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Nevin Manimala Statistics

Challenges in the Assessment of a Disease Model in the NICE Single Technology Appraisal of Tirzepatide for Treating Type 2 Diabetes: An External Assessment Group Perspective

Pharmacoeconomics. 2024 May 8. doi: 10.1007/s40273-024-01394-8. Online ahead of print.

NO ABSTRACT

PMID:38717708 | DOI:10.1007/s40273-024-01394-8

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Nevin Manimala Statistics

Evaluating the cost of robotic-assisted total and unicompartmental knee arthroplasty

J Robot Surg. 2024 May 8;18(1):206. doi: 10.1007/s11701-024-01932-8.

ABSTRACT

As uptake of robotic-assisted arthroplasty increases there is a need for economic evaluation of the implementation and ongoing costs associated with robotic surgery. The aims of this study were to describe the in-hospital cost of robotic-assisted total knee arthroplasty (RA-TKA) and robotic-assisted unicompartmental knee arthroplasty (RA-UKA) and determine the influence of patient characteristics and surgical outcomes on cost. This prospective cohort study included adult patients (≥ 18 years) undergoing primary unilateral RA-TKA and RA-UKA, at a tertiary hospital in Sydney between April 2017 and June 2021. Patient characteristics, surgical outcomes, and in-hospital cost variables were extracted from hospital medical records. Differences between outcomes for RA-TKA and RA-UKA were compared using independent sample t-tests. Logistic regression was performed to determine drivers of cost. Of the 308 robotic-assisted procedures, 247 were RA-TKA and 61 were RA-UKA. Surgical time, time in the operating room, and length of stay were significantly shorter in RA-UKA (p < 0.001); whereas RA-TKA patients were older (p = 0.002) and more likely to be discharged to in-patient rehabilitation (p = 0.009). Total in-hospital cost was significantly higher for RA-TKA cases (AU$18580.02 vs $13275.38; p < 0.001). Robotic system and maintenance cost per case was AU$3867.00 for TKA and AU$5008.77 for UKA. Patients born overseas and lower volume robotic surgeons were significantly associated with higher total cost of RA-UKA. Increasing age and male gender were significantly associated with higher total cost of RA-TKA. Total cost was significantly higher for RA-TKA than RA-UKA. Robotic system costs for RA-UKA are inflated by the software cost relative to the volume of cases compared with RA-TKA. Cost is an important consideration when evaluating long term benefits of robotic-assisted knee arthroplasty in future studies to provide evidence for the economic sustainability of this practice.

PMID:38717705 | DOI:10.1007/s11701-024-01932-8

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Nevin Manimala Statistics

Predicting healthcare expenditure based on Adjusted Morbidity Groups to implement a needs-based capitation financing system

Health Econ Rev. 2024 May 8;14(1):33. doi: 10.1186/s13561-024-00508-4.

ABSTRACT

BACKGROUND: Due to population aging, healthcare expenditure is projected to increase substantially in developed countries like Spain. However, prior research indicates that health status, not merely age, is a key driver of healthcare costs. This study analyzed data from over 1.25 million residents of Spain’s Murcia region to develop a capitation-based healthcare financing model incorporating health status via Adjusted Morbidity Groups (AMGs). The goal was to simulate an equitable area-based healthcare budget allocation reflecting population needs.

METHODS: Using 2017 data on residents’ age, sex, AMG designation, and individual healthcare costs, generalized linear models were built to predict healthcare expenditure based on health status indicators. Multiple link functions and distribution families were tested, with model selection guided by information criteria, residual analysis, and goodness-of-fit statistics. The selected model was used to estimate adjusted populations and simulate capitated budgets for the 9 healthcare districts in Murcia.

RESULTS: The gamma distribution with logarithmic link function provided the best model fit. Comparisons of predicted and actual average costs revealed underfunded and overfunded areas within Murcia. If implemented, the capitation model would decrease funding for most districts (up to 15.5%) while increasing it for two high-need areas, emphasizing allocation based on health status and standardized utilization rather than historical spending alone.

CONCLUSIONS: AMG-based capitated budgeting could improve equity in healthcare financing across regions in Spain. By explicitly incorporating multimorbidity burden into allocation formulas, resources can be reallocated towards areas with poorer overall population health. Further policy analysis and adjustment is needed before full-scale implementation of such need-based global budgets.

PMID:38717699 | DOI:10.1186/s13561-024-00508-4

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Nevin Manimala Statistics

Evolving Improved Sampling Protocols for Dose-Response Modelling Using Genetic Algorithms with a Profile-Likelihood Metric

Bull Math Biol. 2024 May 8;86(6):70. doi: 10.1007/s11538-024-01304-1.

ABSTRACT

Practical limitations of quality and quantity of data can limit the precision of parameter identification in mathematical models. Model-based experimental design approaches have been developed to minimise parameter uncertainty, but the majority of these approaches have relied on first-order approximations of model sensitivity at a local point in parameter space. Practical identifiability approaches such as profile-likelihood have shown potential for quantifying parameter uncertainty beyond linear approximations. This research presents a genetic algorithm approach to optimise sample timing across various parameterisations of a demonstrative PK-PD model with the goal of aiding experimental design. The optimisation relies on a chosen metric of parameter uncertainty that is based on the profile-likelihood method. Additionally, the approach considers cases where multiple parameter scenarios may require simultaneous optimisation. The genetic algorithm approach was able to locate near-optimal sampling protocols for a wide range of sample number (n = 3-20), and it reduced the parameter variance metric by 33-37% on average. The profile-likelihood metric also correlated well with an existing Monte Carlo-based metric (with a worst-case r > 0.89), while reducing computational cost by an order of magnitude. The combination of the new profile-likelihood metric and the genetic algorithm demonstrate the feasibility of considering the nonlinear nature of models in optimal experimental design at a reasonable computational cost. The outputs of such a process could allow for experimenters to either improve parameter certainty given a fixed number of samples, or reduce sample quantity while retaining the same level of parameter certainty.

PMID:38717656 | DOI:10.1007/s11538-024-01304-1

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Nevin Manimala Statistics

Producing two-dimensional dust clouds and clusters using a movable electrode for complex plasma and fundamental physics experiments

Rev Sci Instrum. 2024 May 1;95(5):053503. doi: 10.1063/5.0203259.

ABSTRACT

We report a Bidirectional Electrode Control Arm Assembly (BECAA) for precisely manipulating dust clouds levitated above the powered electrode in RF plasmas. The reported techniques allow the creation of perfectly 2D dust layers by eliminating off-plane particles by moving the electrode from outside the plasma chamber without altering the plasma conditions. The tilting and moving of electrodes using BECAA also allows the precise and repeatable elimination of dust particles one by one to achieve any desired number of grains N without trial and error. Simultaneously acquired top and side view images of dust clusters show that they are perfectly planar or 2D. A demonstration of clusters with N = 1-28 without changing the plasma conditions is presented to show the utility of BECAA for complex plasma and statistical physics experimental design. Demonstration videos and 3D printable part files are available for easy reproduction and adaptation of this new method to repeatably produce 2D clusters in existing RF plasma chambers.

PMID:38717655 | DOI:10.1063/5.0203259

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Nevin Manimala Statistics

A constrained maximum likelihood approach to developing well-calibrated models for predicting binary outcomes

Lifetime Data Anal. 2024 May 8. doi: 10.1007/s10985-024-09628-9. Online ahead of print.

ABSTRACT

The added value of candidate predictors for risk modeling is routinely evaluated by comparing the performance of models with or without including candidate predictors. Such comparison is most meaningful when the estimated risk by the two models are both unbiased in the target population. Very often data for candidate predictors are sourced from nonrepresentative convenience samples. Updating the base model using the study data without acknowledging the discrepancy between the underlying distribution of the study data and that in the target population can lead to biased risk estimates and therefore an unfair evaluation of candidate predictors. To address this issue assuming access to a well-calibrated base model, we propose a semiparametric method for model fitting that enforces good calibration. The central idea is to calibrate the fitted model against the base model by enforcing suitable constraints in maximizing the likelihood function. This approach enables unbiased assessment of model improvement offered by candidate predictors without requiring a representative sample from the target population, thus overcoming a significant practical challenge. We study theoretical properties for model parameter estimates, and demonstrate improvement in model calibration via extensive simulation studies. Finally, we apply the proposed method to data extracted from Penn Medicine Biobank to inform the added value of breast density for breast cancer risk assessment in the Caucasian woman population.

PMID:38717617 | DOI:10.1007/s10985-024-09628-9

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Nevin Manimala Statistics

Association of Renin-Angiotensin Pathway Gene Polymorphisms with COVID-19 Susceptibility and Severity in Moroccans: A Case-Control Study

Biochem Genet. 2024 May 8. doi: 10.1007/s10528-024-10813-6. Online ahead of print.

ABSTRACT

Infection by the recent SARS-CoV-2 virus causes the COVID-19 disease with variable clinical manifestations ranging from asymptomatic or mild respiratory symptoms to severe respiratory distress and multiorgan failure. The renin-angiotensin system, responsible for maintaining homeostasis and governing several critical processes, has been considered the main system involved in the pathogenesis and progression of COVID-19. Here, we aimed to assess the possible association between variants in the RAS-related genes and COVID-19 susceptibility and severity in a sample of the Moroccan population. A total of 325 individuals were recruited in this study, with 102 outpatients, 105 hospitalized patients, and 118 healthy controls negative for SARS-CoV-2 infection, and subjected to NGS gene panel sequencing containing eleven RAS pathway genes. A total of 65 functional variants were identified, including 63 missenses, 1 splice, and 1 INDEL. Most of them were rare, with 47 (72%) found in a single individual. According to the common disease/common variant hypothesis, five common candidate variants with MAF > 10% were identified (ACE2 rs2285666, TMPRSS2 rs12329760, AGT rs699 genes, ACE rs4341, and ACE rs4343). Statistical analysis showed that the ACE rs4343 AA genotype was associated with a 2.5-fold increased risk of severe COVID-19 (p = 0.026), and the T genotype of the ACE2 rs2285666 variant showed a borderline association with susceptibility to SARS-CoV-2 in males (p = 0.097). In conclusion, our results showed that the RAS pathway genes are highly conserved among Moroccans, and most of the identified variants are rare. Among the common variants, the ACE rs4343 polymorphism would lead to a genetic predisposition for severe COVID-19.

PMID:38717614 | DOI:10.1007/s10528-024-10813-6

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Nevin Manimala Statistics

Spatial pattern analysis of the impact of community food environments on foetal macrosomia, preterm births and low birth weight

Geospat Health. 2024 May 7;19(1). doi: 10.4081/gh.2024.1249.

ABSTRACT

Community food environments (CFEs) have a strong impact on child health and nutrition and this impact is currently negative in many areas. In the Republic of Argentina, there is a lack of research evaluating CFEs regionally and comprehensively by tools based on geographic information systems (GIS). This study aimed to characterize the spatial patterns of CFEs, through variables associated with its three dimensions (political, individual and environmental), and their association with the spatial distribution in urban localities in Argentina. CFEs were assessed in 657 localities with ≥5,000 inhabitants. Data on births and CFEs were obtained from nationally available open-source data and through remote sensing. The spatial distribution and presence of clusters were assessed using hotspot analysis, purely spatial analysis (SaTScan), Moran’s Index, semivariograms and spatially restrained multivariate clustering. Clusters of low risk for LBW, macrosomia, and preterm births were observed in the central-east part of the country, while high-risk clusters identified in the North, Centre and South. In the central-eastern region, low-risk clusters were found coinciding with hotspots of public policy coverage, high night-time light, social security coverage and complete secondary education of the household head in areas with low risk for negative outcomes of the birth variables studied, with the opposite with regard to households with unsatisfied basic needs and predominant land use classes in peri-urban areas of crops and herbaceous cover. These results show that the exploration of spatial patterns of CFEs is a necessary preliminary step before developing explanatory models and generating novel findings valuable for decision-making.

PMID:38716709 | DOI:10.4081/gh.2024.1249

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Nevin Manimala Statistics

Cardiovascular Outcomes in Hypertension-Treated Patients With Peripheral Artery Disease: The VALUE Trial

Hypertension. 2024 May 8. doi: 10.1161/HYPERTENSIONAHA.124.22832. Online ahead of print.

ABSTRACT

BACKGROUND: Systolic blood pressure (BP) is a key predictor of cardiovascular events, but patients with peripheral artery disease (PAD) are rarely included in hypertension trials. The VALUE trial (Valsartan Antihypertensive Long-Term Use Evaluation) investigated the long-term effects of valsartan- or amlodipine-based treatments on cardiovascular outcomes in patients with hypertension with a high cardiovascular risk. The aim of this subanalysis was to clarify the relationship between achieved BP on treatment and cardiovascular outcomes in patients with hypertension with PAD.

METHODS: Patients were followed for 4 to 6 years, and BP was measured regularly. The primary end point was time to the first major adverse cardiovascular event, including myocardial infarction, stroke, cardiovascular death, and heart failure requiring hospitalization. Statistical analyses were performed using Cox regression, adjusting for various baseline covariates.

RESULTS: Of the 13 803 participants, 1898 (13.8%) had PAD. During a median follow-up of 4.5 years, patients with PAD had a 23% increased risk of major adverse cardiovascular events compared with patients without PAD. Patients with an achieved systolic BP <130 mm Hg and 130 to 139 mm Hg, compared with those with systolic BP ≥140 mm Hg, were associated with a decreased risk of a major adverse cardiovascular event (hazard ratio, 0.65 [95% CI, 0.43-0.97]; P=0.037; 0.85 [95% CI, 0.74-0.97]; P=0.016, respectively). Additionally, systolic BP <130 mm Hg was associated with a decreased risk of cardiovascular death (hazard ratio, 0.33 [95% CI, 0.12-0.92]; P=0.034). The incidence of the primary outcome did not differ between antihypertensive treatment regimens (P=0.365).

CONCLUSIONS: Our results indicate that more intensive BP control is associated with a reduction in cardiovascular morbidity and mortality in patients with hypertensive PAD.

PMID:38716657 | DOI:10.1161/HYPERTENSIONAHA.124.22832

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Nevin Manimala Statistics

The value of microvascular breast reconstruction: Cost equivalence of TRAM and DIEP flaps implications in the era of CMS reforms

Microsurgery. 2024 May;44(4):e31185. doi: 10.1002/micr.31185.

ABSTRACT

BACKGROUND: Recent CMS billing changes have raised concerns about insurance coverage for deep inferior epigastric perforator (DIEP) flap breast reconstruction. This study compared the costs and utilization of transverse rectus abdominis myocutaneous (TRAM), DIEP, and latissimus dorsi (LD) flaps in breast reconstruction.

METHOD: The study utilized the National Inpatient Sample database to identify female patients who underwent DIEP, TRAM, and LD flap procedures from 2016 to 2019. Key data such as patient demographics, length of stay, complications, and costs (adjusted to 2021 USD) were analyzed, focusing on differences across the flap types.

RESULTS: A total of 17,770 weighted patient encounters were identified, with the median age being 51. The majority underwent DIEP flaps (73.5%), followed by TRAM (14.2%) and LD (12.1%) flaps. The findings revealed that DIEP and TRAM flaps had a similar length of stay (LOS), while LD flaps typically had a shorter LOS. The total hospital charges to costs using cost-to-charge ratio were also comparable between DIEP and TRAM flaps, whereas LD flaps were significantly less expensive. Factors such as income quartile, primary payer of hospitalization, and geographic region significantly influenced flap choice.

CONCLUSION: The study’s results appear to contradict the prevailing notion that TRAM flaps are more cost-effective than DIEP flaps. The total hospital charges to costs using cost-to-charge ratio and hospital stays associated with TRAM and DIEP flaps were found to be similar. These findings suggest that changes in the insurance landscape, which may limit the use of DIEP flaps, could undermine patient autonomy while not necessarily reducing healthcare costs. Such policy shifts could favor less costly options like the LD flap, potentially altering the landscape of microvascular breast reconstruction.

PMID:38716656 | DOI:10.1002/micr.31185