BMJ Open最新文献

{"title":"Global, regional and national burden of colon and rectum cancer: a systematic analysis of prevalence, incidence, deaths and DALYs from 1990 to 2021 using data from the Global Burden of Disease Study 2021 with projections to 2036.","authors":"Yujun He, Xiaoyi Wang, Miao Zhou, Lu Li, Tingfen Han, Jiujie He, Wei Mai, Xiaojun Li","doi":"10.1136/bmjopen-2025-100042","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-100042","url":null,"abstract":"<p><strong>Objectives: </strong>Colon and rectum cancer, the third most common cancer globally, is a considerable health challenge worldwide. Despite the excellent insights offered by the global burden of disease (GBD) study, comprehensive assessments of colon and rectum cancer remain limited. This study utilises the most recent GBD dataset to examine the impacts of colon and rectum cancer, incorporating contemporary data alongside projections for 2036.</p><p><strong>Methods: </strong>We analysed data from the 2021 GBD database, focusing on metrics pertaining to colon and rectum cancer: prevalence, incidence, mortality and disability-adjusted life years (DALYs) across 204 countries and territories, classified into 21 GBD regions and five sociodemographic index (SDI) regions. The data analysis encompassed computations of relative change, annual percentage change and estimated annual percentage change. This research also employed the Pearson algorithm to investigate the relationship between disease burden and SDI, conduct cross-country inequality analysis, perform age-period-cohort analysis and execute decomposition analysis. Finally, an autoregressive integrated moving average model was utilised to project trends over the next 15 years.</p><p><strong>Results: </strong>From 1990 to 2021, the global prevalence of colon and rectum cancer increased significantly, from approximately 4.27 million to 11.68 million cases (age-standardised prevalence rate increased from ~108.25 to 134.84 per 100 000). Incident cases rose by 139.38% (age-standardised incidence rate increased by 6.52%). Mortality increased by 83.07% but with a significant decrease in age-standardised mortality rate (-20.33%), and DALYs increased by 69.49% with a corresponding decrease in age-standardised DALYs (-20.73%). Data on gender from 1990 to 2021 indicates that men experience a greater disease burden than women. A significant correlation exists between the illness burden of SDI and colon and rectum cancer, and the age-period-cohort model has provided further insights. Decomposition analysis reveals that population growth is the primary factor affecting the burden of colon and rectum cancer disease. The predictive study for the forthcoming 15 years indicates that while the mortality and DALYs for both genders will persist in their reduction, the prevalence and incidence rates for males will continue to increase, whereas those for women will remain relatively stable.</p><p><strong>Conclusions: </strong>The burden of colon and rectum cancer has markedly escalated worldwide in the last 30 years. Essential methods to mitigate this trend encompass the reduction of modifiable risk factors, enhancement of early identification and treatment, and augmentation of early screening, particularly for high-risk male populations under 50 years of age. The rising incidence rate among youth underscores the necessity to enhance comprehension of developing risk factors and mechanisms, as well as to advanc","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e100042"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantifying cross-sectional and longitudinal associations in mental health symptoms within families: network models applied to UK cohort data.","authors":"Yushi Bai, Archie Rayner, Kathryn M Abel, Sam Cartwright-Hatton, Ming Wai Wan, Matthias Pierce","doi":"10.1136/bmjopen-2025-104829","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-104829","url":null,"abstract":"<p><strong>Objectives: </strong>Families offer promising targets for mental health interventions. Existing evidence investigates parent-child dyads or partners; we use an innovative approach to look at triads of parents and their children. This gives us more detail on mental health dimensions and individuals central to mental health transmission in families.</p><p><strong>Design: </strong>Both cross-sectional and longitudinal network models SETTING: We identified triads of children (under age 16), mothers and fathers from the UK Household Longitudinal Study, between 2009 and 2022.</p><p><strong>Participants and methods: </strong>Cross-sectional networks captured independent associations between family members' mental health (n=8795 families). Longitudinal networks examined directional temporal associations among family members' emotional symptoms (n=3757 families).</p><p><strong>Primary outcome measures: </strong>Children's and parents' mental health dimensions were assessed using the Strengths and Difficulties Questionnaire and the General Health Questionnaire, respectively.</p><p><strong>Results: </strong>Mothers' mental health, particularly emotional symptoms, was linked to children's mental health, while fathers' symptoms showed no independent association. In the longitudinal network, maternal feelings of being overwhelmed were associated with children's future worry, affecting symptoms of nervousness and unhappiness, which then fed back into worsening maternal emotional symptoms.</p><p><strong>Conclusions: </strong>Investigating family mental health using network models highlights mothers' central role. The longitudinal relationship between maternal feelings of being overwhelmed and children's anxiety, and the subsequent feedback into maternal anxiety, indicates a promising target for intervention.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e104829"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Municipal multidimensional poverty increases the risk of acute myocardial infarction: a retrospective cohort study with sex-stratified analyses in Chile's public health system.","authors":"Natalia Bello-Escamilla, Paulina Pino, Carolina Nazzal","doi":"10.1136/bmjopen-2025-102239","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-102239","url":null,"abstract":"<p><strong>Objectives: </strong>To estimate the association between municipal multidimensional poverty (MMDP) and the risk of a first hospitalised acute myocardial infarction (AMI) among users of the Chilean public health system, and to examine whether this association differs by sex.</p><p><strong>Design: </strong>Multilevel analysis of a retrospective cohort study.</p><p><strong>Setting: </strong>Primary level of care across 138 municipalities in Chile.</p><p><strong>Participants: </strong>A total of 137,162 individuals aged ≥45 years were included, comprising 83,598 women and 53,564 men, all enrolled in the cardiovascular health programme of the Chilean public health system due to the presence of cardiovascular risk factors such as hypertension, type 2 diabetes, dyslipidaemia or tobacco use. Individuals with a prior history of AMI were excluded. Participants were clustered by municipality and followed from 1 January 2015 to 30 April 2019. Sociodemographic and clinical data at the individual level were obtained from electronic health records and linked to municipal-level poverty indicators from the National Socioeconomic Characterization Survey.</p><p><strong>Outcome measures: </strong>The primary outcome was the time to first hospitalised AMI . Cox proportional hazard models with a shared frailty term were used to assess the association between MMDP (defined as being in the upper quartile of the index) and AMI incidence. Models were adjusted for individual sociodemographic characteristics, behavioural risk factors (eg, smoking, diet and physical activity), and biological conditions (eg, hypertension, type 2 diabetes and dyslipidaemia). Sex-stratified analyses were conducted to explore potential differences in the association.</p><p><strong>Results: </strong>MMDP was significantly associated with an increased risk of AMI (HR 1.32, 95% CI 1.06 to 1.64) after adjustment for individual-level risk factors. In stratified models, the association remained significant among women (HR 1.30, 95% CI 1.01 to 1.68), but not among men (HR 1.10, 95% CI 0.93 to 1.31).</p><p><strong>Conclusion: </strong>Residing in municipalities with high levels of multidimensional poverty is associated with an increased risk of AMI among individuals with cardiovascular risk factors, particularly women. These findings underscore the need for intersectoral policies to address the structural determinants of cardiovascular health.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e102239"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of nutritional intervention provided to older people and nutrients indicating food insecurity in primary care settings in Tehran: protocol of a prospective population-based cohort study.","authors":"Nazanin Asghari Hanjani, Alireza Olyaeemanesh, Gita Shafiee, Mitra Zabihi, Leila Azadbakht","doi":"10.1136/bmjopen-2024-097159","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-097159","url":null,"abstract":"<p><strong>Background and aim: </strong>With the growing older population, ensuring effective, accessible nutritional support within primary care as a first line of medical care is becoming increasingly important. Nutritional counselling is a promising approach to enhancing health outcomes and independence among older adults. However, a stronger evidence base is needed to assess its true effect and inform clinical decisions. Additionally, food insecurity remains an under-recognised issue in this population and is often overlooked in primary care settings. This highlights the need for simple, practical methods to identify those at risk. This study aimed to assess the effectiveness of nutritional intervention provided to older people and determine which nutrients may indicate food insecurity in primary care settings in Tehran.</p><p><strong>Methods: </strong>The study will be conducted in two phases. The first phase is a prospective cohort study (single cohort). The second phase is a cross-sectional study on older people who refer to primary care settings affiliated with the Tehran University of Medical Sciences. In the first phase, the effectiveness of nutritional interventions - including counselling and diet - is evaluated based on anthropometric indicators (weight, waist circumference, calf circumference, arm circumference and waist-to-height ratio), blood pressure and scores from the Mini Nutritional Assessment, health-related quality of life, dietary intake and physical activity. Assessments will be evaluated prospectively at the beginning of the study, after 3 months, and at the end of the study. In the second phase of the cross-sectional study, by examining dietary intake and food insecurity, we will identify the specific nutrient or food group that serves as an indicator of food insecurity in the diet of older individuals. Intakes below 50% and 75% of the recommended daily allowance will be analysed. Through sensitivity and specificity analysis, we will identify which nutrient or food group is strongly associated with food insecurity in older people.</p><p><strong>Ethics and dissemination: </strong>This study received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1402.474). Study findings will be disseminated through peer-reviewed journal articles, presentations at national and international conferences and meetings with the Iranian Ministry of Health, facility and community stakeholders.</p><p><strong>Registration number: </strong>69772.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e097159"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring competence in mental health crisis management: a qualitative study of Norwegian prehospital emergency medical personnel.","authors":"Hege Skundberg-Kletthagen, Kari Kirbakk Fjær","doi":"10.1136/bmjopen-2025-098877","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-098877","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to investigate how prehospital emergency medical personnel in Norway perceive their competence and manage encounters with patients who are experiencing mental health crises.</p><p><strong>Design: </strong>A qualitative descriptive design using content analysis was employed, following the Standards for Reporting Qualitative Research guidelines.</p><p><strong>Setting: </strong>The study was conducted within four emergency medical care services in a Norwegian hospital trust, covering both urban and rural areas.</p><p><strong>Participants: </strong>Individual interviews were conducted with 16 health professionals (9 men and 7 women), aged 24-55 years, with 1-18 years of service experience.</p><p><strong>Results: </strong>The results revealed one main theme-'Balancing security and patient care'-with two subthemes-'Increasing mental health-related assignments in prehospital care' and 'Challenges related to the lack of competence and resources in handling mental health crises'.</p><p><strong>Conclusions: </strong>This study highlights the increasing complexity and frequency of mental health crises that are faced by prehospital emergency medical personnel in Norway. These personnel often feel unprepared due to a lack of competence and clear procedures, forcing them to rely on clinical experience. Police involvement, particularly in rural areas, underscores the need for better collaboration between law enforcement and healthcare services. To enhance the quality of care, it is essential to implement a standardised curriculum for paramedicine education and provide comprehensive mental health training for all prehospital emergency medical personnel, including emergency medical communication centre operators and other healthcare professionals involved in emergency care.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e098877"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol for the DISTINCT trial: inDividual, targeted thrombosIS prophylaxis versus the standard 'one-size-fits-all' approach in patients undergoing Total hIp or total kNee replaCemenT - a national, multicentre, randomised, multiarm, open-label trial.","authors":"Ruben Y Kok, Leti van Bodegom-Vos, Harmen B Ettema, Rolf H H Groenwold, Wilbert B van den Hout, Menno V Huisman, Frederikus A Klok, Rob G H H Nelissen, Nienke van Rein, Merel van Veen, Stephan B W Vehmeijer, Jan Joost I Wiegerinck, Suzanne C Cannegieter, Banne Nemeth","doi":"10.1136/bmjopen-2025-101180","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-101180","url":null,"abstract":"<p><strong>Introduction: </strong>Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%-1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.</p><p><strong>Methods and analysis: </strong>The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard 'one-size-fits-all' approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).</p><p><strong>Ethics and dissemination: </strong>The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.</p><p><strong>Trial registration number: </strong>NCT06581965.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e101180"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical complexity within a rural health network: a study protocol.","authors":"Abigail Palaza, Peter Callas, Peter S Dayan, Dennis Z Kuo, Lauren Riney, Sandra P Spencer, Renee Stapleton, Martha Stevens, Christian R Studts, Christian D Pulcini","doi":"10.1136/bmjopen-2025-106842","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-106842","url":null,"abstract":"<p><strong>Introduction: </strong>Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.</p><p><strong>Methods and analysis: </strong>Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.</p><p><strong>Ethics and dissemination: </strong>This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.</p><p><strong>Trial registration number: </strong>NCT06444282.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e106842"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Upfront surgery versus induction chemotherapy followed by surgery in oral cavity squamous cell cancers with advanced nodal disease (SurVIC Trial): a phase 3 multicentre randomised controlled trial.","authors":"Dharma Ram Poonia, Amit Sehrawat, Jeewan Ram Vishnoi, Nivedita Sharma, Parmod Kumar, Bharti Devnani, Aparna Warriere, Akanksha Solanki, Puneet Pareek, Divya Aggarwal, Taruna Yadav, Prem Prakash Sharma, Ashita Gadwal, Anushka Goyal, Poonam Elhence, Pushpinder Khera, Ashish Jakhetiya, Pnahindra Swaim, Dillip Muduly, Rohit Mahajan, Pankaj Garg, Vijay Kumar, Madhabananda Kar, Sanjeev Misra","doi":"10.1136/bmjopen-2025-106644","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-106644","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2-N3).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and analysis: &lt;/strong&gt;The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).The study population consists of patients with operable OSCC and advanced nodal disease (N2-N3), adequate organ function, aged 18-65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;This","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e106644"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Barriers to mental health services for children and adolescents with autism spectrum disorder in Brazil: protocol for a qualitative evidence synthesis and citizen panel (BARRIER-Free-BR Project).","authors":"Luis Phillipe Nagem Lopes, Laura Dos Santos Boeira, Ana Carolina Figueiredo Modesto, Alice Ramos-Silva, Victória Paulo Menin, Flávia Casale Abe, Luciane Cruz Lopes","doi":"10.1136/bmjopen-2025-107543","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-107543","url":null,"abstract":"<p><strong>Introduction: </strong>The perspectives of stakeholders directly affected by mental health services for autism spectrum disorder (ASD) are essential for the quality of these services. However, it is crucial that these perspectives are informed by the best available evidence and adapted to the local context. This study aims to analyse barriers related to mental health services for children and adolescents with ASD from the perspective of families and caregivers, considering social, racial and gender aspects.</p><p><strong>Methods: </strong>Three steps will be taken: stakeholder engagement through an online meeting to refine the research question and understand the magnitude of the problem; (b) qualitative evidence synthesis using five databases and grey literature to identify studies that have collected and analysed qualitative data on barriers to mental health services for children and adolescents with ASD in Brazil. Only studies conducted in Brazil that consider the perspectives of family members and caregivers will be included. (c) A citizen panel with families of children and adolescents with ASD will be used to discuss and validate the synthesis findings.</p><p><strong>Ethics and dissemination: </strong>We will provide a set of evidence-informed and stakeholder-experienced barriers to mental health services for children with ASD in Brazil. This represents an effort to engage stakeholders in evidence descriptions to inform policy. We plan to disseminate the findings through various means, including peer-reviewed journal publications, presentations at national conferences, invited workshops and webinars, patient associations and academic social media platforms. The project was approved by the Ethics Committee for Research at the University of Sorocaba (approval number 78747224.7.0000.5500).</p><p><strong>Trial registration number: </strong>Open Science Framework-10.17605/OSF.IO/DVAKG.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e107543"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial-the EASY-CS study.","authors":"Christophe Beyls, Nicolas Mollet, Louis Gibert, Pierre Huette, Marwa Khamari, Jonathan Meynier, Osama Abou-Arab, Yazine Mahjoub","doi":"10.1136/bmjopen-2025-108600","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-108600","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Fluid overload (FO) is a common complication following cardiac surgery with cardiopulmonary bypass (CPB) and is associated with increased morbidity and mortality. Loop diuretics, particularly furosemide, are widely used to promote sodium and water excretion, but their postoperative use remains largely empirical. International guidelines recommend early assessment of diuretic response using spot urinary sodium concentration, traditionally measured by automated laboratory analysers. Recent advances now enable bedside measurement of natriuresis using point-of-care (POC) urinary sodium sensors. This trial aims to determine whether real-time bedside natriuresis monitoring using a POC device can guide safer and more effective diuretic strategies in the postoperative management of FO.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Materials and methods: &lt;/strong&gt;The EASY-CS trial is a prospective, single-centre, open-label, randomised controlled trial designed to evaluate whether a natriuresis-guided furosemide titration protocol improves diuresis within 48 hours following cardiac surgery with CPB. A total of 102 adult patients undergoing elective cardiac surgery with CPB and requiring postoperative intravenous (IV) furosemide for FO will be randomised in a 1:1 ratio to either standard care (n=51; furosemide titration based on clinical judgement) or a natriuresis-guided arm (n=51), in which furosemide dosing is adjusted according to urinary sodium concentration. All patients will receive an initial 20 mg dose of IV furosemide. In the intervention group, urinary sodium will be measured every 6 hours using a POC sodium sensor (LAQUAtwin Na&lt;sup&gt;+&lt;/sup&gt; metre, Horiba, Japan). If the spot urinary sodium is &lt;70 mmol/L, the furosemide dose will be doubled at the next administration, up to a maximum of 200 mg per bolus. The primary endpoint is cumulative urine output at 48 hours post-randomisation.Secondary outcomes include urinary sodium concentration and urine output at 24 hours, natriuresis at 48 hours, and the venous excess ultrasound score at 48 hours, as determined by transthoracic echocardiography. The study will also assess total loop diuretic dose administered, cumulative fluid balance over 48 hours and the incidence of postoperative complications at day 30, including cardiovascular, renal, respiratory and gastrointestinal events. Safety endpoints include the presence of hypotension, hypokalaemia or acute kidney injury before each diuretic administration. Randomisation will be stratified by EuroSCORE II (&lt;4% vs ≥4%) and baseline serum creatinine (&lt;100 vs≥100 µmol/L). Recruitment has not yet started.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;Ethical approval has been obtained from the Institutional Review Board (IRB) of Amiens University hospital (IRB-ID: 2025-A00925-44). The study's results will be disseminated through peer-reviewed publications and presentations at national and international conferences.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration number","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e108600"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}