients (2,211; 69.6%), those sustaining significant injuries (180; 55.7%), and those who died of their injuries (37; 46.3%), but mortality rates were highest among patients experiencing a fall from a ladder (11.8%; 4 deaths among 34 cases [95% CI 3.3% to 27.5%]) and automobile versus pedestrian events (10.7%; 16 deaths among 149 cases [95% CI 6.3% to 16.9%]). Among older patients who required neurosurgical intervention for their injuries, only 16.4% (95% CI 11.1% to 22.9%) were able to return home, 32.1% (95% CI 25.1% to 39.8%) required extended facility care, and 41.8% (95% CI 34.2% to 49.7%) died from their injuries. CONCLUSIONS: Older blunt head injury patients are at high risk of sustaining serious intracranial injuries even with low-risk mechanisms of injury, such as ground-level falls. Clinical evaluation is unreliable and frequently fails to identify patients with significant injuries. Outcomes, particularly after intervention, can be poor, with high rates of long-term disability and mortality.
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Traumatismos Cerrados de la Cabeza , Heridas no Penetrantes , Masculino , Femenino , Humanos , Anciano , Técnicas de Apoyo para la Decisión , Traumatismos Cerrados de la Cabeza/diagnóstico por imagen , Traumatismos Cerrados de la Cabeza/epidemiología , Radiografía , Tomografía Computarizada por Rayos X , Heridas no Penetrantes/diagnóstico por imagenRESUMEN
OBJECTIVES: Pediatric head trauma is a frequent reason for presentation to the emergency department. Despite this, there are few reports on specific characteristics and injury patterns in head injured children. The goal of this study was to evaluate head injury patterns in children with blunt head injury and their prevalence by age group. METHODS: This is a planned secondary analysis of the NEXUS II Head CT validation study. Consecutive patients with blunt head trauma were enrolled between 2006 and 2015. Demographics and criteria from 2 clinical decision instruments (NEXUS and Canadian Head CT rules) were gathered at the time of enrollment. We abstracted and cataloged injuries for pediatric patients based on radiologist report. Frequencies of injuries and severity were analyzed by developmental age group. RESULTS: A total of 1018 pediatric patients were enrolled, 128 (12.6%) of whom had an injury on computed tomography scan. Median age was 11.9 (Interquartile range 4.5-15.5) for all patients and 12 (4.8-15.5) for injured patients. Of injured patients, 49 (38.3%) had a significant injury, and 27 (21.1%) received an intervention. Teenagers had the highest rate of significant injury (50%) and intervention (30%). Injuries were most frequently noted in the temporal (46.1%), frontal (45.3%), and parietal (45.3%) regions. Subarachnoid hemorrhage (29.7%) and subdural hematoma (28.9%) were the most common injuries observed.Intraparenchymal hemorrhage and cerebral edema were more prevalent in older age groups. The most common injury mechanism overall was fall from height (24.7%). Motor vehicle accidents and nonmotorized wheeled vehicle accidents were more common in older patients. CONCLUSIONS: Serious injuries requiring intervention were rarely encountered in pediatric patients experiencing blunt head trauma. Mechanisms of injury, type of injury, and rates of intervention varied between developmental age groups.
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STUDY OBJECTIVE: We evaluated the emergency department (ED) providers' ability to detect skull fractures in pediatric patients presenting with blunt head trauma. METHODS: This was a secondary analysis of the National Emergency X-Radiography Utilization Study (NEXUS) Head computed tomography (CT) validation study. Demographics and clinical characteristics were analyzed for pediatric patients. Radiologist interpretations of head CT imaging were abstracted and cataloged. Detection of skull fractures was evaluated through provider response to specific clinical decision instrument criteria (NEXUS or Canadian head CT rules) at the time of initial patient evaluation. The presence of skull fracture was determined by formal radiologist interpretation of CT imaging. RESULTS: Between April 2006, and December 2015, 1,018 pediatric patients were enrolled. One hundred twenty-eight (12.5%) children had a notable injury reported on CT head. Skull fracture was present in most (66.4%) children with intracranial injuries. The sensitivity and specificity of provider physical examination to detect skull fractures was 18.5% (95% confidence interval 10.5% to 28.7%) and 96.6% (95.3% to 97.7%), respectively. The most common injuries associated with skull fractures were subarachnoid hemorrhage (27%) and subdural hematoma (22.3%). CONCLUSION: Skull fracture is common in children with intracranial injury after blunt head trauma. Despite this, providers were found to have poor sensitivity for skull fractures in this population, and these injuries may be missed on initial emergency department assessment.
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Traumatismos Craneocerebrales , Traumatismos Cerrados de la Cabeza , Fracturas Craneales , Niño , Humanos , Canadá , Traumatismos Cerrados de la Cabeza/complicaciones , Tomografía Computarizada por Rayos X , Radiografía , Fracturas Craneales/complicaciones , Traumatismos Craneocerebrales/complicacionesRESUMEN
STUDY OBJECTIVE: Developed to decrease unnecessary thoracic computed tomography use in adult blunt trauma patients, the National Emergency X-Radiography Utilization Study (NEXUS) Chest clinical decision instrument does not include the extended Focused Assessment with Sonography in Trauma (eFAST). We assessed whether eFAST improves the NEXUS Chest clinical decision instrument's diagnostic performance and may replace the chest radiograph (CXR) as a predictor variable. METHODS: We performed a secondary analysis of prospective data from 8 Level I trauma centers from 2011-2014. We compared performance of modified clinical decision instruments that (1) added eFAST as a predictor (eFAST-added clinical decision instrument), and (2) replaced CXR with eFAST (eFAST-replaced clinical decision instrument), in screening for blunt thoracic injuries. RESULTS: One thousand nine hundred fifty-seven patients had documented computed tomography, CXR, clinical NEXUS criteria, and adequate eFAST; 624 (31.9%) patients had blunt thoracic injuries, and 126 (6.4%) had major injuries. Compared to the NEXUS Chest clinical decision instrument, the eFAST-added clinical decision instrument demonstrated unchanged screening performance for major injury (sensitivity 0.98 [0.94 to 1.00], specificity 0.28 [0.26 to 0.30]) or any injury (sensitivity 0.97 [0.95 to 0.98], specificity 0.21 [0.19 to 0.23]). The eFAST-replaced clinical decision instrument demonstrated unchanged sensitivity for major injury (sensitivity 0.93 [0.87 to 0.97], specificity 0.31 [0.29 to 0.34]) and decreased sensitivity for any injury (0.93 [0.91 to 0.951] versus 0.97 [0.953 to 0.98]). CONCLUSION: In our secondary analysis, adding eFAST as a predictor variable did not improve the diagnostic screening performance of the original NEXUS Chest clinical decision instrument; eFAST cannot replace the CXR criterion of the NEXUS Chest clinical decision instrument.
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Evaluación Enfocada con Ecografía para Trauma , Traumatismos Torácicos , Heridas no Penetrantes , Adulto , Humanos , Estudios Prospectivos , Sensibilidad y Especificidad , Traumatismos Torácicos/diagnóstico por imagen , Radiografía Torácica/métodos , Heridas no Penetrantes/diagnóstico por imagenRESUMEN
STUDY OBJECTIVE: To describe endotracheal intubation practices in emergency departments by staff intubating patients early in the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Multicenter prospective cohort study of endotracheal intubations conducted at 20 US academic emergency departments from May to December 2020, stratified by known or suspected COVID-19 status. We used multivariable regression to measure the association between intubation strategy, COVID-19 known or suspected status, first-pass success, and adverse events. RESULTS: There were 3,435 unique emergency department endotracheal intubations by 586 participating physicians or advanced practice providers; 565 (18%) patients were known or suspected of having COVID-19 at the time of endotracheal intubation. Compared with patients not known or suspected of COVID-19, endotracheal intubations of patients with known or suspected COVID-19 were more often performed using video laryngoscopy (88% versus 82%, difference 6.3%; 95% confidence interval [CI], 3.0% to 9.6%) and passive nasal oxygenation (44% versus 39%, difference 5.1%; 95% CI, 0.9% to 9.3%). First-pass success was not different between those who were and were not known or suspected of COVID-19 (87% versus 86%, difference 0.6%; 95% CI, -2.4% to 3.6%). Adjusting for patient characteristics and procedure factors in those with low anticipated airway difficulty (n=2,374), adverse events (most commonly hypoxia) occurred more frequently in patients with known or suspected COVID-19 (35% versus 19%, adjusted odds ratio 2.4; 95% CI, 1.7 to 3.3). CONCLUSION: Compared with patients not known or suspected of COVID-19, endotracheal intubation of those confirmed or suspected to have COVID-19 was associated with a similar first-pass intubation success rate but higher risk-adjusted adverse events.
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COVID-19 , Pandemias , Humanos , Laringoscopía/métodos , Estudios Prospectivos , COVID-19/epidemiología , Intubación Intratraqueal/efectos adversos , Intubación Intratraqueal/métodos , Servicio de Urgencia en HospitalRESUMEN
STUDY OBJECTIVE: We determine the percentage of diagnosed and undiagnosed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among a sample of US emergency department (ED) health care personnel before July 2020. METHODS: This was a cross-sectional analysis of ED health care personnel in 20 geographically diverse university-affiliated EDs from May 13, to July 8, 2020, including case counts of prior laboratory-confirmed coronavirus disease 2019 (COVID-19) diagnoses among all ED health care personnel, and then point-in-time serology (with confirmatory testing) and reverse transcriptase-polymerase chain reaction testing in a sample of volunteers without a previous COVID-19 diagnosis. Health care staff were categorized as clinical (physicians, advanced practice providers, and nurses) and nonclinical (clerks, social workers, and case managers). Previously undiagnosed infection was based on positive SARS-CoV-2 serology or reverse transcriptase-polymerase chain reaction result among health care personnel without prior diagnosis. RESULTS: Diagnosed COVID-19 occurred in 2.8% of health care personnel (193/6,788), and the prevalence was similar for nonclinical and clinical staff (3.8% versus 2.7%; odds ratio 1.5; 95% confidence interval 0.7 to 3.2). Among 1,606 health care personnel without previously diagnosed COVID-19, 29 (1.8%) had evidence of current or past SARS-CoV-2 infection. Most (62%; 18/29) who were seropositive did not think they had been infected, 76% (19/25) recalled COVID-19-compatible symptoms, and 89% (17/19) continued to work while symptomatic. Accounting for both diagnosed and undiagnosed infections, 4.6% (95% confidence interval 2.8% to 7.5%) of ED health care personnel were estimated to have been infected with SARS-CoV-2, with 38% of those infections undiagnosed. CONCLUSION: In late spring and early summer 2020, the estimated prevalence of severe acute respiratory syndrome coronavirus 2 infection was 4.6%, and greater than one third of infections were undiagnosed. Undiagnosed SARS-CoV-2 infection may pose substantial risk for transmission to other staff and patients.
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COVID-19/epidemiología , Servicio de Urgencia en Hospital/estadística & datos numéricos , Personal de Salud/estadística & datos numéricos , SARS-CoV-2 , Adulto , COVID-19/diagnóstico , Estudios Transversales , Femenino , Hospitales Universitarios/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Estados Unidos/epidemiologíaRESUMEN
STUDY OBJECTIVE: Enterobacteriaceae resistant to ceftriaxone, mediated through extended-spectrum ß-lactamases (ESBLs), commonly cause urinary tract infections worldwide, but have been less prevalent in North America. Current US rates are unknown. We determine Enterobacteriaceae antimicrobial resistance rates among US emergency department (ED) patients hospitalized for urinary tract infection. METHODS: We prospectively enrolled adults hospitalized for urinary tract infection from 11 geographically diverse university-affiliated hospital EDs during 2018 to 2019. Among participants with culture-confirmed infection, we evaluated prevalence of antimicrobial resistance, including that caused by ESBL-producing Enterobacteriaceae, resistance risk factors, and time to in vitro-active antibiotics. RESULTS: Of 527 total participants, 444 (84%) had cultures that grew Enterobacteriaceae; 89 of 435 participants (20.5%; 95% confidence interval 16.9% to 24.5%; 4.6% to 45.4% by site) whose isolates had confirmatory testing had bacteria that were ESBL producing. The overall prevalence of ESBL-producing Enterobacteriaceae infection among all participants with urinary tract infection was 17.2% (95% confidence interval 14.0% to 20.7%). ESBL-producing Enterobacteriaceae infection risk factors were hospital, long-term care, antibiotic exposure within 90 days, and a fluoroquinolone- or ceftriaxone-resistant isolate within 1 year. Enterobacteriaceae resistance rates for other antimicrobials were fluoroquinolone 32.3%, gentamicin 13.7%, amikacin 1.3%, and meropenem 0.3%. Ceftriaxone was the most common empirical antibiotic. In vitro-active antibiotics were not administered within 12 hours of presentation to 48 participants (53.9%) with ESBL-producing Enterobacteriaceae infection, including 17 (58.6%) with sepsis. Compared with other Enterobacteriaceae infections, ESBL infections were associated with longer time to in vitro-active treatment (17.3 versus 3.5 hours). CONCLUSION: Among adults hospitalized for urinary tract infection in many US locations, ESBL-producing Enterobacteriaceae have emerged as a common cause of infection that is often not initially treated with an in vitro-active antibiotic.
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Servicio de Urgencia en Hospital/estadística & datos numéricos , Estados Unidos/epidemiología , Infecciones Urinarias/tratamiento farmacológico , Resistencia betalactámica , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antibacterianos/uso terapéutico , Enterobacteriaceae/efectos de los fármacos , Infecciones por Enterobacteriaceae/tratamiento farmacológico , Infecciones por Enterobacteriaceae/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Infecciones Urinarias/epidemiología , Adulto JovenRESUMEN
STUDY OBJECTIVE: We determine the prevalence of significant intracranial injury among adults with blunt head trauma who are receiving preinjury anticoagulant or antiplatelet medications. METHODS: This was a multicenter, prospective, observational study conducted from December 2007 to December 2015. Patients were enrolled in 3 emergency departments (EDs) in the United States. Adults with blunt head trauma who underwent neuroimaging in the ED were included. Use of preinjury aspirin, clopidogrel, and warfarin was recorded. Data on direct oral anticoagulants were not specifically recorded. The primary outcome was prevalence of significant intracranial injury on neuroimaging. The secondary outcome was receipt of neurosurgical intervention. RESULTS: Among 9,070 patients enrolled in this study, the median age was 53.8 years (interquartile range 34.7 to 74.3 years) and 60.7% were men. A total of 1,323 patients (14.6%) were receiving antiplatelet medications or warfarin, including 635 receiving aspirin alone, 109 clopidogrel alone, and 406 warfarin alone. Compared with that of patients without any coagulopathy, the relative risk of significant intracranial injury was 1.29 (95% confidence interval [CI] 0.88 to 1.87) for patients receiving aspirin alone, 0.75 (95% CI 0.24 to 2.30) for those receiving clopidogrel alone, and 1.88 (95% CI 1.28 to 2.75) for those receiving warfarin alone. The relative risk of significant intracranial injury was 2.88 (95% CI 1.53 to 5.42) for patients receiving aspirin and clopidogrel in combination. CONCLUSION: Patients receiving preinjury warfarin or a combination of aspirin and clopidogrel were at increased risk for significant intracranial injury, but not those receiving aspirin alone. Clinicians should have a low threshold for neuroimaging when evaluating patients receiving warfarin or a combination of aspirin and clopidogrel.
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Anticoagulantes/efectos adversos , Lesiones Encefálicas/epidemiología , Traumatismos Cerrados de la Cabeza/complicaciones , Inhibidores de Agregación Plaquetaria/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Aspirina/efectos adversos , Lesiones Encefálicas/etiología , Clopidogrel/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Estudios Prospectivos , Factores de Riesgo , Warfarina/efectos adversosRESUMEN
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<.001). However, thoracic spine fracture patients without other thoracic injury had mortality similar to that of patients without thoracic spine fracture (4.6% versus 4%; difference 0.6%; 95% confidence interval -2.5% to 8.6%). Less than half of thoracic spine fractures (47.4%) were clinically significant: 40.8% of patients received thoracolumbosacral orthosis bracing, 10.9% had surgery, and 3.8% had an associated neurologic deficit. CONCLUSION: Thoracic spine fracture is uncommon. Most thoracic spine fractures are associated with other thoracic injuries, and mortality is more closely related to these other injuries than to the thoracic spine fracture itself. More than half of thoracic spine fractures are clinically insignificant; surgical intervention is uncommon and neurologic injury is rare.
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Hospitalización/estadística & datos numéricos , Tiempo de Internación/estadística & datos numéricos , Mortalidad , Traumatismo Múltiple/epidemiología , Fracturas de la Columna Vertebral/epidemiología , Traumatismos Torácicos/epidemiología , Vértebras Torácicas/lesiones , Heridas no Penetrantes/epidemiología , Accidentes por Caídas , Accidentes de Tránsito , Adulto , Anciano , Vértebras Cervicales/lesiones , Clavícula/lesiones , Femenino , Hemotórax/epidemiología , Humanos , Puntaje de Gravedad del Traumatismo , Vértebras Lumbares/lesiones , Masculino , Persona de Mediana Edad , Motocicletas , Peatones , Radiografía Torácica , Fracturas de las Costillas/epidemiología , Escápula/lesiones , Fracturas de la Columna Vertebral/diagnóstico por imagen , Fracturas de la Columna Vertebral/cirugía , Vértebras Torácicas/diagnóstico por imagen , Vértebras Torácicas/cirugía , Tomografía Computarizada por Rayos X , Heridas no Penetrantes/diagnóstico por imagenRESUMEN
BACKGROUND: U.S. emergency department visits for cutaneous abscess have increased with the emergence of methicillin-resistant Staphylococcus aureus (MRSA). The role of antibiotics for patients with a drained abscess is unclear. METHODS: We conducted a randomized trial at five U.S. emergency departments to determine whether trimethoprim-sulfamethoxazole (at doses of 320 mg and 1600 mg, respectively, twice daily, for 7 days) would be superior to placebo in outpatients older than 12 years of age who had an uncomplicated abscess that was being treated with drainage. The primary outcome was clinical cure of the abscess, assessed 7 to 14 days after the end of the treatment period. RESULTS: The median age of the participants was 35 years (range, 14 to 73); 45.3% of the participants had wound cultures that were positive for MRSA. In the modified intention-to-treat population, clinical cure of the abscess occurred in 507 of 630 participants (80.5%) in the trimethoprim-sulfamethoxazole group versus 454 of 617 participants (73.6%) in the placebo group (difference, 6.9 percentage points; 95% confidence interval [CI], 2.1 to 11.7; P=0.005). In the per-protocol population, clinical cure occurred in 487 of 524 participants (92.9%) in the trimethoprim-sulfamethoxazole group versus 457 of 533 participants (85.7%) in the placebo group (difference, 7.2 percentage points; 95% CI, 3.2 to 11.2; P<0.001). Trimethoprim-sulfamethoxazole was superior to placebo with respect to most secondary outcomes in the per-protocol population, resulting in lower rates of subsequent surgical drainage procedures (3.4% vs. 8.6%; difference, -5.2 percentage points; 95% CI, -8.2 to -2.2), skin infections at new sites (3.1% vs. 10.3%; difference, -7.2 percentage points; 95% CI, -10.4 to -4.1), and infections in household members (1.7% vs. 4.1%; difference, -2.4 percentage points; 95% CI, -4.6 to -0.2) 7 to 14 days after the treatment period. Trimethoprim-sulfamethoxazole was associated with slightly more gastrointestinal side effects (mostly mild) than placebo. At 7 to 14 days after the treatment period, invasive infections had developed in 2 of 524 participants (0.4%) in the trimethoprim-sulfamethoxazole group and in 2 of 533 participants (0.4%) in the placebo group; at 42 to 56 days after the treatment period, an invasive infection had developed in 1 participant (0.2%) in the trimethoprim-sulfamethoxazole group. CONCLUSIONS: In settings in which MRSA was prevalent, trimethoprim-sulfamethoxazole treatment resulted in a higher cure rate among patients with a drained cutaneous abscess than placebo. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00729937.).
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Absceso/tratamiento farmacológico , Antibacterianos/uso terapéutico , Drenaje , Enfermedades Cutáneas Bacterianas/tratamiento farmacológico , Combinación Trimetoprim y Sulfametoxazol/uso terapéutico , Absceso/terapia , Adolescente , Adulto , Anciano , Antibacterianos/efectos adversos , Terapia Combinada , Servicio de Urgencia en Hospital , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedades Cutáneas Bacterianas/terapia , Resultado del Tratamiento , Combinación Trimetoprim y Sulfametoxazol/efectos adversos , Adulto JovenRESUMEN
STUDY OBJECTIVE: We examine the utility of emergency department (ED) ultrasonography in treatment of skin and soft tissue infections. METHODS: We enrolled ED patients with skin and soft tissue infections and surveyed clinicians in regard to their pre-ultrasonography certainty about the presence or absence of an abscess, their planned management, post-ultrasonography findings, and actual management. We determined sensitivity and specificity of ultrasonography and clinical evaluation, and assessed appropriateness of management changes based on initial clinical assessment and outcomes through 1-week follow-up. RESULTS: Among 1,216 patients, clinicians were uncertain of abscess presence in 105 cases (8.6%) and certain for 1,111 cases (91.4%). Based on surgical exploration and follow-up through 1 week, sensitivity and specificity for abscess detection by clinical evaluation were 90.3% and 97.7%, and by ultrasonography were 94.0% and 94.1%, respectively. Among 1,111 cases for which the clinician was certain, sensitivity and specificity of clinical evaluation were 96.6% and 97.3% compared with ultrasonographic evaluation sensitivity and specificity of 95.7% and 96.2%, respectively. Of 105 uncertain cases, sensitivity and specificity of ultrasonography were 68.5% and 80.4%. Ultrasonography changed management in 13 of 1,111 certain cases (1.2%), appropriately in 10 of 13 (76.9%) and inappropriately in 3 of 13 (23.1%). Of 105 uncertain cases, ultrasonography changed management in 25 (23.8%), appropriately in 21 of 25 (84.0%) and inappropriately in 4 of 25 (16.0%). CONCLUSION: Ultrasonography rarely changed management when clinicians were certain about the presence or absence of an abscess. When they were uncertain, ultrasonography changed drainage decisions in approximately one quarter of cases, of which most (84%) were appropriate.
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Absceso/diagnóstico por imagen , Sistemas de Atención de Punto , Enfermedades Cutáneas Infecciosas/diagnóstico , Infecciones de los Tejidos Blandos/diagnóstico , Absceso/terapia , Adulto , Servicio de Urgencia en Hospital , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sensibilidad y Especificidad , Piel , Enfermedades Cutáneas Infecciosas/patología , Enfermedades Cutáneas Infecciosas/terapia , Infecciones de los Tejidos Blandos/patología , Infecciones de los Tejidos Blandos/terapia , Ultrasonografía , IncertidumbreRESUMEN
STUDY OBJECTIVE: Although 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. METHODS: This 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. RESULTS: Of 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%). CONCLUSION: Under 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.
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Hemotórax/epidemiología , Neumotórax/epidemiología , Traumatismos Torácicos/diagnóstico por imagen , Heridas no Penetrantes/diagnóstico por imagen , Adulto , Femenino , Hemotórax/diagnóstico por imagen , Humanos , Incidencia , Puntaje de Gravedad del Traumatismo , Masculino , Persona de Mediana Edad , Estudios Observacionales como Asunto , Neumotórax/diagnóstico por imagen , Estudios Prospectivos , Tomografía Computarizada por Rayos XRESUMEN
STUDY OBJECTIVE: Serious adverse outcomes associated with skin and soft tissue infections are uncommon, and current hospitalization rates appear excessive. It would be advantageous to be able to differentiate between patients who require high-level inpatient services and those who receive little benefit from hospitalization. We sought to identify characteristics associated with the need for high-level inpatient care among emergency department patients presenting with skin and soft tissue infections. METHODS: We conducted a nonconcurrent review of existing records to identify emergency department (ED) patients treated for skin and soft tissue infections. For each case, we recorded the presence or absence of select criteria and whether the patient needed high-level care, defined as ICU admission, operating room surgical intervention, or death as the primary outcome. We applied recursive partitioning to identify the principal criteria associated with high-level care. RESULTS: We identified 2,923 patients, including 84 experiencing high-level events. Recursive partitioning identified 6 variables associated with high-level outcomes: abnormal computed tomography, magnetic resonance imaging, or ultrasonographic imaging result; systemic inflammatory response syndrome; history of diabetes; previous infection at the same location; older than 65 years; and an infection involving the hand. One or more of these variables were present in all 84 patients requiring high-level care. CONCLUSION: A limited number of simple clinical characteristics appear to be able to identify skin and soft tissue infection patients who require high-level inpatient services. Further research is needed to determine whether patients who do not exhibit these criteria can be safely discharged from the ED.
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Enfermedades Cutáneas Infecciosas/terapia , Infecciones de los Tejidos Blandos/terapia , Adulto , Anciano , Anciano de 80 o más Años , California , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Sepsis/complicaciones , Enfermedades Cutáneas Infecciosas/complicaciones , Infecciones de los Tejidos Blandos/complicaciones , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , UltrasonografíaRESUMEN
STUDY OBJECTIVE: Two large randomized trials recently demonstrated efficacy of methicillin-resistant Staphylococcus aureus (MRSA)-active antibiotics for drained skin abscesses. We determine whether outcome advantages observed in one trial exist across lesion sizes and among subgroups with and without guideline-recommended antibiotic indications. METHODS: We conducted a planned subgroup analysis of a double-blind, randomized trial at 5 US emergency departments, demonstrating superiority of trimethoprim-sulfamethoxazole (320/1,600 mg twice daily for 7 days) compared with placebo for patients older than 12 years with a drained skin abscess. We determined between-group differences in rates of clinical (no new antibiotics) and composite cure (no new antibiotics or drainage) through 7 to 14 and 42 to 56 days after treatment among subgroups with and without abscess cavity or erythema diameter greater than or equal to 5 cm, history of MRSA, fever, diabetes, and comorbidities. We also evaluated treatment effect by lesion size and culture result. RESULTS: Among 1,057 mostly adult participants, median abscess cavity and erythema diameters were 2.5 cm (range 0.1 to 16.0 cm) and 6.5 cm (range 1.0 to 38.5), respectively; 44.3% grew MRSA. Overall, for trimethoprim-sulfamethoxazole and placebo groups, clinical cure rate at 7 to 14 days was 92.9% and 85.7%; composite cure rate at 7 to 14 days was 86.5% and 74.3%, and at 42 to 56 days, it was 82.4% and 70.2%. For all outcomes, across lesion sizes and among subgroups with and without guideline antibiotic criteria, trimethoprim-sulfamethoxazole was associated with improved outcomes. Treatment effect was greatest with history of MRSA infection, fever, and positive MRSA culture. CONCLUSION: Treatment with trimethoprim-sulfamethoxazole was associated with improved outcomes regardless of lesion size or guideline antibiotic criteria.
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Absceso/tratamiento farmacológico , Antibacterianos/uso terapéutico , Enfermedades Cutáneas Bacterianas/tratamiento farmacológico , Combinación Trimetoprim y Sulfametoxazol/uso terapéutico , Adolescente , Adulto , Anciano , Método Doble Ciego , Esquema de Medicación , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infecciones Cutáneas Estafilocócicas/tratamiento farmacológico , Infecciones Estreptocócicas/tratamiento farmacológico , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Serial hemoglobin measurement (ΔHgb) is intended to aid in the early identification of blunt trauma patients who have significant blood loss requiring intervention. However, the utility of ΔHgb has yet to be rigorously studied. OBJECTIVE: We sought to determine if ΔHgb is a reliable diagnostic tool in assessing blood loss in blunt trauma patients. METHODS: We enrolled consecutive blunt trauma patients ≥18 years of age who presented to a level I trauma center. We measured 2 hemoglobin levels spaced 5 min apart and calculated the difference (ΔHgb) for each patient. We also recorded whether each patient required any of the following interventions to treat their injuries: 1) operation or procedure to control hemorrhage; 2) radiographic embolization; 3) administration of blood and blood products; 4) administration of ≥3 liters of intravenous fluids; and 5) exsanguination. Our primary outcome was the area under the receiver operating characteristic (ROC) curve. RESULTS: We enrolled 251 patients, including 192 males and 59 females with a mean age of 40 years. Interventions occurred in 56 patients and were withheld in 195. The median ΔHgb was -0.1 gm/dL (interquartile range -0.5 to 0.1 gm/dL) for patients requiring intervention and 0.0 gm/dL (interquartile range -0.6 to 0.3 gm/dL) for patients not requiring intervention. We found the area under the ROC curve to be 0.53 (95% confidence interval 0.44-0.62). CONCLUSIONS: Our results indicated that ΔHgb does not reliably distinguish between blunt trauma patients who require intervention and those who do not.
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Hemoglobinas/análisis , Hemorragia/diagnóstico , Hemorragia/etiología , Heridas no Penetrantes/complicaciones , Adulto , Femenino , Humanos , Masculino , Sensibilidad y Especificidad , Centros Traumatológicos , Heridas no Penetrantes/terapiaRESUMEN
BACKGROUND: Clinicians, afraid of missing intracranial injuries, liberally obtain computed tomographic (CT) head imaging in blunt trauma patients. Prior work suggests that clinical criteria (National Emergency X-Radiography Utilization Study [NEXUS] Head CT decision instrument [DI]) can reliably identify patients with important injuries, while excluding injury, and the need for imaging in many patients. Validating this DI requires confirmation of the hypothesis that the lower 95% confidence limit for its sensitivity in detecting serious injury exceeds 99.0%. A secondary goal of the study was to complete an independent validation and comparison of the Canadian and NEXUS Head CT rules among the subgroup of patients meeting the inclusion and exclusion criteria. METHODS AND FINDINGS: We conducted a prospective observational study of the NEXUS Head CT DI in 4 hospital emergency departments between April 2006 and December 2015. Implementation of the rule requires that patients satisfy 8 criteria to achieve "low-risk" classification. Patients are excluded from "low-risk" classification and assigned "high-risk" status if they fail to meet 1 or more criteria. We examined the instrument's performance in assigning "high-risk" status to patients requiring neurosurgical intervention among a cohort of 11,770 blunt head injury patients. The NEXUS Head CT DI assigned high-risk status to 420 of 420 patients requiring neurosurgical intervention (sensitivity, 100.0% [95% confidence interval [CI]: 99.1%-100.0%]). The instrument assigned low-risk status to 2,823 of 11,350 patients who did not require neurosurgical intervention (specificity, 24.9% [95% CI: 24.1%-25.7%]). None of the 2,823 low-risk patients required neurosurgical intervention (negative predictive value [NPV], 100.0% [95% CI: 99.9%-100.0%]). The DI assigned high-risk status to 759 of 767 patients with significant intracranial injuries (sensitivity, 99.0% [95% CI: 98.0%-99.6%]). The instrument assigned low-risk status to 2,815 of 11,003 patients who did not have significant injuries (specificity, 25.6% [95% CI: 24.8%-26.4%]). Significant injuries were absent in 2,815 of the 2,823 patients assigned low-risk status (NPV, 99.7% [95% CI: 99.4%-99.9%]). Of our patients, 7,759 (65.9%) met the inclusion and exclusion criteria of the Canadian Head CT rule, including 111 patients (1.43%) who required neurosurgical intervention and 306 (3.94%) who had significant intracranial injuries. In our study, the Canadian criteria for neurosurgical intervention identified 108 of 111 patients requiring neurosurgical intervention to yield a sensitivity of 97.3% (95% CI: 92.3%-99.4%) and exhibited a specificity of 58.8% (95% CI: 57.7%-59.9%). The NEXUS rule, when applied to this same cohort, identified all 111 patients requiring neurosurgical intervention, yielding a sensitivity of 100% (95% CI: 96.7%-100.0%) with a specificity of 32.6% (95% CI: 31.5%-33.6%). Our study found that the Canadian medium-risk factors identified 301 of 306 patients with significant injuries (sensitivity = 98.4%; 95% CI: 96.2%-99.5%), while the NEXUS rule identified 299 of these patients (sensitivity = 97.7%; 95% CI: 95.3%-99.1%). In our study, the Canadian medium-risk rule exhibited a specificity of 12.3% (95% CI: 11.6%-13.1%), while the NEXUS rule exhibited a specificity of 33.3% (95% CI: 32.3%-34.4%). Limitations of the study may arise from application of the rule by different clinicians in different environments. Clinicians may vary in their interpretation and application of the instrument's criteria and risk assignment and may also vary in deciding which patients require intervention. The instrument's specificity is also subject to spectrum bias and may change with variations in the proportion of "low-risk" patients seen in other centers. CONCLUSIONS: The NEXUS Head CT DI reliably identifies blunt trauma patients who require head CT imaging and could significantly reduce the use of CT imaging.
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Técnicas de Apoyo para la Decisión , Traumatismos Cerrados de la Cabeza/diagnóstico por imagen , Tomografía Computarizada por Rayos X/normas , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , California , Niño , Preescolar , Femenino , Traumatismos Cerrados de la Cabeza/etiología , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Tomografía Computarizada por Rayos X/instrumentación , Heridas no Penetrantes/diagnóstico por imagen , Heridas no Penetrantes/etiología , Adulto JovenRESUMEN
STUDY OBJECTIVE: With 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. METHODS: We 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. RESULTS: Of 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). CONCLUSION: Under 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.
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Fracturas de las Costillas/diagnóstico por imagen , Adulto , Anciano , Aorta/diagnóstico por imagen , Aorta/lesiones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Radiografía Torácica , Fracturas de las Costillas/diagnóstico , Fracturas de las Costillas/mortalidad , Tórax/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Heridas no Penetrantes/diagnóstico , Heridas no Penetrantes/diagnóstico por imagenRESUMEN
STUDY OBJECTIVE: Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy. METHODS: Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics-first-treated participants older than 13 years could be discharged after greater than or equal to 6-hour emergency department (ED) observation with next-day follow-up. Outcomes included 1-month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics-first appendectomy rate. RESULTS: Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics-first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/µL (range 6,200 to 23,100/µL), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic-treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics-first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics-first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics-first-treated participants had less pain and disability. During median 12-month follow-up, 2 of 15 antibiotics-first-treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group. CONCLUSION: A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety.
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Antibacterianos/administración & dosificación , Apendicectomía , Apendicitis/terapia , Cefalosporinas/administración & dosificación , Metronidazol/administración & dosificación , beta-Lactamas/administración & dosificación , Administración Intravenosa , Adolescente , Adulto , Anciano , Apendicectomía/estadística & datos numéricos , Apendicitis/epidemiología , Cefdinir , Niño , Análisis Costo-Beneficio , Quimioterapia Combinada , Ertapenem , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pacientes Ambulatorios , Dolor/epidemiología , Proyectos Piloto , Calidad de Vida , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Estados Unidos/epidemiología , Adulto JovenRESUMEN
Chest imaging plays a prominent role in blunt trauma patient evaluation, but indiscriminate imaging is expensive, may delay care, and unnecessarily exposes patients to potentially harmful ionizing radiation. To improve diagnostic chest imaging utilization, we conducted 3 prospective multicenter studies over 12years to derive and validate decision instruments (DIs) to guide the use of chest x-ray (CXR) and chest computed tomography (CT). The first DI, NEXUS Chest x-ray, consists of seven criteria (Age >60years; rapid deceleration mechanism; chest pain; intoxication; altered mental status; distracting painful injury; and chest wall tenderness) and exhibits a sensitivity of 99.0% (95% confidence interval [CI] 98.2-99.4%) and a specificity of 13.3% (95% CI, 12.6%-14.0%) for detecting clinically significant injuries. We developed two NEXUS Chest CT DIs, which are both highly reliable in detecting clinically major injuries (sensitivity of 99.2%; 95% CI 95.4-100%). Designed primarily to focus on detecting major injuries, the NEXUS Chest CT-Major DI consists of six criteria (abnormal CXR; distracting injury; chest wall tenderness; sternal tenderness; thoracic spine tenderness; and scapular tenderness) and exhibits higher specificity (37.9%; 95% CI 35.8-40.1%). Designed to reliability detect both major and minor injuries (sensitivity 95.4%; 95% CI 93.6-96.9%) with resulting lower specificity (25.5%; 95% CI 23.5-27.5%), the NEXUS CT-All rule consists of seven elements (the six NEXUS CT-Major criteria plus rapid deceleration mechanism). The purpose of this review is to synthesize the three DIs into a novel, cohesive summary algorithm with practical implementation recommendations to guide selective chest imaging in adult blunt trauma patients.
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Algoritmos , Traumatismos Torácicos/diagnóstico por imagen , Heridas no Penetrantes/diagnóstico por imagen , Adulto , Factores de Edad , Intoxicación Alcohólica/epidemiología , Dolor en el Pecho/epidemiología , Trastornos de la Conciencia/epidemiología , Desaceleración , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Radiografía Torácica , Reproducibilidad de los Resultados , Medición de Riesgo , Traumatismos Torácicos/epidemiología , Tomografía Computarizada por Rayos X , Heridas no Penetrantes/epidemiologíaRESUMEN
IMPORTANCE: Emergency department visits for skin infections in the United States have increased with the emergence of methicillin-resistant Staphylococcus aureus (MRSA). For cellulitis without purulent drainage, ß-hemolytic streptococci are presumed to be the predominant pathogens. It is unknown if antimicrobial regimens possessing in vitro MRSA activity provide improved outcomes compared with treatments lacking MRSA activity. OBJECTIVE: To determine whether cephalexin plus trimethoprim-sulfamethoxazole yields a higher clinical cure rate of uncomplicated cellulitis than cephalexin alone. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, randomized superiority trial in 5 US emergency departments among outpatients older than 12 years with cellulitis and no wound, purulent drainage, or abscess enrolled from April 2009 through June 2012. All participants had soft tissue ultrasound performed at the time of enrollment to exclude abscess. Final follow-up was August 2012. INTERVENTIONS: Cephalexin, 500 mg 4 times daily, plus trimethoprim-sulfamethoxazole, 320 mg/1600 mg twice daily, for 7 days (n = 248 participants) or cephalexin plus placebo for 7 days (n = 248 participants). MAIN OUTCOMES AND MEASURES: The primary outcome determined a priori in the per-protocol group was clinical cure, defined as absence of these clinical failure criteria at follow-up visits: fever; increase in erythema (>25%), swelling, or tenderness (days 3-4); no decrease in erythema, swelling, or tenderness (days 8-10); and more than minimal erythema, swelling, or tenderness (days 14-21). A clinically significant difference was defined as greater than 10%. RESULTS: Among 500 randomized participants, 496 (99%) were included in the modified intention-to-treat analysis and 411 (82.2%) in the per-protocol analysis (median age, 40 years [range, 15-78 years]; 58.4% male; 10.9% had diabetes). Median length and width of erythema were 13.0 cm and 10.0 cm. In the per-protocol population, clinical cure occurred in 182 (83.5%) of 218 participants in the cephalexin plus trimethoprim-sulfamethoxazole group vs 165 (85.5%) of 193 in the cephalexin group (difference, -2.0%; 95% CI, -9.7% to 5.7%; P = .50). In the modified intention-to-treat population, clinical cure occurred in 189 (76.2%) of 248 participants in the cephalexin plus trimethoprim-sulfamethoxazole group vs 171 (69.0%) of 248 in the cephalexin group (difference, 7.3%; 95% CI, -1.0% to 15.5%; P = .07). Between-group adverse event rates and secondary outcomes through 7 to 9 weeks, including overnight hospitalization, recurrent skin infections, and similar infection in household contacts, did not differ significantly. CONCLUSIONS AND RELEVANCE: Among patients with uncomplicated cellulitis, the use of cephalexin plus trimethoprim-sulfamethoxazole compared to cephalexin alone did not result in higher rates of clinical resolution of cellulitis in the per-protocol analysis. However, because imprecision around the findings in the modified intention-to-treat analysis included a clinically important difference favoring cephalexin plus trimethoprim-sulfamethoxazole, further research may be needed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00729937.