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.

Does Topical Vancomycin Powder Use in Fracture Surgery Change Bacteriology and Antibiotic Susceptibilities? An Analysis of the VANCO Trial.

OBJECTIVE: To determine whether intrawound vancomycin changes the bacteriology of surgical site infection pathogens and investigate the emergence of antibiotic-resistant pathogens. DESIGN: Secondary analysis of phase III, prospective, randomized clinical trial. SETTING: Thirty-six US trauma centers. PATIENT SELECTION CRITERIA: Patients who became infected after fixation of tibial plateau or pilon fracture. OUTCOME MEASURES AND COMPARISONS: Pathogen types and bacterial susceptibilities as determined from routine clinical culture in the operating room. RESULTS: Seventy-four patients were studied who were 67.5% male with a mean age of 48.6 years. A lower proportion of gram-positive cocci was observed in the vancomycin powder compared with the standard-of-care group (3.7% vs. 8.0%, P = 0.01). Methicillin-resistant Staphylococcus aureus infection incidence was comparable in both the vancomycin powder and the standard-of-care groups, but rates of methicillin-susceptible S. aureus infections were lower in the treatment group (1.4% vs. 4.8%, P = 0.01). The incidence of coagulase-negative Staphylococci and gram-negative rod infections were similar in both groups. There was no significant difference in susceptibilities between groups in rates of vancomycin-resistant enterococcus. CONCLUSIONS: Topical vancomycin powder decreases the likelihood of gram-positive infections consistent with the biologic activity of vancomycin. Fewer methicillin-susceptible S. aureus and coagulase-negative Staphylococci infections were observed in the group treated with vancomycin powder. An effect of vancomycin powder on methicillin-resistant S. aureus infection risk was not detected given the low incidence in both the intrawound vancomycin and the standard-of-care groups. There was no emergence of gram-negative rod infections or increased resistance patterns observed. Use of topical vancomycin powder does not seem to produce infections in these patients with greater antibiotic resistance than would have occurred without its use. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients (PRECISE STUDY).

SUMMARY: Optimal timing and procedure selection that define staged treatment strategies can affect outcomes dramatically and remain an area of major debate in the treatment of multiply injured orthopaedic trauma patients. Decisions regarding timing and choice of orthopaedic procedure(s) are currently based on the physiologic condition of the patient, resource availability, and the expected magnitude of the intervention. Surgical decision-making algorithms rarely rely on precision-type data that account for demographics, magnitude of injury, and the physiologic/immunologic response to injury on a patient-specific basis. This study is a multicenter prospective investigation that will work toward developing a precision medicine approach to managing multiply injured patients by incorporating patient-specific indices that quantify (1) mechanical tissue damage volume; (2) cumulative hypoperfusion; (3) immunologic response; and (4) demographics. These indices will formulate a precision injury signature, unique to each patient, which will be explored for correspondence to outcomes and response to surgical interventions. The impact of the timing and magnitude of initial and staged surgical interventions on patient-specific physiologic and immunologic responses will be evaluated and described. The primary goal of the study will be the development of data-driven models that will inform clinical decision-making tools that can be used to predict outcomes and guide intervention decisions.

Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM) Study: Implementation of the PROMIS Toolbox Within an Orthopaedic Trauma Clinical Trials Consortium.

LEVEL OF EVIDENCE: Prognostic Level II.

Perfusion Pressure Lacks Diagnostic Specificity for the Diagnosis of Acute Compartment Syndrome.

OBJECTIVE: To evaluate the diagnostic performance of perfusion pressure (PP) thresholds for fasciotomy. DESIGN: Prospective observational study. SETTING: Seven Level-1 trauma centers. PATIENTS/PARTICIPANTS: One hundred fifty adults with severe leg injuries and ≥2 hours of continuous PP data who had been enrolled in a multicenter observational trial designed to develop a clinical prediction rule for acute compartment syndrome (ACS). MAIN OUTCOME MEASUREMENTS: For each patient, a given PP criterion was positive if it was below the specified threshold for at least 2 consecutive hours. The diagnostic performance of PP thresholds between 10 and 30 mm Hg was determined using 2 reference standards for comparison: (1) the likelihood of ACS as determined by an expert panel who reviewed each patient's data portfolio or (2) whether the patient underwent fasciotomy. RESULTS: Using the likelihood of ACS as the diagnostic standard (ACS considered present if median likelihood ≥70%, absent if <30%), a PP threshold of 30 mm Hg had diagnostic sensitivity 0.83, specificity 0.53, positive predictive value 0.07, and negative predictive value 0.99. Results were insensitive to more strict likelihood categorizations and were similar for other PP thresholds between 10- and 25-mm Hg. Using fasciotomy as the reference standard, the same PP threshold had diagnostic sensitivity 0.50, specificity 0.50, positive predictive value 0.04, negative predictive value 0.96. CONCLUSION: No value of PP from 10 to 30 mm Hg had acceptable diagnostic performance, regardless of which reference diagnostic standard was used. These data question current practice of diagnosing ACS based on PP and suggest the need for further research. LEVEL OF EVIDENCE: Diagnostic Level I. See Instructions for Authors for a complete description of levels of evidence.

Trauma Collaborative Care Intervention: Effect on Surgeon Confidence in Managing Psychosocial Complications After Orthopaedic Trauma.

OBJECTIVES: The impact of the Trauma Collaborative Care (TCC) program on surgeon confidence in managing the psychosocial sequelae of orthopaedic trauma was evaluated as part of a larger prospective, multisite, cluster clinical trial. We compared confidence and perceived resource availability among surgeons practicing in trauma centers that implemented the TCC program with orthopaedic trauma surgeons in similar trauma centers that did not implement the TCC. DESIGN: Prospective cohort design. SETTING: Level-I trauma centers. PARTICIPANTS: Attending surgeons and fellows (N = 95 Pre and N = 82 Post). MAIN OUTCOME MEASUREMENTS: Self-report 10-item measure of surgeon confidence in managing psychosocial issues associated with trauma and perceived availability of support resources. RESULTS: Analyses, performed on the entire sample and repeated on the subset of 52 surgeons who responded to the survey at both times points, found surgeons at intervention sites experienced a significantly greater positive improvement (P < 0.05) in their (1) belief that they have strategies to help orthopaedic trauma patients change their psychosocial situation; (2) confidence in making appropriate referrals for orthopaedic trauma patients with psychosocial problems; and (3) belief that they have access to information to guide the management of psychosocial issues related to recovery. CONCLUSIONS: Initial data suggest that the establishment of the TCC program can improve surgeons' perceived availability of resources and their confidence in managing the psychosocial sequelae after injury. Further studies will be required to determine if this translates into beneficial patient effects. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.