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Nevin Manimala Statistics

Estimating clinical trial hazard functions

Clin Trials. 2026 Apr 24:17407745261439661. doi: 10.1177/17407745261439661. Online ahead of print.

ABSTRACT

BACKGROUND: Although the analysis of event-based clinical trials commonly relies on assumptions about the underlying hazard functions, in practice it is rare to see estimates of those functions.

METHODS: I describe conventional and novel methods for estimating the hazard function using discrete and discretized continuous survival models. The conventional approach involves parametric modeling; the novel approach applies Bayesian model averaging to flexible modeling by splines or fractional polynomials. I evaluate the methods in a Monte Carlo study and illustrate them in the analysis of three historical clinical trials.

RESULTS: Although flexible models can capture features of the hazard functions-such as multimodality-that parametric models miss, they are not foolproof. Spline modeling was generally the most reliable, in the sense of yielding good coverage probabilities for the mean and median with modest loss of efficiency. In the examples, the discreteness of the measurements-days, weeks, or months-had little effect on the shape of estimated hazard functions. All three data sets showed some evidence of departure from the proportional hazards assumption, but in only one did a test for proportionality detect this departure.

CONCLUSION: Flexible parametric models, estimated in the Bayesian model averaging framework, offer a robust approach to recovering the shape of the hazard function. Analyses of three clinical trial databases suggest that visualization of the hazard function can be a valuable adjunct to conventional survival analysis.

PMID:42028665 | DOI:10.1177/17407745261439661

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Nevin Manimala Statistics

Somatotype and body fat distribution among the slum residents in Guwahati, Assam: Implications for health risks

Anthropol Anz. 2026 Apr 24. doi: 10.1127/anthranz/1961. Online ahead of print.

ABSTRACT

Urban slums are characterized by informal settlements, poor living conditions and inadequate access to basic amenities. Poverty remains the largest structural determinant of health, with an increasing concentration of economically disadvantaged populations in urban areas. The present study aims to evaluate the somatotype and body fat percentage of adult inhabitants living in the urban slums of Guwahati using standardized anthropometric measurements. Assessment of somatotype provides valuable insight into body composition patterns and their potential association with susceptibility to non-communicable diseases (NCDs) in both sexes, thereby facilitating early risk identification. A total of 1,078 adults of 1860 years of age participated in the study. They were from eight slum settlements in Guwahati, representing a heterogeneous population comprising speakers of Bihari, Bengali, Assamese, and Punjabi, along with a small proportion of Telugu-speaking individuals. Anthropometric assessments included linear dimensions, circumferences (girth measurements), skinfold thicknesses, and skeletal breadths. Somatotype classification of the participants was performed using the HeathCarter method and analysed with R Statistical Software. The findings indicate that the maximum stature recorded among both males and females residing in the Guwahati slums was higher than the reported average adult height for the state of Assam. Endomorphic Mesomorph as the most prevalent somatotype indicating higher muscle and fat components with greater risk of obesity and metabolic disorders. The inhabitants face risks associated with both their somatotype and their fat percentage. Age-related declines in physical activity collectively may be is contributing to increased adiposity among the slum residents. Educating the slum residents may play a significant role in helping to understand about their overall health and active lifestyle.

PMID:42028655 | DOI:10.1127/anthranz/1961

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Nevin Manimala Statistics

Malaria in Papua New Guinean infants: a prespecified analysis of a randomised postpartum antimalarial treatment trial

Trans R Soc Trop Med Hyg. 2026 Apr 24:trag042. doi: 10.1093/trstmh/trag042. Online ahead of print.

ABSTRACT

BACKGROUND: There are scant and variable data concerning the incidence of malaria in infants in endemic areas. This study evaluated the impact of maternal antimalarial treatment given postpartum on malaria incidence and growth/development in infants from coastal Papua New Guinea (PNG).

METHODS: In an open-label, randomised controlled trial conducted in Madang Province, PNG, 183 mothers were randomised to no treatment (NT) or to artemisinin combination therapy (ACT) with further random allocation to artemether-lumefantrine or dihydroartemisinin-piperaquine. Their infants were assessed monthly over the next 6 months including for malaria identified by microscopy and/or polymerase chain reaction (PCR).

RESULTS: Of 151 infants who completed study procedures, 2 developed slide-positive malaria (1 Plasmodium falciparum, 1 Plasmodium vivax; 1.3% [95% confidence interval {CI} 0.2 to 5.2]). Three others had PCR-detected infections (two P. falciparum, one P. vivax). The overall 6-month incidence of slide-/PCR-positive malaria was 3.3% (95% CI 1.2 to 8.0). Four of the five cases occurred in infants whose mothers were randomised to NT. There were no statistically significant between-group differences in infant growth and developmental milestones.

CONCLUSIONS: The risk of malaria in early infancy in coastal PNG is low and infections are typically asymptomatic. Postpartum maternal ACT did not influence infant growth or development.

PMID:42028647 | DOI:10.1093/trstmh/trag042

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Nevin Manimala Statistics

Standardizing stem cell enumeration: A methodological comparison of single and dual flow cytometry platforms

Cytometry B Clin Cytom. 2026 Apr 24. doi: 10.1002/cyto.b.70034. Online ahead of print.

ABSTRACT

Two flow cytometry methods are used for stem cell (CD34+) enumeration; single platform (SP) and dual platform (DP). While several studies reported comparable results, others suggested superiority of the SP method. This study evaluated variations between both methods using a modified workflow. A total of 54 fresh and thawed specimens, including mobilized peripheral blood, apheresis products, and umbilical cord blood, were analyzed using both methods. High concordance between SP and DP methods was observed for absolute viable CD34+ counts in fresh and thawed specimens (p = 0.088 and 0.427, respectively), as well as for CD34+ viability (p = 0.085 and 0.801). Absolute viable WBC counts were comparable between methods in thawed specimens (p = 0.124), whereas a modest statistical variation was observed in fresh specimen group (p = 0.039), largely influenced by umbilical cord blood samples. Variation in absolute viable CD34+ counts remained within clinically acceptable limits, with median variations of 2.4 for fresh and 1.4 for thawed samples. SP and DP methods demonstrated high concordance for absolute viable CD34+ enumeration and CD34+ viability in fresh and thawed specimens. Although a modest variation in viable WBC counts was observed in fresh samples, this did not affect CD34+ enumeration and remained clinically acceptable. While SP provides a standardized approach, the DP method offered greater gating flexibility, with fewer technical resources required, and was approximately 70% more cost-effective, supporting its use as a practical alternative in appropriate laboratory settings.

PMID:42028634 | DOI:10.1002/cyto.b.70034

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Nevin Manimala Statistics

Asthma and increased carotid intima-media thickness: A systematic review and meta-analysis

Biomol Biomed. 2026 Apr 24. doi: 10.17305/bb.2026.14164. Online ahead of print.

ABSTRACT

Asthma has been associated with early vascular changes that elevate the risk of atherosclerosis and cardiovascular diseases. Carotid intima-media thickness (CIMT) serves as a non-invasive marker for subclinical atherosclerosis and cardiovascular risk. However, existing literature presents conflicting results regarding CIMT measurements in asthmatic patients. This study aims to evaluate whether CIMT is elevated in asthma patients compared to healthy controls and to explore potential modifiers. We conducted a systematic review following PRISMA guidelines, performing a literature search across PubMed, Web of Science, ScienceDirect, and the WHO VHL. We calculated pooled standardized mean differences (SMD) with 95% confidence intervals (CI) to assess the differences in CIMT values. Heterogeneity was evaluated using the I² statistic, and subgroup analyses and meta-regression were utilized to identify sources of heterogeneity. Our review included a total of 10 studies. The analysis indicated significantly higher CIMT values in asthma patients compared to healthy controls, with a pooled SMD of 0.65 (95% CI: 0.19 to 1.12, p = 0.005). A limited number of studies addressed various factors, such as disease severity and the use of inhaled corticosteroids, which may influence CIMT measurements. Notably, asthmatic patients, particularly children and adolescents, exhibited higher CIMT values compared to healthy controls, suggesting a potential association with subclinical atherosclerosis in this demographic. However, these findings should be interpreted with caution due to the observational nature of the included studies and the risk of residual confounding. Further longitudinal research is necessary to elucidate the effects of disease characteristics and treatment on vascular health.

PMID:42028627 | DOI:10.17305/bb.2026.14164

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Nevin Manimala Statistics

QSPR models for water solubility of organic compounds using correlation intensity index and Las Vegas algorithm

SAR QSAR Environ Res. 2026 Apr 24:1-12. doi: 10.1080/1062936X.2026.2659325. Online ahead of print.

ABSTRACT

Water solubility is an important factor in environmental and toxicological science because it determines the mobility, bioavailability, and potential for absorption by living organisms. Higher solubility often correlates with greater environmental mobility, and toxicity is often inversely related to solubility. In this work, the solubility of 4453 compounds in water was examined using quantitative structure-property relationships (QSPR). The effectiveness of the Monte Carlo method, the correlation intensity index (CII), and the Las Vegas algorithm for developing organic compound solubility models is assessed using CORAL software. Both factors (CII and the Las Vegas algorithm) have been shown to improve the statistical quality of the model set for the calibration and validation sets. The average coefficient of determination for the validation set is 0.94 ± 0.01.

PMID:42028609 | DOI:10.1080/1062936X.2026.2659325

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Nevin Manimala Statistics

Temporomandibular Joint Involvement in Paediatric Patients Affected by Juvenile Idiopathic Arthritis

J Oral Rehabil. 2026 Apr 24. doi: 10.1111/joor.70200. Online ahead of print.

ABSTRACT

BACKGROUND: Juvenile idiopathic arthritis (JIA) is an autoimmune disease that can involve the temporomandibular joint (TMJ).

OBJECTIVES: To investigate the association between clinical signs and symptoms of temporomandibular disorders (TMD) and TMJ inflammation, as detected by magnetic resonance imaging (MRI) in children and adolescents with JIA.

METHODS: Monocentric cross-sectional observational study. Consecutive JIA patients underwent clinical dental examination following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) and performed MRI examination when the presence of signs and/or symptoms was detected. TMJ involvement was assessed using MRI parameters. Data were analysed with descriptive statistics, using parametric statistical tests for normally distributed data and non-parametric statistical tests for other variables. Associations between TMD signs/symptoms and MRI findings were investigated using appropriate statistical tests. Adjustment for multiple comparisons was performed using a false discovery rate approach. A p-value < 0.05 after correction was considered statistically significant.

RESULTS: Seventy-six JIA patients were included. In unadjusted analyses, multiple associations emerged between clinical findings and MRI signs of TMJ involvement. After correction for multiple comparisons, TMJ sounds remained significantly associated with protrusion limitation, and mandibular deviation patterns were significantly associated with inflammatory MRI findings, particularly synovial thickening and bone marrow edema. Other associations did not retain statistical significance after adjustment and should be considered exploratory.

CONCLUSIONS: Dental and TMD evaluations revealed correlations with MRI findings of TMJ involvement. Application of TMD screening at JIA onset might make it possible to detect TMJ-related early signs of arthritis in patients with JIA.

PMID:42028608 | DOI:10.1111/joor.70200

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Nevin Manimala Statistics

Health-related quality of life and functional outcomes of colon cancer patients in the Netherlands: A population-based study

Colorectal Dis. 2026 May;28(5):e70461. doi: 10.1111/codi.70461.

ABSTRACT

BACKGROUND: Colon cancer treatment has evolved significantly through earlier detection, less invasive surgery, optimised perioperative care and shortening chemotherapy duration from 6 to 3 months in 2017. These multidisciplinary improvements may contribute to better health-related quality of life (HRQoL), yet population-based data on their real-world impact on HRQoL and functional outcomes remain limited.

METHODS: This cross-sectional study used data from the Dutch Prospective PLCRC cohort, including patients with stage I-III colon cancer who completed patient-reported outcome measures (PROMs) at 12 or 24 months post-diagnosis. HRQoL was assessed using EORTC QLQ-C30, QLQ-CR29 and the LARS score. Patients diagnosed in 2014-2016 (Group A) were compared with those from 2017 to 2019 (Group B). Propensity score matching (1:4) was applied for age, sex and tumour stage. Multivariable analyses were adjusted accordingly, minimally important differences (MIDs) guided clinical relevance and the values were compared with Dutch population values.

RESULTS: A total of 1,749 patients were included in the analysis. Following propensity score matching, no clinically meaningful differences in the EORTC QLQ-C30 functional or symptom scales were observed at 12 months post-diagnosis between patients diagnosed in 2014-2016 (Group A) and those diagnosed in 2017-2019 (Group B). At 24 months, Group B demonstrated a modestly better QLQ-C30 summary score (mean difference + 1.3; 95% CI: 0.6-1.9), as well as statistically significant but clinically negligible improvements in role and cognitive functioning, and lower reported levels of fatigue, appetite loss and financial difficulties. Functional outcomes assessed via QLQ-CR29 and LARS score were comparable between groups, with a non-significant trend towards fewer major LARS cases in Group B at 24 months (14.6% vs. 19.9%; p = 0.068).

CONCLUSION: Dutch colon cancer patients reported good HRQoL and functional outcomes up to 2 years post-diagnosis, with no clinically relevant differences between 2014-2016 and 2017-2019. These findings suggest a consistently high standard of care nationwide. Ongoing monitoring remains essential to address individual symptom burden and evaluate the impact of evolving treatment strategies.

PMID:42028607 | DOI:10.1111/codi.70461

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Nevin Manimala Statistics

Pretreatment neutrophil percentage-to-albumin ratio for prognostic assessment in locally advanced nasopharyngeal carcinoma

Biomol Biomed. 2026 Apr 24. doi: 10.17305/bb.2026.14023. Online ahead of print.

ABSTRACT

Prognosis in locally advanced nasopharyngeal carcinoma (NPC) is influenced not only by tumor burden but also by systemic inflammatory and nutritional status. This study aimed to evaluate the prognostic value of the pretreatment neutrophil percentage-to-albumin ratio (NPAR) in locally advanced NPC and to determine whether its incorporation could enhance risk stratification beyond conventional staging variables. In this retrospective single-center cohort study, we analyzed 804 patients with stage II-IVa NPC who were treated with definitive radiotherapy, with or without concurrent chemotherapy. These patients were randomly assigned to a training cohort (n = 603) and a validation cohort (n = 201). The pretreatment NPAR was calculated from blood samples collected within one week prior to treatment initiation. Associations with overall survival (OS) and progression-free survival (PFS) were primarily assessed using restricted cubic spline Cox models, supplemented by secondary cutoff-based analyses. A prognostic nomogram was developed and internally validated through bootstrap resampling. Higher pretreatment NPAR was consistently associated with adverse outcomes in OS (adjusted hazard ratio [HR] 1.77, 95% confidence interval [CI] 0.97-3.23; p = 0.062) and PFS (adjusted HR 1.74, 95% CI 0.96-3.15; p = 0.066), although these associations did not achieve conventional statistical significance in fully adjusted models. The nomogram incorporating both clinicopathological variables and NPAR demonstrated superior discrimination compared to tumor-node-metastasis staging alone, with optimism-corrected C-indices of 0.625 for OS and 0.617 for PFS. In comparative analyses, NPAR and the neutrophil-to-lymphocyte ratio exhibited similar prognostic performance. In conclusion, pretreatment NPAR is associated with adverse outcomes in locally advanced NPC and may modestly enhance model-based risk stratification. However, its clinical utility should be interpreted with caution and requires external validation.

PMID:42028606 | DOI:10.17305/bb.2026.14023

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Nevin Manimala Statistics

Cognitive behavioral intervention on digital addiction behavior among nursing students in Saudi Arabia

Health Informatics J. 2026 Apr-Jun;32(2):14604582261444118. doi: 10.1177/14604582261444118. Epub 2026 Apr 24.

ABSTRACT

AimTo assess the effectiveness of a brief cognitive behavioral intervention (CBI) on digital dependence among nursing students in Saudi Arabia and to examine demographic and usage predictors of post-intervention outcomes.MethodsA pretest-posttest quasi-experimental study was conducted with 163 students (aged 18-23 years) at K’ University. Participants completed the Digital Addiction Scale (DAS) before and after a three-session group CBI. Paired t-tests and correlations explored inter-domain relationships, and linear regressions examined predictors of post-intervention scores.ResultsMean DAS scores improved significantly for overuse (mean difference 0.40, p < .001), non-restraint (0.22, p = .010), and dependence (0.39, p < .001). Emotional state increased but not significantly (p = .135) and inhibiting the flow of life was unchanged (p = .742). Post-intervention overuse was predicted by daily hours of device use (β = 0.94 for 3-4 h; β = 1.04 for ≥7 h; all p < .05), while other demographic factors were non-significant.ConclusionA brief CBI improved behavioral aspects of digital dependence but had limited effect on emotional dimensions. Integrating culturally adapted CBIs and digital-wellness modules into nursing curricula could reduce digital distraction and enhance self-regulation. Further controlled studies are needed to validate and expand upon these results.

PMID:42028595 | DOI:10.1177/14604582261444118