Large Administrative Database Research Articles

Epidemiology and Treatment of Patients With Primary Open Angle Glaucoma in Germany: A Health Claims Data Analysis.

Based on a large administrative database of German claims data, our study provides current estimates of the prevalence and incidence of primary open-angle glaucoma (POAG) in Germany and describes selected outcomes for prevalent POAG patients. To estimate the prevalence and incidence of POAG in Germany, to describe the patient population in terms of comorbidity burden, routine care, and overall healthcare resource utilization (HCRU) and associated costs, and to describe treatment patterns over time in patients undergoing relevant laser procedures. Based on anonymized German claims data, we carried out a retrospective, non-interventional study covering calendar years 2016 to 2021. For the adult German population (≥18y), we estimated a POAG one-year prevalence of 1.70% and a one-year incidence of 0.17% in 2018; both increased with age, peaking in 80-89 year-olds. Prevalence and incidence were lower in 2020 (1.65% and 0.16%, respectively), the first year of the SARS-CoV-2 pandemic. Most patients solely received topical treatment. Most surgically-treated patients underwent laser trabeculoplasty, followed by laser iridotomy, trabeculectomy, and filtration operations with implant. In patients undergoing laser trabeculoplasty, the treatment regimen was nearly unchanged in the second year after, compared to two years before the procedure. Multimorbidity was commonly observed; 75.5% of patients had arterial hypertension and 50.0% had disorders of lipoprotein metabolism and other lipidemias, compared to 60.1% and 39.2%, respectively, in an age- and sex-matched control sample. Our study provides insights into epidemiology and routine care of POAG in Germany and HCRU in prevalent patients. There was little change in treatment regimens in patients who underwent laser trabeculoplasty, two years after the procedure. Most patients were multimorbid highlighting the need for comprehensive care.

Impact of government-issued financial incentive to medical facilities on management of secondary dysmenorrhea.

In April 2020, the Japanese government introduced a Specific Medical Fee for managing secondary dysmenorrhea (SD). This initiative provided financial incentives to medical facilities that provide appropriate management of SD with hormonal therapies. We aimed to assess how this policy affects the management processes and outcomes of patients with SD. Using a large Japanese administrative claims database, we identified outpatient visits of patients diagnosed with SD from April 2018 to March 2022. We used an interrupted time-series analysis and defined before April 2020 as the pre-introduction period and after April 2020 as the post-introduction period. Outcomes were the monthly proportions of outpatient visits due to SD and hormonal therapy among women in the database and the proportions of outpatient visits for hormonal therapy and continuous outpatient visits among patients with SD. We identified 815 477 outpatient visits of patients diagnosed with SD during the pre-introduction period and 920 183 outpatient visits during the post-introduction period. There were significant upward slope changes after the introduction of financial incentives in the outpatient visits due to SD (+0.29% yearly; 95% confidence interval, +0.20% to +0.38%) and hormonal therapies (+0.038% yearly; 95% confidence interval, +0.030% to +0.045%) among the women in the database. Similarly, a significant level change was observed after the introduction of continuous outpatient visits among patients with SD (+2.68% monthly; 95% confidence interval, +0.87% to +4.49%). Government-issued financial incentives were associated with an increase in the number of patients diagnosed with SD, hormonal therapies, and continuous outpatient visits.

375 Cervical Arthroplasty in the Treatment of Myelopathy: Clinical Predictors, Utilization, and Outcomes in a Large Administrative Database

INTRODUCTION: Cervical arthroplasty is a treatment for cervical radiculopathy; however, it may also be safe and effective in patients with mild myelopathy. METHODS: Retrospective data spanning 2016-2020 from the PearlDiver Patient Claims Database was used to select patients. Age, gender, osteoporosis, obesity, smoking, diabetes, Charlson Comorbidity Index (CCI), and 1- or 2-level surgery, re-operation rates, 90-day readmission, medical complications, and morphine milligram equivalents (MME) before/after surgery were collected. Univariate & multivariate analyses were performed to identify differences. Reoperation rates were compared using propensity-matched analysis. RESULTS: We identified n = 2,391 (4.5%) CDA and n = 50,845 ACDF procedures for cervical myelopathy. Predictors favoring CDA included female sex, younger age, lower CCI score, lower incidence of obesity, osteoporosis, diabetes, or smoking (p ≤ 0.001); remaining significant after multivariate analysis except sex (p = 0.06). Single-level surgery was more predictive for undergoing CDA. CDA patients had lower 90-day readmissions, complications, and lower opioid utilization. The overall reoperation rate was 5%. Predictors of reoperation included: male sex, younger age, greater CCI, obesity, osteoporosis, diabetes, smoking, and 2-level surgery, remaining significant after multivariable logistic regression except for diabetes (p = 0.23) and CCI (p = 0.05). The robustness of these factors were evaluated by matching patients (n = 2,391) with no difference in re-operation rates identified (p = 0.47). CONCLUSIONS: CDA patients are generally healthier (lower incidence of obesity, smoking, diabetes, CCI) and represents 4.5% of procedures for 1- or 2-level cervical myelopathy. Readmission rates, medical complications, and opiate use was lower with patients undergoing CDA, despite an overall similar reoperation rate. This study is limited by its retrospective nature and the lack of granular outcomes measurements. However, the data suggests that CDA is a viable option for cervical myelopathy.

Treatment patterns and outcomes among adults with immune thrombocytopenia receiving pharmaceutical second-line therapies: a retrospective cohort study using administrative claims data

Objectives To describe and compare real-world treatment patterns and clinical outcomes among individuals with immune thrombocytopenia (ITP) receiving second-line therapies (rituximab, romiplostim, or eltrombopag). Methods A retrospective cohort study was conducted using a large administrative claims database (January 2013–May 2020) among continuously enrolled patients ≥18 years prescribed second-line ITP therapies. The index date was the date of the first claim of the study medications. Treatment patterns and outcomes were measured during the 12-month follow-up period. Inverse probability of treatment weighting (IPTW) was used to balance covariates across treatment groups. Multivariable logistic regression was used to compare treatment patterns and bleeding risk outcomes. Results A total of 695 patients were included (rituximab, N = 285; romiplostim, N = 212; eltrombopag, N = 198). After IPTW, all baseline covariates were balanced. Compared to eltrombopag, patients in the rituximab cohort were 57% more likely to receive other ITP therapies (systematic corticosteroids or third-line therapies) during the follow-up period (odds ratio [OR] = 1.571, p = .030). There was no significant difference in the odds of receiving a different second-line therapy or experiencing a bleeding-related episode among three groups (p > .050). Patients in the romiplostim cohort were 69% more likely to receive rescue therapy compared to those in the rituximab cohort (OR = 1.688, p = .025). Conclusion Patients with ITP receiving rituximab were more likely to need other ITP therapies but did not experience higher risk of bleeding compared to those receiving eltrombopag or romiplostim. Benefits, risks, cost-effectiveness, and patient preference should all be considered in optimizing second-line therapy for ITP.

Patterns of Comorbidities and Prescribing and Dispensing of Non-steroidal Anti-inflammatory Drugs (NSAIDs) Among Patients with Osteoarthritis in the USA: Real-World Study.

Osteoarthritis (OA) is a major cause of chronic pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are analgesics commonly used for musculoskeletal pain; however, NSAIDs can increase the risk of certain adverse events, such as gastrointestinal bleeding, edema, heart failure, and hypertension. The objective of this study was to characterize existing comorbidities among patients with OA. For patients with OA with and without a coexisting medical condition of interest (CMCOI), we estimated the prevalence of prescribing and dispensing NSAIDs pre-OA and post-OA diagnosis. Data from three large administrative claims databases were used to construct an OA retrospective cohort. Databases leveraged were IBM MarketScan Medicare Supplemental Database (MDCR), IBM MarketScan Commercial Database (CCAE), and Optum's de-identified Clinformatics® Data Mart Database (Optum CDM). The OA study population was defined to be those patients who had an OA diagnosis from an inpatient or outpatient visit with at least 365 days of prior observation time in the database during January 2000 through May 2021. Asthma, cardiovascular disorders, renal impairment, and gastrointestinal bleeding risks were the CMCOI of interest. Patients with OA were then classified as having or not having evidence of a CMCOI. For both groups, NSAID dispensing patterns pre-OA and post-OA diagnosis were identified. Descriptive analysis was performed within the Observational Health Data Sciences and Informatics framework. In each database, the proportion of the OA population with at least one CMCOI was nearly 50% or more (48.0% CCAE; 74.4% MDCR; 68.6% Optum CDM). Cardiovascular disease was the most commonly observed CMCOI in each database, and in two databases, nearly one in four patients with OA had two or more CMCOI (23.2% MDCR; 22.6% Optum CDM). Among the OA population with CMCOI, NSAID utilization post-OA diagnosis ranged from 33.0 to 46.2%. Following diagnosis of OA, an increase in the prescribing and dispensing of NSAIDs was observed in all databases, regardless of patient CMCOI presence. This study provides real-world evidence of the pattern of prescribing and dispensing of NSAIDs among patients with OA with and without CMCOI, which indicates that at least half of patients with OA in the USA have a coexisting condition. These conditions may increase the risk of side effects commonly associated with NSAIDs. Yet, at least 32% of these patients were prescribed and dispensed NSAIDs. These data support the importance of shared decision making between healthcare professionals and patients when considering NSAIDs for the treatment of OA in patients with NSAID-relevant coexisting medical conditions.

Developing an individualized treatment rule for Veterans with major depressive disorder using electronic health records.

Efforts to develop an individualized treatment rule (ITR) to optimize major depressive disorder (MDD) treatment with antidepressant medication (ADM), psychotherapy, or combined ADM-psychotherapy have been hampered by small samples, small predictor sets, and suboptimal analysis methods. Analyses of large administrative databases designed to approximate experiments followed iteratively by pragmatic trials hold promise for resolving these problems. The current report presents a proof-of-concept study using electronic health records (EHR) of n = 43,470 outpatients beginning MDD treatment in Veterans Health Administration Primary Care Mental Health Integration (PC-MHI) clinics, which offer access not only to ADMs but also psychotherapy and combined ADM-psychotherapy. EHR and geospatial databases were used to generate an extensive baseline predictor set (5,865 variables). The outcome was a composite measure of at least one serious negative event (suicide attempt, psychiatric emergency department visit, psychiatric hospitalization, suicide death) over the next 12 months. Best-practices methods were used to adjust for nonrandom treatment assignment and to estimate a preliminary ITR in a 70% training sample and to evaluate the ITR in the 30% test sample. Statistically significant aggregate variation was found in overall probability of the outcome related to baseline predictors (AU-ROC = 0.68, S.E. = 0.01), with test sample outcome prevalence of 32.6% among the 5% of patients having highest predicted risk compared to 7.1% in the remainder of the test sample. The ITR found that psychotherapy-only was the optimal treatment for 56.0% of patients (roughly 20% lower risk of the outcome than if receiving one of the other treatments) and that treatment type was unrelated to outcome risk among other patients. Change in aggregate treatment costs of implementing this ITR would be negligible, as 16.1% fewer patients would be prescribed ADMs and 2.9% more would receive psychotherapy. A pragmatic trial would be needed to confirm the accuracy of the ITR.

Improved Activities of Daily Living With Adjunctive Intravenous Steroids in Bacterial Meningitis: A Nationwide, Population-Based Medical Database Study.

The benefit of using adjunctive intravenous steroids (IVS) to reduce the neurological sequelae in bacterial meningitis remains inconclusive. This study evaluated the effect of IVS on improving the subsequent Activities of Daily Living (ADL) in bacterial meningitis by analyzing data from a large nationwide administrative medical database in Japan. Data from 1,132 hospitals, covered by the administrative Diagnosis Procedure Combination (DPC) payment system from 2016 to 2022, were evaluated. The ADL levels at admission and discharge were measured using the Barthel Index (BI). Out of the cumulative 47,366,222 patients hospitalized, 8,736 were diagnosed with acute bacterial meningitis and had BI data available. The BI at discharge, adjusted for sex, age, and BI at admission, was significantly better among those treated with IVS (p<0.0001). Exploratory subgroup analyses suggested that this benefit is expected across a broad spectrum of bacterial species. In summary, the use of IVS for improving the subsequent ADL level in bacterial meningitis was suggested.

Outcomes of Unicompartmental Knee Arthroplasty in Patients Receiving Long-Term Anticoagulation Therapy: A Propensity-Matched Cohort Study

BackgroundAlthough total knee arthroplasty has been considered the gold-standard treatment for severe osteoarthritis of the knee, unicompartmental knee arthroplasty (UKA) has become an increasingly favorable alternative for single-compartment osteoarthritis of the knee. Few studies have examined potential high-risk populations undergoing this procedure. The purpose of this study was to investigate the outcomes of UKA in patients receiving long-term anticoagulation therapy. MethodsIn this study, a large administrative database was queried to identify patients undergoing UKA between 2009 and 2019, who were then divided into a cohort receiving long-term anticoagulation and a control cohort. Propensity scores were utilized to match these patients. Multivariable logistic regression was utilized to compare 90-day and 2-year complication rates between cohorts. ResultsPatients who were on long-term anticoagulation had significantly increased odds of extended length of stay, surgical site infection, wound complication, transfusion, deep vein thrombosis, pulmonary embolism, and readmission at 90-day follow-up. The long-term anticoagulation cohort also experienced significantly higher odds of periprosthetic joint infection and mechanical complications at 2-year follow-up; however, odds of conversion to total knee arthroplasty were not increased. ConclusionsThis study demonstrated that long-term anticoagulation use was associated with poorer medical and surgical outcomes at both 90 days and 2 years postoperatively in patients undergoing UKA, even after rigorous adjustment for confounders.

Real-world utilization patterns of radium-223 in metastatic prostate cancer in the United States: An administrative claims database study.

79 Background: Radium (Ra)-223 is approved for use in men with symptomatic castration resistant prostate cancer (CRPC) with bone metastases, demonstrating benefits in terms of overall survival and quality of life with a reliable safety profile. In the rapidly evolving treatment landscape for prostate cancer, real-world (RW) data on Ra-223 utilization are limited. We aimed to examine the RW utilization patterns of Ra-223 in patients with metastatic prostate cancer using a large administrative claims database in the US. Methods: A retrospective cohort of men treated with Ra-223 was identified using the closed claims private payor database of the Komodo Research Dataset covering the period from 01/01/2017 to 06/30/2022. The earliest administration of Ra-223 in men with bone metastatic prostate cancer was considered as index date. Individuals were required to have continuous insurance coverage at least 12-month pre-index (baseline) and least 6-month post index or until death if patients survived &lt; 6 months (follow-up). Logistic regression was used to identify baseline demographic, clinical, medications, or healthcare resource use-related factors associated with receiving 5+ cycles of Ra-223. Results: The study cohort comprised of 1,376 men with a median age of 68 years at the time of Ra-223 initiation. Most men were treated by oncologists (52.2%), having bone only metastases (51.5%), having Charlson comorbidity index (CCI) ≥ 1 (76.2%). Diabetes (34.1%), peripheral vascular disease (29.9%), pulmonary disease (25.9%) and mild liver disease (25.1%) were the most common pre-existing comorbidities. Therapies received prior to Ra-223 were androgen receptor pathway inhibitors (75.4%), chemotherapy (32.1%), sipuleucel-T (13.7%) and bone health agents (73.7%). Ra-223 was utilized as a combination therapy by 26.0% of the overall population, predominately with enzalutamide. Nearly 15%, 38%, and 31% received Ra-223 (mono or combination therapy) as 1st, 2nd, and 3rd line therapy, respectively. Approximately 46% of the overall cohort and 54% of those who survived ≥ 6 months had received 5+ cycles, respectively. In regression analysis, men with short survival (&lt;6 month) [Odds ratio, OR: 0.05, 95% confidence interval (CI): 0.03, 0.10], low CCI (0 vs. 4+) (OR: 0.38, 95% CI:0.19, 0.76), and pulmonary disease (OR: 0.71, 95% CI: 0.52, 0.97) had lower likelihood of completion of 5+ cycles. Conclusions: Nearly half of men completed 5+ cycles of Ra-223 therapy in a large US cohort of relatively young mCRPC men with private health insurance. Advanced disease state with short survival and low comorbidity were key factors associated with lower completion of 5+ cycles. The findings highlight the importance of utilizing Ra-223 early after mCRPC diagnosis, when the probability of &gt;6-month survival is higher, to enhance treatment completion that has been shown to result in better outcomes.

Early Repair of Rib Fractures Is Associated with Superior Length of Stay and Total Hospital Cost: A Propensity Matched Analysis of the National Inpatient Sample.

Background and Objectives: Previous studies have suggested that early scheduling of the surgical stabilization of rib fractures (SSRF) is associated with superior outcomes. It is unclear if these data are reproducible at other institutions. We hypothesized that early SSRF would be associated with decreased morbidity, length of stay, and total charges. Materials and Methods: Adult patients who underwent SSRF for multiple rib fractures or flail chest were identified in the National Inpatient Sample (NIS) by ICD-10 code from the fourth quarter of 2015 to 2016. Patients were excluded for traumatic brain injury and missing study variables. Procedures occurring after hospital day 10 were excluded to remove possible confounding. Early fixation was defined as procedures which occurred on hospital day 0 or 1, and late fixation was defined as procedures which occurred on hospital days 2 through 10. The primary outcome was a composite outcome of death, pneumonia, tracheostomy, or discharge to a short-term hospital, as determined by NIS coding. Secondary outcomes were length of hospitalization (LOS) and total cost. Chi-square and Wilcoxon rank-sum testing were performed to determine differences in outcomes between the groups. One-to-one propensity matching was performed using covariates known to affect the outcome of rib fractures. Stuart-Maxwell marginal homogeneity and Wilcoxon signed rank matched pair testing was performed on the propensity-matched cohort. Results: Of the 474 patients who met the inclusion criteria, 148 (31.2%) received early repair and 326 (68.8%) received late repair. In unmatched analysis, the composite adverse outcome was lower among early fixation (16.2% vs. 40.2%, p < 0.001), total hospital cost was less (USD114k vs. USD215k, p < 0.001), and length of stay was shorter (6 days vs. 12 days) among early SSRF patients. Propensity matching identified 131 matched pairs of early and late SSRF. Composite adverse outcomes were less common among early SSRF (18.3% vs. 32.8%, p = 0.011). The LOS was shorter among early SSRF (6 days vs. 10 days, p < 0.001), and total hospital cost was also lower among early SSRF patients (USD118k vs. USD183k late, p = 0.001). Conclusion: In a large administrative database, early SSRF was associated with reduced adverse outcomes, as well as improved hospital length of stay and total cost. These data corroborate other research and suggest that early SSRF is preferred. Studies of outcomes after SSRF should stratify analyses by timing of procedure.

Analyzing risk factors for post-acute recovery in older adults with Alzheimer's disease and related dementia: A new semi-parametric model for large-scale medicare claims.

Nearly 300,000 older adults experience a hip fracture every year, the majority of which occur following a fall. Unfortunately, recovery after fall-related trauma such as hip fracture is poor, where older adults diagnosed with Alzheimer's disease and related dementia (ADRD) spend a particularly long time in hospitals or rehabilitation facilities during the post-operative recuperation period. Because older adults value functional recovery and spending time at home versus facilities as key outcomes after hospitalization, identifying factors that influence days spent at home after hospitalization is imperative. While several individual-level factors have been identified, the characteristics of the treating hospital have recently been identified as contributors. However, few methodological rigorous approaches are available to help overcome potential sources of bias such as hospital-level unmeasured confounders, informative hospital size, and loss to follow-up due to death. This article develops a useful tool equipped with unsupervised learning to simultaneously handle statistical complexities that are often encountered in health services research, especially when using large administrative claims databases. The proposed estimator has a closed form, thus only requiring light computation load in a large-scale study. We further develop its asymptotic properties with stabilized inference assisted by unsupervised clustering. Extensive simulation studies demonstrate superiority of the proposed estimator compared to existing estimators.

A NEW METHOD TO IDENTIFY MEDICARE CLAIMS-BASED FACTORS ASSOCIATED WITH POST-ACUTE RECOVERY IN OLDER ADULTS WITH ADRD

Abstract Nearly 300,000 older adults experience a hip fracture every year, the majority of which occur following a fall. Unfortunately, recovery from hip fracture is poor, where older adults diagnosed with Alzheimer’s Disease and Related Dementia (ADRD) spend a particularly long time in hospitals or rehabilitation facilities during the post-operative recuperation period. Because older adults value functional recovery and spending time at home versus facilities as key outcomes after hospitalization, identifying factors that influence days spent at home after hospitalization is imperative. However, few rigorous analytical approaches are available to help overcome potential sources of analysis bias such as hospital-level unmeasured confounders, informative hospital size, and loss to follow-up due to death. To overcome these challenges, we developed a new data science approach equipped with unsupervised learning to simultaneously handle statistical complexities that are often encountered in research using large administrative claims databases. The proposed approach is accessible and performs well in simulation studies. Analysis of 16562 Medicare beneficiaries diagnosed with ADRD who were aged 65 or older and experienced a hip fracture between 2017 and 2019 demonstrated that older age, longer length of stay in the hospital, more chronic health conditions, and less days at home before fracture are significantly associated less days spent at home in the 12-month period after hip fracture (p&amp;lt;.05), while existing methods fail to detect some effects. Findings demonstrate that the proposed method can overcome bias in health services research using Medicare data and can lead to findings that may inform care and resource allocation.

Proteinuria screening and risk of bone fracture: a retrospective cohort study using a nationwide population-based database.

Proteinuria is associated with an increased risk of kidney function deterioration, cardiovascular disease, or cancer. Previous reports suggesting an association between kidney dysfunction and bone fracture may be confounded by concomitant proteinuria and were inconsistent regarding the association between proteinuria and bone fracture. Therefore, we aimed to evaluate the association using a large administrative claims database in Japan. Using the DeSC database, we retrospectively identified individuals with laboratory data including urine dipstick test between August 2014 and February 2021. We evaluated the association between proteinuria and vertebral or hip fracture using multivariable Cox regression analyses adjusted for various background factors including kidney function. We also performed subgroup analyses stratified by sex and kidney function and sensitivity analyses with Fine & Gray models considering death as a competing risk. We identified 603766 individuals and observed 21195 fractures. With reference to the negative proteinuria group, the hazard ratio for hip or vertebral fracture was 1.10 [95% confidence interval (CI), 1.05-1.14] and 1.16 (95%CI, 1.11-1.22) in the trace and positive proteinuria group, respectively, in the Cox regression analysis. The subgroup analyses showed similar trends. The Fine & Gray model showed a subdistribution hazard ratio of 1.09 (95%CI, 1.05-1.14) in the trace proteinuria group and 1.15 (95% CI, 1.10-1.20) in the positive proteinuria group. Proteinuria was associated with an increased risk of developing hip or vertebral fractures after adjustment for kidney function. Our results highlight the clinical importance of checking proteinuria for predicting bone fractures.

EPH137 Healthcare Resource Consumption and Direct Costs of Patients Newly Diagnosed with Acute Myeloid Leukemia from a Large Italian Administrative Database

EPH137 Healthcare Resource Consumption and Direct Costs of Patients Newly Diagnosed with Acute Myeloid Leukemia from a Large Italian Administrative Database

PT8 Five-Year Healthcare Resource Consumption and Direct Costs of Women with a New Diagnosis of Hr+/HER2- Breast Cancer Primary or Advanced: Analysis of a Large Italian Administrative Database

PT8 Five-Year Healthcare Resource Consumption and Direct Costs of Women with a New Diagnosis of Hr+/HER2- Breast Cancer Primary or Advanced: Analysis of a Large Italian Administrative Database

Is single-level cervical disc arthroplasty associated with a lower reoperation rate than anterior cervical discectomy and fusion?

Long-term meta-analysis of cervical disc arthroplasty (CDA) trials report lower rates of subsequent cervical spine surgical procedures with CDA compared with anterior cervical discectomy and fusion (ACDF). The objective of this study was to compare the rate of subsequent cervical spine surgery in single-level CDA-treated patients to that of a matched cohort of single-level ACDF-treated patients by using records from 2010 to 2021 included in a large national administrative claims database (PearlDiver). This retrospective matched-cohort study used a large national insurance claims database; 525,510 patients who had undergone a single-level ACDF or CDA between 2010 and 2021 were identified. Patients with other same-day spine procedures, as well as those for trauma, infection, or tumor, were excluded, yielding 148,531 patients. ACDF patients were matched 2:1 to CDA patients on the basis of clinical and demographic characteristics. The primary outcome was the overall incidence of all-cause cervical reoperation after index surgery. Secondary outcomes included readmission, any adverse event within 90 days, and overall reintervention after index surgery. Multivariable logistic regression analyses were adjusted for covariates and were employed to estimate the effect of the index ACDF or CDA procedure on patient outcomes. Survival was assessed using Kaplan-Meier estimation, and differences between ACDF- and CDA-treated patients were compared using log-rank tests. After the patients were matched, 28,795 ACDF patients to 14,504 CDA patients were included. ACDF patients had higher rates of 90-day adverse events (18.4% vs 14.6%, adjusted odds ratio [aOR] 0.77, 95% CI 0.73-0.82, p < 0.001) and readmission (11.5% vs 9.7%, aOR 0.87, 95% CI 0.81-0.93, p < 0.001). Over a mean 4.3 years of follow-up, 5.0% of ACDF patients and 5.4% of CDA patients underwent reoperation (aOR 1.09, 95% CI 1.00-1.19, p = 0.059). The rate of aggregate reintervention was higher in CDA patients than in ACDF patients (11.7% vs 10.7%, aOR 1.10, p = 0.002). The Kaplan-Meier 10-year reoperation-free survival rate was worse for CDA than ACDF (91.0% vs 92.0%, p = 0.05), as was the rate of reintervention-free survival (81.2% vs 82.0%, p = 0.003). Single-level CDA was associated with a similar rate of reoperation and higher rate of subsequent injections when compared with a matched cohort that underwent single-level ACDF. CDA was associated with lower rates of 90-day adverse events and readmissions.

Real-World Characteristics, Treatment Utilization, and Transfusion Burden in Patients with β-Thalassemia Initiating Luspatercept: A US Cohort Study

Introduction: β-thalassemia is a β-globin gene disorder resulting in decreased production of hemoglobin A and chronic anemia. Disease severity ranges from asymptomatic, mild anemia to life-long red blood cell transfusion dependence. Luspatercept is an erythroid maturation agent that reduces transfusion burden in patients with transfusion-dependent β-thalassemia. We describe real-world baseline demographics and clinical characteristics alongside treatment utilization patterns in US patients with β-thalassemia treated with luspatercept. Methods: This retrospective, observational, cohort study used Komodo Health's Healthcare Map, a large administrative claims database in the USA. Patients with a diagnosis of β-thalassemia (ICD-10 code: D56.1) who initiated luspatercept treatment between January 1, 2020 and September 30, 2021 were included; the full study period was July 1, 2019 to September 30, 2022. The index date was defined as the first documented administration of luspatercept during the identification period. Patients were adults (≥ 18 years of age on index date) continuously enrolled for 6 months before (baseline) and 12 months after (follow-up) the index date. Discontinuation was defined as no medication claim for ≥ 90 days (assuming a 3-week schedule while taking into account potential dose delays). Descriptive statistics were used to analyze and report baseline demographics and clinical characteristics. Time-to-event variables were assessed using Kaplan-Meier methods. Results: The 101 patients included had a mean (standard deviation [SD]) age of 37.7 (14.9) years, with a broad geographical spread throughout the USA (Midwest n = 17, 16.8%; Northeast n = 24, 23.8%; South n = 28, 27.7%; West n = 32, 31.7%). Approximately half (52.5%) were female, and mainly commercially insured (56.4%). Patients were in relatively good health (mean [SD] Charlson Comorbidity Index: 0.8 [1.7]). Bone deformities (n = 16, 15.8%), hepatosplenomegaly (n = 13, 12.9%), and thrombotic events (n = 10, 9.9%) were the most common β-thalassemia-related comorbidities observed in the baseline period. Median (interquartile range) baseline transfusion frequency during the 6-month baseline period was 4.0 (8.0), and 55.0% of the patients were transfusion dependent (≥ 4 transfusions in the 6-month baseline period). Over 40% of patients remained on luspatercept after 1 year of treatment with a median time to discontinuation of 96.5 days (Figure). Approximately one fifth (19.0%) of patients who discontinued luspatercept reinitiated treatment (Figure). Among those who were transfusion-dependent who stayed on luspatercept at 6 months, 31.3% (10/32) experienced a reduction in the frequency of transfusions, with a median decrease of 2 visits in the 6-month follow-up period from baseline, and 28.1% (9/32) observed a decrease in the units of blood transfused, with a median decrease of 5 units in the 6-month follow-up period from baseline (Table). Similarly, among patients who were transfusion-dependent who stayed on luspatercept for 12 months, 32.0% (8/25) experienced a reduction in the frequency of transfusions, with a median decrease of 2.5 visits in the follow-up period from baseline, and 48.0% (12/25) observed a decrease in the units of blood transfused, with a median decrease of 3.7 units in the 12 month follow-up period from baseline (Table). Conclusion: This study shows that patients with β-thalassemia treated with luspatercept saw a substantial reduction in transfusion burden, in both the frequency of blood transfusion and units of blood used. As those who remained on luspatercept longer, through 12 months, saw an increased reduction in transfusion burden from baseline, these findings suggest the clinical and real-world benefit of longer-term luspatercept treatment.

Increased Neonatal Mortality and Increasing Rate of Cerebral Venous Sinus Thrombosis in Hospitalized Children: A Pediatric Health Information System Database Study

Introduction: Pediatric Cerebral Venous Sinus Thrombosis (CVST) poses risks of neurological sequelae and mortality, necessitating timely diagnosis and appropriate antithrombotic therapy. Limited sample sizes in previous studies have led to inconsistent treatment recommendations. To better understand pediatric CVST, we used the Pediatric Health Information System (PHIS) database to compare clinical features, treatment practices, and outcomes in neonates versus older children, and in different time periods, to analyze the influence of various parameters on healthcare outcomes. Methods: Deidentified, retrospective data of pediatric CVST was extracted from the large multi-center PHIS administrative database from January 1, 2011, to October 1, 2022. Diagnostic, imaging, procedure, and pharmaceutical billing codes were used to identify demographic information, clinical characteristics, management, and outcome. Multivariance analysis was performed on study parameters in neonates vs. older children (Table 1) and early (2011-2015) vs. late (2016-2022) study era (Table 2). Results: 6080 hospitalizations with CVST diagnosis (0.1% of all hospitalizations) were identified (61% male; median age 5 years; range 0-17 years). Median hospital stay was 8 days (IQR 4, 22), with 52% (N=3147) admitted to the intensive care unit (ICU). Overall mortality of all children was 4.2%. Neonates constituted 17.3% of the hospitalizations (N=1,054). Clinical features in neonates were less-often reported vs. older children more often had headache, hypertension, vomiting, papilledema and hemiparesis (p&amp;lt;0.001). Congenital heart disease/sepsis were common associated diagnoses in neonates vs. sinusitis/mastoiditis in older children (p&amp;lt;0.001). Neonates had a longer hospital stay (median 24 (IQR 11, 55), vs. 8 days (IQR 4, 17); p &amp;lt;0.001), but lower ICU admission (33.4% vs. 55.6%; p&amp;lt;0.001) and readmission rate (0% vs. 1.0%; p=0.002) when compared to older children. CT without contrast was used less often (33.4% vs. 55.1%; p &amp;lt; 0.001), and head ultrasound more often (76.3% vs. 8.0%; p &amp;lt; 0.001) for neonates vs. older children. Enoxaparin and unfractionated heparin (UFH) remained the primary treatments for CVST, with UFH utilized more often in neonates (71.6% vs. 59.2%; p&amp;lt;0.001). Direct oral anticoagulants (DOACs) were predominantly used in older children in limited numbers. Coma and hydrocephalus as complications were lower (0.7% vs. 5.6%, p&amp;lt;0.001 and 6.2% vs. 9.4%, p=0.001), and intracranial bleeding was (19.1% vs.7.0%, p&amp;lt;0.001) in neonates vs. older children. Neonates had increased mortality rate compared to older children (9.7% vs. 3.1%; p&amp;lt;0.001). The number of CVST admissions increased in the late (2016-2022) compared to the early study era (2011-2015) (0.11% vs. 0.08% of all admissions, p&amp;lt;0.001). Patient demographics, duration of hospital stay, ICU admission rates, clinical features, and imaging modalities remained similar in both groups. The use of bivalirudin, and DOACs was present in the late vs. none in the early era (p&amp;lt;0.001 except Dabigatran). Coma in the late (p&amp;lt;0.001) and brain infarct in the early study era (p&amp;lt;0.001) were more common complications. Both readmission rate (p=0.006) and hospital stay (p=0.006) were slightly higher in the late era. No statistically significant differences were found in mortality rate between the two eras (p= 0.226). Conclusion: Pediatric CVST is a serious disorder, with an overall mortality rate of 4.2% in our study. Neonates had distinct clinical features, associated diagnoses, and complications compared to older children. Predominantly UFH and rarely DOACs were administered in neonates. Neonates experienced longer hospital stay, and statistically significant higher mortality rate when compared to older children, consistent with prior studies. Newer anticoagulants were utilized increasingly in the late vs. early study era. Though readmission rate and hospital stay increased in the late era (not statistically significant), this did not translate into increased mortality. Increasing rate of hospitalizations in late compared to early study era is likely due to increasing medical complexity/technological advances in diagnosis/management of pediatric CVST. Future multi-center, prospective studies are needed to better address the increased neonatal mortality and improve overall care of pediatric CVST which is increasingly prevalent as seen in our study.

Treatment Patterns and Modifications of Tyrosine Kinase Inhibitors (TKI) Therapy in Early Lines in Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Real-World Analysis from a Large Commercial Claims Database in the United States (US)

Introduction: Although current TKI options are often successful in managing CML-CP in early lines of therapy, patients may experience issues related to tolerability or resistance to TKIs. Physicians often have to proceed with treatment modifications including discontinuation, switching, temporary interruptions, or dose modifications when the patient's current treatment is not working as expected. This retrospective cohort study assessed these TKI therapy management patterns in patients with CML in first-line (1L) or second-line (2L) treatment in the US. Methods: A large administrative claims database of commercially insured patients, the OptumInsight Clinformatics database (January 2007-June 2022), was used to select adult patients with CML who received 1L TKI therapy (imatinib, dasatinib, nilotinib, or bosutinib; 1L cohort) and those who received 2L TKI therapy (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib; 2L cohort), with treatment initiation (index date) on or after 2012. Patients were required to have ≥6 months of continuous health plan enrollment pre-index, with no hematopoietic stem cell transplantation (HSCT) or CML-related chemotherapy treatments for accelerated phase (AP) or blast crisis (BC) pre-index. Treatment modifications assessed post-index included 1) treatment discontinuation, defined as the earliest of HSCT/treatment switch (defined below)/initiation of a CML-related chemotherapy for AP or BC, 2) treatment switch defined as initiation of another TKI/omacetaxine mepesuccinate, 3) temporary treatment interruption defined as gap of ≥ 14 days followed by resuming the index TKI, and 4) dose reduction (as compared to the initial dose) were assessed. Time to first event post-index were conducted using Kaplan Meier analyses for each of these treatment modifications, in 1L and 2L cohorts, separately. Results: A total of 2,043 patients were included in the 1L cohort with 47.8% of them receiving imatinib, 31.0% dasatinib, 19.2% nilotinib, and 2.0% bosutinib (median age: 64 years; 44.9% female; 69.7% White; 49.5% with Medicare advantage plan operated by commercial insurance [Part C]). Patients in the 1L cohort were observed for a mean (SD) period of 29.1 (27.3) months from index date to earliest of loss of follow-up/end of data. Overall, more than a quarter of patients (27.3%) experienced treatment discontinuation, with rates of discontinuation of 16.1% at 6 months, 25.0% at 12 months, and 33.5% at 24 months post-index ( Figure 1). Treatment switch was observed in 26.0% of the patients, with rates of 15.5% at 6 months and 24.4% at 12 months post-index. The proportion of patients with temporary treatment interruption was 18.6%, with rates of 20.6% at 6 months and 22.2% at 12 months post-index. Dose reduction (as compared to initial dose) occurred in 21.9% of patients, with rates of 18.8% at 6 months and 23.3% at 12 months post-index. A total of 586 patients were included in the 2L cohort with 23.0% of them receiving imatinib, 36.9% dasatinib, 26.6% nilotinib, 10.9% bosutinib and 2.6% ponatinib (median age: 65 years; 47.3% female; 72.5% White; 48.3% with Medicare advantage plan operated by commercial insurance [Part C]). Patients in the 2L cohort were observed for a mean (SD) period of 28.4 (25.4) months from index date to earliest of loss of follow-up/end of data. Almost a third of patients (32.8%) experienced treatment discontinuation, with rates of discontinuation of 22.1% at 6 months, 29.9% at 12 months, and 43.1% at 24 months post-index ( Figure 1). Treatment switch was observed in 30.5% of patients, with rates of 20.5% at 6 months and 28.3% at 12 months post-index. The proportion of patients with temporary treatment interruption was 21.3%, with rates of 24.8% at 6 months and 25.4% at 12 months post-index. Dose reduction as compared to initial dose occurred in 20.6% of patients, with rates of 17.5% at 6 months and 27.2% at 12 months post-index. Conclusions: Findings from this real-world study demonstrate that almost a quarter of patients with CML treated with current TKI treatment options in 1L or 2L experienced treatment discontinuation/switch in the first year from TKI initiation suggesting lack of optimal response/tolerability to currently available TKIs, with more pronounced rates in 2L. This suggests that unmet clinical needs still persist in this population, warranting optimal 1L and 2L treatment options with better tolerability profile for CML management.

Fibrates and the risk of cardiovascular outcomes in chronic kidney disease patients.

The high risk of major adverse cardiovascular events (MACE) in patients with chronic kidney disease (CKD) has been well described. However, the efficacy of fibrates on the risk of MACE in patients with CKD remains unclear. We conducted a nested case-control study using data from a large administrative database that included more than 1.5 million Japanese patients. We defined cases as CKD patients with incidences of MACE and matched them with controls based on age, sex, calendar year of cohort entry, and CKD stage. Fibrate exposure timing was categorized as current, recent, or past. A conditional logistic regression analysis was used to investigate the association between fibrate use and the risk of MACE. Our study included 47490 patients with CKD, with 15830 MACE identified during a median follow-up of 9.4 months. The number of fibrates used during the study period were 556 (3.5%) in the case group and 1109 (3.5%) in the control group. Fibrate use was significantly associated with a decreased risk of MACE (odds ratio [OR], 0.84; 95% confidence interval [CI], 0.75 to 0.94), particularly for current (OR, 0.81; 95% CI, 0.68-0.97) and recent use (OR, 0.65; 95% CI, 0.48-0.90). Regarding the class effect of fibrates, pemafibrate use, but not bezafibrate or fenofibrate use, was significantly associated with a decreased risk of MACE (OR, 0.73; 95% CI, 0.528-0.997). Recent and current fibrate use, especially pemafibrate use, was associated with a reduced risk of MACE in patients with CKD. This suggests the potential benefits of continuous fibrate therapy and the possible superiority of pemafibrate over other fibrates. However, further investigations in different populations are required to confirm the generalizability of these findings.