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Domestic violence perpetration, victimisation and self-poisoning in Sri Lanka: a protocol for a hospital-based case-control study.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-089913
Dilini Vidusha Hewa Kankanamge, Bruna Rubbo, Karen Morgan, Helen Cramer, Sharon Collard, Ramya Ekanayaka, Afra Latheef, Anushika Athapaththu, Mushfira Siddeek, Imalsha Wickramasuriya, Duleeka W Knipe, Thilini Rajapakse
{"title":"Domestic violence perpetration, victimisation and self-poisoning in Sri Lanka: a protocol for a hospital-based case-control study.","authors":"Dilini Vidusha Hewa Kankanamge, Bruna Rubbo, Karen Morgan, Helen Cramer, Sharon Collard, Ramya Ekanayaka, Afra Latheef, Anushika Athapaththu, Mushfira Siddeek, Imalsha Wickramasuriya, Duleeka W Knipe, Thilini Rajapakse","doi":"10.1136/bmjopen-2024-089913","DOIUrl":"10.1136/bmjopen-2024-089913","url":null,"abstract":"<p><strong>Introduction: </strong>Domestic violence is a key risk factor for suicidal behaviour. While there is some evidence on the association between suicide and victimisation, there is a notable paucity of evidence pertaining to the perpetration of domestic violence and its association with suicidal behaviour. The aim of this study is to investigate the association between domestic violence (victimisation and perpetration) and self-poisoning in Sri Lanka.</p><p><strong>Methods and analysis: </strong>This is a hospital-based case-control study. Cases (n=260) will be individuals admitted to the toxicology ward of the Teaching Hospital Peradeniya, Sri Lanka, for medical management of self-poisoning. We will recruit controls (n=520) from other patients with unrelated conditions or accompanying visitors presenting to the outpatient department of Teaching Hospital Peradeniya. We will use unconditional logistic regression models to investigate the association between domestic violence and self-poisoning.</p><p><strong>Ethics and dissemination: </strong>We obtained ethics approval from the Ethical Review Committee of the Faculty of Medicine, University of Peradeniya, Sri Lanka. The research assistants will be trained in administering the questionnaire and ensuring participant safety. Results will be disseminated in peer-reviewed articles, local media and at national and international conferences.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e089913"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Combining functional electrical stimulation with visual feedback balance training: a qualitative study of end-user perspectives on designing a clinically feasible intervention.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-090791
Elina Nezon, Tanha Patel, Kayla Benson, Katherine Chan, Jae W Lee, Elizabeth L Inness, Dalton L Wolfe, Natasha L Benn, Kei Masani, Kristin E Musselman
{"title":"Combining functional electrical stimulation with visual feedback balance training: a qualitative study of end-user perspectives on designing a clinically feasible intervention.","authors":"Elina Nezon, Tanha Patel, Kayla Benson, Katherine Chan, Jae W Lee, Elizabeth L Inness, Dalton L Wolfe, Natasha L Benn, Kei Masani, Kristin E Musselman","doi":"10.1136/bmjopen-2024-090791","DOIUrl":"10.1136/bmjopen-2024-090791","url":null,"abstract":"<p><strong>Background: </strong>Individuals with stroke or spinal cord injury (SCI) often have poor balance control, leading to falls and activity limitations. One intervention that targets balance control-functional electrical stimulation with visual feedback balance training (FES+VFBT)-may improve balance control but needs modifications for clinical use.</p><p><strong>Objective: </strong>To use a participatory design approach to identify potential challenges and solutions for the clinical implementation of FES+VFBT as a balance intervention.</p><p><strong>Design/methods: </strong>A descriptive qualitative study involving four semi-structured focus group meetings was conducted to explore the perspectives of individuals with stroke and SCI, physical therapists and a hospital administrator on the feasibility and challenges of implementing FES+VFBT into clinical settings. The interviews were transcribed and analysed using deductive and inductive content analyses. The deductive analysis was based on the social ecological model (SEM) levels, while the inductive approach was used to identify categories and codes.</p><p><strong>Setting: </strong>Virtual.</p><p><strong>Participants: </strong>Two individuals with chronic SCI and one individual with chronic stroke who were able to stand but reported deficits in their balance control. Two physical therapists who had experience with FES and the rehabilitation of individuals with SCI or stroke. One hospital administrator who worked within a neurological rehabilitation setting.</p><p><strong>Results: </strong>Themes were organised according to the SEM's four levels: intrapersonal, interpersonal, organisational/training environment and society/policy. Identified categories included potential challenges at the intrapersonal level (ie, lack of knowledge, safety and tolerance of user) and organisational/training environment level (ie, technical challenges, cost, physical space and time). The categories also included possible solutions at all SEM levels, such as intrapersonal (ie, reading and education), interpersonal (ie, practising together), organisational/training environment (ie, technology characteristics and creating resources) and society/policy (ie, purchasing options, guidelines and foundation grants).</p><p><strong>Conclusions: </strong>End-users identified anticipated challenges and solutions to using the FES+VFBT system clinically. The results will inform the design and clinical implementation of a revised version of the system and other FES devices.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e090791"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969585/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Predictive value of novel inflammatory markers combined with GRACE score for in-hospital outcome in patients with ST-segment elevation myocardial infarction: a retrospective observational study.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-096621
Jiayan Xin, Yingwu Liu, Chong Zhang, Qi Wang
{"title":"Predictive value of novel inflammatory markers combined with GRACE score for in-hospital outcome in patients with ST-segment elevation myocardial infarction: a retrospective observational study.","authors":"Jiayan Xin, Yingwu Liu, Chong Zhang, Qi Wang","doi":"10.1136/bmjopen-2024-096621","DOIUrl":"10.1136/bmjopen-2024-096621","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the prognostic efficacy of innovative inflammatory indicators, specifically the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR), in conjunction with the Global Registry of Acute Coronary Events (GRACE) score, for predicting adverse in-hospital outcomes among patients diagnosed with ST-segment elevation myocardial infarction (STEMI).</p><p><strong>Design and setting: </strong>This study is a single-centre retrospective analysis of patients with STEMI treated at the Cardiology Department of Tianjin Third Central Hospital between 1 January 2018 and 31 December 2023. All data were sourced from the hospital's medical record system.</p><p><strong>Outcome measures: </strong>The integration of the GRACE score with NLR and PLR facilitated the creation of an innovative predictive model. The model's predictive efficacy for in-hospital major adverse cardiovascular event (MACE) occurrence was assessed through receiver operating characteristic (ROC) curve analysis and multivariate logistic regression. Additionally, the Net Reclassification Improvement and Integrated Discrimination Improvement were computed to quantify enhancements in predictive value.</p><p><strong>Results: </strong>Patients were stratified into the MACE (N=167) and the non-MACE group (N=1011) based on the incidence of MACE. A comparison of baseline characteristics between the two groups revealed 13 potential confounding variables. The NLR and PLR levels were converted into binary variables using ROC curve analysis. Univariate logistic regression indicated that both NLR and PLR were significant risk factors for MACE during hospitalisation. After adjusting for confounders, multivariate logistic regression confirmed NLR as an independent predictor of MACE risk in this cohort. Furthermore, both NLR and PLR augmented the predictive accuracy of the GRACE score, with their combined use offering a significant improvement in its predictive capacity.</p><p><strong>Conclusions: </strong>The NLR possesses the capability to independently forecast the risk of MACE during the hospitalisation period for patients diagnosed with STEMI. The incorporation of the PLR and NLR with the GRACE score serves to augment its predictive precision.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e096621"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of dynamic neuromuscular stabilisation in treating chronic non-specific low back pain: a systematic review and meta-analysis protocol.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-087036
Linlin Zhang, Shifang Cui, Xiaoming Xi, Hongyan Bi, Yu Pu, Bin Huang
{"title":"Efficacy and safety of dynamic neuromuscular stabilisation in treating chronic non-specific low back pain: a systematic review and meta-analysis protocol.","authors":"Linlin Zhang, Shifang Cui, Xiaoming Xi, Hongyan Bi, Yu Pu, Bin Huang","doi":"10.1136/bmjopen-2024-087036","DOIUrl":"10.1136/bmjopen-2024-087036","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic non-specific low back pain (CNLBP) stands as a predominant factor contributing to disability worldwide. In the recent past, the sphere of medical research has witnessed a burgeoning interest in exploring the therapeutic potential of dynamic neuromuscular stabilisation (DNS) techniques for this condition. Despite the growing body of evidence, a comprehensive synthesis evaluating the effectiveness and safety of these interventions remains absent. This study, therefore, seeks to rigorously assess the therapeutic value and safety profile of DNS techniques in the management of CNLBP.</p><p><strong>Methods and analysis: </strong>We will explicitly follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for conducting the systematic review. Our search strategy will encompass both English and Chinese databases, extending from their inception through March 2024. Specifically, we will explore the Web of Science, PubMed, Embase and the Cochrane Library for English literature, while for Chinese studies, we will delve into the Chinese National Knowledge Infrastructure, the Chinese Science and Technology Periodical Database (VIP), the Wan Fang Database and the China Biology Medicine disc. The outcome metrics we will assess include clinical efficacy, pain (assessed using the Visual Analogue Scale (VAS) and Numerical Pain Rating Scale (NPRS)) and functional disability (evaluated using the Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaire (RMDQ)) and the incidence of adverse reactions. Our focus will be on identifying randomised controlled trials that assess the efficacy of DNS training in the treatment of CNLBP. The data extracted from these trials will be synthesised through a comprehensive meta-analysis to elucidate the effectiveness of this intervention. When applying the Grading of Recommendations Assessment, Development and Evaluation framework to assess the included studies, we may encounter several challenges, for example, the variability in outcome measurements, the sample sizes of the included studies and the heterogeneity of the study populations. We will pay particular attention to these potential limitations to ensure the accuracy and reliability of the evaluation.</p><p><strong>Ethical considerations and dissemination: </strong>Given that our research does not engage human or animal subjects nor does it handle any personal patient data, the requirement for ethical approval is bypassed. We aim to share the insights gleaned from this study through publication in reputable peer-reviewed journals and presentation at professional conferences, ensuring broad and impactful dissemination of our findings.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e087036"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ageism directed at older nurses in the workplace: a scoping review protocol.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-092876
Luana Cardoso Pestana, Aline Coutinho Sento Sé, Elaine Cristine da Conceição Vianna Gonçalves da Costa, Cintia Silva Fassarella, Magda Guimarães de Araújo Faria, Renata Eloah de Lucena Ferretti-Rebustini, Cristiane Helena Gallasch
{"title":"Ageism directed at older nurses in the workplace: a scoping review protocol.","authors":"Luana Cardoso Pestana, Aline Coutinho Sento Sé, Elaine Cristine da Conceição Vianna Gonçalves da Costa, Cintia Silva Fassarella, Magda Guimarães de Araújo Faria, Renata Eloah de Lucena Ferretti-Rebustini, Cristiane Helena Gallasch","doi":"10.1136/bmjopen-2024-092876","DOIUrl":"10.1136/bmjopen-2024-092876","url":null,"abstract":"<p><strong>Introduction: </strong>In the context of global population ageing, there is a continuous and significant increase in the average age of nursing professionals. However, evidence indicates that age bias may hinder older workers' access to the necessary support to remain active in the workforce.</p><p><strong>Method and analysis: </strong>This scoping review aims to map and characterise the scientific literature on age bias directed at older nursing professionals in the workplace, conducted using the Joanna Briggs Institute methodology for scoping reviews and aligned with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Databases include MEDLINE (PubMed), CINAHL (EBSCOhost), LILACS, Scopus, APA PsycInfo and grey literature in Google Scholar. Two independent reviewers will screen titles and abstracts, followed by a full-text review of potentially relevant articles. Another reviewer will reconcile discrepancies. Two independent reviewers will extract data from the included articles using a data extraction tool developed for this review. The results will be tabulated and presented in a diagram and/or tables and summarised to explicitly address the review's objective.</p><p><strong>Ethics and dissemination: </strong>Findings will be disseminated through professional networks, conference presentations and publication in a scientific journal.</p><p><strong>Registration details: </strong>https://doi.org/10.17605/OSF.IO/TR5ZK.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e092876"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969587/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient-reported factors associated with emergency department referrals from a co-located out-of-hours walk-in clinic in Germany: a cross-sectional observational study.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-094312
Johanna Sophie Bobardt-Hartshorn, Penelope-Sophie Peters, Katharina Schmalstieg-Bahr, Bastian Bessert, Ingmar Schäfer, Martin Scherer, Jan Hendrik Oltrogge-Abiry
{"title":"Patient-reported factors associated with emergency department referrals from a co-located out-of-hours walk-in clinic in Germany: a cross-sectional observational study.","authors":"Johanna Sophie Bobardt-Hartshorn, Penelope-Sophie Peters, Katharina Schmalstieg-Bahr, Bastian Bessert, Ingmar Schäfer, Martin Scherer, Jan Hendrik Oltrogge-Abiry","doi":"10.1136/bmjopen-2024-094312","DOIUrl":"10.1136/bmjopen-2024-094312","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to identify patient-reported factors associated with the likelihood of emergency department (ED) referral following treatment at a co-located out-of-hours (OOH) walk-in clinic.</p><p><strong>Design: </strong>Monocentric cross-sectional observational study.</p><p><strong>Setting: </strong>An OOH walk-in clinic co-located with the ED of the University Medical Center Hamburg-Eppendorf, Germany. The study period was from November 2019 to February 2020.</p><p><strong>Participants: </strong>A total of 3708 patients attended the walk-in clinic during the study period, with 2574 patients (69.4%) participating in the study.</p><p><strong>Main outcome measures: </strong>We used logistic regression analysis to calculate adjusted OR (aORs) for patient-reported factors influencing ED referral. The factors examined included reasons for encounter (RFEs), medical history and treatment urgency, categorised according to the International Classification of Primary Care, second edition. Secondary outcomes include descriptive measures of RFE distribution within the study cohort.</p><p><strong>Results: </strong>The mean age of participants was 40 years (±15.8), and 54.5% were women. The ED referral rate was 15.2% (n=392). Patient-reported factors that increased the likelihood of ED referral included trauma (aOR 2.61; 95% CI: 1.24 to 5.50), eye symptoms (aOR 2.67; 95% CI: 1.48 to 4.83), abdominal pain (aOR 2.51; 95% CI: 1.74 to 3.64), history of type 2 diabetes (aOR 2.24; 95% CI: 1.18 to 4.25), neurological symptoms (aOR 2.18; 95% CI: 1.24 to 3.84) and higher self-perceived urgency (aOR 1.46; 95% CI: 1.12 to 1.89). Factors that decreased the likelihood of ED referral included respiratory symptoms (aOR 0.58; 95% CI: 0.36 to 0.93), neck/back symptoms (aOR 0.52; 95% CI: 0.31 to 0.88), urinary tract symptoms (aOR 0.18; 95% CI: 0.06 to 0.57) and a duration of the health problem >4 days (aOR 0.72; 95% CI: 0.55 to 0.95).</p><p><strong>Conclusions: </strong>10 patient-reported factors of ED referrals were identified. Collecting this information during patient registration may enhance resource utilisation and streamline patient flow between walk-in clinic and adjacent ED. These findings could support the development of triage tools for patients in OOH care.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e094312"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969580/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with premature ovarian insufficiency: protocol for a single-centre randomised controlled trial.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-093804
Yaodong Zhang, Hui Liu, Yanru Lou, Jialin Li, Chenhong Liu, Hongxia Zhang, Chen Zhang, Qing Guo, Xiaojuan Liu, Wan Yang, Jia Li, Tian Tian, Lin Zeng, Huiyu Xu, Shuo Yang, Xiumei Zhen, Hongsen Bi, Rui Yang, Yang Yu, Caihong Ma, Rong Li, Ping Liu, Jie Qiao
{"title":"Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with premature ovarian insufficiency: protocol for a single-centre randomised controlled trial.","authors":"Yaodong Zhang, Hui Liu, Yanru Lou, Jialin Li, Chenhong Liu, Hongxia Zhang, Chen Zhang, Qing Guo, Xiaojuan Liu, Wan Yang, Jia Li, Tian Tian, Lin Zeng, Huiyu Xu, Shuo Yang, Xiumei Zhen, Hongsen Bi, Rui Yang, Yang Yu, Caihong Ma, Rong Li, Ping Liu, Jie Qiao","doi":"10.1136/bmjopen-2024-093804","DOIUrl":"10.1136/bmjopen-2024-093804","url":null,"abstract":"<p><strong>Introduction: </strong>Premature ovarian insufficiency (POI) is a complicated reproductive endocrine disease seriously affecting physiological function and fertility in women. Its clinical features include amenorrhoea or infrequent menstruation, oestrogen deficiency and elevated levels of gonadotropins. At present, conventional treatments for POI in clinical practice are unable to fundamentally improve ovarian function or solve fertility problems, and often have certain side effects. Adipose tissue-derived stromal vascular fraction (SVF) contains various cell types, including adipose-derived stem/stromal cells, stromal cells, endothelial cells, fibroblasts and macrophages. Recently, SVF has shown tremendous potential in treating many refractory diseases, offering a promising therapeutic option for improving ovarian function. Although SVF has shown therapeutic effects in animal models of POI, there is insufficient evidence demonstrating the efficacy and safety of autologous SVF in women with POI.</p><p><strong>Methods and analysis: </strong>This study is a single-centre randomised controlled trial designed to explore the efficacy and safety of using autologous SVF in improving pregnancy outcomes in patients with infertility diagnosed with POI. A total of 308 women meeting the eligibility criteria will be randomly assigned in a 1:1 ratio to either the SVF group or the control group. The control group will receive conventional assisted reproductive technology treatment, including in vitro fertilisation, embryo transfer and intracytoplasmic sperm injection. In the SVF group, patients will undergo bilateral intraovarian injections of the SVF suspension under ultrasound guidance. Their in vitro fertilisation cycles will commence 4-8 weeks after SVF injection. The primary outcome of this trial is the cumulative clinical pregnancy rate within 6 months. Aside from this, secondary outcomes including menstrual volume and duration, ovarian volume, antral follicle count, and serum levels of anti-mullerian hormone and sex hormone (oestrogen and follicle-stimulating hormone) will be measured. All adverse events will be monitored and recorded within a 6-month follow-up period. Additionally, pregnancy outcomes and the health status of the offspring will be tracked through telephone follow-up for 2 years.</p><p><strong>Ethics and dissemination: </strong>This trial has been reviewed and approved by the Ethics Committee of Peking University Third Hospital (approval number: IRB00006761-M2024330). We will ensure that each patient has signed informed consent before participation in the trial. The findings will be published in a peer-reviewed journal.</p><p><strong>Trial registration number: </strong>NCT06481969.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e093804"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
European Registry of Hereditary Pancreatic Diseases (EUROPAC): protocol for primary and secondary screening in individuals with inherited pancreatic disease syndromes for pancreatic ductal adenocarcinoma and complications of other pancreatic diseases.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2025-100027
Annabelle Boughey, Phil Hopley, Ioannis Sarantitis, Paul Thomas, Beata Gubacsi, Kayleigh Jevons, Emma Crowe, Eleri Hughes, Isobel Quinn, Liam Royle, Richard J Jackson, William Greenhalf, Chris Halloran
{"title":"European Registry of Hereditary Pancreatic Diseases (EUROPAC): protocol for primary and secondary screening in individuals with inherited pancreatic disease syndromes for pancreatic ductal adenocarcinoma and complications of other pancreatic diseases.","authors":"Annabelle Boughey, Phil Hopley, Ioannis Sarantitis, Paul Thomas, Beata Gubacsi, Kayleigh Jevons, Emma Crowe, Eleri Hughes, Isobel Quinn, Liam Royle, Richard J Jackson, William Greenhalf, Chris Halloran","doi":"10.1136/bmjopen-2025-100027","DOIUrl":"10.1136/bmjopen-2025-100027","url":null,"abstract":"<p><strong>Introduction: </strong>Pancreatic cancer is a devastating disease and one of the top causes of cancer death worldwide. Over 30% of cases are potentially avoidable, and while screening for this disease should be possible, the current methods, without risk stratification to detect high-risk groups, are unlikely to detect these individuals. A tailored screening pathway could be applied to individuals with a germline genetic cause of pancreatic cancer, which may account for around 10% of cases.</p><p><strong>Methods and analysis: </strong>EUROPAC, although having international reach, is described here in relation to the UK only. This national prospective observational study has run for several decades but was modified into the current trial in 2019, which aims to recruit and screen 10 000 individuals with either familial pancreatic cancer or hereditary pancreatitis (HP). Applicants are assessed for eligibility by generating an individual pedigree and by attributing a family risk score (FR). Individual risk is assessed according to age. Individuals over 40 with an FR >30 are offered baseline imaging and then three yearly triplets of annual endoscopic ultrasound (EUS) and an MRI (in the third year). Those with an FR >60 are offered both EUS and MRI yearly. HP patients are screened by CT and/or MRI dependent on risk stratification using the presence of diabetes, smoking or alcohol consumption. Low-risk (absence of these factors) patients have a CT every 2 years, and high-risk (one or more of the above factors) patients have alternate yearly screening with CT, then MRI. Biospecimens are collected at pragmatic intervals with first sampling at registration to support future biomarker development to detect pancreatic cancer early. Detection of early-stage pancreatic cancer and actionable lesions will be evaluated.</p><p><strong>Ethics and dissemination: </strong>The EUROPAC study has been reviewed and approved by the Yorkshire and Humber Research Ethics Committee (Ref 19/YH/0250). Study results will be disseminated through national and international symposium presentations and published in peer-reviewed, open-access journals. All participants provided informed consent prior to entering the study.</p><p><strong>Trial registration number: </strong>ISRCTN62546421.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e100027"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Qualitative study to inform the design and contents of a patient-reported symptom-based risk stratification system for patients referred from primary care on a suspected head and neck cancer diagnostic pathway.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-094197
Abigail Albutt, Lynn McVey, Rebecca Randell, John C Hardman, Ian Kellar, Chinasa Odo, Jo Patterson, Paula Theresa Bradley, Claire Davies, Theofano Tikka, Vinidh Paleri, Nikki Rousseau
{"title":"Qualitative study to inform the design and contents of a patient-reported symptom-based risk stratification system for patients referred from primary care on a suspected head and neck cancer diagnostic pathway.","authors":"Abigail Albutt, Lynn McVey, Rebecca Randell, John C Hardman, Ian Kellar, Chinasa Odo, Jo Patterson, Paula Theresa Bradley, Claire Davies, Theofano Tikka, Vinidh Paleri, Nikki Rousseau","doi":"10.1136/bmjopen-2024-094197","DOIUrl":"10.1136/bmjopen-2024-094197","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to inform the development of a patient-reported symptom questionnaire for head and neck cancer and outline the requirements for a patient-reported symptom-based risk stratification system. The study objectives are to explore how clinicians ask questions and decide subsequent steps for patients referred with suspected head and neck cancer; the language patients and clinicians use to describe symptoms; how clinicians reassure and discharge low-risk patients; and identify clinician and patient experiences of the head and neck cancer diagnostic pathway and their views on a novel diagnostic pathway using patient-reported symptom-based risk stratification.</p><p><strong>Design: </strong>The study employed qualitative methods including observation and recordings of clinic consultations and semistructured interviews with clinicians and patients. Analysis proceeded concurrently with data collection using a rapid qualitative analysis approach.</p><p><strong>Setting: </strong>Three acute UK National Health Service Trusts with variation in service delivery models. Data collection took place between April and October 2023.</p><p><strong>Participants: </strong>One hundred and fifty-six adults referred for suspected head and neck cancer, and 21 clinicians from different subspecialties were recruited. A subset of recruited patients (n=16) and clinicians (n=13) were interviewed. One observation of a general head and neck clinic was conducted.</p><p><strong>Results: </strong>The findings highlight types of symptoms and the language used by patients and clinicians to describe these symptoms in clinic consultations. During interviews, patients described the need for in-person support and human clinical decision-making, an accessible system for reporting their symptoms and reassurance regarding the security of patient data. Clinicians discussed the need for risk scores to be sufficiently validated to be trusted, the potential clinical usefulness of a risk score-based system, for example, to support triage by discriminating symptoms, and accessibility for patients. The observation highlighted inconsistent and sometimes unclear referral information and the limited time clinicians have to read referral information.</p><p><strong>Conclusion: </strong>The findings have implications for the development of a patient-reported symptom-based risk stratification system. As well as ensuring patients can understand the language used, it will be important to consider how their emotional needs can be met. The findings also have wider implications for understanding the impact of language on emotionally evocative healthcare interactions.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e094197"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The German national cohort study on the development of motor performance, physical activity and health in children and adolescents: the MoMo 2.0-Study protocol.
IF 2.4 3区 医学
BMJ Open Pub Date : 2025-04-03 DOI: 10.1136/bmjopen-2024-094895
Alexander Woll, Leon Klos, Annette Worth, Anke Hanssen-Doose, Thomas Hinz, Manuel Völkle, Alexander Burchartz, Claudia Niessner
{"title":"The German national cohort study on the development of motor performance, physical activity and health in children and adolescents: the MoMo 2.0-Study protocol.","authors":"Alexander Woll, Leon Klos, Annette Worth, Anke Hanssen-Doose, Thomas Hinz, Manuel Völkle, Alexander Burchartz, Claudia Niessner","doi":"10.1136/bmjopen-2024-094895","DOIUrl":"10.1136/bmjopen-2024-094895","url":null,"abstract":"<p><strong>Introduction: </strong>Regular physical activity (PA) and good motor performance are essential for children's physical and mental health. However, historical trends suggest that levels of PA and motor performance in children and adolescents are at a low point. The relationships between PA, motor performance, health and their respective determinants, as well as their individual development throughout childhood and adolescence, are not yet fully understood. Therefore, continuous monitoring of PA, motor performance and health is needed to identify vulnerable subpopulations and provide data for policy-makers and health promotion professionals. The Motorik Monitoring 2.0-Study aims to analyse the developmental, historical and periodic trends in motor performance and PA, as well as the underlying determinants, in children and adolescents in Germany.</p><p><strong>Methods and analysis: </strong>A representative sample of children and adolescents aged 4-17 years is drawn across 195 sample points in Germany. The assessment, carried out by test instructors, includes (1) a PA questionnaire covering different settings, including determinants, (2) anthropometric measures, (3) fine and gross motor performance tests focusing on coordination, flexibility, strength and endurance, (4) 24 hours device-based measured physical behaviour by accelerometry for 1 week and (5) a health interview focusing on health behaviour, physical and mental health as well as socioeconomic status. In addition, external data may be linked to the study using geographical information systems (eg, area deprivation, access to sports facilities). Analyses will be conducted using mixed-effects models to account for the nationwide structure of the study.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was obtained from the Ethics Committee of the Karlsruhe Institute of Technology. Results will be published in open-access scientific journals and disseminated at congresses for scientists, policy-makers and stakeholders.</p><p><strong>Trial registration number: </strong>The study was registered in the NFDI4health database (https://csh.nfdi4health.de/resource/1034). The NFDI4health database is a central platform of the National Research Data Infrastructure for Personal Health Data. It is used to collect, manage and provide health data for scientific research and facilitates access to high-quality data for epidemiological and clinical studies.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e094895"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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