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Nevin Manimala Statistics

Impact of smoking, diabetes, and exercise on dementia risk in women with osteoporosis: a nationwide cohort study

Osteoporos Int. 2025 Jun 10. doi: 10.1007/s00198-025-07524-y. Online ahead of print.

ABSTRACT

Having osteoporosis significantly increases the risk of having dementia, particularly when combined with smoking and diabetes, but regular exercise can reduce this risk. Implementing a national health screening program is crucial for early detection of these modifiable risk factors and prevention of dementia in aging populations.

PURPOSE: To assess osteoporosis as a risk factor for dementia in the general population using nationwide dataset.

METHODS: This study included 261,343 women aged 66 years who participated in the National Screening Program for Transitional Ages for Koreans and underwent their first medical checkup between January 2013 and December 2016. Participants were categorized into three groups based on bone mineral density (BMD): normal BMD, osteopenia, and osteoporosis. We investigated participants’ demographic characteristics and chronic comorbidities that could affect dementia incidence. The hazard ratios (HRs) for dementia in individuals with osteoporosis and osteopenia were calculated and adjusted based on several risk factors.

RESULTS: Despite adjusting for demographic characteristics and chronic comorbidities, the risk of dementia was 1.18-fold higher in the osteoporosis group than in the normal BMD group. Regarding Alzheimer’s disease and vascular dementia, the risk was 1.18- and 1.25-fold higher in the osteoporosis group, respectively. Notably, participants with osteoporosis who smoked had a 1.82-fold higher HR than that of nonsmoking participants with normal BMD; participants with diabetes mellitus (DM) had a 1.92-fold higher HR than that of participants with normal BMD without DM. The HR for participants with osteoporosis who exercised regularly was 1.00, whereas it was 1.18 for those who did not exercise.

CONCLUSION: This population-based cohort study demonstrates that having osteoporosis significantly increases dementia risk, which is amplified by smoking and diabetes but reduced by regular exercise.

PMID:40493245 | DOI:10.1007/s00198-025-07524-y

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Nevin Manimala Statistics

Optimizing region of interest size and placement for clinical opportunistic CT trabecular bone Hounsfield unit measurements

Osteoporos Int. 2025 Jun 10. doi: 10.1007/s00198-025-07529-7. Online ahead of print.

ABSTRACT

PURPOSE: No formal guidance exists regarding optimal opportunistic computed tomography (CT) region of interest (ROI) size or placement to clinically obtain bone Hounsfield unit (HU) data. Using clinical CT scans, this study evaluated ROI size/placement and assessed HU reproducibility.

METHODS: Three non-radiologists independently identified the L1 and L4 vertebral body centroid and then placed varying size circular ROIs on axial and sagittal images of 30 clinical CT scans. A 200-mm2 ROI location was varied left to right, anterior to posterior, and cranial to caudal. Intra- and inter-observer reliability was determined using intraclass correlation coefficients (ICC). ROI size and axial/sagittal HU comparison was performed by ANOVA and t-test. Precision of 200-mm2 axial and sagittal ROIs was assessed in a second cohort of 30 patients with two scans obtained within 16 days.

RESULTS: Vertebral body centroid placement was nearly identical between readers (ICC > 0.99). Intra- and inter-observer reliability was excellent for all ROI sizes on both projections (ICC > 0.95). Statistically, but not clinically, significant differences, less than 8 HU, were present between various sized ROIs at L1, with no difference at L4. Axial HU was generally higher than sagittal for all ROI sizes at L1 and L4 by ~ 5-12 HU. In the precision cohort, L1 and L4 HU %CV was 4.8-7.9% yielding least significant change values of 10-16 HU.

CONCLUSIONS: Non-radiologists can reliably identify the vertebral body centroid and measure HU. For clinical use, we recommend a 200-mm2 circular ROI placed at the vertebral body centroid on L1 axial imaging.

PMID:40493237 | DOI:10.1007/s00198-025-07529-7

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Nevin Manimala Statistics

Take charge after long COVID: a mixed methods randomised controlled pilot study protocol

Ann Med. 2025 Dec;57(1):2516694. doi: 10.1080/07853890.2025.2516694. Epub 2025 Jun 10.

ABSTRACT

INTRODUCTION: Post COVID-19 condition is a debilitating illness with over 200 symptoms across 10 organ systems and is presently impacting millions worldwide. The National Institute for Health and Care Excellence recommends a multidisciplinary treatment approach including person-centred self-management strategies, however evidence for specific programs is lacking. The Take Charge intervention is a person-centred, self-management rehabilitation approach that has been effective in recovery after stroke, but not yet tested in post COVID-19 condition.

METHODS & ANALYSIS: A prospective, single-centre, parallel, 2 group, mixed methods, randomized controlled trial with embedded process evaluation of the Take Charge intervention in individuals living with post COVID-19 condition. Participants will be at least 18 years of age, have a confirmed diagnosis of post COVID-19 condition with ongoing symptoms, and be known to a hospital clinic for assessment and treatment of patients with post-acute sequelae of COVID-19. The primary outcomes are the Modified COVID-19 Yorkshire Rehabilitation Scale and the COVID-19 Core Outcome Measure for Recovery. The secondary outcomes include physical and self-report measures, and feasibility measures. Qualitative interviews will also be conducted to understand the clinicians’ and participants’ experiences. Statistical analysis will be performed on an intention-to-treat basis using a multivariate mixed-effect linear regression model.

ETHICS & DISSEMINATION: This study adheres to the Declaration of Helsinki. This study was approved by the Southern Adelaide Clinical Human Research Ethics Committee (approval number: 2022/SSA00695/OFR: 219.22, protocol version 3.3 19 February 2024). The results will be disseminated in peer-reviewed journals, conference presentations, and media.

PMID:40492405 | DOI:10.1080/07853890.2025.2516694

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Nevin Manimala Statistics

Penalized Bayesian methods for product ranking using both positive and negative references

J Biopharm Stat. 2025 Jun 10:1-17. doi: 10.1080/10543406.2025.2489287. Online ahead of print.

ABSTRACT

Product ranking according to pre-specified criteria is essential for developing new technologies, allowing identification of more preferable candidates for further development. Such ranking often builds on the results of a network meta-analysis, where the relative or absolute performances of the various products are synthesized across multiple clinical studies, each of which considered only a subset of the products. Ranking involving both a negative and a positive reference enables the scientist to directly compare tested products against known benchmarks. Here, more preferable candidates are those products that approach the positive reference while remaining distant from the negative reference. We provide a new metric to quantify this multivariate distance following Bayesian meta-analysis. Our method does not simply rely on point estimates to perform the comparisons, but also accounts for their uncertainties via their posterior distributions. For each product, posterior probabilities of being comparable to the positive reference are computed, and subsequently penalized by the posterior probability of performing worse than the negative reference. Each product is then compared to a hypothetical product about which we have no knowledge, as captured by a uniform distribution. The result is a prospective metric that is directly interpretable as the improvement of any product beyond this state of ignorance. We illustrate our approach using a case study, in which the goal is to rank 16 antiperspirant products. Here, the FDA-recommended summary statistic (a measure of the relative sweat reduction between each product and no treatment) intrinsically features both positive and negative references. We then offer a brief simulation study to check our metric’s performance in less complex, idealized settings where the true ranking is known. Our results indicate that our Bayesian approach is a novel and useful addition to the statistical ranking toolkit.

PMID:40492403 | DOI:10.1080/10543406.2025.2489287

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Nevin Manimala Statistics

Approximate Bayesian estimation of time to clinical benefit using Frequentist approaches: an application to an intensive blood pressure control trial

J Biopharm Stat. 2025 Jun 10:1-11. doi: 10.1080/10543406.2025.2512985. Online ahead of print.

ABSTRACT

BACKGROUND: Time to Benefit (TTB) is a critical metric in clinical practice, reflecting the duration required to achieve therapeutic goals post-treatment. Traditionally, TTB estimation has relied on Bayesian Weibull regression, which, despite its merits, can be computationally intensive. To address this, we propose and evaluate Frequentist methods as efficient alternatives to approximate Bayesian TTB estimation.

METHODS: We evaluated three Frequentist methods, parametric delta, Monte Carlo, and nonparametric bootstrap, for TTB estimation, comparing their performance with the Bayesian approach.

RESULTS: Extensive simulations demonstrated that the proposed Frequentist methods outperformed the Bayesian method in efficiency. Real-world data applications further validated these findings, with the Monte Carlo (MC) method exhibiting significantly faster computational speed compared to the nonparametric bootstrap, while the Bayesian method was the least efficient.

CONCLUSIONS: The proposed Frequentist methods offer significant advantages to approximate the Bayesian approach for TTB estimation, particularly in efficiency and practicality. The Monte Carlo method, with its median point estimate and percentile confidence intervals, is the recommended choice for its balance of efficacy and expedience.

PMID:40492388 | DOI:10.1080/10543406.2025.2512985

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Nevin Manimala Statistics

Multivariable Modeling of Postoperative Risk in Infant Cardiac Surgery: Integrating Clinical Variables and 20 Inflammatory Biomarkers

Acta Anaesthesiol Scand. 2025 Jul;69(6):e70073. doi: 10.1111/aas.70073.

ABSTRACT

INTRODUCTION: Cardiac surgery in infants often triggers a severe inflammatory response. The role of biomarkers in predicting clinical outcomes in this group of patients has been debated in the literature. This study aimed to investigate the predictive value of 20 inflammatory biomarkers, in combination with clinical data, for acute kidney injury, ventilator support duration, and inotropic score following infant cardiac surgery by developing and comparing three models: Clinical-Data-Only, Biomarker-Only, and Combined.

METHODS: This secondary analysis of the MiLe-1 study included infants undergoing surgery with cardiopulmonary bypass. Biomarkers were measured before and after CPB. Using BIC-guided logistic regression, we developed and compared three multivariable models-Clinical-Data-Only, Biomarker-Only, and Combined-for each outcome. Model performance was assessed using c-statistics and p-contrast tests.

RESULTS: Regarding AKI risk prediction, the c-statistics for Biomarker-Only, Clinical-Data-Only, and Combined Model were 0.79, 0.60, and 0.78 respectively. The difference in performance between the Combined and Clinical-Data-Only Models was statistically significant (p < 0.001). Concerning ventilator support time prediction, the c-statistics were 0.80, 0.72, and 0.77 for the models respectively (p-contrast = 0.10). As for inotropic score prediction, the c-statistics were 0.83, 0.77, and 0.85 for the models (p-contrast = 0.007).

CONCLUSION: Inflammatory biomarkers may enhance risk stratification for postoperative outcomes in infant cardiac surgery. However, given the exploratory nature of this study, further validation in larger and more diverse cohorts is needed.

PMID:40492379 | DOI:10.1111/aas.70073

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Nevin Manimala Statistics

Comparison of Surgical Outcomes Between Vaginally Assisted NOTES Hysterectomy and Laparoscopic Hysterectomy in Primary Hospitals: A Prospective Cohort Study

J Invest Surg. 2025 Dec;38(1):2515054. doi: 10.1080/08941939.2025.2515054. Epub 2025 Jun 10.

ABSTRACT

BACKGROUND: This study aimed to compare the operative outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) and total laparoscopic hysterectomy (TLH). We also aimed to determine the feasibility of performing vNOTES hysterectomy in primary hospitals.

METHODS: This prospective cohort study enrolled 54 patients with indications for hysterectomy related to benign uterine disease without prolapse, between September 1, 2020, and November 30, 2024. The patients were categorized into two groups: vNOTES hysterectomy and TLH (n = 27 each). Surgical outcomes, including operative time, blood loss, recovery parameters, and complications, were assessed.

RESULTS: Preoperative baseline characteristics were comparable between the two groups. The vNOTES group had a longer mean operative time (187.6 vs. 154.4 min, p < 0.05) and greater median blood loss (100 vs. 30 mL, p < 0.05) compared to the TLH group. However, there were no significant differences in conversion rates, uterine weights, complications, 24-h pain scores, hospital stay, costs, or readmission rates. The vNOTES group demonstrated shorter times to postoperative ambulation, earlier return of bowel function (anal exhaust), and reduced urinary catheter insertion duration (p < 0.05).

CONCLUSION: vNOTES hysterectomy is feasible in primary hospitals, with surgical outcomes comparable to those of TLH. Patients who underwent vNOTES experienced faster recovery, indicating that it serves as a potential minimally invasive alternative to TLH. However, the small sample size warrants further studies to validate these findings.

PMID:40492370 | DOI:10.1080/08941939.2025.2515054

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Nevin Manimala Statistics

Effects of different oral barrier membranes on the efficacy and safety of guided bone regeneration in patients with dental implants: a systematic review and meta-analysis

Acta Odontol Scand. 2025 Jun 10;84:318-331. doi: 10.2340/aos.v84.43758.

ABSTRACT

OBJECTIVE: This study aims to systematically evaluate the effects of different oral barrier membranes on bone regeneration, focusing on their clinical efficacy and safety during dental implant procedures.

METHODS: A comprehensive search was conducted in PubMed, EMBASE, ScienceDirect, Cochrane Library, CNKI, VIP, and CBM databases for case-control and cohort studies published between January 2002 and March 2025. Two independent researchers screened and extracted data, and statistical analysis was performed using RevMan 5.3. The study was registered in PROSPERO (CRD492390).

RESULTS: A total of 11 clinical controlled and cohort studies with 1,003 patients were included. The absorbable membrane group demonstrated a significantly higher success rate (p < 0.05), greater bone graft thickness (p < 0.05), and fewer adverse reactions (p < 0.05). Meta-analysis showed no significant difference in osseointegration, total mineralised tissue, and non-mineralised tissue (p > 0.05).

CONCLUSION: Absorbable oral barrier membranes exhibit superior safety and efficacy profiles, making them a preferred choice for guided bone regeneration. However, further studies with higher methodological quality and longer follow-up durations are required.

PMID:40492364 | DOI:10.2340/aos.v84.43758

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Nevin Manimala Statistics

Addressing barriers to addiction recovery services in the Northwest Territories, Canada

Int J Circumpolar Health. 2025 Dec;84(1):2516872. doi: 10.1080/22423982.2025.2516872. Epub 2025 Jun 10.

ABSTRACT

The Northwest Territories, Canada, has high rates of alcohol- and drug-related hospitalisations and deaths. There is considerable debate over how to provide substance use recovery services in this region, due to its small, culturally diverse population. The aim of this study was to examine demographic differences in ethnicity, gender and sex for individuals in the barriers to accessing services, supports to stay in recovery, and reasons they struggled to stay in recovery. A total of 439 respondents completed online and paper-based surveys on their experiences accessing recovery services in the Northwest Territories. A mixed methods approach was applied, in which Fisher’s exact test was applied to test for statistically significant demographic differences in quantitative responses, and themed analysis was performed using deductive coding using written survey responses. Several statistically significant demographic differences were identified in barriers to services, supports to recovery, and barriers to staying in recovery. Cultural incongruity, and the importance of social support to substance use disorder recovery, were identified as key themes that emerged in qualitative analysis. There is a need for community-based, culturally safe, and family-inclusive holistic supports at the community level to address substance use issues in the NT, including more informal confidential supports and efforts to reduce stigma and normalise and celebrate recovery.

PMID:40492355 | DOI:10.1080/22423982.2025.2516872

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Nevin Manimala Statistics

Preliminary Insights Into the Relationship Between the Gut Microbiome and Host Genome in Posttraumatic Stress Disorder

Genes Brain Behav. 2025 Jun;24(3):e70025. doi: 10.1111/gbb.70025.

ABSTRACT

Posttraumatic stress disorder (PTSD) may develop following trauma exposure; however, not all trauma-exposed individuals develop PTSD, suggesting the presence of susceptibility and resilience factors. The gut microbiome and host genome, which are interconnected, have been implicated in the aetiology of PTSD. However, their interaction has yet to be investigated in a South African population. Using genome-wide genotype data and 16S rRNA (V4) gene amplicon sequencing data from 53 trauma-exposed controls and 74 PTSD cases, we observed no significant association between the host genome and summed abundance of Mitsuokella, Odoribacter, Catenibacterium and Olsenella, previously reported as associated with PTSD status in this cohort. However, PROM2 rs2278067 T-allele was significantly positively associated with the summed relative abundance of these genera, but only in individuals with PTSD and not trauma-exposed controls (p < 0.014). Polygenic risk scores generated using genome-wide association study summary statistics from the PGC-PTSD Overall Freeze 2 were not predictive of gut microbial composition in this cohort. These preliminary results suggest a potential role for the interaction between genetic variation and gut microbial composition in the context of PTSD, underscoring the need for further investigation.

PMID:40492293 | DOI:10.1111/gbb.70025