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Nevin Manimala Statistics

Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania

Ther Innov Regul Sci. 2026 Apr 27. doi: 10.1007/s43441-026-00973-5. Online ahead of print.

ABSTRACT

BACKGROUND: Sub-Saharan Africa carries 25.0% of the global disease burden but hosts only 2.0% of clinical trials worldwide. A key measure to address this challenge is shortening review timelines and enhancing the capacity of protocol reviewers in regulatory authorities. This study, triggered by the Tanzania medicines and medical devices authority and stakeholders, aimed to assess the competency of assessors in reviewing clinical trial applications and to conduct an intervention involving didactic and hands-on training.

METHODS: A descriptive cross-sectional study was conducted from February 2021 to June 2021 using an online survey targeting 128 participants from medicines regulatory authorities, regional ethical committees, institutional review boards, and research institutions. A 70-hour (7 credit) course was developed and implemented in 30 clinical trial assessors.

RESULTS: The survey had a 70.3% response rate, with 58.9% male participants. Over half of the participants held a master’s degree. The study revealed that 94.0% needed training in clinical assessment, 92.2% in quality assessment, and 92.6% in statistical assessment for clinical trial protocols. Following pre- and post-training evaluation, one sample t-test indicated a statistically significant difference in the mean scores, 18.96, CI (13.15-24.76), indicating an improvement in the knowledge of the participants.

CONCLUSION: The study identified significant gaps in the competency of clinical trial applications assessors and ethical reviewers in Tanzania according to the African vaccine regulatory forum guidelines for review of clinical trial protocols. The targeted training improved the capacity of 30 assessors, yet further targeted and stratified capacity-building trainings are recommended to enhance regulatory capacity.

PMID:42036537 | DOI:10.1007/s43441-026-00973-5

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Nevin Manimala Statistics

Observer-Based Source Localization in Tree Infection Networks via Laplace Transforms

Bull Math Biol. 2026 Apr 27;88(5):83. doi: 10.1007/s11538-026-01640-4.

ABSTRACT

We address the problem of localizing the source of infection in an undirected, tree-structured network under a susceptible-infected outbreak model. The infection propagates with independent random time increments (i.e., edge-delays) between neighboring nodes, while only the infection times of a subset of nodes can be observed. We show that a reduced set of observers may be sufficient, in the statistical sense, to localize the source and characterize its identifiability via the joint Laplace transform of the observers’ infection times. Using the explicit form of these transforms in terms of the edge-delay probability distributions, we propose scale-invariant estimators of the source. We evaluate their performance on synthetic trees and on a river network, demonstrating accurate localization under diverse edge-delay models.

PMID:42036518 | DOI:10.1007/s11538-026-01640-4

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Nevin Manimala Statistics

Antibiotic use and adherence to Finnish treatment guidelines in pediatric acute otitis media

Eur J Pediatr. 2026 Apr 27;185(5):303. doi: 10.1007/s00431-026-06964-w.

ABSTRACT

Finnish guidelines recommend antimicrobial treatment for acute otitis media (AOM), with both amoxicillin and amoxicillin-clavulanate as equally acceptable first-line treatment options. This study aimed to investigate in what proportion different antimicrobial agents are prescribed for children with AOM. Our hypothesis was that amoxicillin is the most frequently prescribed antimicrobial agent. This register-based cohort study included all children less than 16 years of age with a diagnosis of AOM in two Finnish hospitals in 2023. Data on children’s demographics, AOM symptoms, findings and treatment were collected individually from the patient charts. The primary outcome was the proportion of children who were prescribed amoxicillin, amoxicillin-clavulanate, or other antimicrobial agents for the treatment of AOM. The antimicrobial treatment choices and durations were compared between Turku and Vaasa and reported as percentage differences with 95% confidence intervals. A total of 1,240 children in Turku and 393 children in Vaasa were included in this study. Among these, 80.9% (1,003/1,240) and 80.7% (317/393) were prescribed amoxicillin for the treatment of AOM in Turku and Vaasa, respectively. Amoxicillin-clavulanate was the second most used antimicrobial treatment, prescribed to 10.1% (125/1,240) and 8.7% (34/393) of the children in Turku and Vaasa, respectively. Most of the children with AOM were prescribed a short 5-day course of treatment.

CONCLUSION: A short 5-day course of amoxicillin was the most frequently prescribed antimicrobial treatment for children with AOM. The adherence to AOM guidelines appears to be high in the two hospitals studied.

WHAT IS KNOWN: • Amoxicillin and amoxicillin-clavulanate are recommended as first-line treatments for acute otitis media in Finland. • National data on real-world antibiotic choices have been limited.

WHAT IS NEW: • Amoxicillin was the most frequently prescribed antibiotic in the two Finnish hospitals studied. • The most common treatment duration was a short 5-day course of treatment.

PMID:42036512 | DOI:10.1007/s00431-026-06964-w

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Nevin Manimala Statistics

A comparative analysis of the starting modality of kidney replacement therapy amongst UK children and young adults and the association with all-cause mortality

Pediatr Nephrol. 2026 Apr 27. doi: 10.1007/s00467-026-07290-x. Online ahead of print.

ABSTRACT

BACKGROUND: Few studies have compared the long-term survival of children by their first modality of kidney replacement therapy (KRT). This study aimed to compare the mortality outcomes of children starting dialysis as their first KRT modality to those who received a pre-emptive kidney transplant (PKT).

METHODS: Historical cohort analyses of UK children starting KRT between 1997-2020 were undertaken, using data from the UK Renal Registry linked to Hospital Episodes Statistics. Crude and multivariable Cox proportional hazards regression analyses were performed to compare mortality amongst children with complete records who received (i) haemodialysis (HD) and (ii) peritoneal dialysis (PD) for ≥ 3 months with those receiving PKT, stratified by the time-period of KRT initiation. Mortality estimates were adjusted for sociodemographic, time-period, primary kidney disease and comorbidity-related covariates.

RESULTS: 242 deaths were recorded amongst 2440 children included in complete-case analyses. Adjusted mortality amongst children was highest (HR 3.70, 95% CI: 1.41-9.74), when compared to PKT) for those starting HD in 1997-2008. Evidence for a difference in mortality amongst children receiving HD (compared to PKT) was weak in later time-periods (2009-14, 2015-20). Mortality did not differ amongst children receiving PD first compared to those who had been pre-emptively transplanted.

CONCLUSIONS: Whilst adjusted mortality was highest for children starting HD at KRT onset in the earliest time-period, there were no differences in long-term survival amongst those starting dialysis (HD or PD) to those pre-emptively transplanted in more recent years.

PMID:42036508 | DOI:10.1007/s00467-026-07290-x

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Nevin Manimala Statistics

Multitype SIR epidemics among a population partitioned into households with proportionate global mixing

J Math Biol. 2026 Apr 26;92(5):77. doi: 10.1007/s00285-026-02359-5.

ABSTRACT

A stochastic model for an SIR epidemic among a population of households that contains J types of individuals is considered. Infectives make two kinds of contacts: local contacts with individuals in their own household and global contacts with individuals from the entire population. Global mixing is proportionate. The behaviour of the model as the population size tends to infinity is analysed. An approximating branching process for the early stages of an epidemic is used to determine several different reproduction numbers and the early exponential growth rate. The means of certain final outcome quantities of an epidemic which takes off are determined, together with an associated multivariate central limit theorem. The assumption of proportionate global mixing leads to considerable simplification in both the calculation and proof of asymptotic properties, since key underlying processes are one-dimensional rather than J-dimensional.

PMID:42036476 | DOI:10.1007/s00285-026-02359-5

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Nevin Manimala Statistics

Flexural Strength, Monomer Release, and Wear of Occlusal Splint Materials Fabricated Through Conventional, Milled, or 3D-Printed Methods

Clin Exp Dent Res. 2026 Apr;12(2):e70361. doi: 10.1002/cre2.70361.

ABSTRACT

OBJECTIVE: To evaluate the flexural strength, monomer release, and wear resistance between conventional, milled polymethylmethacrylate (PMMA), and 3D-printed resins built at 90° and 60° printing angles for occlusal splints.

MATERIALS AND METHODS: 60-rectangular and 100-disc specimens were fabricated from heat-cured PMMA (Oracryl [HP], Bracon Dental, United Kingdom), milled PMMA (Kerox Premia [KP], Kerox Dental, Hungary), and 3D-printed resins (FreePrint Splint2.0 [FS], Detax, Ettlingen, Germany, and KeySplint Hard [KS], Keystone Industries, Myerstown, USA) at 90° and 60° printing angles. Specimens for flexural strength and wear tests were immersed immediately in 37°C water for 50 h and thermally aged for 20,000 cycles. Flexural strength was evaluated using a three-point bend test. Wear was tested using a chewing simulator for 140,000 cycles, and volume loss was calculated using Autodesk MeshMixer software. Monomer release was analyzed via UV spectrophotometry over 7 days. Statistical analysis was performed using the Shapiro-Wilk test and one-way ANOVA with Tukey’s multiple comparison tests.

RESULTS: KP showed the highest mean flexural strength (115.5 ± 5.3 MPa, p < 0.0001), followed by HP (86.6 ± 10.8 MPa, p < 0.0001), with 3D-printed resin showed the lowest. Meanwhile 90° FS showed greater flexural strength (60.5 ± 3.8 MPa) compared to 60° FS (p < 0.001) and KS (p < 0.01). The difference between 90° and 60° KS were not statistically significant (p > 0.05). Monomer release peaked on Day 3 for all groups, with KS consistently showing the highest concentration (29.7 ± 3.6 ppm), followed by FS (28.8 ± 3.8 ppm), HP (27.9 ± 4.9 ppm), and lastly, KP showed the lowest concentration (24.9 ± 3.8 ppm). KP demonstrated the lowest mean volume loss (2.5 ± 1.3 mm3, p < 0.01), followed by HP (4.4 ± 1.7 MPa), whereas 3D-printed resin showed the highest. No significant wear differences were observed between 90° and 60° printing angles.

CONCLUSION: Milled PMMA outperformed other materials, followed by conventional PMMA, while 3D-printed resin showed inferior performance in flexural strength, wear resistance, and monomer release. Printing angles significantly influenced flexural strength but not wear properties in 3D-printed resins.

PMID:42035479 | DOI:10.1002/cre2.70361

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Nevin Manimala Statistics

Association Between Obstructive Sleep Apnea and Periodontitis: A Systematic Umbrella Review

Clin Exp Dent Res. 2026 Apr;12(2):e70300. doi: 10.1002/cre2.70300.

ABSTRACT

AIM: The aim of this study was to evaluate the association between obstructive sleep apnea (OSA) and periodontitis using an umbrella meta-analysis (MA).

METHODS: PubMed, MEDLINE, Web of Science, Scopus, Embase, and Google Scholar databases were systematically searched before December 2025. MAs reporting odds ratios (OR) for the association between OSA and periodontitis were included. Methodological quality was assessed using AMSTAR-2, and certainty of evidence was evaluated using GRADE. Random-effects MA was performed. Egger’s test and trim-and-fill analysis were used to assess the publication bias.

RESULTS: Seven MAs encompassing over 225,000 participants were included. A significant association was found between OSA and periodontitis (OR 1.96, 95% CI 1.68-2.29, p < 0.0001), with substantial heterogeneity (I2 = 69.5%). After using trim-and-fill method to adjust for publication bias, the association strengthened (OR 2.24, 95% CI 1.92-2.60, p < 0.0001). A dose-response pattern emerged, with severe OSA showing higher odds (OR 2.25) compared to mild-moderate OSA (OR 1.82), though not statistically different (p = 0.44). The association remained consistent among different study qualities and sample sizes. The GRADE assessment rated the certainty of evidence of the main outcome as low due to heterogeneity and publication bias. Further, a high overlap ratio of 26.8% was observed among the included MAs.

CONCLUSIONS: The results of this review suggest a significant association between OSA and periodontitis, with a greater association of severe OSA with periodontitis. Future studies should examine the impact of periodontal therapy on OSA severity and vice versa.

PROSPERO REGISTRATION: CRD420251241137.

PMID:42035465 | DOI:10.1002/cre2.70300

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Nevin Manimala Statistics

“Prevalence of Peri-Implant Diseases in Patients With Type 2 Diabetes Mellitus: A Cross-Sectional Study”

Clin Exp Dent Res. 2026 Apr;12(2):e70352. doi: 10.1002/cre2.70352.

ABSTRACT

OBJECTIVES: Type 2 diabetes mellitus (T2DM) is a major systemic disease, predisposing patients to inflammatory conditions, and it is considered a grade modifier of periodontitis. However, its association with peri-implant diseases is still under investigation. This study aimed to investigate the possible association between diabetes and peri-implant disease.

MATERIAL AND METHODS: Seventy patients (35 with T2DM and 35 non-diabetic) were included, for a total of 227 dental implants in function for at least 1 year. Patient characteristics, implant features, and peri-implant diseases (including peri-implant mucositis and peri-implantitis) were recorded.

RESULTS: The overall prevalence of peri-implant diseases was not statistically different between diabetic and non-diabetic subjects (80% vs. 77%, p = 0.99). When distinguishing between peri-implant mucositis and peri-implantitis, the prevalence of peri-implant mucositis (51% in diabetic patients vs. 63% in non-diabetic individuals; p = 0.47) and peri-implantitis (51% in diabetic patients vs. 43% in non-diabetic individuals; p = 0.63) did not differ significantly between the two groups.

CONCLUSIONS: Our findings did not suggest different occurrence of peri-implant mucositis and peri-implantitis in diabetic and non-diabetic subjects. Therefore, type 2 diabetes may not play a relevant role in peri-implant diseases.

PMID:42035463 | DOI:10.1002/cre2.70352

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Nevin Manimala Statistics

Side-Specific Mastication Prevalence and Its Association With Sex, Anxiety, and Somatic Symptoms: A Cross-Sectional Study Among Italian University Students

Clin Exp Dent Res. 2026 Apr;12(2):e70348. doi: 10.1002/cre2.70348.

ABSTRACT

OBJECTIVE: To assess the prevalence of unilateral chewing among Italian university students and investigate its association with sex, anxiety, and somatic symptom severity.

MATERIAL AND METHODS: In this cross-sectional study, 1536 students completed a self-administered questionnaire. Prevalence of unilateral chewing behavior, anxiety, and somatic symptoms was described using frequencies and percentages. Anxiety and somatic symptoms were measured using the self-reported Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-15 (PHQ-15). Pearson Chi-square and Cramér’s V examined the association between sex and unilateral chewing behavior. Differences in GAD-7 and PHQ-15 scores across unilateral chewing categories were analyzed using ANOVA-based methods with post hoc tests. Ordinal logistic regression was performed to assess the association between unilateral chewing behavior, anxiety, and somatic symptom severity while controlling for age and sex.

RESULTS: Overall, 19% of participants reported unilateral chewing “most” or “all of the time.” Moderate-to-severe anxiety and somatic symptoms were each reported by 45% of participants, assessed separately. A significant weak to moderate association between sex and unilateral chewing was reported (p < 0.001). Unilateral chewing behavior was significantly associated with total anxiety scores (p < 0.001), with “all of the time” chewers having four points higher scores than “none of the time” or “a little of the time,” and three points higher scores than “some of the time” chewers. A significant association (p < 0.001) was also observed between unilateral chewing and PHQ-15 scores, with “all of the time” chewers having three points higher scores than “none of the time” and two points higher scores than “a little of the time.” Ordinal regression analysis confirmed these associations, although the effect sizes were modest.

CONCLUSION: Frequent unilateral chewing behavior is associated with higher levels of anxiety and somatic symptoms. Assessing unilateral chewing may help guide interventions promoting bilateral mastication and mindful eating.

PMID:42035459 | DOI:10.1002/cre2.70348

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Nevin Manimala Statistics

Psychometric Validity of the CES-D Scale for Assessing Depressive Symptoms in University Students in Bogotá. Colombia

Int J Methods Psychiatr Res. 2026 Jun;35(2):e70072. doi: 10.1002/mpr.70072.

ABSTRACT

INTRODUCTION: The Center for Epidemiological Studies Depression Scale (CES-D) is a widely used tool for assessing depressive symptoms. This study examined its psychometric properties in a sample of 1738 university students in Bogotá.

METHODS: Instrumental study with a cross-sectional, single-center design with two-stage sampling. Exploratory and two-factor factorial analyses were applied, along with reliability estimates and subgroup analyses by gender and social stratum.

RESULTS: Exploratory factor analysis revealed a three-factor structure (depressive affect, positive affect, and social aspects), which explained 56% of the total variance. The KMO index was 0.95, and Bartlett’s sphericity test was significant (χ2 = 17,902.82, df = 190, p < 0.001). The bifactor model showed a strong overall factor (hierarchical omega = 0.85; ECV = 0.71), supporting the use of a total score. Internal consistency was high (α = 0.93; ω = 0.94). Women scored significantly higher than men (p < 0.001). Differentiated cut-off points by sex are proposed: ≥ 52 for women and ≥ 45 for men.

CONCLUSIONS: These findings support the validity and reliability of the CES-D as a unidimensional measure of depressive symptoms in the Colombian university population and highlight its usefulness as a screening tool in public health settings, particularly within Latin American regional contexts where early detection of mental health problems is a priority.

PMID:42035458 | DOI:10.1002/mpr.70072