Minimal Clinically Important Difference (MCID) for the Short Musculoskeletal Function Assessment (SMFA) in Severe Lower Extremity Trauma: Pooled Data from 7 Multicenter, Prospective Clinical Trials.

BACKGROUND: The Short Musculoskeletal Function Assessment (SMFA) is a well validated, widely used patient-reported outcome (PRO) measure for orthopaedic patients. Despite its widespread use and acceptance, this measure does not have an agreed upon minimal clinically important difference (MCID). The purpose of the present study was to create distributional MCIDs with use of a large cohort of research participants with severe lower extremity fractures. METHODS: Three distributional approaches were used to calculate MCIDs for the Dysfunction and Bother Indices of the SMFA as well as all its domains: (1) half of the standard deviation (one-half SD), (2) twice the standard error of measurement (2SEM), and (3) minimal detectable change (MDC). In addition to evaluating by patient characteristics and the timing of assessment, we reviewed these calculations across several injury groups likely to affect functional outcomes. RESULTS: A total of 4,298 SMFA assessments were collected from 3,185 patients who had undergone surgical treatment of traumatic injuries of the lower extremity at 60 Level-I trauma centers across 7 multicenter, prospective clinical studies. Depending on the statistical approach used, the MCID associated with the overall sample ranged from 7.7 to 10.7 for the SMFA Dysfunction Index and from 11.0 to 16.8 for the SMFA Bother Index. For the Dysfunction Index, the variability across the scores was small (<5%) within the sex and age subgroups but was modest (12% to 18%) across subgroups related to assessment timing. CONCLUSIONS: A defensible MCID can be found between 7 and 11 points for the Dysfunction Index and between 11 and 17 points for the Bother Index. The precise choice of MCID may depend on the preferred statistical approach and the population under study. While differences exist between MCID values based on the calculation method, values were consistent across the categories of the various subgroups presented. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials.

BACKGROUND: Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment. METHODS: This retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs. RESULTS: No study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible. CONCLUSIONS: Our data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner. TRIAL REGISTRATION: Please see Table 1 for individual trial registration numbers and dates of registration.

Effect of Aspirin Versus Low-Molecular-Weight Heparin Thromboprophylaxis on Medication Satisfaction and Out-of-Pocket Costs: A Secondary Analysis of a Randomized Clinical Trial.

BACKGROUND: Current guidelines recommend low-molecular-weight heparin for thromboprophylaxis after orthopaedic trauma. However, recent evidence suggests that aspirin is similar in efficacy and safety. To understand patients' experiences with these medications, we compared patients' satisfaction and out-of-pocket costs after thromboprophylaxis with aspirin versus low-molecular-weight heparin. METHODS: This study was a secondary analysis of the PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT) trial, conducted at 21 trauma centers in the U.S. and Canada. We included adult patients with an operatively treated extremity fracture or a pelvic or acetabular fracture. Patients were randomly assigned to receive 30 mg of low-molecular-weight heparin (enoxaparin) twice daily or 81 mg of aspirin twice daily for thromboprophylaxis. The duration of the thromboprophylaxis, including post-discharge prescription, was based on hospital protocols. The study outcomes included patient satisfaction with and out-of-pocket costs for their thromboprophylactic medication measured on ordinal scales. RESULTS: The trial enrolled 12,211 patients (mean age and standard deviation [SD], 45 ± 18 years; 62% male), 9725 of whom completed the question regarding their satisfaction with the medication and 6723 of whom reported their out-of-pocket costs. The odds of greater satisfaction were 2.6 times higher for patients assigned to aspirin than those assigned to low-molecular-weight heparin (odds ratio [OR]: 2.59; 95% confidence interval [CI]: 2.39 to 2.80; p < 0.001). Overall, the odds of incurring any out-of-pocket costs for thromboprophylaxis medication were 51% higher for patients assigned to aspirin compared with low-molecular-weight heparin (OR: 1.51; 95% CI: 1.37 to 1.66; p < 0.001). However, patients assigned to aspirin had substantially lower odds of out-of-pocket costs of at least $25 (OR: 0.15; 95% CI: 0.12 to 0.18; p < 0.001). CONCLUSIONS: Use of aspirin substantially improved patients' satisfaction with their medication after orthopaedic trauma. While aspirin use increased the odds of incurring any out-of-pocket costs, it protected against costs of ≥$25, potentially improving health equity for thromboprophylaxis. LEVEL OF EVIDENCE: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

The 1-Year Economic Impact of Work Productivity Loss Following Severe Lower Extremity Trauma.

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.

Changes in Opioid Prescribing Following the Implementation of State Policies Limiting Morphine Equivalent Daily Dose in a Commercially Insured Population.

BACKGROUND: Prescription opioid mortality doubled 2002-2016 in the United States. Given the association between high-dose opioid prescribing and opioid mortality, several states have enacted morphine equivalent daily dose (MEDD) policies to limit high-dose prescribing. The study objective is to evaluate the impact of state-level MEDD policies on opioid prescribing among the privately insured. METHODS: Claims data, 2010-2015 from 9 policy states and 2 control states and a comparative interrupted time series design were utilized. Primary outcomes were any monthly opioid use and average monthly MEDD. Stratified analyses evaluated theorized weaker policies (guidelines) and theorized stronger policies (passive alert systems, legislative acts, and rules/regulations) separately. Patient groups explicitly excluded from policies (eg, individuals with cancer diagnoses or receiving hospice care) were also examined separately. Analyses adjusted for covariates, state fixed effects, and time trends. RESULTS: Both guideline and strong policy implementation were both associated with 15% lower odds of any opioid use, relative to control states. However, there was no statistically significant change in the use of high-dose opioids in policy states relative to control states. There was also no difference in direction and significance of the relationship among targeted patient groups. CONCLUSIONS: MEDD policies were associated with decreased use of any opioids relative to control states, but no change in high-dose prescribing was observed. While the overall policy environment in treatment states may have discouraged opioid prescribing, there was no evidence of MEDD policy impact, specifically. Further research is needed to understand the mechanisms through which MEDD policies may influence prescribing behavior.

Can financial payments incentivize short-term smoking cessation in orthopaedic trauma patients? Evidence from a discrete choice experiment.

BACKGROUND: Smoking increases the risk of complications and related costs after an orthopaedic fracture. Research in other populations suggests that a one-time payment may incentivize smoking cessation. However, little is known on fracture patients' willingness to accept financial incentives to stop smoking; and the level of incentive required to motivate smoking cessation in this population. This study aimed to estimate the financial threshold required to motivate fracture patients to stop smoking after injury. METHODS: This cross-sectional study utilized a discrete choice experiment (DCE) to elicit patient preferences towards financial incentives and reduced complications associated with smoking cessation. We presented participants with 12 hypothetical options with several attributes with varying levels. The respondents' data was used to determine the utility of each attribute level and the relative importance associated with each attribute. RESULTS: Of the 130 enrolled patients, 79% reported an interest in quitting smoking. We estimated the financial incentive to be of greater relative importance (ri) (45%) than any of the included clinical benefits of smoking cessations (deep infection (ri: 24%), bone healing complications (ri: 19%), and superficial infections (ri: 12%)). A one-time payment of $800 provided the greatest utility to the respondents (0.64, 95% CI: 0.36 to 0.93), surpassing the utility associated with a single $1000 financial incentive (0.36, 95% CI: 0.18 to 0.55). CONCLUSIONS: Financial incentives may be an effective tool to promote smoking cessation in the orthopaedic trauma population. The findings of this study define optimal payment thresholds for smoking cessation programs.

Outpatient Physical Therapy Use Following Tibial Fractures: A Retrospective Commercial Claims Analysis.

OBJECTIVE: The purpose of this study was to characterize outpatient physical therapy (OPT) use following tibial fractures and examine the variability of OPT attendance, time of initiation, number of visits, and length of care by patient, injury, and treatment factors. In the absence of clinical guidelines, results will guide future efforts to optimize OPT following tibial fractures. METHODS: This study used 2016 to 2017 claims from the IBM MarketScan Commercial Claims Research Database. The cohort included 9079 patients with International Classification of Diseases: Tenth Revision (ICD-10) diagnosis codes for tibial fractures. Use in the year following initial fracture management was determined using Current Procedural Terminology codes. Differences in use were examined using χ2 tests, t tests, and Kruskal-Wallace tests. RESULTS: Sixty-seven percent of patients received OPT the year following fracture. OPT attendance was higher in female patients, in patients with 1 or no major comorbidity, and in the western United States. Attendance was higher in patients with upper tibial fractures, moderate-severity injuries, and treatment with external fixation and in patients discharged to an inpatient rehabilitation facility. Patients started OPT on average [SD] 50 [52.6] days after fracture and attended 18 [16.1] visits over the course of 101 [86.4] days. The timing of OPT, the number of visits attended, and the length of OPT care varied by patient, injury, and treatment-level factors. CONCLUSIONS: One-third of insured patients do not receive OPT following tibial fracture. The timing of OPT initiation, the length of OPT care, and the number of visits attended by patients with tibial fractures were highly variable. Further research is needed to standardize referral and prescription practices for OPT following tibial fractures. IMPACT: OPT use varies based on patient, injury, and treatment-level factors following tibial fractures. Results from this study can be used to inform future efforts to optimize rehabilitation care for patients with tibial fractures.

The Impact of Adherence to Clinical Practice Guidelines on Medical Costs.

OBJECTIVE: To examine the association between non-adherence to clinical practice guidelines (CPGs) and medical and indemnity spending among back and shoulder injury patients. METHODS: Workers compensation claims data was used from a large, US insurer (1999 to 2010). Least square regression models were created to examine the association between spending and guideline-discordant care. RESULTS: Non-adherence to CPGs was associated with higher medical and indemnity spending for 11 of the 28 CPG indicators. Failure to adhere to the other CPGs did not increase medical or total spending. After covariate adjustment, non-adherence to these 11 CPGs was associated with spending increases that ranged from $16,000 for physical therapy (PT) to $114,000 for surgery. CONCLUSIONS: Our results demonstrate that failure to adhere to a subset of CPG indicators significantly predicts increased medical and indemnity spending for two important occupational injuries.

The Impact of Morphine Equivalent Daily Dose Threshold Guidelines on Prescribed Dose in a Workers' Compensation Population.

BACKGROUND: Prescription opioid overdose has increased markedly and is of great concern among injured workers receiving workers' compensation insurance. Given the association between high daily dose of prescription opioids and negative health outcomes, state workers' compensation boards have disseminated Morphine Equivalent Daily Dose (MEDD) guidelines to discourage high-dose opioid prescribing. OBJECTIVE: To evaluate the impact of MEDD guidelines among workers' compensation claimants on prescribed opioid dose. METHODS: Workers' compensation claims data, 2010-2013 from 2 guideline states and 3 control states were utilized. The study design was an interrupted time series with comparison states and average monthly MEDD was the primary outcome. Policy variables were specified to allow for both instantaneous and gradual effects and additional stratified analyses examined evaluated the policies separately for individuals with and without acute pain, cancer, and high-dose baseline use to determine whether policies were being targeted as intended. RESULTS: After adjusting for covariates, state fixed-effects, and time trends, policy implementation was associated with a 9.26 mg decrease in MEDD (95% confidence interval, -13.96 to -4.56). Decreases in MEDD also became more pronounced over time and were larger in groups targeted by the policies. CONCLUSIONS: Passage of workers' compensation MEDD guidelines was associated with decreases in prescribed opioid dose among injured workers. Disseminating MEDD guidelines to doctors who treat workers' compensation cases may address an important risk factor for opioid-related mortality, while still allowing for autonomy in practice. Further research is needed to determine whether MEDD policies influence prescribing behavior and patient outcomes in other populations.

Reducing High-Dose Opioid Prescribing: State-Level Morphine Equivalent Daily Dose Policies, 2007-2017.

OBJECTIVE: To describe current state-level policies in the United States, January 1, 2007-June 1, 2017, limiting high morphine equivalent daily dose (MEDD) prescribing. METHODS: State-level MEDD threshold policies were reviewed using LexisNexis and Westlaw Next for legislative acts and using Google for nonlegislative state-level policies. The websites of each state's Medicaid agency, health department, prescription drug monitoring program, workers' compensation board, medical board, and pharmacy board were reviewed to identify additional policies. The final policy list was checked against existing policy compilations and academic literature and through contact with state health agency representatives. Policies were independently double-coded on the categories: state, agency/organization, policy type, effective date, threshold level, and policy exceptions. RESULTS: Currently, 22 states have at least one type of MEDD policy, most commonly guidelines (14 states), followed by prior authorizations (four states), rules/regulations (four states), legislative acts (three states), claim denials (two states), and alert systems/automatic patient reports (two states). Thresholds range widely (30-300 mg MEDD), with higher thresholds generally corresponding to more restrictive policies (e.g., claim denial) and lower thresholds corresponding to less restrictive policies (e.g., guidelines). The majority of policies exclude some groups of opioid users, most commonly patients with terminal illnesses or acute pain. CONCLUSIONS: MEDD policies have gained popularity in recent years, but considerable variation in threshold levels and policy structure point to a lack of consensus. This work provides a foundation for future evaluation of MEDD policies and may inform states considering adopting such policies.

Factors mediating demographic determinants of injury mortality.

PURPOSE: Elevated injury mortality rates persist for men and people of color despite attempts to standardize trauma care in the United States. This study investigates the role of injury characteristics and access to trauma care as mediators of the relationships between race, ethnicity, sex, and injury mortality. METHODS: Data on prehospital and trauma center care were examined for adult injured patients in Maryland who were transported by emergency medical services to designated trauma centers (n = 15,355) or who died while under emergency medical services care (n = 727). Potential mediators of the relationship between demographic characteristics and injury mortality were identified through exploratory analyses. Total, direct, and indirect effects of race, ethnicity, and sex were estimated using multivariable mediation models. RESULTS: Prehospital time, hospital distance, injury mechanism, and insurance status mediated the effect of African American race, resulting in a 5.7% total increase (95% CI: 1.6%, 9.9%) and 5.6% direct decrease (95% CI: 1.1%, 9.9%) in odds of death. Mechanism, insurance, and distance mediated the effect of Hispanic ethnicity, resulting in an 11.4% total decrease (95% CI: 6.4%, 16.2%) and 13.4% direct decrease (95% CI: 8.1%, 18.3%) in odds of death. Injury severity, mechanism, insurance, and time mediated the effect of male sex, resulting in a 27.3% total increase (95% CI: 21.6%, 10.9%) and a 6.2% direct increase (95% CI: 1.8%, 10.9%) in odds of death. CONCLUSIONS: Distance, injury characteristics, and insurance mediate the effects of demographic characteristics on injury mortality and appear to contribute to disparities in injury mortality.

Associations of Distance to Trauma Care, Community Income, and Neighborhood Median Age With Rates of Injury Mortality.

Importance: Rural, low-income, and historically underrepresented minority communities face substantial barriers to trauma care and experience high injury incidence and mortality rates. Characteristics of injury incident locations may contribute to poor injury outcomes. Objective: To examine the association of injury scene characteristics with injury mortality. Design, Setting, and Participants: In this cross-sectional study, data from trauma center and emergency medical services provided by emergency medical services companies and designated trauma centers in the state of Maryland from January 1, 2015, to December 31, 2015, were geocoded by injury incident locations and linked with injury scene characteristics. Participants included adults who experienced traumatic injury in Maryland and were transported to a designated trauma center or died while in emergency medical services care at the incident scene or in transit. Exposures: The primary exposures of interest were geographic characteristics of injury incident locations, including distance to the nearest trauma center, designation level and ownership status of the nearest trauma center, and land use, as well as community-level characteristics such as median age and per capita income. Main Outcomes and Measures: Odds of death were estimated with multilevel logistic regression, controlling for individual demographic measures and measures of injury and health. Results: Of the 16 082 patients included in this study, 8716 (52.4%) were white, and 5838 (36.3%) were African American. Most patients were male (10 582; 65.8%) and younger than 65 years (12 383; 77.0%). Odds of death increased by 8.0% for every 5-mile increase in distance to the nearest trauma center (OR, 1.08; 95% CI, 1.01-1.15; P = .03). Compared with privately owned level 1 or 2 centers, odds of death increased by 49.9% when the nearest trauma center was level 3 (OR, 1.50; 95% CI, 1.06-2.11; P = .02), and by 80.7% when the nearest trauma center was publicly owned (OR, 1.81; 95% CI, 1.39-2.34; P < .001). At the zip code tabulation area level, odds of death increased by 16.0% for every 5-year increase in median age (OR, 1.16; 95% CI, 1.03-1.30; P = .02), and decreased by 26.6% when the per capita income was greater than $25 000 (OR, 0.73; 95% CI, 0.54-0.99; P = .05). Conclusions and Relevance: Injury scene characteristics are associated with injury mortality. Odds of death are highest for patients injured in communities with higher median age or lower per capita income and at locations farthest from level 1 or 2 trauma centers.

The impact of practice guidelines on opioid utilization for injured workers.

BACKGROUND: Opioid use is rising in the US and may cause special problems in workers compensation cases, including addiction and preventing a return to work after an injury. OBJECTIVE: This study evaluates a physician-level intervention to curb opioid usage. An insurer identified patients with out-of-guideline opioid utilization and called the prescribing physician to discuss the patient's treatment protocol. RESEARCH DESIGN: This study uses a differences-in-differences study design with a propensity-score-matched control group. Medical and pharmaceutical claims data from 2005 to 2011 were used for analyses. RESULTS: Following the intervention, the use of opioids increased for the intervention group and there is little impact on medical spending. CONCLUSIONS: Counseling physicians about patients with high opioid utilization may focus more attention on their care, but did not impact short-term outcomes. More robust interventions may be needed to manage opioid use. PERSPECTIVE: While the increasing use of opioids is of growing concern around the world, curbing the utilization of these powerfully addictive narcotics has proved elusive. This study examines a prescribing guidelines intervention designed to reduce the prescription of opioids following an injury. The study finds that there was little change in the opioid utilization after the intervention, suggesting interventions along other parts of the prescribing pathway may be needed.

Risk Factors for Failure of Bone Grafting of Tibia Nonunions and Segmental Bone Defects: A New Preoperative Risk Assessment Score.

OBJECTIVE: To develop a clinically useful prediction model of success at the time of surgery to promote bone healing for established tibial nonunion or traumatic bone defects. DESIGN: Retrospective case controlled. SETTING: Level 1 trauma center. PATIENTS: Adult patients treated with surgery for established tibia fracture nonunion or traumatic bone defects from 2007 to 2016. Two hundred three patients met the inclusion criteria and were available for final analysis. INTERVENTION: Surgery to promote bone healing of established tibia fracture nonunion or segmental defect with plate and screw construct, intramedullary nail fixation, or multiplanar external fixation. MAIN OUTCOME MEASURES: Failure of the surgery to promote bone healing that was defined as unplanned revision surgery for lack of bone healing or deep infection. No patients were excluded who had a primary outcome event. RESULTS: Multivariate logistic modeling identified 5 significant (P < 0.05) risk factors for failure of the surgery to promote bone healing: (1) mechanism of injury, (2) Increasing body mass index, (3) cortical defect size (mm), (4) flap size (cm), and (5) insurance status. A prediction model was created based on these factors and awarded 0 points for fall, 17 points for high energy blunt trauma (OR = 17; 95% CI, 1-286, P = 0.05), 22 points for industrial/other (OR = 22; 95% CI, 1-4, P = 0.04), and 28 points for ballistic injuries (OR = 28; 95% CI, 1-605, P = 0.04). One point is given for every 10 cm of flap size (OR = 1; 95% CI, 1-1.1, P < 0.001), 10 mm of mean cortical gap distance (OR = 1; 95% CI, 1-2, P = 0.004), and 10 units BMI, respectively (OR = 1.5; 95% CI, 1-3, P = 0.16). Two points are awarded for Medicaid or no insurance (OR = 2; 95% CI, 1-5, P = 0.035) and 3 points for Medicare (3; 95% CI, 1-9, P = 0.033). Each 1-point increase in risk score was associated with a 6% increased chance of requiring at least 1 revision surgery (P < 0.001). CONCLUSIONS: This study presents a clinical score that predicts the likelihood of success after surgery for tibia fracture nonunions or traumatic bone defects and may help clinicians better determine which patients are likely to fail these procedures and require further surgery.

Survivorship After High-Energy Geriatric Trauma.

OBJECTIVES: To evaluate in-hospital, 1-year, and 5-year survivorship of geriatric patients after high-energy trauma, to compare survivorship of geriatric patients who sustained high-energy trauma with that of those who sustained low-energy trauma, and to identify predictors for mortality. DESIGN: Retrospective. SETTING: Urban Level I trauma center. PATIENTS: Study group of 1849 patients with high-energy trauma and comparison group of 761 patients with low-energy trauma. INTERVENTION: Each patient was observed from the time of index admission through the end of the study period or until death or readmission. MAIN OUTCOME MEASUREMENT: Long-term survivorship based on the Social Security Death Index. RESULTS: Survivorship between patients with high-energy and low-energy injuries was statistically significant. Among patients who sustained high-energy injuries, in-hospital mortality was 8%, 1-year mortality was 15%, and 5-year mortality was 25%. Among patients who sustained low-energy injuries, in-hospital mortality was 3%, 1-year mortality was 23%, and 5-year mortality was 40%. Low-energy mechanism of injury was an independent predictor for 1-year and 5-year mortality, even when controlling for Charlson Comorbidity Index (CCI), Injury Severity Score (ISS), age, sex, body mass index (BMI), and admission Glasgow Coma Scale (GCS) score. CONCLUSIONS: Geriatric patients with high-energy injuries and those with low-energy injuries seem to represent different patient populations, and low-energy mechanism seems to be a marker for frailty. High-energy mechanism was associated with lower long-term mortality rates, even when controlling for CCI, ISS, age, sex, BMI and admission GCS score. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation With Subsequent Postclosure Deep Wound Infection (Bioburden Study).

Infection remains the most common and significant complication after high-energy fractures. The Bioburden Study is a multicenter, prospective, observational cohort study of wound bacterial bioburden and antibiotic care in severe open lower extremity fractures. The aims of this study are to (1) characterize the contemporary extremity wound "bioburden" at the time of definitive wound closure; (2) determine the concordance between polymerase chain reaction results and hospital microbiology; (3) determine, among those who develop deep infections, the concordance between the pathogens at wound closure and at deep infection; and (4) compare the probability of deep infection between those who did and did not receive an appropriate course of antibiotics based on bioburden at the time of wound closure. To address these aims, sites collected tissue samples from severe lower extremity injuries at the time of wound closure and at first surgery for treatment of a deep infection, nonunion, flap failure, amputation, or other complications (because these surgeries may be due to undetected infection). Otherwise, if no further surgical treatment occurred, participants were followed for 12 months. The study was conducted at 38 US trauma centers and has enrolled 655 participants aged 18-64 years. This is the first large multi-institutional study evaluating the wound bioburden of severe open tibia fractures and correlating this bioburden with the risk of wound complications after definitive soft tissue closure.

A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

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 to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study).

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.

Traumatic injuries and persistent opioid use in the USA: findings from a nationally representative survey.

BACKGROUND: Although opioid abuse is a rising epidemic in the USA, there are no studies to date on the incidence of persistent opioid use following injuries. Therefore, the aims of this study are: (1) to examine the incidence of persistent opioid use among a nationally representative sample of injured and non-injured populations; (2) to evaluate whether an injury is an independent predictor of persistent opioid use. METHOD: Data from the Medical Expenditure Panel Survey were pooled (years 2009-2012). Adults were followed for about 2 years, during which they were surveyed about injury status and opioid use every 4-5 months. To determine whether injuries are associated with persistent opioid use, weighted multiple logistic regressions were constructed. RESULTS: While 2.3 million injured individuals received any opioid during the follow-up, 371 170 (15.6%) individuals became persistent opioid users (defined as opioid use across multiple time points). In a multiple logistic regression analysis adjusting for sociodemographic characteristics and self-reported health, those who sustained injuries were 1.4 times (95% CI 1.1 to 1.9) more likely to report persistent opioid use than those without injuries. CONCLUSIONS: We found injuries to be significantly associated with persistent opioid use in a nationally representative sample. Further investment in injury prevention may facilitate reduction of persistent opioid use and, thus, improve population health and reduce health expenditures.

Longitudinal assessment of injury recidivism among adults in the United States: findings from a population-based sample.

BACKGROUND: Repeated injuries, as known as injury recidivism, pose a significant burden on population health and healthcare settings. Therefore, identifying those at risk of recidivism can highlight targeted populations for primary prevention in order to improve health and reduce healthcare expenditures. There has been limited research on factors associated with recidivism in the U.S. Using a population-based sample, we aim to: 1) identify the prevalence and risk factors for injury recidivism among non-institutionalized adults; 2) investigate the trend in nationwide recidivism rates over time. METHODS: Using the Medical Expenditure Panel Survey (MEPS), 19,134 adults with at least one reported injury were followed for about 2 years. Reported injuries were those associated with healthcare utilization, disability days or any effects on self-reported health. The independent associations between risk factors for recidivism were evaluated incorporating a weighted logistic regression model. RESULTS: There were 4,136 recidivists representing over nine million individuals in the U.S. over a 2-year follow-up. About 44 % of recidivists sustained severe injuries requiring a hospitalization, a physician's office visit or an emergency department visit. Compared with those who sustained a single injury, recidivists were more likely to be white, unmarried, reside in metropolitan areas, and report a higher prevalence of chronic conditions. Age, sex, race/ethnicity, marital status, urbanicity, region, diabetes, stroke, asthma and depression symptoms were significant predictors of recidivism. Significant interaction effects between age and gender suggested those in the 18-25 age group, the odds of being a recidivist were 1.45 higher among males than females adjusting for other covariates. While having positive screens for depression in both follow-up years was associated with 1.46 (95 % CI = 1.21-1.77) higher odds of recidivisms than the reference group adjusting for other variables. CONCLUSIONS: We observed a higher recidivism rate among injured individuals in this study than previously reported. Our findings emphasize the pressing need for injury prevention to reduce the burden of repeated injuries. Preventative efforts may benefit from focusing on males between 18 and 25 years of age and those with comorbidities such as diabetes, stroke and depression.