Implementation of a multi-site neonatal simulation improvement program: a cost analysis.

BACKGROUND: To improve patient outcomes and provider team practice, the California Perinatal Quality Care Collaborative (CPQCC) created the Simulating Success quality improvement program to assist hospitals in implementing a neonatal resuscitation training curriculum. This study aimed to examine the costs associated with the design and implementation of the Simulating Success program. METHODS: From 2017-2020, a total of 14 sites participated in the Simulating Success program and 4 of them systematically collected resource utilization data. Using a micro-costing approach, we examined costs for the design and implementation of the program occurring at CPQCC and the 4 study sites. Data collection forms were used to track personnel time, equipment/supplies, space use, and travel (including transportation, food, and lodging). Cost analysis was conducted from the healthcare sector perspective. Costs incurred by CPQCC were allocated to participant sites and then combined with site-specific costs to estimate the mean cost per site, along with its 95% confidence interval (CI). Cost estimates were inflation-adjusted to 2022 U.S. dollars. RESULTS: Designing and implementing the Simulating Success program cost $228,148.36 at CPQCC, with personnel cost accounting for the largest share (92.2%), followed by program-related travel (6.1%), equipment/supplies (1.5%), and space use (0.2%). Allocating these costs across participant sites and accounting for site-specific resource utilizations resulted in a mean cost of $39,210.69 per participant site (95% CI: $34,094.52-$44,326.86). In sensitivity analysis varying several study assumptions (e.g., number of participant sites, exclusion of design costs, and useful life span of manikins), the mean cost per site changed from $35,645.22 to $39,935.73. At all four sites, monthly cost of other neonatal resuscitation training was lower during the program implementation period (mean = $1,112.52 per site) than pre-implementation period (mean = $2,504.01 per site). In the 3 months after the Simulating Success program ended, monthly cost of neonatal resuscitation training was also lower than the pre-implementation period at two of the four sites. CONCLUSIONS: Establishing a multi-site neonatal in situ simulation program requires investment of sufficient resources. However, such programs may have financial and non-financial benefits in the long run by offsetting the need for other neonatal resuscitation training and improving practice.

Economic considerations for resuscitative interventions in the immediate newborn period.

We present a systematic scoping review of the literature, which documents that only a very small number of interventions related to delivery room stabilization and resuscitation have been studied for their economic impact. Published analyses are mostly of programmatic interventions such as resuscitation training programs, are mostly in low-resource settings, and are of variable methodological quality. Investigators who are conducting clinical studies of delivery room interventions can address these deficiencies in the literature by engaging with health services researchers to assess economic outcomes alongside those studies. We provide a framework of five questions that clinical researchers may use to decide on when such an ancillary study is indicated, and to provide them with the necessary language to discuss the methodological details of potential evaluations with their health services colleagues. Emphasis should be given to interventions that are targeted to high volumes of patients, are expensive, or are likely to lead to changes in costly chronic outcomes.

Economical provision of blood components for critical patient transport across a large geographic area.

BACKGROUND: Rapid air transport of critically injured patients to sites of appropriate care can save lives. The provision of blood products on critical care transport flights may save additional lives by starting resuscitation earlier. METHODS: Our regional trauma center transfusion service provided 2 units of O-negative red blood cells and 2 units of A low-titer anti-B liquid plasma in an internally monitored and sealed eutectic box weighing 10.4 pounds to eight air bases once weekly. Flight crews were instructed to transfuse plasma units first. Unused blood was returned to the transfusion service. Total blood use and wastage were recorded. RESULTS: Over a 6-year period, ≈ 7400 blood components were provided, and >1000 were used by the air transport service in patient care. Plasma units were 57% of all units given. Unused units were returned to the providing transfusion service and used in hospital patient care with <3% loss. Estimated cost of providing blood per mission was $63 and per patient transfused was $1940. CONCLUSIONS: With appropriate attention to detail, it is possible to provide life-saving blood components to aeromedical transport services across a large geographic area with efficient blood component usage, minimal blood wastage, and low cost.

Liquid plasma reduces waste and health care expenses compared with thawed plasma at a Level I trauma center.

BACKGROUND: Balanced resuscitation strategies have led to increased utilization of plasma. Fresh frozen plasma that is thawed and never used is a large source of blood component wastage. Thawed plasma (TP) and can only be stored for 5 days. Liquid plasma (LP) has never been frozen and can be stored for 26 days. Due to longer storage duration, we hypothesized that using LP would result in decreased waste and cost savings compared with TP. METHODS: We performed a retrospective review of all trauma patients at our Level I trauma center in the years 2015 to 2016. We compared 2015 when only TP was used to 2016 when both TP and LP were used. All plasma units ordered for trauma patients were tracked until the time of transfusion or wastage. Wastage rates were compared between years and plasma type. RESULTS: There were 5,789 trauma patients admitted to our institution from 2015 to 2016. There were 4,107 plasma units ordered with 487 (11.9%) units wasted. During 2015, 2,021 total units of plasma were ordered with 273 (13.5%) units wasted which was a significantly higher rate than 2016 when 2,086 total units of plasma were ordered and 214 (10.3%) units were wasted (p = 0.0013). During 2016, 1,739 units of TP were ordered and 204 (11.7%) units were wasted which was significantly higher than LP wastage, 347 units ordered and 10 (2.9%) units wasted (p < 0.001). Of the 477 wasted TP units, 76.9% were ordered no more than two times before being wasted and 95.8% were ordered no more than three times before being wasted. Of the 10 LP units wasted, 40% were ordered no more than two times before being wasted, and 50% were ordered no more than three times before being wasted. If TP was wasted at the same rate as LP, 368 fewer units of plasma would have been wasted representing US $39,376 (US $107/unit) of wasted health care expenses. CONCLUSION: At a Level I trauma center, the addition of LP to the blood bank for trauma resuscitations significantly reduced plasma wastage rates and health care expenses. LEVEL OF EVIDENCE: Level III, Economic/Decision.

Dynamic Assessment of Fluid Responsiveness in Surgical ICU Patients Through Stroke Volume Variation is Associated With Decreased Length of Stay and Costs: A Systematic Review and Meta-Analysis.

Static indices, such as the central venous pressure, have proven to be inaccurate predictors of fluid responsiveness. An emerging approach uses dynamic assessment of fluid responsiveness (FT-DYN), such as stroke volume variation (SVV) or surrogate dynamic variables, as more accurate measures of volume status. Recent work has demonstrated that goal-directed therapy guided by FT-DYN was associated with reduced intensive care unit (ICU) mortality; however, no study has specifically assessed this in surgical ICU patients. This study aimed to conduct a systematic review and meta-analysis on the impact of employing FT-DYN in the perioperative care of surgical ICU patients on length of stay in the ICU. As secondary objectives, we performed a cost analysis of FT-DYN and assessed the impact of FT-DYN versus standard care on hospital length of stay and mortality. We identified all randomized controlled trials (RCTs) through MEDLINE, EMBASE, and CENTRAL that examined adult patients in the ICU who were randomized to standard care or to FT-DYN from inception to September 2017. Two investigators independently reviewed search results, identified appropriate studies, and extracted data using standardized spreadsheets. A random effect meta-analysis was carried out. Eleven RCTs were included with a total of 1015 patients. The incorporation of FT-DYN through SVV in surgical patients led to shorter ICU length of stay (weighted mean difference [WMD], -1.43d; 95% confidence interval [CI], -2.09 to -0.78), shorter hospital length of stay (WMD, -1.96d; 95% CI, -2.34 to -1.59), and trended toward improved mortality (odds ratio, 0.55; 95% CI, 0.30-1.03). There was a decrease in daily ICU-related costs per patient for those who received FT-DYN in the perioperative period (WMD, US$ -1619; 95% CI, -2173.68 to -1063.26). Incorporation of FT-DYN through SVV in the perioperative care of surgical ICU patients is associated with decreased ICU length of stay, hospital length of stay, and ICU costs.

Implementation of a prehospital air medical thawed plasma program: Is it even feasible?

BACKGROUND: The Prehospital Air Medical Plasma (PAMPer) trial demonstrated a 30-day survival benefit among hypotensive trauma patients treated with prehospital plasma during air medical transport. We characterized resources, costs and feasibility of air medical prehospital plasma program implementation. METHODS: We performed a secondary analysis using data derived from the recent PAMPer trial. Intervention patients received thawed plasma (5-day shelf life). Unused plasma units were recycled back to blood bank affiliates, when possible. Distribution method and capability of recycling varied across sites. We determined the status of plasma units deployed, utilized, wasted, and returned. We inventoried thawed plasma use and annualized costs for distribution and recovery. RESULTS: The PAMPer trial screened 7,275 patients and 5,103 plasma units were deployed across 22 air medical bases during a 42-month period. Only 368 (7.2%) units of this total thawed plasma pool were provided to plasma randomized PAMPer patients. Of the total plasma pool, 3,716 (72.8%) units of plasma were returned to the blood bank with the potential for transfusion prior to expiration and 1,019 (20.0%) thawed plasma units were deemed wasted for this analysis. The estimated average annual cost of implementation of a thawed plasma program per air medical base at an average courier distance would be between US $24,343 and US $30,077, depending on the ability to recycle plasma and distance of courier delivery required. CONCLUSION: A prehospital plasma program utilizing thawed plasma is resource intensive. Plasma waste can be minimized depending on trauma center and blood bank specific logistics. Implementation of a thawed plasma program can occur with financial cost. Products with a longer shelf life, such as liquid plasma or freeze-dried plasma, may provide a more cost-effective prehospital product relative to thawed plasma. LEVEL OF EVIDENCE: Therapeutic, level III.

Cost Effectiveness of Neonatal Resuscitation at 22 Weeks of Gestation.

OBJECTIVE: To evaluate the cost effectiveness of three different approaches to the care of neonates born at 22 weeks of gestation: universal resuscitation, selective resuscitation, or no resuscitation. METHODS: We constructed a decision-analytic model using TreeAge to compare the outcomes of death and survival with and without neurodevelopmental impairment in a theoretical cohort of 5,176 neonates (an estimate of the annual number of deliveries that occur in the 22nd week of gestation in the United States). We took a societal perspective using a lifetime horizon, and all costs were expressed in 2017 U.S. dollars. Effectiveness was based on combined maternal and neonatal quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio was determined (cost/QALY) for each additional survivor. The willingness to pay threshold was set at $100,000/QALY. All model inputs were derived from the literature. Deterministic and probabilistic sensitivity analyses were performed to interrogate model assumptions. RESULTS: Universal resuscitation would result in 373 survivors, 123 of whom would have severe disability. Selective resuscitation would produce 78 survivors with 26 affected by severe impairments. No resuscitation would result in only eight survivors and three neonates with severe sequelae. Selective resuscitation was eliminated by extended dominance because this strategy had a higher incremental cost-effectiveness ratio than universal resuscitation, which was a more effective intervention. The incremental cost-effectiveness ratio of universal resuscitation compared with no resuscitation was not cost effective at $106,691/QALY. Monte Carlo simulations demonstrated that universal resuscitation is more effective but also more expensive compared with no resuscitation, with only 35% of simulations below the willingness to pay threshold. CONCLUSION: In our model, neither selective nor universal resuscitation of 22-week neonates is a cost-effective strategy compared with no resuscitation.

Low-Fidelity, In-Situ Pediatric Resuscitation Simulation Improves RN Competence and Self-Efficacy.

PROBLEM: ED staff lack adequate exposure to critical pediatric patients to develop competence and confidence in resuscitation scenarios. Simulations of various designs have shown success at increasing health care staff performance and self-efficacy. METHODS: We developed a nurse-led, low-fidelity in situ simulation of a pediatric sepsis scenario. The primary goal was to improve staff adherence to resuscitation guidelines, as measured by the Clinical Performance Tool, a set of checklists designed to measure adherence to Pediatric Advanced Life Support algorithms by multidisciplinary teams during simulations. The secondary goal was to improve staff confidence, measured by the Confidence Scale, a 5-item Likert-type scale that can measure any psychomotor skill. RESULTS: A total of 43 RNs participated in 12 simulations over a period of 3 months. Mean Clinical Performance score improved by 74%, from 5.3 to 9.2 (P < 0.001). Mean confidence score for RNs improved by 56%, from 2.48 (standard deviation [SD] 0.83) to 3.88 (SD 0.66) (P < 0.001). Several systems issues were identified and addressed by multidisciplinary teams, such as increasing respiratory therapist response to the emergency department and updating of the Broselow cart. DISCUSSION: In situ low-fidelity simulations led by RNs contributed to significant improvement in adherence to resuscitation guidelines and in staff confidence. The simulation design had minimal impact on staffing and budget and enabled identification and correction of systems issues.

Is Albumin-based Resuscitation in Severe Sepsis and Septic Shock Justifiable? An Evidence from a Cost-effectiveness Evaluation.

BACKGROUND: Fluid and antimicrobial therapy are the essential parts of sepsis management. The type of fluid to resuscitate with is an unsettled issue in the treatment of severe sepsis and septic shock. The objective of this study was to evaluate the cost-effectiveness of albumin-based resuscitation over crystalloids. METHODS: A cost-effectiveness analysis was conducted by extracting data from a database of Sina Hospital, Islamic Republic of Iran. A decision tree was constructed by using Tree Age Pro 2011. The patients were grouped based on the types of fluids used for resuscitation into crystalloid alone or crystalloid + albumin groups at the initial decision node. The patients were followed from the onset of severe sepsis and septic shock upto 28 days. The healthcare payers' perspective was considered in constructing the model. The cost was measured in US dollars and the effectiveness was measured by life years gained. RESULTS: The addition of albumin during resuscitation of patients with severe sepsis and septic shock has an effectiveness gain of 0.09 life years and cost increment of 495.00 USD. The estimated ICER for this analysis was 5500.00 USD per life year gained. The probability that albumin is cost-effective at one GDP per capita is 49.5%. CONCLUSION: Albumin-based resuscitation is not cost-effective in Iran when a GDP per capita was considered for a life year gain. The cost-effectiveness was insensitive to the cost of standard care. We recomend the caustious use albumin as per the Surviving Sepsis Campaign guideline.

Drivers of choice of resuscitation fluid in the intensive care unit: a discrete choice experiment.

OBJECTIVE: To understand the fundamental drivers, and their relative importance, of doctors' and nurses' choice of resuscitation fluid in critically ill patients in Australia and New Zealand. DESIGN: A discrete choice experiment (DCE) administered via an online survey. Respondents were presented with one of four randomly selected DCE choice sets, each including five patient scenarios. The respondent chose between two types of hypothetical resuscitation fluid. The fluid type was characterised by several attributes and each attribute had pre-specified levels. PARTICIPANTS: Convenience sample of 367 Australian and New Zealand intensive care unit doctors and nurses. MAIN OUTCOME MEASURES: The dependent variable was fluid choice, and a regression equation was used to estimate the effect of each fluid attribute on the probability of observing the sequence of choices made over the five patient scenarios. The relative importance of each of the respective fluid attributes was calculated based on the percentage contribution to overall utility (ie, fluid preference). RESULTS: For doctors, safety concerns, patient type and fluid type were collectively responsible for almost three-quarters of decision-making utility (71%). The volume of intravenous fluid administered was the only clinical parameter not reaching statistical significance as a driver of fluid choice (P = 0.06). For nurses, decision making was influenced to a greater extent by the same three attributes (90%), although other unmeasured attributes may have been driving choice. CONCLUSIONS: Doctors and nurses rely on different information when choosing resuscitation fluids, although both cohorts are heavily influenced by safety concerns, patient type and fluid type. This information can be used to modify prescribing behaviour.

Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis.

BACKGROUND: After a single-center trial and observational studies suggesting that early, goal-directed therapy (EGDT) reduced mortality from septic shock, three multicenter trials (ProCESS, ARISE, and ProMISe) showed no benefit. This meta-analysis of individual patient data from the three recent trials was designed prospectively to improve statistical power and explore heterogeneity of treatment effect of EGDT. METHODS: We harmonized entry criteria, intervention protocols, outcomes, resource-use measures, and data collection across the trials and specified all analyses before unblinding. After completion of the trials, we pooled data, excluding the protocol-based standard-therapy group from the ProCESS trial, and resolved residual differences. The primary outcome was 90-day mortality. Secondary outcomes included 1-year survival, organ support, and hospitalization costs. We tested for treatment-by-subgroup interactions for 16 patient characteristics and 6 care-delivery characteristics. RESULTS: We studied 3723 patients at 138 hospitals in seven countries. Mortality at 90 days was similar for EGDT (462 of 1852 patients [24.9%]) and usual care (475 of 1871 patients [25.4%]); the adjusted odds ratio was 0.97 (95% confidence interval, 0.82 to 1.14; P=0.68). EGDT was associated with greater mean (±SD) use of intensive care (5.3±7.1 vs. 4.9±7.0 days, P=0.04) and cardiovascular support (1.9±3.7 vs. 1.6±2.9 days, P=0.01) than was usual care; other outcomes did not differ significantly, although average costs were higher with EGDT. Subgroup analyses showed no benefit from EGDT for patients with worse shock (higher serum lactate level, combined hypotension and hyperlactatemia, or higher predicted risk of death) or for hospitals with a lower propensity to use vasopressors or fluids during usual resuscitation. CONCLUSIONS: In this meta-analysis of individual patient data, EGDT did not result in better outcomes than usual care and was associated with higher hospitalization costs across a broad range of patient and hospital characteristics. (Funded by the National Institute of General Medical Sciences and others; PRISM ClinicalTrials.gov number, NCT02030158 .).

Costs of care at the end of life among elderly patients with chronic kidney disease: patterns and predictors in a nationwide cohort study.

BACKGROUND: Despite the urgent need for evidence to guide the end-of-life (EOL) care for patients with chronic kidney disease (CKD), we have limited knowledge of the costs and intensity of EOL care in this population. The present study examined patterns and predictors for EOL care intensity among elderly patients with CKD. METHODS: We conducted a retrospective nationwide cohort study utilizing the Taiwan National Health Insurance (NHI) Research Database. A total of 65,124 CKD patients aged ≥ 60 years, who died in hospitals or shortly after discharge between 2002 and 2012 were analyzed. The primary outcomes were inpatient expenses and use of surgical interventions in the last 30 days of life. Utilization of intensive care unit (ICU), mechanical ventilation, resuscitation, and dialysis was also examined in a sub-sample of 2072 patients with detailed prescription data. Multivariate log-linear and logistic regression analyses were performed to assess patient-, physician-, and facility-specific predictors and the potential impact of a 2009 payment policy to reimburse hospice care for non-cancer patients. RESULTS: During the last 30 days of life, average inpatients costs for elderly CKD patients were approximately US$10,260, with 40.9% receiving surgical interventions, 40.2% experiencing ICU admission, 45.3% undergoing mechanical ventilation, 14.7% receiving resuscitation and 42.0% receiving dialysis. Significant variability was observed in the inpatient costs and use of intensive services. Costs were lower among individuals with the following characteristics: advanced age; high income; high Charlson Comorbidity Index scores; treatment by older physicians, nephrologists, and family medicine physicians; and treatment at local hospitals. Similar findings were obtained for the use of surgical interventions and other intensive services. A declining trend was detected in the costs of EOL care, use of surgical interventions and resuscitation between 2009 and 2012, which is consistent with the impact of a 2009 NHI payment policy to reimburse non-cancer hospice care. CONCLUSIONS: Overall EOL costs and rates of intensive service use among older patients with CKD were high, with significant variability across various patient and provider characteristics. Several opportunities exist for providers and policy makers to reduce costs and enhance the value of EOL care for this population.

Cost analysis of large-scale implementation of the 'Helping Babies Breathe' newborn resuscitation-training program in Tanzania.

BACKGROUND: Helping Babies Breathe (HBB) has become the gold standard globally for training birth-attendants in neonatal resuscitation in low-resource settings in efforts to reduce early newborn asphyxia and mortality. The purpose of this study was to do a first-ever activity-based cost-analysis of at-scale HBB program implementation and initial follow-up in a large region of Tanzania and evaluate costs of national scale-up as one component of a multi-method external evaluation of the implementation of HBB at scale in Tanzania. METHODS: We used activity-based costing to examine budget expense data during the two-month implementation and follow-up of HBB in one of the target regions. Activity-cost centers included administrative, initial training (including resuscitation equipment), and follow-up training expenses. Sensitivity analysis was utilized to project cost scenarios incurred to achieve countrywide expansion of the program across all mainland regions of Tanzania and to model costs of program maintenance over one and five years following initiation. RESULTS: Total costs for the Mbeya Region were $202,240, with the highest proportion due to initial training and equipment (45.2%), followed by central program administration (37.2%), and follow-up visits (17.6%). Within Mbeya, 49 training sessions were undertaken, involving the training of 1,341 health providers from 336 health facilities in eight districts. To similarly expand the HBB program across the 25 regions of mainland Tanzania, the total economic cost is projected to be around $4,000,000 (around $600 per facility). Following sensitivity analyses, the estimated total for all Tanzania initial rollout lies between $2,934,793 to $4,309,595. In order to maintain the program nationally under the current model, it is estimated it would cost $2,019,115 for a further one year and $5,640,794 for a further five years of ongoing program support. CONCLUSION: HBB implementation is a relatively low-cost intervention with potential for high impact on perinatal mortality in resource-poor settings. It is shown here that nationwide expansion of this program across the range of health provision levels and regions of Tanzania would be feasible. This study provides policymakers and investors with the relevant cost-estimation for national rollout of this potentially neonatal life-saving intervention.

Hydroxyethyl starch versus saline for resuscitation of patients in intensive care: long-term outcomes and cost-effectiveness analysis of a cohort from CHEST.

BACKGROUND: Hydroxyethyl starch for fluid resuscitation in critically ill patients is not associated with improved short-term patient-centred outcomes compared with crystalloid fluid solutions. However, its effect on longer term health economic outcomes has not been reported. METHODS: We did a prespecified cost-effectiveness analysis of a cohort of patients from New South Wales enrolled in the Crystalloid versus Hydroxyethyl Starch Trial (CHEST), who were randomised to treatment with either 6% hydroxyethyl starch with a molecular weight of 130 kD and a molar substitution ratio of 0·4 or 0·9% sodium chloride (saline) for fluid resuscitation. Clinical outcomes were mortality and life-years gained at 6 months and 24 months, health-related quality of life at 6 months, and quality-adjusted life-years gained at 6 months. Health economic outcomes were hospital and intensive-care unit (ICU) resource use and costs at 24 months and cost-effectiveness, which we defined as the probability of reaching a willingness-to-pay threshold of less than A$50 000 per quality-adjusted life-year gained at 6 months and $100 000 per life-year gained at 24 months. CHEST is registered with ClinicalTrials.gov, number NCT00935168. FINDINGS: 3537 (51%) of 7000 patients were enrolled into CHEST from New South Wales, of whom 3450 (98%) were included in our cost-effectiveness analysis. Mortality at both 6 months and 24 months did not differ between the hydroxyethyl starch and saline groups (6 months: 397/1684 [24%] vs 382/1706 [22%]; relative risk [RR] 1·05, 95% CI 0·93-1·19; p=0·41; 24 months: 586/1687 [35%] vs 594/1708 [35%]; RR 1·00, 95% CI 0·91-1·10; p=0·89). The mean number of life-years gained at 6 months and 24 months was similar between the hydroxyethyl starch and saline groups (6 months: 0·41 days [SD 0·18] vs 0·41 days [0·17]; p=0·25; 24 months: 1·46 years [SD 0·80] vs 1·47 years [0·79]; p=0·72). At 6 months, the mean health-related quality of life score was 0·67 (SD 0·34) with hydroxyethyl starch versus 0·69 (0·35) with saline (p=0·33). The mean number of quality-adjusted life-years gained did not differ between the hydroxyethyl starch and saline groups at 6 months (0·26 days [SD 0·18] vs 0·26 days [0·18]; p=0·33). Total hospital costs (including ICU costs) at 24 months were similar between the hydroxyethyl starch and saline groups (A$62 196 [55 935] vs $62 617 [56 452]; p=0·83). The probability that hydroxyethyl starch was cost effective was 11% at 6 months and 29% at 24 months. INTERPRETATION: Although longer term clinical outcomes did not differ between patients resuscitated with hydroxyethyl starch or saline in the ICU, from a health-care payer's perspective, the probability that hydroxyethyl starch is cost effective in these patients is low. FUNDING: Division of Critical Care and Trauma, George Institute for Global Health.

Early Appropriate Care: A Protocol to Standardize Resuscitation Assessment and to Expedite Fracture Care Reduces Hospital Stay and Enhances Revenue.

OBJECTIVES: We hypothesized that a standardized protocol for fracture care would enhance revenue by reducing complications and length of stay. DESIGN: Prospective consecutive series. SETTING: Level 1 trauma center. PATIENTS/PARTICIPANTS: Two hundread and fifty-three adult patients with a mean age of 40.7 years and mean Injury Severity Score of 26.0. INTERVENTION: Femur, pelvis, or spine fractures treated surgically. MAIN OUTCOME MEASUREMENTS: Hospital and professional charges and collections were analyzed. Fixation was defined as early (<36 hours) or delayed. Complications and hospital stay were recorded. RESULTS: Mean charges were US $180,145 with a mean of US $66,871 collected (37%). The revenue multiplier was US $59,882/$6989 (8.57), indicating hospital collection of US $8.57 for every professional dollar, less than half of which went to orthopaedic surgeons. Delayed fracture care was associated with more intensive care unit (4.5 vs. 9.4) and total hospital days (9.4 vs. 15.3), with mean loss of actual revenue US $6380/patient delayed (n = 47), because of the costs of longer length of stay. Complications were associated with the highest expenses: mean of US $291,846 charges and US $101,005 collections, with facility collections decreased by 5.1%. An uncomplicated course of care was associated with the most favorable total collections: (US $60,017/$158,454 = 38%) and the shortest mean stay (8.7 days). CONCLUSIONS: Facility collections were nearly 9 times more than professional collections. Delayed fixation was associated with more complications, and facility collections decreased 5% with a complication. Furthermore, delayed fixation was associated with longer hospital stay, accounting for US $300K more in actual costs during the study. A standardized protocol to expedite definitive fixation enhances the profitability of the trauma service line. LEVEL OF EVIDENCE: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

THE GLYCOCALYX AND TRAUMA: A REVIEW.

In the United States trauma is the leading cause of mortality among those under the age of 45, claiming approximately 192,000 lives each year. Significant personal disability, lost productivity, and long-term healthcare needs are common and contribute 580 billion dollars in economic impact each year. Improving resuscitation strategies and the early acute care of trauma patients has the potential to reduce the pathological sequelae of combined exuberant inflammation and immune suppression that can co-exist, or occur temporally, and adversely affect outcomes. The endothelial and epithelial glycocalyx has emerged as an important participant in both inflammation and immunomodulation. Constituents of the glycocalyx have been used as biomarkers of injury severity and have the potential to be target(s) for therapeutic interventions aimed at immune modulation. In this review, we provide a contemporary understanding of the physiologic structure and function of the glycocalyx and its role in traumatic injury with a particular emphasis on lung injury.

Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock.

BACKGROUND: Early goal-directed therapy (EGDT) is recommended in international guidance for the resuscitation of patients presenting with early septic shock. However, adoption has been limited and uncertainty remains over its clinical effectiveness and cost-effectiveness. OBJECTIVES: The primary objective was to estimate the effect of EGDT compared with usual resuscitation on mortality at 90 days following randomisation and on incremental cost-effectiveness at 1 year. The secondary objectives were to compare EGDT with usual resuscitation for requirement for, and duration of, critical care unit organ support; length of stay in the emergency department (ED), critical care unit and acute hospital; health-related quality of life, resource use and costs at 90 days and at 1 year; all-cause mortality at 28 days, at acute hospital discharge and at 1 year; and estimated lifetime incremental cost-effectiveness. DESIGN: A pragmatic, open, multicentre, parallel-group randomised controlled trial with an integrated economic evaluation. SETTING: Fifty-six NHS hospitals in England. PARTICIPANTS: A total of 1260 patients who presented at EDs with septic shock. INTERVENTIONS: EGDT (n = 630) or usual resuscitation (n = 630). Patients were randomly allocated 1 : 1. MAIN OUTCOME MEASURES: All-cause mortality at 90 days after randomisation and incremental net benefit (at £20,000 per quality-adjusted life-year) at 1 year. RESULTS: Following withdrawals, data on 1243 (EGDT, n = 623; usual resuscitation, n = 620) patients were included in the analysis. By 90 days, 184 (29.5%) in the EGDT and 181 (29.2%) patients in the usual-resuscitation group had died [p = 0.90; absolute risk reduction -0.3%, 95% confidence interval (CI) -5.4 to 4.7; relative risk 1.01, 95% CI 0.85 to 1.20]. Treatment intensity was greater for the EGDT group, indicated by the increased use of intravenous fluids, vasoactive drugs and red blood cell transfusions. Increased treatment intensity was reflected by significantly higher Sequential Organ Failure Assessment scores and more advanced cardiovascular support days in critical care for the EGDT group. At 1 year, the incremental net benefit for EGDT versus usual resuscitation was negative at -£725 (95% CI -£3000 to £1550). The probability that EGDT was more cost-effective than usual resuscitation was below 30%. There were no significant differences in any other secondary outcomes, including health-related quality of life, or adverse events. LIMITATIONS: Recruitment was lower at weekends and out of hours. The intervention could not be blinded. CONCLUSIONS: There was no significant difference in all-cause mortality at 90 days for EGDT compared with usual resuscitation among adults identified with early septic shock presenting to EDs in England. On average, costs were higher in the EGDT group than in the usual-resuscitation group while quality-adjusted life-years were similar in both groups; the probability that it is cost-effective is < 30%. FUTURE WORK: The ProMISe (Protocolised Management In Sepsis) trial completes the planned trio of evaluations of EGDT across the USA, Australasia and England; all have indicated that EGDT is not superior to usual resuscitation. Recognising that each of the three individual, large trials has limited power for evaluating potentially important subgroups, the harmonised approach adopted provides the opportunity to conduct an individual patient data meta-analysis, enhancing both knowledge and generalisability. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36307479. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 97. See the NIHR Journals Library website for further project information.

Changes in the care of patients with cervical spine fractures following health reform in Massachusetts.

INTRODUCTION: There is a substantial concern among spine surgeons that healthcare reform efforts will alter the processes through which spinal care is delivered and decrease overall quality. We used the Statewide Inpatient Dataset for Massachusetts to evaluate changes in hospital processes and quality of care for patients with cervical fractures following the implementation of health reform. METHODS: This was a pre-post retrospective analysis of patients (n=9,387) treated for cervical fractures in Massachusetts between 2003-2006 and 2008-2010. Changes in hospital processes (surgical intervention, length of stay (LOS) and environment of care) and quality of care (mortality, complications, reoperation and failure to rescue (FTR)) were the outcomes of interest. FTR is a quality measure that evaluates a hospital's capacity to avoid mortality following the occurrence of a sentinel complication. Patients treated between 2003 and 2006 were considered the pre-reform group. The post-reform cohort consisted of those treated from 2008 to 2010. Baseline differences between cohorts were evaluated using chi-square or Mann-Whitney U tests. Unadjusted comparisons between the dependent variables and the onset of healthcare reform were performed, followed by regression techniques that adjusted for differences in case-mix and whether a surgical intervention was performed. Multivariable logistic regression was used for categorical variables and negative binomial regression was employed for continuous variables. RESULTS: The rates of surgical intervention remained unchanged pre- and post-reform (p=0.25). Hospital length of stay (RC: -0.18, 95% CI: -0.22, -0.14) and the FTR rate following surveillance insensitive complications (OR: 0.49, 95% CI: 0.25, 0.94) were significantly reduced following health reform. Post-reform, academic centers experienced a 22% reduction in mortality (95% CI: 0.61, 0.99) a 40% decrease in FTR (95% CI: 0.40, 0.89), a 30% decrease in surveillance insensitive complications (95% CI: 0.51, 0.96) and a 67% reduction in FTR after surveillance insensitive morbidity (95% CI: 0.11, 0.94). CONCLUSIONS: In the period following Massachusetts healthcare reform, significant improvements were noted in hospital process and quality measures around the care of patients with cervical spine fractures. Such findings were particularly robust among academic centers. These results may forecast changes in the delivery of spine surgical care following other health reform initiatives. Level of Evidence III.

Trial of early, goal-directed resuscitation for septic shock.

BACKGROUND: Early, goal-directed therapy (EGDT) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock. However, adoption has been limited, and uncertainty about its effectiveness remains. METHODS: We conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in 56 hospitals in England. Patients were randomly assigned to receive either EGDT (a 6-hour resuscitation protocol) or usual care. The primary clinical outcome was all-cause mortality at 90 days. RESULTS: We enrolled 1260 patients, with 630 assigned to EGDT and 630 to usual care. By 90 days, 184 of 623 patients (29.5%) in the EGDT group and 181 of 620 patients (29.2%) in the usual-care group had died (relative risk in the EGDT group, 1.01; 95% confidence interval [CI], 0.85 to 1.20; P=0.90), for an absolute risk reduction in the EGDT group of -0.3 percentage points (95% CI, -5.4 to 4.7). Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids, vasoactive drugs, and red-cell transfusions and reflected by significantly worse organ-failure scores, more days receiving advanced cardiovascular support, and longer stays in the intensive care unit. There were no significant differences in any other secondary outcomes, including health-related quality of life, or in rates of serious adverse events. On average, EGDT increased costs, and the probability that it was cost-effective was below 20%. CONCLUSIONS: In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation, hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme; ProMISe Current Controlled Trials number, ISRCTN36307479.).