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Nevin Manimala Statistics

Long-Term Results of Bladder Preservation with Twice-Daily Radiation plus 5-Flourouracil/Cisplatin or Daily Radiation plus Gemcitabine for MIBC – Updated Report of NRG/RTOG 0712: A Randomized Phase 2 Trial

Int J Radiat Oncol Biol Phys. 2024 Aug 13:S0360-3016(24)03230-9. doi: 10.1016/j.ijrobp.2024.08.007. Online ahead of print.

ABSTRACT

PURPOSE: 5-FU/cisplatin and twice-daily radiation (FCT) or gemcitabine and once daily radiation (GD) are effective chemoradiation (CRT) regimens for bladder sparing treatment of muscle-invasive bladder cancer (MIBC). This trial evaluated these regimens and demonstrated efficacy with either regimen at 3 years. With further follow-up, longer term results are reported here.

METHODS AND MATERIALS: Patients with cT2-4a MIBC were randomized to FCT or GD. Patients had a transurethral resection and induction CRT to 40 Gy. Patients with a complete response (CR) received consolidation CRT to 64 Gy. Others had cystectomy. Adjuvant gemcitabine/cisplatin chemotherapy was administered. The primary endpoint was freedom from distant metastasis (FDM). This updated analysis reports 7-year data. Toxicity and efficacy endpoints, including bladder intact distant metastasis free survival (BI-DMFS) were also assessed.

RESULTS: From 12/2008 to 4/2014, 70 patients were enrolled; 66 eligible for analysis, 33 per arm. Median follow-up was 9.1 years for eligible living patients. At 7 years, FDM was 65% and 73% for FCT and GD, respectively. BI-DMFS was 58% (95% CI: 41 – 76) and 68% (95% CI: 51-84), respectively. The post-hoc hazard ratio of 0.75 (95% CI: 0.37-1.55) showed no difference between treatments (p=0.44). Overall survival at 7 years was 48% and 59%. There were 4 and 5 cystectomies performed for FCT and GD, respectively. In the FCT arm, there were 5 (16%), 1 (3%) and 0 grade 3, 4 and 5 late toxicities reported. In the GD arm, there were 7 (23%), 0 and 0.

CONCLUSIONS: Both regimens maintained high FDM rates at 7 years. Cystectomy rates were low and overall survival rates high on both arms. Late toxicity rates were low. Either gemcitabine and daily radiation or a cisplatin-based regimen are effective bladder sparing therapies.

PMID:39147209 | DOI:10.1016/j.ijrobp.2024.08.007

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Systematic review and meta-analysis of adjuvant radiation dose for pediatric patients (≤22y) with non-metastatic intracranial ependymomas

Int J Radiat Oncol Biol Phys. 2024 Aug 13:S0360-3016(24)03206-1. doi: 10.1016/j.ijrobp.2024.07.2335. Online ahead of print.

ABSTRACT

BACKGROUND/PURPOSE: Ependymomas are the third most common brain tumors in children. Standard of care is surgery followed by adjuvant radiotherapy. Controversy in the literature still exists over optimal radiotherapy dose. We completed a systematic review and meta-analysis to determine the optimal dose for local control (LC), event-free survival (EFS), and overall survival (OS) in pediatric patients.

MATERIALS & METHODS: We searched MEDLINE (PubMed), Cochrane Database of Systematic Reviews, and Web of Science through January 2024. We included cohort studies that compared adjuvant radiotherapy of ≤54Gy to >54Gy in pediatric patients (≤22 years) with non-metastatic intracranial ependymomas. We assessed study quality using the Newcastle-Ottawa Quality Assessment Scale of Cohort Studies. We pooled studies using a random effects meta-analysis for hazard ratios (HR), 95% confidence intervals (CI), and assessed statistical heterogeneity via I2. When HRs were unavailable, we transformed risks using established methods. We narratively summarized qualitative outcomes.

RESULTS: Seven studies met our inclusion criteria, covering a combined 1321 patients. Studies included a range of doses from 45-66.6Gy. Compared with >54Gy, we found no difference in LC for those receiving ≤54Gy (HR=0.83, 95% CI 0.56-1.24, I2=49.1%), in EFS (HR=1.02, 95% CI 0.95-1.09, I2=0.00%), and OS (HR=0.99, 95% CI 0.82-1.20, I2=37.5%). Two studies reported on subtotal resection by radiotherapy dose, neither study reporting statistical differences in LC, EFS, or OS, though the number of patients was small (n≤30). Five studies reported on late effects, with brainstem radionecrosis, radiation-induced vasculopathy, and secondary tumors being the most frequent. Overall study quality was high, though lower scores were consistently seen in comparability of cohorts. No studies reported on molecular subgroups.

CONCLUSIONS: We found no difference in LC, EFS, or OS for those treated with ≤54Gy compared to >54Gy. There was insufficient data to complete a subgroup meta-analysis on radiotherapy dosing based on extent of resection or molecular subgroups.

PMID:39147207 | DOI:10.1016/j.ijrobp.2024.07.2335

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Association of longitudinal changes in 24-h blood pressure level and variability with cognitive decline

J Hypertens. 2024 Aug 14. doi: 10.1097/HJH.0000000000003824. Online ahead of print.

ABSTRACT

OBJECTIVE: A high office blood pressure (BP) is associated with cognitive decline. However, evidence of 24-h ambulatory BP monitoring is limited, and no studies have investigated whether longitudinal changes in 24-h BP are associated with cognitive decline. We aimed to test whether higher longitudinal changes in 24-h ambulatory BP measurements are associated with cognitive decline.

METHODS: We included 437 dementia-free participants from the Maracaibo Aging Study with prospective data on 24-h ambulatory BP monitoring and cognitive function, which was assessed using the selective reminding test (SRT) and the Mini-Mental State Examination (MMSE). Using multivariate linear mixed regression models, we analyzed the association between longitudinal changes in measures of 24-h ambulatory BP levels and variability with cognitive decline.

RESULTS: Over a median follow-up of 4 years (interquartile range, 2-5 years), longitudinal changes in 24-h BP level were not associated with cognitive function (P ≥ 0.09). Higher longitudinal changes in 24-h and daytime BP variability were related to a decline in SRT-delayed recall score; the adjusted scores lowered from -0.10 points [95% confidence interval (CI), -0.16 to -0.04) to -0.07 points (95% CI, -0.13 to -0.02). We observed that a higher nighttime BP variability during follow-up was associated with a decline in the MMSE score (adjusted score lowered from -0.08 to -0.06 points).

CONCLUSION: Higher 24-h BP variability, but not BP level, was associated with cognitive decline. Prior to or in the early stages of cognitive decline, 24-h ambulatory BP monitoring might guide strategies to reduce the risk of major dementia-related disorders including Alzheimer’s disease.

PMID:39146553 | DOI:10.1097/HJH.0000000000003824

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Nevin Manimala Statistics

Early Adversity and Socioeconomic Factors in Pediatric Multiple Sclerosis: A Case-Control Study

Neurol Neuroimmunol Neuroinflamm. 2024 Sep;11(5):e200282. doi: 10.1212/NXI.0000000000200282. Epub 2024 Aug 15.

ABSTRACT

BACKGROUND AND OBJECTIVES: Psychosocial adversity and stress, known to predispose adults to neurodegenerative and inflammatory immune disorders, are widespread among children who experience socioeconomic disadvantage, and the associated neurotoxicity and proinflammatory profile may predispose these children to multiple sclerosis (MS). We sought to determine associations of socioeconomic disadvantage and psychosocial adversity with odds of pediatric-onset MS (POMS), age at POMS onset, and POMS disease activity.

METHODS: This case-control study used data collected across 17 sites in the United States by the Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis Study. Cases (n = 381) were youth aged 3-21 years diagnosed with POMS or a clinically isolated demyelinating syndrome indicating high risk of MS. Frequency-matched controls (n = 611) aged 3-21 years were recruited from the same institutions. Prenatal and postnatal adversity and postnatal socioeconomic factors were assessed using retrospective questionnaires and zip code data. The primary outcome was MS diagnosis. Secondary outcomes were age at onset, relapse rate, and Expanded Disability Status Scale (EDSS). Predictors were maternal education, maternal prenatal stress events, child separation from caregivers during infancy and childhood, parental death during childhood, and childhood neighborhood disadvantage.

RESULTS: MS cases (64% female, mean age 15.4 years, SD 2.8) were demographically similar to controls (60% female, mean age 14.9 years, SD 3.9). Cases were less likely to have a mother with a bachelor’s degree or higher (OR 0.42, 95% CI 0.22-0.80, p = 0.009) and were more likely to experience childhood neighborhood disadvantage (OR 1.04 for each additional point on the neighborhood socioeconomic disadvantage score, 95% CI 1.00-1.07; p = 0.025). There were no associations of the socioeconomic variables with age at onset, relapse rate, or EDSS, or of prenatal or postnatal adverse events with risk of POMS, age at onset, relapse rate, or EDSS.

DISCUSSION: Low socioeconomic status at the neighborhood level may increase the risk of POMS while high parental education may be protective against POMS. Although we did not find associations of other evaluated prenatal or postnatal adversities with POMS, future research should explore such associations further by assessing a broader range of stressful childhood experiences.

PMID:39146511 | DOI:10.1212/NXI.0000000000200282

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Medicare Advantage customer service is used most by higher-need patients

Am J Manag Care. 2024 Aug;30(8):381-386. doi: 10.37765/ajmc.2024.89589.

ABSTRACT

OBJECTIVES: To examine characteristics of Medicare Advantage (MA) enrollees who use their plan’s customer service to help plans understand how to better meet members’ needs.

STUDY DESIGN: National sample of 259,533 respondents to MA Consumer Assessment of Healthcare Providers and Systems survey enrolled in any of the 559 MA contracts in 2022.

METHODS: We assessed the association between self-reported customer service use in the prior 6 months and enrollee demographic, coverage, health, and health care utilization characteristics. We used weighted linear regression models to test for bivariate and multivariate associations between customer service use and enrollee characteristics.

RESULTS: Forty-two percent of MA enrollees reported using customer service in the prior 6 months. Use was 20 percentage points (PP) higher for those in poor vs excellent/very good general health, 13 PP higher for those in poor vs excellent/very good mental health, and 14 PP higher for those reporting 3 or more vs no chronic conditions. Those using customer service more often had lower educational attainment, had limited income and assets, preferred another language to English, and had greater health care utilization.

CONCLUSIONS: MA customer service supports a less healthy, higher-need population with greater-than-average barriers to health care, and so should be designed and staffed to effectively serve medically complex, high-need patients. Commercial plan evidence suggests that continuity in customer service support for a member or a given issue may be helpful. Customer service is an important mechanism for improving quality and addressing health equity.

PMID:39146487 | DOI:10.37765/ajmc.2024.89589

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Geographic variability of Medicaid acceptance among allergists in the US

Am J Manag Care. 2024 Aug;30(8):374-379. doi: 10.37765/ajmc.2024.89588.

ABSTRACT

OBJECTIVE: To determine the geographic variability of Medicaid acceptance among allergists in the US.

STUDY DESIGN: Geospatial analysis predicted Medicaid acceptance across space, and a multivariable regression identified area-level population demographic variables associated with acceptance.

METHODS: We used the National Plan & Provider Enumeration System database to identify allergists. Medicaid acceptance was determined from lists or search engines from state Medicaid offices and calls to provider offices. Spatial analysis was performed using the empirical Bayesian kriging tool. Multivariate logistic regression was used to identify county-level characteristics associated with provider Medicaid acceptance.

RESULTS: Of 5694 allergists, 55.5% accepted Medicaid. Acceptance in each state ranged from 13% to 90%. Washington, Arizona, and the Northeast had lowest predicted proportion of both Medicaid acceptance and Medicaid acceptance per 10,000 enrollees. Overall, county-level characteristics were not associated with the likelihood of accepting Medicaid in multivariate analyses. Only the percentage of individuals living in poverty was associated with a higher likelihood of providers accepting Medicaid (OR, 1.245; 95% CI, 1.156-1.340; P < .001).

CONCLUSIONS: A barrier to accessing allergy-related health care is finding a provider who accepts a patient’s insurance, which is largely variable by state. Lack of access to allergy care likely affects health outcomes for children with prevalent atopic conditions such as food allergy.

PMID:39146486 | DOI:10.37765/ajmc.2024.89588

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Inadequate insurance coverage for overweight/obesity management

Am J Manag Care. 2024 Aug;30(8):365-371. doi: 10.37765/ajmc.2024.89587.

ABSTRACT

OBJECTIVES: To discuss the social, psychological, and access barriers that inhibit weight loss, and to propose steps and initiatives for addressing the growing obesity epidemic.

STUDY DESIGN: Narrative review of the obesity epidemic in the US and associated racial/ethnic and socioeconomic disparities.

METHODS: An internet search of relevant studies and government reports was conducted.

RESULTS: Obesity is a significant health crisis affecting more than 123 million adults and children/adolescents in the US. An estimated 1 in 5 deaths in Black and White individuals aged 40 to 85 years in the US is attributable to obesity. Obesity puts individuals at elevated risk for type 2 diabetes, cardiovascular disease, chronic kidney disease, gastrointestinal disorders, nonalcoholic fatty liver disease, cancer, respiratory ailments, dementia/Alzheimer disease, and other disorders. In the US, significantly more Black (49.9%) and Hispanic (45.6%) individuals are affected by obesity than White (41.4%) and Asian (16.1%) individuals. Health care costs for obesity account for more than $260 billion of annual US health care spending-more than 50% greater in excess annual medical costs per person than individuals with normal weight.

CONCLUSIONS: Addressing the obesity epidemic will require a multifaceted approach that focuses on prevention, treatment, and reducing the impact of stigma. Continued advocacy and education efforts are necessary to make progress and improve the health and well-being of individuals affected by obesity.

PMID:39146485 | DOI:10.37765/ajmc.2024.89587

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Care management improves total cost of care for patients with dementia

Am J Manag Care. 2024 Aug;30(8):353-358. doi: 10.37765/ajmc.2024.89559.

ABSTRACT

OBJECTIVES: To examine a 12-month dementia care management program’s effect on health care cost, utilization, and overall return on investment in a Medicare managed care population.

STUDY DESIGN: Pre-post analysis of participants (n = 121) enrolled in Ochsner’s Care Ecosystem program from 2019 through 2021 compared with propensity-matched controls (n = 121). The primary outcome comparison was total cost of care. Secondary outcomes included components of total cost of care (eg, inpatient, outpatient, emergency department [ED] costs), health care utilization (eg, number of ED visits), and differences in Hierarchical Condition Category (HCC) risk scores.

METHODS: Difference-in-differences analyses were conducted from baseline through 12 months comparing various financial metrics and utilization between groups.

RESULTS: Care Ecosystem participants had significantly lower total cost of care at 12 months, mean savings of $475.80 per member per month compared with controls. Care Ecosystem participants had fewer ED, outpatient, and professional visits. HCC risk scores were also better relative to matched controls.

CONCLUSIONS: A collaborative dementia care program demonstrated significant financial benefit in a managed Medicare population.

PMID:39146484 | DOI:10.37765/ajmc.2024.89559

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Nevin Manimala Statistics

Cross-validation of insurer and hospital price transparency data

Am J Manag Care. 2024 Aug 1;30(8):e247-e250. doi: 10.37765/ajmc.2024.89594.

ABSTRACT

Given recent congressional interest in codifying price transparency regulations, it is important to understand the extent to which newly available price transparency data capture true underlying procedure-level prices. To that end, we compared the prices for maternity services negotiated between a large payer and 26 hospitals in Mississippi across 2 separate price transparency data sources: payer and hospital. The degree of file overlap is low, with only 16.3% of hospital-billing code observations appearing in both data sources. However, for the observations that overlap, pricing concordance is high: Corresponding prices have a correlation coefficient of 0.975, 77.4% match to the penny, and 84.4% are within 10%. Exact price matching rates are greater than 90% for 3 of the 4 service lines included in this study. Taken together, these results suggest that although administrative misalignment exists between payers and hospitals, there is a measure of signal amid the price transparency noise.

PMID:39146482 | DOI:10.37765/ajmc.2024.89594

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Hospitals’ strategies to reduce costs and improve quality: survey of hospital leaders

Am J Manag Care. 2024 Aug 1;30(8):e240-e246. doi: 10.37765/ajmc.2024.89593.

ABSTRACT

OBJECTIVES: Hospitals in the US operate under various value-based payment programs, but little is known regarding the strategies they use in this context to improve quality and reduce costs, overall or in voluntary programs including Bundled Payments for Care Improvement Advanced (BPCI-A).

STUDY DESIGN: A survey was administered to hospital leaders at 588 randomly selected acute care hospitals, with oversampling of BPCI-A participants, from November 2020 to June 2021. Twenty strategies and 20 barriers were queried in 4 domains: inpatient, postacute, outpatient, and community resources for vulnerable patients.

METHODS: Summary statistics were tabulated, and responses were adjusted for sampling strategy and nonresponse.

RESULTS: There were 203 respondents (35%), of which 159 (78%) were BPCI-A participants and 44 (22%) were nonparticipants. On average, respondents reported implementing 89% of queried strategies in the inpatient domain, such as care pathways or predictive analytics; 65% of postacute strategies, such as forming partnerships with skilled nursing facilities; 84% of outpatient strategies, such as scheduling close follow-up to prevent emergency department visits/hospitalizations; and 82% of strategies aimed at high-risk populations, such as building connections with community resources. There were no differences between BPCI-A and non-BPCI-A hospitals in 19 of 20 care redesign strategies queried. However, 78.3% of BPCI-A-participating hospitals reported programs aimed at reducing utilization of skilled nursing and inpatient rehabilitation facilities compared with 37.6% of non-BPCI-A hospitals (P < .0001).

CONCLUSIONS: Hospitals pursue a broad range of efforts to improve quality. BPCI-A hospitals have attempted to reduce use of postacute care, but otherwise the strategies they pursue are similar to other hospitals.

PMID:39146481 | DOI:10.37765/ajmc.2024.89593