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.

Opioid Prescribing Rate for Nonoperative Distal Radius Fractures and Clinician Response to a Clinical Decision Support Alert.

BACKGROUND: Opioids are commonly prescribed for the management of acute orthopedic trauma pain, including nonoperative distal radius fractures. OBJECTIVES: This prospective study aimed to determine if a clinical decision support intervention influenced prescribing decisions for patients with known risk factors. We sought to quantify frequency of opioid prescriptions for acute nonoperative distal radius fractures treated. METHODS: We performed a prospective study at one large health care system. Utilizing umbrella code S52.5, we identified all distal radius fractures treated nonoperatively, and the encounters were merged with the Prescription Reporting with Immediate Medication Mapping (PRIMUM) database to identify encounters with opioid prescriptions and patients with risk factors for opioid use disorder. We used multivariable logistic regression to determine patient characteristics associated with the prescription of an opioid. Among encounters that triggered the PRIMUM alert, we calculated the percentage of encounters where the PRIMUM alert influenced the prescribing decision. RESULTS: Of 2984 encounters, 1244 (41.7%) included an opioid prescription. Age increment is a significant factor to more likely receive opioid prescriptions (p < 0.0001) after adjusting for other factors. Among encounters where the physician received an alert, those that triggered the alert for early refill were more likely to influence physicians' opioid prescribing when compared with other risk factors (p = 0.0088). CONCLUSION: Over 90% of patients (106/118) continued to receive an opioid medication despite having a known risk factor for abuse. Additionally, we found older patients were more likely to be prescribed opioids for nonoperatively managed distal radius fractures.

Do Transtibial Amputations Outperform Amputations of the Hind- and Midfoot Following Severe Limb Trauma?: A Secondary Analysis of the OUTLET Study.

BACKGROUND: The purpose of this study was to compare 18-month clinical and patient-reported outcomes between patients with severe lower-limb injuries treated with a transtibial amputation or a hind- or midfoot amputation. Despite the theoretical benefits of hind- and midfoot-level amputation, we hypothesized that patients with transtibial amputations would report better function and have fewer complications. METHODS: The study included patients 18 to 60 years of age who were treated with a transtibial amputation (n = 77) or a distal amputation (n = 17) and who were enrolled in the prospective, multicenter Outcomes Following Severe Distal Tibial, Ankle, and/or Foot Trauma (OUTLET) study. The primary outcome was the difference in Short Musculoskeletal Function Assessment (SMFA) scores, and secondary outcomes included pain, complications, amputation revision, and amputation healing. RESULTS: There were no significant differences between patients with distal versus transtibial amputation in any of the domains of the SMFA: dysfunction index [distal versus transtibial], 31.2 versus 22.3 (p = 0.13); daily activities, 37.3 versus 26.0 (p = 0.17); emotional status, 41.4 versus 29.3 (p = 0.07); mobility, 36.5 versus 27.8 (p = 0.20); and bother index, 34.4 versus 23.6 (p = 0.14). Rates of complications requiring revision were higher for distal amputations but not significantly so (23.5% versus 13.3%; p = 0.28). One distal and no transtibial amputees required revision to a higher level (p = 0.18). A higher proportion of patients with distal compared with transtibial amputation required local surgical revision (17.7% versus 13.3%; p = 0.69). There was no significant difference between the distal and transtibial groups in scores on the Brief Pain Index at 18 months post-injury. CONCLUSIONS: Surgical complication rates did not differ significantly between patients who underwent transtibial versus hind- or midfoot amputation for severe lower-extremity injury. The average SMFA scores were higher (worse), although not significantly different, for patients undergoing distal compared with transtibial amputation, and more patients with distal amputation had a complication requiring surgical revision. Of note, more patients with distal amputation required closure with an atypical flap, which likely contributed to less favorable outcomes. LEVEL OF EVIDENCE: Therapeutic 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.

Deep Surgical Site Infection after Fracture Has a Profound Effect on Functional Outcomes.

Background: Fracture-related infection is one of the most challenging complications in orthopaedic trauma surgery. However, the effect of infection on functional and pain-related outcomes has not been well established. The aims of this study were to evaluate functional recovery for patients with fracture and a deep surgical site infection compared with patients with fracture without infection and to evaluate whether pain severity, social support, and preinjury mental health have a moderating effect on the magnitude and direction of the relationship between deep surgical site infection and functional recovery. Methods: This is a secondary retrospective cohort study using prospectively collected data from the VANCO trial (Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection) and the OXYGEN (Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery) trial. In this study, 2,116 patients with tibial plateau, pilon, or calcaneal fractures at high risk for infection were included. Patients were divided into cohorts of patients who experienced a deep surgical site infection and those who did not. The primary outcome measure was the functional outcome using the Veterans RAND 12-Item Health Survey (VR-12). Results: After controlling for covariates, deep surgical site infection was independently associated with functional outcome, with a 3.3-point reduction in the VR-12 Physical Component Score, and pain severity was independently associated with functional outcome, with a 2.5-point reduction in the VR-12 Physical Component Score. Furthermore, the Brief Pain Inventory pain severity demonstrated an important moderating effect on the relationship between infection and functional outcome. In patients with lower pain scores, infection had a large negative impact on functional outcome, whereas, in patients with higher pain scores, infection had no significant impact on functional outcome. Furthermore, the functional outcome in the entire cohort remains at only 61% of baseline. Conclusions: This study documents the negative impact of postoperative infection on functional recovery after injury, as well as the novel finding of pain severity as an important moderating factor. This study emphasizes not only the importance of developing effective interventions designed to reduce postoperative infection, but also the role that factors that moderate pain severity plays in limiting recovery of physical function. Level of evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

The VANCO Trial Findings Are Generalizable to a North American Trauma Registry.

OBJECTIVES: To estimate the generalizability of treatment effects observed in the VANCO trial to a broader population of patients with tibial plateau or pilon fractures. METHODS: Design and Setting: Clinical trial data from 36 United States trauma centers and Trauma Quality Programs registry data from more than 875 Level I-III trauma centers in the United States and Canada.Patient Selection Criteria: Patients enrolled in the VANCO trial treated with intrawound vancomycin powder from January 2015 to June 2017 and 31,924 VANCO-eligible TQP patients admitted in 2019 with tibial plateau and pilon fractures.Outcome Measure and Comparisons: Deep surgical site infection and gram-positive deep surgical site infection estimated in the TQP sample weighed by the inverse probability of trial participation. RESULTS: The 980 patients in the VANCO trial were highly representative of 31,924 TQP VANCO-eligible patients (Tipton generalizability index 0.96). It was estimated that intrawound vancomycin powder reduced the odds of deep surgical infection by odds ratio (OR) = 0.46 (95% confidence interval [CI] 0.25-0.86) and gram-positive deep surgical infection by OR = 0.39 (95% CI, 0.18-0.84) within the TQP sample of VANCO-eligible patients. For reference, the trial average treatment effects for deep surgical infection and gram-positive deep surgical infection were OR = 0.60 (95% CI, 0.37-0.98) and OR = 0.44 (95% CI, 0.23-0.80), respectively. CONCLUSIONS: This generalizability analysis found that the inferences of the VANCO trial generalize and might even underestimate the effects of intrawound vancomycin powder when observed in a wider population of patients with tibial plateau and pilon fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Patients with glenohumeral arthritis are more likely to be prescribed opioids in the emergency department or urgent care setting.

OBJECTIVE: The objective is to quantify the rate of opioid and benzodiazepine prescribing for the diagnosis of shoulder osteoarthritis across a large healthcare system and to describe the impact of a clinical decision support intervention on prescribing patterns. DESIGN: A prospective observational study. SETTING: One large healthcare system. PATIENTS AND PARTICIPANTS: Adult patients presenting with shoulder osteoarthritis. INTERVENTIONS: A clinical decision support intervention that presents an alert to prescribers when patients meet criteria for increased risk of opioid use disorder. MAIN OUTCOME MEASURE: The percentage of patients receiving an opioid or benzodiazepine, the percentage who had at least one risk factor for misuse, and the percent of encounters in which the prescribing decision was influenced by the alert were the main outcome measures. RESULTS: A total of 5,380 outpatient encounters with a diagnosis of shoulder osteoarthritis were included. Twenty-nine percent (n = 1,548) of these encounters resulted in an opioid or benzodiazepine prescription. One-third of those who received a prescription had at least one risk factor for prescription misuse. Patients were more likely to receive opioids from the emergency department or urgent care facilities (40 percent of encounters) compared to outpatient facilities (28 percent) (p < .0001). Forty-four percent of the opioid prescriptions were for "potent opioids" (morphine milliequivalent conversion factor > 1). Of the 612 encounters triggering an alert, the prescribing decision was influenced (modified or not prescribed) in 53 encounters (8.7 percent). All but four (0.65 percent) of these encounters resulted in an opioid prescription. CONCLUSION: Despite evidence against routine opioid use for osteoarthritis, one-third of patients with a primary diagnosis of glenohumeral osteoarthritis received an opioid prescription. Of those who received a prescription, over one-third had a risk factor for opioid misuse. An electronic clinic decision support tool influenced the prescription in less than 10 percent of encounters.