Category: Nevin Manimala

Inquiry. 2026 Jan-Dec;63:469580251413526. doi: 10.1177/00469580251413526. Epub 2026 Jan 29.

ABSTRACT

Sleep quality is a critical component of student well-being and academic performance. This study aimed to examine the association between demographic characteristics, health and mental behaviors, smartphone usage, and sleep quality among undergraduate students at Jazan University in Saudi Arabia. A cross-sectional web-based survey was conducted between April and June 2023. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire included demographic data, health behaviors (exercise, diet, stimulant intake, smoking, qat use), anxiety levels, and smartphone usage patterns. Data were analyzed using descriptive statistics, t-tests, ANOVA, and multivariable linear regression. A total of 1564 students participated. Demographic variables were not significantly associated with sleep quality. However, poor sleep quality was significantly associated with several factors. Students who exercised less (mean PSQI = 8.19 vs 7.67; P = .003) or followed an unhealthy diet (8.10 vs 7.33; P = .001) reported worse sleep. High intake of stimulants, such as coffee (>3 times/day: β = 1.08, P = .021), tea, and soft drinks, was also linked to poorer sleep. Anxiety showed a clear dose-response effect, with mild, moderate, and severe anxiety associated with PSQI increases of 0.89, 2.27, and 3.43 points, respectively (all P < .001). Evening (β = .52, P = .016) and bedtime (β = .42, P = .029) smartphone use further predicted worse sleep quality, independent of total usage time. Sleep quality among undergraduate students is primarily influenced by modifiable lifestyle and psychological factors. Interventions promoting healthier routines, reducing stimulant intake, managing anxiety, and improving digital habits are essential to support student well-being.

PMID:41608860 | DOI:10.1177/00469580251413526

Biometrics. 2026 Jan 6;82(1):ujag001. doi: 10.1093/biomtc/ujag001.

ABSTRACT

Invasive mold infections (IMIs) are rare but life-threatening. Regulatory approval for new antifungal drugs requires a well-powered, randomized noninferiority trial, which is nearly infeasible due to the rarity of IMIs. Additionally, heterogeneity among mold types complicates study design and treatment effect interpretation when a study includes patients infected by different types of pathogens. Despite the success of single-arm oncology basket trials in evaluating treatment effect in multiple disease types, statistical methods for randomized basket trials in nononcologic settings remain underdeveloped. We propose a robust borrowing strategy to enhance the efficiency of randomized basket trials for IMIs by (i) borrowing treatment effects across mold types while accounting for heterogeneity and (ii) augmenting control arms using external data. The proposed approach increases the efficiency and precision of the treatment effect estimates for various molds. It also increases the ethical appeal by reducing the number of patients required for the control arm. Using simulation and real-life examples, we demonstrated the proposed approach can significantly increase statistical power and precision while maintaining the family-wise type I error rate at an acceptable level. Our approach offers a substantial improvement over the current practice of pooling different molds together for inference and is applicable to rare disease trials facing similar accrual and ethical challenges.

PMID:41608839 | DOI:10.1093/biomtc/ujag001

Rev Esp Enferm Dig. 2026 Jan 29. doi: 10.17235/reed.2026.11729/2025. Online ahead of print.

ABSTRACT

BACKGROUND: Anal cancer mortality has increased across high-income countries, yet subnational patterns remain poorly characterized. This study provides the first comprehensive, sex-stratified, spatiotemporal analysis of anal cancer (ICD-10 C21) mortality in Spain from 1999 to 2023.

METHODS: We conducted an ecological, descriptive, province-level analysis of mortality using data from the National Institute of Statistics. Sex-stratified Bayesian hierarchical models were applied to estimate smoothed relative risks (RRs) by province and year, incorporating spatial, temporal, and interaction effects. Model selection was guided by the Deviance Information Criterion and Widely Applicable Information Criterion. Posterior probabilities (PP) were used to identify high-risk provinces (PP > 0.95).

RESULTS: Among 160 candidate models, optimal structures differed by sex: males showed intrinsic Conditional Autoregressive (iCAR) spatial prior with RW1 temporal prior and Type IV interaction; females showed iCAR with RW2 temporal prior and Type III interaction. Mortality rose in both sexes: male RR increased steadily to 1.39 in 2023; female RR followed a nonlinear trajectory with delayed surge to 1.30. Variance decomposition indicated male mortality was mainly temporal (80.2%), female mortality largely spatial (58.1%). Male hotspots clustered in southern/insular provinces (e.g., Las Palmas RR=1.22, Cádiz 1.18, Valencia 1.18); female hotspots were more dispersed (e.g., Las Palmas 1.34, Málaga 1.33, Barcelona 1.26).

CONCLUSIONS: Anal cancer mortality in Spain is rising, revealing persistent sex-specific and geographic inequalities beyond national temporal trends. Precision prevention-via gender-neutral HPV vaccination, targeted screening, and prioritization of hotspot provinces-is urgently needed.

PMID:41608833 | DOI:10.17235/reed.2026.11729/2025

Clin Transl Sci. 2025 Sep;18(9):e70339. doi: 10.1111/cts.70339.

ABSTRACT

While the accelerated approval (AA) program in the United States expedites the availability of drugs based on preliminary evidence to fulfill unmet medical needs, it has also raised significant concerns, including a lack of robust evidence of efficacy and subsequent withdrawals. Although drug lag and drug loss are growing regulatory concerns in Japan, considering the stricter withdrawal criteria in Japan, careful evaluation of clinical evidence of accelerated approval and approval timing differences is necessary. Here, we aimed to investigate differences in approval timing between the U.S. and Japan, as well as the clinical evidence of accelerated approval drugs that have not yet been approved in Japan. Using the U.S. Food and Drug Administration (FDA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) databases, we examined the Japanese and U.S. regulatory status of cancer drugs granted accelerated approval in the U.S. between 2012 and 2022 and the characteristics of evidence for drugs not yet approved in Japan. Of 132 drug-indication pairs that received accelerated approval between 2012 and 2022, 72 (54.5%) were approved in Japan by June 2024. Of the remaining 60 (45.5%) drugs not yet approved in Japan, the majority had methodological limitations, including a lack of comparators (93.2%) and scarcity of phase III trials (8.5%), as permitted by the accelerated approval program. Our findings suggest the need for an approach that addresses drug lag while ensuring both careful regulatory review and generation of robust evidence for efficacy and safety.

PMID:41608832 | DOI:10.1111/cts.70339

Eur J Psychotraumatol. 2026 Dec;17(1):2611511. doi: 10.1080/20008066.2025.2611511. Epub 2026 Jan 29.

ABSTRACT

Background and Objective: Previous studies have shown that experience of racial discrimination is associated with increased mental health problems, especially stress. Using a cluster analytical procedure, the current study aimed to examine stress characteristics related to racial discrimination in individuals from diverse racial identities.Method: In total, 4220 participants completed the questionnaires assessing stress, resilience, everyday racial discrimination, and experience of major racial discrimination. K-means cluster analysis was performed to cluster participants’ features regarding stress, resilience, everyday racial discrimination, and major racial discrimination. To determine the optimal number of clusters, the gap statistic was employed. Extracted clusters were then compared across racial groups using chi-square tests.Results: Cluster analysis revealed a three-cluster solution, including ‘low stress’, ‘stress cluster with high racial discrimination’, and ‘stress cluster with low racial discrimination’ clusters. Concerning the race-differences, Black (32.57%) and Indigenous (33.63%) participants had higher membership in the stress cluster with high racial discrimination compared to other racialized groups. Regarding the stress cluster with low racial discrimination, a higher membership was observed among Arab participants (30.82%) and those with other racial identities (30.40%) compared to other racialized groups.Conclusions: The findings demonstrate a type of stress characterized by high levels of racial discrimination and accompanying psychosocial burdens. Implications for intervention, prevention, and future research are discussed in the paper.

PMID:41608817 | DOI:10.1080/20008066.2025.2611511

Glob Chang Biol. 2026 Feb;32(2):e70728. doi: 10.1111/gcb.70728.

ABSTRACT

Tropospheric ozone (O₃) is a pervasive stressor that impairs forest biomass and alters carbon allocation strategies. This study assessed biomass responses across 17 woody taxa under free-air controlled exposure (FACE), integrating a decade of experiments conducted with an analogous exposure regime applied to deciduous and evergreen species. The analysis provided a comparative evaluation of existing flux-based metrics. Statistical analyses revealed consistent reductions in relative total (RTB), aboveground (RTAB), and belowground (RTBB) biomass with increasing O₃ uptake in terms of phytotoxic ozone dose (POD₁ mmol m^-2). Deciduous species reached the 4% biomass reduction threshold (CL₄) at lower POD₁ levels for RTBB (10.21), RTAB (13.16), and RTB (10.77) and displayed relatively small ${△}_{{\mathrm{POD}}_1}$ values for RTBB (2.75), RTAB (5.70), and RTB (3.31), where ${△}_{{\mathrm{POD}}_1}$ represents the increment in O₃ uptake required to reach the CL₄ threshold. In contrast, evergreen species showed higher CL₄ for RTBB (11.48), RTAB (15.40), and RTB (13.86) and larger ${△}_{{\mathrm{POD}}_1}$ values for RTBB (8.40), RTAB (12.32), and RTB (10.78), reflecting a slower biomass decline. Contrasting relationships suggest that leaf habit-specific patterns are associated with divergent carbon allocation strategies under O₃ stress. In deciduous species, POD₁ and Leaf Index Flux (LIF) were negatively correlated with shoot-to-root ratio (S/R), whereas in evergreen species, both indices were positively correlated with leaf area ratio (LAR) and S/R. In conclusion, flux-based metrics provided a biologically robust framework for quantifying O₃-induced biomass losses, revealing higher sensitivity in deciduous species than in evergreens and highlighting the root as the most vulnerable compartment under O₃ exposure. The findings should be interpreted considering the spatial and temporal constraints of a single-site FACE experiment and the focus on O₃ as a stand-alone stressor without interaction effects. Future research should combine O₃ uptake with multi-stressor frameworks to better predict biomass and carbon responses in complex field conditions.

PMID:41608815 | DOI:10.1111/gcb.70728

Circ Cardiovasc Interv. 2026 Jan 29:e016191. doi: 10.1161/CIRCINTERVENTIONS.125.016191. Online ahead of print.

ABSTRACT

BACKGROUND: The DynamX bioadaptor, a novel coronary implant, is designed to restore vessel function when the thin polymer coating covering the helical strands resorbs 6 months post-percutaneous coronary intervention. We aimed to evaluate vessel conformability 1 year after percutaneous coronary intervention with the bioadaptor, compared with conventional drug-eluting stents (DESs).

METHODS: Vessel segments were 1:1 randomized to a novolimus-eluting bioadaptor or a durable polymer novolimus-eluting second-generation DES. Coronary computed tomography angiography was performed at 1 and 12 months post-implantation, and the 3-dimensional geometry of the treated segments in coronary computed tomography angiography was analyzed. The primary outcome was the change in dynamic vessel geometry, including curvature flexibility (bending motion), torsion flexibility (twisting motion), and path flexibility (3-dimensional motion) of the treated segment during the cardiac cycle.

RESULTS: A total of 48 vessel segments in 48 patients were randomized, with 24 receiving bioadaptor and 24 receiving DES. In within-group paired analyses, the bioadaptor group showed a significant improvement in torsion flexibility from 1 to 12 months, whereas no significant change was observed in the DES group. Although curvature and path flexibility increased numerically in the bioadaptor group, these within-group differences were not statistically significant. However, when comparing the magnitude of change between groups, the increase in path flexibility was significantly greater with the bioadaptor than with DES, indicating a superior restoration of 3-dimensional vessel motion.

CONCLUSIONS: The novel bioadaptor technology demonstrated favorable restoration of 3-dimensional dynamic geometry of the treated vessel segment 12 months after implantation, in comparison with traditional DES. These initial mechanistic findings suggest a potential explanation for the favorable clinical outcomes observed in prior trials, and our analytical approach may offer new insights to guide future vascular implant designs and evaluations.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04936191.

PMID:41608781 | DOI:10.1161/CIRCINTERVENTIONS.125.016191

Am J Sports Med. 2026 Jan 29:3635465251400357. doi: 10.1177/03635465251400357. Online ahead of print.

ABSTRACT

BACKGROUND: Total knee arthroplasty (TKA) provides pain relief and functional improvement for end-stage knee osteoarthritis patients. As TKA use increases in younger patients, return to sports (RTS) has become a key outcome measure. While RTS rates after TKA are generally high, they vary significantly across studies due to differences in study design, patient populations, and RTS definitions.

PURPOSE: To determine RTS rates, evaluate return to preoperative sport levels, quantify time to RTS, and identify factors affecting RTS after TKA.

STUDY DESIGN: Cohort study; Level of evidence, 2.

METHODS: We analyzed 21,466 primary TKAs performed between 2016 and 2022. Of these, 1782 patients (8.3%) were athletes at baseline, with 1464 (82.2%) completing 1-year follow-up. We recorded demographic characteristics, comorbidities, baseline and 1-year RTS status, time to RTS, athlete type, and patient-reported outcomes. Analysis included descriptive statistics, Cox regression for time to RTS, and logistic regression for RTS-associated factors.

RESULTS: Of 1464 patients, 782 (53.4%) achieved RTS, while 676 (46.6%) did not; both contact and noncontact sports were included. Among those who returned, 62% resumed their previous sport at the same level, 34.5% at a reduced intensity, and 3.4% switched to a different sport. The median RTS time was 12 weeks, with 90% returning within 27 weeks. Medicaid patients had a delayed RTS compared with those with commercial insurance (hazard ratio [HR], 0.51). Overweight patients returned sooner than normal-weight patients (HR, 1.41). Female patients (odds ratio [OR], 0.76) and Black patients (OR, 2.34) had lower RTS odds, while recreational (OR, 0.06) and competitive athletes (OR, 0.10) had higher RTS odds versus those not participating in athletic activities.

CONCLUSION: Over half of athletes returned to sports within 1 year of TKA, most within 27 weeks. RTS rates varied by preoperative competitive level, sex, race, body mass index, and comorbidity burden. These findings can guide patient expectations and shared decision-making regarding post-TKA sports participation. Future research should focus on improving RTS rates in high-risk groups, standardizing RTS criteria, and stratifying outcomes by sport type and impact level to enable more individualized patient recommendations.

PMID:41608778 | DOI:10.1177/03635465251400357

Stroke Vasc Interv Neurol. 2025 Nov 14;5(6):e001702. doi: 10.1161/SVIN.124.001702. eCollection 2025 Nov.

ABSTRACT

BACKGROUND: Mechanical thrombectomy is a critical intervention for patients with acute ischemic stroke with large vessel occlusion. However, significant barriers remain in its widespread implementation, particularly in low- to middle-income countries, including a shortage of trained physicians and limited access to advanced medical technologies. This systematic review and meta-analysis aimed to comprehensively evaluate current mechanical thrombectomy training methodologies and assess their effectiveness in improving procedural skills among neurointerventional teams.

METHODS: We conducted a systematic review following Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines, searching PubMed, Scopus, and Web of Science. Eight studies were included, with 3 studies eligible for meta-analysis. We assessed training approaches, participant demographics, and procedural outcomes using the Risk of Bias in Non-randomized Studies of Interventions tool and performed statistical analysis using OpenMetaAnalyst software.

RESULTS: Various training modalities, including virtual reality simulations and hands-on workshops, consistently demonstrated positive effects on procedural skills and professional confidence, demonstrating significant improvements across multiple metrics. Our systematic review and meta-analysis revealed statistically significant reductions in total procedure time (average decrease of 17.84 minutes, 95% CI: [-22.19 to -13.48]), number of handling errors (decreased by 6.34 errors, 95% CI: [-13.16 to 0.48]), contrast volume (decreased by 27.35 mL, 95% CI: [-45.11 to -9.60]), and fluoroscopy time (reduced by 8.07 minutes, 95% CI: [-10.71 to -5.44]). Participants showed increased procedural steps completed, with an average increase of 6.52 steps (95% CI: [3.99-9.05]).

CONCLUSION: Structured, simulation-based mechanical thrombectomy training programs can significantly enhance procedural skills, clinical decision-making, and professional confidence among neurointerventional teams, potentially improving stroke care.

PMID:41608732 | PMC:PMC12697599 | DOI:10.1161/SVIN.124.001702

Stroke Vasc Interv Neurol. 2025 Sep 16;5(6):e001933. doi: 10.1161/SVIN.125.001933. eCollection 2025 Nov.

ABSTRACT

BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are commonly prescribed for the management of type 2 diabetes, and recent studies have highlighted their neuroprotective and anti-inflammatory properties. However, their influence on clinical outcomes in patients undergoing endovascular treatment for unruptured intracranial aneurysms remains largely unexplored.

METHODS: This retrospective cohort study utilized the TriNetX database to identify patients with type 2 diabetes (International Classification of Diseases, Tenth Revision [ICD-10]: E11) and unruptured intracranial aneurysms (ICD-10: I67.1). Patients were categorized based on the use of GLP-1RAs. The outcomes included overall survival, poor functional outcome, new subarachnoid hemorrhage, and hydrocephalus. The propensity score matching method was applied.

RESULTS: A total of 6824 patients met the inclusion criteria, with 447 patients in each group following propensity score matching. No statistically significant differences were observed in short- and mid-term mortality between GLP-1RAs users and non-users. However, long-term mortality was significantly lower in the GLP-1 group (odds ratio 0.58, 95% CI 0.36-0.94). Furthermore, GLP-1RAs users demonstrated significantly reduced risks of poor functional outcomes (odds ratio 0.37, 95% CI 0.21-0.66), new subarachnoid hemorrhage (odds ratio 0.39, 95% CI 0.27-0.56), and hydrocephalus (odds ratio 0.57, 95% CI 0.33-0.97) at 3 months, with similar trends persisting in mid- and long-term follow-up.

CONCLUSION: Use of GLP-1RAs in patients with unruptured intracranial aneurysms treated via endovascular intervention is associated with improved long-term survival and reduced risks of subarachnoid hemorrhage, hydrocephalus, and poor functional outcomes. These findings suggest a potential therapeutic benefit beyond glycemic control. Prospective studies are needed to validate these results and explore their implications for clinical decision-making in aneurysm treatment.

PMID:41608727 | PMC:PMC12697656 | DOI:10.1161/SVIN.125.001933