Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis.

In 2020, the European Commission up-classified metal cobalt as Class 1B Carcinogen (presumed to have carcinogenic potential) based primarily on data from rodent inhalation carcinogenicity studies. This up-classification requires an assessment under the Medical Device Regulations of cobalt cancer risk from medical devices. We performed a systematic review and meta-analysis to evaluate site-specific cancer risks with cobalt exposure from either total joint replacement (TJR) or occupational exposure (OC). Results were stratified by exposure type (OC or TJR), exposure level (metal-on-metal (MoM) or non-MoM), follow-up duration (latency period: <5, 5-10 or >10 years), and cancer incidence or mortality (detection bias assessment). From 30 studies (653,104 subjects, average 14.5 years follow-up), the association between TJR/OC and cancer risk was null for 22 of 27 cancer sites, negative for 3 sites, and positive for prostate cancer and myeloma. Significant heterogeneity and large estimate ranges were observed for many cancer sites. No significant increase in estimates was observed by exposure level or follow-up duration. The current evidence, including weak associations, heterogeneity across studies and no increased association with exposure level or follow-up duration, is insufficient to conclude that there exists an increased risk for people exposed to cobalt in TJR/OC of developing site-specific cancers.

Demographic and clinical profile of patients treated with proximal femoral nails - a 10-year analysis of more than 40,000 Cases.

BACKGROUND: Hip fractures are common in elderly populations and can be life threatening. Changes in healthcare delivery and outcomes for patients with hip fracture treated with intramedullary nails are not well characterized. The objectives of our study were: 1) the characterization of patients treated with the Trochanteric Fixation Nail -Advanced™(TFNA) Proximal Femoral Nailing System or comparable nails (index) and estimate 12-month all-cause readmissions (ACR) and reoperations following index; and 2) the evaluation of 10-year healthcare utilization (HCU) trends for treatment of femoral fractures with femoral nails. METHODS: This is a retrospective database analysis using the Premier hospital database. All adults with femoral fracture treated with an intramedullary nail, from 2010 to Q3 2019, in the inpatient setting, were identified. Exclusion criteria included patients with bilateral hip surgery and presence of breakage at time of initial surgery. The primary outcome was ACR and reoperation, the secondary outcomes were healthcare utilization metrics. Variables included demographics, comorbidities (Elixhauser Index (EI)), surgical intervention variables and hospital characteristics. RESULTS: Forty-one thousand one hundred four patients were included in the study, of which 14,069 TFNA patients, with average age 77.9 (Standard deviation (SD): 12.0), more than 60% with 3 or more comorbidities (more than 64% for TFNA), 40% with severe or extreme disease severity and one third with severe or extreme risk for mortality. ACR reached 60.1% (95% confidence interval (CI): 59.6%-60.5%) - for TFNA: 60.0% (95%CI: 59.2%-60.8%). The reoperation rate was 4.0% (95%CI: 3.8%-4.2%) - for TFNA: 3.8% (95%CI: 3.5%-4.1%). Length of stay (LOS) averaged 5.8 days (SD: 4.8), and 12-month hip reoperation was 4.0% (3.8%-4.2%), in TFNA cohort: 3.8% (3.5%-4.1%). From 2010 to 2019: the percentage patients operated within 48 h of admission significantly increased, from 75.2% (95%CI: 74.3%-76.1%) to 84.3% (95%CI: 83.9%-84.6%); LOS significantly decreased, from 6.2 (95%CI: 6.0-6.4) to 5.6 (95%CI: 5.5-5.7) days; discharge to skilled nursing facilities (SNF) increased from 56.0% (95%CI: 54.8%-57.2%) to 61.5% (95%CI: 60.8%-62.2%); ACR rates decreased but reoperation rates remained constant. CONCLUSIONS: ACR and reoperation rates were similar across device types and averaged 60.1% and 4.0%, respectively. Ten-year analyses showed reductions in hospital HCU and greater reliance on SNF.

Incidence, costs and post-operative complications following ankle fracture - A US claims database analysis.

BACKGROUND: The epidemiology and payer costs for ankle fractures are not well documented. This study evaluated: (1) the incidence of ankle fracture and ankle surgery following fracture in the US population; and (2) the clinical presentation of patients presenting with ankle fractures requiring surgery, their complication rates, and payer costs. METHODS: Patients in the IBM® MarketScan® Commercial and Medicare Supplemental databases with an inpatient/outpatient diagnosis of ankle fracture from 2016 to 2019 were stratified by age group and gender, and rates of fracture per 10,000 enrollees were estimated. Surgically-treated patients between January 2016 - October 2021 were further analyzed. One-year post-surgical outcomes evaluated complication rates (e.g., infection, residual pain), reoperations, and 1-year payments. Standard descriptive statistics were calculated for all variables and outcomes. Generalized linear models were designed to estimate payments for surgical care and incremental payments associated with postoperative complications. RESULTS: Fracture cases affected 0.14% of the population; 23.4% of fractures required surgery. Pediatric and elderly patients were at increased risk. From 3 weeks to 12 months following index ankle surgery, 5.5% (5.3% - 5.7%) of commercially insured and 5.9% (5.1% - 6.8%) of Medicare patients required a new surgery. Infection was observed in 4.4% (4.2% - 4.6%) commercially insured and 9.8% (8.8% - 10.9%) Medicare patients, and residual pain 3 months post-surgery was observed in 29.5% (28.7% - 30.3%) commercially-insured and 39.3% (36.0% - 42.6%) Medicare patients. Commercial payments for index surgery ranged from $9,821 (95% CI: $9,697 - $9,945) in the ambulatory surgical center to $28,169 (95% CI: $27,780 - $28,559) in the hospital inpatient setting, and from $16,775 (95% CI: $16,668 - $16,882) in patients with closed fractures, to $41,206 (95% CI: $38,795 - $43,617) in patients with Gustilo III fractures. Incremental commercial payments for pain and infection averaged $5,200 (95% CI: $4,261 - $6,139) and $27,510 (95% CI: $21,759 - $33,261), respectively. CONCLUSION: Ankle fracture has a high incidence and complication rate. Residual pain affects more than one-third of all patients. Ankle fracture thus presents a significant societal impact in terms of patient outcomes and payer burden.

Hospitalization for computer-assisted hexapod ring fixation application - analyses of patient variability, peri-operative complications, hospital costs, and discharge status.

BACKGROUND: Computer-assisted hexapod ring fixation systems (HRF) are used for multiple conditions and in very diverse patient populations. This study analyzes perioperative outcomes following HRF application based on patient etiology and clinical presentation. METHODS: Data from patients in the Premier Hospital Billing Database between 2007-2019 undergoing HRF application were analyzed for the duration of patients' hospitalizations. Patients were grouped based on etiology: acquired deformity, arthrosis, congenital deformity, deep infection, infected nonunion, fracture, nonunion, and other post-operative complications. Demographics, comorbidities, operating room time (ORT), length of stay (LOS), peri-operative complications, and hospital costs were estimated using generalized linear models. Logistic regression evaluated factors associated with peri-operative complications. RESULTS: One thousand eight hundred eighteen patients (average age: 46.9, standard deviation (SD) (19.6) - 38.9% female) were included in the study, and included 72% fracture cases, 9.6% deep infection, 10.2% deformity (acquired: 5.9%, congenital: 4.3%), 4.2% nonunions, 2% arthrosis and 1.4% other sequelas from prior fractures. Comorbidities varied across diagnosis categories and age, 40% adults and 86% pediatric had no comorbidities. Pediatric cases mostly suffered from obesity (16.1%) and pulmonary disease (10.7%). Complicated diabetes was present in 45.9% of arthropathy and 34.3% of deep infection patients. ORT, LOS and inflation-adjusted hospital costs for all patients averaged 277.7 min (95% Confidence interval (CI): 265.1-290.3), 7.07 days (95% CI: 6.6-7.5) and $41,507 (95%CI: $39,728-$43,285), respectively, but were highest in patients with deep infection (ORT: 369 min (95%CI: $321.0-$433.8); LOS: 14.4 days (95%CI: $13.7-$15.1); Cost: $54,666 (95%CI: $47,960-$63,553)). The probability of having an intraoperative complication averaged 35% (95%CI: 28%-43%) in adult patients with deep infection vs 7% (95%CI: 2%-20%) in pediatric cases treated for congenital deformity. The risk for intraoperative complications was mostly associated with preexisting comorbidities, an Elixhauser > 5 was the most predictive risk factor for complications (odds ratios: 4.53 (95%CI: 1.71-12.00, p = 0.002). CONCLUSIONS: There is important heterogeneity among HRF patients. Adults with HRF for fracture, deep infection and arthrosis are at far greater risk for peri-operative complications vs. patients with deformity, especially pediatric deformity cases, mostly due to existing comorbidities and age. Device-specific HRF clinical studies cannot be generalized beyond their exact patient population.

Two-year clinical and economic burden, risk and outcomes following application of software-assisted hexapod ring fixation systems.

BACKGROUND: Multiplanar external fixation systems that employ software-assisted deformity correction consist of rings connected by angled struts, defined as hexapod ring fixators (HRF). Costs and outcomes associated with the application of HRFs are not well documented. This study was designed to provide a nationwide baseline understanding of the clinical presentation, risks, outcomes and payer costs, and healthcare resource utilization (HCU) of patients requiring application of an HRF, from the day of, and up to 2 years, post-application. METHODS: Patients with HRF application ("index") between 2007 and 2019 within the IBM Marketscan® Commercial Claims database were identified and categorized based on diagnosis: acquired deformity, arthropathy, congenital deformity, deep infection, nonunion, fracture, and other post-operative fracture sequelae. Demographics, comorbidities at index, complications post-index, HCU, and payments were analyzed. Payments were estimated using a generalized linear model and were adjusted for inflation to the 2020 consumer price index. Rates of deep infection and amputation were estimated up to 2 years post-index using Poisson regressions, and risk factors for each were estimated using logistic regression models. RESULTS: Six hundred ninety-five patients were included in our study (including 219 fractures, 168 congenital deformities, 68 deep infections, 103 acquired deformities). Comorbidities at index were significantly different across groups: less than 2% pediatrics vs 18% adults had 3 or more comorbidities, < 1% pediatric vs 29% adults had diabetes. Index payments ranged from $39,250-$75,350, with 12-months post-index payments ranging from $14,350 to $43,108. The duration of the HRF application ranged from 96 days to 174 days. Amputation was observed in patients with deep infection (8.9, 95% confidence interval (CI): 3.2-23.9%), nonunion (5.0, 95%CI: 1.6-15.4%) or fracture (2.7, 95%CI: 0.9-7.6%) at index. Complicated diabetes was the main predictor for deep infection (odds ratio (OR): 5.14, 95%CI: 2.50-10.54) and amputation (OR: 5.26, 95%CI: 1.79-15.51). CONCLUSIONS: Findings from this longitudinal analysis demonstrate the significant heterogeneity in patients treated with HRF, and the wide range in treatment intensity, payments, and outcomes. Risks for deep infection and amputation were primarily linked to the presence of complicated diabetes at the time of HRF application, suggesting a need for careful management of comorbid chronic conditions in patients requiring HRF for orthopedic care.

Surgical treatment, complications, reoperations, and healthcare costs among patients with clavicle fracture in England.

INTRODUCTION: The clinical and economic burden of clavicle fractures in England is not well documented. This study evaluated rates of surgical treatment, post-surgical complications, reoperations and costs in patients with clavicle fractures using the Clinical Practice Research Datalink (CPRD) database. METHODS: CPRD data were linked to National Health Service Hospital Episode Statistics data. Patients with a diagnosis of clavicle fracture between 2010-2018 were selected in CPRD (date of fracture = index date). Of those, patients with surgical intervention within 180 days from index fracture were identified. Rates of post-surgical complications (i.e., infection, non-union, and mal-union), reoperations (for device removal or for postoperative complications), post-operative costs and median time to reoperations were evaluated up to 2 years after surgery. RESULTS: 21,340 patients with clavicle fractures were identified (mean age 35.0 years(standard deviation (SD): 26.5), 66.7% male). Surgery was performed on 672 patients (3.2% of total cohort) at an average 17.1 (SD: 25.2) days post-fracture. Complications (i.e., infection, non-union, or malunion) affected 8.1% of surgically treated clavicle fracture patients; the rate of infection was 3.5% (95% CI, 1.7%- 5.2%), non-union 4.4% (95% CI, 2.4%-6.5%), and mal-union 0.3% (95% CI, 0%-0.7%). Adjusting for age, gender, comorbidities and time to surgery, the all-cause reoperation rate was 20.2% (13.2%-30.0%) and the adjusted rate of reoperation for implant removal was 17.0% (10.7%-25.9%)-84% of all-cause reoperations were thus performed for implant removal. Median time to implant removal was 254 days. The mean cost of reoperations for all causes was £5,000. The most expensive reoperations were for cases that involved infection (mean £6,156). CONCLUSIONS: Complication rates following surgical clavicle fracture care averaged 8.1%. However, reoperation rates exceed 20%, the vast majority of reoperations being performed for device removal. Technologies to alleviate secondary device removal surgeries would address a significant clinical unmet need.

Carcinogenic assessment of cobalt-containing alloys in medical devices or cobalt in occupational settings: A systematic review and meta-analysis of overall cancer risk from published epidemiologic studies.

In 2020, the European Commission up-classified pure cobalt metal to a Category 1B hazard, based primarily on data from rodent inhalation carcinogenicity studies of metallic cobalt. The European Commission review did not evaluate cobalt-containing alloys in medical devices, which have very different properties vs. pure cobalt metal and did not include a systematic epidemiologic review. We performed a systematic review and meta-analysis of published, peer-reviewed epidemiologic studies evaluating the association between overall cancer risk and exposure to orthopedic implants containing cobalt alloys or cobalt particulates in occupational settings. Study-specific estimates were pooled using random-effects models. Analyses included 20 papers on orthopedic implants and 10 occupational cohort papers (~1 million individuals). The meta-analysis summary estimates (95% confidence intervals) for overall cancer risk were 1.00 (0.96-1.04) overall and 0.97 (0.94-1.00) among high-quality studies. Results were also similar in analyses stratified by type of exposure/data sources (occupational cohort, implant registry or database), comparators (general or implant population), cancer incidence or mortality, follow-up duration (latency period), and study precision. In conclusion, meta-analysis found no association between exposure to orthopedic implants containing cobalt alloys or cobalt particulates in occupational settings and overall cancer risk, including an analysis of studies directly comparing metal-on-metal vs. non-metal-on-metal implants.

Assessment of the Risk and Economic Burden of Surgical Site Infection Following Colorectal Surgery Using a US Longitudinal Database: Is There a Role for Innovative Antimicrobial Wound Closure Technology to Reduce the Risk of Infection?

BACKGROUND: Colorectal surgical procedures place substantial burden on health care systems because of the high complication risk, of surgical site infections in particular. The risk of surgical site infection after colorectal surgery is one of the highest of any surgical specialty. OBJECTIVE: The purpose of this study was to determine the incidence, cost of infections after colorectal surgery, and potential economic benefit of using antimicrobial wound closure to improve patient outcomes. DESIGN: Retrospective observational cohort analysis and probabilistic cost analysis were performed. SETTINGS: The analysis utilized a database for colorectal patients in the United States between 2014 and 2018. PATIENTS: A total of 107,665 patients who underwent colorectal surgery were included in the analysis. MAIN OUTCOME MEASURES: Rate of infection was together with identified between 3 and 180 days postoperatively, infection risk factors, infection costs over 24 months postoperatively by payer type (commercial payers and Medicare), and potential costs avoided per patient by using an evidence-based innovative wound closure technology. RESULTS: Surgical site infections were diagnosed postoperatively in 23.9% of patients (4.0% superficial incisional and 19.9% deep incisional/organ space). Risk factors significantly increased risk of deep incisional/organ-space infection and included several patient comorbidities, age, payer type, and admission type. After 12 months, adjusted increased costs associated with infections ranged from $36,429 to $144,809 for commercial payers and $17,551 to $102,280 for Medicare, depending on surgical site infection type. Adjusted incremental costs continued to increase over a 24-month study period for both payers. Use of antimicrobial wound closure for colorectal surgery is projected to significantly reduce median payer costs by $809 to $1170 per patient compared with traditional wound closure. LIMITATIONS: The inherent biases associated with retrospective databases limited this study. CONCLUSIONS: Surgical site infection cost burden was found to be higher than previously reported, with payer costs escalating over a 24-month postoperative period. Cost analysis results for adopting antimicrobial wound closure aligns with previous evidence-based studies, suggesting a fiscal benefit for its use as a component of a comprehensive evidence-based surgical care bundle for reducing the risk of infection. See Video Abstract at http://links.lww.com/DCR/B358. EVALUACIÓN DEL RIESGO Y LA CARGA ECONÓMICA DE LA INFECCIÓN DEL SITIO QUIRÚRGICO DESPUÉS DE UNA CIRUGÍA COLORRECTAL UTILIZANDO UNA BASE DE DATOS LONGITUDINAL DE EE.UU.: ¿EXISTE UN PAPEL PARA LA TECNOLOGÍA INNOVADORA DE CIERRE DE HERIDAS ANTIMICROBIANAS PARA REDUCIR EL RIESGO DE INFECCIÓN?: Los procedimientos quirúrgicos colorrectales suponen una carga considerable para los sistemas de salud debido al alto riesgo de complicaciones, particularmente las infecciones del sitio quirúrgico. El riesgo de infección posoperatoria del sitio quirúrgico colorrectal es uno de los más altos de cualquier especialidad quirúrgica.El propósito de este estudio fue determinar la incidencia, el costo de las infecciones después de la cirugía colorrectal y el beneficio económico potencial del uso del cierre de la herida con antimicrobianos para mejorar los resultados de los pacientes.Análisis retrospectivo de cohorte observacional y análisis de costo probabilístico.El análisis utilizó la base de datos para pacientes colorrectales en los Estados Unidos entre 2014 y 2018.Un total de 107,665 pacientes sometidos a cirugía colorrectal.Se identificó una tasa de infección entre 3 y 180 días después de la operación, los factores de riesgo de infección, los costos de infección durante 24 meses posteriores a la operación por tipo de pagador (pagadores comerciales y Medicare), y los costos potenciales evitados por paciente utilizando una tecnología innovadora de cierre de heridas basada en evidencias.Infecciones del sitio quirúrgico, diagnosticadas postoperatoriamente en el 23,9% de los pacientes (4,0% incisional superficial y 19,9% incisional profunda / espacio orgánico). Los factores de riesgo aumentaron significativamente el riesgo de infección profunda por incisión / espacio orgánico e incluyeron comorbilidades selectivas del paciente, edad, tipo de pagador y tipo de admisión. Después de 12 meses, el aumento de los costos asociados con las infecciones varió de $ 36,429 a $ 144,809 para los pagadores comerciales y de $ 17,551 a $ 102,280 para Medicare, según el tipo de infección del sitio quirúrgico. Los costos incrementales ajustados continuaron aumentando durante un período de estudio de 24 meses para ambos pagadores. Se prevé que el uso del cierre antimicrobiano de la herida para la cirugía colorrectal reducirá significativamente los costos medios del pagador en $ 809- $ 1,170 por paciente en comparación con el cierre tradicional de la herida.Los sesgos inherentes asociados a las bases de datos retrospectivas limitaron este estudio.Se encontró que la carga del costo de la infección del sitio quirúrgico es mayor que la reportada previamente, y los costos del pagador aumentaron durante un período postoperatorio de 24 meses. Los resultados del análisis de costos para la adopción del cierre de heridas antimicrobianas se alinean con estudios previos basados en evidencia, lo que sugiere un beneficio fiscal para su uso como componente de un paquete integral de atención quirúrgica basada en evidencia para reducir el riesgo de infección. Consulte Video Resumen en http://links.lww.com/DCR/B358.

Cost and effectiveness of prescribing emollient therapy for atopic eczema in UK primary care in children and adults: a large retrospective analysis of the Clinical Practice Research Datalink.

BACKGROUND: The Clinical Practice Research Datalink (CPRD) was used to evaluate the overall costs to the National Health Service, including healthcare utilisation, of prescribing emollients in UK primary care for dry skin and atopic eczema (DS&E). METHODS: Primary care patients in the UK were identified using the CPRD and their records were interrogated for the 2 years following first diagnosis of DS&E. Data from patients with (n = 45,218) and without emollient prescriptions (n = 9780) were evaluated. Multivariate regression models were used to compare healthcare utilisation and cost in the two matched groups (age, sex, diagnosis). Two sub-analyses of the Emollient group were performed between matched groups receiving (1) a colloidal oatmeal emollient (Aveeno-First) versus non-colloidal oatmeal emollients (Aveeno-Never) and (2) Aveeno prescribed first-line (Aveeno-First) versus prescribed Aveeno later (Aveeno-Subsequently). Logistic regression models calculated the odds of prescription with either potent / very potent topical corticosteroids (TCS) or skin-related antimicrobials. RESULTS: Costs per patient were £125.80 in Emollient (n = 7846) versus £128.13 in Non-Emollient (n = 7846) matched groups (p = 0.08). The Emollient group had fewer visits/patient (2.44 vs. 2.66; p < 0.0001) and lower mean per-visit costs (£104.15 vs. £113.25; p < 0.0001), compared with the Non-Emollient group. Non-Emollient patients had 18% greater odds of being prescribed TCS and 13% greater odds of being prescribed an antimicrobial than Emollient patients. In the Aveeno-First (n = 1943) versus Aveeno-Never (n = 1943) sub-analysis, costs per patient were lower in the Aveeno-First compared with the Aveeno-Never groups (£133.46 vs. £141.11; p = 0.0069). The Aveeno-Never group had ≥21% greater odds of being prescribed TCS or antimicrobial than the Aveeno-First group. In the Aveeno-First (n = 1357) versus Aveeno-Subsequently (n = 1357) sub-analysis, total costs were lower in the Aveeno-First group (£140.35 vs. £206.43; p < 0.001). Patients in the Aveeno-Subsequently group had 91% greater odds of being prescribed TCS and 75% greater odds of being prescribed an antimicrobial than the Aveeno-First group. CONCLUSIONS: Acknowledging limitations from unknown disease severity in the CRPD, the prescription of emollients to treat DS&E was associated with fewer primary care visits, reduced healthcare utilisation and reduced cost. Prescribing emollients, especially those containing colloidal oatmeal, was associated with fewer TCS and antimicrobial prescriptions. TRIAL REGISTRATION: The study is registered at http://isrctn.com/ISRCTN91126037 .

Persistent racial disparities in postoperative management after tibia fracture fixation: A matched analysis of US medicaid beneficiaries.

INTRODUCTION: Racial and ethnic disparities in orthopaedic surgery are well documented. However, the extent to which these persist in fracture care is unknown. This study sought to assess racial disparities in the postoperative surgical and medical management of patients after diaphyseal tibia fracture fixation. METHODS: Patients with surgically treated tibial shaft fractures from October 1, 2015, to December 31, 2020, were identified in the MarketScan® Medicaid Database. Exclusion criteria included concurrent fractures or amputation. Outcomes included 2-year postoperative complications, reoperation rates, and filled prescriptions. Surgically-treated Black and White cohorts were propensity-score matched using nearest-neighbor matching on patient demographics, comorbidities, fracture pattern and severity, and fixation type. Chi-square tests and survival analyses (Kaplan-Meier and Cox proportional hazard models) were conducted. RESULTS: 5,472 patients were included, 2,209 Black and 3,263 White patients. After matching, 2,209 were retained in each cohort. No significant differences in complication rates were observed in the matched Black vs White cohorts. Rates of reoperation, however, were significantly lower in Black as compared to White patients (28.5 % vs. 35.5 % rate, risk difference = 7.0 % (95 % confidence interval (CI): 4.2 % to 9.7 %)). Implant removal was also significantly lower in Black (17.9 %) vs. White (25.1 %) patients (Risk difference = 7.2 %, (95 %CI: 4.8 % to 9.6 %)). The adjusted hazard ratio comparing the reoperation rate in Black versus White patients was 0.77 (95 %CI: 0.69-0.82, p < 0.0001). Significantly lower proportions of Black vs White patients filled at least one prescription for benzodiazepine, antidepressants, strong opiates, or antibiotics at every time point post-index. DISCUSSION: Fewer resources were used in post-operative management after surgical treatment of tibial shaft fractures for Black versus White Medicaid-insured patients. These results may be reflective of the undertreatment of complications after tibia fracture surgery for Black patients and highlight the need for further interventions to address racial disparities in trauma care.

Machine Learning Methods Using Artificial Intelligence Deployed on Electronic Health Record Data for Identification and Referral of At-Risk Patients From Primary Care Physicians to Eye Care Specialists: Retrospective, Case-Controlled Study.

BACKGROUND: Identification and referral of at-risk patients from primary care practitioners (PCPs) to eye care professionals remain a challenge. Approximately 1.9 million Americans suffer from vision loss as a result of undiagnosed or untreated ophthalmic conditions. In ophthalmology, artificial intelligence (AI) is used to predict glaucoma progression, recognize diabetic retinopathy (DR), and classify ocular tumors; however, AI has not yet been used to triage primary care patients for ophthalmology referral. OBJECTIVE: This study aimed to build and compare machine learning (ML) methods, applicable to electronic health records (EHRs) of PCPs, capable of triaging patients for referral to eye care specialists. METHODS: Accessing the Optum deidentified EHR data set, 743,039 patients with 5 leading vision conditions (age-related macular degeneration [AMD], visually significant cataract, DR, glaucoma, or ocular surface disease [OSD]) were exact-matched on age and gender to 743,039 controls without eye conditions. Between 142 and 182 non-ophthalmic parameters per patient were input into 5 ML methods: generalized linear model, L1-regularized logistic regression, random forest, Extreme Gradient Boosting (XGBoost), and J48 decision tree. Model performance was compared for each pathology to select the most predictive algorithm. The area under the curve (AUC) was assessed for all algorithms for each outcome. RESULTS: XGBoost demonstrated the best performance, showing, respectively, a prediction accuracy and an AUC of 78.6% (95% CI 78.3%-78.9%) and 0.878 for visually significant cataract, 77.4% (95% CI 76.7%-78.1%) and 0.858 for exudative AMD, 79.2% (95% CI 78.8%-79.6%) and 0.879 for nonexudative AMD, 72.2% (95% CI 69.9%-74.5%) and 0.803 for OSD requiring medication, 70.8% (95% CI 70.5%-71.1%) and 0.785 for glaucoma, 85.0% (95% CI 84.2%-85.8%) and 0.924 for type 1 nonproliferative diabetic retinopathy (NPDR), 82.2% (95% CI 80.4%-84.0%) and 0.911 for type 1 proliferative diabetic retinopathy (PDR), 81.3% (95% CI 81.0%-81.6%) and 0.891 for type 2 NPDR, and 82.1% (95% CI 81.3%-82.9%) and 0.900 for type 2 PDR. CONCLUSIONS: The 5 ML methods deployed were able to successfully identify patients with elevated odds ratios (ORs), thus capable of patient triage, for ocular pathology ranging from 2.4 (95% CI 2.4-2.5) for glaucoma to 5.7 (95% CI 5.0-6.4) for type 1 NPDR, with an average OR of 3.9. The application of these models could enable PCPs to better identify and triage patients at risk for treatable ophthalmic pathology. Early identification of patients with unrecognized sight-threatening conditions may lead to earlier treatment and a reduced economic burden. More importantly, such triage may improve patients' lives.

Insurer costs of COVID-19 by disease severity and duration.

OBJECTIVES: To analyze US commercial insurance payments associated with COVID-19 as a function of severity and duration of disease. STUDY DESIGN: Retrospective database analysis. METHODS: Patients with COVID-19 between April 1, 2020, and June 30, 2021, in the Merative MarketScan Commercial database were identified and stratified as having asymptomatic, mild, moderate (with and without lower respiratory disease), or severe/critical (S/C) disease based on the severity of the acute COVID-19 infection. Duration of disease (DOD) was estimated for all patients. Patients with DOD longer than 12 weeks were defined as having post-COVID-19 condition (PCC). Outcomes were all-cause payments (ACP) and disease-specific payments (DSP) for the entire DOD. Variables included demographic and comorbidities at the time of acute disease. Adjusted payments by disease severity were estimated using generalized linear models (γ distribution with log link). RESULTS: A total of 738,339 patients were included (374,401 asymptomatic, 156,220 mild, 180,213 moderate, and 27,505 S/C cases). DSP increased from $217 (95% CI, $214-221) for asymptomatic cases to $2744 (95% CI, $2678-$2811) for moderate cases with lower respiratory disease and $28,250 (95% CI, $26,963-$29,538) for S/C cases. ACP increased from $505 (95% CI, $497-$512) for asymptomatic cases to $46,538 (95% CI, $44,096-$48,979) for S/C cases. The DSP and ACP further increased by $50,736 (95% CI, $45,337-$56,136) and $94,839 (95% CI, $88,029-$101,649), respectively, in S/C cases with PCC vs a DOD of fewer than 4 weeks. CONCLUSIONS: COVID-19 payments for S/C cases were more than 10-fold greater than those of moderate cases and further increased by nearly $95,000 in S/C cases with PCC vs a DOD of fewer than 4 weeks.

Nail fixation of unstable trochanteric fractures with or without cement augmentation: A cost-utility analysis in the United States: Cost-utility of cement augmentation.

OBJECTIVES: Recent clinical studies have shown favorable outcomes for cement augmentation for fixation of trochanteric fracture. We assessed the cost-utility of cement augmentation for fixation of closed unstable trochanteric fractures from the US payer's perspective. METHODS: The cost-utility model comprised a decision tree to simulate clinical events over 1 year after the index fixation surgery, and a Markov model to extrapolate clinical events over patients' lifetime, using a cohort of 1,000 patients with demographic and clinical characteristics similar to that of a published randomized controlled trial (age ≥75 years, 83 % female). Model outputs were discounted costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) over a lifetime. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of parameter uncertainty on results. RESULTS: Fixation with augmentation reduced per-patient costs by $754.8 and had similar per-patient QALYs, compared to fixation without augmentation, resulting in an ICER of -$130,765/QALY. The ICER was most sensitive to the utility of revision surgery, mortality risk ratio after the second revision surgery, mortality risk ratio after successful index surgery, and mortality rate in the decision tree model. The probability that fixation with augmentation was cost-effective compared with no augmentation was 63.4 %, 58.2 %, and 56.4 %, given a maximum acceptable ceiling ratio of $50,000, $100,000, and $150,000 per QALY gained, respectively. CONCLUSION: Fixation with cement augmentation was the dominant strategy, driven mainly by reduced costs. These results may support surgeons in evidence-based clinical decision making and may be informative for policy makers regarding coverage and reimbursement.

Real-world 2-year clinical and economic outcomes among patients receiving a medial collared, triple tapered primary hip system versus other implants for total hip arthroplasty.

OBJECTIVE: To evaluate real-world outcomes of patients receiving ACTIS, a medial collared, triple-tapered (MCTT) hip system vs. other implants, for primary total hip arthroplasty (THA). METHODS: Patients with THA between 2016-2021 from Mercy Healthcare Systems-Orthopedics Database were evaluated. The primary outcome was the 2-year revision. Secondary outcomes included operating room (OR) time, length of stay (LOS), and discharge disposition. Fine Stratification and Weighting (FSW) controlled for baseline characteristic differences between ACTIS and other implant groups. Cox proportional regression evaluated the hazard ratio (HR) for revision. RESULTS: Among 9,225 patients with 10,205 THAs (mean [SD] age 66.8 [11.3] years, 56.0% female), MCTT was implanted in 1,591 hips and other implants in 8,614 hips. The balanced cohort included all 10,205 procedures (54.2% female; age 65.5 [11.3]; 14.1% Elixhauser index ≥5; 84.5% MCTT, 82.2% other since 2018; obesity 43.6% MCTT, 43.0% other). Two-year revision was 0.9% for MCTT and 1.8% for other implants (p = .021). HR for revision MCTT vs. other was 0.53 (95% CI 0.30-0.92; p = .023). Mean (SD) OR time was 69.07 (18.93) minutes for MCTT, 83.69 (43.88) for other implants (p < .001). LOS was 1.99 (1.15) days for MCTT, 2.45 (2.91) for other implants (p < .001). MCTT patients were more likely to be discharged home (90.7% vs 33.8%, p < .001) and less likely to be discharged to skilled nursing facilities (SNF) (4.2% vs 9.6%, p < .001). One-year cost savings per patient with MCTT was projected at $2,342. CONCLUSIONS: MCTT patients had fewer revisions, reduced OR time, shorter LOS, more home and less SNF discharge, leading to cost savings.

Total knee arthroplasty in the outpatient vs inpatient settings: impact of site of care on early postoperative economic and clinical outcomes.

BACKGROUND: The incidence of total knee arthroplasty (TKA) surgery performed in the outpatient setting has increased as a result of improved perioperative recovery protocols, bundled payments, and challenges brought by the coronavirus disease of 2019 (COVID-19) pandemic on health systems. This study evaluates early postoperative clinical and economic outcomes of patients treated in the inpatient vs outpatient setting using the Attune Knee System (AKS). METHODS: Patients with an elective, primary TKA implanted with the AKS, from Q4 2015 to Q1 2021, were identified within the Premier Healthcare Database. The index was defined as the admission date for inpatient cases and the service day for outpatient procedures. Inpatient and outpatient cases were matched on patient characteristics. Outcomes included 90-day all-cause readmissions, 90-day knee reoperations, and index- and 90-day costs of care. Generalized linear models were used to evaluate outcomes (Reoperation: binomial distribution; costs: Gamma distribution with log link). RESULTS: Before matching, 39,337 inpatient and 9,365 outpatient cases were identified, with greater comorbidities in the inpatient cohort. The outpatient cohort had a lower average Elixhauser Index (EI) compared to the inpatient cohort (1.94 (standard deviation (SD): 1.46) vs 2.17 (SD: 1.53), p < 0.001), and the rates for each individual comorbidities were also slightly lower in the outpatient compared to the inpatient cohorts. Post-match, 9,060 patients were retained in each cohort [mean age: ~ 67, EI = 1.9 (SD: 1.5), 40% male]. Post-match comorbidity rates were similar between inpatient and outpatient cohorts (outpatient EI: 1.94 (SD: 1.44)-inpatient EI: 1.96 (SD: 1.45), p = 0.3516): in both, 54.1% of patients had an EI between 1 and 2, and 5.1% had an EI ≥ 5. No differences were observed in 3-month reoperation rates (0.6% in outpatient, 0.7% in inpatient cohort). Index and post-index 90-day costs were lower in the outpatient vs inpatient cases [(savings for index-only costs: $2,295 (95% CI: $1,977-$2,614); 90 days post-index knee-related care only: $2,540 (95% CI: $2,205-$2,876); 90 days post-index all-cause care: $2,679 (95% CI: $2,322-$3,036)]. CONCLUSIONS: Compared to matched inpatient cases, outpatient TKA cases treated with AKS showed similar 90-day outcomes, at lower cost.

Risk factors and healthcare costs associated with long bone fracture non-union: a retrospective US claims database analysis.

BACKGROUND: Few contemporary US-based long bone non-union analyses have recently been published. Our study was designed to provide a current understanding of non-union risks and costs, from the payers' perspective. METHODS: The Merative™ MarketScan® Commercial Claims and Encounters database was used. Patients with surgically treated long bone (femur, tibia, or humerus) fractures in the inpatient setting, from Q4 2015 to most recent, were identified. Exclusion criteria included polytrauma and amputation at index. The primary outcome was a diagnosis of non-union in the 12 and 24 months post-index. Additional outcomes included concurrent infection, reoperation, and total healthcare costs. Age, gender, comorbidities, fracture characteristics, and severity were identified for all patients. Descriptive analyses were performed. Crude and adjusted rates of non-union (using Poisson regressions with log link) were calculated. Marginal incremental cost of care associated with non-union and infected non-union and reoperation were estimated using a generalized linear model with log link and gamma distribution. RESULTS: A total of 12,770, 13,504, and 4,805 patients with femoral, tibial, or humeral surgically treated fractures were identified, 74-89% were displaced, and 18-27% were comminuted. Two-year rates of non-union reached 8.5% (8.0%-9.1%), 9.1% (8.6%-9.7%), and 7.2% (6.4%-8.1%) in the femoral, tibial, and humeral fracture cohorts, respectively. Shaft fractures were at increased risk of non-union versus fractures in other sites (risk ratio (RR) in shaft fractures of the femur: 2.36 (1.81-3.04); tibia: 1.95 (1.47-2.57); humerus: 2.02 (1.42-2.87)). Fractures with severe soft tissue trauma (open vs. closed, Gustilo III vs. Gustilo I-II) were also at increased risk for non-union (RR for Gustilo III fracture (vs. closed) for femur: R = 1.96 (1.45-2.58), for tibia: 3.33 (2.85-3.87), RR for open (vs. closed) for humerus: 1.74 (1.30-2.32)). For all fractures, younger patients had a reduced risk of non-union compared to older patients. For tibial fractures, increasing comorbidity (Elixhauser Index 5 or greater) was associated with an increased risk of non-union. The two-year marginal cost of non-union ranged from $33K-$45K. Non-union reoperation added $16K-$34K in incremental costs. Concurrent infection further increased costs by $46K-$86K. CONCLUSIONS: Non-union affects 7-10% of surgically treated long bone fracture cases. Shaft and complex fractures were at increased risk for non-union.

Racial and Health Insurance Differences in Patient Outcomes After Surgical Treatment for Cauda Equina Syndrome: A United States Retrospective Hospital Claims Database Analysis.

STUDY DESIGN: Retrospective database evaluation. OBJECTIVES: To study the association between race, health care insurance, mortality, postoperative visits, and reoperation within a hospital setting in patients with cauda equina syndrome (CES) undergoing surgical intervention. SUMMARY OF BACKGROUND DATA: CES can lead to permanent neurological deficits if the diagnosis is missed or delayed. Evidence of racial or insurance disparities in CES is sparse. MATERIALS AND METHODS: Patients with CES undergoing surgery from 2000 to 2021 were identified from the Premier Health care Database. Six-month postoperative visits and 12-month reoperations within the hospital were compared by race ( i.e ., White, Black, or Other [Asian, Hispanic, or other]) and insurance ( i.e. , Commercial, Medicaid, Medicare, or Other) using Cox proportional hazard regressions; covariates were used in the regression models to control for confounding. Likelihood ratio tests were used to compare model fit. RESULTS: Among 25,024 patients, most were White (76.3%), followed by Other race (15.4% [ 8.8% Asian, 7.3% Hispanic, and 83.9% other]) and Black (8.3%). Models with race and insurance combined provided the best fit for estimating the risk of visits to any setting of care and reoperations. White Medicaid patients had the strongest association with a higher risk of 6-month visits to any setting of care versus White patients with commercial insurance (HR: 1.36 (1.26,1.47)). Being Black with Medicare had a strong association with a higher risk of 12-month reoperations versus White commercial patients (HR: 1.43 (1.10,1.85)). Having Medicaid versus Commercial insurance was strongly associated with a higher risk of complication-related (HR: 1.36 (1.21, 1.52)) and ER visits (HR: 2.26 (2.02,2.51)). Medicaid had a significantly higher risk of mortality compared with Commercial patients (HR: 3.19 (1.41,7.20)). CONCLUSIONS: Visits to any setting of care, complication-related, ER visits, reoperation, or mortality within the hospital setting after CES surgical treatment varied by race and insurance. Insurance type had a stronger association with the outcomes than race. LEVEL OF EVIDENCE: Level-III.

Risk and economic burden of surgical site infection following spinal fusion in adults.

BACKGROUND: Spinal fusion surgery (SFS) is one of the most common operations in the United States, >450,000 SFSs are performed annually, incurring annual costs >$10 billion. OBJECTIVES: We used a nationwide longitudinal database to accurately assess incidence and payments associated with management of postoperative infection following SFS. METHODS: We conducted a retrospective, observational cohort analysis of 210,019 patients undergoing SFS from 2014 to 2018 using IBM MarketScan commercial and Medicaid-Medicare databases. We assessed rates of superficial/deep incisional SSIs, from 3 to 180 days after surgery using Cox proportional hazard regression models. To evaluate adjusted payments for patients with/without SSIs, adjusted for inflation to 2019 Consumer Price Index, we used generalized linear regression models with log-link and γ distribution. RESULTS: Overall, 6.6% of patients experienced an SSI, 1.7% superficial SSIs and 4.9% deep-incisional SSIs, with a median of 44 days to presentation for superficial SSIs and 28 days for deep-incisional SSIs. Selective risk factors included surgical approach, admission type, payer, and higher comorbidity score. Postoperative incremental commercial payments for patients with superficial SSI were $20,800 at 6 months, $26,937 at 12 months, and $32,821 at 24 months; incremental payments for patients with deep-incisional SSI were $59,766 at 6 months, $74,875 at 12 months, and $93,741 at 24 months. Corresponding incremental Medicare payments for patients with superficial incisional at 6, 12, 24-months were $11,044, $17,967, and $24,096; while payments for patients with deep-infection were: $48,662, $53,757, and $73,803 at 6, 12, 24-months. CONCLUSIONS: We identified a 4.9% rate of deep infection following SFS, with substantial payer burden. The findings suggest that the implementation of robust evidence-based surgical-care bundles to mitigate postoperative SFS infection is warranted.

Readmission rate and healthcare utilization outcomes of computer-assisted fluoroscopy-based hip navigation versus manual total hip arthroplasty.

INTRODUCTION: The study evaluates the technology of fluoroscopy-based hip navigation that has shown to improve implant positioning in total hip arthroplasty (THA). METHODS: Premier Healthcare data for patients undergoing manual THA or fluoroscopy-based hip navigation THA between 1 January 2016-30 September 2021, were analyzed 90- and 365-day post-THA. The primary outcome was inpatient readmission. Secondary outcomes were operating room (OR) time, length of stay, discharge status, and hospital costs. Baseline covariate differences were balanced using fine stratification and analyzed using generalized linear models. RESULTS: Among 4,080 fluoroscopy-based hip navigation THA and 429,533 manual THA balanced patients, hip-related readmission rates were statistically significantly lower for the fluoroscopy-based hip navigation THA cohort vs. manual THA for both 90-day (odd ratio [95% CI]: 0.69 [0.52 to 0.91] and 365-day (0.63 [0.49 to 0.81] follow-up. OR time was higher with fluoroscopy-based hip navigation THA vs. manual THA (134.65 vs. 132.04 minutes); however, fluoroscopy-based hip navigation THA patients were more likely to be discharged to home (93.73% vs. 90.11%) vs. manual THA. Hospital costs were not different between cohorts at 90- and 365-day post-operative. CONCLUSIONS: Fluoroscopy-based hip navigation THA resulted in fewer readmissions, greater discharge to home, and similar hospital costs compared to manual THA.

Computer-assisted solutions are becoming more ubiquitous in surgical procedures. However, most of the current research is limited to small sample size and limited economic endpoints. The current study utilizes hospital billing data and fine stratification methodology to address the issue around sample size and covariate balancing. Hospital billing data provide a large sample across the US along with hospital costs that can be broken into different categories. Fine stratification methodology allows for covariate balancing while keeping all the samples. It is particularly advantageous when the treated or exposed group represents less than 5% of the entire cohort for a given study, as was observed in this study. Covariate balancing was done on patient, provider (hospital) and surgeon characteristics to minimize confounding. Furthermore, a generalized linear model was utilized to minimize any residual confounding. The study evaluated both short term (3-month) and long term (1-year) outcomes. Study suggested clinical benefits in using computer-assisted fluoroscopy-based hip navigation system in THA compared to manual THA as well as showed cost parity between computer-assisted fluoroscopy-based hip navigation system in THA and manual THA.