Category: Nevin Manimala

Nicotine Tob Res. 2026 Feb 27:ntag041. doi: 10.1093/ntr/ntag041. Online ahead of print.

ABSTRACT

INTRODUCTION: This study assesses the Italian population’s support for innovative tobacco control policies, which aims at reducing use of nicotine-containing products and exposure to secondhand smoke and aerosol.

METHODS: A cross-sectional study was conducted in 2024 among a representative sample of 3125 Italian adults. We assessed support on banning tobacco sales to people born after a certain year (Smoke-Free Generation, SFG), raising the minimum age for purchasing tobacco to 21 years (Tobacco 21, T21), substantially increasing tobacco taxation, banning electronic cigarettes (e-cigarette) and heated tobacco products (HTP) in indoor public places and workplaces, and prohibiting tobacco and e-cigs advertising.

RESULTS: Support for tobacco control policies was 67.0% for the SFG policy, 72.9% for the T21 policy, 61.5% for a tax increase, 80.8% for a ban on indoor e-cigarette and HTP use in public places and 81.7% in workplaces respectively, and 78.2% for an advertising ban for all nicotine products. Support for all policies increased with age (p-values for trend ranging from <0.001 to 0.037) and was significantly lower among current smokers (support ranging from 17.9% to 59.7%). E-cigarette users showed lower support for a SFG (32.4%) and advertising bans (41.4%), while HTP users were less supportive of all policies except the T21 policy (support ranging from 13.2% to 43.9%).

CONCLUSION: In Italy, strong public support exists for new tobacco control laws, especially among never smokers and non-users of novel products. However, also a considerable proportion of current smokers, e-cigarette and HTP users support these policies. Policymakers can confidently advance these strategies, while public campaigns should target less supportive groups.

PMID:41757497 | DOI:10.1093/ntr/ntag041

J Bone Miner Res. 2026 Feb 27:zjag046. doi: 10.1093/jbmr/zjag046. Online ahead of print.

ABSTRACT

Fracture risk in mid-life (ages 35-65) is under-recognised despite its implications for long-term skeletal health. Using UK Biobank data, we aimed to characterize fracture epidemiology in this critical age group through two complementary approaches. We conducted two studies: a cross-sectional analysis of self-reported fractures (2006-2010) to estimate annualized incidence risk per 10,000 people, and a longitudinal cohort analysis using linked Hospital Episode Statistics (2001-2022) to calculate incidence rates per 10,000 person years, both stratified by sex, skeletal site, and 10-year age bands. Fracture incidence varied substantially by age and sex. Among women, risk increased from age 35 years and accelerated notably from the mid-40s, peaking at 246 per 10,000 people in the 56-65 age group. This female trajectory, emerging earlier than previously recognized, contrasts with men, whose highest fracture risk occurred in early mid-life (peak: 232 per 10,000 people, ages 35-45). Across both sexes and age bands, the most reported fracture sites were: “other” (including digits and facial bones), wrist, ankle, arm, leg, spine, and hip, in descending order. In HES-linked data, 43,572 fractures were identified. Incidence patterns mirrored those from self-report: higher early mid-life fracture rates in men, followed by a transition to female predominance from around age 45. This large-scale, dual-method analysis offers the first clear evidence that female fracture risk begins to rise from age 35, with a marked acceleration from 45 onward. These sex-specific trajectories in mid-life fracture incidence are not fully captured in current clinical models and indicate that further work is needed to determine whether earlier or tailored approaches to risk assessment could provide cost-effective benefit in reducing the burden of fracture in mid-life.

PMID:41757485 | DOI:10.1093/jbmr/zjag046

J Am Heart Assoc. 2026 Feb 27:e045151. doi: 10.1161/JAHA.125.045151. Online ahead of print.

ABSTRACT

BACKGROUND: Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention improves patient outcomes, yet the impact of a center’s IVUS experience on long-term outcomes remains unclear. We evaluated whether the prognostic association of IVUS-guided percutaneous coronary intervention in patients with acute myocardial infarction differs based on a center’s level of IVUS use.

METHODS: We retrospectively analyzed 9752 patients with acute myocardial infarction treated with second-generation drug-eluting stents from the KAMIR-NIH (Korean Acute Myocardial Infarction Registry-National Institutes of Health). The primary outcome was 3-year major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction, and coronary revascularization. The secondary outcome was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization. Centers were classified into higher- or lower-IVUS-use groups on the basis of median institutional usage (10.3%).

RESULTS: In higher-use centers, IVUS-guided percutaneous coronary intervention was associated with lower rates of major adverse cardiovascular events (15.3% versus 18.5%, P=0.016) and target-lesion failure (6.3% versus 8.3%, P=0.039) in propensity score-matched populations. Multivariate Cox analysis confirmed lower risks of major adverse cardiovascular events (hazard ratio [HR], 0.80 [95% CI, 0.69-0.93]; P=0.003) and target-lesion failure (HR, 0.75 [95% CI, 0.59-0.93]; P=0.01). Conversely, in lower-use centers, IVUS guidance was not associated with significant differences in major adverse cardiovascular events (15.7% versus 18.6%, P=0.422) or target-lesion failure (8.9% versus 10.4%, P=0.644).

CONCLUSIONS: The association of IVUS-guided percutaneous coronary intervention with lower adverse event rates was more apparent and statistically demonstrable in centers with higher IVUS use. These findings suggest that institutional experience may amplify the observable impact of IVUS guidance, underscoring the potential value of standardized IVUS implementation in acute myocardial infarction management.

PMID:41757462 | DOI:10.1161/JAHA.125.045151

J Am Heart Assoc. 2026 Feb 27:e045541. doi: 10.1161/JAHA.125.045541. Online ahead of print.

ABSTRACT

BACKGROUND: The ONCO PE (Optimal Duration of Anticoagulation Therapy for Low-Risk Pulmonary Embolism Patients With Cancer) trial demonstrated the superiority of 18-month compared with 6-month rivaroxaban treatment for cancer-associated low-risk pulmonary embolism in reducing recurrent venous thromboembolism. However, it was uncertain whether the results could be applicable to patients with different performance status (PS) scores, which evaluate the physical condition of patients with cancer undergoing anticancer treatment.

METHODS: In this post hoc subgroup analysis of the ONCO PE trial, we compared the 18-month and 6-month rivaroxaban treatment groups in 2 subgroups: the low PS score (no restricted physical activity: PS=0; n=79) and high PS score (restricted physical activity: PS ≥1; n=99) subgroups. The primary end point was recurrent venous thromboembolism, and the major secondary end point was major bleeding.

RESULTS: The rate of recurrent venous thromboembolism was lower in the 18-month rivaroxaban group than in the 6-month rivaroxaban group, significantly among the low PS score subgroup (2.7% versus 19.0%, P=0.049) and numerically among the high PS score subgroup without statistical significance (7.7% versus 19.1%, P=0.10). The rate of major bleeding was not different between the 2 groups among the low PS score subgroup (2.7% versus 7.1%, P=0.39), while it was numerically higher in the 18-month rivaroxaban group than in the 6-month rivaroxaban group among the high PS score subgroup, without statistical significance (11.5% versus 4.3%, P=0.20).

CONCLUSIONS: Extended anticoagulation therapy for patients with cancer-associated low-risk pulmonary embolism might have a potential benefit in reducing thrombotic risk irrespective of PS score, whereas there might be some concerns on an increased risk of major bleeding in patients with a high PS score.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT04724460.

PMID:41757461 | DOI:10.1161/JAHA.125.045541

Anal Chem. 2026 Feb 27. doi: 10.1021/acs.analchem.5c07249. Online ahead of print.

ABSTRACT

The advancement of hydrogen energy is an urgent necessity for the global energy transition and the realization of carbon neutrality. In water electrolysis, the development of novel catalysts is pivotal, while continued innovation in in situ electrochemical characterization is equally essential. This work presents a high-throughput in situ total internal reflection imaging (TIRi) platform that provides a “one stone, three birds” solution-concurrently enabling visualization of catalyst spatial uniformity, rapid qualitative performance screening, and quantitative evaluation of compositional sets. The system integrates a redesigned optical architecture with a 4 × 4 electrode array, establishing a direct correlation between optical contrast and electrochemical response. Using representative catalysts (Pt/C, NiFe, MoS₂, and WS₂) patterned on the array, we verify spatial consistency and elucidate activity variations in the hydrogen evolution reaction (HER). Furthermore, a Mo-Ru compositional-gradient alloy was fabricated, through which the optimal composition (Mo:Ru = 1:0.339) was identified, revealing the intrinsic correlation between electrocatalytic performance and compositional ratio. This nondestructive, cost-efficient, and inherently scalable method enables statistically robust, high-throughput catalyst discovery without compromising mechanistic insight, while offering a broadly generalizable operando framework that accelerates the rational design and optimization of electrocatalysts for sustainable energy technologies.

PMID:41757444 | DOI:10.1021/acs.analchem.5c07249

Med Phys. 2026 Mar;53(3):e70344. doi: 10.1002/mp.70344.

ABSTRACT

BACKGROUND: Micrometer-scale evaluation of energy deposition is important for radiation protection and therapy as well as for advancing knowledge of responses to radiation in materials and biological systems. Due to the stochastic nature of radiation interactions, there is significant variation in energy deposition in micrometer-sized targets, especially at low doses. This variability underscores the need for a framework for microdosimetry, particularly in low-dose scenarios.

PURPOSE: The goal of this work is to develop a novel system for micron-scale characterization of energy deposition and response to radiation that is applicable at low doses, using a combination of Monte Carlo (MC) simulations and experimental techniques.

METHODS: EBT3 radiochromic film samples are irradiated to absorbed doses of 0.003-0.5 Gy using the 6-MV beam from a clinical linear accelerator. To quantify energy deposition, MC simulations of the experimental irradiations are conducted to evaluate specific energy deposited within micron-scale voxels in the active layer of the film. To investigate the dose response of the film, the following two methods are employed: (i) flatbed scanner measurement of changes in optical density (OD) of the film, and (ii) Raman spectroscopy (RS) to measure response intensity across doses with micron-scale resolution. Experimental film responses are compared to predictions from the microdosimetric one-hit model.

RESULTS: Specific energy distributions obtained from MC simulations show large variation in energy deposition at low doses and within small targets; the “microdosimetric spread” (relative standard deviation) is significantly higher ( $>$ 10 times) at 0.003 Gy than at 0.5 Gy, and is observed to decrease with increases in dose and target size. Both RS and OD measurements exhibit a near linear dose-response relationship, reflecting the film’s sensitivity across micro- and macroscopic spatial scales. Overall, the OD and RS values determined using the one-hit model with MC-obtained specific energy distributions fit well to experimental measurements, with percentage differences up to 15 and 9.8%, respectively. An initial comparison of the relative standard deviation of RS and OD measurements (corrected for offset signal) shows qualitative agreement with the trends observed for MC-determined microdosimetric spread.

CONCLUSION: This study provides first results of a system that combines simulations with experimental techniques to investigate radiation response in micron-scale targets, with a focus on low-dose radiation exposure. The system shows promise in enabling future investigations of energy deposition within small volumes at low doses, where biological responses may be heterogeneous as some cells may receive high energy deposits and incur damage, while others may experience minimal or no deposition.

PMID:41757432 | DOI:10.1002/mp.70344

J Comp Eff Res. 2026 Feb 27:e250183. doi: 10.57264/cer-2025-0183. Online ahead of print.

ABSTRACT

Aim: Real-world evidence (RWE) – defined here as clinical evidence derived from the analysis of real-world data (RWD) on patient health status and healthcare delivery – has become a cornerstone of regulatory and health technology assessment (HTA) decision making. However, despite broad consensus on its value, policy frameworks governing RWE generation and evaluation remain heterogeneous across jurisdictions. Importantly, this heterogeneity partly reflects the distinct purposes for which RWE is used, including regulatory safety assessment, effectiveness evaluation, health-economic modeling and natural-history research. These functional differences are not inherently problematic; however, fragmented operational requirements can create duplication, inefficiency and delays in patient access. Materials & methods: This study employed a narrative comparative policy review of RWE guidance issued by twelve major regulatory and HTA agencies, including the Medicines and Healthcare products Regulatory Agency (MHRA), the EMA, the US FDA and the Canadian Agency for Drugs and Technologies in Health (CADTH). Frameworks were compared across four domains: data quality, statistical methods, registry governance and transparency. Harmonization is defined as alignment across these domains sufficient to enable consistent planning, analysis and interpretation of RWE across jurisdictions, rather than uniformity of decision making. Results: The analysis identified convergence in high-level principles but persistent divergence in operational expectations. The MHRA emphasizes flexibility and scientific dialogue; the EMA prioritizes consistency and structured governance; and the FDA provides comprehensive but resource-intensive guidance, reflecting detailed documentation requirements, prespecified analytic expectations and extensive methodological review. HTA bodies apply additional evidentiary criteria related to comparative effectiveness and value, sustaining functional fragmentation even within the same healthcare systems. Conclusion: RWE fragmentation reflects both legitimate functional differences and avoidable operational misalignment. Progress toward harmonization therefore requires shared minimum standards and transparency mechanisms rather than additional guidance documents. The UK’s post-Brexit autonomy positions it as a test environment for collaborative pilots with the European Medicines Agency, the International Council for Harmonization (ICH) and the International Coalition of Medicines Regulatory Authorities (ICMRA). Six strategic actions are proposed to support pragmatic alignment while preserving contextual flexibility.

PMID:41757419 | DOI:10.57264/cer-2025-0183

J Comp Eff Res. 2026 Feb 27:e250174. doi: 10.57264/cer-2025-0174. Online ahead of print.

ABSTRACT

Aim: Treatment options for late-onset Pompe disease (LOPD) include enzyme replacement therapy (ERT) with alglucosidase alfa (alg), cipaglucosidase alfa plus miglustat (cipa + mig) and avalglucosidase alfa. However, only one randomized controlled trial (RCT) directly compared cipa + mig and alg and had relatively few ERT-naive patients. A multilevel network meta-regression (ML-NMR) integrated individual patient data and aggregate data into indirect treatment comparisons, with relative effects adjusted to any target population, to compare the efficacy of cipa + mig and alg. Materials & methods: A Bayesian ML-NMR was conducted to compare the efficacy of cipa + mig and alg for 6-minute walk distance (6MWD, meters) and percent predicted forced vital capacity (ppFVC) across any target population, using patient-level and aggregate data from RCTs (PROPEL, COMET, LOTS) and phase I/II and open-label extension (OLE) trials (PROPEL OLE, LOTS OLE, COMET OLE, ATB200-02, NEO-1/NEO-EXT), adjusting for baseline covariates. Relative effect estimates were obtained for 6MWD and ppFVC change from baseline to week 52. Two networks were analyzed: network A (RCTs only) and network B (RCTs and single-arm OLE and phase I/II studies matched to comparator arms). To assess the impact of prior ERT exposure, simulations were conducted by only varying ERT duration among included covariates. Results: For cipa + mig compared with alg, both networks were associated with relative increases in 6MWD (mean difference [95% credible interval], Bayesian probability for network A: 13.48 m [6.79, 19.85], >99.9%; network B: 12.59 m [7.89, 17.45], >99.9%) and ppFVC (network A: 1.63% [0.71, 2.60], >99.9%; network B: 3.17% [2.53, 3.81], >99.9%). Network B suggested cipa + mig was favorable (>99.9%) in all groups for both end points and appeared more favorable with increasing ERT duration. Conclusion: Cipa + mig was associated with an improvement in 6MWD and ppFVC relative to alg independent of prior ERT exposure, which appeared more favorable when all available evidence was used. These data could inform decision-making in treating ERT-naive and ERT-experienced patients with LOPD.

PMID:41757410 | DOI:10.57264/cer-2025-0174

Child Dev. 2026 Feb 27;97(1):168-181. doi: 10.1093/chidev/aacaf014.

ABSTRACT

The present study investigated the role of visual statistical learning in how developing readers learn to identify morphemes within words. A total of 121 children (55 girls, aged 6-11 years, M = 8.82, SD = 1.30) were recruited in Trieste, Italy, between January and June 2019. They were familiarized with pseudo-letter strings containing affix-like chunks, which could be identified only by their statistical properties. After passively observing the stimuli, children were more likely to attribute previously unseen strings to the familiarization lexicon if they contained a chunk, regardless of its position within the string. Results indicate that children can acquire morpho-orthographic knowledge through visual regularities from printed input. This ability was not modulated by age nor reading fluency, suggesting an early-maturing learning mechanism. The findings emphasize the importance of incorporating this fundamental, language-agnostic mechanism into morphology and reading acquisition theories.

PMID:41757407 | DOI:10.1093/chidev/aacaf014

J Diabetes Metab Disord. 2026 Feb 24;25(1):78. doi: 10.1007/s40200-026-01898-4. eCollection 2026 Jun.

ABSTRACT

​PURPOSE: Diabetes distress (DD) represents significant emotional burden that hinders self-management in individuals with Type 2 Diabetes Mellitus (T2DM). In Pakistan, where T2DM is rapidly increasing, evidence on the magnitude and determinants of DD remains limited and fragmented. This systematic review aimed to estimate the pooled prevalence of DD and identify its associated factors among adults with T2DM in Pakistan.

METHODS: Seven electronic databases: PubMed, EMBASE, Scopus, Web of Science, PsycInfo, PakMediNet, and Google Scholar were systematically searched. Studies reporting DD prevalence using validated tools such as Diabetes Distress Scale (DDS) or Problem Areas in Diabetes (PAID) were included. Two reviewers independently extracted data and appraised quality using the Joanna Briggs Institute checklist. A random-effects model estimated pooled prevalence, with heterogeneity assessed using I² and Q statistics.

RESULTS: Seven studies, published between 2013 and 2024, involving 1560 adults with T2DM were included. The pooled prevalence of DD was 66.8% (95% CI: 52.3%-79.8%), with substantial heterogeneity (I² = 96.96%), likely due to variations in the study settings and sample characteristics. Funnel plot showed slight asymmetry; however, Egger’s test (p = 0.21) and trim-and-fill analysis indicated no publication bias. Narrative synthesis highlighted key factors, including suboptimal glycemic control, longer disease duration, complications, female gender, low education, low income, limited social support, low self-efficacy and inadequate self-care.

​CONCLUSION: About two-thirds of adults with T2DM in Pakistan experience DD, influenced by clinical, psychosocial, and behavioral factors. Integrating psychosocial screening, culturally tailored education, and support into T2DM care can enhance emotional well-being and adherence.​.

PMID:41757382 | PMC:PMC12932764 | DOI:10.1007/s40200-026-01898-4