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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. 德黑兰初级保健机构向老年人提供营养干预的有效性和表明粮食不安全的营养素:一项前瞻性人群队列研究的方案
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2024-097159
Nazanin Asghari Hanjani, Alireza Olyaeemanesh, Gita Shafiee, Mitra Zabihi, Leila Azadbakht
{"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}
引用次数: 0
Exploring competence in mental health crisis management: a qualitative study of Norwegian prehospital emergency medical personnel. 探讨挪威院前急救医务人员的心理健康危机管理能力。
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-098877
Hege Skundberg-Kletthagen, Kari Kirbakk Fjær
{"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}
引用次数: 0
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. DISTINCT试验的研究方案:在接受全髋关节置换术或全膝关节置换术的患者中,个体、靶向血栓预防与标准“一刀切”方法的对比——一项全国性、多中心、随机、多组、开放标签的试验。
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-101180
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
{"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}
引用次数: 0
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. 随机混合1型试点试验评估急诊护理行动计划(ECAP)在农村卫生网络中的初步有效性和实施:一项研究方案。
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-106842
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
{"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}
引用次数: 0
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. 前期手术与诱导化疗后手术治疗口腔鳞状细胞癌伴晚期淋巴结疾病(SurVIC试验):一项3期多中心随机对照试验
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-106644
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
{"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}
引用次数: 0
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). 巴西患有自闭症谱系障碍的儿童和青少年获得心理健康服务的障碍:定性证据综合和公民小组议定书(无障碍br项目)。
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-107543
Luis Phillipe Nagem Lopes, Laura Dos Santos Boeira, Ana Carolina Figueiredo Modesto, Alice Ramos-Silva, Victória Paulo Menin, Flávia Casale Abe, Luciane Cruz Lopes
{"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}
引用次数: 0
Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial-the EASY-CS study. 评估心脏手术后钠引导耗竭:单中心、开放标签、随机对照试验方案- EASY-CS研究
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-108600
Christophe Beyls, Nicolas Mollet, Louis Gibert, Pierre Huette, Marwa Khamari, Jonathan Meynier, Osama Abou-Arab, Yazine Mahjoub
{"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}
引用次数: 0
From policy to action: a document content analysis reviewing the adoption of the healthcare inequalities programme in local health system plans in England. 从政策到行动:一份文件内容分析,审查在英格兰地方卫生系统计划中采用医疗不平等方案。
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-102163
Hannah Elliott, Chloe Tozer, Andrew Fenton, Cassandra Powers, Cathy Lines, Mary Hill, Bola Owolabi, John Alexander Ford
{"title":"From policy to action: a document content analysis reviewing the adoption of the healthcare inequalities programme in local health system plans in England.","authors":"Hannah Elliott, Chloe Tozer, Andrew Fenton, Cassandra Powers, Cathy Lines, Mary Hill, Bola Owolabi, John Alexander Ford","doi":"10.1136/bmjopen-2025-102163","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-102163","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This analysis aimed to explore how local health system strategies and plans seek to tackle health and care inequalities and address national policies. Specifically, the analysis considered alignment with five national priority areas: restoring services inclusively, mitigating digital exclusion, ensuring the completeness and timeliness of datasets, accelerating preventative programmes and strengthening leadership and accountability. In addition, the analysis explored the extent to which systems are engaging with the Core20PLUS5 approach, which targets the most deprived 20% of the population ('Core 20') and population groups experiencing disproportionately poor access, outcomes or experiences of care ('PLUS').&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design and setting: &lt;/strong&gt;Integrated Care Systems (ICSs) are statutory partnerships that bring together healthcare, social care, local government and wider system organisations to collaboratively address the root causes of ill health and health inequalities. We conducted a document analysis of available ICS strategies, 5-year plans and health inequalities plans published in England between 1 January 2022 and 31 July 2023. A total of 43 strategy documents, 38 5-year plans and 7 health inequalities plans were analysed. A data extraction framework was used to guide reviewers and independent quality assurance was completed to ensure internal validity, intrarater reliability, and reproducibility of the project.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The analysis highlighted good alignment with national healthcare inequalities policies and local approaches to tackling healthcare inequalities, with the majority of systems citing the Core20PLUS5 framework. There was notable variation between systems on the adoption of the framework with the children and young people's framework being less widely considered than the adult's framework. Across systems, equity-focused tools were widely used, and numerous systems had developed outcome frameworks to monitor progress. Leadership for health inequalities was strengthened with senior leadership roles being established to hold integrated care boards accountable for improving access, experiences and outcomes. However, competing priorities, particularly concerning implementations of new organisational models and multiple national priorities, were evident within the plans which may challenge progress on reducing health and healthcare inequalities.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The review concluded that while progress has been made in adopting national healthcare inequalities policies and steers, significant variation exists between systems, possibly reflecting local population needs and varying levels of maturity of the systems across England. The review highlights the need for further evaluations at both national and local levels, allowing for further development of the systems. Additionally, consistent and sustainable funding and more robust training for health ine","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e102163"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243722","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}
引用次数: 0
Alcohol-hypertension association among Chinese Tibetans and potential mechanism: a cross-sectional analysis.
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-103854
Jieru Peng, Yue Yu, Guoyuan Peng, Luo Yingjuan, Zongji Zhaxi, Haibo Yao, Chun-Xia Yang, Guoxia Bai
{"title":"Alcohol-hypertension association among Chinese Tibetans and potential mechanism: a cross-sectional analysis.","authors":"Jieru Peng, Yue Yu, Guoyuan Peng, Luo Yingjuan, Zongji Zhaxi, Haibo Yao, Chun-Xia Yang, Guoxia Bai","doi":"10.1136/bmjopen-2025-103854","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-103854","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to examine the relationship between alcohol consumption patterns and hypertension in high-altitude populations. Additionally, it seeks to assess the mediating effects of metabolic factors on this association.</p><p><strong>Design: </strong>Cross-sectional study.</p><p><strong>Setting: </strong>A subproject of a national survey conducted in high-altitude regions of Tibet, China.</p><p><strong>Participants: </strong>A total of 53 460 residents aged 35-75 years were selected using multistage cluster sampling.</p><p><strong>Outcome measures: </strong>Hypertension was defined as a systolic blood pressure ≥140 mm Hg and/or a diastolic blood pressure ≥90 mm Hg, self-reported physician-diagnosed hypertension or current use of antihypertensive medications.</p><p><strong>Analysis methods: </strong>Multivariate logistic regression analyses were used to assess the association between different frequencies of alcohol consumption and hypertension. Simple and parallel multiple multicategorical mediation analyses were performed to estimate the individual and combined mediation effects of dyslipidaemia and obesity.</p><p><strong>Results: </strong>Finally, 50 044 participants were included in the analysis, with a hypertension prevalence of 42.97%. Among them, 41.3% were males, and the mean age was 51.12 years. Compared with non-drinkers, occasional alcohol consumption was not significantly associated with hypertension in the overall population. However, in subgroup analysis, it was linked to a 12% increase in odds among males (OR 1.12, 95% CI 1.02 to 1.24) and an 11% decrease among females (OR 0.89, 95% CI 0.81 to 0.97). The odds of hypertension rose significantly by 1.25 (95% CI 1.15 to 1.36), 1.23 (95% CI 1.12 to 1.36) and 1.51 (95% CI 1.37 to 1.65) times in the groups consuming alcohol two to four times a month, two to three times a week and ≥4 times a week, respectively. The indirect effects of these mediators were evident in the light-to-moderate alcohol consumption group but not in the heavy drinking group, a pattern that was also confirmed in sensitivity analyses.</p><p><strong>Conclusions: </strong>This large-scale study underscores that the impact of occasional drinking on hypertension varies by gender, while consistent associations between frequent alcohol consumption and a higher prevalence of hypertension were observed. Given the differing mediating effects of metabolic abnormalities across individuals with varying alcohol consumption patterns, tailored interventions should be implemented. These findings provide valuable evidence to inform public health strategies to prevent hypertension.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e103854"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243456","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}
引用次数: 0
Virtual reality interventions to reduce social isolation in older adults: a protocol for systematic review. 减少老年人社会孤立的虚拟现实干预措施:用于系统审查的方案。
IF 2.3 3区 医学
BMJ Open Pub Date : 2025-10-06 DOI: 10.1136/bmjopen-2025-100830
Ravi Shankar, Fiona Devi, Qian Xu
{"title":"Virtual reality interventions to reduce social isolation in older adults: a protocol for systematic review.","authors":"Ravi Shankar, Fiona Devi, Qian Xu","doi":"10.1136/bmjopen-2025-100830","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-100830","url":null,"abstract":"<p><strong>Introduction: </strong>Social isolation and loneliness are prevalent among older adults and associated with negative health outcomes. Virtual reality (VR) interventions have emerged as a potential approach to address this problem, but their effectiveness remains unclear. This systematic review aims to synthesise evidence on the effects of VR interventions on social isolation and loneliness in adults aged 60 years and older.</p><p><strong>Methods and analysis: </strong>We will search PubMed, Web of Science, Embase, CINAHL, MEDLINE, The Cochrane Library, PsycINFO and Scopus from inception to February 2025 for randomised controlled trials, quasi-experimental studies and before-after studies that evaluate VR interventions compared with usual care, wait-list, no treatment or other active interventions in older adults. The primary outcomes will be measures of social isolation and loneliness assessed with validated scales. Secondary outcomes will include depression, quality of life, cognitive function, physical function and adverse events. Two reviewers will independently screen, select and extract data from studies. Risk of bias will be evaluated using the Cochrane Risk of Bias Tool 2 for randomised trials and ROBINS-I for non-randomised studies. If feasible, meta-analysis will be performed; otherwise, a narrative synthesis will be conducted. The quality of evidence will be assessed using GRADE.</p><p><strong>Ethics and dissemination: </strong>Ethical approval is not required for this systematic review, as it will only include published data. The review findings will be disseminated through a peer-reviewed publication and conference presentations.</p><p><strong>Prospero registration number: </strong>CRD42025637230.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e100830"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243693","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}
引用次数: 0
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