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Nevin Manimala Statistics

COVID-19 Booster Vaccine Messaging in Emergency Departments: A Cluster Randomized Clinical Trial

JAMA Netw Open. 2025 Oct 1;8(10):e2537655. doi: 10.1001/jamanetworkopen.2025.37655.

ABSTRACT

IMPORTANCE: Patient uptake of updated COVID-19 vaccines is crucial for reducing severe outcomes, yet national uptake remains low.

OBJECTIVE: To determine if tailored messaging or simple inquiry about vaccine acceptance increases 30-day uptake of updated COVID-19 vaccines among emergency department (ED) patients.

DESIGN, SETTING, AND PARTICIPANTS: This 3-arm, cluster randomized clinical trial conducted from January 29 to June 18, 2024, enrolled adult ED patients who had not received a COVID-19 vaccine in the prior 6 months across 6 EDs in San Francisco, California; Philadelphia, Pennsylvania; Houston, Texas; and Durham, North Carolina.

INTERVENTIONS: Intervention M involved tailored messaging about updated COVID-19 vaccines and inquiry about vaccine acceptance. Intervention Q involved only inquiry about vaccine acceptance. Usual care (no messaging or vaccine acceptance questions) served as the control.

MAIN OUTCOMES AND MEASURES: The primary outcome was updated COVID-19 vaccine receipt within 30 days of the ED visit, assessed via electronic health record review and follow-up telephone calls. Secondary outcomes included vaccine acceptance and vaccination during the ED visit. Outcomes were also compared between study sites that had the updated COVID-19 vaccine available and those that did not.

RESULTS: Of 852 participants (median age, 47 years [IQR, 33-63 years]; 464 [54.5%] women), 247 (29.0%) were in the intervention M group, 273 (32.0%) in the intervention Q group, and 332 (39.0%) in the control group. Vaccine uptake at 30 days was not significantly higher in either the intervention M group compared with control (14 participants [5.7%] vs 10 [3.0%]; absolute difference, 2.7 percentage points [pp] [95% CI, -0.8 to 6.3 pp]) or the intervention Q group compared with control (11 [4.0%] vs 10 [3.0%]; absolute difference, 1.0 pp [95% CI, -2.0 to 4.2 pp]). However, at sites where vaccines were available, the intervention M group had higher uptake compared with control (13 of 132 [9.8%] vs 5 of 150 [3.3%]; absolute difference, 6.5 pp [95% CI, 0.5-12.5 pp]).

CONCLUSIONS AND RELEVANCE: In this cluster randomized clinical trial of adult ED patients, tailored messaging and simple inquiry alone did not significantly increase 30-day updated COVID-19 vaccine uptake among patients. The slight increase in uptake among participants in the EDs that had access to the updated COVID-19 vaccines suggested that vaccine availability was an effect modifier, underscoring the importance of opportunity and convenience in vaccine delivery.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06156215.

PMID:41091465 | DOI:10.1001/jamanetworkopen.2025.37655

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CALLY index as an independent predictor of pathological complete response in HER2-positive breast cancer receiving neoadjuvant therapy

Clin Transl Oncol. 2025 Oct 15. doi: 10.1007/s12094-025-04077-8. Online ahead of print.

ABSTRACT

PURPOSE: Pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) is a validated endpoint for long-term survival in HER2-positive breast cancer. Identifying clinical and biomarker-based predictors of pCR is essential for optimizing treatment strategies. This study investigated the predictive role of nutrition- and inflammation-based indices (HALP, CALLY, PNI, SII, PIV, SIRI, NLR) in determining pCR.

METHODS: A total of 169 HER2-positive patients who underwent NACT followed by surgery at Ankara Etlik City Hospital between January 2023 and December 2024 were retrospectively analyzed. Indices were calculated from baseline laboratory values. Receiver operating characteristic (ROC) analysis was used to evaluate discriminatory ability and determine cut-off values for significant variables. Univariate logistic regression was performed initially; variables significant at the univariate level were included in the multivariate model.

RESULTS: The overall pCR rate was 56.8%. ROC analysis identified the CALLY index (AUC = 0.681; p < 0.001) and Ki-67 (AUC = 0.603; p = 0.022) as significant predictors, while HALP, PNI, NLR, PIV, SII, and SIRI lacked predictive value. In univariate analysis, high CALLY (p < 0.001), high Ki-67 (p = 0.012), and pertuzumab-containing regimens [AC + taxane + trastuzumab + pertuzumab (p = 0.003) and docetaxel + trastuzumab + carboplatin + pertuzumab (THCP) (p = 0.004)] were associated with higher pCR, whereas ER positivity was associated with a reduced likelihood of pCR (OR = 0.41; p = 0.011). In multivariate analysis, CALLY (OR = 4.03; p < 0.001), Ki-67 (OR = 2.21; p = 0.038), and pertuzumab-containing regimens remained independent predictors: AC + taxane + trastuzumab + pertuzumab (OR = 3.24; p = 0.020) and THCP (OR = 3.86; p = 0.037). Although ER positivity was significant in univariate analysis, it lost statistical significance in the multivariate model (OR = 0.49; p = 0.072).

CONCLUSIONS: High CALLY index and high Ki-67 were found to be statistically significant in predicting pCR, and pertuzumab-containing regimens were shown to increase pCR rates. In contrast, classical histopathological parameters and other immunonutritional scores demonstrated limited predictive value. These findings require validation through prospective, multicenter studies. The limited number of studies investigating the association between pCR and CALLY highlights the originality of our work.

PMID:41091451 | DOI:10.1007/s12094-025-04077-8

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Anti-hypertensive Drug Classes and Risk of New-Onset Atrial Fibrillation in Healthy Older Adults: A Post Hoc Analysis of ASPREE Trial

Drugs Aging. 2025 Oct 15. doi: 10.1007/s40266-025-01258-6. Online ahead of print.

ABSTRACT

BACKGROUND: Prior studies have suggested potential benefits of antihypertensive medication (AHM) in preventing atrial fibrillation. It remains uncertain whether these benefits are uniform across different AHM classes. This study aims to compare the risk of AF across AHM classes in older adults.

METHODS: This study included 8942 individuals from a randomized trial of aspirin, who were aged ≥ 65 years, free of cardiovascular disease (CVD) and AF, treated with any AHM at baseline. Exposures of interest included four first-line AHM medications: angiotensin-converting-enzyme inhibitors (ACEIs), angiotensin-receptor blockers (ARBs), calcium channel blockers (CCBs), and diuretics. Participants were assigned a diagnosis of probable, possible or no AF via a clinical algorithm. Possible AF cases were excluded. Cox proportional-hazards model was used to compare risk of probable AF among baseline users of different AHM classes, adjusting for potential confounders and blood pressure.

RESULTS: Over 4.5 years, 535 (6.0%) participants developed probable AF. CCB-based therapy, alone or in combination, showed the lowest AF risk among all classes (HR [95% CI] for CCB-based therapy versus ARB-, ACEI-, and diuretic-based therapy, alone or in combination: 0.74 [0.57-0.98], 0.85 [0.64-1.13], and 0.81 [0.62-1.06], respectively). A lower AF risk was also observed with CCB monotherapy (HR from 0.58-0.71 compared with monotherapy of other classes).

CONCLUSIONS: CCB-based AHM therapy was linked to a lower risk of probable AF events compared with non-CCB regimens in older adults who were initially free of CVD and AF and treated with any AHM. Additional studies are warranted to clarify the mechanisms underlying this association.

PMID:41091441 | DOI:10.1007/s40266-025-01258-6

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Area-Specific State of Suicide Deaths Among Foreign Nationals Living in Japan: A National Vital Statistics Study 2013-2022

J Immigr Minor Health. 2025 Oct 15. doi: 10.1007/s10903-025-01788-6. Online ahead of print.

ABSTRACT

This study compared the state of suicide deaths among foreign nationals across government ordinance-designated cities in Japan between 2013 and 2022 using vital statistics data containing information on all suicide deaths. We analyzed data on suicide deaths, defined as deaths due to “intentional self-harm” (codes X60-X84) in accordance with the International Statistical Classification of Diseases and Related Health Problems 10th Revision, among foreign nationals and Japanese citizens aged ≥ 10 years who lived in a designated city between 2013 and 2022. Standardized mortality ratios (SMRs) and 95% confidence intervals (CIs) were calculated for each city, with the total population of Japanese citizens as the standard population. Suicide mortality differed across designated cities. The number of deaths and mortality rate from suicide were particularly high among Korean residents, especially those living in Osaka where the presence of a significant Korean population is largely rooted in historical circumstances. Osaka also had a significantly higher relative suicide mortality for female foreign nationals compared with other designated cities (SMR 1.6, 95% CI 1.4-2.0). To achieve an inclusive society that guarantees well-being for all of its population, area-specific trends in suicide deaths among foreign nationals living in Japan, especially Korean and elderly residents in a specific urban area, should be recognized and considered in developing suicide prevention policies and measures for foreign nationals.

PMID:41091429 | DOI:10.1007/s10903-025-01788-6

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Effect of extrinsic and intrinsic factors on colour stability of 3D-printed, thermoplastic, and conventional resin materials: an in vitro study

Saudi Dent J. 2025 Oct 15;37(7-9):63. doi: 10.1007/s44445-025-00071-6.

ABSTRACT

The colour stability of occlusal devices is a critical factor in their long-term aesthetic performance. This in vitro study aimed to evaluate and compare the colour stability of 3D-printed, thermoplastic, and conventional resin materials used in occlusal devices under extrinsic and intrinsic factors. In vitro – comparative study. Sixty rectangular specimens (15 × 15 × 2 mm) of Dentaclear (CAD/CAM 3D-printed), IMPAK (CAD/CAM milled thermoplastic), and ProBase Hot (heat-polymerised) resins were fabricated. Each material group consisted of 20 specimens, with 10 assigned to a control group (immersed in artificial saliva(serving both as the control group and as the intrinsic factor) and 10 to a test group (subjected to 5000 thermocycles in coffee). Baseline colour measurements (L*, a*, b*) were obtained using a spectrophotometer with D65 standard illumination. Colour changes (ΔE00) were calculated using the CIEDE2000 formula, and statistical analysis was performed using 2-way ANOVA (α = 0.05). 2-way ANOVA (α = 0.05). Significant colour changes (ΔE00) were observed in all materials following coffee thermocycling (P < .001). ProBase Hot exhibited the lowest ΔE00 values, indicating the highest colour stability, while IMPAK and Dentaclear showed higher ΔE00 values, with no significant difference between them (P = .287). The control group showed minimal colour change, indicating the negligible effect of intrinsic factors like saliva. Coffee thermocycling significantly impacted colour stability, with ProBase Hot demonstrating superior colour stability compared to IMPAK and Dentaclear. Intrinsic factors like Saliva had minimal influence on colour stability when compared to extrinsic factors like coffee.

PMID:41091420 | DOI:10.1007/s44445-025-00071-6

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Mapping the prosthodontic workforce in Saudi Arabia: Patterns, training backgrounds, professional ranks, and regional distributions

Saudi Dent J. 2025 Oct 15;37(7-9):50. doi: 10.1007/s44445-025-00070-7.

ABSTRACT

PURPOSE: This study aimed to provide a comprehensive national overview of the prosthodontic workforce in Saudi Arabia, focusing on its demographic composition, educational background, geographic distribution, and workforce trends. The findings are intended to support policymakers in postgraduate education planning, and equitable access strategies to prosthodontics care.

MATERIALS AND METHODS: A retrospective cross-sectional analysis was conducted using official data obtained from the Saudi Commission for Health Specialties (SCFHS) as of May 2025. The dataset included all registered practicing prosthodontists across Saudi Arabia. Key variables included gender, nationality, professional classification, practice region, and postgraduate training background. The prosthodontist-to-population ratio was calculated based on the 2024 national census data. Descriptive statistics were used to analyze the characteristics of the prosthodontic workforce.

RESULTS: A total of 1,542 prosthodontists were identified across Saudi Arabia, resulting in a national ratio of 4.37 prosthodontists per 100,000 population. The workforce was predominantly male (65.8%), with females representing 34.2%. Non-Saudis accounted for 56.5% of the workforce, while Saudis made up 43.5%. Most prosthodontists were located in major metropolitan areas, with 34.1% practicing in Riyadh, 24.6% in Makkah, and 11.8% in the Eastern Region. The most common countries of postgraduate education were Egypt (29.3%), Saudi Arabia (27.3%), India (9.0%), and the United States (7.2%). The workforce was almost evenly divided between the public sector (48.3%) and the private sector (47.8%).

CONCLUSION: Saudi Arabia has witnessed steady growth in its prosthodontics workforce, marked by increased training capacity, diverse educational backgrounds, and encouraging participation of female practitioners. Despite this progress, challenges remain in achieving balanced gender representation, equitable regional distribution, and consistency in training standards. These findings highlight the importance of thoughtful workforce planning and the need to reassess classification systems and align training pathways with internationally recognized benchmarks. Such efforts will be essential to ensure high-quality, inclusive, and sustainable prosthodontics care across all regions.

PMID:41091410 | DOI:10.1007/s44445-025-00070-7

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Evaluation of the relationship between different types of skeletal malocclusions and nasal form: A cross-sectional study

Saudi Dent J. 2025 Oct 15;37(7-9):51. doi: 10.1007/s44445-025-00063-6.

ABSTRACT

Considering the significant impact of the nasal form on the appearance of an individual, this study aimed to investigate the relationship between nasal morphology and skeletal malocclusion in a sample of Iranian population. In this descriptive cross-sectional study, 141 lateral cephalograms of individuals of both genders, aged 18 to 30 years were selected. The participants were classified into Class I, II, and III malocclusions. Then, naso-facial landmarks related to the form and shape of the nose and facial skeleton were manually traced on each lateral cephalogram and 13 angular and linear parameters were measured. These parameters were compared among the three types of malocclusions. Statistical analysis of the data was performed using ANOVA, Kruskal-Wallis, and Chi-square tests. P < 0.05 was considered significant. Most of the measurements such as nasal morphology as well as nasal height, nasal bone length, nasal bone angle, nasofrontal angle, dorsum length, total nasal length, nasal depth, columellar convexity, and nasal hump did not show significant differences among different malocclusions (p > 0.05). However, lower dorsum convexity, soft tissue convexity, naso-facial angle, and naso-mental angle were reported to have significant differences among different malocclusions (p < 0.05). According to the results of the present study, the overall shape of the nose is not affected by the type of underlying skeleton in the sample studied. However, future studies with larger sample sizes are recommended to further confirm the results of the present study.

PMID:41091395 | DOI:10.1007/s44445-025-00063-6

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Statistical methods for composite analysis of recurrent and terminal events in clinical trials

Lifetime Data Anal. 2025 Oct 15. doi: 10.1007/s10985-025-09672-z. Online ahead of print.

ABSTRACT

In many clinical trials, one is interested in evaluating the treatment effect based on different types of outcomes, including recurrent and terminal events. The most popular approach is the time-to-first-event analysis (TTFE), based on the composite outcome of the time to the first event among all events of interest. The motivation for the composite outcome approach is to increase the number of events and potentially increase power. Other composite outcome or composite analysis methods are also studied in the literature, but are less adopted in practice. In this article, we first review the mainstream composite analysis methods and classify them into three categories: (A) Composite-outcome Methods, which combine multiple events into a composite outcome before analysis, e.g., combining events into a time-to-event outcome in TTFE and into a single recurrent event process in the combined-recurrent-event analysis (CRE); (B) Joint-analysis Methods, which test for the recurrent event process and the terminal event jointly, e.g., Joint Frailty Model (JFM), Ghosh-Lin Method (GL), and Nelsen-Aalen Method (NA); (C) Win-ratio type Methods that account for the ordering of two types of events, e.g., Win-fraction Regression (WR). We conduct comprehensive simulation studies to evaluate the performance of various types of methods in terms of type I error control and power under a wide range of scenarios. We found that the non-parametric joint testing approach (GL/NA) and CRE have overall the best performance. However, TTFE and WR exhibit relatively low power. Also, adding events that have no or weak association with treatment usually decreases power.

PMID:41091394 | DOI:10.1007/s10985-025-09672-z

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Post fatigue fracture resistance of lithium disilicate and zirconia crowns: vertical versus horizontal preparations (an in vitro study)

Saudi Dent J. 2025 Oct 15;37(7-9):57. doi: 10.1007/s44445-025-00064-5.

ABSTRACT

To assess and compare the post-fatigue fracture resistance of two types of ceramic crowns, zirconia and lithium-disilicate, when used with two margin designs (vertical and horizontal). Forty sound human premolar teeth collected from the orthodontic department were divided randomly into two main groups according to the type of ceramic material (n = 20): Group A: Lithium-disilicate and Group B: Monolithic zirconia. Each group was further subdivided according to the margin design into two subgroups (n = 10): feather-edge (1) and shoulder (2) preparation designs. After digital scanning and designing, the crowns were bonded with self-adhesive resin cement. Each assembly underwent cyclic loading (1,000,000 cycles; 100 N; 1 Hz) in water and was then subjected to axial compressive loading till fracture. Failure modes were analyzed through fractographic analysis under SEM. The highest mean of fracture resistance was recorded for subgroup B1 (Zirconia with vertical preparation: 3129 N), followed by subgroup B2 (Zirconia with horizontal preparation: 2616 N). while lithium-disilicate crowns showed lower fracture values (Group A1: 1880 N, Group A2: 1512 N). One-way ANOVA test revealed statistically significant differences in fracture resistance between the two crown materials (p < 0.05). However, there was no statistically significant difference between the vertical and horizontal preparation designs within the same material group (p > 0.05). Both zirconia and lithium-disilicate crowns demonstrated fracture strengths exceeding the level of biting forces in the premolar area, supporting the use of conservative feather-edge preparation for lithium-disilicate and zirconia crowns in posterior regions.

PMID:41091390 | DOI:10.1007/s44445-025-00064-5

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Salivary IL-6 levels in chronic periodontitis patients with and without oral squamous cell carcinoma: A comparative cross-sectional study at khartoum dental teaching hospital, 2016-2017

Saudi Dent J. 2025 Oct 15;37(7-9):65. doi: 10.1007/s44445-025-00069-0.

ABSTRACT

Periodontal disease is an inflammatory disease that affects periodontal tissue, such as the gingiva, periodontal ligament and alveolar bone. Recently, a link between periodontal disease, oral cancer and inflammation has been suggested. In this study, the concentration of the inflammatory cytokine salivary IL-6 was measured to determine its role in the inflammatory process of periodontitis and oral squamous cell carcinoma. An analytical cross-sectional study was conducted at the Khartoum Dental Teaching Hospital, Sudan. Three study groups were enrolled with their consent: patients diagnosed with chronic periodontitis with at least two interproximal sites showing clinical attachment loss > 4 mm and pocket depth > 5 mm. (n = 32); patients with chronic periodontitis and oral squamous cell carcinoma (OSCC) pathology reports of OSCC at the time of saliva collection (n = 22); and matched healthy controls (n = 30). Patients were excluded if they had any chronic inflammatory condition or disease; had a history of recent trauma, acute infection, burns, laceration, previous surgery, chemotherapy, or radiotherapy; had used antibiotics within the previous three months; had a history of periodontal treatment within the previous three months; were pregnant or lactating; were taking drugs that induce hyposalivation; or had a history of previous radiation therapy to the head and neck area. A trained dentist clinically examined the participants. Periodontal parameters (plaque index, bleeding on probing, probable pocket depth and clinical attachment level) were measured, and the IL-6 concentration in the saliva samples was measured via enzyme-linked immunosorbent assay. A statistically significant difference in periodontal parameters was observed between the OSCC patient group and the other groups. OSCC patients had significantly greater IL-6 concentrations in their saliva (log 2.40 ± 0.37) pg/ml) than did chronic periodontitis patients (CP) (log 1.42 ± 0.418 pg/ml) and healthy controls (log 1.25 ± 0.13 pg/ml) (P < 0.001). High salivary IL-6 levels suggest potential utility as a biomarker for OSCC unconfounded by chronic periodontitis.

PMID:41091387 | DOI:10.1007/s44445-025-00069-0