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.

Lumbar Decompression With and Without Fusion for Lumbar Stenosis With Spondylolisthesis: A Cost Utility Analysis.

STUDY DESIGN: Markov model. OBJECTIVE: To compare the cost-effectiveness of lumbar decompression alone (DA) with lumbar decompression with fusion (DF) for the management of adults undergoing surgery for lumbar stenosis with associated degenerative spondylolisthesis. SUMMARY OF BACKGROUND DATA: Rates of lumbar fusion have increased for all indications in the United States over the last 20 years. Recent randomized controlled trial data, however, have suggested comparable functional outcomes and lower reoperation rates for lumbar decompression and fusion as compared with DA in the treatment of lumbar stenosis with degenerative spondylolisthesis. MATERIALS AND METHODS: A multistate Markov model was constructed from the US payer perspective of a hypothetical cohort of patients with lumbar stenosis with associated spondylolisthesis requiring surgery. Data regarding clinical improvement, costs, and reoperation were generated from contemporary randomized trial evidence, meta-analyses of recent prospective studies, and large retrospective cohorts. Base case, one-way sensitivity analysis, and probabilistic sensitivity analyses were conducted, and the results were compared with a WTP threshold of $100,000 (in 2022 USD) over a two-year time horizon. A discount rate of 3% was utilized. RESULTS: The incremental cost and utility of DF relative to DA were $12,778 and 0.00529 aggregated quality adjusted life years. The corresponding incremental cost-effectiveness ratio of $2,416,281 far exceeded the willingness to pay threshold of $100,000. In sensitivity analysis, the results varied the most with respect to rate of improvement after DA, rate of improvement after lumbar decompression and fusion, and odds ratio of reoperation between the two groups. Zero percent of one-way and probabilistic sensitivity analyses achieved cost-effectiveness at the willingness-to-pay threshold. CONCLUSIONS: Within the context of contemporary surgical data, DF is not cost-effective compared with DA in the surgical management of lumbar stenosis with associated spondylolisthesis over a two-year time horizon.

Ambulatory Surgery Centers Versus Hospital Outpatient Departments for Orthopaedic Surgeries.

BACKGROUND: The goals of this study were to compare the utilization and costs of ambulatory surgery centers (ASCs) versus hospital outpatient department (HOPD) for commonly performed outpatient orthopaedic surgical procedures. METHODS: Commercially insured patients undergoing elective, outpatient orthopaedic surgery were queried using an administrative claims database. We queried the following surgeries: carpal tunnel release, lumbar microdiskectomy, anterior cruciate ligament reconstruction, knee arthroscopy, arthroscopic rotator cuff repair, and bunion repair. Total costs were defined as the sum of all payments for a surgical episode. Professional fees were defined as payments to the primary orthopaedic surgeon and technical fees as all other payments. Comparisons between ASC and HOPD reimbursements were conducted using bivariate statistics and generalized linear models controlling for patient age, sex, and Elixhauser comorbidity index. RESULTS: Among 990,980 cases of outpatient orthopaedic surgery done from 2013 to 2018, the utilization rate of ASCs increased from 31% to 34% across all procedures assessed: compound annual growth rate of 3.3% for lumbar microdiscectomy, 1.8% for knee arthroscopy, 1.4% for anterior cruciate ligament, 1.4% for carpal tunnel release, 1.2% for arthroscopic rotator cuff repair, and 0.5% for bunion repair (P < 0.001 for all). The average total costs were 26% lower at ASCs than HOPDs (P < 0.001 for each procedure). The average technical fees were 33% lower at ASCs than HOPDs (P < 0.001 for each procedure). Both total costs and technical fees were less for ASCs than HOPDs after controlling for patient age, sex, and Elixhauser comorbidity index (P < 0.001 for each procedure). Over the study period, the mean total costs at HOPDs increased by 2.5% yearly, whereas the mean total costs at ASCs decreased by 0.1% yearly. The average surgeon professional fees declined in both care settings over time. CONCLUSION: From 2013 to 2018, there was an increase in ASC utilization for common outpatient orthopaedic surgeries. ASCs were overall less costly than HOPDs for outpatient orthopaedic surgeries. LEVEL OF EVIDENCE: IV.

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.

The Impact of the COVID-19 Pandemic on Elective Inpatient Surgical Admissions: Evidence From Maryland.

BACKGROUND: The COVID-19 pandemic led to large-scale cancellation and deferral of elective surgeries. We quantified volume declines, and subsequent recoveries, across all hospitals in Maryland. MATERIALS AND METHODS: Data on elective inpatient surgical volumes were assembled from the Maryland Health Service Cost Review Commission for years 2019-2020. The data covered all hospitals in the state. We compared the volume of elective inpatient surgeries in the second (Q2) and fourth quarters (Q4) of 2020 to those same quarters in 2019. Analysis was stratified by patient, hospital, and service characteristics. RESULTS: Surgical volumes were 55.8% lower in 2020 Q2 than in 2019 Q2. Differences were largest for orthopedic surgeries (74.3% decline), those on Medicare (61.4%), and in urban hospitals (57.3%). By 2020 Q4, volumes for most service lines were within 15% of volumes in 2019 Q4. Orthopedic surgery remained most affected (44.5% below levels in 2019 Q4) and Plastic Surgery (21.9% lower). CONCLUSIONS: COVID-19 led to large volume declines across hospitals in Maryland followed by a partial recovery. We observed large variability, particularly across service lines. These results can help contextualize case-specific experiences and inform research studying potential health effects of these delays and cancellations.

A Latent Class Approach to Modeling Trajectories of Health Care Cost in Pediatric Cystic Fibrosis.

Introduction. Estimating costs of medical care attributable to treatments over time is difficult due to costs that cannot be explained solely by observed risk factors. Unobserved risk factors cannot be accounted for using standard econometric techniques, potentially leading to imprecise prediction. The goal of this work is to describe methodology to account for latent variables in the prediction of longitudinal costs. Methods. Latent class growth mixture models (LCGMMs) predict class membership using observed risk factors and class-specific distributions of costs over time. Our motivating example models cost of care for children with cystic fibrosis from birth to age 17. We compare a generalized linear mixed model (GLMM) with LCGMMs. Both models use the same covariates and distribution to predict average costs by combinations of observed risk factors. We adopt a Bayesian estimation approach to both models and compare results using the deviance information criterion (DIC). Results. The 3-class LCGMM model has a lower DIC than the GLMM. The LCGMM latent classes include a low-cost group where costs increase slowly over time, a medium-cost group with initial higher costs than the low-cost group and with more rapidly increasing costs at older ages, and a high-cost group with a U-shaped trajectory. The risk profile-specific mixtures of classes are used to predict costs over time. The LCGMM model shows more delineation of costs by age by risk profile and with less uncertainty than the GLMM model. Conclusions. The LCGMM approach creates flexible prediction models when using longitudinal cost data. The Bayesian estimation approach to LCGMM presented fits well into cost-effectiveness modeling where the estimated trajectories and class membership can be used for prediction.

Evaluating the Cost-Effectiveness of Hydrogel Rectal Spacer in Prostate Cancer Radiation Therapy.

PURPOSE: A hydrogel rectal spacer (HRS) is a medical device that is approved by the U.S. Food and Drug Administration to increase the separation between the prostate and rectum. We conducted a cost-effectiveness analysis of HRS use for reduction in radiation therapy (RT) toxicities in patients with prostate cancer (PC) undergoing external beam RT (EBRT). METHODS AND MATERIALS: A multistate Markov model was constructed from the U.S. payer perspective to examine the cost-effectiveness of HRS in men with localized PC receiving EBRT (EBRT alone vs EBRT + HRS). The subgroups analyzed included site of HRS placement (hospital outpatient, physician office, ambulatory surgery center) and proportion of patients with good baseline erectile function (EF). Data on EF, gastrointestinal and genitourinary toxicities incidence, and potential risks associated with HRS implantation were obtained from a recently published randomized clinical trial. Health utilities and costs were derived from the literature and the 2018 Physician Fee Schedule and were discounted 3% annually. Quality-adjusted life years (QALYs) and costs were modeled for a 5-year period from receipt of RT. Probabilistic sensitivity analysis and value-based threshold analyses were conducted. RESULTS: The per-patient 5-year incremental cost for spacers administered in a hospital outpatient setting was $3578, and the incremental effectiveness was 0.0371 QALYs. The incremental cost-effectiveness ratio was $96,440/QALY for patients with PC undergoing HRS insertion in a hospital and $39,286/QALY for patients undergoing HRS insertion in an ambulatory facility. For men with good baseline EF, the incremental cost-effectiveness ratio was $35,548/QALY and $9627/QALY in hospital outpatient and ambulatory facility settings, respectively. CONCLUSIONS: Based on the current Medicare Physician Fee Schedule, HRS is cost-effective at a willingness to pay threshold of $100,000. These results contain substantial uncertainty, suggesting more evidence is needed to refine future decision-making.

Innovative assessment of inpatient and pulmonary drug costs for children with cystic fibrosis.

BACKGROUND: Previous estimates of the cost of care for pediatric Cystic fibrosis (CF) showed wide variation, without specific summary of pulmonary drug costs. METHODS: Enrolled CF children from the Wisconsin newborn screening trial were evaluated quarterly per protocol. Assessments systematically included all treatments, hospitalizations, and nutritional and pulmonary outcomes. Direct medical costs from hospital billing and medical records from 1989 to 2010 were used to describe costs by age-ranges and subgroups throughout follow-up. Outpatient drugs were separated by category (pulmonary/otherwise). Inpatient and drug costs were examined by clinical risk factors (presence of meconium ileus, pancreatic insufficiency, and expected severity of genetic mutations). RESULTS: Seventy-three children were followed for an average of 12.9 years with an average annual total cost of care of $24,768. Outpatient drug costs (53%) and hospitalizations (32%) represented the majority of costs. Drug costs were 48% for pulmonary indications and 52% for non-pulmonary. Pulmonary drug costs for children taking dornase were 54% of their drug costs while pulmonary drug costs were only 31% for children not taking dornase. Significant differences in frequency of inpatient stays existed for children with pancreatic insufficiency. Substantial differences in treatment costs exist as children age and by clinical risk factor. CONCLUSION: This study provides more accurate longitudinal estimates of CF care costs throughout childhood and shows that increasing age, pancreatic insufficiency, use of dornase, and hospitalizations are key determinants of cost. These estimates can be included in evaluations of the cost-effectiveness of new, highly expensive treatments being introduced for any CF population. Pediatr Pulmonol. 2016;51:1295-1303. © 2016 Wiley Periodicals, Inc.