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Background: Severe lower extremity trauma among working-age adults is highly consequential for returning to work; however, the economic impact attributed to injury has not been fully quantified. The purpose of this study was to examine work and productivity loss during the year following lower extremity trauma and to calculate the economic losses associated with lost employment, lost work time (absenteeism), and productivity loss while at work (presenteeism). Methods: This is an analysis of data collected prospectively across 3 multicenter studies of lower extremity trauma outcomes in the United States. Data were used to construct a Markov model that accumulated hours lost over time due to lost employment, absenteeism, and presenteeism among patients from 18 to 64 years old who were working prior to their injury. Average U.S. wages were used to calculate economic loss overall and by sociodemographic and injury subgroups. Results: Of 857 patients working prior to injury, 47.2% had returned to work at 1 year. The average number of productive hours of work lost was 1,758.8/person, representing 84.6% of expected annual productive hours. Of the hours lost, 1,542.3 (87.7%) were due to working no hours or lost employment, 71.1 (4.0%) were due to missed hours after having returned, and 145.4 (8.3%) were due to decreased productivity while working. The 1-year economic loss due to injury totaled $64,427/patient (95% confidence interval [CI], $63,183 to $65,680). Of the 1,758.8 lost hours, approximately 88% were due to not being employed (working zero hours), 4% were due to absenteeism, and 8% were due to presenteeism. Total productivity loss was higher among older adults (>=40 years), men, those with a physically demanding job, and the most severe injuries (i.e. those leading to amputation as well as Gustilo type-IIIB tibial fractures and type-III pilon/ankle fractures). Conclusions: Patients with severe lower extremity trauma carry a substantial economic burden. The costs of lost productivity should be considered when evaluating outcomes. [ABSTRACT FROM AUTHOR]

Background: The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom energy-storing carbon fiber ankle-foot orthosis developed for lower-extremity trauma patients. Studies conducted at the military treatment facility where the IDEO was developed demonstrated benefits of the IDEO when used with the Return to Run Physical Therapy (RTR PT) program. The current study was designed to determine if results could be replicated at other military treatment facilities and to examine whether early performance gains in patient-reported functional outcomes remained at 12 months.Methods: Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. Participants were evaluated before receiving the IDEO, immediately following completion of RTR PT, and at 6 and 12 months. Agility, strength/power, and speed were assessed using well-established performance tests. Self-reported function was measured using the Short Musculoskeletal Function Assessment (SMFA). The Orthotics and Prosthetics Users' Survey was administered to assess satisfaction with the IDEO. Of 87 participants with complete baseline data, 6 did not complete any physical therapy and were excluded from the analysis. Follow-up rates immediately following completion of the RTR PT and at 6 and 12 months were 88%, 75%, and 79%, respectively.Results: Compared with baseline, improvement at completion of RTR PT was observed in all but 1 performance test. SMFA scores for all domains except hand and arm function were lower (improved function) at 6 and 12 months. Satisfaction with the IDEO was high following completion of RTR PT, with some attenuation at the time of follow-up.Conclusions: This study adds to the evidence supporting the efficacy of the IDEO coupled with RTR PT. However, despite improvement in both performance and self-reported functioning, deficits persist compared with population norms.Level Of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) constitute the gold standard for the generation of evidence-based medicine, but may not always be feasible. Furthermore, randomization alone does not guarantee the utility of the research, as evidenced by thousands of uninformative RCTs documented in the literature. Observational studies, including longitudinal, retrospective, and case-control designs, can contribute to the body of evidence in meaningful ways, provide useful information when an RCT is unethical or not feasible, generate hypotheses for RCTs, or provide preliminary work to better inform design of future RCTs. They can also be used to study rare outcomes, risk factors, and side effects, and to examine whether results from RCTs translate into effective treatment in routine practice. Use of modern statistical techniques, both in the study design and in the analysis stage, can improve the usefulness of the evidence obtained from observational studies. [ABSTRACT FROM AUTHOR]

We summarize and elaborate on the recently published National Research Council report entitled "The Prevention and Treatment of Missing Data in Clinical Trials." We tailor our discussion to orthopaedic trials. In particular, we discuss the intent-to-treat principle, review study design and prevention ideas to minimize missing data, and present state-of-the-art sensitivity analysis methods for analyzing and reporting the results of studies with missing data. [ABSTRACT FROM AUTHOR]

Background: Although studies have shown that treatment at a trauma center reduces a patient's risk of dying following major trauma, important questions remain as to the effect of trauma centers on functional outcomes, especially among patients who have sustained major lower-limb trauma. Methods: Domain-specific scores on the Medical Outcomes Study Short Form Health Survey (SF-36) supplemented by scores on the mobility subscale of the Musculoskeletal Function Assessment (MFA) and the Revised Center for Epidemiologic Studies Depression Scale (CESD-R) were compared among patients treated in eighteen hospitals with a level-I trauma center and fifty-one hospitals without a trauma center. Included in the study were 1389 adults, eighteen to eighty-four years of age, with at least one lower-limb injury with a score of ≤3 points according to the Abbreviated Injury Scale (AIS). To account for the competing risk of death, we estimated the survivors' average causal effect. Estimates were derived for all patients with a lower-limb injury and separately for a subset of patients without associated injuries of the head or spinal cord. Results: For patients with a lower-limb injury resulting from a high-energy force, care at a trauma center yielded modest but clinically meaningful improvements in physical functioning and overall vitality at one year after the injury. After adjustment for differences in case mix and the competing risk of death, the average differences in the SF-36 physical functioning and vitality scores and the MFA mobility score were 7.82 points (95% confidence interval: 2.65, 12.98), 6.80 points (95% confidence interval: 2.53, 11.07), and 6.31 points (95% confidence interval: 0.25, 12.36), respectively. These results were similar when the analysis was restricted to patients without associated injuries to the head or spine. [ABSTRACT FROM AUTHOR]

A number of clinical studies in the spine literature suggest that the use of local vancomycin powder may substantially reduce surgical site infections (SSIs). These studies are primarily retrospective and observational and few focus on orthopaedic trauma patients. This study is a phase III, prospective, randomized, clinical trial to assess the efficacy of locally administered vancomycin powder in the prevention of SSI after fracture surgery. The primary goal of the VANCO Study is to compare the proportion of deep SSI 6 months after fracture fixation surgery. A secondary objective is to compare species and antibacterial susceptibilities among study patients who develop SSI. An additional objective is to build and validate a risk prediction model for the development of SSI. The study population consists of patients aged 18-80 years with tibial plateau or pilon (tibial plafond) fractures, at higher risk of infection, and definitively treated with plate and screw fixation. Participants are block randomized (within center) in a 1:1 ratio to either treatment group (local vancomycin powder up to a maximum dose of 1000 mg, placed immediately before wound closure) or control group (standard of care) for each study injury location, and return to the clinic for evaluations at 2 weeks, 3 months, and 6 months after fixation. The targeted sample size for the study is 500 fractures per study arm. This study should provide important information regarding the use of local vancomycin powder during the definitive treatment of lower extremity fractures and has the potential to significantly reduce the incidence of infection after orthopaedic trauma.

The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation. Patients are block randomized (within center) in a 1:1 ratio to either treatment group (FiO2 80%) or control group (FiO2 30%) and stratified by each study injury location. Secondary objectives of the study are to compare species and antibacterial sensitivities of the bacteria in patients who develop SSIs, to validate a previously developed risk prediction model for the development of SSI after fracture surgery, and to measure and compare resource utilization and cost associated with SSI in the 2 study groups. SPO is a low cost and readily available resource that could be easily disseminated to trauma centers across the country and the world if proved to be effective.

Background: The cost of trauma center care is high, raising questions about the value of a regionalized approach to trauma care. To address these concerns, we estimate 1-year and lifetime treatment costs and measure the cost-effectiveness of treatment at a Level I trauma center (TC) compared with a nontrauma center hospital (NTC)., Methods: Estimates of cost-effectiveness were derived using data on 5,043 major trauma patients enrolled in the National Study on Costs and Outcomes of Trauma, a prospective cohort study of severely injured adult patients cared for in 69 hospitals in 14 states. Data on costs were derived from multiple sources including claims data from the Centers for Medicare and Medicaid Services, UB92 hospital bills, and patient interviews. Cost-effectiveness was estimated as the ratio of the difference in costs (for treatment at a TC vs. NTC) divided by the difference in life years gained (and lives saved). We also measured cost-effectiveness per quality-adjusted life year gained where quality of life was measured using the SF-6D. We used inverse probability of treatment weighting to adjust for observable differences between patients treated at TCs and NTCs., Results: The added cost for treatment at a TC versus NTC was $36,319 per life-year gained ($790,931 per life saved) and $36,961 per quality-adjusted life years gained. Cost-effectiveness was more favorable for patients with injuries of higher versus lower severity and for younger versus older patients., Conclusions: Our findings provide evidence that regionalization of trauma care is not only effective but also it is cost-effective.

Background: An evaluation of the effect of a healthcare intervention (or an exposure) must consider multiple possible outcomes, including the primary outcome of interest and other outcomes such as adverse events or mortality. The determination of the likelihood of benefit from an intervention, in the presence of other competing outcomes, is a competing risks problem. Although statistical methods exist for quantifying the probability of benefit from an intervention while accounting for competing events, these methods have not been widely adopted by clinical researchers., Objectives: (1) To demonstrate the importance of considering competing risks in the evaluation of treatment effectiveness, and (2) to review appropriate statistical methods, and recommend how they might be applied., Research Design and Methods: We reviewed 3 statistical approaches for analyzing the competing risks problem: (a) cause-specific hazard (CSH), (b) cumulative incidence function (CIF), and (c) event-free survival (EFS). We compare these methods using a simulation study and a reanalysis of a randomized clinical trial., Results: Simulation studies evaluating the statistical power to detect the effect of intervention under different scenarios showed that: (1) CSH approach is best for detecting the effect of an intervention if the intervention only affects either the primary outcome or the competing event; (2) EFS approach is best only when the intervention affects both primary and competing events in the same manner; and (3) CIF approach is best when the intervention affects both primary and competing events, but in opposite directions. Using data from a randomized controlled trial, we demonstrated that a comprehensive approach using all 3 approaches provided useful insights on the effect of an intervention on the relative and absolute risks of multiple competing outcomes., Conclusions: CSH is the fundamental measure of outcome in competing risks problems. It is appropriate for evaluating treatment effects in the presence of competing events. Results of CSH analysis for primary and competing outcomes should always be reported even when EFS or CIF approaches are called for. EFS is appropriate for evaluating the composite effect of an intervention, only when combining different endpoints is clinically and biologically meaningful, and the treatment has similar effects on all event types. CIF is useful for evaluating the likelihood of benefit from an intervention over a meaningful period. CIF should be used for absolute risk calculations instead of the widely used complement of the Kaplan-Meier (1 - KM) estimator.

The National Study on the Costs and Outcomes of Trauma Care (NSCOT) was designed to address the need for better information on the value of trauma center care. It is a multi-institutional, prospective study that involved the examination of costs and outcomes of care received by over 5,000 adult trauma patients 18 to 84 years of age treated at 69 hospitals located in 12 states. The study had three major objectives: (1) to examine variations in care provided to trauma patients in Level I trauma centers and nontrauma center hospitals; (2) to determine the extent to which differences in care correlate with patient outcome, where outcome is defined not just in terms of mortality and morbidity, but also in terms of major functional outcomes at 3 months and 12 months after injury; and (3) to estimate acute and 1-year treatment costs for trauma center and nontrauma center care, and to describe the relationship between costs and effectiveness for trauma centers and nontrauma centers. In this article, we describe the design of the NSCOT study and point to some of the methodological challenges faced in its implementation and in the analysis of the data. We also present a description of the study population to serve as a basis of future reports. We conclude with lessons learned and some recommendations for future research.

Objective: To evaluate the effect of an intensivist-model of critical care delivery on the risk of death following injury., Summary Background Data: An intensivist-model of ICU care is associated with improved outcomes and less resource utilization in mixed medical and surgical ICUs. The process of trauma center verification assures a relatively high standard of care and quality assurance; thus, it is unclear what the effect of a specific model of ICU care delivery might have on trauma-related mortality., Methods: Using data from a large multicenter (68 centers) prospective cohort study, we evaluated the relationship between the model of ICU care (open vs. intensivist-model) and in-hospital mortality following severe injury. An intensivist-model was defined as an ICU where critically ill trauma patients were either on a distinct ICU service (led by an intensivist) or were comanaged with an intensivist (a physician board-certified in critical care)., Results: After adjusting for differences in baseline characteristics, the relative risk of death in intensivist-model ICUs was 0.78 (0.58-1.04) compared with an open ICU model. The effect was greatest in the elderly [RR, 0.55 (0.39-0.77)], in units led by surgical intensivists [RR, 0.67 (0.50-0.90)], and in designated trauma centers 0.64 (0.46-0.88)., Conclusions: Care in an intensivist-model ICU is associated with a large reduction in in-hospital mortality following trauma, particularly in elderly patients who might have limited physiologic reserve and extensive comorbidity. That the effect is greatest in trauma centers and in units led by surgical intensivists suggests the importance of content expertise in the care of the critically injured. Injured patients are best cared for using an intensivist-model of dedicated critical care delivery, a criterion that should be considered in the verification of trauma centers.