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Medicine Jun 2024Evidence on real-world clinical and economic outcomes in patients with multiple myeloma (MM) and renal impairment (RI) is limited in the United States. This... (Observational Study)
Observational Study
Evidence on real-world clinical and economic outcomes in patients with multiple myeloma (MM) and renal impairment (RI) is limited in the United States. This retrospective study aimed to generate an updated comprehensive assessment of the clinical and economic outcomes of MM patients with RI using the Medicare research identifiable files data with Part D linkage, which might assist in assessing the total clinical and socioeconomic burden of these high-risk and challenging-to-treat patients. Treatment patterns and clinical and economic outcomes in first line (1L) to fourth line (4L) therapy were described in Medicare beneficiaries (2012 to 2018) for MM patients with RI (RI MM cohort). For reference purposes, information on a general cohort of MM patients was generated and reported to highlight the clinical and economic burden of RI. Since the goal was to describe the burden of these patients, this study was not designed as a comparison between the 2 cohorts. Compared with the general MM cohort (n = 13,573), RI MM patients (24.9%) presented high MM-associated comorbidities. In the RI MM cohort, bortezomib-dexamethasone (45.7%), bortezomib-lenalidomide (18.6%), lenalidomide (12.3%), and bortezomib-cyclophosphamide (12.1%) were the most prevalent regimens in 1L; carfilzomib and pomalidomide were mostly received in 3L to 4L; and daratumumab in 4L. Across 1L to 4L, the RI MM cohort presented shorter median real-world progression-free survival (1L: 12.9 and 16.4 months) and overall survival (1L: 31.1 and 46.8 months) and higher all-cause healthcare resource utilization (1L incidence rate of inpatient days: 12.1 and 7.8 per person per year) than the general MM cohort. In the RI MM cohort, the mean all-cause total cost increased from 1L to 4L ($14,549-$18,667 per person per month) and was higher than that of the general MM cohort. RI MM patients presented higher clinical and economic burdens across 1L to 4L than the general MM patients in real-world clinical practice.
Topics: Humans; Multiple Myeloma; United States; Male; Female; Aged; Retrospective Studies; Medicare; Aged, 80 and over; Renal Insufficiency; Cost of Illness; Antineoplastic Combined Chemotherapy Protocols
PubMed: 38941411
DOI: 10.1097/MD.0000000000038609 -
Journal of Surgical Oncology Jun 2024Surgeon sex has been associated with perioperative clinical outcomes among patients undergoing oncologic surgery. There may be variations in financial outcomes relative...
BACKGROUND AND OBJECTIVES
Surgeon sex has been associated with perioperative clinical outcomes among patients undergoing oncologic surgery. There may be variations in financial outcomes relative to the surgeon-patient dyad. We sought to define the association of surgeon's sex with perioperative financial outcomes following cancer surgery.
METHODS
Patients who underwent resection of lung, breast, hepato-pancreato-biliary (HPB), or colorectal cancer between 2014 and 2021 were identified from the Medicare Standard Analytic Files. A generalized linear model with gamma regression was utilized to characterize the association between sex concordance and expenditures.
RESULTS
Among 207,935 Medicare beneficiaries (breast: n = 14,753, 7.1%, lung: n = 59,644, 28.7%, HPB: n = 23,400, 11.3%, colorectal: n = 110,118, 53.0%), 87.8% (n = 182,643) and 12.2% (n = 25,292) of patients were treated by male and female surgeons, respectively. On multivariable analysis, female surgeon sex was associated with slightly reduced index expenditures (mean difference -$353, 95%CI -$580, -$126; p = 0.003). However, there were no differences in 90-day post-discharge inpatient (mean difference -$-225, 95%CI -$570, -$121; p = 0.205) and total expenditures (mean difference $133, 95%CI -$279, $545; p = 0.525).
CONCLUSIONS
There was minor risk-adjusted variation in perioperative expenditures relative to surgeon sex. To improve perioperative financial outcomes, a diverse surgical workforce with respect to patient and surgeon sex is warranted.
PubMed: 38941176
DOI: 10.1002/jso.27752 -
JAMA Health Forum Jun 2024Sponsorship of promotional events for health professionals is a key facet of marketing campaigns for pharmaceuticals and medical devices; however, there appears to be...
IMPORTANCE
Sponsorship of promotional events for health professionals is a key facet of marketing campaigns for pharmaceuticals and medical devices; however, there appears to be limited transparency regarding the scope and scale of this spending.
OBJECTIVE
To develop a novel method for describing the scope and quantifying the spending by US pharmaceutical and medical companies on industry-sponsored promotional events for particular products.
DESIGN AND SETTING
This was a cross-sectional study using records from the Centers for Medicare & Medicaid's Open Payments database on payments made to prescribing clinicians from January 1 to December 21, 2022.
MAIN OUTCOMES AND MEASURES
An event-centric approach was used to define sponsored events as groupings of payment records with matching variables. Events were characterized by value (coffee, lunch, dinner, or banquet) and number of attendees (small vs large). To test the method, the number of and total spending for each type of event across professional groups were calculated and used to identify the top 10 products related to dinner events. To validate the method, we extracted all event details advertised on the websites of 4 state-level nurse practitioner associations that regularly hosted industry-sponsored dinner events during 2022 and compared these with events identified in the Open Payments database.
RESULTS
A total of 1 154 806 events sponsored by pharmaceutical and medical device companies were identified for 2022. Of these, 1 151 351 (99.7%) had fewer than 20 attendees, and 922 214 (80.0%) were considered to be a lunch ($10-$30 per person). Seven companies sponsored 16 031 dinners for the top 10 products. Of the 227 sponsored in-person dinner events hosted by the 4 state-level nurse practitioner associations, 168 (74.0%) matched events constructed from the Open Payments dataset.
CONCLUSIONS AND RELEVANCE
These findings indicate that an event-centric analysis of Open Payments data is a valid method to understand the scope and quantify spending by pharmaceutical and medical device companies on industry-sponsored promotional events attended by prescribers. Expanding and enforcing the reporting requirements to cover all payments to all registered health professionals would improve the accuracy of estimates of the true extent of all sponsored events and their impact on clinical practice.
Topics: Humans; Cross-Sectional Studies; United States; Drug Industry; Marketing; Conflict of Interest; Centers for Medicare and Medicaid Services, U.S.
PubMed: 38941087
DOI: 10.1001/jamahealthforum.2024.1581 -
Sarcoidosis, Vasculitis, and Diffuse... Jun 2024Social predictors affect severity of sarcoidosis, with Black patients, older individuals, those with lower income, and those without insurance having greater severity....
BACKGROUND AND AIM
Social predictors affect severity of sarcoidosis, with Black patients, older individuals, those with lower income, and those without insurance having greater severity. This study aimed to explore potential disparities affecting access to care in sarcoidosis patients with a primary focus on metrics such as area deprivation index (ADI) and its association with adherence to the proposed regimen.
METHODS
A retrospective chart review study of all patients seen in pulmonary clinics at a large urban tertiary care center over 2 years with sarcoidosis patients identified with International Classification of Diseases diagnosis code D86. Data collected included age, race, sex, ADI, insurance, online patient portal usage, chest x-rays, pulmonary function tests, missed visits, hospitalizations, positive biopsy, communication and visits around bronchoscopy. Categorical variables were described using frequency and percentage. Numerical variables were described using median, mean and standard deviation. Statistical analysis included chi-square test, two-sample T-test and Wilcoxon rank sum test. Multivariate logistic regression analysis was performed to model independent association with 12 month no-show occurrence as a metric of adherence to the proposed regimen.
RESULTS
Among sarcoidosis patients (N = 788), univariate models showed the presence of active online patient portal use among younger patients (58.6 years with portal vs. 65.1 years without portal, p < 0.001), those with lower ADI (73 with portal vs. 92 without portal, p < 0.001) and with commercial insurance (48.5% with portal vs. 20.7% without portal, p < 0.001); more x-rays (45.6% with x-rays vs. 36.6% without x-rays, p = 0.018) and hospitalizations (50.3% with hospitalizations vs. 36.2% without hospitalizations, p < 0.001) in Medicare patients. Sarcoidosis patients with positive biopsies on file from 2013-2023 were more likely to be male (44.19% with positive biopsy vs. 33.91% without positive biopsy, p = 0.006), White (36.29% with positive biopsy vs. 22.9% without positive biopsy, p < 0.001) or other races (3.23% with positive biopsy vs. 2.25% without positive biopsy, p < 0.001), younger (55.8 years with positive biopsy vs. 61.7 years without positive biopsy, p < 0.001) and belonged to lower national ADI ranks (73 with positive biopsy vs. 80 without biopsy, p = 0.041). A multivariate analysis was done with those variables found to be significant in the univariate analyses, which revealed that higher ADI national was associated with failure to adhere to the proposed regimen.
CONCLUSIONS
We identified intricate patterns of sociodemographic variables affecting access to care in sarcoidosis patients, especially higher ADI national associated with failure to adhere to the proposed regimen, raising concerns for potential healthcare barriers. Understanding these barriers is vital for equitable high-quality care, assisting in timely and efficient management of the patient's disease.
PubMed: 38940707
DOI: 10.36141/svdld.v41i2.15587 -
Neurosurgery Jun 2024Surgery for the very elderly is a progressively important paradigm as life expectancy continues to rise. Patients with glioblastoma multiforme often undergo surgery,...
BACKGROUND AND OBJECTIVES
Surgery for the very elderly is a progressively important paradigm as life expectancy continues to rise. Patients with glioblastoma multiforme often undergo surgery, radiotherapy (RT), and chemotherapy (CT) to prolong overall survival (OS). However, the efficacy of these treatment modalities in patients aged 80 years and older has yet to be fully assessed in the literature.
METHODS
The National Cancer Database was used to retrospectively identify patients aged 65 years and older with glioblastoma multiforme (1989-2016). All available patient demographic characteristics, disease characteristics, and clinical outcomes were collected. To study OS, bivariable survival models were created using Kaplan-Meier estimates. A Cox proportional-hazards model was used for final adjusted analyses.
RESULTS
A total of 578 very elderly patients (aged 80 years and older) and 2836 elderly patients (aged 65-79 years) were identified. Compared with elderly patients, very elderly patients were more likely to have Medicare (odds ratio [OR] 1.899 [95% CI: 1.417-2.544], P < .001) while less likely to have private insurance status (OR 0.544 [95% CI: 0.401-0.739], P < .001). In addition, very elderly patients were more likely to travel the least distance for treatment and have multiple tumors (P < .001). When controlling for demographic and disease characteristics, very elderly patients were less likely to receive gross total resection (GTR) (OR 0.822 [95% CI: 0.681-0.991], P < .041), RT (OR 0.385 [95% CI: 0.319-0.466], P < .001), or postoperative CT (OR 0.298 [95% CI: 0.219-0.359], P < .001) relative to elderly counterparts. Within very elderly patients, GTR, RT, and CT all independently and significantly predicted improved OS (P < .001 for all). These predictive models were deployed in an online calculator (https://spine.shinyapps.io/GBM_elderly).
CONCLUSION
Very elderly patients are less likely to receive GTR, RT, or CT when compared with elderly counterparts despite use of these therapies conferring improved OS. Selected very elderly patients may benefit from more aggressive attempts at surgical and adjuvant treatment.
PubMed: 38940573
DOI: 10.1227/neu.0000000000003072 -
JACC. Advances Jan 2024Low-density lipoprotein cholesterol (LDL-C) is used to guide lipid-lowering therapy after a myocardial infarction (MI). Lack of LDL-C testing represents a missed...
BACKGROUND
Low-density lipoprotein cholesterol (LDL-C) is used to guide lipid-lowering therapy after a myocardial infarction (MI). Lack of LDL-C testing represents a missed opportunity for optimizing therapy and reducing cardiovascular risk.
OBJECTIVES
The purpose of this study was to estimate the proportion of Medicare beneficiaries who had their LDL-C measured within 90 days following MI hospital discharge.
METHODS
We conducted a retrospective cohort study of Medicare beneficiaries ≥66 years of age with an MI hospitalization between 2016 and 2020. The primary analysis used data from all beneficiaries with fee-for-service coverage and pharmacy benefits (532,767 MI hospitalizations). In secondary analyses, we used data from a 5% random sample of beneficiaries with fee-for-service coverage without pharmacy benefits (10,394 MI hospitalizations), and from beneficiaries with Medicare Advantage (176,268 MI hospitalizations). The proportion of beneficiaries who had their LDL-C measured following MI hospital discharge was estimated accounting for the competing risk of death.
RESULTS
In the primary analysis (mean age 76.9 years, 84.4% non-Hispanic White), 29.9% of beneficiaries had their LDL-C measured within 90 days following MI hospital discharge. Among Hispanic, Asian, non-Hispanic White, and non-Hispanic Black beneficiaries, the 90-day postdischarge LDL-C testing was 33.8%, 32.5%, 30.0%, and 26.0%, respectively. Postdischarge LDL-C testing within 90 days was highest in the Middle Atlantic (36.4%) and lowest in the West North Central (23.4%) U.S. regions. In secondary analyses, the 90-day postdischarge LDL-C testing was 26.9% among beneficiaries with fee-for-service coverage without pharmacy benefits, and 28.6% among beneficiaries with Medicare Advantage coverage.
CONCLUSIONS
LDL-C testing following MI hospital discharge among Medicare beneficiaries was low.
PubMed: 38939806
DOI: 10.1016/j.jacadv.2023.100753 -
JACC. Advances Apr 2024Statins are highly effective for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and mortality. Data on the benefit of statins in adults with heart...
BACKGROUND
Statins are highly effective for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and mortality. Data on the benefit of statins in adults with heart failure with preserved ejection fraction (HFpEF) and without ASCVD are limited.
OBJECTIVES
The purpose of this study was to determine whether statins are associated with a lower risk of mortality and major adverse cardiovascular events (MACE) in HFpEF.
METHODS
Veterans Health Administration data from 2002 to 2016, linked to Medicare and Medicaid claims and pharmaceutical data, were collected. Patients had a new HFpEF diagnosis and no known ASCVD or prior statin use at baseline. Cox proportional hazards models were fit to evaluate the association of new statin use with outcomes (all-cause mortality and MACE). Propensity score overlap weighting (PSW) was used to balance baseline characteristics.
RESULTS
Among 7,970 Veterans, 47% initiated a statin over a mean 6.0-year follow-up. At HFpEF diagnosis, mean age was 69 ± 12 years, 96% were male, 67% were White, 14% were Black, and mean EF was 60% ± 6%. Before PSW, statin users were younger with more prevalent metabolic syndrome, arthritis, and other chronic conditions. All characteristics were balanced after PSW. There were 5,314 deaths and 4,859 MACE events. After PSW, the hazard for all-cause mortality for statin users vs nonusers was 22% lower (HR: 0.78; 95% CI: 0.73-0.83). The HR for MACE was 0.79 (95% CI: 0.74-0.84), 0.69 (95% CI: 0.60-0.80) for all-cause hospitalization, and 0.72 (95% CI: 0.59-0.88) for HF hospitalization.
CONCLUSIONS
New statin use was associated with reduced all-cause mortality, MACE, and hospitalization in Veterans with HFpEF without prevalent ASCVD.
PubMed: 38939680
DOI: 10.1016/j.jacadv.2024.100869 -
JACC. Advances Apr 2024Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models...
BACKGROUND
Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models have important limitations, including reliance on data that may not be routinely available, narrow focus on primary prevention, limited patient populations, and longtime horizons for risk prediction.
OBJECTIVES
The purpose of this study was to derive and internally validate a claims-based prediction model for 1-year risk of MACE in type 2 diabetes.
METHODS
Using medical and pharmacy claims for adults with type 2 diabetes enrolled in commercial, Medicare Advantage, and Medicare fee-for-service plans between 2014 and 2021, we derived and internally validated the annualized claims-based MACE estimator (ACME) model to predict the risk of MACE (nonfatal acute myocardial infarction, nonfatal stroke, and all-cause mortality). The Cox proportional hazards model was composed of 30 covariates, including patient age, sex, comorbidities, and medications.
RESULTS
The study cohort comprised 6,623,526 adults with type 2 diabetes, mean age 68.1 ± 10.6 years, 49.8% women, and 73.0% Non-Hispanic White. ACME had a concordance index of 0.74 (validation index range: 0.739-0.741). The predicted 1-year risk of the study cohort ranged from 0.4% to 99.9%, with a median risk of 3.4% (IQR: 2.3%-6.5%).
CONCLUSIONS
ACME was derived in a large usual care population, relies on routinely available data, and estimates short-term MACE risk. It can support population risk stratification at the health system and payer levels, participant identification for decentralized clinical trials of cardiovascular disease, and risk-stratified observational studies using real-world data.
PubMed: 38939660
DOI: 10.1016/j.jacadv.2024.100852 -
Innovation in Aging 2024Fall injuries are prevalent in older adults, yet whether higher spending occurs after nonfracture (NFFI) and fracture is unknown. We examined whether incident fall...
BACKGROUND AND OBJECTIVES
Fall injuries are prevalent in older adults, yet whether higher spending occurs after nonfracture (NFFI) and fracture is unknown. We examined whether incident fall injuries, including NFFI and fractures, were associated with higher Medicare spending in 12 months after incident events in older adults.
RESEARCH DESIGN AND METHODS
The Health, Aging, and Body Composition Study included 1 595 community-dwelling adults (53% women, 37% Black; 76.7 ± 2.9 years) with linked Medicare Fee-For-Service (FFS) claims at 2000/01 exam. Incident outpatient and inpatient fall injuries ( = 448) from 2000/01 exam to December 31, 2008 were identified using the first claim with a nonfracture injury diagnosis code with a fall E-code, or a fracture diagnosis code with/without an E-code. Up to 3 participants without fall injuries ( = 1 147) were matched on nonfall events to 448 participants in the fall injury month. We calculated the change in monthly FFS spending in 12 months before versus after index events in both groups. Generalized linear regression with centered outcomes and gamma distributions examined the association of prepost expenditure changes with fall injuries (including NFFI and fractures) adjusting for related covariates.
RESULTS
Monthly spending increased after versus before fall injuries (USD$2 261 vs $981), nonfracture ( = 105; USD$2 083 vs $1 277), and fracture ( = 343; USD$2 315 vs $890) injuries (all < .0001). However, after adjusting for covariates in final models, fall injuries were not significantly associated with larger increases in spending/month versus nonfall events (differential increase: USD$399.58 [95% CI: -USD$44.95 to $844.11]). Fracture prepost change in monthly spending was similar versus NFFI (differential increase: USD$471.93 [95% CI: -USD$21.17 to $965.02]).
DISCUSSION AND IMPLICATIONS
Although substantial increases occurred after injuries, with fracture and NFFI increasing similarly, changes in monthly spending after fall injury were not different compared to nonfall events. Our results contribute to the understanding of subsequent spending after fall injury that may inform further research on fall injury-related health care spending.
PubMed: 38939652
DOI: 10.1093/geroni/igae051 -
JACC. Advances Jul 2023Transcatheter aortic valve implantation (TAVI) rates are lower among Black compared with White individuals. However, it is unclear whether racial residential...
BACKGROUND
Transcatheter aortic valve implantation (TAVI) rates are lower among Black compared with White individuals. However, it is unclear whether racial residential segregation, which remains common in the United States, contributes to observed disparities in TAVI rates.
OBJECTIVES
The purpose of this study was to evaluate the association between county-level racial segregation, and aortic stenosis (AS) diagnosis, management, and outcomes.
METHODS
We identified Black and White Medicare fee-for-service beneficiaries age ≥65 years living in metropolitan areas of the United States (2016-2019). Using the American Community Survey's Black-White residential segregation index, a measure of geographic racial distribution, we determined segregation in each beneficiary's county of residence. Using hierarchical modeling, we determined the association between racial segregation and rates of AS diagnosis, TAVI receipt, and 30-day clinical outcomes (mortality, readmission, stroke).
RESULTS
There were 29,264,075 beneficiaries, of whom 22% lived in a high-segregation county. Among Black beneficiaries, high-segregation county residence was associated with decreased rates of AS diagnosis (OR: 0.97; 95% CI: 0.96-0.98) and TAVI (OR: 0.89; 95% CI: 0.86-0.93) compared with low-segregation county residence. In contrast, among White beneficiaries, high-segregation county residence was associated with higher rates of AS diagnosis (OR: 1.02; 95% CI: 1.02-1.03) and no differences in TAVI (OR: 1.00; 95% CI: 0.99-1.00). Segregation and race were not independently associated with 30-day mortality.
CONCLUSIONS
Among Black Medicare fee-for-service beneficiaries, living in a high-segregation county was independently associated with decreased rates of AS diagnosis and TAVI, an association not seen among White beneficiaries. Residential racial segregation may contribute to racial disparities seen in AS care.
PubMed: 38939010
DOI: 10.1016/j.jacadv.2023.100415