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.

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.

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.

The National Study on Costs and Outcomes of Trauma.

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.