Tag: statistics

Vaccine. 2026 Jun 30;89:128870. doi: 10.1016/j.vaccine.2026.128870. Online ahead of print.

ABSTRACT

BACKGROUND: Newcastle disease virus hexapro spike (NDV-HXP-S) is a recombinant vaccine designed to elicit both systemic and mucosal immunity against SARS-CoV-2. Intramuscular vaccines protect against severe disease but provide limited mucosal protection. We conducted a Phase 1 trial of live NDV-HXP-S administered intranasally (IN), intramuscularly (IM), or simultaneously (IN+IM) in previously vaccinated adults.

METHODS: Thirty-five healthy adults without prior COVID-19 were enrolled at a single site in New York City (Feb 2022-Apr 2024). Participants received low- or high-dose NDV-HXP-S via IN, IM, or IN+IM routes, or placebo. Safety was monitored for 365 days; immune responses in serum and saliva were measured through day 84.

FINDINGS: All 35 participants completed follow-up. NDV-HXP-S was safe and well tolerated, with only grade 1-2 adverse events. Placebo recipients showed waning antibody titers, whereas NDV-HXP-S maintained or boosted serum IgG and neutralizing activity. Salivary sIgA rose modestly. Participants with low baseline CD4+ T-cell activity exhibited increases by day 28. The study was not powered for statistical significance.

INTERPRETATION: Live NDV-HXP-S was safe and well tolerated in this small Phase 1 study. Exploratory immunogenicity analyses showed variable systemic and mucosal responses, supporting further evaluation of updated NDV-HXP-S formulations in larger controlled studies.

FUNDING: Supported by the Icahn School of Medicine Dean’s Philanthropic Fund, CastleVax Inc., Mount Sinai CTSA (UL1TR004419), and philanthropic and federal grants.

TRIAL REGISTRATION: ClinicalTrials.govNCT05181709.

PMID:42378814 | DOI:10.1016/j.vaccine.2026.128870

Vaccine. 2026 Jun 30;89:128889. doi: 10.1016/j.vaccine.2026.128889. Online ahead of print.

ABSTRACT

BACKGROUND: Human papillomavirus (HPV) vaccination is a key component of the World Health Organization’s global strategy for cervical cancer elimination. The effect of malaria, a known immunomodulator, on HPV vaccine immunogenicity is poorly understood. This study assessed the effect of malaria parasitaemia at the time of vaccination on HPV vaccine immune responses among participants in a dose-reduction immunogenicity trial (DoRIS).

METHODS AND FINDINGS: 930 HIV-negative Tanzanian schoolgirls aged 9-14 years were randomised to receive one, two or three doses of Cervarix® or Gardasil®9 (155 per arm) and followed to month (M)36. One-dose and two-dose arms participants were enrolled in a long-term extension and are included in this malaria sub-study. Dried blood spots at each vaccination visit were tested for malaria parasitaemia by quantitative polymerase chain reaction. HPV16/18 antibody responses were measured at M12, 24, 36 and 60. In the one-dose arms, there was no evidence of a difference in antibody geometric mean concentrations (GMC) or avidity index (AI) between participants with and without malaria at the time of vaccination. In the two-dose Cervarix® arm, M36 HPV16 antibody GMCs and AI results were lower in participants with malaria at either vaccination visit (HPV16 GMC ratio = 0.74, 95%CI = 0.55-0.99; AI ratio = 0.95, 95%CI = 0.91-0.99). In the two-dose Gardasil®9 arm, M36 HPV18 antibody GMCs and AI results were lower in participants with malaria at the first vaccine dose than those without malaria (HPV18 GMC ratio = 0.58, 95%CI = 0.37-0.92; AI ratio = 0.93, 95%CI = 0.87-0.99). These trends were also observed at M60.

CONCLUSIONS: Whilst some effect of malaria on antibody responses was observed in the two-dose arms, these were mostly small in magnitude and unlikely to have clinical significance. Single-dose arms results are reassuring but further evaluations in larger populations would be valuable to confirm the findings. The potential for an effect of moderate or severe infection with greater parasite burden remains unclear. (NCT02834637).

PMID:42378813 | DOI:10.1016/j.vaccine.2026.128889

Public Health. 2026 Jun 30;258:106391. doi: 10.1016/j.puhe.2026.106391. Online ahead of print.

ABSTRACT

OBJECTIVES: Antimicrobial resistance (AMR) is a major global health threat, largely driven by inappropriate and excessive antibiotic use. Italy has historically reported antibiotic consumption rates above the European average, especially in primary care. In 2017, Italy implemented the National Action Plan on Antimicrobial Resistance (NAP-AMR), including targets for reducing overall community antibiotic and fluoroquinolone use. This study evaluated the impact of NAP-AMR on antibiotic consumption trends in Italian primary care from 1999 to 2024.

STUDY DESIGN: Quasi-experimental interrupted time series study.

METHODS: Annual ECDC data were expressed as defined daily doses (DDD) per 1000 inhabitants per day. Total antibiotic consumption was analyzed for 1999-2024 and fluoroquinolone consumption for 2005-2024. Segmented linear regression with Newey-West standard errors estimated post-2017 changes in level and trend. Total systemic antibiotic consumption was the primary outcome, and fluoroquinolone consumption was the secondary outcome.

RESULTS: Total antibiotic consumption showed a significant pre-intervention upward trend, increasing annually by 0.10 DDD per 1000 inhabitants per day (annual change = 0.096; p = 0.032; 95% CI: 0.014 to 0.178). NAP-AMR implementation was associated with a significant immediate reduction in total antibiotic use (mean level difference = -4.940; p = 0.003; 95% CI: -7.864 to -2.016), while the post-intervention slope change was not significant (annual change = 0.126; p = 0.606; 95% CI: -0.346 to 0.599). Fluoroquinolone consumption showed a significant pre-intervention upward trend (annual change = 0.039; p = 0.016; 95% CI: 0.011 to 0.066) and a significant immediate reduction (mean level difference = -1.079; p = 0.023; 95% CI: -1.910 to -0.248). The post-intervention trend was negative but not significant (annual change = -0.219; p = 0.096; 95% CI: -0.459 to 0.021).

CONCLUSIONS: NAP-AMR was associated with immediate reductions in total antibiotic and fluoroquinolone consumption, but sustained trend changes were not statistically significant. No significant long-term trend change was observed, underscoring ongoing surveillance and future evaluation.

PMID:42378783 | DOI:10.1016/j.puhe.2026.106391

Drug Alcohol Depend. 2026 Jun 26;286:113249. doi: 10.1016/j.drugalcdep.2026.113249. Online ahead of print.

ABSTRACT

INTRODUCTION: Novel psychoactive substances (NPSs), due to rapid emergence and evolving use patterns, pose a significant public health surveillance challenge. Traditional surveillance lags street-level reality, necessitating the exploration of novel strategies and data sources like Reddit for continuous NPS trend monitoring and presenting a public dashboard.

METHODS: We mined data from 60,601 subreddits between January 2015 and June 2025 for seven NPSs (kratom, xylazine, medetomidine, nitazenes, tianeptine, bromazolam, and 2C-B) using keyword-variants. We performed Mann-Kendall trend tests to assess temporal patterns, computed correlations to compare post volumes with National Forensic Laboratory Information System (NFLIS) drug report counts (2015-2024), conducted cross-correlation analyses at ±2-year lags to identify lead-lag relationships, and created a public dashboard for data visualization.

RESULTS: The dataset comprised 328,223 posts from 139,901 accounts. We observed moderate to strong correlations between Reddit volumes and three out of five NPSs with NFLIS reports: bromazolam (ρ = 0.81, p < 0.001), tianeptine (ρ = 0.48, p = 0.04), xylazine (ρ = 0.60, p < 0.001). Cross-correlation analyses indicated Reddit discussions preceded NFLIS reports for medetomidine (ρ = 0.93, lag = -2 years), bromazolam (ρ = 0.86, lag = -1year), tianeptine (ρ = 0.81, lag = -2years), and xylazine (ρ = 0.62, lag = -2years), suggesting Reddit discussions as a potential leading indicator. Co-mention of other substances with NPSs often matched known trends from retrospective data.

CONCLUSION: Reddit-based surveillance provides timely and complementary signals to traditional forensic systems for NPS monitoring. Interactive visualizations and downloadable aggregated statistics are available via our dashboard.

PMID:42378779 | DOI:10.1016/j.drugalcdep.2026.113249

J Hazard Mater. 2026 Jun 27;514:142819. doi: 10.1016/j.jhazmat.2026.142819. Online ahead of print.

ABSTRACT

Dairy farm waste may serve as a reservoir for multidrug-resistant (MDR) Escherichia coli clones, but the genomic characteristics and dissemination potential of such clones remain incompletely understood. Here, we performed whole-genome sequencing and comprehensive genomic analysis of 64 MDR E. coli strains isolated from feces and sewage samples collected from two large dairy farms in Gansu Province, China. Genomic analysis revealed that strains carried 16-32 antibiotic resistance genes (ARGs), 1-6 plasmid replicon types, and 26-96 virulence genes (VGs), with numerically higher (though not statistically significant) counts in feces compared to sewage isolates. Multi-locus sequence typing (MLST) identified globally disseminated clones (ST10, ST38, ST58, ST155) and, for the first time in China, documented the presence of ST1508 (the predominant clone, 42% of isolates), as well as ST2520, ST7207, and ST7588 from dairy farm waste. Network analysis showed co-occurrence of these clones with transferable IncF plasmids harboring broad-spectrum resistance genes (e.g., rmtB, bla_CTX-M-55) and multidrug efflux systems (e.g., acrAB-tolC). Contig-level analysis suggested that tet(A) and aph(3′)-IIa were located on IncX1 plasmids, bla_TEM-1B on IncFIC(FII), and bla_CTX-M-55 on IncI1 plasmids, indicating potential for horizontal gene transfer. These findings identify dairy farm waste as a potential environmental reservoir of MDR E. coli clones with genomic features associated with resistance and virulence. While functional validation of transferability and environmental persistence is needed, the presence of these clones – particularly the emerging ST1508 lineage in untreated farm waste suggests that improved waste management, enhanced surveillance, and integrated One Health strategies may help mitigate dissemination risks. Further studies incorporating environmental sampling, persistence assays, and conjugation experiments are required to establish the actual hazard status.

PMID:42378761 | DOI:10.1016/j.jhazmat.2026.142819

Complement Ther Med. 2026 Jun 30;100:103402. doi: 10.1016/j.ctim.2026.103402. Online ahead of print.

ABSTRACT

OBJECTIVE: This review evaluates the effects of wearable device-telemonitored Baduanjin on exercise tolerance and cardiac function in patients with chronic heart failure (CHF).

METHODS: A comprehensive literature search was performed in PubMed, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database and Chinese Biomedical Literature Database (CBM) from their inception to 1 January 2026. The search aimed to identify randomised controlled trials investigating Baduanjin for CHF that explicitly used wearable devices. Study screening, data extraction and Cochrane RoB 2.0 bias assessment were performed independently by two reviewers with discrepancies were resolved by a third. Given significant clinical heterogeneity across the included studies, a narrative synthesis of the findings was conducted, supported by tabulated presentation of outcome data.

RESULTS: Three randomized controlled trials involving 248 participants were included. Individual studies reported that wearable device-telemonitored Baduanjin was associated with improvements in several clinical outcomes in patients with CHF. Reported benefits included increased 6-minute walking distance (568.58 m vs. 367.47 m, P < 0.05), higher peak oxygen uptake (19.00 vs. 17.00 ml/[kg·min], P < 0.001) and improved left ventricular ejection fraction (52.60% vs. 45.28% and 42.79%, P < 0.05). Improvements were also observed in quality of life, depression symptoms, cardiovascular readmission in the intervention group of individual studies. No exercise-related adverse events were reported.

CONCLUSION: Current evidence suggests that wearable device-telemonitored Baduanjin may potentially improve key outcomes in patients with chronic heart failure, However, these findings are based on a narrative synthesis of individual studies and should therefore be interpreted cautiously. Further high-quality, standardised randomised controlled trials are urgently needed.

PMID:42378743 | DOI:10.1016/j.ctim.2026.103402

J Biomech. 2026 Jun 26;205:113437. doi: 10.1016/j.jbiomech.2026.113437. Online ahead of print.

ABSTRACT

In individuals with musculoskeletal disorders such as chronic metatarsalgia, foot orthoses (FOs) are frequently prescribed to reduce plantar pressure, improve foot function and alleviate pain. During walking, medially wedged FOs (MWFO + MPs) with a metatarsal pad are more effective than standard FOs (SFOs) in reducing plantar pressure under the metatarsal heads. As stair ambulation involves higher physical demands than walking and modifies plantar loading, we questioned whether FOs remain effective during more challenging tasks. This study aimed to determine whether MWFO + MPs reduce peak plantar pressure under the metatarsal heads compared to SFOs during stair ambulation in individuals with chronic metatarsalgia. A secondary objective was to examine the effects of these FOs on lower limb 3D joint angles and moments. Twenty-two individuals (16 females and 6 males) with chronic metatarsalgia were recruited to participate in this cross-sectional descriptive study. Participants ascended and descended stairs under three conditions: (1) Shoe-only, (2) SFOs, and (3) MWFO + MPs. Peak plantar pressure, midfoot, ankle, knee, hip angles and moments were compared across conditions using repeated-measures ANOVAs and statistical parametric mapping. Both FOs reduced plantar pressure under the metatarsal heads and heel compared to shoe-only during stair ambulation. MWFO + MPs increased plantar pressure under the medial midfoot, decreased midfoot dorsiflexion, ankle plantarflexion angles compared to shoe-only. MWFO + MPs were more effective than SFOs in reducing peak plantar pressure under the 1st metatarsal head and modifying lower limb joint angles and moments. These findings extend the known biomechanical benefits of FOs in individuals with chronic metatarsalgia during more demanding tasks.

PMID:42378738 | DOI:10.1016/j.jbiomech.2026.113437

J Med Internet Res. 2026 Jun 30;28:e72226. doi: 10.2196/72226.

ABSTRACT

BACKGROUND: Despite the growing amount of patients who underwent coronary artery bypass grafting (CABG) in low- and middle-income countries like China, their glucose control was suboptimal, likely due to poor adherence to healthy lifestyles and preventive medications. Mobile health tools facilitating secondary prevention seem promising, but evidence focusing on this high-risk population is scarce.

OBJECTIVE: This study aimed to evaluate the significance of mobile health tools in long-term glycemic management for post-CABG patients with comorbid diabetes mellitus.

METHODS: GUIDEME (glycemic control using mini program-based intervention in patients with diabetes undergoing coronary artery bypass to promote self-management) is a multicenter, open-label, closed-user group, randomized controlled trial, in which 1066 patients with diabetes who had recently undergone CABG were enrolled and allocated into 2 groups. Patients in the control group received conventional health education before discharge, whereas those in the intervention group additionally received automatic delivery of bite-sized health education and medication reminders through a smartphone app during the 6 months after discharge. The primary end point was a change in glycosylated hemoglobin (HbA1c) from baseline to 6 months.

RESULTS: Among the 1066 eligible participants enrolled, a total of 1038 (97.4%) had completed the follow-up, while 1000 (93.8%) had 6-month HbA1c results available. Although only 79 (14.9%) patients in the intervention group were defined as active users, a greater reduction of HbA1c in the intervention group was observed (adjusted between-group mean difference -0.13, 95% CI -0.25 to -0.01; P=.04). The intervention group also had a high proportion of good medication adherence (96.1% vs 93.2%, P=.04). There was no difference between the 2 groups regarding the secondary end points.

CONCLUSIONS: Health education and medication reminders based on smartphone app achieved a statistically significant but modest between-group difference in HbA1c, the clinical relevance of which remains uncertain.

PMID:42378688 | DOI:10.2196/72226

JMIR Infodemiology. 2026 Jun 30;6:e85379. doi: 10.2196/85379.

ABSTRACT

BACKGROUND: Mpox was declared a public health emergency of international concern in 2022. Instagram is widely used by age groups and communities disproportionately affected by mpox; yet platform-specific evidence on mpox information characteristics and engagement remains limited.

OBJECTIVE: The aim of this study is to characterize sources, content, and engagement features of mpox-related Instagram posts, to describe prevention and treatment framing, and to compare the top 10% most-liked posts with the remaining corpus.

METHODS: We retrieved English-language public Instagram posts via CrowdTangle containing “mpox” or “monkeypox” dated May 5, 2022, to January 17, 2023 (initial N=18,616). Using a pretested, deductive codebook adapted from prior Instagram health studies, 2 coders completed 2 pilot rounds; variables with low agreement were excluded. A randomized analytic sample of 1000 posts was coded for source type, content features, and prevention/treatment framing. Descriptive statistics were computed. For engagement contrasts, we compared the top 10% most-liked posts with the bottom 90% using tests of differences in independent proportions (mean differences [MD] with P values).

RESULTS: Most posts originated from organizations (760/1000, 76%) versus individuals (240/1000, 24%). Organizational sources most commonly included businesses (436/760, 57.4%) and news/media outlets (401/760, 52.8%); government (174/760, 22.9%), nonprofits (131/760, 17.3%), and health care organizations (70/760, 9.2%) were less frequent. About one-third of posts cited a source (344/1000, 34.4%), most often the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC)/other federal entity. Posts predominantly used illustrated images/infographics (827/1000, 82.7%); photos appeared in 47.3% (473/1000) and videos in 12.4% (124/1000) of posts. Prevention content appeared in 38.4% (384/1000) of posts, most commonly vaccination (684/1000, 68.5% of prevention posts), followed by avoiding close contact (145/1000, 14.5%), avoiding contact with objects (83/1000, 8.3%), abstaining from sexual activity (76/1000, 7.6%), and condom use (13/1000, 1.3%); 28.9% (289/1000) of prevention posts noted barriers. Treatment mentions were uncommon (25/1000, 2.5% traditional biomedical; 2/1000, 0.2% alternative). Compared with the bottom 90%, the top 10% most-liked posts (1) were more likely to originate from public figures/celebrities among individuals (MD=-0.591; P<.001) and from businesses (MD=-0.299; P<.001) or news/media (MD=-0.350; P<.001) among organizations; (2) were less likely to be from government (P<.001) , nonprofit (P=.006), or health care organizations (P=.005); and (3) more often included nonmoving images (MD=-0.119; P=.024), visible lesion depictions (MD=-0.081; P=.035), prevalence mentions (MD=-0.180; P<.001), and citations (MD=-0.162; P=.001).

CONCLUSIONS: During the initial outbreak period, the highly engaged mpox content on Instagram skewed toward posts by public figures and news/business accounts and toward static, citation-bearing visuals that included prevalence context and occasionally lesion imagery. Public-health communicators seeking reach on Instagram should prioritize clear static infographics with explicit source citation and epidemiologic context and consider copublishing with trusted creators and news outlets, while addressing access barriers highlighted in prevention posts.

PMID:42378678 | DOI:10.2196/85379

J Ultrasound Med. 2026 Jun 30. doi: 10.1002/jum.70359. Online ahead of print.

NO ABSTRACT

PMID:42378662 | DOI:10.1002/jum.70359