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Nevin Manimala Statistics

Power and sample size considerations for test-negative design with bias correction: a case study on the world first malaria vaccine

BMC Med Res Methodol. 2025 Jul 29;25(1):178. doi: 10.1186/s12874-025-02628-9.

ABSTRACT

BACKGROUND: Test-negative design (TND) studies are increasingly common in evaluating vaccine effectiveness (VE) for various infectious diseases. TND studies are susceptible to bias due to disease outcome misclassification caused by imperfect test sensitivity and specificity. Several bias correction methods have been proposed. However, sample size or power considerations for TND studies incorporating bias correction for such misclassification have not yet been investigated.

METHODS: We used Monte Carlo simulations to assess how bias correction affects the statistical power and sample size for VE estimation in TND studies. Simulations were conducted under varying levels of diagnostic test sensitivities (60%, 80%, and 95%). Bias correction was implemented using the multiple over-imputation method, which accounts for test misclassification through a parametric bootstrapping approach. Using a malaria vaccine as an example, we defined six vaccination status categories based on the time since receipt of the third or fourth vaccine dose. In the simulated target population, vaccination coverage was assumed to be low (< 10%) except for the group vaccinated more than 12 months after dose 4. We assumed relatively low VE (< 50%) against clinical malaria cases and a 30% malaria positivity rate among unvaccinated individuals presenting with malaria-related symptoms. Statistical power to detect VE was estimated for each vaccination status, both with and without bias correction.

RESULTS: Estimated VEs based on observed data were consistently underestimated across all vaccination status groups due to diagnostic misclassification. In contrast, bias-corrected estimates were approximately unbiased but displayed wider confidence intervals, with their precision decreasing at lower test sensitivities. Statistical power to detect VE declined substantially when diagnostic test sensitivity was low. For instance, at 80% sensitivity, only three vaccination status groups reached 80% power with a sample size of 10,000, whereas the same power was achieved with just 6,000 individuals under a perfect test.

CONCLUSIONS: Bias due to imperfect diagnostic testing can substantially reduce the power of TND studies. Power calculations should account for outcome misclassification and potential correction methods. Failure to do so may lead to underpowered studies and misleading VE estimates.

PMID:40730954 | DOI:10.1186/s12874-025-02628-9

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Nevin Manimala Statistics

The Relationship Between Adult Attachment Styles and Emotion Dysregulation With Fragile and Grandiose Narcissism

Psychol Rep. 2025 Jul 29:332941251363909. doi: 10.1177/00332941251363909. Online ahead of print.

ABSTRACT

This study aimed to investigate the relationships between adult attachment patterns, emotion dysregulation, and pathological narcissism-both fragile and grandiose dimensions. Previous research has indicated that attachment styles and emotion regulation difficulties play significant roles in narcissism development; however, the combined effects of these variables on both dimensions of narcissism remain insufficiently explored. The sample consisted of 114 individuals aged at least 18 years who were selected using convenience sampling from Sakarya University’s student population. The gender distribution was balanced, with 57 (50%) female and 57 (50%) male participants. The Difficulties in Emotion Regulation Scale, Pathological Narcissism Inventory, Relationship Scales Questionnaire, and a Demographic Information Form were administered to participants. Data analysis was conducted using SPSS statistical software. Between-group differences were examined using t test analysis, relationships between variables were investigated using Pearson correlation analysis, and predictive capacity was determined using hierarchical regression analysis. The results revealed a significant negative relationship between fragile narcissism and secure attachment, while positive relationships were found between fragile narcissism and preoccupied attachment, dismissive attachment, and emotion dysregulation difficulties. No significant relationships were found between grandiose narcissism and attachment styles. When all independent variables were included in the regression analysis, they collectively explained 36% of the variance in fragile narcissism, with emotion dysregulation (β = .395) and preoccupied attachment (β = .287) emerging as the strongest predictors. These findings highlight the importance of addressing emotion regulation skills and insecure attachment patterns in therapeutic interventions for individuals with fragile narcissistic traits, which may contribute to more effective clinical approaches and psychological support strategies.

PMID:40729757 | DOI:10.1177/00332941251363909

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Nevin Manimala Statistics

Bridging the Gaps: Imputation of Parkinson’s Disease Clinical Assessments With Federated Learning

IEEE J Biomed Health Inform. 2025 Jul 29;PP. doi: 10.1109/JBHI.2025.3593459. Online ahead of print.

ABSTRACT

Routine clinical assessments for Parkinson’s disease are essential instruments in both clinical practice and research that are often used to identify disease sub-types and monitor the progression of disease severity. However, each clinic has limited access to information and the quality of these assessments is often degraded by the amount of missing information recorded at the time of each visit. The main objective of this study is to evaluate the performance of Federated Learning (FL) algorithms for imputing missing clinical data, enhancing the quality of decentralized Parkinson’s disease assessments while maintaining data privacy. Specifically, we explore the impact of various aggregation strategies on the imputation of clinical data from 1,370 patients in the Parkinson Progression Marker Initiative (PPMI). Notably, the Cyclic Weight Transfer (CWT) algorithm stands out for its lower imputation errors. To validate this study, we conducted a downstream analysis using imputed data to predict symptoms progression. We observed that a FL-based approach yields superior model performance based on imputation errors, when compared to a traditional learning strategies. These improvements can achieve 37.7% and 31.5% lower mean imputation errors with low and moderate degree of missing scores in the training data, respectively. In addition, we achieved better classification scores with Random Forest models trained with imputed data from FL-based approaches, compared to traditional statistical methods, with improvements of 0.5% in PR-AUC, 0.6% in ROC-AUC, and 1.3% in F-1 score. These results highlight FL as a robust and secure solution for decentralized clinical data management, offering improved performance while preserving patient privacy.

PMID:40729715 | DOI:10.1109/JBHI.2025.3593459

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Nevin Manimala Statistics

Housing and Preterm Birth, Stillbirth and Neonatal Death in Canada: A Population-based Study Using 2006 and 2016 National Census Data

Epidemiology. 2025 Sep 1;36(5):e21-e23. doi: 10.1097/EDE.0000000000001886. Epub 2025 Jul 29.

NO ABSTRACT

PMID:40729682 | DOI:10.1097/EDE.0000000000001886

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Nevin Manimala Statistics

Exploratory Impact of iCARE Nigeria, a Combined mHealth and Peer Navigation Intervention, on Depressive Symptoms and Substance Use Among Youth Living With HIV in Nigeria: Single-Arm Trial

JMIR Form Res. 2025 Jul 29;9:e71141. doi: 10.2196/71141.

ABSTRACT

BACKGROUND: Mental health problems are a barrier to the well-being of youth living with HIV. Many youth living with HIV in Nigeria face peculiar biopsychosocial vulnerabilities that predispose them to mental health problems including depression and substance use. In addition to improving treatment outcomes like medication adherence and linkage to care, peer engagement has shown some promise in improving the social and emotional well-being of this population. Mobile health (mHealth) interventions like SMS text messaging medication reminders may also contribute to better outcomes in youth living with HIV. Emerging evidence suggests that combination interventions may be more effective than single interventions in improving key HIV testing and treatment outcomes among youth in Nigeria.

OBJECTIVE: This study aims to explore the impact of Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents (iCARE Nigeria) study-an mHealth and peer navigation intervention primarily aimed at medication adherence and viral suppression-on depressive symptoms and substance use among youth living with HIV in Nigeria.

METHODS: A single-arm clinical trial was conducted at the Infectious Disease Institute, College of Medicine, University of Ibadan, Nigeria- primarily to improve medication adherence and viral suppression among youth living with HIV attending its HIV clinic. The intervention combined peer navigation and daily, 2-way, text message medication reminders delivered over a period of 48 weeks. Participants were screened at baseline and follow-up visits (24 and 48 weeks) for depression and substance use using standardized measures. Paired t tests and McNemar tests were used to investigate the change in depressive symptoms and the change in the proportion of participants reporting substance use over time, respectively.

RESULTS: All 40 enrolled participants (n=20, 50% male; mean age 19.9 y, SD 2.5 y) completed baseline and follow-up visits at week 24, while 37 (92.5%) participants completed the week 48 visit. Compared with baseline, there were significantly fewer self-reported depressive symptoms observed at 48 weeks (mean 2.89 vs 2.08; t36=2.04, 95% CI 0.006-1.615) but not at 24 weeks (mean 2.89 vs 2.62; t36=0.47, 95% CI -0.74 to 1.44). There were fewer self-reports of substance use at weeks 24 and 48 when compared to baseline, but these were not statistically significant (odds ratio [OR] ∞, 95% CI 0.189-∞ and OR 3.0, 95% CI 0.24-157.49, respectively).

CONCLUSIONS: These findings suggest a statistically significant reduction in depressive symptoms among youth living with HIV over the 48-week intervention period that may be due to the iCARE Nigeria intervention. However, given limitations such as low levels of depressive symptoms at baseline, small sample size, and the lack of a control group, future studies such as the randomized stepped wedge evaluation of the iCARE intervention are needed to provide better insights into these exploratory findings.

PMID:40729632 | DOI:10.2196/71141

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Nevin Manimala Statistics

Statistical Learning-Assisted Dual-Signal Sensing Arrays Based on Conjugated Molecules for Pathogen Detection and Identification

ACS Appl Mater Interfaces. 2025 Jul 29. doi: 10.1021/acsami.5c08450. Online ahead of print.

ABSTRACT

Pathogenic microbial infections pose a serious threat to human health and safety. Therefore, rapid detection and accurate identification of pathogenic microorganisms are critical for effective diagnosis and prevention. However, clinical testing often faces challenges such as processing large sample volumes and achieving a high detection efficiency. Here, we developed a series of sensing arrays based on cationic conjugated polymer/silver nanoparticle (CCP/Ag) composites, enabling fluorescence and colorimetric dual-signal readouts for microbial detection and identification. Five conjugated polymers with distinct optical and electronic properties were selected to construct a diverse sensor array: fluorenephenylene-based PFP, phenylenevinylene-based PPV, BODIPY-based PBF, thiophene-based PMNT, and phenylenevinylene-based oligomer OPV. These polymers bind to microbial surfaces through hydrophobic and electrostatic interactions, producing polymer-specific signal changes upon target recognition. The incorporation of silver nanoparticles regulates the interaction-induced responses by modulating local plasmonic effects, leading to changes in both the fluorescence and colorimetric signals. The resulting complex signals were then analyzed by using elastic net regression to distinguish different microbial samples and classify unknown ones. This dual-signal system supports rapid and high-throughput analysis, providing a reliable and straightforward strategy for microbial identification and improving the diagnostic efficiency.

PMID:40729613 | DOI:10.1021/acsami.5c08450

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Nevin Manimala Statistics

Impact of Modifiable Surgical Factors on Ossiculoplasty Outcomes After Controlling for Ear Environment Risk: A Multi-Institutional Study

Otol Neurotol. 2025 Jul 25. doi: 10.1097/MAO.0000000000004611. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the impact of modifiable surgical factors on ossiculoplasty outcomes after controlling for ear environment risk.

STUDY DESIGN: Multi-institutional retrospective review.

SETTING: Six tertiary care centers from 2011 to 2019.

PATIENTS: Adults and children.

INTERVENTIONS: Ossiculoplasty, including synthetic ossicular replacement prosthesis, autograft interposition, bone cement repair, and mobilization.

MAIN OUTCOME MEASURE: Correlation between modifiable surgical factors and pure-tone average air-bone gap (ABG) at most recent audiogram after controlling for preoperative risk using the statistically validated Ear Environment Risk (EER) score.

RESULTS: A total of 1,679 cases were included with a median follow-up time of 20 months (IQR, 5-51). After controlling for EER score, malleus engagement of prosthesis yielded favorable ABG versus direct contact to tympanic membrane without malleus engagement (beta = -2.4 dB [-3.8, -1.1], p < 0.001). For total ossicular replacement prostheses (TORP), use of a footplate prosthesis yielded favorable ABG as compared with no footplate prosthesis (-3.6 dB [-6.1, -1.1], p = 0.005). For synthetic prostheses, polyethylene prostheses had a less favorable ABG compared with full titanium or titanium with hydroxyapatite prostheses (p < 0.05). In cases where the malleus was not engaged in reconstruction, amputation of the malleus head yielded worse ABG (+3.9 dB [1.2, 6.7], p = 0.005). There was no significant difference (p > 0.05) in ABG for single-stage versus multistaged approach, use of a cartilage cap over the prosthesis versus no cartilage, use of bone cement to secure a PORP to the stapes versus no cement, mastoid cavity obliteration versus no obliteration, and incudostapedial joint reconstruction with joint prosthesis/bone cement versus synthetic PORP.

CONCLUSIONS: With statistical correction for ear environment risk, several modifiable surgical factors are noted to impact ossiculoplasty hearing outcomes.

LEVEL OF EVIDENCE: 4.

PMID:40729578 | DOI:10.1097/MAO.0000000000004611

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Nevin Manimala Statistics

Risk Factors for Postoperative Lower Extremity Deep Venous Thrombosis Following Severe Traumatic Brain Injury: A Systematic Review and Meta-Analysis

Shock. 2025 Jul 25. doi: 10.1097/SHK.0000000000002676. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aims to systematically evaluate the risk factors associated with the development of postoperative lower extremity deep venous thrombosis (LEDVT) in patients with severe traumatic brain injury (sTBI).

METHODS: A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Comprehensive searches of Chinese and English databases, including PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, and Wanfang, were conducted from inception to December 12, 2024. Two researchers independently screened articles and extracted relevant data. Study quality was assessed using the Newcastle-Ottawa Scale and the Agency for Healthcare Research and Quality criteria. Meta-analyses were performed using RevMan 5.3, applying a random-effects model to combine effect sizes, with subsequent sensitivity analyses and assessments for publication bias. The review was registered in PROSPERO (CRD42024629624).

RESULTS: A total of 13 studies (n = 777,327) were included, comprising 8 case-control studies, 2 cohort studies, and 3 cross-sectional studies. Eleven significant risk factors for postoperative LEDVT were identified: advanced age (odds ratio [OR] = 1.12, 95% confidence interval [CI]: 1.10-1.14), use of dehydrant (OR = 2.04, 95% CI: 1.38-3.04), mechanical ventilation (OR = 1.01, 95% CI: 1.01-1.02), elevated D-dimer level (OR = 1.19, 95% CI: 1.11-1.27), polytrauma (OR = 1.63, 95% CI: 1.29-2.03), hypertension (OR = 1.11, 95% CI: 1.07-1.15), surgical duration (OR = 1.60, 95% CI: 1.06-2.42), elevated body mass index (OR = 1.30, 95% CI: 1.16-1.45), deep venous catheterization (OR = 1.36, 95% CI: 1.15-1.60), length of hospital stay (OR = 1.36, 95% CI: 1.18-1.56), and blood transfusion (OR = 3.56, 95% CI: 1.91-6.63), with all p values <0.05. No statistically significant associations were observed for Glasgow Coma Scale score (OR = 1.12, 95% CI: 0.98-1.28) or diabetes mellitus (OR = 1.02, 95% CI: 0.97-1.07).

CONCLUSIONS: Eleven variables were identified as significant risk factors for postoperative LEDVT among patients with sTBI. These findings underscore the importance of implementing individualized preventive strategies for patients identified as high risk.

PMID:40729566 | DOI:10.1097/SHK.0000000000002676

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Nevin Manimala Statistics

Proteomic Signatures of Epigenetic Age in African Green Monkey Cerebrospinal Fluid and Plasma

Aging Cell. 2025 Jul 29:e70168. doi: 10.1111/acel.70168. Online ahead of print.

ABSTRACT

Strategies to slow the aging process or mitigate its consequences on health rely on the validation of minimally-invasive biomarkers of aging that can be used to track aging and test the effectiveness of antiaging interventions. Study of aging in a nonhuman primate species offers a robust translational approach to achieving these aims, avoiding wide differences in genetics and environmental exposures that confound human aging studies. As epigenetic age appears to predict biological aging, biomarkers linked to epigenetic aging should be especially valuable in identifying individual differences in aging progression and documenting the impact of antiaging strategies. Proteins are the final effectors in most signaling pathways, indicating that alteration in levels of circulating proteins potentially offers an informative and valuable quantitative index of aging. Accordingly, a proteomic analysis was conducted on matching CSF and plasma samples collected from a large group of African green monkeys, with epigenetic ages ranging from young to old as determined by differential methylation of blood DNA. In addition to analyzing the data with linear statistical models, a gradient boosting machine learning technique was employed to identify not only individual CSF and plasma proteins that correlated with aging progression but also groups of proteins that could be used as predictors of global aging and of specialized aspects of aging such as inflammation. Overall, this study identified new CSF and plasma protein targets for understanding aging biology, together with identifying biomarkers to track changes in the rate of biological aging in a translationally relevant nonhuman primate model.

PMID:40729555 | DOI:10.1111/acel.70168

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Nevin Manimala Statistics

Trajectories of psychotic-like experiences in youth and associations with lifestyle factors

J Child Psychol Psychiatry. 2025 Jul 29. doi: 10.1111/jcpp.14179. Online ahead of print.

ABSTRACT

BACKGROUND: Persistent and/or distressing psychotic-like experiences (PLEs) during adolescence are associated with poorer subsequent psychiatric outcomes. Modifiable lifestyle factors (such as sleep quality or regular exercise) may improve mental health outcomes; however, it is unknown how lifestyle factors are linked to trajectories of PLEs.

METHODS: Using data from the Adolescent Brain Cognitive Development Study (N = 10,075, age 9-10 years at baseline), we characterized trajectories of PLEs using latent growth mixture models assessed using the Prodromal Questionnaire-Brief Child Version. We examined trajectories of Total and Distress scores. We used multinomial logistic regressions to examine associations between baseline lifestyle behaviors (including self-reported screen time, physical activity and caffeine intake, and parent-reported sleep disturbances and recreational activities) and PLE trajectories.

RESULTS: We identified four trajectories of distress-related PLEs: No Distress (27%), Rapid Decreasing (17%), Gradual Decreasing (36%), and Persistent Elevated Distress (21%). Compared with the No Distress trajectory, individuals in the Persistent Elevated Distress trajectory spent more time using screens (adjusted Odds Ratio [OR] 2.27, 95% confidence interval [CI] 2.03-2.53), had higher caffeine intake (OR 1.62, 95% CI 1.28-2.04), greater sleep disturbance (OR 1.58, 95% CI 1.45-1.73), participated in fewer recreational activities (OR 0.75, 95% CI 0.68-0.83) and less frequent physical activity (OR 0.81, 95% CI 0.74-0.89). Greater screen time and sleep disturbances further distinguished the most severe group from all other trajectories. Findings were similar when examining total scores. Results remained statistically significant when we included established risk factors of psychosis in each model.

CONCLUSIONS: Lifestyle factors associate with trajectories of PLE-related distress, providing novel tools for intervention and risk prediction.

PMID:40729543 | DOI:10.1111/jcpp.14179