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Nevin Manimala Statistics

Investigating the population health impact of an oral tobacco-derived nicotine pouch product utilizing a three-product tobacco use population model

Front Public Health. 2026 Feb 25;14:1772045. doi: 10.3389/fpubh.2026.1772045. eCollection 2026.

ABSTRACT

BACKGROUND: This study employed a three-product agent-based model (ABM) to evaluate the potential population-level effects of granting market authorization for on! ® nicotine pouches, an oral tobacco-derived nicotine product. Previous research has typically relied on simplified two-product models comparing cigarette use in a “Base Case” with a “Modified Case” scenario, limiting the ability to reflect real-world multi-product tobacco use patterns. To address this, the ABM in this study incorporated cigarettes and smokeless tobacco (ST) products in the Base Case and added the on! ® nicotine pouches as the Test Product in the Modified Case.

METHODS: Developed in MATLAB® version 9.2, the model consisted of a transition sub-model, which simulated annual changes in product use based on national survey data and Test Product-specific studies, and a mortality sub-model, which linked survival outcomes to product transitions using an excess relative risk estimate of 5% for the Test Product relative to cigarettes. The simulation ran over an 80-year time horizon, predicting individual-level agent dynamics and annual transitions.

RESULTS: Model outputs indicated that introducing the Test Product could prevent approximately 476,000 premature deaths, reduce cigarette prevalence by 0.6 percentage points, and ST product use by 0.3 percentage points, while increasing Test Product use by 1.6 percentage points.

CONCLUSION: These findings suggest that regulatory authorization of on! ® nicotine pouches could yield a net public health benefit by lowering all-cause mortality and reducing the prevalence of use of tobacco products associated with greater health risks.

PMID:41822933 | PMC:PMC12975934 | DOI:10.3389/fpubh.2026.1772045

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Association Between Nasal Septal Deviation and Estimated Pulmonary Artery Pressures-Scoping Review

Clin Otolaryngol. 2026 Mar 12. doi: 10.1111/coa.70098. Online ahead of print.

ABSTRACT

OBJECTIVE: Nasal septal deviation (NSD) is a common cause of chronic upper airway obstruction (UAO), and surgical correction via nasal septoplasty results in improvements in airflow. Multiple studies have been conducted to assess possible relationships between chronic UAO (including due to NSD) and cardiorespiratory function (such as pulmonary artery pressures). The objective of this scoping review is to identify and examine the current evidence on the potential relationship between nasal septal deviation, estimated mean pulmonary artery pressure (mPAP), and estimated pulmonary artery systolic pressure (ePASP) in patients who undergo nasal septoplasty.

DATA SOURCES: PubMed, EMBASE, Ovid.

METHODS: A scoping review was performed in accordance with the PRISMA Extension for Scoping Reviews guidelines.

RESULTS: Two independent reviewers screened 411 articles; 9 before-after studies met eligibility criteria for review inclusion. There was a total of 458 study participants, of which 395 underwent septoplasty and 63 were matched controls. All studies reported a statistically significant decrease between the pre-operative and post-operative estimated mPAP (p < 0.05) and/or ePASP (p < 0.001) in subjects who underwent nasal septoplasty. Two studies included control participants and reported a statistically significant difference between the pre-operative estimated mPAP of patients with NSD and controls (p < 0.001).

CONCLUSION: This scoping review highlights the current evidence on the potential relationship between NSD, estimated mPAP, and ePASP in patients who undergo nasal septoplasty for NSD. Further studies of higher statistical and methodological quality are required to assess for cause-and-effect relationships and examine the potential link between chronic UAO and cardiorespiratory function.

PMID:41820243 | DOI:10.1111/coa.70098

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Late diagnosis of HIV persists in Sweden: Differing social determinants among migrant and non-migrant people with HIV

HIV Med. 2026 Mar 12. doi: 10.1111/hiv.70217. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine temporal changes in late diagnosis of HIV (LD) among migrant and non-migrant people with HIV in Sweden 2003-2023 and to assess demographic and socioeconomic risk factors for LD in these two populations.

METHODS: People with HIV diagnosed with HIV-1 in Sweden 2003-2023 were included (n = 6278). LD was defined as a first CD4+ T-cell count <350 cells/μL or an AIDS-defining event within 3 months of diagnosis. People with HIV with evidence of recent infection were reclassified as non-late. Temporal changes in LD were examined using descriptive statistics and regression analyses. To assess risk factors for LD, modified Poisson regression was employed. Risk factor analyses were restricted to 2010-2020 when complete sociodemographic data were available (n = 2778). Data were obtained from Swedish national registries.

RESULTS: The absolute incidence of total and late HIV diagnoses decreased over the study period, whereas the annual proportion of LD varied between 46% and 60% and trended upwards. LD occurred in 41% of non-migrant people with HIV and 58% of migrant people with HIV. Among non-migrant people with HIV, having an upper secondary education or less was associated with LD compared to post-secondary education, as was male sex with heterosexual HIV acquisition and higher age. For migrant people with HIV, neither lower education nor income was statistically significantly associated with LD. Instead, higher age, certain birth regions, heterosexual acquisition and male sex with acquisition through injection drug use were associated with LD.

CONCLUSIONS: LD declined in absolute terms yet constituted a high and increasing proportion of new HIV cases in Sweden 2003-2023, with differing sociodemographic determinants by migrant status.

PMID:41820237 | DOI:10.1111/hiv.70217

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Design of Bayesian Clinical Trials With Clustered Data

Stat Med. 2026 Mar;45(6-7):e70488. doi: 10.1002/sim.70488.

ABSTRACT

In the design of clinical trials, it is essential to assess the design operating characteristics (e.g., power and the type I error rate). Common practice for the evaluation of operating characteristics in clinical trials that employ Bayesian analysis and decision procedures relies on estimating the sampling distribution of posterior summaries via Monte Carlo simulation. It is computationally intensive to repeat this estimation process for each design configuration considered, particularly for clustered data that are analyzed using complex, high-dimensional models. In this paper, we propose an efficient method to assess operating characteristics and determine sample sizes for Bayesian trials with clustered data. We prove theoretical results that enable posterior probabilities to be modeled as a function of the number of clusters. Using these functions, we assess operating characteristics at a range of sample sizes given simulations conducted at only two values for the number of clusters. These theoretical results are also leveraged to quantify the impact of simulation variability on our sample size recommendations. The applicability of our methodology is illustrated using an example Bayesian cluster-randomized clinical trial.

PMID:41820232 | DOI:10.1002/sim.70488

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Dynamic Borrowing With a Bias-Tolerance Cap in Augmented Randomized Controlled Trials

Stat Med. 2026 Mar;45(6-7):e70473. doi: 10.1002/sim.70473.

ABSTRACT

Although randomized controlled trials (RCTs) are the gold standard for evaluating the efficacy and safety of treatments, they are challenged by cost, duration, enrollment, or ethical concerns. A possible solution is to incorporate external control data as a hybrid control group, for which various statistical methods are available. However, only a few of them account for confounding bias due to unknown/unmeasured covariates between the internal and external control data. Moreover, the amount of this potential bias cannot be measured using most existing methods without extensive simulations. Here, we propose a novel method for estimating the confounding effects of unmeasured covariates based on model-based regression standardization, inverse probability weighting, and augmented inverse probability weighting for continuous or binary outcomes. We also propose an estimator that dynamically borrows external data and uses a weighted mean, adjusting weights according to the estimated confounding effect of unmeasured covariates. In the proposed method, the expected amount of bias can be controlled within a prespecified “bias-tolerance cap,” which may facilitate a better discussion among stakeholders about whether an effect estimate has unacceptable bias by utilizing external control data in a planning phase. Simulations showed that the proposed method regulates bias within the tolerance cap, regardless of the magnitude of confounding by unmeasured covariates, while greatly improving power and efficiency when confounding is absent. Finally, we illustrate an applicational example of our proposed method to an actual RCT and the external control datasets for patients with advanced pancreatic cancer.

PMID:41820222 | DOI:10.1002/sim.70473

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Assessment of Micro-TRAIN simulation in otologic microsurgery

Eur Ann Otorhinolaryngol Head Neck Dis. 2026 Mar 11:S1879-7296(26)00048-7. doi: 10.1016/j.anorl.2026.02.008. Online ahead of print.

ABSTRACT

OBJECTIVES: Temporal bone drilling simulators are valuable tools for developing anatomical knowledge and drill handling motor skills. However, there are currently no simulators focusing on learning fine microsurgical gestures using micro-instruments. The aim of this study was to validate a training kit and simulation program dedicated to otologic microsurgery.

MATERIALS AND METHODS: A prospective single-center comparative study was conducted. The Micro-TRAIN kit comprised a mannequin and six interchangeable exercise modules. Two simulation sessions were conducted two months apart, with debriefing for two selected subgroups after the first session. Progression in performance, assessed by task completion time, execution time and technical skills, was evaluated in three groups: 10 novices, 10 intermediate level and 5 experts. Content validity, face validity and participant satisfaction were also assessed.

RESULTS: In session 1, there were significant differences in performance between the three groups (P<0.005). Both the novice and intermediate groups showed improvement between sessions. Improvement in total score in the intermediate group was statistically significant (P=0.0019) and suggestive in the novice group (P=0.0059). Participants who received debriefing tended to improve more (novices: P=0.012; intermediate: P=0.036). Experts rated the simulator’s realism and relevance as above 8/10.

CONCLUSION: This study confirmed the content, face and construct validity of the Micro-TRAIN simulator. It is an effective tool for acquiring microsurgical skills in otologic surgery.

PMID:41820176 | DOI:10.1016/j.anorl.2026.02.008

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Outcomes of SARS-CoV-2 infection post-solid organ transplantation in the cystic fibrosis population

J Cyst Fibros. 2026 Mar 11:S1569-1993(26)00038-X. doi: 10.1016/j.jcf.2026.02.009. Online ahead of print.

ABSTRACT

BACKGROUND: Cystic fibrosis (CF) transplant recipients infected with SARS-CoV-2 are at high risk for hospitalization or death. We aimed to (1) assess whether time since solid organ transplantation impacts severity of SARS-CoV-2 infection and (2) to evaluate the impact of SARS-CoV-2 infection on the slope of lung function trajectory.

METHODS: This is a retrospective international cohort study of individuals with CF post-solid organ transplant with a confirmed SARS-CoV-2 infection between January 2020 and December 2021. The primary outcome was death or hospitalization. The secondary outcome was change in lung function trajectory following infection. To assess the impact of time from transplant on the primary outcome, logistic regression was performed while lung function trajectory was assessed using a linear mixed-effects model.

RESULTS: A total of 526 SARS-CoV-2 infections from 19 countries were recorded. The median age at time of infection was 36 years (IQR 29-44). Median time since transplant was 5.8 years (IQR 3.3-10.8). The timing of transplant relative to infection was not significantly associated with hospitalization or death (OR 0.975 CI 0.928-1.025). A higher baseline ppFEV1 was associated with a decreased odds of death or hospitalization (OR 0.989, 95% CI 0.983, 0.995). In a subgroup of participants, lung function trajectory did not change significantly in the year following SARS-CoV-2 infection.

CONCLUSIONS: In a diverse global post-transplant CF population, the timing of transplantation was not significantly associated with severe outcomes following SARS-CoV-2 infection. Those with more severe lung disease were at increased risk for worse outcomes and should be monitored closely.

PMID:41820127 | DOI:10.1016/j.jcf.2026.02.009

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Automated Creak Detection in Spanish Speakers with and without AdLD

J Voice. 2026 Mar 11:S0892-1997(26)00049-4. doi: 10.1016/j.jvoice.2026.01.045. Online ahead of print.

ABSTRACT

OBJECTIVES: Adductor laryngeal dystonia (AdLD) is a neurological voice disorder characterized by involuntary spasms of the adductor laryngeal muscles during phonation. An automated creak detector has shown promise in differentiating English speakers with AdLD from controls. However, no study has yet investigated creak in AdLD in Spanish speakers. In fact, there is a paucity of research validating tools to identify laryngeal dystonia (LD) in languages other than English. The purpose of this study was to determine whether creak differentiates Spanish-speaking individuals with and without AdLD.

METHODS: Twenty speakers with AdLD, twenty speakers without voice disorders (controls), and twenty speakers with glottic insufficiency were recorded in a clinical environment. Each participant read a set of recently developed Spanish stimuli designed for LD screening, containing voiced and voiceless loaded sentences. An open-source creak detector was used to calculate the percentage of creak in each speaker’s recording. Mean smoothed cepstral peak prominence (CPPS) per speaker was calculated in Praat.

RESULTS: A Pearson’s correlation revealed a moderate relationship between creak and CPPS across groups (r = -0.56). An analysis of covariance revealed a statistically significant effect of creak between groups (F(3, 56) = 13.52, P > 0.05, R2 = 0.39). Three receiver operating characteristic curve analyses indicated that creak differentiated AdLD and Controls (area under the curve [AUC] = 0.88), as well as AdLD and Glottic Insufficiency with acceptable diagnostic accuracy (AUC = 0.73), but not between control or glottic insufficiency groups.

CONCLUSIONS: Creak differentiated Spanish speakers with and without AdLD with moderate discrimination. Although creak and CPPS were moderately correlated, when controlling for CPPS, creak was statistically different between speakers with AdLD and speakers with glottic insufficiency, and between speakers with AdLD and controls. Further work is needed to determine the clinical utility of creak in aiding a differential diagnosis of AdLD and muscle tension dysphonia in Spanish-speaking individuals.

PMID:41820120 | DOI:10.1016/j.jvoice.2026.01.045

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Analysis of clinical, pathological and molecular genetic characteristics of conjunctival melanoma

Zhonghua Yan Ke Za Zhi. 2026 Mar 11;62(3):214-222. doi: 10.3760/cma.j.cn112142-20250425-00203.

ABSTRACT

Objective: To investigate the clinical, pathological and molecular genetic characteristics of conjunctival melanoma (CoM). Methods: A retrospective case series study was conducted. The clinical, imaging and pathological data of patients diagnosed with CoM from January 2004 to June 2025 at Shaanxi Eye Hospital of Xi’an People’s Hospital (Xi’an Fourth Hospital) and Xi’an First Hospital were analyzed. Some patients were detected for the BRAF V600E mutation. The χ2 test or the χ2 correction test was used for statistical analysis. Results: A total of 70 patients (70 eyes) with CoM were enrolled, aged (60.8±10.6) years, including 40 males (57.1%) and 30 females (42.9%). There were 33 cases (47.1%) in the left eye and 37 cases (52.9%) in the right eye. The tumor was located at the bulbar conjunctiva in 37 cases (52.9%), at the vault conjunctiva in 24 cases (34.2%), and at the palpebral conjunctiva in 9 cases (12.9%), involving the orbit in 13 cases (18.6%), the eyeball in 3 cases (4.3%), and the lacrimal sac in 6 cases (8.6%). Most patients presented with black nodules or cauliflower-like masses in the conjunctival area. Some tumors were accompanied by superficial vascular hyperplasia and pigmentation of adjacent tissues, while some invaded the cornea or orbit, resulting in clinical manifestations such as visual field defects, exophthalmos and limited movement. Imaging showed irregular soft tissue density shadows at the conjunctival site. According to the criteria of the American Joint Committee on Cancer, the tumor was at the T1 stage in 10 cases (14.3%), T2 stage in 41 cases (58.6%), and T3 stage in 19 cases (27.1%), with superficial ulcers in 6 cases (8.6%). Histopathology results disclosed that 67 cases (95.7%) were of the nodular type, 3 cases (4.3%) were of the superficially diffuse type, 47 cases (67.1%) were of the epithelial cell type, and 23 cases (32.9%) were of the mixed cell type. Sixty-three cases (90.0%) were accompanied by melanin, 32 cases (45.7%) were accompanied by primary acquired melanosis, including 23 cases (32.9%) with atypical primary acquired melanosis and 2 cases (2.9%) with conjunctival nevus, and 48 cases (68.6%) had tumor infiltrating lymphocytes. Immunohistochemistry demonstrated positive melanin markers such as human melanoma-associated antigen 45, melanocyte antigen A, S-100 protein and sex-determining region Y-frame protein 10. Thirty cases (42.9%) completed the detection of BRAF V600E mutations, of which 11 had BRAF V600E point mutations, with a positive rate of 36.7%. Sixty-two patients (88.6%) were followed up, with a recurrence rate of 27.4% (17/62), a metastasis rate of 19.4% (12/62), and a case fatality rate of 54.8% (34/62). The recurrence rate was 4/5 among patients with ulcers, versus 22.8% (13/57) among patients without ulcers (χ2=4.96, P=0.026); it was 8/13 among patients with orbital invasion, versus 18.3% (9/49) among patients without orbital invasion (χ2=9.62, P=0.002). Thirty-four patients (48.5%) underwent complete resection of the ocular mass, 16 (22.9%) underwent partial resection, and 20 (28.6%) underwent ocular or intraorbital enucleation. Ten patients (14.3%) received BRAF inhibitor-targeted therapy. Seven patients had a significant reduction of the residual mass and no tumor progression, and 3 patients did not respond to the treatment and died from the disease progression. Conclusions: CoM mostly occurs in the unilateral eye of middle-aged and elderly patients, more common at the bulbar conjunctiva and fornix conjunctiva, and histopathological epithelial cell types are the main types, with a high recurrence and metastasis rate.

PMID:41820066 | DOI:10.3760/cma.j.cn112142-20250425-00203

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Recurrence of peripheral anterior synechiae following phacoemulsification combined with intraocular lens implantation and goniosynechialysis in primary angle-closure glaucoma: an intermediate and long-term analysis

Zhonghua Yan Ke Za Zhi. 2026 Mar 11;62(3):202-208. doi: 10.3760/cma.j.cn112142-20250425-00198.

ABSTRACT

Objective: To report the recurrence of peripheral angle synechiae (PAS) in primary angle-closure glaucoma (PACG) after phacoemulsification combined with intraocular lens implantation and goniosynechialysis (PEI-GSL) during an intermediate-and long-term follow-up. Methods: This retrospective case series included patients with acute or chronic PACG who underwent PEI-GSL performed by the same surgeon at the Eye Hospital of Wenzhou Medical University between January 2017 and December 2019, with complete postoperative gonioscopic records. The primary outcome measures were the incidence and extent (in clock hours) of recurrent PAS at the last follow-up. The secondary outcomes included the surgical success rate, intraocular pressure, and the number of intraocular pressure-lowering medications. The intergroup comparisons were performed using the generalized estimating equation. The intragroup comparisons before and after surgery were analyzed using the Wilcoxon signed-rank test. The categorical data were compared using the Chi-square test or Fisher’s exact test. Results: A total of 57 patients (69 eyes) were included, with a mean follow-up of 23.3±9.0 months. Among them, 37 patients (41 eyes) had acute PACG [9 males (24.3%), 28 females (75.7%); mean age, (68.6±8.6) years], and 20 patients (28 eyes) had chronic PACG [8 males (40.0%), 12 females (60.0%); mean age, (65.1±8.8) years]. There were no statistically significant differences in gender or age between the two groups (both P>0.05). At the last follow-up, 46.4% (32/69) of eyes maintained a full-circle anterior chamber angle opening or had only several spot adhesions, 82.6% (57/69) had PAS limited to one quadrant, and 89.9% (62/69) had PAS involving fewer than 6 clock hours. The recurrence rate of PAS was 31.9% (22/69) in all eyes, while it was 26.8% (11/41) in eyes with acute PACG, and 39.3% (11/28) in eyes with chronic PACG, with no statistically significant difference (χ²=1.92, P=0.165). However, the extent of recurrent PAS was greater in chronic PACG patients [4.50 (2.50, 8.50) clock hours] than in acute PACG patients [3.00 (1.50, 4.50) clock hours], and this difference was statistically significant (Wald χ²=5.39, P=0.020). Conclusions: Approximately 30% of eyes with PACG develop recurrent PAS after PEI-GSL, but 90% maintain an angle opening over 180°.

PMID:41820064 | DOI:10.3760/cma.j.cn112142-20250425-00198