Search

Objective: Physicians and paramedics in the Israel Defense Forces are trained to perform advanced medical procedures using standardized training modalities, such as manikins. We studied the association of experience using these training modalities with self-reported confidence in procedure performance.Methods: Providers were sent a questionnaire regarding their experience with and self-confidence levels for performing endotracheal intubation, cricothyroidotomy, needle chest decompression, tube thoracostomy, and intraosseous infusion.Results: Provider level (physician or paramedic) and gender were associated with reported self-confidence levels. Manikin and supervised and unsupervised patient experience exhibited positive associations with self-confidence, but (animal) model experience did not. For many procedure-training modality pairs, we identified a plateau level above which additional experience was minimally associated with an increase in self-confidence.Conclusions: Among military advanced life support providers, self-confidence levels in procedure performance are positively associated with experience gained from manikins and supervised and unsupervised patient application. We were not able to demonstrate a clear benefit of an animal model in increasing self-confidence. A plateau was generally identified, indicating decreased benefit from the use of a particular training modality for a particular procedure. Modifying training regimens in light of these findings may help maximize the self-confidence of advanced life support providers more efficiently. [ABSTRACT FROM AUTHOR]

Study Objective: Subgroup analyses examine associations (eg, between treatment and outcome) within subsets of a larger study sample. The traditional approach evaluates the data in each of the subgroups independently. More accurate answers, however, may be expected when the rest of the data are considered in the analysis of each subgroup, provided there are 3 or more subgroups.Methods: We present a conceptual introduction to subgroup analysis that makes use of all the available data and then illustrate the technique by applying it to a previously published study of pediatric airway management. Using WinBUGS, freely available computer software, we perform an empirical Bayesian analysis of the treatment effect in each of the subgroups. This approach corrects the original subgroup treatment estimates toward a weighted average treatment effect across all subjects.Results: The revised estimates of the subgroup treatment effects demonstrate markedly less variability than the original estimates. Further, using these estimates will reduce our total expected error in parameter estimation compared with using the original, independent subgroup estimates. Although any particular estimate may be adjusted inappropriately, adopting this strategy will, on average, lead to results that are more accurate.Conclusion: When multiple subgroups are considered, it is often inadvisable to ignore the rest of the study data. Authors or readers who wish to examine associations within subgroups are encouraged to use techniques that reduce the total expected error. [ABSTRACT FROM AUTHOR]

Objective: The number of pediatric trauma patients requiring surgical interventions has been steadily decreasing allowing for a judicious approach to immediately available resources. This study aimed to derive and validate a prediction rule that reliably identifies injured children who are at very low risk for requiring emergency surgery upon emergency department (ED) arrival., Methods: A retrospective cohort study of data included in the Israeli National Trauma Registry from January 1, 2011, through December 31, 2020, was conducted. We included children aged 0-14 years who presented to EDs from the scene of injury and were hospitalized. We excluded patients transferred between facilities or with isolated burns. The primary outcome was emergency operative intervention (EOI) performed within one hour of ED arrival. We tested mechanism, GCS, heart rate, and blood pressure as candidate predictors. We then randomized patients to two cohorts, derived and internally validated a prediction rule., Results: During the study period, 83,859 children met enrollment criteria. The median age was 6 years (IQR 2-10) and 56,867 (67.8 %) were male; 75,450 (90.0 %) sustained blunt trauma. One hundred sixty-nine (0.20 %) children underwent EOI. In the derivation and validation cohorts, 34,138 (81.4 %) and 34,271 (81.7 %) patients, were classified as low risk based on blunt trauma mechanism, normal GCS (15), and low-risk heart rate (according to age). Of those, 8 (0.02 %) and 13 (0.04 %) required an EOI, respectively. In the validation cohort, the prediction rule for EOI had a sensitivity of 84 % (95 % CI 75-91), a specificity of 82 % (95 % CI 81-82), and a negative predictive value of 99.96 % (95 % CI 99.94-99.98). Among children with an Injury Severity Score>15, the sensitivity was 87 % (95 % CI 77-94), the specificity of 57 % (95 % CI 54-59), and the negative predictive value was 98.97 % (95 % CI 98.13-99.44)., Conclusions: A limited set of physiologic parameters, readily available at hospital admission can effectively identify injured children at very low risk for emergent surgery. For these children, immediate deployment of surgical resources may not be necessary., Competing Interests: Declaration of competing interest Yulia GIMELRAIKH, Danny EPSTEIN, Irina RADOMISLENSKY, Ari M. LIPSKY, Adi GIVON, Ron BERANT, Baruch BERZON, Danny BEN-ELI, Moran BODAS, and Nir SAMUEL declare that they have no conflict of interest. Aeyal RAZ reports receiving consultant fees and research support from Medtronic and consultant fees from Neuroindex (none related to this work). This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: On Saturday, October 7th, approximately 3000 Hamas-led terrorists infiltrated Israel's southern border and attacked civilians and soldiers. Terrorists murdered close to 1200 people, abducted hundreds, and injured thousands. This surprise attack involved an unprecedented number of casualties. This article describes the injuries and outcomes of the hospitalized casualties., Methods: Hospitalized trauma casualties with an injury date of October 7 to 8, 2023, and with ICD9 E-codes E979 and E990 through E999, were extracted from the Israel National Trauma Registry. Demographic, injury, and hospital resource-use data were analyzed., Results: A total of 630 hospitalized casualties (277 civilians and 353 soldiers) suffered from gunshot wounds (90%), explosion-related wounds (19%), and multiple injury mechanisms (16%). The median age for civilians was 33 years (ages <1-88) and 21 years for soldiers. The most frequently injured body regions were lower (49%) and upper (42%) extremities, abdominal (28%), and thoracic (23%) injuries. Four hundred thirty-one (68%) patients underwent surgery, of which 240 within 12 hours. Over half of the severe and critical (Injury Severity Score 16+) casualties were discharged to a rehabilitation center. In-hospital mortality rate was 2.5%., Conclusion: Israel's hospitals faced many challenges following the mega mass casualty incident, including the absorption, diagnosis, treatment, and rehabilitation of a massive number of casualties. Hospitals needed to immediately repurpose to provide additional imaging equipment and operating rooms. Additionally, the huge demand for rehabilitation resources necessitated immediate reorganization and transformation of existing medical facilities to accommodate the many casualties requiring rehabilitation. The injury details and outcomes from this mega mass casualty incident provide important information for planning and preparedness at local, regional, and national levels., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Prehospital endotracheal intubation (PEI) of head injured children with impaired level of consciousness (LOC) aims to minimize secondary brain injury. However, PEI is controversial in otherwise stable children. We aimed to investigate the indications for PEI among pediatric trauma patients and the prevalence of clinically significant traumatic brain injury (csTBI) among those intubated solely due to impaired consciousness., Methods: This is a multicenter retrospective cohort study of children who underwent PEI in northern Israel between January 2014 and December 2020 by six EMS agencies and were transported to two trauma centers in the area. We extracted data from EMS records and trauma registries., Results: PEI was attempted in 179/986 (18.2%) patients and was successful in 92.2% of cases. Common indications for PEI were hypoxemia not corrected by supplemental oxygen (n = 30), traumatic cardiac arrest (n = 16), and facial injury compromising the airway (n = 13). 112 patients (62.6%) were intubated solely due to impaired or deteriorating LOC. Among these patients, 68 (62.4%) suffered csTBI. The prevalence of csTBI among those with field Glasgow Coma Scale (GCS) of 3, 4-8, and > 8 was 81.4%, 55.8%, and 28.6%, respectively (p < 0.001). Among children ≤ 10 years old intubated due to impaired LOC, 50% had csTBI., Conclusion: Impaired LOC is a major indication for PEI. However, a significant proportion of these patients do not suffer csTBI. Older age and lower pre-intubation GCS are associated with more accurate field classification. Our data indicate that further investigation and better characterization of patients who may benefit from PEI is necessary., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Objectives: Tranexamic acid (TXA) administration confers a survival benefit in bleeding trauma patients; however, data regarding its use in pediatric patients are limited. This study evaluates the prehospital treatment with TXA in pediatric trauma patients treated by the Israel Defense Forces Medical Corps (IDF-MC)., Design: Retrospective, cohort study using the Israel Defense Forces registry, 2011-2021., Patients: Pediatric trauma patients less than 18 years old. We excluded patients pronounced dead at the scene., Interventions: None., Setting: All cases of pediatric trauma in the registry were assessed for treatment with TXA. Propensity score matching was used to assess the association between prehospital TXA administration and mortality., Measurements and Main Results: Overall, 911 pediatric trauma patients were treated with TXA by the IDF-MC teams; the median (interquartile) age was 10 years (5-15 yr), and 72.8% were male. Seventy patients (7.6%) received TXA, with 52 of 70 (74%) receiving a 1,000 mg dose (range 200-1,000 mg). There were no prehospital adverse events associated with the use of TXA (upper limit of 95% CI for 0/70 is 4.3%). Compared with pediatric patients who did not receive TXA, patients receiving TXA were more likely to suffer from shock (40% vs 10.7%; p < 0.001), sustain more penetrating injuries (72.9% vs 31.7%; p < 0.001), be treated with plasma or crystalloids (62.9% vs 11.4%; p < 0.001), and undergo more lifesaving interventions (24.3% vs 6.2%; p < 0.001). The propensity score matching failed to identify an association between TXA and lesser odds of mortality, although a lack of effect (or even adverse effect) could not be excluded (non-TXA: 7.1% vs TXA: 4.3%, odds ratio = 0.584; 95% CI 0.084-3.143; p = 0.718)., Conclusions: Although prehospital TXA administration in the pediatric population is feasible with adverse event rate under 5%, more research is needed to determine the appropriate approach to pediatric hemostatic resuscitation and the role of TXA in this population., Competing Interests: Dr. Gelikas disclosed the off-label product use of tranexamic acid in the pediatric population. Dr. Yazer received funding from Grifols, Verax, Octapharma, Haemonetics, Cerus, and Macopharma. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Objective: The role of basic life support (BLS) vs. advanced life support (ALS) in pediatric trauma is controversial. Although ALS is widely accepted as the gold standard, previous studies have found no advantage of ALS over BLS care in adult trauma. The objective of this study was to evaluate whether ALS transport confers a survival advantage over BLS among severely injured children., Methods: A retrospective cohort study of data included in the Israeli National Trauma Registry from January 1, 2011, through December 31, 2020 was conducted. All the severely injured children (age < 18 years and injury severity score [ISS] ≥16) were included. Patient survival by mode of transport was analyzed using logistic regression., Results: Of 3167 patients included in the study, 65.1% were transported by ALS and 34.9% by BLS. Significantly more patients transported by ALS had ISS ≥25 as well as abnormal vital signs at admission. The ALS and BLS cohorts were comparable in age, gender, mechanism of injury, and prehospital time. Children transported by ALS had higher in-hospital mortality (9.2% vs. 0.9%, p < 0.001). Following risk adjustment, patients transported by ALS teams were significantly more likely to die than patients transported by BLS (adjusted OR 2.27, 95% CI 1.05-5.41, p = 0.04). Patients with ISS ≥50 had comparable mortality rates in both groups (45.9% vs. 55.6%, p = 0.837) while patients with GCS <9 transported by ALS had higher mortality (25.9% vs. 11.5%, p = 0.019). Admission to a level II trauma center vs. a level I hospital was also associated with increased mortality (adjusted OR 2.78 (95% CI 1.75-4.55, p < 0.001)., Conclusions: Among severely injured children, prehospital ALS care was not associated with lower mortality rates relative to BLS care. Because of potential confounding by severity in this retrospective analysis, further studies are warranted to validate these results., Competing Interests: Declaration of Competing Interest Aeyal Raz reports receiving consultant fees and research support from Medtronic and consultant fees from Neuroindex (none related to this work). All the authors declare that they have no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Purpose: Under-vehicle explosions caused by improvised explosive devices (IED) came to the public's attention during armed conflicts. However, IEDs are also used by criminals in the civilian setting. This study aimed to determine the pattern of injury, medical management, and outcomes of civilians injured during under-vehicle explosions caused by IEDs., Methods: This is a retrospective cohort study based on the Israeli National Trauma Registry of patients injured from under vehicle explosions caused by IEDs during 2006-2020. Injuries resulting from terror attacks and war were excluded. Descriptive statistics were used for data analysis., Results: During the study period, 58 incidents were recorded, resulting in 74 patients who arrived alive to the hospitals and 17 who died on scene. Seventy-one (95.9%) were male with a median age of 32 years (IQR 24-42). 42% were severely injured (ISS ≥ 16). There was an average of 2.4 injured regions per patient, with extremity injuries being the most common (70.3%). Face (34%), abdomen (28%), and chest (22%) injuries were frequent. 45% were immediately transferred to the operating theatre, and 72% underwent at least one operation. Orthopedic surgeries were the most common interventions. 27 amputations were performed., Conclusions: Injuries caused by under-vehicle IEDs in civilian settings differ from those caused by IEDs used during military conflicts or acts of terrorism: they are associated with fewer victims per incident, more severe injuries, more truncal injuries, and more lower extremity injuries requiring amputations. This can be attributed to the lack of personal and vehicle protection, and the different explosive types., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Current guidelines advocate prehospital endotracheal intubation (ETI) in patients with suspected severe head injury and impaired level of consciousness. However, the ability to identify patients with traumatic brain injury (TBI) in the prehospital setting is limited and prehospital ETI carries a high complication rate. We investigated the prevalence of significant TBI among patients intubated in the field for that reason., Methods: Data were retrospectively collected from emergency medical services and hospital records of trauma patients for whom prehospital ETI was attempted and who were transferred to Rambam Health Care Campus, Israel. The indication for ETI was extracted. The primary outcome was significant TBI (clinical or radiographic) among patients intubated due to suspected severe head trauma., Results: In 57.3% (379/662) of the trauma patients, ETI was attempted due to impaired consciousness. 349 patients were included in the final analysis: 82.8% were male, the median age was 34 years (IQR 23.0-57.3), and 95.7% suffered blunt trauma. 253 patients (72.5%) had significant TBI. In a multivariable analysis, Glasgow Coma Scale>8 and alcohol intoxication were associated with a lower risk of TBI with OR of 0.26 (95% CI 0.13-0.51, p < 0.001) and 0.16 (95% CI 0.06-0.46, p < 0.001), respectively., Conclusion: Altered mental status in the setting of trauma is a major reason for prehospital ETI. Although most of these patients had TBI, one in four of them did not suffer a significant TBI. Patients with a higher field GCS and those suffering from intoxication have a higher risk of misdiagnosis. Future studies should explore better tools for prehospital assessment of TBI and ways to better define and characterize patients who may benefit from early ETI., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Fever is a physiologic response to a wide range of pathologies and one of the most common complaints and clinical signs in the emergency medicine department (ED). The association between fever magnitude and clinical outcomes has been evaluated in specific populations with inconsistent results., Objectives: In this study we aimed to investigate the association between the degree of fever in the ED and clinical outcomes of hospitalized febrile adult patients., Methods: This was a retrospective single-center cohort study of all the patients with maximal body temperature (BT) ≥ 38.0 °C, as recorded during the ED evaluation, who were hospitalized between January 2015 and December 2020. Patients with heatstroke were excluded. The primary outcome was 30-day all-cause mortality and secondary outcomes were intensive care unit (ICU) admission and development of acute kidney injury (AKI)., Results: Fever was recorded among 8.1% of patients evaluated in the ED. Elevated BT was associated with increased risk of hospital admission (70.3% vs. 49.4%, p < 0.001), 30-day mortality (12.3% vs. 2.6%, p < 0.001), ICU admission (5.7% vs. 2.8%, p < 0.001), and AKI 11.7% vs. 3.8%, p < 0.001). After exclusion of nine patients with heatstroke, 21,252 hospitalized febrile patients were included in the final analysis. BT > 39.7 °C was progressively associated with increased mortality (OR 1.64-2.22, 95% CI 1.16-2.81, p < 0.005) as compared to BT 38.0-38.1 °C. More AKI events were observed in patients with BT > 39.5 °C (OR 1.48-2.91, 95% CI 1.11-3.66, p < 0.007). Temperature between 39.2 and 39.5 °C was associated with lower mortality (OR 0.62-0.71, 95% CI 0.51-0.87, p < 0.001). In a multiple logistic regression analysis BT > 39.9 °C was independently associated with increased mortality and AKI. BT > 39.7 °C was progressively associated with an increased risk of ICU admission., Conclusion: Among febrile patients admitted to the hospital, BT > 39.5 °C was associated with adverse clinical course, as compared to patients with lower-grade fever (38.0-38.1 °C). These patients should be flagged on arrival to the ED and likely warrant more aggressive evaluation and treatment., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The current study explores the trends in the application of combat casualty care following the publication of clinical practice guidelines (CPGs) in five domains for 13 years., Methods: The Israel Defense Forces Trauma Registry was used to assess practice and adherence to guidelines in five domains: (a) crystalloid transfusions, (b) tranexamic acid use, (c) freeze-dried plasma use, (d) chest decompression, and (e) airway management. All patients injured between January 2006 and December 2018 were included in the analysis. Trends were analyzed and presented monthly using linear regression and were compared using the Chow test., Results: The mean ± SD crystalloid volume transfused decreased from 1,179 ± 653 mL in 2006 to 466 ± 202 mL in 2018 (B = 0.016, 0.006-0.044). The proportion of patients with an indication treated with tranexamic acid dropped from 8% (238 of 2,979 patients) to 2.5% (60 of 2,356 patients) following the stricter guideline's publication. Freeze-dried plasma administration in indicated casualties rose from 12.5% in 2013 to 48% in 2018 (B = 1.63, 1.3-2.05). The overall proportion of casualties undergoing chest decompression rose from 1% (61 of 6,036 casualties) to 1.5% (155 of 10,493 casualties) following the release of a new CPG in 2012 (p = 0.013). There were no significant trends in intubation ratios before (B = 0.987, 0.953-1.02) or after 2012 (B = 10.2, 0.996-1.05)., Conclusion: Some aspects demonstrate the desired trends in response to new CPGs; in others, initial improvement is achieved but followed by stagnation. In some medical care aspects, completely unexpected and undesirable trends are observed. Every change and update in CPGs should be based on reliable data. The effect of every change must be monitored carefully to ensure adequate adherence to lifesaving guidelines., Level of Evidence: Epidemiological study, level IV., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Predictive models for critical events in the intensive care unit (ICU) might help providers anticipate patient deterioration. At the heart of predictive model development lies the ability to accurately label significant events, thereby facilitating the use of machine learning and similar strategies. We conducted this study to establish the validity of an automated system for tagging respiratory and hemodynamic deterioration by comparing automatic tags to tagging by expert reviewers., Methods: This retrospective cohort study included 72,650 unique patient stays collected from Electronic Medical Records of the University of Massachusetts' eICU. An enriched subgroup of stays was manually tagged by expert reviewers. The tags generated by the reviewers were compared to those generated by an automated system., Results: The automated system was able to rapidly and efficiently tag the complete database utilizing available clinical data. The overall agreement rate between the automated system and the clinicians for respiratory and hemodynamic deterioration tags was 89.4% and 87.1%, respectively. The automatic system did not add substantial variability beyond that seen among the reviewers., Conclusions: We demonstrated that a simple rule-based tagging system could provide a rapid and accurate tool for mass tagging of a compound database. These types of tagging systems may replace human reviewers and save considerable resources when trying to create a validated, labeled database used to train artificial intelligence algorithms. The ability to harness the power of artificial intelligence depends on efficient clinical validation of targeted conditions; hence, these systems and the methodology used to validate them are crucial.

Background: Trauma is the leading cause of death among casualties between 1 and 44 years. A large proportion of trauma deaths occurs even before arriving at a medical facility. The paucity of prehospital data is a major reason for the lagging development of prehospital trauma care research. This study aims to describe the Israel Defense Forces Prehopistal Trauma Registry, the steps taken to improve data collection and quality, the resulting trends, and the registry's contribution to policymaking., Methods: This study explores the quantity and quality of point of injury and prehospital data in the registry between the years 1997 and 2018. We assessed the number of recorded casualties per year, casualties characteristics, and documentation variables in the registry, with a specific focus on documentation of vital signs throughout the years., Results: Overall, 17,905 casualties were recorded. Most casualties were young males (88.6%)-military personnel (52.7%), Syrian refugees (16.2%), Israeli civilians (11.5%), and Palestinians (9.0%). The median number of annual records from 2006 onward was significantly higher compared with before 2006 (1,000 [IQR, 792-1,470] vs. 142 [IQR, 129-156]). Between 2010 and 2018, documentation rate increased in all vital signs investigated including heart rate (56.3% vs. 1.0%), level of consciousness (55.1% vs. 0.3%), respiratory rate (51.8% vs. 0.3%), blood oxygen saturation (50.0% vs. 1.0%), Glasgow Coma Scale (48.2% vs. 0.4%), systolic blood pressure (45.7% vs. 0.8%), and pain (19.1% vs. 0.5%)., Conclusion: Point of injury and prehospital documentation are rare yet essential for ongoing improvement of combat casualty care. The Israel Defense Forces Trauma Registry is one of the largest and oldest prehospital computerized military trauma registries in the world. This study shows a major improvement in the quantity and then in the quality of prehospital documentation throughout the years that affected guidelines and policy. Further work will focus on improving data completeness and accuracy., Level of Evidence: Retrospective study, level III.

Introduction: All modern military jet aircraft are equipped with rocket-assisted ejection systems. Jet aircraft operate in the majority of the conflict regions throughout the world, and in nearly all modern countries during peacetime. Civilian and military emergency services may be called upon to treat aircrews that have ejected and should be familiar with the common injury patterns associated with aircraft ejection., Methods: A systematic review and meta-analysis of the literature were undertaken using the preferred reporting for systematic reviews and meta-analyses (PRISMA) methodology. Peer-reviewed journal and conference papers published between 1 January 1971 and 15 June 2019 were included. Our primary outcomes of interest were mortality and major injury rates. The I 2 test was used to assess heterogeneity among the included studies, and data were pooled under random effects models. In addition, all ejection cases in the Israeli Air Force (IAF) between 1990 and 2019 were studied. The data were manually extracted from the accident records and the electronic medical records system., Results: We identified 14 studies that included 1710 aircrew ejections. Heterogeneity was high (I 2 >75%). Pooled mean mortality and major injury rates were 10.5% (95% CI 6.8-14.8%) and 29.8% (95% CI 20.1-40.6%), respectively. The major injuries included spinal fractures (61.6%), extremity trauma (27.3%), and head trauma (8.9%). During the IAF study period, a total of 37 aircrew ejected from 26 IAF aircraft. The fatality rate was 5.4% and 18.9% suffered major injuries., Conclusions: Although ejection is lifesaving, it is associated with unique injury patterns that should be addressed during clinical evaluation. Because of their high prevalence, spinal precautions are paramount until spinal injury can be ruled out, generally by advanced imaging. Looking forward, injury patterns will continue to evolve in parallel with improving ejection seat systems., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: A walking blood bank (WBB) refers to the use of fellow combatants for battlefield blood donation. This requires pretesting combatants for infectious diseases and blood type. A fundamental prerequisite for this technique is that the donating soldier will suffer minimal physiological and mental impact. The purpose of the current study is to assess the effect of blood shedding on battlefield performance., Methods: This is a double-blind randomized control trial. Forty Israel Defense Forces combatants volunteered for the study. Participants underwent baseline evaluation, including repeated measurement of vital signs, cognitive evaluation, physical evaluation, and a strenuous shooting test. Three weeks after the baseline evaluation, subjects were randomized to either blood donation or the control group. For blinding purposes, all subjects underwent venous catheterization for the duration of a blood donation. Repeated vital signs and function evaluation were then performed., Results: Thirty-six patients were available for randomization. Baseline measurements were similar for both groups. Mean strenuous shooting score was 80.5 ± 9.5 for the control group and 82 ± 6.6 for the test group (p = 0.58). No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions. Vital signs taken multiple times were also similar between the test and control groups., Conclusions: Executive, cognitive, and physical functions were well preserved after blood donation. This study supports the hypothesis that a WBB does not decrease donor combat performance. The categorical prohibition of physical exercise following blood donation might need to be reconsidered in both military and civilian populations., (© 2019 AABB.)

We describe the case of a young man admitted due to mild COVID-19 infection. During his hospitalization in an isolation ward, he had no respiratory distress or fever but developed symptoms consistent with anxiety and insomnia. Despite the appropriate supportive intervention, on hospital day 7, he attempted suicide by jumping from the third-floor ward. The patient underwent urgent surgery and was transferred to a level I trauma center under strict isolation. Our findings emphasize the importance of the mental health aspects of patients treated during the COVID-19 pandemic., Learning Points: The COVID-19 pandemic requires social distancing, quarantine and isolation, which may precipitate new psychiatric symptoms in people without mental illness or aggravate existing conditions.Mental health service providers, including psychiatrists, clinical psychologists and social workers, should be available in every facility taking care of COVID-19 patients.Health workers treating patients during the COVID-19 pandemic should be aware of symptoms of depression, anxiety, insomnia and/or distress developing in their patients and colleagues., Competing Interests: Conflicts of Interests: The Authors declare that there are no competing interests., (© EFIM 2020.)

Designing optimal, Bayesian decision-theoretic trials has traditionally required the use of computationally-intensive backward induction. While methods for addressing this barrier have been put forward, few are both computationally tractable and non-myopic, with applications of the Gittins index being one notable example. Here we explore the look-ahead approach with adaptive-randomization, with designs ranging from the fully myopic to the fully informed. We compare the operating characteristics of the look-ahead designed trials, in which decision rules are based on a fixed number of future blocks, with those of trials designed using traditional backward induction. The less-myopic designs performed well. As the designs become more myopic or the trials longer, there were disparities in regions of the decision space that are transition zones between continuation and stopping decisions. The more myopic trials generally suffered from early stopping as compared to the less myopic and backward induction trials. Myopic trials with adaptive randomization also saw as many as 28 % of their continuation decisions change to a different randomization ratio as compared to the backward induction designs. Finally, early stages of myopic-designed trials may have disproportionate effect on trial characteristics.

Introduction: Multicystic dysplastic kidney (MCDK) is the most common type of renal cystic disease. It is associated with urinary tract abnormalities in the contralateral kidney in up to 30% of cases, most commonly vesicoureteral reflux (VUR)., Objectives: The objective of this study was to describe the incidence and selected issues in management and evolution for each VUR grade in the contralateral kidney of patients with unilateral MCDK, in order to strengthen the scientific basis regarding the need for voiding cystourethrography (VCUG) screening., Methods: A comprehensive search of standard and gray literature was performed. Full-text screening, data abstraction, and quality appraisal were conducted in duplicates. Included studies reported a primary diagnosis of unilateral MCDK with contralateral VUR determined by VCUG. Articles had to include a distribution of VUR grade to meet the eligibility criteria., Results: From 698 retrieved articles, 37 studies enrolling 2057 patients were analyzed. Of the patients, 80% were male; 50% had left unilateral MCDK; and 87% were diagnosed prenatally. A total of 1800 patients had VCUG, of whom 303 had VUR (weighted proportion: 17%; 95% confidence interval [CI]: 14-20%). Weighted proportions of VUR were 9%, 7%, and 17% for grades I-II, III-V, and I-V, respectively. Of the patients, 99% (95% CI: 97-100%) were on continuous antibiotic prophylaxis (CAP) and 18% (95% CI: 8-37%) had urinary tract infections (UTIs), with a higher rate of UTIs (23% vs 10%) in patients with dilating (grades III-V) VUR, over a mean follow-up of 40 months. In patients with dilating VUR, reflux resolved or downgraded to grade I in 52% (95% CI: 37-67%) of patients, and 32% (95% CI: 19-49%) had surgical correction of VUR., Conclusions: Among patients with unilateral MCDK, 17% have VUR in the contralateral kidney, 41% of which is dilating VUR. Of the cases with dilating VUR, half will resolve or downgrade to grade I during follow-up; 23% will develop a UTI despite CAP; and one-third will undergo ureteral re-implantation. While many physicians may thus choose to forego routine VCUG screening of the single functional kidney, shared decision-making with the patient's caregivers is currently recommended, where the risks and benefits of the different approaches can be discussed. The data from this analysis can help inform the discussions., (Copyright © 2018 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.)

Background: Data regarding the effect of prehospital blood administration to trauma patients during short-to-moderate time evacuations is scarce. The Israel Air Force Airborne Combat Search and Rescue is the only organization that deals with aeromedical evacuation for both military and civilian casualties in Israel and the only one with the ability to give blood in the prehospital setting., Methods: Data on packed red blood cells (PRBCs) administration in the evacuation missions from January 2003 to June 2010 were analyzed and actual transfusion practice was compared to clinical practice guidelines (CPGs)., Results: Over the studied 101 months, a total of 1,721 patients were evacuated by Combat Search and Rescue. Of these, 87 (5.1%) trauma patients were transfused with PRBC. Demographics included 83% male and 17% female with a median age of 23 years. Main mechanisms of injury included gunshot wounds (36%), motor vehicle accidents (28%), and blast injuries (24%) with an average of 2.6 injured regions per casualty. The most commonly injured body regions included lower extremities (52%), chest (45%), and abdomen (38%). Overall, 10 (11%) casualties died. Lifesaving intervention included tourniquets (27%), endotracheal intubation (24%), tube thoracostomy (24%), and needle thoracostomy (21%) times. For 98% of the patients, clinical judgment led to administration of red blood cells before indicated by the CPG. The heart rate tended to decrease during the evacuation, whereas there was no clear trend in systolic or diastolic blood pressure or shock index., Conclusions: In our aeromedical experience, transfusion of PRBCs for trauma patients was safe, feasible, and most likely beneficial. PRBCs were administered according to the flight surgeons' clinical judgment and not in complete adherence to CPGs in most cases. Data collected from this and similar studies worldwide have led to change in CPGs with the shift from hypertensive resuscitation to hypotensive-hemostatic Remote Damage Control Resuscitation., (Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.)

Objective: To describe the contributions of on-call, volunteer first responders to mass-casualty terrorist attacks in Israel during the Second Intifada., Design: Descriptive study evaluating data obtained from postevent debriefings after 15 terrorist attacks in Israel between 2001 and 2004., Results: An average of 7.9 deaths (median 7.0, interquartile range [IQR] 2.5-12.5) and 53.8 injuries (median 50.0, IQR 34.0-62.0) occurred in each of these attacks. The average number of volunteers responding to each event was 50.3 (median 43.0, IQR 27.5-55.5). The volunteers were involved in extricating victims from imminent danger, and performing emergent tasks such as bag-valve ventilation, tourniquet application, and intravenous line insertion. They were also integral to the rapid evacuation of casualties from the scene., Conclusion: On-call, volunteer first responders are an integral part of Israel's emergency medical response to mass-casualty terrorist attacks. This system may be used as a model for the development of similar services worldwide.

Background: Hemostatic dressings are advanced topical dressings designed to control hemorrhage by enhancing clot formation. These dressings may be effective when used on injuries sustained in junctional zones. The Israeli Defense Forces Medical Corps (IDF-MC) chose to equip its medical personnel with the QuikClot Combat Gauze. There is a paucity of data describing clinical use and results of hemostatic dressing especially at the point of injury. The purpose of this article was to report the IDF-MC experience with prehospital use of the QuikClot Combat Gauze in junctional zones in a case series retrieved from the IDF Trauma Registry., Methods: All IDF Trauma Registry documented cases of prehospital use of hemostatic dressings in the IDF-MC between January 2009 and September 2014 were retrieved. Data collection included injury mechanism, wound location, reported success of hemostatic dressing, tourniquet use, lifesaving interventions, mortality, and caregiver identity., Results: A total of 122 patients on whom 133 hemostatic dressings were applied were identified. Median age was 22 years. Of the patients, 118 (96.7%) were male and 2 (1.6%) were female (missing, n = 2). Injury mechanism was penetrating in 104 (85.2%), blunt in 4 (3.3%), and combined in 14 (11.5%) patients. Seven patients (5.9%) died. Thirty-seven dressings (27.8%) were used for junctional hemorrhage control (pelvis, shoulder, axilla, buttocks, groin, neck), and 92 dressings (72.1%) were placed in nonjunctional areas (missing, n = 4). Nonjunctional dressings included 63 (47.4%) applied to the extremities, 14 (10.5%) to the back, and 4 (3%) to the head. Hemostatic dressing application was reported as successful in 88.6% (31 of 35 available; missing, n = 2) of junctional hemorrhage applications and in 91.9% (57 of 62 available; missing, n = 1) of extremity hemorrhage applications., Conclusion: Hemostatic dressings seem to be an effective tool for junctional hemorrhage control and should be considered as a second-line treatment for extremity hemorrhage control at the point of injury., Level of Evidence: Therapeutic study, level V.

Currently available triage and monitoring tools are often late to detect life-threatening clinically significant physiological aberrations and provide limited data in prioritizing bleeding patients for treatment and evacuation. The Compensatory Reserve Index (CRI) is a novel means of assessing physiologic reserve, shown to correlate with central blood volume loss under laboratory conditions. The purpose of this study was to compare the noninvasive CRI device with currently available vital signs in detecting blood loss. Study subjects were soldiers volunteering for blood donation (n = 230), and the control group was composed of soldiers who did not donate blood (n = 34). Data collected before and after blood donation were compared, receiver operator characteristic curves were generated after either donation or the appropriate time interval, and areas under the curves (AUCs) were compared. Compared with pre-blood loss, blood donation resulted in a mean reduction of systolic blood pressure by 3% (before, 123 mmHg; after, 119 mmHg; P < 0.01). The CRI demonstrated a 16% reduction (before, 0.74; after, 0.62; P < 0.01). Heart rate, diastolic blood pressure, and oxygen saturation remained unchanged. The AUC for change in CRI was 0.81, 0.56 for change in heart rate, 0.53 for change in systolic blood pressure, 0.55 and 0.58 for pulse pressure and shock index, respectively. The AUCs for detecting mild blood loss at a single measurement were 0.73 for heart rate, 0.60 for systolic blood pressure, 0.62 for diastolic blood pressure, 0.45 for pulse oximetry, and 0.84 for CRI. The CRI was better than standard indices in detecting mild blood loss. Single measurement of CRI may enable a more accurate triage, and CRI monitoring may allow for earlier detection of casualty deterioration.

Abstract Objective: We investigated the accuracy of initial critical care triage in blast-injured versus non-blast-injured trauma patients, focusing on those inappropriately triaged to the intensive care unit (ICU) for brief (<16 h) stays., Methods: We conducted a retrospective review of the Israel National Trauma Registry, applying a predetermined definition of need for initial ICU admission., Results: A total of 883 blast-injured and 112 185 non-blast-injured patients were categorized according to their need for ICU admission. Of these admissions, 5.7% in the blast setting and 8.4% in the non-blast setting were considered unnecessary. The sensitivity, specificity, and positive and negative likelihood ratios for the triage officers' decisions in assigning patients to the ICU were 95.5%, 98.8%, 77.2, and 0.05, respectively, in the blast setting, and 91.2%, 99.5%, 200.5, and 0.09, respectively, in the non-blast setting., Conclusions: Triage officers do a better job sending to the ICU only those patients who require initial intensive care in the non-blast setting, though this is obscured by a much greater overall need for ICU-level care in the blast setting. Implementing triage protocols in the blast setting may help reduce the number of patients sent initially to the ICU for brief periods, thus increasing the availability of this resource.

Objective: We compared the survival of trauma patients in urban versus rural settings after the implementation of a novel rural non-trauma center alternative care model called the Model Rural Trauma Project (MRTP)., Materials and Methods: We conducted an observational cohort study of all trauma patients brought to eight rural northern California hospitals and two southern California urban trauma centers over a one-year period (1995-1996). Trauma patients with an injury severity score (ISS) of >10 were included in the study. We used logistic regression to assess disparities in odds of survival while controlling for Trauma and Injury Severity Score (TRISS) parameters., Results: A total of 1,122 trauma patients met criteria for this study, with 336 (30%) from the rural setting. The urban population was more seriously injured with a higher median ISS (17 urban and 14 rural) and a lower Glasgow Coma Scale (GCS) (GCS 14 urban and 15 rural). Patients in urban trauma centers were more likely to suffer penetrating trauma (25% urban versus 9% rural). After correcting for differences in patient population, the mortality associated with being treated in a rural hospital (OR 0.73; 95% CI 0.39 to 1.39) was not significantly different than an urban trauma center., Conclusion: This study demonstrates that rural and urban trauma patients are inherently different. The rural system utilized in this study, with low volume and high blunt trauma rates, can effectively care for its population of trauma patients with an enhanced, committed trauma system, which allows for expeditious movement of patients toward definitive care.

Background: The leading cause of preventable death in the military setting is haemorrhage. Accumulating evidence has established the benefit of tranexamic acid (TXA), an antifibrinolytic, for treating traumatic haemorrhage in the hospital setting. The use of TXA in the prehospital setting, however, has not been previously described. The present study details our initial experience with a field protocol that advances TXA administration to (or as close as possible to) the point of injury., Methods: We present a series of all casualties treated with TXA by Israel Defense Forces' (IDF) prehospital advanced life support providers between December 2011 and February 2013. Data were abstracted from the IDF Trauma Registry at the Research Section of the Trauma and Combat Medicine Branch, Surgeon General's Headquarters., Results: Forty casualties who received TXA in the prehospital setting were identified. Most casualties were male (n=35; 88%) and young adults (median 28 years). The mechanism of injury was penetrating in 22 cases (55%). TXA was administered earlier than it could have been in the hospital setting without delaying evacuation. There were no reports of adverse outcomes that could be reasonably attributed to TXA. Casualties who received TXA per protocol were sicker than those who received it not per protocol., Conclusions: We have shown that TXA may be successfully given in the prehospital setting without any apparent delays in evacuation. In light of recent evidence, the ability to give TXA closer to the time of wounding represents an important step towards improving the survival of trauma victims with haemorrhage, even before definitive care is available. While this may be especially relevant in austere combat environments, there is likely benefit in the civilian sector as well. The safety profile of TXA is an important consideration as prehospital personnel tended to overtreat casualties without indications for TXA per protocol. We suggest that TXA be considered a viable option for use by advanced life support providers at or near the point of injury., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

At the time of this study, the Sheba Medical Center Emergency Department (ED) in Israel had no formal triage system in place. To evaluate the interobserver reliability of two triage scales among nurses in our ED, the time-based Australasian Triage Scale (ATS) and the resource-based Emergency Severity Index (ESI), 10 nurses participated in a workshop on ATS and ESI. They then independently assessed 100 simulated triage scenarios taken from actual ED patients, and completed a survey. Intraclass correlation coefficients were calculated. The intraclass correlation coefficient for ATS was 0.64 (95% confidence interval: 0.57, 0.71), whereas for ESI, it was 0.52 (95% confidence interval: 0.45, 0.61). The nurses felt that ESI was slightly easier to use. Using conventional interpretations, the agreement for ATS is considered substantial, whereas that for ESI is considered moderate. Conversely, the nurses found the ESI somewhat easier to use.

We describe a case of peripheral intravenous catheter fracture occurring during a routine training exercise. The supervising instructor immediately placed a venous tourniquet proximal to the insertion site and urgently transported the patient to the hospital. The missing catheter segment was identified within the median cubital vein under ultrasonography and was removed by venous cutdown under local anesthesia. An investigation determined that reinsertion of the needle into the advanced catheter likely caused the fracture and that application of a tourniquet may have prevented embolism of the fractured segment. Our literature review suggested that peripheral intravenous catheter fracture is likely vastly underreported, with only one prior case identified in the English literature. Action was taken following the event to educate all Israeli Defense Force medical providers regarding both proper preventive measures and recognition and treatment of catheter fracture should it occur. This case highlights the importance of health care providers being aware of the possibility of catheter fracture, as well as steps to take to prevent and mitigate its occurrence.

Adaptive randomization is used in clinical trials to increase statistical efficiency. In addition, some clinicians and researchers believe that using adaptive randomization leads necessarily to more ethical treatment of subjects in a trial. We develop Bayesian, decision-theoretic, clinical trial designs with response-adaptive randomization and a primary goal of estimating treatment effect and then contrast these designs with designs that also include in their loss function a cost for poor subject outcome. When the loss function did not incorporate a cost for poor subject outcome, the gains in efficiency from response-adaptive randomization were accompanied by ethically concerning subject allocations. Conversely, including a cost for poor subject outcome demonstrated a more acceptable balance between the competing needs in the trial. A subsequent, parallel set of trials designed to control explicitly types I and II error rates showed that much of the improvement achieved through modification of the loss function was essentially negated. Therefore, gains in efficiency from the use of a decision-theoretic, response-adaptive design using adaptive randomization may only be assumed to apply to those goals that are explicitly included in the loss function. Trial goals, including ethical ones, which do not appear in the loss function, are ignored and may even be compromised; it is thus inappropriate to assume that all adaptive trials are necessarily more ethical. Controlling types I and II error rates largely negates the benefit of including competing needs in favor of the goal of parameter estimation., (Copyright © 2013 John Wiley & Sons, Ltd.)

Background: Mass casualty incidents (MCIs) represent one of the most difficult prehospital challenges faced by medical personnel. When they occur at sea, this challenge may be further complicated by isolation, distance, vessel structure, number of passengers, and limited evacuation means., Methods: We describe our experience and lessons learned from a dynamic MCI in an austere environment at sea., Results: Following an armed attack on navy operators boarding the MV Mavi Marmara, a vessel heading for Gaza, the Israel Defense Forces' medical teams triaged and cared for 62 casualties, among them 9 soldiers; 9 additional casualties were declared dead at the scene. The injured, including 10 triaged as severely wounded, were all evacuated to Israeli hospitals within several hours of the start of the event. Despite the austere conditions and the severity of injuries, all of the injured passengers were able to return to their home countries, and all soldiers returned to duty. Multiple issues were identified as requiring changes or heightened awareness so as to be better prepared for future events of this special nature., Conclusion: The primary lessons learned related to difficulties in functioning without effective communication, maintaining command and control, coordinating serial evacuation of casualties who were being triaged in parallel, planning for an event with lengthy evacuation times, resolving real-time ethical dilemmas, and preparing our providers mentally. As MCIs tend to be unexpected, preplanning, using preestablished manuals, and drilling for them may prove crucial in such extreme events. Importantly, the lessons learned from this event, with its unique synthesis of multiple contributing factors, remain relevant even in less austere settings.

Background: Advanced airway management is composed of a set of vital yet potentially difficult skills for the prehospital provider, with widely different clinical guidelines. In the military setting, there are few data available to inform guideline development. We reevaluated our advanced airway protocol in light of our registry data to determine if there were a preferred maximum number of endotracheal intubation (ETI) attempts; our success with cricothyroidotomy (CRIC) as a backup procedure; and whether there were cases where advanced airway interventions should possibly be avoided., Methods: This is a descriptive, registry-based study conducted using records of the Israel Defense Forces Trauma Registry at the research section of the Trauma and Combat Medicine Branch, Surgeon General's Headquarters. We included all casualties for whom ETI was the initial advanced airway maneuver, and the number of ETI attempts was known. Descriptive statistics were used., Results: Of 5,553 casualties in the Israel Defense Forces Trauma Registry, 406 (7.3%) met the inclusion criteria. Successful ETI was performed in 317 casualties (78%) after any number of ETI attempts; an additional 46 (11%) underwent CRIC, and 43 (11%) had advanced airway efforts discontinued. ETI was successful in 45%, 36%, and 31% of the first, second, and third attempts, respectively, with an average of 28% success over all subsequent attempts. CRIC was successful in 43 (93%) of 46 casualties in whom it was attempted. Of the 43 casualties in whom advanced airway efforts were discontinued, 29 (67%) survived to hospital discharge., Conclusion: After the first ETI attempt, success with subsequent attempts tended to fall, with minimal improvement in overall ETI success seen after the third attempt. Because CRIC exhibited excellent success as a backup airway modality, we advocate controlling the airway with CRIC if ETI efforts have failed after two or three attempts. We recommend that providers reevaluate whether definitive airway control is truly necessary before each attempt to control the airway.

Background: Current research in trauma resuscitation indicates that it is important to strike a balance between withholding intravenous fluid therapy, on one hand, and giving too much, on the other. The Israel Defense Forces' former protocol for prehospital fluid administration in the trauma setting was intended to navigate this balancing act. It turned out that the protocol was not being appropriately implemented in field conditions., Objectives: We describe our process improvement, which resulted in our revised protocol. Our goal in drafting the new protocol was to achieve yet another balance, this time between the recommendations derived from accumulating science, and the efficacy with which they could likely be implemented in the field., Discussion: We review the available research in prehospital fluid administration, and then develop our current protocol. Per our a priori requirements, the protocol is unified in that medical personnel from a very wide spectrum of caregivers can apply it; and it is appropriate for both short evacuation time scenarios (e.g., low-intensity conflicts) and lengthier evacuation scenarios (e.g., high-intensity conflicts)., Conclusion: Survival is likely improved if guidelines do not add unnecessary complexity and are easily implemented. We believe that the current protocol is suitable for the large majority of trauma patients, and helps guide providers toward a primary decision-point regarding fluid administration. Nonetheless, as long as only coarse clinical parameters for identifying shock are available, and data regarding optimal treatment are conflicting, offering truly balanced fluid resuscitation guidelines is a lot like walking between the drops., (Copyright © 2013. Published by Elsevier Inc.)

Objective: Elevated blood glucose levels (BGL) are known to be part of the physiologic response to stress following physical trauma. We aimed to study whether a measured BGL might help improve accuracy of field triage., Methods: We conducted a retrospective study using the Israel Defense Forces Trauma Registry. BGLs were determined upon hospital arrival and were not available to medical providers in the field., Results: There were 706 casualties in the registry who had a recorded BGL upon hospital arrival. Sixty percent (18/30) of casualties who had a BGL ≥200 mg/dL had been triaged in the field as severely wounded, whereas 11% (71/651) of casualties who had a BGL <200 mg/dL had been triaged as severely wounded. For predicting an Injury Severity Score >15, the positive likelihood ratio using field triage of severe was 11, using BGL ≥200 mg/dL was 8, and using a combination of the two tests was 26. For predicting the need for intensive care unit (ICU) admission, the ratios were 8, 13, and 23, respectively., Conclusions: Elevated BGL improved prediction of high Injury Severity Score and ICU use among casualties triaged as severe. If future research using BGL measured in the field yields similar results, combining BGL with standard field triage may allow for more accurate identification of casualties who need acute field intervention, have major injury, or require ICU admission., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: While adaptive trials tend to improve efficiency, they are also subject to some unique biases., Purpose: We address a bias that arises from adaptive randomization in the setting of a time trend in disease incidence., Methods: We use a potential-outcome model and directed acyclic graphs to illustrate the bias that arises from a changing subject allocation ratio with a concurrent change in background risk., Results: In a trial that uses adaptive randomization, time trends in risk can bias the crude effect estimate obtained by naively combining the data from the different stages of the trial. We illustrate how the bias arises from an interplay of departures from exchangeability among groups and the changing randomization proportions., Limitations: We focus on risk-ratio and risk-difference analysis., Conclusions: Analysis of trials using adaptive randomization should involve attention to or adjustment for possible trends in background risk. Numerous modeling strategies are available for that purpose, including stratification, trend modeling, inverse-probability-of-treatment weighting, and hierarchical regression.

The decision to terminate a controlled clinical trial at the time of an interim analysis is perhaps best made by weighing the value of the likely additional information to be gained if further subjects are enrolled against the various costs of that further enrollment. The most commonly used statistical plans for interim analysis (eg, O'Brien-Fleming), however, are based on a frequentist approach that makes no such comparison. A two-armed Bayesian decision-theoretic clinical trial design is developed for a disease with two possible outcomes, incorporating a quadratic decision loss function and using backward induction to quantify the cost of future enrollment. Monte Carlo simulation is used to compare frequentist error rates and mean required sample sizes for these Bayesian designs with the two-tailed frequentist group-sequential designs of, O'Brien-Fleming and Pocock. When the terminal decision loss function is chosen to yield typical frequentist error rates, the mean sample sizes required by the Bayesian designs are smaller than those of the corresponding O'Brien-Fleming frequentist designs, largely due to the more frequent interim analyses typically used with the Bayesian designs and the ability of the Bayesian designs to terminate early and conclude equivalence. Adding stochastic curtailment to the frequentist designs and using the same number of interim analyses results in largely equivalent trials. An example of a Bayesian design for the data safety monitoring of a clinical trial is given. Our design assumes independence of the probabilities of success in the two trial arms. Additionally, we have chosen non-informative priors and selected loss functions to produce trials with appealing frequentist error rates, rather than choosing priors that reflect realistic prior information and loss functions that reflect true costs. Our Bayesian designs allow interpretation of the final results along either Bayesian or frequentist lines. For the Bayesian, they minimize the total cost and allow the direct calculation of the probability density function for the difference in efficacy. For the frequentist, they have well-characterized type I and II error rates and in some cases lead to a reduction in the mean sample size.

Background: To determine whether prehospital hypotension predicts the need for an emergent, therapeutic operation in trauma patients who present to the emergency department (ED) with normal systolic blood pressure (SBP)., Methods: An observational, cohort study was conducted at a Level I, urban, county trauma center. Consecutive trauma patients not in cardiopulmonary arrest and transported to the ED by emergency medical services during a one-year period were studied. Data on prehospital and ED vital signs, subsequent hospital course, and surgical procedures were collected. The occurrence of an emergent, therapeutic operation, which was defined based on the types of injuries found or repaired within 6 hours of arrival, was determined from operative and hospital records., Results: Of the 1,227 total trauma patients, 160 were excluded because of cardiopulmonary arrest or inadequate documentation, leaving 1,067 study patients. Of those, 1,028 were normotensive on arrival to the ED. Seventy-one of the 1,028 patients (7%) were hypotensive in the field; 37% of these patients received an emergent, therapeutic operation and 6% died. Of the 1,028 patients, 957 (93%) were normotensive in the field; 11% of these patients received an emergent, therapeutic operation and 3% died. Thus, in trauma patients who were normotensive on arrival to the ED, the need for an emergent, therapeutic operation was more than three times more likely compared with those who had normal SBP in the field (odds ratio 4.5, 95% confidence interval 2.7-7.6). Mortality was also higher in the prehospital hypotension group (odds ratio 2.3, 95% confidence interval 0.8-6.9)., Conclusion: Prehospital hypotension is a strong predictor of the need for an emergent, therapeutic operation in trauma patients with normal SBP on arrival to the ED.

Mesenteric injuries after blunt abdominal trauma are infrequent and difficult to diagnose. We investigated whether a delay in diagnosis of more than 6 hours had a significant impact on morbidity, mortality, and length of stay at our Level I trauma center. A retrospective chart review spanning the period from January 1995 to September 2005 identified 85 patients with laparotomy-confirmed mesenteric injuries, 81 of whom survived to hospital discharge. Nineteen (23%) of the 81 patients had a delay in diagnosis of greater than 6 hours. After controlling for identified confounders, we found that the delayed diagnosis group experienced 30 per cent longer hospital stays (P = 0.03), 55 per cent longer intensive care unit stays (P = 0.006), and 38 per cent longer duration of mechanical ventilation (P = 0.05). Patients in the delayed group also had significantly higher odds of developing acute respiratory distress syndrome, as well as trends toward higher odds of wound infection, pneumonia, multiple organ dysfunction syndrome, abdominal compartment syndrome, renal failure, and ileus. No significant difference in mortality was observed among all 85 patients (P = 0.67). Thus, in contradiction to some previous studies, our review indicates that a delay in the diagnosis of mesenteric injuries results in significantly increased morbidity and hospital and intensive care unit lengths of stay.