BMJ Open最新文献

{"title":"How are clinical exercise physiology postgraduate courses taught and assessed in the UK? A multimethod qualitative exploration.","authors":"Anthony Crozier, Gemma Miller, Lee Graves, Ellen A Dawson, Connor Osin, Ian Sadler, Louise H Naylor, Daniel J Green, Christopher David Askew, Helen Jones","doi":"10.1136/bmjopen-2025-099240","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-099240","url":null,"abstract":"<p><strong>Introduction: </strong>Development of clinical skills in areas, such as exercise risk stratification, testing, prescription, monitoring and outcome assessment, is vital for patient safety and clinical effectiveness in clinical exercise physiology (CEP). This study explored how current CEP courses are being taught and assessed and to identify potential best practice recommendations from a variety of stakeholders METHODS: Qualitative methods were employed to explore the thoughts of CEPs, academics and current students regarding the teaching and assessment of CEPs in the UK. Research design involved (1) semistructured interviews with students (n=16) and (2) focus groups with academics (n=8) and CEP (n=5) stakeholders. Data obtained were audio recorded using a portable Dictaphone and transcribed verbatim, then thematically analysed manually.</p><p><strong>Results: </strong>Three themes: (1) in situ learning/real-world practice (working with patients and specialist practitioners); (2) programme design (scaffold learning and integrated modules) and (3) teaching approach (simulated learning and research competency) were generated concerning teaching methods and approaches across CEP postgraduate degrees. The current use of simulated tasks for the delivery of taught content was identified as lacking effectiveness, with clinical placements identified as being the most important source of knowledge and skill attainment due to the real-world exposure to patients and practitioners. Clinical placements and simulated learning were recognised as the two main methods of problem-based learning used to develop student knowledge, skills and competency to practice. Two themes (placement tariffs/assessors in situ and role play/simulation) were identified for the assessment of students.</p><p><strong>Conclusion: </strong>Clinical placements remain the optimal method for developing the knowledge, skills and competency to practice for student CEPs. However, suitable placements remain limited, and novel approaches such as university-led exercise services require consideration for student competency development. A standardised and accredited training pathway from undergraduate through to postgraduate level should be explored to allow student competency to be developed over a longer period, to enhance knowledge, skills and competency on graduation and registration.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e099240"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172261","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":"Effect of low-molecular-weight heparin on pregnancy outcomes in Chinese women with recurrent implantation failure undergoing frozen embryo transfer: a double-blind, randomised, placebo-controlled trial.","authors":"Minmin Cao, Wenjing Wan, Yaxuan Zhang, Yan Zhao, Anmiao Sun, Shanshan Gao, Linlin Cui, Wenting Wang","doi":"10.1136/bmjopen-2024-094528","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-094528","url":null,"abstract":"<p><strong>Introduction: </strong>The incidence of recurrent implantation failure (RIF) can reach up to 10% among patients undergoing in vitro fertilisation and embryo transfer worldwide. However, the clinical efficacy of low-molecular-weight heparin (LMWH) in RIF remains a subject of controversy. Currently, there is a lack of high-quality clinical research validating the effectiveness of LMWH in treating patients with RIF, particularly during frozen embryo transfer (FET) cycles. Therefore, this randomised controlled trial aimed to investigate the impact of LMWH on pregnancy outcomes in women with RIF undergoing FET.</p><p><strong>Methods and analysis: </strong>This prospective, single-centre, double-blind randomised, placebo-controlled clinical trial will be conducted in the Second Hospital of Shandong University, China. A total of 414 women with RIF, aged ≤40 years, who are undergoing FET cycles will be recruited and randomly assigned to the study group (LMWH) or the control group (placebo). Only one blastocyst which is from day 5 or day 6 and has a Gardner morphology score ≥4 BC will be transferred. LMWH 4000-6000 IU per day or placebo will be administered by subcutaneous injection from the day of transplantation. The primary outcome is the live birth rate. The secondary outcomes include the clinical pregnancy rate, biochemical pregnancy rate, embryo implantation rate, early miscarriage rate, ongoing pregnancy rate, ectopic pregnancy rate, pregnancy-related complications, perinatal complications, fetal birth weight, congenital malformations and other adverse reactions.</p><p><strong>Ethics and dissemination: </strong>The protocol received approval from the Ethics Committee of the Second Hospital, Cheeloo College of Medicine, Shandong University (KYLL-2023-442). The findings will be disseminated in peer-reviewed publications.</p><p><strong>Trial registration number: </strong>Chinese Clinical Trial Registry, ChiCTR2400083577.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e094528"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172152","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":"Point-of-caRE DiagnostICs for respiraTOry tRact infectionS (PREDICTORS) study: developing guidance for using C-reactive protein point-of-care tests in the management of lower respiratory tract infections in primary care using a Delphi consensus technique.","authors":"Joseph O'Shea, Carmel Hughes, Gerard J Molloy, Cathal Cadogan, Akke Vellinga, Tom Fahey, Cristín Ryan","doi":"10.1136/bmjopen-2025-101438","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-101438","url":null,"abstract":"<p><strong>Objective: </strong>Antimicrobial resistance is a significant global health challenge, exacerbated by unnecessary antibiotic prescribing. Respiratory tract infections (RTIs) are common reasons for antibiotic prescribing in primary care, despite most being viral or bacterial infections that are self-limiting. C-reactive protein (CRP) point-of-care tests (POCTs) are promising tools to support antibiotic stewardship by guiding the management of lower RTIs (LRTIs). The aim of this study was to develop best practice guidance for using CRP POCT in the management of LRTIs in primary care.</p><p><strong>Design: </strong>Scoping review findings informed guidance statements, which were then evaluated through a three-round Delphi process with an expert panel via web-based questionnaires. Statements focused on intended use, detection of bacterial LRTIs, communication strategies, device features, performance and ease of use of CRP POCT.</p><p><strong>Setting and participants: </strong>The panel of experts included 19 healthcare professionals across several specialties, including general practitioners, community pharmacists, hospital pharmacists and respiratory physicians.</p><p><strong>Main outcome measures: </strong>Panellists rated each guidance statement using a 5-point Likert scale, with acceptance, revision or rejection determined using predefined cut-off scores for medians and interquartile ranges. Statements were revised between rounds using the feedback provided by panellists.</p><p><strong>Results: </strong>In the first round, 49 statements were evaluated; 16 were accepted, nine removed and 24 revised for the second round. Of the 24 statements evaluated in the second round, 17 were accepted and seven were revised. In the third round, consensus was reached on four of the seven statements presented, resulting in 37 final guidance statements. These statements covered key areas, including the appropriate use of CRP POCTs to guide antibiotic prescribing, CRP cut-off values, integration with clinical decision rules, device performance and operational considerations, training requirements and financial reimbursement. The panel emphasised the need for structured guidelines to align CRP POCT use with clinical context and highlighted its role in improving diagnostic confidence while supporting antibiotic stewardship.</p><p><strong>Conclusions: </strong>This study provides a set of best practice guidance statements to support the use of CRP POCT in the management of LRTIs in primary care. Dissemination and further research are required to assess their impact.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e101438"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172300","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":"Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial - REACH-HFpEF trial.","authors":"Rod S Taylor, Emma Burrell, Claire O'Hare, Elizabeth A Thomson, Anna Placzek, Jessica C Bollen, John G F Cleland, Aynsley Cowie, Hasnain M Dalal, Christi Deaton, Patrick J Doherty, Katie Dudman, Heather Fraser, Julia Frost, Colin Greaves, Nick Hartshorne-Evans, Melvyn Hillsdon, Tracy Ibbotson, Mohammad Jarallah, Kate Jolly, Alex McConnachie, Emma McIntosh, Valerie Smith, Iain Squire, Louise Taylor, Samantha van Beurden, Chim C Lang","doi":"10.1136/bmjopen-2024-094254","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-094254","url":null,"abstract":"<p><strong>Introduction: </strong>Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.</p><p><strong>Methods and analysis: </strong>REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients' disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators' experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.</p><p><strong>Ethics and dissemination: </strong>The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.</p><p><strong>Trial registration number: </strong>ISRCTN47894539.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e094254"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172850","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":"Functional vision tests as clinical trial outcome measures in ophthalmology: a scoping review.","authors":"Shabnam Raji, Arun James Thirunavukarasu, Laura Jayne Taylor, Robert Edward MacLaren","doi":"10.1136/bmjopen-2024-097970","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-097970","url":null,"abstract":"<p><strong>Objectives: </strong>To identify currently available functional vision tests and evaluate their use as clinical trial outcome measures in ophthalmology.</p><p><strong>Design: </strong>Scoping review using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-analysis Extension for Scoping Reviews) guidelines.</p><p><strong>Methods: </strong>A literature search was conducted in MEDLINE and Embase (via Ovid) for articles published between 1 January 2003 and 1 August 2024. Additional grey literature was sourced from institutional repositories, conference proceedings and a manual citation search. Article screening was conducted against a predefined inclusion criteria by two independent, masked reviewers, with a third reviewer acting as arbiter. The inclusion criteria were English language articles which feature a test assessing functional vision in patients with an ophthalmological disease. Details of source characteristics, test methodology and accessibility and evidence of test validation were collected.</p><p><strong>Results: </strong>Of 2665 articles returned by the search, 73 were included and 45 unique tests of functional vision were identified. Diseases affecting the peripheral retina were mainly affected, accounting for 77% (56 out of 73) of the diseases featured in all included studies. Overall, 82% (37 out of 45) functional vision tests reported evidence of statistical validation with varying robustness. Functional vision tests were mapped to domains of orientation and mobility, facial recognition, observer-rated task performance, visual search and driving. Obstacle courses assess vision-guided orientation and mobility, correlate highly with clinical measures of visual function in severe peripheral retinal disease and have been validated for use in clinical trials. Their requirement of physical space and time limits utility in multicentre trials; equivalent tests leveraging virtual reality and eye tracking technologies are in development. Early iterations of visual search tests to simulated realistic scenes have demonstrated discriminative ability, even in paediatric patients.</p><p><strong>Conclusions: </strong>Functional vision tests can facilitate research into future novel ophthalmological treatments that prioritise patients in terms of how clinical benefit is defined. The principal barriers to the uptake of these tests are lack of accessibility, low quality validation and that many tests remain early in their development stage. This review captures the current landscape of functional vision tests and serves as a reference for investigators and regulatory bodies to evaluate the suitability of these tests for ophthalmic clinical trials.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e097970"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172158","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":"Maternal periconception serum vitamin B12 concentration and risk of preterm birth: a prospective cohort study.","authors":"Yuanzhou Peng, Yi Zhang, Xiaotian Chen, Yalan Dou, Jun Huang, Xiaohua Zhang, Guoying Huang, Xiangfeng Lu, Weili Yan","doi":"10.1136/bmjopen-2025-100064","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-100064","url":null,"abstract":"<p><strong>Background: </strong>Maternal vitamin B12 levels during pregnancy have been implicated in the risk of preterm birth, but current evidence remains controversial and just focuses on measurements during pregnancy.</p><p><strong>Objective: </strong>To assess the association of maternal periconception serum vitamin B12 concentration, including levels before conception and at early gestation, with the risk of preterm birth and its subtypes in a large Chinese population.</p><p><strong>Design: </strong>Prospective cohort study.</p><p><strong>Participants: </strong>A total of 26 977 women from Shanghai, China, with serum vitamin B12 concentration measured either before conception or at early gestation.</p><p><strong>Outcome measures: </strong>Preterm birth was defined as delivery before 37 weeks of gestation and was stratified as preterm birth <32 and <34 weeks. Cox regression was used to estimate the association between maternal vitamin B12 and preterm birth.</p><p><strong>Results: </strong>Overall, 1599 (5.9%) of participants delivered preterm. The median periconception vitamin B12 concentration was 483.0 (IQR, 368.0-622.0) pg/mL. No evidence was observed of an association between maternal vitamin B12 concentration and risk of preterm birth (per 100 pg/mL increment: adjusted hazard ratio (aHR), 0.99; 95% CI, 0.96 to 1.02, <i>P</i>=0.572). Similarly, null associations were observed for preterm birth subtypes (aHR, 0.98 [0.89 to 1.09] and 0.97 [0.90 to 1.05] for preterm birth <32 and <34 weeks, respectively).</p><p><strong>Conclusions: </strong>No evidence of associations was found between maternal vitamin B12 concentration and risk of preterm birth in a population with relatively sufficient vitamin B12 levels. Future studies in populations with varied baseline levels of vitamin B12 are needed to validate these findings across different populations and regions.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e100064"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172299","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":"Community burden of acute respiratory infections in Shanghai, a longitudinal cohort study in respiratory pathogens, China, 2024-2027.","authors":"Chuchu Ye, Jianxing Yu, Bing Zhao, Yifeng Shen, Xiao Wang, Li Zhang, Xuya Yu, Yan Luo, Ling Xin, Yanxin Xie, Yilin Jia, Xinmei Zhou, Linghui Zhao, Yaoyao Wang, Yu Li, Hualei Xin, Ting Zhang, Lance Rodewald, Benjamin J Cowling, Weizhong Yang, Lipeng Hao, Lili Ren, Zhongjie Li","doi":"10.1136/bmjopen-2024-097732","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-097732","url":null,"abstract":"<p><strong>Purpose: </strong>We are conducting a longitudinal cohort study-the Community Burden of Acute Respiratory Infections in Shanghai-to assess age-stratified incidence, healthcare utilisation and risk factors of influenza virus, respiratory syncytial virus (RSV) and SARS-CoV-2 associated acute respiratory infections (ARIs) in Shanghai, China.</p><p><strong>Participants: </strong>Study participants were enrolled by family doctors in all 47 community health services centres in Pudong New Area District, Shanghai, China. All permanent residents 6 months and older living in Pudong for at least 6 months were eligible for enrolment; residents who planned to leave Pudong for more than 1 month in the first study year were excluded. During enrolment, study staff conducted baseline assessments of sociodemographics, underlying medical conditions, vaccination history and household and self-rated health status. Study participants are being followed for ARIs for 3 years. Nasopharyngeal and oropharyngeal swab specimens are being obtained from suspected ARI cases. Influenza virus, RSV, SARS-CoV-2 and other respiratory pathogens are tested for by multiplex respiratory pathogen real-time quantitative PCR assays. Illness courses and clinical recoveries of ARI cases are assessed through weekly contact with ARI cases for 28 days post ascertainment.</p><p><strong>Findings to date: </strong>Between 14 October 2024 and 22 November 2024, we enrolled 5387 community residents into the cohort, including 233 children aged from 6 months to 2 years, 278 preschool children aged 3-6 years, 575 school-age children aged 7-18 years, 2150 adults aged 19-64 years and 2151 older adults aged 65+years. All finished baseline assessment and started follow-up. Surveillance of ARI symptoms, collection of specimens and laboratory testing are ongoing.</p><p><strong>Future plans: </strong>Findings from this study will be used to provide valuable scientific data to inform ongoing control efforts and future pandemic preparedness for respiratory diseases in China. Planned analyses include analysis of annual pathogen-specific incidence by age group and exploration of healthcare seeking behaviour and factors associated with ARIs and severe ARIs. We will also assess transmission dynamics of common respiratory pathogens in a household transmission subcohort.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e097732"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172128","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":"Knowledge, attitude and practice of Chinese medical staff in early pulmonary rehabilitation during acute exacerbation of chronic obstructive pulmonary disease: a cross-sectional study.","authors":"Tingrui Wang, Zhangyi Wang, Li Yao, Fangrong Jia, Yaling Li, Pe Cai, Qinqin Li, Yan Liu, Tingshu Wang, Yuhan Chen","doi":"10.1136/bmjopen-2024-087610","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-087610","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the knowledge, attitude and practice (KAP) of early pulmonary rehabilitation (PR) of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) among Chinese medical staff and the relationship between them.</p><p><strong>Design: </strong>A multicentre cross-sectional survey was used in this study.</p><p><strong>Setting: </strong>The study was conducted at multiple hospitals in Guizhou Province, China.</p><p><strong>Participants: </strong>A total of 745 medical staff were recruited from several hospitals in Guizhou Province by convenient sampling method.</p><p><strong>Primary and secondary outcome measures: </strong>A 41-item questionnaire was used to collect the demographic characteristics of the respondents and the KAP of the medical staff on the early PR of AECOPD.</p><p><strong>Results: </strong>The average KAP scores were 64.49±17.24, 42.81±5.95 and 41.39±8.97. There were significant positive correlations between knowledge and attitude (r=0.491, p<0.001), knowledge and practice (r=0.129, p<0.001), and attitude and practice (r=0.246, p<0.001). Medical staff with prior PR training and AECOPD early PR experience had higher knowledge and practice scores. Attitudes were significantly influenced by gender, hospital level, professional title and respiratory staff status, while practice scores were significantly affected by prior experience, knowledge and patient contact frequency.</p><p><strong>Conclusions: </strong>The study found that medical staff's knowledge and attitudes affect their practices, and experience and education influence their knowledge. It suggests that organisations should enhance education and training to improve medical staff's knowledge and attitudes, thus enhancing clinical practice. However, the study's focus on Guizhou Province and the high number of nurses in the sample may limit the generalisability of the results.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e087610"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172294","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":"Prehospital antibiotics and intravenous fluids for patients with sepsis: protocol for a 2×2 factorial randomised controlled trial.","authors":"Damon C Scales, Anna Rogowsky, Lisa Burry, Jim Christenson, Nick Daneman, Ian R Drennan, Morgan Hillier, Sandra Jenneson, Gail Klein, Tony Mazzulli, Philip Moran, Andrew M Morris, Laurie J Morrison, Ruxandra Pinto, Gordon D Rubenfeld, Christopher W Seymour, Rob Stenstrom, P Richard Verbeek, Sheldon Cheskes","doi":"10.1136/bmjopen-2025-104257","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-104257","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Prompt recognition and treatment of patients with sepsis improve survival. Patients transported to hospital with sepsis often do not receive treatment until they are assessed in emergency departments. Initiation of treatments by paramedics at the point of first contact may improve outcomes for these patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and analysis: &lt;/strong&gt;The study design involves two randomised controlled trials (RCTs) conducted using a 2×2 factorial design comparing use of (1) early intramuscular ceftriaxone versus placebo and (2) an early liberal intravenous fluid strategy (up to 2 L normal saline) versus usual care resuscitation guided by paramedic medical directives. Patients who are ≥18 years of age will be eligible for inclusion if they have sepsis, defined as (1) paramedic suspicion of infection, (2) fever (temperature ≥38.0°C measured by paramedic or history of fever during the previous 24 hours), and (3) hypotension: SBP &lt;100 mm Hg. The primary outcome is mortality prior to hospital discharge or within 90 days of admission. Secondary outcomes are all-cause mortality at 90 days after enrolment; organ dysfunction during first 24 hours (mechanical ventilation, vasopressor therapy, dialysis) and hospitalisation (mechanical ventilation; dialysis); rates and duration of hospital admission; rates of ICU admission during index hospitalisation; discharge destination; proportion of patients with positive blood cultures obtained in hospital (first 24 hours); microbiological profile including distribution of microorganism species and resistant organisms; proportion of patients receiving additional antibiotics within 6 hours and within 24 hours of hospital admission; frequency distribution of first antibiotics (if any) delivered within 24 hours of hospital arrival; mean time to antibiotics delivered within 24 hours of hospital arrival (if any); proportion of patients receiving fluid bolus (&gt;250 mL) within 24 hours of hospital arrival; total amount of crystalloid infused during transport and first 24 hours of hospitalisation; and proportion of enrolled patients not suspected to have sepsis or infection by emergency department physicians. Safety outcomes include the proportion of patients with pulmonary oedema during transport to hospital and on initial chest X-ray and the proportion of patients with anaphylaxis or suspected allergic reactions to study medication.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;This study has been approved through Clinical Trials Ontario's streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre). It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. The final results will be disseminated to participating paramedic services through educational materials, presentations and interactive training. We anticipate our trial will achieve wide dissemination through publication in a peer-re","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e104257"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172303","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":"Interventional arterial chemotherapy versus sorafenib for advanced hepatocellular carcinoma in China: a health economic evaluation of open-label, randomised, phase 3 study.","authors":"Qi-Feng Chen, Xiongying Jiang, Yue Hu, Song Chen, Ning Lyu, Ming Zhao","doi":"10.1136/bmjopen-2024-095508","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-095508","url":null,"abstract":"<p><strong>Objectives: </strong>This post hoc study aimed to evaluate the cost-effectiveness of hepatic artery infusion chemotherapy (HAIC) with fluorouracil, leucovorin and oxaliplatin (HAIC-FO) compared with sorafenib in patients with advanced hepatocellular carcinoma (HCC). The analysis was conducted from the perspective of Chinese payers.</p><p><strong>Design: </strong>A cost-effectiveness analysis was performed using a Markov model derived from data obtained in the FOHAIC-1 trial (phase 3 randomised controlled trial; conducted 2017-2020).</p><p><strong>Setting: </strong>The study was conducted in tertiary care centres in China.</p><p><strong>Participants: </strong>The study included advanced HCC patients enrolled in the FOHAIC-1 trial. Inclusion criteria followed the trial protocols, with patients stratified by disease severity (including the presence of Vp4 portal vein tumour thrombus (PVTT) and high tumour burden).</p><p><strong>Interventions: </strong>HAIC-FO (fluorouracil, leucovorin and oxaliplatin) was compared with sorafenib for cost and health outcomes.</p><p><strong>Primary outcome measure: </strong>The primary outcome was the incremental cost-effectiveness ratio (ICER), calculated as the additional cost per quality-adjusted life year (QALY) gained.</p><p><strong>Results: </strong>Sorafenib yielded 0.66 QALYs at a cost of $15 011.73, whereas HAIC-FO yielded 1.00 QALY at a cost of $18 470.98. The ICER of HAIC-FO compared with sorafenib was $10 235.56 per QALY, which was below the willingness-to-pay (WTP) threshold of $30 492.00 per QALY. Sensitivity analyses confirmed that HAIC-FO remained cost-effective across variable assumptions, with probabilistic sensitivity analysis showing a 99.9% probability of cost-effectiveness at the WTP threshold. Subgroup analyses demonstrated more favourable ICERs for patients with Vp4 PVTT ($7003.33 per QALY) and those with high tumour burden ($7382.86 per QALY).</p><p><strong>Conclusions: </strong>HAIC-FO is a more cost-effective treatment for advanced HCC than sorafenib from the Chinese payer's perspective, particularly in patients with Vp4 PVTT and/or high tumour burden. Further research is needed to explore long-term economic implications and real-world effectiveness data.</p><p><strong>Trial registration number: </strong>NCT03164382.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 5","pages":"e095508"},"PeriodicalIF":2.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172289","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}