Racial, Ethnic, and Socioeconomic Disparities in Treatment Delay Among Patients With Hepatocellular Carcinoma in the United States.

BACKGROUND & AIMS: Failures have been reported across the cancer care continuum in patients with hepatocellular carcinoma (HCC); however, the impact of treatment delays on outcomes has not been well-characterized. We described the prevalence of treatment delays in a racially and ethnically diverse cohort of patients and its association with overall survival. METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare database, we identified patients diagnosed with HCC between 2001 and 2015. We performed multivariable logistic regression analysis to identify factors associated with treatment delay (ie, receipt of HCC-directed therapy >3 months after diagnosis). Cox proportional hazards regression analysis with a 5-month landmark was used to characterize the association between treatment delay and overall survival, accounting for immortal time bias. RESULTS: Of 8450 patients with treatment within 12 months of HCC diagnosis, 1205 (14.3%) experienced treatment delays. The proportion with treatment delays ranged from 6.8% of patients undergoing surgical resection to 21.6% of those undergoing liver transplantation. In multivariable analysis, Black patients (odds ratio, 1.96; 95% confidence interval [CI], 1.21-3.15) and those living in high poverty neighborhoods (odds ratio, 1.55; 95% CI, 1.25-1.92) were more likely to experience treatment delays than white patients and those living in low poverty neighborhoods, respectively. Treatment delay was independently associated with worse survival (hazard ratio 1.15, 95% CI, 1.05-1.25). CONCLUSIONS: Nearly 1 in 7 patients with HCC experience treatment delays, with higher odds in Black patients and those living in high poverty neighborhoods. Treatment delays are associated with worse survival, highlighting a need for interventions to improve time-to-treatment.

Cost-impact analysis of baroreflex activation therapy in chronic heart failure patients in the United States.

BACKGROUND: The study evaluated the cost of baroreflex activation therapy plus guideline directed therapy (BAT + GDT) compared to GDT alone for HF patients with reduced ejection fraction and New York Heart Association Class III or II (with a recent history of III). Baroreflex activation therapy (BAT) is delivered by an implantable device that stimulates the baroreceptors through an electrode attached to the outside of the carotid artery, which rebalances the autonomic nervous system to regain cardiovascular (CV) homeostasis. The BeAT-HF trial evaluated the safety and effectiveness of BAT. METHODS: A cost impact model was developed from a U.S. health care payer or integrated delivery network perspective over a 3-year period for BAT + GDT versus GDT alone. Expected costs were calculated by utilizing 6-month data from the BeAT-HF trial and existing literature. HF hospitalization rates were extrapolated based on improvement in NT-proBNP. RESULTS: At baseline the expected cost of BAT + GDT were $29,526 per patient more than GDT alone due to BAT device and implantation costs. After 3 years, the predicted cost per patient was $9521 less expensive for BAT + GDT versus GDT alone due to lower rates of significant HF hospitalizations, CV non-HF hospitalizations, and resource intensive late-stage procedures (LVADs and heart transplants) among the BAT + GDT group. CONCLUSIONS: BAT + GDT treatment becomes less costly than GDT alone beginning between years 1 and 2 and becomes less costly cumulatively between years 2 and 3, potentially providing significant savings over time. As additional BeAT-HF trial data become available, the model can be updated to show longer term effects.

The effect of expanded insurance coverage under the Affordable Care Act on emergency department utilization in New York.

BACKGROUND: One of the proposed benefits of expanding insurance coverage under the Affordable Care Act (ACA) was a reduction in emergency department (ED) utilization for non-urgent visits related to lack of health insurance coverage and access to primary care providers. The objective of this study was to estimate the effect of the 2014 ACA implementation on ED use in New York. METHODS: We used the Healthcare Cost and Utilization Project State Emergency Department and State Inpatient Databases for all outpatient and all inpatient visits for patients admitted through an ED from 2011 to 2016. We focused on in-state residents aged 18 to 64, who were covered under Medicaid, private insurance, or were uninsured prior to the 2014 expansion. We estimated the effect of the expanded insurance coverage on average monthly ED visits volumes and visits per 1000 residents (rates) using interrupted time-series regression analyses. RESULTS: After ACA implementation, overall average monthly ED visits increased by around 3.0%, both in volume (9362; 95% Confidence Intervals [CI]: 1681-17,522) and in rates (0.80, 95% CI:0.12-1.49). Medicaid covered ED visits volume increased by 23,972 visits (95% CI: 16,240 -31,704) while ED visits by the uninsured declined by 13,297 (95% CI:-15,856 - -10,737), and by 1453 (95% CI:-4027-1121) for the privately insured. Medicaid ED visits rates per 1000 residents increased by 0.77 (95% CI:-1.96-3.51) and by 2.18 (95% CI:-0.55-4.92) for those remaining uninsured, while private insurance visits rates decreased by 0.48 (95% CI:-0.79 - -0.18). We observed increases in primary-care treatable ED visits and in visits related to mental health and alcohol disorders, substance use, diabetes, and hypertension. All estimated changes in monthly ED visits after the expansion were statistically significant, except for ED visit rates among Medicaid beneficiaries. CONCLUSION: Net ED visits by adults 18 to 64 years of age increased in New York after the implementation of the ACA. Large increases in ED use by Medicaid beneficiaries were partially offset by reductions among the uninsured and those with private coverage. Our results suggest that efforts to expand health insurance coverage only will be unlikely to reverse the increase in ED use.

The Effect of the Medicaid Expansion on Frequent Emergency Department Use in New York.

BACKGROUND: There is limited evidence on the effect of the Affordable Care Act (ACA) on frequent emergency department (ED) use. OBJECTIVES: To estimate the effect of the ACA Medicaid expansion on frequent ED use in New York. METHODS: We used data from the Healthcare Cost and Utilization Project State Emergency Department Databases and State Inpatient Databases from 2011 to 2016. A consistent and unique patient identifier enabled us to identify ED visits by the same patient across different facilities within the state for each calendar year. Multivariate logistic regressions were used to quantify the policy's effect on frequent ED use (≥ 4 ED visits/year). We included in-state residents 18 to 64 years of age who were covered by Medicaid, private insurance, or were uninsured. Sensitivity analyses were conducted using alternative definitions of frequent use. To validate the findings, a falsification analysis was also conducted using only the 3 pre-expansion years. RESULTS: Our study included 14.3 million ED patients with 23.8 million ED visits from 2011 to 2016. Frequent users (7.2%) accounted for 26.6% of all ED visits. The likelihood of frequent ED use declined by 4% among Medicaid beneficiaries (adjusted odds ratio [AOR] 0.96, 95% confidence intervals (CI) 0.95-0.97) and by 12% for the uninsured (AOR 0.88, 95% CI 0.86-0.89) in the post-expansion period, compared with the pre-expansion period. Private insurance enrollees were 9% more likely to exhibit frequent use in the post-expansion period (AOR 1.09, 95% CI 1.08-1.11). The sensitivity analyses yielded results similar to those of the main model. The falsification analyses revealed small and insignificant year-to-year changes in the 3 pre-expansion years. CONCLUSION: The likelihood of frequent ED use decreased 3 years after New York implemented the ACA Medicaid expansion, particularly for Medicaid beneficiaries and the uninsured, highlighting the importance of expanding health insurance and provisions tailored at high-need populations.

Predictors of Multiple Emergency Department Utilization Among Frequent Emergency Department Users in 3 States.

BACKGROUND: Research on frequent emergency department (ED) use shows that a subgroup of patients visits multiple EDs. This study characterizes these individuals. OBJECTIVE: The objective of this study was to determine how many frequent ED users seek care at multiple EDs and to identify sociodemographic, clinical, and contextual factors associated with such behavior. RESEARCH DESIGN: We used the 2011-2014 Healthcare Cost and Utilization Project State Emergency Department Databases data on all outpatient ED visits in New York, Massachusetts, and Florida. We studied all adult ED users with ≥5 visits in a year and defined multisite use as visits to ≥3 different sites. We estimated predictors of multisite use with multivariate logistic regressions. RESULTS: Across all 3 states, 1,033,626 frequent users accounted for 7,613,077 ED visits. Of frequent users, 25% were multisite users, accounting for 30% of the visits studied. Frequent users with at least 1 visit for mental health or substance use-related diagnosis were more likely to use multiple sites. Uninsured frequent users and those with public insurance were associated with less use of multiple EDs than those with private coverage while lacking consistent coverage by the same insurance within each year were associated with using multiple sites. CONCLUSIONS: Health policy interventions to reduce duplicative or unnecessary ED use should apply a population health perspective and engage multiple hospitals. Community-level preventive approaches and a stronger infrastructure for mental health and substance use are essential to mitigate multisite ED use.

Hepatocellular Carcinoma Screening Is Associated With Increased Survival of Patients With Cirrhosis.

BACKGROUND & AIMS: Hepatocellular carcinoma (HCC) screening of patients with cirrhosis is recommended by professional societies to increase detection of early stage tumors and survival, but is underused in clinical practice. METHODS: We conducted a retrospective cohort study of 13,714 patients diagnosed with HCC from 2003 through 2013 included in the Surveillance, Epidemiology, and End Results Program-Medicare database. We characterized receipt of HCC screening in the 3 years before HCC diagnosis using mutually exclusive categories (consistent vs inconsistent vs no screening) and the proportion of time covered with screening. Correlates for screening receipt were assessed using a multivariable 2-part regression model. We examined the association between screening receipt and early detection of tumors using multivariable logistic regression. We evaluated associations between screening receipt and overall survival using a Cox proportional hazards model, after adjustments for effects of lead-time bias and length-time bias on survival rate estimators. RESULTS: Most patients with cirrhosis (51.1%) did not receive any screening in the 3 years before a diagnosis of HCC, and only 6.8% of patients underwent consistent annual screening. The proportion with consistent screening increased from 5.4% in 2003 to 2006 to 8.8% in 2011 to 2013 (P < .001). The mean proportion of time covered was 13.4% overall, which increased from 11.7% in 2003 to 2006 to 15.2% in 2011 to 2013. Receipt of consistent screening was associated with detection of early stage tumors (odds ratio, 1.98; 95% CI, 1.68-2.33) and a reduced risk of death after correction for lead-time bias (hazard ratio, 0.76; 95% CI, 0.70-0.83). Inconsistent screening was associated with a slightly smaller increase in early detection of HCC (odds ratio, 1.31; 95% CI, 1.20-1.43) and a reduced risk of death (hazard ratio, 0.86; 95% CI, 0.83-0.90). After correction for lead- and length-time biases, higher proportions of patients with consistent (23%; 95% CI, 21%-25%) and inconsistent screening (19%; 95% CI, 19%-20%) survived for 3 years compared with patients without screening (13%; 95% CI, 12%-14%). CONCLUSIONS: In an analysis of the Surveillance, Epidemiology, and End Results Program-Medicare database, we found HCC screening to be underused for patients with cirrhosis. This contributes to detection of liver tumors at later stages and shorter times of survival. However, the proportion of patients screened for HCC has increased over time.

Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis.

OBJECTIVES: The study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC). METHODS: A systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years. RESULTS: For the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (-0.434; 95% CI -0.667 to -0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group. CONCLUSIONS: PS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.

Women, family medicine, and career choice: An opportunity cost analysis.

OBJECTIVE: This study compared the cost of physician versus physician assistant (PA) education for women practicing in family medicine. METHODS: Using 2013 salary survey data from both the Medical Group Management Association and the American Academy of PAs as well as other publicly available data sources, the authors compared the current net present value (NPV) of physician and PA training for women practicing in family medicine. RESULTS: Considering a base case scenario involving a 24-year-old woman, the NPV to become a family medicine physician was $2,015,000 compared with an NPV of $1,751,000 to become a family medicine PA. Alternative projections produced an NPV for PA training that slightly exceeded the NPV for family medicine physician training. CONCLUSIONS: For a woman practicing in family medicine, becoming a physician or a PA offers similar financial rewards.

Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a US health system perspective.

BACKGROUND: Whether or not antibiotic stewardship protocols based on procalcitonin levels results in cost savings remains unclear. Herein, our objective was to assess the economic impact of adopting procalcitonin testing among patients with suspected acute respiratory tract infection (ARI) from the perspective of a typical US integrated delivery network (IDN) with a 1,000,000 member catchment area or enrollment. METHODS: To conduct an economic evaluation of procalcitonin testing versus usual care we built a cost-impact model based on patient-level meta-analysis data of randomized trials. The meta-analytic data was adapted to the US setting by applying the meta-analytic results to US lengths of stay, costs, and practice patterns. We estimated the annual ARI visit rate for the one million member cohort, by setting (inpatient, ICU, outpatient) and ARI diagnosis. RESULTS: In the inpatient setting, the costs of procalcitonin-guided compared to usual care for the one million member cohort was $2,083,545, compared to $2,780,322, resulting in net savings of nearly $700,000 to the IDN for 2014. In the ICU and outpatient settings, savings were $73,326 and $5,329,824, respectively, summing up to overall net savings of $6,099,927 for the cohort. RESULTS were robust for all ARI diagnoses. For the whole US insured population, procalcitonin-guided care would result in $1.6 billion in savings annually. CONCLUSIONS: Our results show substantial savings associated with procalcitonin protocols of ARI across common US treatment settings mainly by direct reduction in unnecessary antibiotic utilization. These results are robust to changes in key parameters, and the savings can be achieved without any negative impact on treatment outcomes.

PATTERNS OF ONSITE MAGNETIC RESONANCE IMAGING EQUIPMENT AMONG ORTHOPEDIC PRACTICES.

BACKGROUND: Despite ongoing policy debate, little is known about the growth in orthopedic surgery practices with onsite magnetic resonance imaging (MRI) capacity, or practice characteristics associated with the acquisition of in-office MRI equipment. METHODS: In July 2012, American Academy of Orthopaedic Surgeons (AAOS) member practices received a web-based survey requesting general information about their practice, such as number practice providers authorized to order MRIs, the type of onsite MRI capacity present (if any), and the date of acquisition for the MRI equipment. Survey responses were augmented with county-level measures of practice area characteristics as of the year of first onsite MRI acquisition (or 2012 for practices without an onsite MRI). RESULTS: The survey obtained usable responses from 740 orthopedic practices, which were geographically representative of AAOS member practices. Forty percent (298) reported onsite MRI capacity. Onsite MRI acquisition occurred at a steady pace over 2000-2012, with no dramatic increase occurring in any particular year over that period. Multivariate logistic regression indicated that practice size (number of providers) was the most important factor affecting the likelihood of onsite MRI acquisition. There was no association between onsite MRI acquisition and any of the county-level practice area characteristics included in the analysis. CONCLUSIONS: Orthopedic practices acquiring onsite MRI equipment on average are much larger than practices without onsite MRI capacity. Larger practices may be more likely to attain the economies of scale necessary to absorb the fixed costs associated with onsite MRI acquisition.

Do rural and urban women experience differing rates of maternal rehospitalizations?

INTRODUCTION: Conditions such as postpartum complications and mental disorders of new mothers contribute to a relatively large number of maternal rehospitalizations and even some deaths. Few studies have examined rural-urban differences in hospital readmissions, and none of them have addressed maternal readmissions. This research directly compares readmissions for patients who delivered in rural versus urban hospitals. METHODS: The data for this cross-sectional study were drawn from the 2011 California Healthcare Cost and Utilization Project. Readmission rates were reported to demonstrate rural-urban differences. Generalized estimating equation models were also used to estimate the likelihood of a new mother being readmitted over time. RESULTS: The 323 051 women who delivered with minor assistance and 158 851 women who delivered by cesarean section (C-section) were included in this study. Of those, seven maternal mortalities occurred after vaginal deliveries and 14 occurred after C-section procedures. Fewer than 1% (0.98% or 3171) women with normal deliveries were rehospitalized. The corresponding number for women delivering via C-section was 1.41% (2243). For both types of deliveries, women giving birth in a rural hospital were more likely to be readmitted. CONCLUSIONS: This is the first study examining rural-urban differences in maternal readmissions. The results indicate the importance of monitoring and potentially improving the quality of maternal care, especially when the delivery involves a C-section. More studies investigating rural health disparities in women's health are clearly necessary.

Can an Internet-based health risk assessment highlight problems of heart disease risk factor awareness? A cross-sectional analysis.

BACKGROUND: Health risk assessments are becoming more popular as a tool to conveniently and effectively reach community-dwelling adults who may be at risk for serious chronic conditions such as coronary heart disease (CHD). The use of such instruments to improve adults' risk factor awareness and concordance with clinically measured risk factor values could be an opportunity to advance public health knowledge and build effective interventions. OBJECTIVE: The objective of this study was to determine if an Internet-based health risk assessment can highlight important aspects of agreement between respondents' self-reported and clinically measured CHD risk factors for community-dwelling adults who may be at risk for CHD. METHODS: Data from an Internet-based cardiovascular health risk assessment (Heart Aware) administered to community-dwelling adults at 127 clinical sites were analyzed. Respondents were recruited through individual hospital marketing campaigns, such as media advertising and print media, found throughout inpatient and outpatient facilities. CHD risk factors from the Framingham Heart Study were examined. Weighted kappa statistics were calculated to measure interrater agreement between respondents' self-reported and clinically measured CHD risk factors. Weighted kappa statistics were then calculated for each sample by strata of overall 10-year CHD risk. Three samples were drawn based on strategies for treating missing data: a listwise deleted sample, a pairwise deleted sample, and a multiple imputation (MI) sample. RESULTS: The MI sample (n=16,879) was most appropriate for addressing missing data. No CHD risk factor had better than marginal interrater agreement (κ>.60). High-density lipoprotein cholesterol (HDL-C) exhibited suboptimal interrater agreement that deteriorated (eg, κ<.30) as overall CHD risk increased. Conversely, low-density lipoprotein cholesterol (LDL-C) interrater agreement improved (eg, up to κ=.25) as overall CHD risk increased. Overall CHD risk of the sample was lower than comparative population-based CHD risk (ie, no more than 15% risk of CHD for the sample vs up to a 30% chance of CHD for the population). CONCLUSIONS: Interventions are needed to improve knowledge of CHD risk factors. Specific interventions should address perceptions of HDL-C and LCL-C. Internet-based health risk assessments such as Heart Aware may contribute to public health surveillance, but they must address selection bias of Internet-based recruitment methods.

Costs of breast cancer recurrence after initial treatment for HR+, HER2-, high-risk early breast cancer: estimates from SEER-Medicare linked data.

OBJECTIVE: To assess the costs of treated recurrence and survival in elderly patients with early breast cancer (EBC) at high risk of recurrence using Surveillance Epidemiology and End Results (SEER) registry-Medicare linked claims data. METHODS: This retrospective study included patients aged ≥65 years with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), node-positive EBC at high risk of recurrence. Treated recurrences were defined based on treatment events/procedure codes from claims. Primary outcomes were monthly total extra costs and cumulative extra costs of treated recurrence relative to patients with non/untreated recurrence. Costs were calculated using a Kaplan-Meier sampling average estimator method and inflated to 2021 US$. Secondary outcomes included analysis by recurrence type and overall survival (OS) after recurrence. Subgroup analysis evaluated costs in patients with Medicare Part D coverage. RESULTS: Among 3,081 eligible patients [mean (SD) age at diagnosis was 74.5 (7.1) years], the majority were females (97.4%) and white (87.8%). Treated recurrence was observed in 964 patients (31.3%). The monthly extra cost of treated recurrence was highest at the beginning of the first treated recurrence episode, with 6-year cumulative cost of $117,926. Six-year cumulative extra costs were higher for patients with distant recurrences ($168,656) than for patients with locoregional recurrences ($96,465). Median OS was 4.34 years for all treated recurrences, 1.92 years for distant recurrence, and 6.78 years for locoregional recurrence. Similar cumulative extra cost trends were observed in the subgroup with Part D coverage as in the overall population. LIMITATIONS: This study utilizes claims data to identify treated recurrence. Due to age constraints of the dataset, results may not extrapolate to a younger population where EBC is commonly diagnosed. CONCLUSION: EBC recurrence in this elderly population has substantial costs, particularly in patients with distant recurrences. Therapies that delay or prevent recurrence may reduce long-term costs significantly.

Racial and Ethnic Disparities in Hepatocellular Carcinoma Treatment Receipt in the United States: A Systematic Review and Meta-Analysis.

BACKGROUND: Racial and ethnic disparities in hepatocellular carcinoma (HCC) prognosis exist, partly related to differential failures along the cancer care continuum. We characterized racial and ethnic disparities in treatment receipt among patients with HCC in the United States. METHODS: We searched Medline, Embase, and CINAHL databases to identify studies published between January 2012 and March 2022 reporting HCC treatment receipt among adult patients with HCC, stratified by race or ethnicity. We calculated pooled odds ratios for HCC treatment using random effects models. RESULTS: We identified 15 studies with 320,686 patients (65.8% White, 13.9% Black, 10.4% Asian, and 8.5% Hispanic). Overall, 33.2% of HCC patients underwent any treatment, and 22.7% underwent curative treatment. Compared with White patients, Black patients had lower odds of any treatment (OR 0.67, 95% CI 0.55-0.81) and curative treatment (OR 0.74, 95% CI 0.71-0.78). Similarly, Hispanic patients had lower pooled odds of curative treatment (OR 0.79, 95% CI 0.73-0.84). CONCLUSIONS: There were significant racial and ethnic disparities in HCC treatment receipt, with Black patients having lower odds of receiving any and curative treatment while Hispanic patients having lower odds of curative treatment. IMPACT: Racial and ethnic differences in treatment receipt serve as an intervention target to reduce disparities in HCC prognosis.

Economic Impact of Ambulatory Blood Pressure Monitoring Compared With Clinical Blood Pressure Monitoring: A Simulation Model.

Background: Ambulatory blood pressure monitoring (ABPM) is considered the gold standard for proper diagnosis of hypertension. Yet, access to ABPM in the U.S. is limited, and the extent of coverage by commercial health plans remains uncertain, potentially limiting access to ABPM among commercially insured patients. Objective: This study aims to assess the net cost impact of using ABPM in comparison to clinical blood pressure monitoring (CBPM) in the U.S. over a 5-year time period. Design methods: Using a Markov Model, we estimate the 5-year cumulative cost impact of using ABPM to confirm a prior diagnosis of primary hypertension using CBPM to avoid treatment for white-coat hypertension (WCH) in a hypothetical cohort of 1000 patients from a U.S. healthcare system perspective. The probability and cost inputs for the model were derived from available literature. Base-case model parameters were varied to account for different scenarios. Results: Base-case results indicate using ABPM instead of CBPM over 5 years saves a total of $348,028, reflecting an average per-person-per-year (PPPY) cost saving of $70. In sensitivity analyses, almost all cases reveal ABPM as a cost-saving approach compared to CBPM, with cost savings reaching up to $228 PPPY in the highest hypertension treatment cost model. Regression results reveal that ABPM was cost-saving compared to CBPM if ABPM annual payment rates are $100 or less and annual hypertension treatment costs are ⩾$300. Conclusion: The potential cost-savings of using ABPM instead of CBPM found in our simulation model underscores the need for confirmatory research using real-world data to support increased use of ABPM as the standard diagnostic approach for hypertension.

Unfavorable Outcomes Associated With Glucocorticoid Use in Current Standard-of-Care Management of Systemic Lupus Erythematosus in Canada.

OBJECTIVE: Our objective was to describe the administration of glucocorticoids (GCs) and characterize its association with organ damage in a longitudinal systemic lupus erythematosus (SLE) cohort over a time period spanning the introduction of biologics in Canada. METHODS: A retrospective observational study was conducted using data from a large SLE cohort in Canada, including adults without lupus nephritis or central nervous system lupus. Patients were observed from time of entry into the cohort to the last available clinic visit (up to December 31, 2020), with a minimum of 24 months of follow-up. Demographic and clinical characteristics, including average disease activity, treatment administration, and prevalence of organ damage, were examined. Organ damage was stratified by GC administration. RESULTS: A total of 1,255 patients were included. The mean follow-up duration was 10.5 (SD 8.6) years. One hundred eighty-two (15%) patients had organ damage at baseline. More than 80% of patients were prescribed GCs over the follow-up period, almost all patients had long-term GC treatment, and only 5% of patients took any biologics. Organ damage was more frequent in patients with a higher average GC dose and greater years of GC exposure. CONCLUSION: In this large cohort of patients with SLE, the majority of patients continue to rely on GC for SLE symptom management, with limited administration of biologics. GC administration was correlated with increased irreversible organ damage. Access to novel GC-sparing treatment options is critical to improve long-term outcomes for patients with SLE, especially given the continued reliance on GC despite the introduction of biologics.

Cost-Effectiveness of a Shock Team Approach in Refractory Cardiogenic Shock.

BACKGROUND: Multidisciplinary Shock Teams have improved clinical outcomes for cardiogenic shock, but their implementation costs have not been studied. This study's objective was to compare costs between patients treated with and without a Shock Team and determine if the team's implementation is cost-effective compared with standard of care. METHODS: We examined patients with refractory cardiogenic shock treated with or without a Shock Team at a tertiary academic hospital from 2009 to 2018. Real-world hospital data were used to compare costs and outcomes, including survival at discharge, 1-year survival, and quality-adjusted life years gained at 1 year. Incremental cost-effectiveness ratios were calculated over a 1-year time horizon, with parameter uncertainty evaluated through probabilistic sensitivity analysis using 1000 second-order Monte Carlo simulations. RESULTS: The study involved 244 patients, with 123 treated by the Shock Team and 121 receiving standard of care. Patients were predominantly male (77.5%), with a mean age of 58 (18-92) years. The Shock Team approach improved survival rates at hospital discharge and 1-year follow-up (61.0% versus 47.9%; P=0.04 and 55.0% versus 40.5%; P=0.03, respectively). The incremental cost-effectiveness ratio for increases in survival probability at discharge for the multidisciplinary Shock Team compared with standard of care was $102 088. The incremental cost-effectiveness ratio for increases in survival probability at 1-year was estimated at $96 152 and at $127 862 per 1 quality-adjusted life year gained. Probabilistic sensitivity analysis estimates showed that the Shock Team was cost-effective in the majority of simulations using a willingness-to-pay threshold of $150 000, while it was also dominant in almost one-third of the simulations. CONCLUSIONS: The Shock Team approach for treating refractory cardiogenic shock may be a cost-effective alternative to traditional standard of care. These findings can help prioritize the implementation of Shock Team initiatives to further improve cardiogenic shock outcomes.

Descriptive study of the real-world, long-term cost estimates and duration of use for hormonal and nonhormonal intrauterine devices using US commercial insurance claims.

BACKGROUND: Intrauterine devices (IUDs) have comparable efficacy to permanent surgical contraceptive methods; however, long-term costs are infrequently considered. Existing estimates inconsistently account for costs outside of IUD insertion or removal, actual duration of use, or differences between hormonal and nonhormonal IUDs. OBJECTIVE: To describe health care resource utilization and commercial payer costs that arise throughout hormonal and nonhormonal IUD use. METHODS: In this retrospective cohort study, paid claims data (Merative, MarketScan) from a large US commercial claims database were evaluated between 2013 and 2019. Claims were included from individuals aged 12 to 45 years who had an IUD inserted in 2014, continuous insurance coverage for 1 year prior to insertion and throughout follow-up, and no insertion, removal, or reinsertion in the previous year. Procedures and services that could be IUD-related were identified using Current Procedural Terminology and International Classification of Diseases, Ninth and Tenth Edition codes. Duration of IUD use was evaluated by Kaplan-Meier analysis of time to IUD removal. Event rates were determined for identified procedures and services; costs were calculated as the sum of payer reimbursements per enrolled individual. All IUD types available during the study period were described: 2 hormonal IUDs (52-mg and 13.5-mg levonorgestrel-releasing [LNG]) and the nonhormonal (380-mm2 copper) IUD. RESULTS: Of 195,009 individuals meeting the age requirement and receiving an IUD in 2014, 63,386 met the inclusion criteria and 53,744 had their IUD type on record-42,777 (67.5%) 52-mg LNG, 2,932 (4.6%) 13.5-mg LNG, and 8,035 (12.7%) nonhormonal IUD users. Despite differences in their indicated duration (13.5-mg LNG, 3 years; 52-mg LNG, 5 years; and nonhormonal, 10 years), most individuals had their IUD removed before its indicated full duration of use (13.5-mg LNG, 56.1%; 52-mg LNG, 61.3%; nonhormonal [at 5 years], 54.6%). The event rate per 100 individuals during the follow-up period was highest for abnormal uterine bleeding (16.2), ovarian cysts (9.3), and surgical management of uterine perforations (4.5). IUD insertion costs (mean ± SE) per enrolled individual for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $931 ± $9, $1,107 ± $4, and $897 ± $6, respectively. Cumulative mean ± SE 5-year postinsertion costs for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $2,892 ± $232, $1,514 ± $31, and $1,389 ± $97, respectively, among the remaining enrolled individuals. CONCLUSIONS: In this descriptive study of commercially insured IUD users, at least half had their IUD removed before its indicated duration. IUD improvements that reduce the frequency of abnormal uterine bleeding, ovarian cysts, and uterine perforations may help reduce long-term IUD costs.

Economic impact of potential CYP450 pharmacokinetic drug-drug interactions among chronic low back pain patients taking opioids.

Chronic low back pain (cLBP) patients who take at least 1 CYP450-metabolized opioid analgesic agent concurrent with at least 1 other CYP450-metabolized medication experience a drug-drug exposure (DDE), which puts them at risk for a pharmacokinetic drug-drug interaction (PK DDI). This study compared utilization of healthcare resources and associated payments in cLBP patients with and without incident DDEs with the potential to cause PK DDIs. A retrospective database analysis examined the associated clinical events, healthcare utilization (measured in terms of claims for office visits, outpatient visits, emergency department visits, and hospitalization), and cost to the health plan, as defined as the sum of health plan payments for resources used. Patients were grouped into 2 cohorts by age (those under 65 and those 65 years and over). In the 6 months after exposure, total healthcare payments were significantly higher for DDE patients than those without DDEs (no-DDE), in both in the younger ($7,086, SD = $8,370) and $6,353, SD = $8,352, respectively, P < 0.001) and the older cohorts ($7,806 vs. $7,043, respectively, P = 0.013). Younger and older patients with DDE had significantly higher prescription payments than those without DDE ($2,041, SD = $2,706 vs. $1,565, SD = $2,349, respectively, P < 0.001 for younger and $2,482, SD = $2,481 vs. $2,286, SD = $2,521, respectively, P = 0.044 for older patients). Both older and younger patients with DDE had significantly more claims for office visits and higher associated payments than similar patients without DDE. Patients in the study who experienced DDEs that placed them at risk for PK DDIs had significantly greater utilization rates of healthcare resources and higher associated payments in the 6-month observation period following exposure.

Economic impact of potential drug-drug interactions among osteoarthritis patients taking opioids.

Patients with osteoarthritis (OA) taking at least one CYP450-metabolized opioid concurrently with another CYP450-metabolized medication experience a drug-drug exposure (DDE), which puts them at risk of a pharmacokinetic drug-drug interaction (PK DDI). This study compared patients with and without such an incident DDE to determine healthcare utilization and associated payments. Using a retrospective database analysis, the impact of DDEs was evaluated in terms of associated clinical events, healthcare services utilization (office visits, outpatient visits, ED visits, hospitalization), and payments in patient populations based on age (those under age 65 and those 65 years of age and older), during the 6 months after exposure. DDE patients had significantly more inpatient hospitalizations than no-DDE patients. Mean total payments at 6 months were significantly higher for both younger and older patients with DDE compared to similar patients without DDE ($9,469, SD = $12,192 vs. $8,382, SD = $14,078, respectively, for younger patients, resulting in a difference of $1,087, P < 0.004, and $9,829, SD = $11,721 vs. $8,622, SD = $10,131, respectively, for older patients, resulting in a difference of $1,207, P = 0.001). In both age groups, DDE patients had significantly higher payments for nonopioid prescription drugs ($1,824 SD = $2,420 vs. $1,362, SD = $1,891, respectively, for younger patients, resulting in a difference of $462, P < 0.001, and $2,197 SD = $2,332 vs. $2,013, SD = $2,437, respectively, for older patients, resulting in a difference of $184, P = 0.020). Overall, patients with OA who experienced DDEs had significantly greater utilization rates of healthcare resources and higher associated payments in the 6-month observation period following the exposure, compared to patients without DDEs, consistent with the risk of PK DDIs associated with DDEs.