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Changes in tobacco sales before, during, and after the COVID-19 pandemic in Japan: An interrupted time series analysis

by Kanae Kondo, Ichizo Morita, Shigemitsu Sakuma, Isao Ohsawa

Objectives

This study aimed to longitudinally examine nationwide changes in smoking behavior among the Japanese population in response to the COVID-19 pandemic.

Design and setting

A secondary analysis was conducted using cigarette sales data from the Tobacco Institute of Japan, monthly tobacco expenditures from the Family Income and Expenditure Survey conducted by the Ministry of Internal Affairs and Communications, and smoking prevalences from the National Database of Open Data Japan. An interrupted time-series segmented regression model adjusted for seasonality and autocorrelation was used to examine changes in cigarette sales and monthly tobacco expenditures before and after the first declaration of a state of emergency.

Participants

Depending on the data source, data from 2014 to 2022, from 2015 to 2025, or from 2015 to February 2026 were used.

Primary and secondary outcome measures

Changes in level and slope were evaluated before and after the first state of emergency and after COVID-19 was downgraded to a common infectious disease.

Results

Cigarette sales declined at a significantly slower rate after the first state of emergency than before. Price-adjusted monthly tobacco expenditures increased significantly by 132 JPY compared with the previous month, although the expenditure findings were less robust in the quadratic sensitivity analysis. The smoking prevalence among men declined slightly each year, from 34.2% in 2014 to 31.9% in 2022. In contrast, the smoking prevalence among women remained relatively stable, ranging between 9.4% and 9.9%.

Conclusions

Although cigarette sales declined more slowly and household tobacco expenditures increased during the first state of emergency in Japan, smoking prevalences did not change substantially. These findings suggest changes in tobacco purchasing patterns, including stockpiling, and possible changes in smoking intensity among continuing smokers, rather than a meaningful population-level decline in smoking behavior. There was no robust evidence of a clear reversal after May 2023.

Association between venous access-site closure device use and postoperative nausea and vomiting after atrial fibrillation ablation under propofol sedation: a single-centre retrospective observational study in Okayama, Japan

Por: Sakanoue · H. · Yamaji · H. · Okamoto · S. · Okano · K. · Fujita · Y. · Higashiya · S. · Murakami · T. · Hirohata · S. · Kusachi · S.
Objectives

To examine whether the use of a venous access-site closure device is associated with the occurrence of postoperative nausea and vomiting (PONV) after atrial fibrillation (AF) ablation under propofol sedation.

Design

Observational study.

Setting

A single-centre retrospective observational study in Okayama, Japan.

Participants

We retrospectively analysed consecutive patients who underwent AF ablation under deep propofol sedation with adaptive servo-ventilation. A total of 686 patients were included. Patients were managed using a standardised sedation protocol with or without low-dose pentazocine. Patients treated with conventional manual compression for haemostasis (n=383) were compared with those treated using a venous access-site closure device (n=303).

Interventions

Postprocedural bed rest duration and the incidence and timing of PONV were compared between groups. Associations between closure device use and PONV were evaluated using logistic regression analysis.

Primary outcome measure

The primary outcome was the occurrence of PONV following AF ablation.

Results

All procedures were completed under propofol sedation without conversion to general anaesthesia. The duration of postprocedural bed rest was shorter in the device group than in the conventional-compression group (mean difference –14.7 hours, 95% CI –15.2 to –14.0).

PONV occurred in 6/303 patients (2.0%) in the device group and 20/383 patients (5.2%) in the conventional-compression group, corresponding to a relative risk of 0.38 (95% CI 0.15 to 0.93), an OR 0.25 (95% CI 0.10 to 0.62) and a risk difference of –3.2% (95% CI –6.0% to –0.5%).

In multivariable analysis, use of a venous closure device was associated with a lower likelihood of PONV.

Conclusions

In this single-centre observational study, use of a venous access-site closure device was associated with a lower occurrence of PONV after AF ablation under propofol sedation. These findings suggest that postprocedural management strategies enabling earlier mobilisation may be associated with improved patient comfort; however, causal inference is limited by the observational design.

Impact of the COVID-19 pandemic on obesity: a prospective cohort study of the Canadian Longitudinal Study on Aging (CLSA)

Por: Sakib · M. N. · Griffith · L. E. · Erbas Oz · U. · Basta · N. E. · Gerstein · H. C. · Morgenstern · J. D. · Kirkland · S. · Thabane · L. · Smith · B. T. · Balion · C. · McMillan · J. M. · Raina · P. · Anderson · L. N.
Objectives

To examine the impact of the COVID-19 pandemic on body mass index (BMI) and obesity status among Canadian residents and explore how this association varied by sociodemographic and health status.

Design

Prospective cohort study.

Setting

Canada.

Participants

41 302 adults, aged 45–85 at baseline, participating in the Canadian Longitudinal Study on Aging.

Primary and secondary outcomes

BMI and BMI-defined obesity were measured at baseline, follow-up 1 and follow-up 2 (FUP2), with 33% of FUP2 data (n=13 444) gathered after 16 March 2020, when COVID-19 restrictions began. Correction factors were applied for self-reported BMI and weighted generalised estimating equations assessed BMI changes before and during the pandemic.

Results

We found a significant interaction between follow-up time and timing of FUP2 data collection (before or during the pandemic). Participants measured during the pandemic had an excess BMI increase of 0.21 kg/m² (95% CI 0.15 to 0.28) and 1.06 times higher odds of obesity (95% CI 1.03 to 1.09) compared with prepandemic trends. Increases were more pronounced among females, middle-aged adults and those without diabetes.

Conclusions

The COVID-19 pandemic was associated with a modest increase in BMI and obesity among Canadian adults. Ongoing research is needed to assess long-term trends.

Mapping metabolic reprogramming in lung and breast cancer through integrative bioinformatics

by Nosayba Al-Damook, Molham Sakkal, Mostafa Khair, Walaa K. Mousa, Rose Ghemrawi

Metabolic reprogramming is central to cancer biology, enabling tumor cells to sustain rapid proliferation, resist stress, and adapt to therapy. However, these alterations are highly heterogeneous across cancer types, and current treatments rarely exploit subtype-specific metabolic vulnerabilities. To address this gap, we developed a unified bioinformatics framework that integrates transcriptomic profiling (UALCAN), drug–gene interactions (DGIdb), gene–disease associations (Open Targets), pathway enrichment (Enrichr), and protein–protein interaction networks (STRING/Cytoscape). This pipeline was applied to lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LSCC), breast cancer (BRCA), and metastatic breast tumors (MET500) to uncover cancer type–specific metabolic programs and prioritize translational targets. Our analysis revealed distinct signatures: LUAD showed glycolytic activation, LSCC coupled glycolysis with oxidative phosphorylation, BRCA favored anabolic and lipogenic pathways, and MET500 tumors adopted stress-adaptive states with elevated antioxidant and autophagy programs. Integration of pharmacological evidence highlighted clinically actionable interactions between metabolic genes and FDA-approved drugs, including ASNS–asparaginase, DHODH–teriflunomide, and G6PD–rasburicase. Gene–disease associations further prioritized G6PD, SLC2A1, and TK1 as robust targets strongly linked to lung and breast cancers. Pathway enrichment pinpointed the pentose phosphate pathway, pyrimidine metabolism, and glutathione metabolism as conserved axes sustaining tumor survival, while network analysis positioned the G6PD–PGD hub as a central metabolic node connecting glucose uptake, redox balance, and nucleotide biosynthesis. To place these bioinformatics-derived findings within a functional and clinical context, we complemented the computational analyses with patient survival assessment, clinical trial screening, and targeted literature appraisal. Survival analysis demonstrated cancer type–specific prognostic relevance for selected metabolic genes, while clinical and literature-based screening revealed both ongoing translational efforts and substantial gaps between computational target prioritization and experimental or clinical validation. This integrative analysis shows that cancer metabolism is altered in subtype-specific ways that can be systematically mapped to reveal potential therapeutic targets. By linking transcriptomic evidence with drug–gene interactions and clinical context, this framework provides a scalable approach for cancer metabolism research and supports the prioritization of pathways with potential translational relevance.

Development and validation of a screening scale to predict postdischarge depression in patients with acute coronary syndrome after percutaneous coronary intervention: a prospective longitudinal study

Por: Doi · M. · Sakamoto · Y. · Tanaka · A. · Tsunashima · R. · Miyabe · A. · Minamizaki-Kanno · M. · Hibi · K. · Kanoya · Y.
Objectives

To develop a simple screening scale to predict depression after discharge in patients with acute coronary syndrome after percutaneous coronary intervention (ACS-PCI) and to verify its reliability, validity and cutoff value.

Design

Prospective longitudinal study was conducted 1 week and 3 months after discharge.

Setting

Two hospitals where PCI is performed in Japan.

Participants

A total of 183 patients were potential candidates for the survey, of whom 42 provided valid responses (response rate: 23.0%).

Results

The number of items was reduced from 14 to 12 with item-total correlations and principal component analysis. Cronbach’s alpha coefficient was 0.832 and the intraclass correlation coefficient (1, 2) was 0.811 (95% CI 0.650 to 0.898). Significant correlations were observed for concurrent validity (r=0.699, p

Conclusions

This study developed a simple screening scale for predicting postdischarge depression in patients with ACS-PCI (SDACS-12) and demonstrated its reliability, validity and predictive ability with 12 items. Nevertheless, its results should be interpreted cautiously given the moderate variance explained by PCA and the low specificity and PPV.

Voice-assisted artificial intelligence in cardiovascular disease management: a systematic review and meta-analysis protocol

Por: Issaka · A. · Maddison · R. · Lamaro Haintz · G. · Shariful Islam · S. M.
Introduction

Cardiovascular disease (CVD) remains a leading cause of global morbidity and mortality, with self-management playing a pivotal role in improving outcomes. Voice-assisted artificial intelligence (AI) technologies such as virtual assistants and voice-controlled applications have emerged as innovative tools for healthcare delivery. While the technologies show promise in areas like primary prevention and chronic disease management, their effectiveness in supporting self-management for patients with CVD remains underexplored. This study aims to evaluate the impact of voice-assisted AI technologies on CVD self-management, specifically focusing on cardiovascular-related mortality, health-related quality of life (HRQoL) and adherence to lifestyle modifications.

Methods and analysis

A systematic review and meta-analysis will be conducted following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. A comprehensive search will be performed across databases such as MEDLINE, Scopus, Embase and Cochrane Central Register of Controlled Trials (CENTRAL), from 2010 to 2025. The review will include randomised controlled trials (RCTs), non-RCTs and observational studies that evaluate voice-assisted AI interventions (eg, voice-controlled fitness apps, smart health assistants) aimed at CVD self-management. The primary outcome will be cardiovascular-related mortality. Secondary outcomes will include HRQoL, clinical outcomes (eg, high blood pressure), lipid profiles (eg, cholesterol and glucose levels) and lifestyle modifications (eg, dietary habits and levels of physical activity). Data management and analysis will be conducted using Comprehensive Meta-Analysis software V.2.0. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias tool for RCTs and the Newcastle-Ottawa Scale for observational studies. The meta-analysis will use random-effects models, with heterogeneity assessed using Q and I² statistics. Subgroup analyses and meta-regression will be conducted to explore potential sources of heterogeneity.

Ethics and dissemination

No formal ethical assessment is required, as this study involves analysis of publicly available secondary data. Findings will be disseminated through publications in peer-reviewed scientific journals, conference presentations and media coverage to inform healthcare providers, policymakers and patients.

PROSPERO registration number

CRD42024568702.

Non-inferiority of saline versus corticosteroid injections for trapeziometacarpal osteoarthritis: a protocol for a pilot and feasibility randomised controlled trial

Por: Gevers-Montoro · C. · Freire · V. · Harris · P. G. · Ruel · M. · Luong · D. H. · Bureau · N. J. · Bois · M.-C. · Aribert · M. · Efanov · J. I. · Filali-Mouhim · A. · Piche · M. · Hamasaki · T.
Introduction

Trapeziometacarpal osteoarthritis (TMO) is among the most prevalent forms of upper extremity osteoarthritis. It is frequently associated with significant levels of pain and disability, particularly among ageing women. The typical care pathway for TMO relies on non-surgical approaches for up to 2 years, before surgery is considered. One of the most common non-surgical approaches is an intra-articular cortisone injection. However, these are not universally recommended due to their safety profile and unclear efficacy compared with saline injections. Recent evidence suggests that saline might be non-inferior to cortisone, but this remains to be clarified. This pilot trial aims to assess the feasibility of a trial examining the non-inferiority of saline compared with cortisone injections for TMO.

Methods and analysis

This trial will recruit 40 adults with a diagnosis of TMO and a prescription for a cortisone injection from the Centre hospitalier de l’Université de Montréal (CHUM), Canada. Participants will be randomised to receive either an intra-articular injection of 0.9% sodium chloride (experimental arm, n=20) or triamcinolone acetonide (standard of care, n=20) under fluoroscopic guidance at the Radiology Department or under ultrasound guidance at the Physiatry Clinic. Opaque syringes will be used to blind participants and physicians. Feasibility outcomes, collected at all time points, will include recruitment rates, follow-up completion rates and blinding indices. Preliminary efficacy outcomes, collected at baseline and at 1 day, 1 month, 3 months and 6 months post-injection, will include pain intensity (0–10 scales), hand function (QuickDASH 11-items), cumulative analgesic consumption scores, concurrent interventions, adverse events and number of participants receiving a second injection or an arthroplasty. Descriptive statistics will be used to present feasibility outcomes. Preliminary data on the effectiveness of saline and cortisone injections will inform the design of a large-scale study for formal hypothesis testing.

Ethics and dissemination

The trial was approved by the CHUM Human Research Ethics Board (2025-11815). The research output will be presented at conferences and published in a peer-reviewed journal.

Trial registration number

NCT06401317.

Psychological self-care, burnout and quality of life among university students in health-related fields across three regions of Thailand

Por: Seangpraw · K. · Kantow · S. · Sakulwattana · W. · Auttama · N. · Sukhabot · K. · Bootsikeaw · S. · Khaonuan · B. · Ong-Artborirak · P.
Objectives

Public health students face academic and training pressures as well as challenges arising from patient and community expectations, which may adversely affect their quality of life (QoL) and contribute to burnout and student dropout. This study aimed to examine psychological self-care, burnout and QoL as well as the factors associated with these outcomes among university students.

Design

A cross-sectional study conducted between January and March 2024.

Setting

Universities in northern, southern and northeastern Thailand.

Participants

A total of 1426 health-related students aged 18–25 years were recruited using non-probability sampling.

Primary and secondary outcome measures

Data were collected using a self-administered questionnaire, which included the Thai version of the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF-THAI), the Maslach Burnout Inventory to assess emotional exhaustion (EE) and cynicism (CY) and a psychological self-care assessment.

Results

Most participants (79.9%) reported a moderate level of QoL. The prevalence of burnout was 18.9%. Pearson’s correlation analysis indicated statistically significant relationships between psychological self-care, EE, CY and QoL (all p values

Conclusions

Good mental healthcare behaviours and lower levels of burnout are associated with higher QoL among public health students. Universities and programme administrators should implement mental health support strategies, including routine screening, counselling services and self-care promotion, to reduce burnout and improve students’ overall well-being.

Feasibility assessment of double-blind, crossover, randomized controlled trial protocol comparing two oxygen-supplemented pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: A pilot study

by Akihiro Ito, Akane Morito, Masahiro Ishizaka, Yukihiro Ogawa, Yuki Kawai, Yuta Hanawa, Naotaka Onodera, Yoshiaki Endo, Isato Fukushi, Kotaro Takeda, Taichi Mochizuki, Yasushi Inoue, Yasuo To, Seiichiro Sakao, Kazuyuki Chibana, Hideaki Yamasawa, Satoshi Fuke, Sarah Kesler, David Gozal, Yasumasa Okada, Akira Umeda

Background

Pulmonary rehabilitation (PR) for patients with chronic obstructive pulmonary disease (COPD) improves exercise tolerance and COPD assessment test score (CAT). Oxygen supplementation during PR facilitates exercise physiological benefits. This study aimed to assess the feasibility of a trial comparing two oxygen supplementation methods, with the hypothesis that both would be effective and produce distinct outcomes.

Methods

This double-blind, crossover, randomized controlled trial compared two PR programs—Program A (including PR under FiO₂ 0.3) and Program B (including PR under FiO₂ 0.5)—using high-flow nasal cannula oxygen therapy in patients with COPD and exertional dyspnea (n = 6). Data on the 6-minute walk distance (6MWD), CAT, muscle strength, body composition analysis, respiratory function, and joint range of motion were collected. Participants underwent one month of regular PR followed by two months of oxygen-supplemented PR, with data collected again after this period. Statistical significance was set at 0.05 with a power of 0.8, and the required sample size was calculated accordingly.

Results

The required sample size could not be calculated based on the 6MWD. The improvement in CAT by Program A was greater than that by Program B. The improvements in muscle parameters by Program B were greater than those by Program A. The standardized effect size and the corresponding required sample sizes for the CAT, quadriceps muscle power, lower leg circumference, trunk muscle mass, and leg muscle mass were 0.32/81, 0.66/8, 0.17/114, 0.27/88, and 0.24/56, respectively.

Conclusions

Given the small number of participants, the 6MWD and CAT were not appropriate primary endpoints for comparing the effectiveness of the two oxygen supplementations during PR in patients with COPD. However, the quadriceps muscle power was identified as the most suitable primary endpoint among all the investigated parameters.

Efficacy and Safety of a Defined Two‐Dose Protocol of Autologous Platelet‐Rich Plasma (PRP) Injection for Refractory Chronic Non‐Healing Wounds: A Prospective Clinical Study

ABSTRACT

Chronic non-healing wounds represent a major global public health challenge. Their persistence is frequently attributed to localized biological deficits that cause them unresponsive to conventional therapeutic modalities. While Platelet-Rich Plasma (PRP) has demonstrated promising results as an adjunctive treatment by delivering highly concentrated growth factors, its clinical application is currently impeded by a lack of clinical standardization, particularly optimal injection frequency, interval, and dosage. The aim of this study is to rigorously evaluate the efficacy and safety of a specific, non-intensive two-dose PRP injection protocol for accelerating the reduction of wound area in patients with various types of refractory chronic wounds. We conducted a prospective, single-arm, pretest-posttest study enrolling 18 patients with refractory non-healing wounds, defined as lesions persisting for a minimum period of 4 weeks which had failed to achieve definitive closure under optimized standard care. Autologous high-concentration PRP was injected intradermally around the wound margin at baseline (Day 0) and again 3 weeks later (Day 21). Wound area was digitally measured at baseline and subsequently at 7, 11 and 15 weeks. The primary outcome was the mean reduction in wound area (cm2) at the 15-week follow-up, assessed using a Paired Samples t-test. The mean patient age was 57.89 ± 15.64 years, and wounds had a mean chronicity of 15.83 ± 19.05 months. The PRP preparation achieved a mean platelet concentration 8.5 times greater than the peripheral blood threshold (first injection) and 7.0 times greater than the threshold (second injection), confirming high therapeutic quality. Analysis of the total cohort demonstrated a statistically significant reduction in mean wound area from baseline 27.41 ± 70.38 cm2 to 15 weeks 21.5 ± 68.96 cm2. Three patients (16.67%) achieved complete epithelialization. Subgroup trends suggested diabetic and venous ulcers responded more favourably than radiation-induced ulcers. The protocol was safe, with no systemic or severe localized adverse events observed among participants. The defined two-dose PRP injection protocol provides a clinically effective and safe adjunctive therapy that significantly promotes wound area reduction in challenging chronic non-healing wounds. This reproducible, low-frequency protocol offers a rationale for standardization in advanced wound care, warranting validation through future large-scale Randomized Controlled Trials (RCTs).

Evaluation of the efficacy of empagliflozin in patients with preserved left ventricular ejection fraction undergoing transcatheter aortic valve implantation for aortic stenosis: protocol for a randomised, open-label, controlled study

Por: Okita · S. · Kitahara · H. · Shoji · M. · Sugawara · T. · Miyakoda · K. · Yaginuma · H. · Yamamoto · H. · Kanda · T. · Kinoshita · M. · Sasaki · H. · Suzuki-Eguchi · N. · Takaoka · H. · Matsuura · K. · Ozawa · Y. · Hanaoka · H. · Matsumiya · G. · Kobayashi · Y.
Introduction

Heart failure occasionally develops after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), despite procedural success. Most cases present with mildly reduced or preserved left ventricular ejection fraction (LVEF), underscoring the role of diastolic dysfunction. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown benefits across the heart failure spectrum, independent of LVEF. The purpose of this randomised controlled trial is to determine whether adding a SGLT2 inhibitor to conventional medications improves LV diastolic function in patients with preserved LVEF after TAVI.

Methods and analysis

This study is a prospective, single-centre, open-label, randomised, parallel-group, two-arm trial enrolling patients with mildly reduced or preserved LVEF (≥40%) undergoing TAVI for severe AS. Participants will be randomised in a 1:1 ratio to receive either conventional medications plus empagliflozin or conventional medications alone. In the empagliflozin group, participants will receive conventional medical therapy plus empagliflozin 10 mg orally once daily, initiated 4 weeks after TAVI. Empagliflozin treatment will continue throughout the study period. Participants in the control group will receive conventional medications without empagliflozin. The primary endpoint is the change in E/e’, assessed by echocardiography from treatment initiation at 4 weeks post TAVI (day 1) to day 168 (week 24). Each group will include 50 patients, totalling 100 patients.

Ethics and dissemination

Ethical approval for this study has been obtained from the Chiba University Hospital Certified Clinical Research Review Board (CRB0111-25).

Trial registration number

jRCT1031250190.

Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial

Por: Miyake · M. · Takahashi · A. · Baba · T. · Maruko · I. · Ohnaka · M. · Kuroda · A. · Tada · H. · Hidaka · Y. · Ibi · Y. · Muraoka · Y. · Ito · T. · Morita · S. · Sakamoto · T. · Imai · H. · Yamamoto · S. · Iida · T. · Tsujikawa · A.
Introduction

Chronic central serous chorioretinopathy (CSC) can cause progressive and permanent vision loss. Although photodynamic therapy (PDT) is a primary treatment option globally, it is not approved for CSC worldwide, limiting therapeutic access. The REPLAY trial is a phase III, investigator-initiated trial to evaluate the efficacy and safety of reduced-fluence PDT (rf-PDT) for chronic CSC to seek the first regulatory approval globally.

Methods and analysis

This study comprises two cohorts. The ‘untreated cohort’ is a multicentre, randomised, placebo-controlled, double-masked trial involving 60 patients with untreated, fovea-involving chronic CSC, randomised 2:1 to receive a single rf-PDT or placebo treatment. The ‘previously treated cohort’ is a single-arm, open-label trial for up to 10 patients with recurrent CSC after PDT. The primary endpoint for both cohorts is the proportion of eyes with a complete resolution of subfoveal fluid at 12 weeks post-treatment, assessed by optical coherence tomography. Secondary endpoints include changes in best-corrected visual acuity, central choroidal thickness, recurrence rates and incidence of adverse events over a 48 week follow-up.

Ethics and dissemination

The study protocol was approved by the Kyoto University Hospital Institutional Review Board, IRB of Chiba University Hospital, Tokyo Women’s Medical University Institutional Review Board and Institutional Review Board of Kansai Medical University Hospital. Written informed consent is obtained from all participants. The results will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences.

Trial registration number

jRCT2051230156 (URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2051230156).

Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer with positive peritoneal lavage and/or stamp cytology: An exploratory phase II study

by Gen Tsujio, Masakazu Yashiro, Yuichiro Miki, Kohei Matsuoka, Koji Maruo, Mami Yoshii, Tatsuro Tamura, Katsunobu Sakurai, Takahiro Toyokawa, Naoshi Kubo, Shigeru Lee, Tomohisa Okuno, Kishu Kitayama, Go Masuda, Masaichi Ohira, Kiyoshi Maeda

Background

Our group revealed that the combination of intra-operative stamp cytology and peritoneal lavage cytology (CY) improved the identification of individuals with high risk of peritoneal metastasis. In this exploratory Phase II study, we aimed to evaluate the effect on relapse-free survival (RFS) of extensive intraoperative peritoneal lavage (EIPL) for gastric cancer with positive peritoneal cytology (CY1) and/or stamp cytology positive (stamp+).

Materials and methods

This study was a single arm, multi-institutional, exploratory phase 2 trial to assess the effects of EIPL after open gastrectomy for gastric cancer with CY1 and/ or stamp+. The primary endpoint was RFS. Secondary endpoints were overall survival (OS), postoperative recurrence site and incidence of postoperative adverse events.

Results

Between 2017 and 2021, 13 patients from 2 institutions were enrolled in this study. Because of the recent decline in open abdominal surgery, the number of cases did not increase and the trial was closed due to lack of applicants at 13 cases. Median 3-year RFS was 14.5 months (95% CI 5.4-NA), median 3-year OS was not reached (95% CI 14.5-NA) and median3-year peritoneal RFS was 16.0 months (95% CI 5.4-NA). Median 3-year peritoneal RFS rate was 83% in CY0 and stamp+ cases (n=6), and 0% in CY1 and stamp+/- cases (n=7). (Log-rank p=0.015).

Conclusion

Because of the slow accrual pace and early stop of the trial, we were not able to evaluate the prespecified endpoints thoroughly. However, EIPL might be effective to prevent perineal recurrence, especially in CY0 and stamp+ case.

Children on the Move in ECOWAS: A Structural Violence Approach to Child Migration and Protection Frameworks

ABSTRACT

Introduction

Children on the move in the ECOWAS subregion are part of historical mobility networks shaped by structural poverty, inadequate services, and inequalities. Using the Structural Violence Theory framework, the review examines how economic, social service, and governance policies interact to both create the demand for migration and increase the risks faced by children on the move. The review has three research objectives.

Design

Systematic literature review guided by PRISMA.

Methods

There was an overwhelming response of relevant literature sources. Literature from 1966 to 2025 on child migration, trafficking, displacement, and protection by ECOWAS was collected. Among the 987 sources identified through a literature search of central academic databases and institutional repositories, 56 met the selection criteria. Qualitative analysis was employed to evaluate the robustness of the sources based on their methods.

Results

Findings indicate rising levels of children on the move, driven by independent migration from rural areas to cities and cross-border migration along traditional migration routes. Factors such as economic hardship, limited access to quality education, conflict, gender-related labor market conditions, and family dynamics are interconnected and play crucial roles. Children on the move are increasingly vulnerable to exploitation, labor dangers, trafficking, and social exclusion. While international, regional, and national frameworks set standards legally, their implementation remains inefficient.

Conclusion

Children on the move within ECOWAS are seen as an inevitable result of structural factors rather than isolated incidents. One policy implication of this analysis is to include children on the move within the ECOWAS mobility framework. Additionally, social protection programs for children need to be expanded in countries with high emigration rates.

Clinical Relevance

Nurses and allied frontline providers are well-positioned to identify mobility-related risks, deliver trauma-informed, non-discriminatory care, document safeguarding concerns, and activate referral pathways for child protection, psychosocial support, and legal assistance.

Positive and Negative Appraisals and Quality of Life Among Family Caregivers of Adults With Formal Long‐Term Care Needs: An Exploration of Model Using Structural Equation Modelling

ABSTRACT

Aims

To examine a model of the caregiving adaptation process among family caregivers supporting care recipients at home.

Background

Global demand for the support of adults with long-term care needs and family caregivers is increasing. Caregivers' quality of life is affected by positive and negative appraisals of care; however, few studies have simultaneously investigated these factors.

Design

A cross-sectional study.

Method

The STROBE checklist for cross-sectional studies was followed. Seventy-four randomly selected home-visit nursing stations in Japan participated in this study from June 2023 to June 2024. A self-administered anonymous questionnaire was provided to family caregivers with care recipients at home. A total of 168 questionnaires were analysed. The variables included in the model were the European Quality of Life five-dimension five-level (EQ-5D-5L) instrument, positive and negative appraisals of care scale, four external resources and three internal resources, and six characteristics of caregivers and care recipients. Descriptive statistics and correlations between variables were analysed. The model was tested using structural equation modelling.

Results

Family caregivers' negative appraisal of care directly and negatively affected quality of life, and positive appraisal of care had no statistically significant association with quality of life. Positive appraisal of care had a direct negative association with negative appraisal of care. External resources such as support from nurses directly affected the positive appraisal of care. Internal resources such as caregivers' coping strategies had a significant negative effect on negative appraisal of care.

Conclusion

The findings suggest that improving caregivers' quality of life requires support to decrease negative appraisal of care by increasing internal resources and increase positive appraisal of care by providing external resources. Understanding the caregivers' adaptation process model is essential to prevent the deterioration of their quality of life.

Reporting Method

STROBE guidelines.

Patient or Public Contribution

Seventy-four home visit nursing stations and participants who care for family members through home visit nursing were involved in the survey investigation and answering the questionnaires.

Implications for the Profession and Patient Care

For supporting family caregivers' QoL, a reduction in negative appraisals of care is essential, increasing internal resources such as caregivers' coping and positive appraisal of care directly reduces negative appraisal of care.

Effect of different velocity loss thresholds during a resistance training program on jump and sprint performances in trained female athletes

by Hiroki Kambara, Kazuhiro Sakamoto, Yuya Watanabe, Mitsuo Neya

This study aimed to explore the effects of velocity-based resistance training (VBT) using different velocity loss (VL) thresholds on jump and sprint performance in trained female athletes. Fifteen college-level female basketball players completed an 8-week VBT program (2 sessions/week), involving parallel back squats performed at a target mean propulsive velocity of 0.7 m/s. Participants were randomly assigned to two groups: VL10% (n = 8) and VL20% (n = 7), where training sets were terminated when the target velocity-loss threshold was exceeded for the second time within the same set. Performance tests, including one-repetition maximum (1RM), squat jump (SJ), countermovement jump (CMJ), and 20-m sprint (SP20) with split times recorded at 5 m (SP5) and 10 m (SP10), were conducted pre- and post-intervention. The VL10% group showed significant improvements in SJ (p = 0.048, d = 1.30), SP10 (p = 0.004, d = 0.62), SP20 (p = 0.002, d = 0.67), and 1RM (p = 0.002, d = 0.29). The VL20% group also showed improvements in SP10 (p = 0.004, d = 0.42), SP20 (p = 0.002, d = 0.56), and 1RM (p = 0.002, d = 0.62), although SJ did not significantly improve. Despite no significant interaction effects, effect sizes suggest possible differences that require verification in adequately powered trials. VBT using low VL thresholds may be useful for maintaining movement velocity with lower training volume; however, between-group differences were not statistically significant and CMJ did not show clear improvement. Larger-scale studies are needed to confirm these trends.

Anti-cancer effect of a novel photodynamic therapy using glucose-linked chlorin e6 conjugated trastuzumab for HER2-positive gastrointestinal cancers

by Makiko Sasaki, Mamoru Tanaka, Akihiro Nomoto, Ryusei Yamasaki, Tomokazu Yoshimura, Shigenobu Yano, Yasunari Sasaki, Yuki Kojima, Taketo Suzuki, Hirotada Nishie, Keiji Ozeki, Takaya Shimura, Eiji Kubota, Hiromi Kataoka

Photodynamic therapy (PDT) is an anti-cancer therapy that employs a photosensitizer (PS) and an optimal wavelength of light, causing a photochemical reaction that releases reactive oxygen species, thereby inducing cancer cell death via oxidative stress. Because light irradiation is limited to the tumor site, PDT has minimal adverse effects. The cancer cell selectivity of the PS is important for reducing damage to the normal mucosa caused by scattered light. Antibody-drug conjugates (ADC) are novel anti-cancer therapies that combine a monoclonal tumor-surface-receptor-targeting antibody with a drug bonded through chemical linkers. ADCs enable the targeted delivery of a variety of drugs to cancer cells while minimizing their delivery to healthy tissues. One such tumor surface receptor is the human epidermal growth factor receptor 2 (HER2), which is of interest in the treatment of many cancers, including gastrointestinal cancer. To improve tumor selectivity and minimize damage to the mucosa surrounding the tumor in PDT, we established a novel PS glucose-linked chlorin e6-conjugated trastuzumab (G-Ce6-trastuzumab) that is conjugated to existing PS glucose-linked chlorin e6 (G-Ce6) and evaluated its anti-cancer effect compared to G-Ce6. The effect of PDT was evaluated using HER2-high-expression cells NCI-N87 and HER2-low-expression cells MKN-45. G-Ce6-trastuzumab is internalized by the intracellular organelles in cancer cells. Evaluation of cell death using the WST-8 assay also demonstrated a significantly higher cytotoxic effect of G-Ce6-trastuzumab in HER2-high-expression cells compared with conventional PS G-Ce6. Thereby, G-Ce6-trastuzumab may be an excellent novel PS for PDT because of its strong selectivity for HER2-high-expression cells.

Bayesian randomised controlled trial of guided parent-delivered cognitive behavioural therapy for children with anxiety disorders via remote sessions in Japan: a study protocol

Por: Okawa · S. · Blackwell · S. E. · Violato · M. · Creswell · C. · Ishikawa · S.-i. · Obikane · E. · Takahashi · T. · Arai · H. · Nakamura · H. · Ishitsuka · K. · Shimizu · E. · Sasaki · T.
Introduction

Guided parent-delivered cognitive behavioural therapy (GPD-CBT) is an evidence-based, low-burden treatment programme for childhood anxiety disorders with demonstrated efficacy, cost-effectiveness and accessibility. However, it has been tested primarily in Western countries, and the efficacy and cost-effectiveness have not been evaluated in Japanese families. The current study aims to examine GPD-CBT’s efficacy and cost-effectiveness in Japanese samples and explore potential cultural adaptations of the programme.

Method and analysis

This study is designed as a Bayesian single-blind randomised controlled trial with two parallel groups: GPD-CBT (intervention group) and a waitlist control group. The primary outcome is remission of primary anxiety disorders evaluated through diagnostic interviews by independent evaluators. Secondary outcomes include child and parent-reported child anxiety symptoms, depressive symptoms and life interference. Additionally, measures of parental psychological characteristics, programme acceptability and quality of life are collected. We will conduct qualitative interviews with parents who participated in the programme and therapists who delivered the intervention to explore potential cultural adaptations. We aim to recruit 54–170 families, depending on the results of sequential Bayesian analyses. GPD-CBT consists of seven weekly 20 min sessions and a 1-month follow-up session. Assessments will be conducted at baseline, 13 weeks post randomisation (primary endpoint for between-group comparison), with an additional 25 weeks post randomisation. The waitlist control group will receive GPD-CBT after the 13-week assessment.

Ethics and dissemination

This study has been approved by the Ethics Review Committees of Chiba University and the University of Tokyo. We will disseminate results through academic conference presentations and peer-reviewed journal publications. If the GPD-CBT intervention proves efficacious, we will promote wider implementation in Japan through the development of training programmes for mental health professionals and key stakeholders.

Trial registration numbers

jRCT1032250421 (https://jrct.mhlw.go.jp/latest-detail/jRCT1032250421) and jRCT1030250422 (https://jrct.mhlw.go.jp/latest-detail/jRCT1030250422) registered on 9 October 2025.

Nurse Practitioner Students' Perceptions of an Artificial Intelligence Differential Diagnosis Tool: A Pilot Study

ABSTRACT

Aim

The aim of this study is to assess nurse practitioner students' perceptions and engagement with Isabel's artificial intelligence (AI) based differential diagnosis tool to support their decision-making skills during their theoretical and clinical placement training.

Design

This pilot study used a cross-sectional design.

Methods

Twenty-six nurse practitioner students provided feedback on their use of an AI differential diagnosis tool in both academic and clinical contexts. This survey used the Post-Study System Usability Questionnaire to assess the engagement levels and usability of the AI tool. Additional questions were included to evaluate the usage patterns, adequacy in training and confidence in diagnosis.

Results

There were mixed engagement levels: 44.4% (n = 8/18) used Isabel in two subjects—typically one or both clinical placement units—and 27.8% (n = 5/18) in one subject; students most often used the tool to confirm differential diagnoses. Usability was rated positively with the disease ranking, red flag diagnosis and link to national guideline features demonstrating the highest student usage. While most students found the tool beneficial to use during clinical placement and completing university assignments, some reported challenges due to insufficient training, impacting confidence in clinical application.

Conclusion

Isabel has potential as a valuable educational tool in Nurse Practitioner programs, but successful implementation depends on adequate training and support. The findings highlight the importance of comprehensive training and support to maximise AI tool utilisation, with direct implications for programme curricula, clinical education strategies and potential improvements in diagnostic reasoning skills for future nurse practitioners.

Implications for the Profession and/or Patient Care

This study provides an example of integrating artificial intelligence (AI) guided clinical decision-making training in nurse practitioner (NP) education. The findings can be used by educational institutions to trial similar AI-integrated learning approaches, enhancing diagnostic competence and potentially improving patient care outcomes.

Reporting Method

The Study adhered to the STROBE checklist for reporting.

Patient or Public Contribution

No patient or public contribution was made to this study.

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