A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103).

BACKGROUND AND OBJECTIVE: Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI. METHODS: Randomized, double-blind, placebo-controlled trial of single dose reltecimod (0.5 mg/kg) administered within 6 hours of NSTI diagnosis at 65 of 93 study sites. Inclusion: surgical confirmation of NSTI and organ dysfunction [modified Sequential Organ Failure Assessment Score (mSOFA) score ≥3]. Primary analysis was modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution). A prespecified, per protocol (PP) analysis excluded 17 patients with major protocol violations before unblinding. RESULTS: Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148): mean age 55 ±â€Š15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5 ±â€Š2.4. Twenty-eight-day mortality was 15% in both groups. mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 and PP was 54.3% reltecimod versus 40.3% placebo, P = 0.021. Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP. CONCLUSION: Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status.

Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial.

OBJECTIVE: To compare the incidence of hypersensitivity reactions following copperhead envenomation treated with Fab antivenom (FabAV) or placebo. METHODS: Patients with copperhead snakebites received treatment and follow-up in a prospective, randomized, double-blind, placebo-controlled trial of FabAV or placebo. The treatment allocation ratio was 2:1 (FabAV:placebo). All of the included patients received at least one dose of study treatment. We reviewed all treatment-emergent adverse events (AEs) using a previously published scale to classify likely hypersensitivity reactions as mild, moderate, or severe. RESULTS: We enrolled 74 patients at 13 sites. Forty-five patients received FabAV, and 29 patients received placebo. Five FabAV patients and 4 placebo patients had moderate envenomations; the rest were mild. Twenty-five FabAV patients and 8 placebo patients had at least 1 AE. Mild skin reactions occurred in 11 (24%) FabAV patients (pruritis, urticaria, rash, ecchymosis, erythema) and 1 (3%) placebo patient (pruritis). Moderate gastrointestinal AEs occurred in 7 (16%) FabAV patients (nausea, vomiting, constipation, diarrhea, oral paresthesia) and in 2 (7%) placebo patients (nausea). Respiratory AEs occurred in 3 (7%) FabAV patients (dyspnea, pulmonary embolism, nasal congestion, sneezing) and no placebo patients. Hypotension occurred in 1 patient in each group. CONCLUSIONS: In a randomized controlled trial of FabAV for copperhead bites, the incidence of hypersensitivity reactions was low. Most reactions were mild skin reactions.

The Efficacy of Crotalidae Polyvalent Immune Fab (Ovine) Antivenom Versus Placebo Plus Optional Rescue Therapy on Recovery From Copperhead Snake Envenomation: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.

STUDY OBJECTIVE: Copperhead snake (Agkistrodon contortrix) envenomation causes limb injury resulting in pain and disability. It is not known whether antivenom administration improves limb function. We determine whether administration of antivenom improves recovery from limb injury in patients envenomated by copperhead snakes. METHODS: From August 2013 through November 2015, we performed a multicenter, randomized, double-blind, placebo-controlled, clinical trial to evaluate the effect of ovine Crotalidae polyvalent immune Fab (ovine) (CroFab; FabAV) antivenom therapy on recovery of limb function in patients with copperhead snake envenomation at 14 days postenvenomation. The study setting was 18 emergency departments in regions of the United States where copperhead snakes are endemic. Consecutive patients aged 12 years or older with mild- to moderate-severity envenomation received either FabAV or placebo. The primary outcome was limb function 14 days after envenomation, measured by the Patient-Specific Functional Scale. Additional outcomes included the Patient-Specific Functional Scale at other points; the Disorders of the Arm, Shoulder, and Hand, Lower Extremity Functional Scale, and Patient's Global Impression of Change instruments; grip strength; walking speed; quality of life (Patient-Reported Outcomes Measurement Information System Physical Fucntion-10); pain; and analgesic use. RESULTS: Seventy-four patients received study drug (45 FabAV, 29 placebo). Mean age was 43 years (range 12 to 86 years). Fifty-three percent were men, 62% had lower extremity envenomation, and 88% had mild initial severity. The primary outcome, the least square mean Patient-Specific Functional Scale score at 14 days postenvenomation, was 8.6 for FabAV-treated subjects and 7.4 for placebo recipients (difference 1.2; 95% confidence interval 0.1 to 2.3; P=.04). Additional outcome assessments generally favored FabAV. More FabAV-treated subjects experienced treatment-emergent adverse events (56% versus 28%), but few were serious (1 in each group). CONCLUSION: Treatment with FabAV reduces limb disability measured by the Patient-Specific Functional Scale 14 days after copperhead envenomation.

Patterns of Platelet Mapping Thromboelastography Abnormalities in Trauma.

OBJECTIVES: Platelet mapping thromboelastography (TEG-PM) to evaluate trauma induced coagulopathy has become more prevalent. The objective of this study was to evaluate associations between TEG-PM and outcomes in trauma patients, including patients with TBI. METHODS: A retrospective review was conducted utilizing the American College of Surgeons National Trauma Database. Chart review was conducted to obtain specific TEG-PM parameters. Patients were excluded if they were on anti-platelets, anticoagulation, or received blood products prior to arrival. TEG-PM values and their associations with outcomes were evaluated using generalized linear model and Cox cause-specific hazards model. Outcomes included in-hospital death, hospital and ICU length of stay (LOS). Relative risk (RR) and hazard ratio (HR) and their 95% confidence intervals (CIs) are provided. RESULTS: A total of 1066 patients were included, with 151 (14%) diagnosed with isolated TBI. ADP inhibition was associated with significant increase rate of hospital LOS and ICU LOS (RR per % increase = 1.002 and RR = 1.006 per % increase, respectively) while increased MA(AA) and MA(ADP) were significantly associated with decrease rate of hospital LOS and ICU LOS (RR = .993 per mm increase and RR = .989 per mm increase, respectively, and RR = .986 per mm increase and RR = .989 per mm increase). R (per minute increase) and LY30 (per % increase) were associated with increased risk of in-hospital mortality (HR = 1.567 and HR = 1.057, respectively). No TEG-PM values significantly correlated with ISS. CONCLUSION: Specific TEG-PM abnormalities are associated with worse outcomes in trauma patients, including TBI patients. These results require further investigation to understand associations between traumatic injury and coagulopathy.

A Statewide Analysis of Predictors of Trauma Center Transfer: The Burden of Non-Clinical Factors.

OBJECTIVES: There is a perception, with mixed literary support, that patients are transferred from community hospitals to tertiary medical centers for non-clinical reasons (ie, payor, race, and admission time). Over-triage risks unequally burdening the tertiary medical centers within a trauma system. This study aims to identify potential non-clinical factors associated with the transfer of injured patients. METHODS: Using the 2018 North Carolina State Inpatient Database, patients with a primary diagnosis of spine, rib or extremity fractures, or TBI were identified using ICD-10-CM code and admission type of "Urgent," "Emergency," or "Trauma." Patients were divided into cohorts of "retained" (at community hospital) or "transferred" (Level-1 or 2 trauma centers). RESULTS: 11,095 patients met inclusion criteria; 2432 (21.9%) patients made up the transfer cohort. The mean ISS for all retained patients was 2.2 (±.9) and 2.9 (±1.4) for all transferred patients. The transfer cohort was younger (mean age 66 v 75.8), underinsured, and more likely to be admitted after 1700 (P < .001). Similar differences were seen regardless of injury pattern. CONCLUSIONS: Patients transferred to trauma centers were more likely to be underinsured and be admitted outside of normal business hours. These transferred patients had longer lengths of stay and higher mortality rates. Across all cohorts, similar ISS suggests that a portion of the transfers could be managed at a community hospital. After hours transfers suggest a need for more robust community hospital coverage. Intentional triage of the injured patient encourages appropriate utilization of resources and is crucial to maintaining high-functioning trauma centers and systems.

Stop the Bleed®: Medical Students as Instructors of the Bleeding Control Basics Course.

BACKGROUND: The Bleeding Control Basics (B-Con) Course was developed to teach lifesaving hemorrhage control techniques to the public. Currently, medical students (MS) without prior clinical experience (CE) may not act as autonomous instructors, limiting the instructor pool. PURPOSE: To assess the bleeding control knowledge of MS (phase I) and compare the knowledge of students taught by a certified instructor vs a medical student (phase II). METHODS: Phase I: 20 MS, 6 with prior CE and 14 without clinical experience (NCE) completed a pre-course and post-course knowledge assessment. Results were assessed by independent sample t-tests. Phase II: 91 first-year MS were taught the B-Con Course by either a third-year MS (n = 45) or certified instructor (n = 46). An analysis of covariance (ANCOVA) was performed to compare scores by instructor type (certified vs MS) using prior CE and pretest scores as confounding variables. RESULTS: In Phase I, the CE group scored higher on the pretest assessment compared to the NCE group (P = .003). All students improved in posttest scoring, and there was no difference in posttest scores between the groups (P = .597). In Phase II, despite no difference in pretest scores between groups, the MS taught learners scored significantly higher on the posttest compared to the certified instructor group (P < .01). Prior CE did not correlate to posttest scores (P = .719). DISCUSSION: Medical students are as effective as certified instructors at conveying the B-Con learning objectives. Based on near-perfect assimilation of content by students, MS should be permitted to teach B-Con Courses.

Shelter in Place and an Alarming Increase in Penetrating Trauma in Children and Concerning Decrease in Child Abuse.

BACKGROUND: On March 14, 2020, schools across North Carolina (NC) closed in response to Covid-19, forcing completion of the school year at home. Most pediatric trauma occurs at home with a higher prevalence when children are out of school. We queried the state trauma database to assess if the 2020 "shelter in place" was associated with an increase in pediatric trauma statewide. METHODS: The NC trauma database was queried for injuries in children (age < 18 yrs) from 13 March-1 August 2020, and the corresponding months of 2018 and 2019. The number and type of injuries were compared. We also queried the NC death certificate and child welfare databases. Data were analyzed by standard statistical methods using chi-squared or Kruskal-Wallis test. RESULTS: Total pediatric trauma cases were lower during 2020 (71.6 per 100,000) compared to 2018 (92.4 per 100,000) and 2019 (80 per 100,000) (P < .001); however, average injury severity score (ISS) was higher (P = .001). A significant increase in firearm injuries were seen in 2020 (P = .016), with an increase in mortality (P = .08) and ISS (P = .013). The rate of child abuse trauma decreased in 2020 (P = .005) as did the number of child abuse and neglect reports (P < .001). There were also significant decreases in trauma due to sports, burns, falls, and motor vehicle accidents. CONCLUSION: While overall pediatric trauma decreased during the Covid-19 pandemic, there was an alarming increase in penetrating injuries in children. Child abuse trauma and reports decreased, which is concerning for lower identification of abuse.

Direct Peritoneal Resuscitation in Trauma Patients Results in Similar Rates of Intra-Abdominal Complications.

Background: Trauma patients undergoing damage control surgery (DCS) have a propensity for complicated abdominal closures and intra-abdominal complications. Studies show that management of open abdomens with direct peritoneal resuscitation (DPR) reduces intra-abdominal complications and accelerates abdominal closure. This novel study compares intra-abdominal complication rates and the effect of DPR initiation in patients who received DPR and those who did not. Patients and Methods: A retrospective chart review was performed on 120 patients who underwent DCS. Fifty patients were identified as DCS with DPR, and matched to 70 controls by gender, race, age, body mass index (BMI), past medical history, mechanism of trauma, and injury severity score. Results: The two groups of patients, those without DPR (-DPR) and those with DPR (+DPR), were similar in their characteristics. The +DPR group was more likely to have a mesh closure than the -DPR (14% and 3%; p = 0.022). The +DPR group took longer to have a final closure (3.5 ± 2.6 days vs. 2.5 ± 1.8; p = 0.020). Infection complications and mechanical failure of the closure technique were similar among the two groups. Timing of DPR initiation had no effect on closure type but did statistically increase the number of days to closure (initiation at first operation 2.8 ± 1.8 days vs. initiation at subsequent operations 6.0 ± 3.3 days; p ≤ 0.001). Conclusions: The use of DPR did not result in different outcomes in trauma patients. Therefore, traditional resuscitative measures for DCS may not be inferior to DCS with DPR. When choosing to use DPR, initiating it at the first operation could reduce the number of days to closure.

The Impact of Delays in Interfaculty Transfer on Outcomes in Elderly Trauma Patients.

BACKGROUND: Delay to definitive treatment is a significant and persistent challenge to trauma systems across the United States, especially in rural communities with limited resources. We hypothesized that elderly trauma patients with delay in transfer would have increased morbidity and mortality. This study evaluates the relationship between inter-facility transfer time and outcomes in elderly trauma patients, and the validity of the 4-hour dwell time as a performance improvement benchmark. METHODS: The National Trauma Registry and Emergency Medical Services Database were queried from January 2010 to January 2018. Inclusion criteria included age ≥65, blunt mechanism, and transfer from another facility. Correlation analysis was used to evaluate the association between clinical and demographic variables and transfer time. Multicollinearity was evaluated using the variance inflation factor. RESULTS: 1535 patients were identified. This cohort was further subdivided into 4 cohorts based on dwell time: 0-1.5 hours (n = 384), ≥1.5-1.9 hours (n = 379), 1.9-<2.5 hours (n = 383), and ≥2.5 hours (n = 388). Analysis revealed that shorter dwell time was associated with male gender (P = .0039), higher ISS (injury severity score) (P < .0001), lower RTS (revised trauma score) (P < .0001), higher pre-hospital arrest (P = .0066), lower initial GCS (Glasgow Coma Scale) (P = .0012), higher mortality, longer ICU, and ventilator length of stay (P < .0001). Longer dwell times were associated with discharge from the hospital to home or skilled nursing facility as well as lower mortality (P < .0001). DISCUSSION: Longer dwell time was inversely related to outcome. More severely injured patients were rapidly transferred. This represents a mature rural trauma system. In addition, dwell time should be scrutinized as a meaningful indicator within a performance improvement program.

Where to Draw the Line for Intracranial Hypertension; Opening Pressures and Mortality.

BACKGROUND: Intracranial pressure (ICP) monitoring and treatment is a mainstay of severe TBI management but the relationship between intracranial opening pressure (OP) and outcomes has not been well established. The purpose of our study was to assess the relationship between OP and outcomes in severe TBI patients, with a focus on in-hospital mortality. METHODS: Adult blunt TBI patients with ICP monitoring between 2007 and 2017 were evaluated using sequential multivariable binary logistic modeling. Generalized additive model (GAM) was used to evaluate the relationship between OP and death. Odds ratio (OR) and 95% confidence interval (CI) were calculated for measures of strength of association and precision. RESULTS: A total of 182 patients were identified, with 61 (33.5%) having OP >20 mmHG (overall mean ± OP = 19.4 ± 17.8 mmHG). Forty-eight percent, 9% and 8% of patients were discharged to rehabilitation, skilled nursing institution, and home, respectively. Thirty-five percent died in the hospital. A linear relationship was found between OP and log-odds of mortality. OP (OR = 1.07; 95% CI = 1.04-1.11), age (OR = 1.05;95%CI = 1.02-1.07), and injury severity score (ISS) (OR = 1.06; 95% CI = 1.02-1.10) were independently associated with increased odds of death while adjusting for sex, race, and year. DISCUSSION: Elevated opening pressure is strongly predictive of death in severe TBI. Age and ISS are independent predictors of mortality regardless of OP. These results suggest that maintaining low levels of ICP should result in decreased mortality in severe TBI patients. The patient's age and ISS should be considered in the decision-making processes related to ICP utilization and management.

Trauma intensive care unit survival: how good is an educated guess?

BACKGROUND: Resource utilization in medicine is becoming a more and more urgent issue with ongoing national discussions on healthcare coverage. In the management of a trauma system, large amounts of resources and money are expended on individual patients in hope of a "great save." In addition, those of us caring for these patients are required to estimate outcomes daily to the family in an effort to choose the best course of care for an individual patient. Hence, we undertook a study to analyze the accuracy of outcomes predictions of various members of the healthcare team. METHODS: During a period of 38 months (July 2005 to August 2008), an observational study of patients admitted to a Level I Trauma Center Intensive Care Unit (ICU) was undertaken. Institutional Review Board permission was obtained before starting the study. Only patients older than 18 years were included. Patients who were moribund or expected discharge within 72 hours were excluded.Our traumatized ICU patients are cared for by a multidisciplinary team consisting of a trauma/ICU attending, all of whom have additional certification in surgical critical care and who rotate through the ICU on a weekly basis, a surgical ICU fellow, residents and medical students of several levels of training who rotate on a monthly basis, trauma advanced-level practitioners who rotate weekly, and bedside ICU nurses who work routine shifts. Respiratory therapists, nutritionists, ICU pharmacists, and other members of the rounding team were not included in the study because they do not provide global patient care. Regardless of admitting physician, the patients are managed by the team, and our practice of care is similar across the group, based on protocols and consensus.For each of the study patients, a survey tool was filled out by the ICU rounding team on hospital day 1 and hospital day 3. The tool was completed by members of the team providing global care to the patient and varied depending on the members of the group at each day's rounds. All current and admission data on injuries, study and laboratory results, and current patient status were available to all members of the team. Each member was expected to fill out the survey tool independently, and the results of the tool were not discussed during rounds.Concurrently, data were collected by the ICU fellow and research nurse. These data and the results of the survey tools were entered in a database for analysis after patient discharge. A retrospective analysis was undertaken to analyze the relative accuracy of the care, team members' assessment, and actual survival. Statistical analysis was done using by-chance accuracy comparisons. RESULTS: Two hundred twenty-three patients had 326 observations performed. Day 3 accuracy improved for most groups. In all groups, accuracy was found to be statistically significantly better than by-chance accuracy. Given that the majority of patients in the trauma population are survivors, sensitivity and positive predictive value of the observer's ability to predict death were also evaluated. CONCLUSIONS: Although significantly better than chance prediction, the ability of members of the ICU team to predict survival of trauma patients remains poor, particularly on initial evaluation. A period of clinical observation improves the accuracy. Unfortunately, experience of the observer does not seem to improve accuracy of survival prediction. This data indicate that care must be taken when describing likely outcomes to patient family members.

Assessing Risk for Mortality in Trauma: The Value of Admission Hemoglobin A1c.

BACKGROUND: Recent efforts have been made to identify admission characteristics of trauma patients that are associated with increased risk of mortality. Contemporary literature has established an increased risk of mortality with admission hyperglycemia. However, the effects of longstanding hyperglycemia, as surrogated by hemoglobin A1c (HbA1c), has not been studied. METHODS: A prospective trauma database was retrospectively reviewed identifying patients with collected HbA1c at admission. Three cohorts were defined by HbA1c: normal (N), <5.7; prediabetic (PD) 5.7-6.5; and diabetic (D) >6.5. Regression models were used to evaluate the risk of increased hospital and intensive care unit (ICU) length of stay (LOS), ventilator days, and mortality. Relative risk (RR) and 95% CI are provided as measures of significance. RESULTS: A total of 2978 patients were included in the analysis (N: n = 1895, PD: n = 744, and D: n = 339). The D cohort was more likely to be older, female, obese, suffered blunt trauma, and triaged at the highest activation acuity level (P < .0001). Mean injury severity score (ISS) was similar between groups. The D group was more likely to have longer ICU-LOS (RR 1.5; 95% CI 1.10-2.07) and ventilator days (RR 1.52; 95% CI 1.03-2.26) than the N group. Relative to the N group, the risk of mortality was 50% higher in the PD (RR 1.49; 95% CI 1.17-1.90) and in the D cohorts (RR 1.50; 95% CI 1.03-2.18). DISCUSSION: Trauma patients with an elevated admission HbA1c have a significantly higher risk of mortality regardless of their history of diabetes. These data add to the body of literature that documents the untoward effect of hyperglycemia on the trauma patient.

Recovery from Copperhead Snake Envenomation: Role of Age, Sex, Bite Location, Severity, and Treatment.

INTRODUCTION: Few data exist to understand the recovery phase of pit viper envenomation. A recently published placebo-controlled clinical trial affords this opportunity. The purpose of this study is to examine the time course of recovery from copperhead snake (Agkistrodon contortrix) envenomation patients managed with and without the use of antivenom, stratified by age, sex, anatomic site of envenomation, initial severity of envenomation, and geographic region. METHODS: This is a post-hoc subgroup analysis of data from a multi-center double-blinded clinical trial of Fab antivenom (FabAV) vs. placebo. Outcomes were the Patient-Specific Functional Scale (PSFS) score at 3, 7, 10, and 14 days after envenomation. Least-squares mean PSFS score curves were calculated for each subgroup, and repeated measures ANOVA was used to estimate between-group comparisons. RESULTS: Seventy-two subjects were included, of whom 44 received FabAV. Males demonstrated better overall recovery than females (model predicted PSFS score 6.18 vs 4.99; difference 1.19; 95% CI 0.12 to 2.25; p = 0.029). No sex difference was found in response to FabAV. Overall recovery and effect of FabAV were similar in adult vs adolescent patients, patients with upper vs lower extremity envenomation, and patients with initially mild vs moderate envenomation signs. Analysis by geographic location was not successful due to ANOVA mode instability. CONCLUSIONS: Male victims of copperhead snake envenomation demonstrate slightly better recovery than females, but response to Fab antivenom overall is similar across all subgroups studied.

What price commitment: what benefit? The cost of a saved life in a developing level I trauma center.

BACKGROUND: In 1999, a Level I Trauma Center committed significant resources for development, recruitment of trauma surgeons, and call pay for subspecialists. Although this approach has sparked a national ethical debate, little has been published investigating efficacy. This study examines the price of commitment and outcomes at a Level I Trauma Center. METHODS: Direct personnel costs including salary, call pay, and personnel expenses were analyzed against outcomes for two periods defined as PRE (1994-1999) and POST (2000-2005). Patient care costs and 1999 to 2000 transition data were excluded. Demographics, outcomes, and direct personnel costs were compared. Significant mortality reductions stratified by age and injury severity score (ISS) were used to calculate lives saved in relation to direct personnel costs. Student's t test and chi were used (significance *p < 0.05). RESULTS: In the PRE period, there were 7,587 admissions compared with 11,057 POST. There were no significant differences PRE versus POST for age (41.4 +/- 24.4 years vs. 41.3 +/- 24.9 years), gender (62.4% vs. 63.7% male), mechanism of injury (11.5% vs. 11.8% penetrating), and percent intensive care unit admissions (30.1 vs. 29.9). Significant differences were noted for ISS (10.5 +/- 9.7 vs. 11.6 +/- 10.1*), percent admissions with ISS >or=16 (18.5 vs. 27.3*), and revised trauma score (10.8 +/- 2.8 vs. 10.7 +/- 2.8*). Both the average length of stay (6.8 +/- 8.8 vs. 6.5 +/- 9.8*) and percent mortality for ISS >or=16 (23 vs. 17*) were reduced. When mortality was stratified by both age and ISS, significant reductions were noted and a total of 173 lives were saved as a result. However, direct personnel costs increased from $7.6 million to $22.7 million. When cost is allocated to lives saved; the cost of a saved life was more than $87,000. CONCLUSIONS: Resources for program development, including salary and call pay, significantly reduced mortality. Price of commitment: $3 million per year. The cost of a saved life: $87,000. The benefit: 173 surviving patients who would otherwise be dead.

The elderly trauma patient: an investment for the future?

BACKGROUND: The cost of care in elderly (ELD) trauma patients is high compared with younger patients, but the association between age and reimbursement relative to cost is less clear. The purpose of this study was to explore the relationship between total costs (TC) and reimbursement in young (YNG) and ELD trauma patients. METHODS: The National Trauma Registry of the American College of Surgeons was queried for patients admitted to a level I trauma center between January 2002 and December 2004. YNG patients (18-64 years) were compared with ELD patients (> or =65 years) for mechanism of injury, Injury Severity Score, and outcome variables. Data obtained from the hospital cost accounting system included TC, total payment, and net margin (P-L). Virtually, all patients were reimbursed based on the fixed diagnostic-related group payment. RESULTS: There were 641 ELD and 3,470 YNG patients included in the study. ELD patients were more commonly injured via a blunt mechanism than the YNG patients (97% vs. 83%; p < 0.001). The ELD were more severely injured (Injury Severity Score 14.9 +/- 10.8 vs. 13.3 +/- 10.9), developed more complications (54% vs. 34%), and died more frequently (17% vs. 4.7%; all p < 0.05). TC for the ELD were significantly higher than the YNG ($20,788.92 +/- $28,305.54 vs. $19,161.11 +/- $30,441.56; p = 0.02). Total payment ($20,049.75 +/- $29,754.52 vs. $16,766.14 +/- $31,169.15) and P-L (-$739.18 +/- $17,207.84 vs. -$2,294.98 +/- $22,309.51; both p < 0.05) were significantly better for the ELD cohort. However, a financial loss was realized for all patients with trauma. CONCLUSION: When compared with YNG trauma patients, reimbursement in the ELD appears favorable. However, compensation via diagnostic-related group payment fails to cover costs even in the ELD. Reimbursement for all patients with trauma is suboptimal and needs to be improved.

High-frequency oscillatory ventilation as a rescue therapy for adult trauma patients.

BACKGROUND: High-frequency oscillatory ventilation is an alternative ventilation mode that improves oxygenation in trauma patients in whom conventional ventilation strategies have been unsuccessful. OBJECTIVE: To evaluate the effect of high-frequency oscillatory ventilation on oxygenation, survival, and parameters predictive of survival in trauma patients. METHODS: A retrospective case series of 24 adult patients admitted to the trauma intensive care unit at a level I trauma center between November 2001 and July 2005 and treated with high-frequency oscillatory ventilation. Survivors and nonsurvivors were compared for mechanism and severity of injury, oxygenation parameters related to high-frequency oscillatory ventilation, and hospital course. RESULTS: Of the 8577 patients admitted during the study period, acute respiratory distress syndrome developed in 103 (1%). Of those 103 patients, 24 (23%) were treated with high-frequency oscillatory ventilation. Most of the patients treated with high-frequency oscillatory ventilation had sustained blunt trauma (79%). Oxygenation parameters improved significantly with high-frequency oscillatory ventilation in all patients, regardless of survival. Of the 24 patients treated with this ventilation mode, 15 (62%) survived. Survival did not correlate with improved oxygenation parameters but with the number of failed organ systems and injury severity. CONCLUSION: Although high-frequency oscillatory ventilation improves oxygenation, severity of traumatic injury and organ failure, not respiratory parameters, are predictors of survival. High-frequency oscillatory ventilation should be considered for pulmonary rescue of severely injured patients with acute respiratory distress syndrome.

Trauma system resource preservation: A simple scene triage tool can reduce helicopter emergency medical services overutilization in a state trauma system.

BACKGROUND: Helicopter emergency medical services improve survival in some injured patients but current utilization leads to significant overtriage with considerable numbers of transported patients discharged home from the emergency department or found to have non-time-sensitive injuries. Current triage models for utilization are complex and untested. METHODS: Data from a state trauma registry were reviewed from 1987 to 1993 and from 2013 to 2015 and compared. Data from 2013 to 2015 were analyzed for field information found to influence mortality and a model for low mortality-risk patients designed. RESULTS: Indexed to population, a major increase in numbers of injured patients transported directly to designated trauma centers (39.849-167.626/100,000/year) occurred with an increased portion transported by helicopter emergency medical services from 7.28% to 9.26%. A simple triage tool to predict low mortality rates was designed utilizing results from logistic regression. Nongeriatric adult patients (age, 16.0-69.9 years) with a blunt injury mechanism, normal Glasgow Coma Scale motor score, pulse rate of 60 bpm to 120 bpm and respiratory rate of 10 breaths per minute to 29 breaths per minute are at low risk for mortality. Cost for helicopter transportation was substantially higher than ground transportation based on available data. Cost differentials in transport mode increased patient financial risk when helicopter transportation was utilized. CONCLUSION: Implementing a simple decision tool designating nongeriatric adult patients with a blunt injury mechanism, normal Glasgow Coma Scale motor score, systolic blood pressure greater than 90 mm Hg, pulse rate of 60 bpm to 120 bpm, and respiratory rate of 10 breaths per minute to 29 breaths per minute to ground transportation would result in substantial savings without an increase in mortality and reduce risk of patient financial harm. LEVEL OF EVIDENCE: Prognostic/Epidemiological study, level IV. Economic and value based evaluation, level IV.

Early administration of Fab antivenom resulted in faster limb recovery in copperhead snake envenomation patients.

BACKGROUND: No previous research has studied whether early snake antivenom administration leads to better clinical outcomes than late antivenom administration in North American pit viper envenomation. METHODS: A secondary analysis of data from a clinical trial of Fab antivenom (FabAV) versus placebo for copperhead snake envenomation was conducted. Patients treated before the median time to FabAV administration were classified as receiving early treatment and those treated after the median time were defined as the late treatment group. A Cox proportional hazards model was used to compare time to full recovery on the Patient-Specific Functional Scale (PSFS) instrument between groups. Secondary analyses compared estimated mean PSFS scores using a generalized linear model and the estimated proportion of patients with full recovery at each time point using logistic regression. To evaluate for confounding, the main analysis was repeated using data from placebo-treated subjects. RESULTS: Forty-five subjects were treated with FabAV at a median of 5.47 h after envenomation. Patients in the early treatment group had a significantly shorter time to full recovery than those treated late (median time: 17 versus 28 days, p = .025). Model-estimated PSFS scores were numerically higher at each time point in the early group. No difference was found between patients treated early versus late with placebo. CONCLUSIONS: In this secondary analysis of trial data, recovery of limb function was faster when Fab antivenom was administered soon after envenomation, as opposed to late administration.

The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation.

OBJECTIVE: Valid, reliable, and clinically relevant outcome measures are necessary in clinical studies of snake envenomation. The aim of this study was to evaluate the psychometric (validity and reliability) and clinimetric (minimal clinically important difference [MCID]) properties of the Patient-Specific Functional Scale (PSFS) in snakebite envenomation. METHODS: We performed a secondary analysis of two existing snakebite trials that measured clinical outcomes using the PSFS as well as other quality of life and functional assessments. Data were collected at 3, 7, 10, and 17 days. Reliability was determined using Cronbach's alpha for internal consistency and the intraclass correlation coefficient (ICC) for temporal stability at 10 and 17 days. Validity was assessed using concurrent validity correlating with the other assessments. The MCID was evaluated using the following criteria: (1) the distribution of stable patients according to both standard error of measurement (SEM) and responsiveness techniques, and (2) anchor-based methods to compare between individuals and to detect discriminant ability of a positive change with a receiver operator characteristic (ROC) curve and optimal cutoff point. RESULTS: A total of 86 patients were evaluated in this study. The average PSFS scores were 5.37 (SD 3.23), 7.95 (SD 2.22), and 9.12 (SD 1.37) at 3, 7, and 10 days, respectively. Negligible floor effect was observed (maximum of 8% at 3 days); however, a ceiling effect was observed at 17 days (25%). The PSFS showed good reliability with an internal consistency of 0.91 (Cronbach's alpha) (95% CI 0.88, 0.95) and a temporal stability of 0.83 (ICC) (95% CI 0.72, 0.89). The PSFS showed a strong positive correlation with quality of life and functional assessments. The MCID was approximately 1.0 for all methods. CONCLUSIONS: With an MCID of approximately 1 point, the PSFS is a valid and reliable tool to assess quality of life and functionality in patients with snake envenomation.

Validity and reliability of telephone administration of the patient-specific functional scale for the assessment of recovery from snakebite envenomation.

OBJECTIVES: Although more than 1.8 million people survive snakebite envenomation each year, their recovery is understudied. Obtaining long-term follow-up is challenging in both high- and low-resource settings. The Patient-Specific Functional Scale (PSFS) is an easily administered, well-accepted patient-reported outcome that is validated for assessing limb recovery from snakebite envenomation. We studied whether the PSFS is valid and reliable when administered by telephone. METHODS: This is a secondary analysis of data from a randomized clinical trial. We analyzed the results of PSFS collected in-person on days 3, 7, 14, 21, and 28 and by telephone on days 10, 17, and 24. We assessed the following scale psychometric properties: (a) content validity (ceiling and floor effects), (b) internal structure and consistency (Cronbach's alpha), and (c) temporal and external validity using Intraclass Correlation Coefficient (ICC). Temporal stability was assessed using Spearman's correlation coefficient and agreement between adjacent in-person and telephonic assessments with Cohen's kappa. Bland Altman analysis was used to assess differential bias in low and high score results. RESULTS: Data from 74 patients were available for analysis. Floor effects were seen in the early post-injury time points (median: 3 (IQR: 0, 5) at 3 days post-enrollment) and ceiling effects in the late time points (median: 9 (IQR: 8, 10). Internal consistency was good to excellent with both in-person (Cronbach α: 0.91 (95%CI 0.88, 0.95)) and telephone administration (0.81 (0.73, 0.89). Temporal stability was also good (ICC: 0.83 (0.72, 0.89) in-person, 0.80 (0.68, 0.88) telephone). A strong linear correlation was found between in-person and telephone administration (Spearman's ρ: 0.83 (CI: 0.78, 0.84), consistency was assessed as excellent (Cohen's κ 0.81 (CI: 0.78, 0.84), and Bland Altman analysis showed no systematic bias. CONCLUSIONS: Telephone administration of the PSFS provides valid, reliable, and consistent data for the assessment of recovery from snakebite envenomation.