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Nevin Manimala Statistics

Supporting Primary Care for Medically and Socially Complex Patients in Medicaid Managed Care

JAMA Netw Open. 2025 Feb 3;8(2):e2458170. doi: 10.1001/jamanetworkopen.2024.58170.

ABSTRACT

IMPORTANCE: In 2023, the Massachusetts Medicaid and Children’s Health Insurance Program (MassHealth) required accountable care organizations (ACOs) to increase payments to primary care practices and shift to monthly payments, currently calibrated to historical revenues and enhanced practice capabilities, such as being staffed to address behavioral health needs. To prevent rewarding practices for avoiding difficult patients, future payments to primary care practices should reflect their patients’ apparent need.

OBJECTIVE: To describe MassHealth’s initiative and a complexity-adjusted payment model.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study of payment model development and performance was conducted between February 2022 and November 2024. Participants included all 2019 Massachusetts Medicaid managed-care eligible members who were enrolled for 183 days or longer.

EXPOSURES: Medical and social complexity.

MAIN OUTCOMES AND MEASURES: For each member, the primary care activity level (PCAL) outcome proxies the resources that primary care clinicians need to provide comprehensive, coordinated care. Models were evaluated via R2 and through ratios of observed-to-expected (ie, estimated by the model) outcomes for selected subgroups, which will be approximately 1.0 when payments and expected costs are well matched. The implications of paying practices using PCAL (vs a model based only on age and sex) were explored by examining financial and practice-level characteristics in high and low deciles of practice-level estimated mean.

RESULTS: Among 1 092 742 MassHealth members enrolled in 3602 primary care practices (1 014 252 person-years; mean [SD] age, 25.9 [18.4] years; 538 065 [53.1%] female), the PCAL model achieved R2 = 69.6% and estimates within 10% of observed PCAL spending for high-risk populations (mental health disorders, substance use disorders, complex chronic conditions, and disabilities) and across racial and ethnic groups. Age-adjusted and sex-adjusted payments would overpay practices in the lowest-need decile by 10% and underpay those in the highest-need decile by 34%, while the PCAL model would match payment to estimated need almost exactly in the lowest decile and underpay by just 6% in the highest decile.

CONCLUSIONS AND RELEVANCE: MassHealth’s 2023 reform invests in primary care. This cross-sectional study developed a risk model that can adjust primary care payments to patient needs. Neither age and sex adjustments nor inflated historical payments would provide adequate resources to primary care practices caring for the most complex patients.

PMID:39899293 | DOI:10.1001/jamanetworkopen.2024.58170

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Using ultrasound sequential images processing to predict radiotherapy-induced sternocleidomastoid muscle fibrosis

Int J Radiat Biol. 2025 Feb 3:1-11. doi: 10.1080/09553002.2025.2453995. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to evaluate the thickness and biomechanical parameters of the sternocleidomastoid muscle (SCM) before, during, and after radiotherapy using ultrasound elastography to predict radiotherapy-induced muscle fibrosis.

MATERIALS AND METHODS: The mean daily absorbed doses of 20 SCMs were determined. To find out the Young and shear modulus, shear wave elastography (SWE) and the B-mode sequential images processing method were implemented. In the B-mode sequential images processing method, by administering dynamic stress, the Young and shear modulus were estimated utilizing the maximum gradient and the block-matching algorithms, respectively. The imaging was done before, during the third and sixth weeks of treatment, and 3 months after radiotherapy.

RESULTS: There was a statistically significant increase in the maximum thickness during the sixth week compared to before radiotherapy (p = .043). However, this parameter did not change significantly 3 months later (p = .095). The Young modulus (p = .611) derived from SWE did not differ significantly throughout any of the weeks of radiotherapy. But Young and shear modulus increased significantly in the B-mode sequential images processing method before and during the third and sixth weeks of treatment (p = .001). The outcomes observed 3 months after radiotherapy revealed a statistically significant increase in both Young modulus (p = .029) and shear modulus (p = .004) compared to pre-radiotherapy.

CONCLUSION: The Young modulus and shear modulus are introduced as biological markers used to detect the onset of the fibrosis process during the initial radiotherapy fractions.

PMID:39899279 | DOI:10.1080/09553002.2025.2453995

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Sex-related outcomes after percutaneous coronary intervention of in-stent restenosis

Cardiovasc Interv Ther. 2025 Feb 3. doi: 10.1007/s12928-025-01092-y. Online ahead of print.

ABSTRACT

Limited data are available for sex-related long-term outcomes of patients treated for coronary drug-eluting stent (DES) restenosis. The aim of this observational, retrospective analysis was to close this lack of evidence. Between January 2007 and February 2021, a total of 3511 patients with 5497 in-stent restenosis (ISR) lesions were treated at two large-volume centers in Munich, Germany, of which 763 (21.7%) were female. Endpoints of interest were all-cause mortality and rates of repeat revascularization. Outcomes are presented as Kaplan-Meier event rates. Univariate and multivariate analyses were performed. Female patients were older (72.1 ± 10.4 versus 68.4 ± 10.4 years, p < 0.001) and suffered more often from diabetes (38.8% versus 34.4%, p = 0.029). There was no statistical difference regarding the clinical presentation and interventional treatment strategy. After 10 years, the risk of all-cause mortality was higher in female patients [hazard ratio (HR) 1.18 (1.02-1.35); p = 0.022]; however, after adjustment for age, the risk did not differ significantly between both sexes [adjusted HR 0.96 (0.83-1.11); p = 0.6]. Regarding target vessel revascularization (TVR) and non-target vessel revascularization (NTVR), the risk was lower in female patients [HR 0.73 (0.61-0.87); p < 0.001 and HR 0.74 (0.64-0.86); p < 0.001] even after age adjustment. No statistical differences were found regarding the risk of target lesion revascularization, target vessel myocardial infarction and stent thrombosis. In the long term, all-cause mortality after percutaneous coronary intervention of DES-ISR did not differ between both sexes after age adjustment. The risk of TVR and NTVR was lower in female patients even after age adjustment.

PMID:39899260 | DOI:10.1007/s12928-025-01092-y

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Growth hormone replacement therapy enhances humoral response to COVID-19 mRNA vaccination in patients with adult-onset growth hormone deficiency

J Endocrinol Invest. 2025 Feb 3. doi: 10.1007/s40618-024-02528-7. Online ahead of print.

ABSTRACT

PURPOSE: Given the established link between GH/insulin-like growth factor 1 (IGF-1) deficiency and severe COVID-19 outcomes, this research seeks to determine whether GH therapy can enhance vaccine efficacy in patients with adult-onset growth hormone deficiency (aGHD).

METHODS: We conducted an observational retrospective study involving two groups: a cohort of 10 patients (8 females, 2 males) with obesity and aGHD who initiated recombinant GH replacement therapy at a standard dose of 0.1 mg/day six months to one year before their first vaccine dose, and a matched control group of 7 patients (5 females, 2 males) with aGHD who had not started GH treatment. Both groups were matched for age, gender, and body mass index (BMI) to ensure comparability. Blood samples were collected 3 to 6 months after the third booster dose of the COVID-19 vaccine (BNT162b2, Pfizer-BioNTech) and analyzed for anti-SARS-CoV-2 antibodies using a commercially available assay.

RESULTS: The GH-treated group exhibited a significantly greater humoral response compared to the untreated group, with a mean antibody titer of 19,122.1 ± 7,736.84 U/mL versus 9,539.14 ± 5,408.90 U/mL in the control group (p = 0.01). Multivariate regression analysis revealed that GH replacement therapy was the only statistically significant predictor of vaccine response, while factors such as male sex, age, and visceral adipose tissue showed negative correlations that did not reach significance.

CONCLUSION: Our findings suggest that GH replacement therapy may enhance the immune response to COVID-19 vaccination in patients with aGHD, potentially improving their overall metabolic health and immune function.

PMID:39899245 | DOI:10.1007/s40618-024-02528-7

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Correction: Baseline Characteristics of the DISCOVER CKD Prospective Cohort

Adv Ther. 2025 Feb 3. doi: 10.1007/s12325-025-03107-9. Online ahead of print.

NO ABSTRACT

PMID:39899224 | DOI:10.1007/s12325-025-03107-9

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Liquid Medication Dosing Errors: Comparison of a Ready-to-Use Vigabatrin Solution to Reconstituted Solutions of Vigabatrin Powder for Oral Solution

Adv Ther. 2025 Feb 3. doi: 10.1007/s12325-024-03089-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Vigabatrin (VGB) is intended for use by caregivers of infants (1 month to 2 years old) diagnosed with infantile spasms (IS). Commercially available vigabatrin powders require caregiver reconstitution prior to oral administration. This study compared the ability of caregivers to accurately provide a targeted dose of vigabatrin using a ready-to-use (RTU) vigabatrin oral solution (VGB-RTU solution) and SABRIL® (vigabatrin) powder for oral solution, Lundbeck LLC, (vigabatrin powder) without instruction from a healthcare professional.

METHODS: A crossover comparative usability study with 30 lay users (15 caregivers with vigabatrin powder experience and 15 oral-syringe/medication preparation naïve users) which required users to deliver a single dose of both VGB-RTU surrogate solution and vigabatrin powder to a sample collection bottle was performed. Doses were measured analytically with a primary endpoint to deliver doses within ± 10% of the target dose of 1125 mg.

RESULTS: All 30 participants administered VGB-RTU solution doses within ± 5% of the target, while only 23/30 of the vigabatrin powder doses were within ± 10%. All naïve users delivered vigabatrin doses using VGB-RTU solution within ± 5% of the target; whereas only 13/15 delivered doses within ± 10% for vigabatrin powder. All experienced vigabatrin users delivered calculated vigabatrin doses using VGB-RTU solution within ± 3%; whereas only 10/15 delivered doses within ± 10% for vigabatrin powder. Users were equally able to accurately deliver the prescribed volumes of both products. Calculated doses of VGB-RTU solution (mg) were significantly less variable (p < 0.0001) and more accurate (p < 0.01) than doses of vigabatrin powder.

CONCLUSION: Caregivers delivered more accurate and less variable doses of the ready-to-use solution compared to solutions prepared from vigabatrin powders for oral solution. These differences were shown to be due to caregiver errors in reconstituting vigabatrin powders for oral solution.

PMID:39899223 | DOI:10.1007/s12325-024-03089-0

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Predicting the risk of invasive fungal infections in ICU sepsis population: the AMI risk assessment tool

Infection. 2025 Feb 3. doi: 10.1007/s15010-024-02465-w. Online ahead of print.

ABSTRACT

BACKGROUND: Invasive fungal infections (IFI) represent a significant contributor to mortality among sepsis patients in the Intensive Care Unit (ICU). Early diagnosis of IFI is challenging, and currently, there are no predictive tools for identifying sepsis patients who may develop IFI. Our study aims to develop a predictive scoring system to assess the risk of IFI in patients with sepsis admitted to the ICU.

METHODS: A retrospective collection of data from a total of 549 patients was conducted. Data-driven, clinically knowledge-driven, and decision tree models were used to identify predictive variables for risk of IFI in ICU patients with sepsis. Demographic data, vital signs, laboratory values, comorbidities, medication use, and clinical outcomes were all collected. The optimal model was selected based on model performance and clinical utility to establish a risk score.

RESULTS: Among adult patients with sepsis admitted to the ICU, 127 patients (23.1%) developed IFI. The final data-driven model included four predictive factors, the clinically knowledge-driven model included three predictive factors, and the decision tree model included two. Based on the good performance and clinical utility of the clinically knowledge-driven model, it was chosen as the optimal risk scoring model (C-statistics: 0.79 (95% confidence interval (CI): 0.75-0.83); Hosmer-Lemeshow (H-L) test P = 0.884). The ICU sepsis patient invasive fungal infection risk (AMI) score, created based on the clinically knowledge-driven model, includes mechanical ventilation, application of immunosuppressants, and the types of antibiotics used. The C-statistics for this risk score was 0.79 (95% CI:0.75-0.84) with good calibration (H-L test P = 0.992 and see calibration curve: Fig. 2). Moreover, in terms of clinical utility, the decision curve analysis for AMI showed a favorable net benefit.

CONCLUSIONS: The application of the AMI score can effectively distinguish whether ICU sepsis patients will develop IFI, which is beneficial for clinicians to formulate targeted and timely preventive and treatment measures based on the risk of IFI.

PMID:39899210 | DOI:10.1007/s15010-024-02465-w

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Human epidermal growth factor receptor-2/neu expression in gallbladder cancer is significantly associated with clinicopathological parameters and survival

Indian J Gastroenterol. 2025 Feb 3. doi: 10.1007/s12664-024-01723-x. Online ahead of print.

ABSTRACT

BACKGROUND: Anti-human epidermal growth factor receptor-2 (Her-2/neu) target therapy has substantially improved the disease outcome of patients with breast and gastric/gastroesophageal cancers characterized by Her-2/neu overexpression and/or amplification. Consequently, evaluating Her-2/neu expression in other cancers to predict response to Her-2/neu targeting agents emerges as a crucial approach. We aimed at investigating the positivity rate of this receptor in gallbladder cancer (GBC) and assess the relationship between Her-2/neu status, clinicopathological parameters and survival to identify patients who would benefit most from anti-Her-2/neu-targeted therapy. The Her-2/neu expression was correlated with clinicopathological parameters and survival of GBC cases.

METHODS: Total 235 surgically resected and histopathologically proven primary GBC cases were collected over a five-year period from January 1, 2017, and December 31, 2020. Her-2/neu expression in these cases was analyzed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH).

RESULTS: Employing testing algorithms (IHC scoring based on gastric cancer criteria, followed by FISH in equivocal cases), Her-2/neu positivity was identified in 43 (18.29%) GBC cases and was significantly associated with grade I tumors, tumor stage > T2, perineural invasion, surgical margin positivity and advanced TNM stage. The mean survival time for Her-2/neu-positive cases was 14 months (SE, 1.1; 95%CI, 11.7-16.06), while it was 20 months (SE, 0.69; 95%CI, 18.1-20.9) for Her-2-negative cases (p < 0.001).

CONCLUSIONS: Her-2/neu is expressed in about one-fifth of GBC patients and is significantly associated with tumor behavior and patient survival. Utilizing novel targeted agents may hold the key to improving the prognosis of these patients.

PMID:39899204 | DOI:10.1007/s12664-024-01723-x

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Effect of atrial high-rate episodes (AHREs) on functional status and quality of life (QoL) in heart failure-cardiac resynchronization therapy population

Egypt Heart J. 2025 Feb 3;77(1):19. doi: 10.1186/s43044-025-00613-7.

ABSTRACT

BACKGROUND: New type of arrhythmia called atrial high-rate episodes (AHREs) has been discovered thanks to the ability of cardiac electronic implantable devices to track, record, and analyze complex arrhythmias. The aim is to determine factors associated with AHRE in HFrEF/CRT patients and the effect of AHRE on functional capacity and quality of life (QoL).

RESULTS: We interrogated 100 patients’ devices to gauge the incidence and burden of AHRE, then assessed their functional capacity using the standard 6-min walk test (6MWT), and evaluated their QoL using the Minnesota Living with HF questionnaire (MLHFQ) score. 34% of patients had AHRE, and 91.2% of them had AF. By multivariate logistic regression analysis, smoking (OR 9.426, 95% CI [1.33, 66.65], P 0.025), higher BMI (OR 1.336, 95% CI [1.09, 1.635], P 0.005), and increased LAVI (OR 1.16, 95% CI [1.063, 1.262], P < 0.001) are independent predictors for AHRE. There was a significant correlation between AHRE and the distance walked during 6MWT when compared to the distance expected for an equivalent healthy individual (82.02 ± 17.22% in the non-AHRE group vs. 75.15 ± 15.78% in the AHRE group, P < 0.001). It was found that AHRE was statistically linked to a higher total MLHFQ score (46.76 ± 9.82 in the AHRE group vs. 36.97 ± 7.76 in the non-AHRE group, P 0.032), with higher physical scores in the AHRE group.

CONCLUSION: AHRE significantly reduces functional status and perceived quality of life in HFrEF patients receiving CRT. Longer than five minutes of AHRE was associated with a higher MLHFQ score and worse performance on the 6MWT. In that patient population, smoking, obesity, and elevated LAVI were independent predictors of AHRE.

PMID:39899192 | DOI:10.1186/s43044-025-00613-7

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Multi-modal dataset creation for federated learning with DICOM-structured reports

Int J Comput Assist Radiol Surg. 2025 Feb 3. doi: 10.1007/s11548-025-03327-y. Online ahead of print.

ABSTRACT

Purpose Federated training is often challenging on heterogeneous datasets due to divergent data storage options, inconsistent naming schemes, varied annotation procedures, and disparities in label quality. This is particularly evident in the emerging multi-modal learning paradigms, where dataset harmonization including a uniform data representation and filtering options are of paramount importance.Methods DICOM-structured reports enable the standardized linkage of arbitrary information beyond the imaging domain and can be used within Python deep learning pipelines with highdicom. Building on this, we developed an open platform for data integration with interactive filtering capabilities, thereby simplifying the process of creation of patient cohorts over several sites with consistent multi-modal data.Results In this study, we extend our prior work by showing its applicability to more and divergent data types, as well as streamlining datasets for federated training within an established consortium of eight university hospitals in Germany. We prove its concurrent filtering ability by creating harmonized multi-modal datasets across all locations for predicting the outcome after minimally invasive heart valve replacement. The data include imaging and waveform data (i.e., computed tomography images, electrocardiography scans) as well as annotations (i.e., calcification segmentations, and pointsets), and metadata (i.e., prostheses and pacemaker dependency).Conclusion Structured reports bridge the traditional gap between imaging systems and information systems. Utilizing the inherent DICOM reference system arbitrary data types can be queried concurrently to create meaningful cohorts for multi-centric data analysis. The graphical interface as well as example structured report templates are available at https://github.com/Cardio-AI/fl-multi-modal-dataset-creation .

PMID:39899185 | DOI:10.1007/s11548-025-03327-y