BMJ Open最新文献

{"title":"PERIGENOMED-CLINICS 1-the first study on feasibility, acceptability and psychosocial impact of PERIGENOMED: a pilot project aimed at providing initial concrete evidence on the relevance of panel-based genome sequencing for newborn screening (NBS) in France.","authors":"Camille Level, Christel Thauvin-Robinet, Christine Binquet, Yannis Duffourd, Emeline Davoine, Martin Chevarin, Frédéric Tran-Mau-Them, Margot Lemaitre, Ange-Line Bruel, Hana Safraou, Dominique Salvi, Emilie Tisserant, Emmanuelle Lecommandeur, Amandine Charreton, Amir Hassine, Marie de Tayrac, Richard Redon, Julien Barc, Sebatien Schmitt, Juliette Piard, Paul Kuentz, Coline Cormier, Marlène Malbos, Caroline Racine, Brigitte Chabrol, David Cheillan, Véronique Tardy, Estelle Colin, Celine Bris, Sandra Mercier, Mathilde Nizon, Léa Gaudillat, Virginie Loizeau, Camille Lenelle, Nicolas Mottet, Emmanuel Simon, Jean-Baptiste Arnoux, Maud Carpentier, Catherine Renaud, Alban Ziegler, Catherine Lejeune, Anne-Sophie Jannot, Marie-Laure Asensio, Paul Rollier, Sylvie Odent, Stéphane Bezieau, Laurent Pasquier, Frédéric Huet, Laurence Faivre","doi":"10.1136/bmjopen-2025-105752","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-105752","url":null,"abstract":"<p><strong>Introduction: </strong>International pilot projects focusing on next-generation sequencing in newborn screening (NBS), that is, genomic NBS (gNBS), have been established thanks to continuous therapeutic progress and the massive development of new genetic technologies with rapidly decreasing costs. Given the highly encouraging results of the French SeDeN project regarding anticipated acceptability among professionals and parents, it is now appropriate to launch a similar pilot project in France, in collaboration with other international initiatives under the International Consortium on Newborn Sequencing framework.</p><p><strong>Methods and analysis: </strong>PERIGENOMED is a large-scale project designed to provide the first concrete evidence on the relevance of gNBS in France. It includes two clinical trials. We present here the design chosen for the first clinical trial (PERIGENOMED-CLINICS 1). PERIGENOMED-CLINICS 1 aims to assess the feasibility, real-world acceptability, psychosocial impact and organisational pathways of panel-based genomic newborn screening in France, involving 2500 participants. Solo-GS targeting two lists of gene-disease dyads responsible for treatable (list 1; 400 genes, 171 diseases/group of diseases) or actionable (list 2 optional; 407 genes, 218 diseases/group of diseases) rare and severe early-onset diseases will be proposed in five health institutions. Ancillary social and impact studies will also be included.</p><p><strong>Ethics and dissemination: </strong>All study procedures have been reviewed and approved by relevant French ethics committees and regulatory authorities (CPP Est II-2024-A02224-43, 1 January 2025). Results of the project will be disseminated through peer-reviewed publications, national and international conferences, and public engagement initiatives, in coordination with stakeholders.</p><p><strong>Trial registration number: </strong>NCT06875089.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e105752"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353554","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":"Predictive factors for very poor outcomes after endovascular thrombectomy in anterior circulation large vessel occlusion: a multicentre retrospective study in China.","authors":"Zhixia Li, Jiheng Hao, Changming Wen, Tao Cheng, Yanxin Zhao, Xuesong Bai, Xiaofan Guo, Wenbo Cao, Tianhua Li, Xiao-Li Min, Liqun Jiao, Liyong Zhang, Bin Yang","doi":"10.1136/bmjopen-2025-101244","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-101244","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to investigate the predictors of very poor outcomes in patients with acute ischaemic stroke due to large vessel occlusion after successful endovascular thrombectomy.</p><p><strong>Design: </strong><b>A</b> multicentre, retrospective study.</p><p><strong>Setting: </strong>Data were derived from tertiary care facilities in five cities of China.</p><p><strong>Participants: </strong>This study included 1242 patients with anterior circulation large-vessel occlusion who underwent endovascular thrombectomy, and they were stratified by 90-day modified Rankin Scale (mRS) scores into a very poor outcome group (mRS 5-6) and a non-very poor outcome group (mRS 0-4).</p><p><strong>Primary outcome measures: </strong>The primary outcome was very poor outcomes. Data from 1242 patients were analysed for demographic, laboratory, imaging and perioperative data.</p><p><strong>Results: </strong>Among the 1242 recruited patients, 318 (25.60%) exhibited very poor outcomes. In multivariate analysis, predictors of very poor outcomes were higher age (OR 1.059, 95% CI 1.043 to 1.075, p<0.001), stroke history (OR 1.993, 95% CI 1.373 to 2.888, p<0.001), coronary heart disease history(CHD;OR=1.816,95% CI 1.291-2.552,P=0.001),higher baseline National Institute of Health Stroke Scale (NIHSS; OR 1.076, 95% CI 1.054 to 1.099, p<0.001), higher neutrophil count (OR 1.078, 95% CI 1.025 to 1.134, p=0.003), lower Alberta Stroke Program Early CT Score (ASPECTS; OR 0.901, 95% CI 0.845 to 0.962, p=0.002), higher malignant cerebral oedema (MCE, OR 3.246,95% CI 2.241 to 4.713, p<0.001) and symptomatic intracranial haemorrhage (sICH, OR 3.97, 95% CI 2.569 to 6.169, p<0.001) and receiving intravenous thrombolysis (IVT, OR = 0.600,95% CI 0.431-0.830, P =0.002) . The predictive model demonstrated a certain degree of accuracy (area under the curve 0.839, 95% CI 0.813 to 0.864).</p><p><strong>Conclusions: </strong>The very poor outcomes were associated with advanced age, CHD history, stroke history, high NIHSS score, high neutrophil count, low ASPECTS and presence of MCE and sICH, while receiving intravenous thrombolysis was a protective factor. These poor outcome predictors might play a crucial role in informing clinical decision-making.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov (NCT06290076); pre-results.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e101244"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353647","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":"Protocol for the FibroCAN study: a randomised controlled trial of finerenone treatment for early-stage cardiovascular autonomic neuropathy in type 2 diabetes.","authors":"Maria Bitsch Poulsen, Tina Okdahl, Jens Hove Buciek, Asbjørn Mohr Drewes, Pall Karlsson, Tarunveer Singh Ahluwalia, Birgitte Brock, Christina Brock, Peter Rossing, Christian Stevns Hansen","doi":"10.1136/bmjopen-2025-101074","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-101074","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiovascular autonomic neuropathy (CAN) is a serious, untreatable complication of diabetes that contributes to excess cardiovascular mortality and morbidity. CAN is associated with increased fibrosis and inflammation, possibly driven by increased sympathetic activity and overactive mineralocorticoid receptors (MRs). These may represent a potential therapeutic target. MR antagonists (MRAs) improve autonomic function in non-diabetic diseases, and finerenone, a non-steroidal MRA, has demonstrated promising results in managing diabetic kidney disease and cardiovascular complications, suggesting its potential as a novel therapy for early-stage CAN. This trial aims to evaluate whether daily administration of finerenone can modify the disease progression of early-stage CAN.</p><p><strong>Methods and analysis: </strong>This trial is a two-centre, double-blind, parallel-group, 1:1 randomised, placebo-controlled study evaluating the effect of 78 weeks of intervention with finerenone or placebo on early-stage CAN in 100 individuals with type 2 diabetes in Denmark. The primary endpoint is the between-group difference in the expiration:inspiration ratio of the cardiovascular autonomic reflex tests (CARTs). Secondary endpoints are the between-group differences in the remaining CARTs, heart rate variability measures and fibrosis markers. Treatment effects on other forms of neuropathy and related pathological mechanisms will be explored.</p><p><strong>Ethics and dissemination: </strong>The study complies with the Declaration of Helsinki and the International Counsil for Harmonisation good clinical practice guidelines, with ethics approval obtained from the Danish Medical Research Ethics Committee. All participants will provide written informed consent. Due to the risk of hyperkalaemia associated with finerenone, safety will be closely monitored throughout the study. Findings will be disseminated through peer-reviewed publications, conference presentations and clinical trial registries. A lay summary will be provided to participants on study completion.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov: NCT06906081; registration date: 25 March 2025. Clinical Trials Information System: EUCT no. 2024-516597-30-00; registration date: 3 September 2024.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e101074"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353703","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":"Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study.","authors":"Yao Jiang, Zhongwei Sun, Bo Yu, Wei Liu, Hai Gao, Jianping Li, Zening Jin, Huai Yu, Bo Zheng, Changdong Guan, Han Zhang, Yin Zhang, Lijian Gao, Cheng Cui, Ying Song, Jingjing Xu, Kefei Dou, Weixian Yang, Jie Qian, Yongjian Wu, Lei Song","doi":"10.1136/bmjopen-2025-105796","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-105796","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with acute myocardial infarction (AMI) and multivessel disease are at elevated risk of recurrent events. Radial wall strain (RWS), a novel indicator derived from angiography, has emerged as a potentially useful adjunct to optical coherence tomography (OCT) for assessing plaque vulnerability. The NASCENT trial is a prospective, multicentre cohort study designed to assess the natural history of coronary plaque in this high-risk AMI population and investigate the predictive value of angiography-based RWS for lesion progression, compared with OCT-assessed vulnerable plaque.</p><p><strong>Methods and analysis: </strong>Following successful culprit lesion revascularisation for AMI patients with multivessel disease, we assessed eligible non-culprit lesions (30%-80% diameter stenosis) in non-flow-limiting, non-infarct-related arteries (Murray law-based quantitative flow ratio >0.80) using OCT and offline RWS analysis. The primary endpoint is lesion progression at 1 year, defined as a ≥20% increase in diameter stenosis percentage measured by quantitative coronary angiography. Between April 2024 and April 2025, 131 patients were enrolled. The 1-year angiographic and OCT follow-ups will be completed by May 2026. Clinical follow-ups are planned at 1 month, 6 months, 1 year and annually up to 3 years. As the first prospective trial comparing angiography-based RWS with OCT for predicting lesion progression in the AMI population, this study may provide crucial evidence for RWS as a valuable tool for risk stratification and clinical decision-making.</p><p><strong>Ethics and dissemination: </strong>The protocol has been approved by the Institutional Review Board and Ethics Committee (Fuwai Hospital Approval No. 2023-2039) and will be conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all participants. The study results will undergo peer-reviewed publication.</p><p><strong>Trial registration number: </strong>NCT06040073.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e105796"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353528","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":"Prehabilitation of frail elderly PAtients undergoing majoR surgEry at HOME (PREPARE-HOME): a superiority parallel-group randomised controlled trial protocol evaluating smart wearable enhanced prehabilitation versus usual care.","authors":"Yun Hao Leong, Victoria Yu Jia Tay, XinYi Yang, Chun Ju Tan, Phui-Sze Au-Yong, Jacqueline Ling Xiu Sim, Roderica Rui Ge Ng, Marcus Eng Hock Ong, Brenda Pei Yi Tan, Hairil Rizal Abdullah, Yuhe Ke","doi":"10.1136/bmjopen-2024-094986","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-094986","url":null,"abstract":"<p><strong>Introduction: </strong>Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation-targeting improvements in physical function before surgery-can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.</p><p><strong>Methods and analysis: </strong>This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure <100 cm H₂O). The primary outcome is change in 6 min walk test distance from baseline to 1-3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.</p><p><strong>Ethics and dissemination: </strong>Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences.</p><p><strong>Contact: </strong>irb@singhealth.com.sg TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT06633614.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e094986"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353721","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":"Crowding-out and crowding-in effects of out-of-pocket expenditures for non-communicable diseases care on household consumption patterns in Bangladesh: a cross-sectional analysis of the 2022 household income and expenditure survey.","authors":"Md Tauhidul Islam, Adelakun Odunyemi, Mieghan Bruce, Khurshid Alam","doi":"10.1136/bmjopen-2025-098791","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-098791","url":null,"abstract":"<p><p>This study aims to analyse the crowding-out and crowding-in effects of non-communicable diseases (NCDs) related out-of-pocket (OOP) health expenditures on household consumption in Bangladesh.</p><p><strong>Objective: </strong>DESIGN: This study used data from the nationally representative Bangladesh household income and expenditure survey (HIES) 2022.</p><p><strong>Setting: </strong>Eight divisions of Bangladesh.</p><p><strong>Participants: </strong>14 395 households.</p><p><strong>Primary and secondary outcome measures: </strong>We examined how household consumption patterns across 20 expenditure categories were impacted by OOP health spending for NCD management, with a focus on income-level disparities.</p><p><strong>Results: </strong>In Bangladesh, OOP health expenditures for NCDs crowded out household expenditures on essential items like food and rent. Across all households, OOP health expenditures for NCDs by 10 US$ crowded out -3.8 US$ of expenditure on food (95% CI -5.1 to -2.5), and more specifically on protein-rich foods (-2.0 US$, 95% CI -2.8 to -1.2), spices (-0.2 US$, 95% CI -0.3 to -0.1), and restaurant and café meals (-0.9 US$, 95% CI -1.4 to -0.5). Crowding-out was also seen for tobacco, rent, durable goods and miscellaneous. In lower-income households, expenditures on food (-4.1 US$, 95% CI -7.2 to -1.1), restaurant and café meals (-2.0 US$, 95% CI -3.1 to -0.8), spices (-0.4 US$, 95% CI -0.7 to -0.09), and rent (-3.1 US$, 95% CI -4.5 to -1.6) were significantly crowded out.</p><p><strong>Conclusion: </strong>This research demonstrates that NCD-related spending in Bangladesh reduces budgets for both food and non-food expenditures, with a stronger crowding-out effect on food items and rent, particularly in lower-income households. Effective financial and social protection mechanisms against NCDs are warranted to safeguard the consumption of the NCD-affected households in Bangladesh.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e098791"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353750","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":"Adult pain scores in the emergency department: a scoping review protocol.","authors":"Emma Duffield, Liza Keating, Sarah Wilson, Amelia Hollywood","doi":"10.1136/bmjopen-2025-106729","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-106729","url":null,"abstract":"<p><strong>Introduction: </strong>Pain is a common complaint in patients presenting to an Emergency Department (ED). Data show that timely delivery of pain relief in this setting remains a challenge. Adequate treatment of pain requires recognition and assessment. The Royal College of Emergency Medicine advocates for early pain assessment and reassessment post-analgesia; however, it does not specify how best to do this. Therefore, a review of existing literature is needed to identify which pain assessment tools have been shown to be useful in the ED.</p><p><strong>Methods and analysis: </strong>This scoping review will use the Joanna Briggs Institute methodology. A search of PubMed, Embase, Cumulated Index in Nursing and Allied Health Literature, Web of Science, Scopus and the Cochrane Library will identify relevant studies published in English since January 2004. Studies will be included that recruit adults (aged 18 years and over) presenting to an ED with acute pain (duration under 3 months). Publications must assess or compare tools for measuring pain in an ED setting. Full-text articles published internationally will be considered. After duplicate removal, abstract screening and full-text analysis by two independent reviewers will identify relevant papers, using the inclusion criteria. Discrepancy resolution will be via a third reviewer. Pain measurement tools and their evidence will be extracted, collated and described. The findings will be reported according to Preferred Reporting Items for Systematic reviews and Meta-Analyses for Scoping Reviews.</p><p><strong>Ethics and dissemination: </strong>Ethical approval is not required for this review. Published results will be shared with relevant parties interested in ED pain management. Potential next steps include patient involvement in the evaluation of pain assessment tools identified in this review and implementation into practice. The insights of patients with relevant lived experience in assessing these tools would be invaluable to the objective of improving pain management in the emergency setting.</p><p><strong>Trial registration number: </strong>This project is registered with the Open Science Framework accessible at https://doi.org/10.17605/OSF.IO/ENVPY.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e106729"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353732","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":"Early life determinants of skeletal maturation, body composition and endocrine health in young adults (EPIPEAK): protocol for a nationwide birth cohort study.","authors":"Mina Nicole Händel, Niklas Rye Jørgensen, Jonas Bybjerg-Grauholm, Rasmus Bo Jansen, Pia Eiken, Charlotte Landbo Tofteng, Anne Pernille Hermann, Pernille Bach-Mortensen, Berit Lilienthal Heitmann, Katrine Hass Rubin, Bente Lomholt Langdahl, Peter Vestergaard, Bo Abrahamsen","doi":"10.1136/bmjopen-2025-101632","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-101632","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18-19 years.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and analysis: &lt;/strong&gt;Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18-19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e101632"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353765","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":"Application of the socio-ecological model to understand the drivers of excessive alcohol and salt consumption: a qualitative study in Ghana.","authors":"Joseph Prince Mensah, Robert Akparibo, Chloe Thomas, Richmond Aryeetey, Alan Brennan","doi":"10.1136/bmjopen-2025-100490","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-100490","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to identify the key factors driving excessive alcohol and salt consumption in Ghana, both of which are modifiable risk factors for diseases such as cardiovascular conditions and cancers. Using the socio-ecological model (SEM), we qualitatively examine stakeholder perspectives to gain a comprehensive understanding of the influences contributing to these unhealthy consumption patterns.</p><p><strong>Design and methods: </strong>A qualitative study was conducted using semi-structured interviews. Transcripts were analysed thematically, with identified drivers mapped onto the corresponding levels of influence within the SEM.</p><p><strong>Participants: </strong>The study included 21 purposively sampled stakeholders from government and academic institutions in Ghana, including policymakers, practitioners and researchers.</p><p><strong>Results: </strong>Drivers of excessive salt and alcohol consumption were identified across all five levels of the SEM. At the intrapersonal level, disregard for health risks was a key factor. Community-level drivers included easy access to unhealthy foods and cultural norms promoting alcohol use at social events and salt in traditional dishes. At the societal and policy levels, inadequate regulation of the alcohol and food industries was found to reinforce lower-level drivers, further encouraging unhealthy consumption.</p><p><strong>Conclusions: </strong>This study highlights the multilevel influences on alcohol and salt consumption, emphasising the interactions across SEM levels. It highlights that addressing unhealthy consumption is not solely a matter of personal responsibility, demonstrating that societal and policy factors play a significant role in shaping health and dietary behaviours. The findings underscore the need for comprehensive public health strategies that address influences at multiple levels to effectively reduce excessive alcohol and salt intake.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e100490"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353797","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":"Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19.","authors":"Fabrizio Carinci, Rossella Messina, Massimo Michelini, Amelia Bici, Arianna Berardo, Alessandra Dei Cas, Elisa Iezzi, Concetta Tania Di Iorio, Stefano Gualdi, Raffaella Aldigeri, Maria Pia Fantini, Riccardo C Bonadonna, Massimo Massi Benedetti, Paolo Di Bartolo","doi":"10.1136/bmjopen-2025-102401","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-102401","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia-Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.</p><p><strong>Methods and analysis: </strong>The study has a mixed retrospective/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019-2024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0-6 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.</p><p><strong>Ethics and dissemination: </strong>The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.</p><p><strong>Trial registration number: </strong>NCT06639100.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e102401"},"PeriodicalIF":2.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353672","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}