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Nevin Manimala Statistics

Advanced paternal age at birth and risk of cyanotic congenital heart defects in the United States

Maturitas. 2026 Feb 2;207:108863. doi: 10.1016/j.maturitas.2026.108863. Online ahead of print.

ABSTRACT

INTRODUCTION: Limited inconsistent evidence suggests a potential association between advanced paternal age (APA) and simple congenital heart defects, which often resolve without surgical interventions, in offspring. There is no reported potential relationship between APA with major cardiac defects like cyanotic congenital heart defects (CCHD). This study evaluated the association between APA (age at birth ≥40 years) and the occurrence of CCHD among livebirths in the USA, accounting for maternal and other potential confounding factors.

METHODS: Data were from the National Vital Statistics System, comprising 9.9 million singleton first-time livebirths among mothers and fathers aged ≥15 years from 2016 to 2023. Logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (CI).

RESULTS: From 2016 to 2023, the proportion of births to fathers with APA increased from 7.5% to 7.9%. A greater proportion of fathers with APA had offspring with CCHD (62.0 vs. 53.1 per 100,000), used infertility treatment (9.5% vs. 2.3%), and their partners were also older (34.6 vs. 27.0 years). In models adjusted for paternal factors (age, race and ethnicity, and education), APA was associated with a modest elevated odds for CCHD (OR = 1.22, 95% CI 1.11-1.34) which remained significant after further control for maternal pre-pregnancy sociodemographic and health factors (OR = 1.12, 95% CI 1.01-1.25). However, additional adjustments for infertility treatment attenuated the observed association (OR = 1.08, 95% CI 0.98-1.20).

CONCLUSIONS: The findings of this large population-based study suggest no association between APA and CCHD after accounting for important confounders, including maternal factors and infertility treatment.

PMID:41643280 | DOI:10.1016/j.maturitas.2026.108863

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PROspectiVe imaging research DEsign and coNducT (PROVIDENT): Considerations for clinical trials and studies using imaging (Part I)

Radiography (Lond). 2026 Feb 4;32(3):103322. doi: 10.1016/j.radi.2025.103322. Online ahead of print.

ABSTRACT

OBJECTIVES: Imaging is used in a wide range of contexts in clinical research projects, but adds complexity to the design, conduct and analysis. This paper is the first of two in which we use a consensus approach to bring together multidisciplinary perspectives on the challenges in conducting prospective clinical trials and research studies that include imaging. In this first part we consider challenges in ethics, participant information and consent, recruitment, trial/study and site set-up, training and trial or study conduct.

KEY FINDINGS: Effective communication with patients regarding the purpose, benefits and risks, and potential future use of imaging data is essential to build trust and support informed participation. Transparency around data handling, including de-identification processes and the right to withdraw consent, underpins ethical research practice. Successful recruitment requires strong collaboration between clinical and imaging teams to ensure clarity, consistency, and efficiency. To reduce participant burden, flexibility should be offered in scheduling and scan requirements, taking into account accessibility and personal commitments. Site setup and staff training benefit from feasibility assessments that evaluate equipment capabilities and identify specific imaging training needs. Clearly defined roles and responsibilities of key personnel support streamlined workflows and accountability. Communication of planned changes to procedures during the study to all stakeholders is key to avoid delays and risks to data integrity. Effective monitoring of procedures, radiation doses (where applicable) and data quality should be pre-planned.

CONCLUSION: These considerations derived from a multidisciplinary team will be useful for funding applications, protocol design, trial implementation, conduct, commercialisation and uptake of new imaging techniques.

IMPLICATIONS FOR PRACTICE: Many prospective imaging studies could be improved by the upfront awareness of potential challenges and understanding of real-world examples these considerations provide.

PMID:41643277 | DOI:10.1016/j.radi.2025.103322

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Nurse-led interventions targeting post-intensive care syndrome domains in adult intensive care unit survivors: A systematic review

Aust Crit Care. 2026 Feb 4;39(2):101529. doi: 10.1016/j.aucc.2025.101529. Online ahead of print.

ABSTRACT

OBJECTIVES: The objective of this study was to evaluate the effectiveness of nurse-led interventions designed to prevent or mitigate the severity of post-intensive care syndrome (PICS) among adult intensive care unit (ICU) survivors.

REVIEW METHOD USED: A systematic review was conducted.

DATA SOURCES: A systematic search was conducted in five databases (EMBASE, CINAHL, PsycINFO, PubMed, and the Cochrane Library) from January 2012 to April 2024.

METHOD: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we performed a systematic review. We included studies involving original experimental designs and nurse-led interventions aimed at addressing PICS outcomes in adult ICU survivors. The methodological quality of the studies was evaluated using revised Risk of Bias tool and Risk of Bias Assessment Tool for Nonrandomized Studies 2. Given the heterogeneity of the included studies, we conducted a synthesis without a meta-analysis.

RESULTS: Twenty-one studies (13 randomised controlled trials and 8 quasi-experimental studies) were included. Five types of nurse-led interventions were identified: clinical interventions (7 studies), patient education (3 studies), consultation and counselling (5 studies), follow-up programs (3 studies), and diary interventions (3 studies). Psychological outcomes were the most frequently assessed domain (17 studies), yet findings were inconsistent across interventions. Physical health was the least examined domain (2 studies), both reporting statistically significant effects. Cognitive function (4 studies) and quality of life (6 studies), however, showed no significant effects.

CONCLUSIONS: Nurse-led interventions demonstrated effects, particularly in psychological and physical domains, but showed limited effects on cognitive outcomes and quality of life. Due to methodological heterogeneity, definitive conclusions regarding overall effectiveness remain challenging. Despite these limitations, the findings underscore the central role of nurses in delivering and coordinating diverse interventions throughout the ICU survivorship trajectory. This review further highlights insufficient preventive strategies prior to ICU admission and the lack of comprehensive assessments across all PICS domains, supporting the need for a continuum of care approach in future research.

PMID:41643272 | DOI:10.1016/j.aucc.2025.101529

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Preoperative Glucagon-like Peptide-1 Therapy in Bariatric Surgery Patients with Morbid Obesity (PreMO): Rationale and Study Design for a Randomized Controlled Trial

J Surg Res. 2026 Feb 4;319:58-65. doi: 10.1016/j.jss.2026.01.004. Online ahead of print.

ABSTRACT

INTRODUCTION: Bariatric surgery is the most effective treatment modality for individuals with morbid obesity, providing significant and durable weight loss and comorbidity resolution. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide receptor agonists have shown promise as weight loss drugs, in addition to their use in the treatment of metabolic disorders. While multimodal weight management is the standard of care for individuals with morbid obesity, the benefit of antecedent GLP-1 therapy prior to bariatric surgery has not been well-studied. The objective of this study is to conduct a clinical trial testing the hypothesis that preoperative treatment with a dual GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist enhances preoperative weight loss and decreases tissue inflammation, resulting in improved postoperative outcomes.

MATERIALS AND METHODS: We designed a randomized controlled trial (RCT) comparing preoperative treatment with tirzepatide versus standard medical care prior to minimally invasive bariatric surgery with a target enrollment of 50 patients randomized 1:1. For 3 mo preoperatively, the control arm will receive standard care in the form of dietary and lifestyle modification recommendations, whereas the treatment arm will receive weekly tirzepatide, in addition to standard care. Blood will be collected at enrollment through 12-mo postoperatively and analyzed for inflammatory and metabolic markers. Tissues (adipose, stomach, and liver) will be collected intraoperatively for transcriptome profiling and histological assessment.

RESULTS: This is an ongoing trial with no reportable results.

CONCLUSION: Completion of this pilot RCT will provide data to support initiation of a multicenter RCT to determine therapeutic efficacy, and mechanisms of action, by which patients could benefit from preoperative treatment with tirzepatide.

PMID:41643256 | DOI:10.1016/j.jss.2026.01.004

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Gaps in the Electronic Medical Record May Contribute to Low Participation in Lung Cancer Screening

J Surg Res. 2026 Feb 4;319:40-46. doi: 10.1016/j.jss.2025.11.074. Online ahead of print.

ABSTRACT

INTRODUCTION: Best Practice Advisories (BPAs) are electronic medical record (EMR) tools that help increase uptake of recommended health care behaviors, such as cancer screenings, by identifying eligible patients and alerting providers. However, incomplete/inaccurate documentation within the EMR can be a potential barrier to BPA utility. The purpose of this work was to investigate the effectiveness of a BPA tool to identify eligible patients for lung cancer screening (LCS) using available EMR smoking histories.

MATERIALS AND METHODS: Retrospective observational review was conducted of a BPA programmed to identify LCS-eligible patients at a single quaternary, LCS-accredited, academic medical center. Programming targeted patients aged 50-77 y classified as “current” or “former smokers,” excluding patients with recent lung computed tomography scans and/or lung cancer diagnoses. Data analyzed included frequency of BPA activation and the associated smoking history. Descriptive statistics were used to analyze outcomes.

RESULTS: Between January 2017 and December 2021, there were 25,172 BPA activations, of which 11,701 were removed because they occurred outside a clinical/telehealth visit. This left 14,101 BPAs linked to 3150 patients. EMR information was not sufficient to calculate pack-year history for 48.9% (1541/3150), and the LCS order rate was 2.5% (78/3150). Although pulmonary disease specialists accounted for 13.7% (236/1721) of total LCS orders, the BPA did not activate for them.

CONCLUSIONS: Incomplete EMR data entry may contribute to the complexities of identifying LCS-eligible patients. This highlights the value of improving the completeness of EMR smoking history data and conducting targeted BPA audits to understand optimal activation parameters to improve clinician orders for LCS.

PMID:41643255 | DOI:10.1016/j.jss.2025.11.074

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Where is the ‘Anxious’ in climate anxiety? Evidence from Chinese social media big data

J Anxiety Disord. 2026 Jan 30;118:103127. doi: 10.1016/j.janxdis.2026.103127. Online ahead of print.

ABSTRACT

Climate anxiety has emerged as a significant global psychological and social response to climate change, potentially shaping public engagement and support for climate-related technologies and policies. Here we develop a framework for analyzing online climate anxiety using social media data from China based on 177,232 geo-referenced Weibo posts from 2010 to 2024. The analysis began with the investigation of climate anxiety themes using climate-anxious dictionaries and machine learning methods. Next, the emotional intensity of climate anxiety was assessed through the semantic similarity-based scoring approach. Finally, statistical models were applied to measure the factors influencing climate anxiety. Four major findings are arrived. First, extreme weather events (52.36 %) and livelihood and resource insecurity (22.87 %) were the most discussed and concerning themes, with a notable increase in discussions during summer and autumn. Second, the intensity of climate anxiety has risen significantly. The average intensity increased from 4.42 during the period of 2010-2017 to 7.08 during 2018-2024, with a further notable rise to 7.49 in the more recent period from 2020 to 2024. Third, regions such as Beijing (8.70), Guangdong (8.31), and Zhejiang (7.94) exhibited the highest levels of climate anxiety. Fourth, the intensity of climate anxiety is associated with key demographic and regional factors. Specifically, younger individuals and those residing in climate-vulnerable or informationally developed regions exhibited stronger emotional responses. The framework provides a scalable method for tracking the spatiotemporal dynamics of collective climate anxiety online. The findings demonstrate that digital expressions of climate anxiety constitute a measurable indicator of public concern and carry significant implications for anticipating societal responses and designing targeted communication within climate governance.

PMID:41643241 | DOI:10.1016/j.janxdis.2026.103127

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Non-emerging primary trial results from the Bandim health project

Vaccine. 2026 Feb 4;75:128302. doi: 10.1016/j.vaccine.2026.128302. Online ahead of print.

NO ABSTRACT

PMID:41643234 | DOI:10.1016/j.vaccine.2026.128302

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Nevin Manimala Statistics

Febrile seizure risk following monovalent COVID-19 mRNA vaccination in US children aged 2-5 years

Vaccine. 2026 Feb 4;75:128225. doi: 10.1016/j.vaccine.2026.128225. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate febrile seizure risk following monovalent COVID-19 mRNA vaccination among children aged 2-5 years.

METHODS: The primary analysis evaluated children who had a febrile seizure outcome in the 0-1 days following COVID-19 vaccination. A self-controlled case series analysis was performed in three commercial insurance databases to compare the risk of seizure in the risk interval (0-1 days) to a control interval (8-63 days). The exposure of interest was receipt of dose 1 and/or dose 2 of monovalent COVID-19 mRNA vaccinations. The primary outcome was febrile seizure (0-1 day risk interval). A conditional Poisson regression model was used to compare outcome rates in risk and control intervals and estimate incidence rate ratios (IRR) and 95% confidence intervals (CIs). Meta-analyses were used to pool results across databases.

RESULTS: The primary meta-analysis found a statistically significant increased incidence of febrile seizure, in the 0-1 days following mRNA-1273 vaccination compared to the control interval (IRR: 2.52, 95% CI: 1.35 to 4.69, risk difference (RD)/100,000 doses = 3.22 (95% CI -0.31 to 6.75)). For the BNT162b2 vaccination, the IRR was elevated but not statistically significant (IRR: 1.41, 95% CI: 0.48 to 4.11, RD/100,000 doses = -0.25 (95% CI -2.75 to 2.24).

CONCLUSIONS: Among children aged 2-5 years, the analysis showed a small elevated incidence rate ratio of febrile seizures in the 0-1 days following the mRNA-1273 vaccination.

PMID:41643233 | DOI:10.1016/j.vaccine.2026.128225

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Effect of melatonin enriched with L-Tryptophan and 5-Hydroxytryptophan on sleep parameters in children with neurodevelopmental disorders

Sleep Med. 2026 Jan 30;141:108818. doi: 10.1016/j.sleep.2026.108818. Online ahead of print.

ABSTRACT

INTRODUCTION: Melatonin plays a key role in sleep regulation. Combining melatonin with its precursors, L-tryptophan (LT) and 5-Hydroxytryptophan (5HTP), may influence sleep-related outcomes, but evidence in children with neurodevelopmental disorders (NDDs) is limited. This exploratory study compares the effects of melatonin combined with 5HTP (M-5HTP) and melatonin combined with LT (M-LT) on sleep disorders in children with NDDs.

METHODS: This single-center, randomized pilot comparative trial involved children under five years of age with NDDs free of sleep-inducing drugs. Baseline evaluations and actigraphy monitoring were performed. Children were randomly assigned to either M-5HTP (1 mg Melatonin +10 mg 5HTP) or M-LT (1 mg Melatonin +20 mg LT) treatment at 8 p.m. for at least four weeks. Post-treatment actigraphy monitoring assessed sleep parameters.

RESULTS: Of 51 screened children, 26 were enrolled and 13 completed the study (M-5HTP: 9, M-LT: 4). No statistically significant between-group differences in change scores were observed. Within-group analyses showed a significant reduction in the Sleep Movement Index (SMI) from baseline to follow-up in the M-5HTP group (T0: 6.55; T1: 1.25; p=0.006), whereas no significant changes were observed in the M-LT group.

DISCUSSION: In this exploratory pilot study, a within-group reduction in nocturnal motor activity was observed among M-5HTP completers. Given the small sample size, high attrition rate, and limited statistical power, these findings should be interpreted cautiously and considered hypothesis-generating.

PMID:41643230 | DOI:10.1016/j.sleep.2026.108818

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Geospatial insights: an analysis of a bullying prevention educational program in pathology laboratory medicine

Am J Clin Pathol. 2026 Jan 5;165(2):aqaf148. doi: 10.1093/ajcp/aqaf148.

ABSTRACT

OBJECTIVE: The prevalence of mistreatment in the laboratory workforce is concerning. This study aimed to develop an antibullying course for laboratories and to pilot-test its effectiveness in improving knowledge, readiness for organizational change, and coping self-efficacy. In addition, it used geographic information system mapping to explore the geospatial distribution of bullying and course participation and to describe the program for potential implementation by other institutions.

METHODS: An 8-module online course was developed for laboratory management and nonsupervisory staff, focusing on best practices to address incivility at the organizational and individual levels. Participants completed a pre-course assessment, including the Short Negative Acts Questionnaire and a pretest, before taking the course. The program’s effectiveness was evaluated by comparing pre-course and post-course scores using paired sample t tests and geospatial analysis.

RESULTS: Of 127 laboratory professionals who completed the pre-course survey, 92 (72.4%) completed the bullying prevention course and post-course evaluation. More than half (55.1%) were classified as victims of workplace bullying, with regional analysis showing the highest bullying intensity in the West and Midwest regions that also showed contrasting course completion rates (85%-87% in the West vs <70% in the Midwest). Post-course assessment revealed statistically significant improvements in participants’ knowledge (mean increase from 2.57 to 3.08, P < .001) and coping strategies (2.60-2.94, P < .001), supporting the course’s efficacy. Most participants (77.2%) rated the course positively.

CONCLUSIONS: The issue is persistent and will require deliberate interventions. The piloted bullying prevention educational platform presented is promising and can be a foundation for future targeted educational interventions for pathology laboratories.

PMID:41643208 | DOI:10.1093/ajcp/aqaf148