BMJ Open Respiratory Research最新文献

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Primary Care Integrated Management of chronic obstructive pulmonary disease (PRIM-COPD): study protocol for a cluster-randomised controlled trial. 慢性阻塞性肺疾病(PRIM-COPD)的初级保健综合管理:一项集群随机对照试验的研究方案。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-07-08 DOI: 10.1136/bmjresp-2025-003771
Yiwen Yu, Xiaoxia Ren, Xu Chu, Jisong Yan, Feng Guo, Quan Wan, Ke Huang, Jieping Lei, Xingyao Tang, Xing Qi, Junsheng Zheng, Yong Li, Fang Fang, Jun Pan, Cunbo Jia, Ting Yang, Chen Wang
{"title":"Primary Care Integrated Management of chronic obstructive pulmonary disease (PRIM-COPD): study protocol for a cluster-randomised controlled trial.","authors":"Yiwen Yu, Xiaoxia Ren, Xu Chu, Jisong Yan, Feng Guo, Quan Wan, Ke Huang, Jieping Lei, Xingyao Tang, Xing Qi, Junsheng Zheng, Yong Li, Fang Fang, Jun Pan, Cunbo Jia, Ting Yang, Chen Wang","doi":"10.1136/bmjresp-2025-003771","DOIUrl":"10.1136/bmjresp-2025-003771","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, with China bearing a particularly high burden. Major gaps persist in early diagnosis, guideline-based treatment and long-term disease management, especially in primary care. This study aims to evaluate the efficacy and feasibility of the National Essential Public Health Services (NEPHS) COPD management approach and to generate evidence to inform the optimisation of national COPD care standards.</p><p><strong>Methods and analysis: </strong>The Primary Care Integrated Management (PRIM) trial is a prospective, multicentre, cluster-randomised controlled study conducted in seven pilot regions in China, with primary healthcare institutions as the unit of randomisation. Participants are adults aged ≥35 years with spirometry-confirmed COPD, recruited either through screening or from existing patient databases. Institutions will be randomised in a 1:1 ratio to the intervention (PRIM) or usual care arms using a computer-generated allocation sequence, stratified by urban-rural location. The intervention comprises quarterly general practitioner (GP)-led follow-ups, health education and disease management according to pilot NEPHS COPD guidelines, supported by a three-tier oversight structure involving the National Center for Respiratory Medicine, leading tertiary hospitals and primary healthcare institutions. Co-primary outcomes are the annual number of acute exacerbations and health-related quality of life (European Quality of Life-5 Dimensions and 5 Levels). Secondary outcomes include smoking status, health status assessed by the COPD Assessment Test (CAT), dyspnoea score and GP knowledge. Analyses will follow the intention-to-treat principle, using multivariable regression models adjusted for clustering and prespecified baseline covariates. Cost-effectiveness analyses of the PRIM intervention in the Chinese population are also planned.</p><p><strong>Ethics and dissemination: </strong>Ethics approval has been granted by China-Japan Friendship Hospital (approval number 2024-KY-163).</p><p><strong>Trial registration number: </strong>NCT06573580.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13347819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148410514","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
Measurement agreement between a portable and a conventional impulse oscillometry system: a two-centre method-comparison study. 便携式和传统脉冲振荡测量系统的测量一致性:双中心方法的比较研究。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-07-06 DOI: 10.1136/bmjresp-2026-004292
Shihua Yao, Rui Zhang, Bingxia Chen, Linchong Huang, Kuiqing Lin, Lingling Ji, Zhongping Wu, Dongfei Huang, Minqi Zhu, Yanqing Xie, Beilan Shen, Liping Zhong, Jinping Zheng, Fang Chen, Yi Gao
{"title":"Measurement agreement between a portable and a conventional impulse oscillometry system: a two-centre method-comparison study.","authors":"Shihua Yao, Rui Zhang, Bingxia Chen, Linchong Huang, Kuiqing Lin, Lingling Ji, Zhongping Wu, Dongfei Huang, Minqi Zhu, Yanqing Xie, Beilan Shen, Liping Zhong, Jinping Zheng, Fang Chen, Yi Gao","doi":"10.1136/bmjresp-2026-004292","DOIUrl":"10.1136/bmjresp-2026-004292","url":null,"abstract":"<p><strong>Background: </strong>Impulse oscillometry (IOS) enables tidal-breathing assessment of airway mechanics and is useful in patients with limited cooperation. With the growing use of portable IOS devices for bedside and community pulmonary function assessment, agreement with established laboratory systems requires evaluation.</p><p><strong>Objective: </strong>To assess measurement agreement and clinical classification agreement between the portable IOS 600 and the conventional Jaeger MasterScreen-IOS.</p><p><strong>Methods: </strong>In this prospective two-centre method-comparison study with randomised measurement-sequence allocation, adult and paediatric participants underwent IOS measurement using both devices during a single visit. Core parameters (respiratory impedance at 5 Hz (Z5), resistance at 5 Hz (R5), resistance at 20 Hz (R20), reactance at 5 Hz (X5), reactance area and resonant frequency (Fres)) and secondary parameters were analysed. Interdevice agreement was assessed using intraclass correlation coefficients (ICCs), Bland-Altman analysis and coefficients of variation. Clinical classification agreement for core parameters was evaluated using Gwet's agreement coefficient 1 (AC1).</p><p><strong>Results: </strong>Of 200 enrolled participants, 164 were included in the final paired analysis. Core IOS parameters showed high interdevice agreement, with ICCs ranging from 0.902 to 0.961. Bland-Altman analysis demonstrated small mean interdevice differences; however, proportional bias was observed for Z5, R5 and Fres, indicating that agreement at markedly abnormal values should be interpreted cautiously. Coefficients of variation did not differ significantly between devices. Clinical classification agreement was strong to almost perfect, with Gwet's AC1 values of 0.90, 0.92, 0.91 and 0.96 for Z5, R5, R20 and X5, respectively. Adult-only and exploratory disease-subgroup analyses showed generally consistent agreement estimates. Most secondary resistance parameters showed strong-to-almost-perfect agreement, whereas reactance at 15 Hz and reactance at 25 Hz showed lower agreement.</p><p><strong>Conclusions: </strong>The portable IOS 600 demonstrated high measurement agreement and clinical classification agreement with the MasterScreen-IOS for core IOS parameters under standardised testing conditions. Because the final cohort was predominantly adult, these findings are primarily applicable to adult participants. IOS 600 may serve as a complementary tool for airway function assessment, although further validation is needed in paediatric, disease-specific, bedside, primary care and community settings.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13358288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148395884","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
Impact of race-neutral GLI reference equations in Northeast Asian patients with IPF. 种族中性GLI参考方程对东北亚IPF患者的影响。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-07-02 DOI: 10.1136/bmjresp-2025-003957
Hyeonsu Lee, Chang-Hoon Lee, Kwonhyung Hyung, Sun Mi Choi, Sang-Min Lee, Jimyung Park
{"title":"Impact of race-neutral GLI reference equations in Northeast Asian patients with IPF.","authors":"Hyeonsu Lee, Chang-Hoon Lee, Kwonhyung Hyung, Sun Mi Choi, Sang-Min Lee, Jimyung Park","doi":"10.1136/bmjresp-2025-003957","DOIUrl":"10.1136/bmjresp-2025-003957","url":null,"abstract":"<p><strong>Background: </strong>The Global Lung Function Initiative (GLI) has recently introduced race-neutral reference equations for pulmonary function tests, replacing traditional ethnic-specific equations. However, the clinical impact of this transition in Northeast Asian patients with idiopathic pulmonary fibrosis (IPF) remains unclear.</p><p><strong>Methods: </strong>We evaluated the implications of switching from the ethnic-specific equations to the race-neutral GLI equations in 903 Korean patients newly diagnosed with IPF between 2005 and 2020. Per cent predicted values of forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO) were calculated using both equations and used to derive the baseline gender-age-physiology (GAP) index scores. We then compared the prognostic performance of GAP staging derived from each equation in predicting all-cause mortality. Additionally, we assessed the clinical impacts of 1-year absolute declines in FVC and DLCO % predicted, as determined by each equation.</p><p><strong>Results: </strong>The race-neutral GLI equations yielded higher FVC % predicted and lower DLCO % predicted values compared with the ethnic-specific equations, resulting in GAP stage reclassification in 203 of 903 patients (22.5%), predominantly toward lower stages. Despite these differences, the agreement in GAP staging between the two equations was substantial (Cohen's kappa 0.628) and their predictive performance for mortality did not significantly differ (C-index 0.686 vs 0.684; p=0.598). One-year absolute declines in FVC and DLCO % predicted were similarly associated with increased mortality, regardless of reference equation used.</p><p><strong>Conclusions: </strong>In Northeast Asian patients with IPF, race-neutral GLI equations resulted in reclassification of GAP stage for some patients but did not affect the overall prognostic performance of the GAP index in predicting mortality.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13330946/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148374517","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
Should household air quality monitoring be considered in selected patients with asthma and COPD? 哮喘和慢性阻塞性肺病患者是否应考虑进行室内空气质量监测?
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-07-01 DOI: 10.1136/bmjresp-2025-003899
Rubèn González-Colom, Alba Gómez-López, Alicia Aguado, Néstor Soler, Núria Sánchez-Ruano, Marta Sorribes, Antonio Montilla-Ibarra, María Figols, Alberto Rodríguez, Emili Vela, Jordi Piera-Jiménez, Ramón Farre, Josep Roca, Isaac Cano, Jose Fermoso, Ebymar Arismendi
{"title":"Should household air quality monitoring be considered in selected patients with asthma and COPD?","authors":"Rubèn González-Colom, Alba Gómez-López, Alicia Aguado, Néstor Soler, Núria Sánchez-Ruano, Marta Sorribes, Antonio Montilla-Ibarra, María Figols, Alberto Rodríguez, Emili Vela, Jordi Piera-Jiménez, Ramón Farre, Josep Roca, Isaac Cano, Jose Fermoso, Ebymar Arismendi","doi":"10.1136/bmjresp-2025-003899","DOIUrl":"10.1136/bmjresp-2025-003899","url":null,"abstract":"<p><strong>Background: </strong>Indoor air quality (IAQ) is a well demonstrated actionable determinant of health status. Low-cost sensors (LCS) could enable patient-centred assessments, but real-world clinical utility is uncertain.</p><p><strong>Objective: </strong>Evaluate the feasibility, usability and clinical indications of home IAQ monitoring with LCS.</p><p><strong>Methods: </strong>We conducted a cohort study involving household continuous IAQ monitoring with LCS of 205 adults with chronic obstructive pulmonary disease, bronchiectasis or asthma. Household IAQ was profiled prospectively over a 2-month period registering concentrations of carbon dioxide, particulate matter 2.5 µm (PM<sub>2.5</sub>) and formaldehyde every 10 min. For each pollutant, dwellings were classified as good, moderate or unhealthy according to the Global Open Air Quality Standards thresholds. Pulmonary exacerbations requiring unplanned hospitalisations and all-cause emergency department (ED) visits over the preceding 12 months were registered and potential relationships with household IAQ results were explored.</p><p><strong>Results: </strong>Of the 205 participants, 178 were included in the final analysis after excluding dropouts and cases with insufficient monitoring data. More than half of homes (51.7%) had at least one pollutant in an at-risk category. The burden was mostly generated by PM<sub>2.5</sub>: 40.1% of dwellings were classified as at risk (32.8% moderate; 7.3% unhealthy). Formaldehyde exceeded the low-risk threshold in 22 homes (12.4%). Tobacco smoking, either active or passive, was significantly associated with PM<sub>2.5</sub> levels (p<0.001). No relationships were found between IAQ categories and hospitalisations nor with all-cause ED visits.</p><p><strong>Conclusions: </strong>LCS are useful tools for short-term, targeted household IAQ screening in chronic respiratory patients. Indoor pollution is highly prevalent and largely PM<sub>2.5</sub> driven. Further research is needed to assess the short-term health impacts of these exposures.</p><p><strong>Trial registration number: </strong>NCT06421402.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13331015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148366843","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
Protocol for Mesothelioma Observational study of Risk prediction and Generation of paired benign-meso tissue samples, Including a Nested MRI Substudy (Meso-ORIGINS). 间皮瘤风险预测的观察性研究方案和成对良性间质组织样本的产生,包括一个嵌套的MRI亚研究(Meso-ORIGINS)。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-07-01 DOI: 10.1136/bmjresp-2025-004045
Mark D J Neilly, Alexandrea MacPherson, Laura Alexander, Nicola Walker, Caroline Kelly, Joshua Roche, Emad Abugassa, Liam Allan, Adeel Ashraf, Avinash Aujayeb, Anna Bibby, Rocco Bilancia, John Corcoran, Mahendran Chetty, Kevin Conroy, Christopher Craig, Rebecca Crook, Alveena D'Souza, Cyrus Daneshvar, Duneesha DeFoneska, Poppy Denniston, Janet Fallon, Katie Ferguson, Timothy Gatheral, Andrew Lloyd Griffiths, Mohammed Haris, Mohammed Hashim, Alina Ionescu, Owais Kadwani, Michelle Macdougall, John D Maclay, Oliver Nesfield Mann, Nick Maskell, Morvern Morrison, Rakesh Panchal, Benjamin Prudon, Najib M Rahman, Rajini Sudhir, Sudarshan Ramsaroop, Raja Reddy, Phil Reid, Elizabeth Sage, Philip Short, Andrew E Stanton, Laura Succony, Georgios Tsaknis, Selina Tsim, Gordon Cowell, Kevin Lamote, Kevin G Blyth
{"title":"Protocol for Mesothelioma Observational study of Risk prediction and Generation of paired benign-meso tissue samples, Including a Nested MRI Substudy (Meso-ORIGINS).","authors":"Mark D J Neilly, Alexandrea MacPherson, Laura Alexander, Nicola Walker, Caroline Kelly, Joshua Roche, Emad Abugassa, Liam Allan, Adeel Ashraf, Avinash Aujayeb, Anna Bibby, Rocco Bilancia, John Corcoran, Mahendran Chetty, Kevin Conroy, Christopher Craig, Rebecca Crook, Alveena D'Souza, Cyrus Daneshvar, Duneesha DeFoneska, Poppy Denniston, Janet Fallon, Katie Ferguson, Timothy Gatheral, Andrew Lloyd Griffiths, Mohammed Haris, Mohammed Hashim, Alina Ionescu, Owais Kadwani, Michelle Macdougall, John D Maclay, Oliver Nesfield Mann, Nick Maskell, Morvern Morrison, Rakesh Panchal, Benjamin Prudon, Najib M Rahman, Rajini Sudhir, Sudarshan Ramsaroop, Raja Reddy, Phil Reid, Elizabeth Sage, Philip Short, Andrew E Stanton, Laura Succony, Georgios Tsaknis, Selina Tsim, Gordon Cowell, Kevin Lamote, Kevin G Blyth","doi":"10.1136/bmjresp-2025-004045","DOIUrl":"10.1136/bmjresp-2025-004045","url":null,"abstract":"<p><strong>Introduction: </strong>Pleural mesothelioma (PM) is often presaged by benign asbestos-associated pleural inflammation (AAPI), offering a unique window of opportunity for translational research. The PREDICT-Meso International Accelerator Network is leveraging this natural history to perform target identification and develop novel therapies for early-stage or pre-invasive disease. This requires assembly of a unique bioresource of longitudinal human tissue samples spanning the terminal stages of PM evolution, development of preclinical models for drug screening and reliable tools for risk prediction in patients presenting with AAPI.</p><p><strong>Methods and analysis: </strong>Mesothelioma Observational study of Risk prediction and Generation of paired benign-meso tissue samples, Including a Nested MRI Substudy (Meso-ORIGINS) is a prospective, multicentre observational study, comprising two arms (A and B), with a nested MRI substudy in arm A. Arm A will recruit 300 AAPI patients and perform 6-monthly surveillance for 2 years. Suspicion of PM evolution will prompt repeat biopsy and banking, delivering a primary objective of ≥38 longitudinal AAPI-PM tissue pairs. This target reflects a projected PM evolution rate of 14% (95% CI 10.5 to 19.2) derived from a prior multicentre feasibility trial. Multiomic risk profiling will be performed in arm A, using blood proteomics, exhaled breath metabolomics and perfusion MRI. Arm B will recruit 300 patients with suspected PM, permitting collection of multiregion pleural biopsies in patients spanning AAPI and PM timepoints for evaluation of anatomical heterogeneity. Where possible, patients in arm B diagnosed with AAPI will be recruited to arm A for 2-year surveillance +/- repeat biopsy in subsequent PM evolution cases. Pleural fluid will be collected in arm B for cell-line generation and diagnostic biomarker evaluation. Exhaled breath will be collected in arm B for diagnostic biomarker evaluation.</p><p><strong>Ethics and dissemination: </strong>The study has ethical approval (REC Ref 21/WS/0120). Results will be disseminated via peer-reviewed journals and national/international scientific conferences. Tissues, data and derived omics will be shared via the PREDICT-Meso Research Tissue Bank (REC Ref 21/WS/0011).</p><p><strong>Trial registration number: </strong>ISRCTN22929761.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13331108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148366750","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
British Thoracic Society quality standard for pulmonary rehabilitation. 英国胸科学会肺康复质量标准。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-06-30 DOI: 10.1136/bmjresp-2025-003872
Sally J Singh, Maria Buxton, Enya Daynes, Samantha S C Kon, Claire M Nolan, Miguel Souto, Ioannis Vogiatzis, Thomas Jc Ward, Jane S Watson, William D-C Man
{"title":"British Thoracic Society quality standard for pulmonary rehabilitation.","authors":"Sally J Singh, Maria Buxton, Enya Daynes, Samantha S C Kon, Claire M Nolan, Miguel Souto, Ioannis Vogiatzis, Thomas Jc Ward, Jane S Watson, William D-C Man","doi":"10.1136/bmjresp-2025-003872","DOIUrl":"10.1136/bmjresp-2025-003872","url":null,"abstract":"<p><p>The purpose of the document is to provide commissioners, service providers and individuals with a guide to the minimum standards of care that participants attending pulmonary rehabilitation should expect, together with measures of good practice.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13331195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148359291","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
Maternal, Infant, Reproductive and Child Health in Cystic Fibrosis (MATRIARCH_CF): a prospective, observational study to evaluate pregnancy and parenthood in females with cystic fibrosis and health of the offspring in the CFTR-modulator era. 囊性纤维化中的母亲、婴儿、生殖和儿童健康(MATRIARCH_CF):一项前瞻性观察性研究,旨在评估cftr调节时代囊性纤维化女性的妊娠和生育以及后代健康。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-06-30 DOI: 10.1136/bmjresp-2026-004270
Amy Downes, Idan Bokobza, Ladina Weitnauer, Rebecca Scott, Rebecca Dobra, Christopher Short, Thomas Semple, Olivia Beaumont, Catherine Williamson, Jane C Davies, Imogen Felton
{"title":"Maternal, Infant, Reproductive and Child Health in Cystic Fibrosis (MATRIARCH_CF): a prospective, observational study to evaluate pregnancy and parenthood in females with cystic fibrosis and health of the offspring in the CFTR-modulator era.","authors":"Amy Downes, Idan Bokobza, Ladina Weitnauer, Rebecca Scott, Rebecca Dobra, Christopher Short, Thomas Semple, Olivia Beaumont, Catherine Williamson, Jane C Davies, Imogen Felton","doi":"10.1136/bmjresp-2026-004270","DOIUrl":"10.1136/bmjresp-2026-004270","url":null,"abstract":"<p><strong>Introduction: </strong>Cystic fibrosis transmembrane conductance regulator (CFTR) modulators (CFTRm) have altered the landscape of pregnancy and parenthood in cystic fibrosis (CF). As pregnant and breastfeeding females with CF (FwCF) were excluded from pivotal CFTRm trials, evidence to guide management and counsel families on maternal and child outcomes is limited. While CFTRm are unlicensed for use in pregnancy, substantial clinical benefit means most continue therapy. Early studies indicate that CFTRm cross the placenta and are detectable in breastmilk; reported associations include infant liver dysfunction and cataracts but risks remain poorly characterised. We describe the protocol for the first UK-based prospective study evaluating pregnancy and parenthood in FwCF and health outcomes in their children in the CFTRm era.</p><p><strong>Methods and analysis: </strong>A single protocol underpins three linked prospective observational substudies in the MATRIARCH_CF research programme. The 'Mama' cohort recruits FwCF planning pregnancy or pregnant, with follow-up from preconception to 24 months postpartum, assessing physical and psychological health, lung function and CF-related complications. 'Mini' recruits children aged 0-24 months born to a parent with CF and compares offspring exposed and unexposed to CFTRm in utero and/or through breastfeeding; measures include birth outcomes, congenital anomalies, liver biochemistry, growth and neurodevelopment. 'Midi' recruits children aged 3-6 years from the same exposure groups and assesses neurodevelopment and lung function. Longitudinal data across cohorts will strengthen the evidence base, support risk-benefit discussions and inform clinical guidance.</p><p><strong>Ethics and dissemination: </strong>The protocol was approved by NHS ethics HSC REC A committee (25/NI/0027 19 March 2025). Assessments align with routine care where possible. Visit windows are flexible and participants may decline individual assessments. The research team does not influence CFTRm initiation, cessation or dose adjustment. People with CF contributed throughout study design to ensure acceptability. Findings will be disseminated through PhD theses, conference presentations and peer-reviewed publications.</p><p><strong>Trial registration number: </strong>NCT06797206.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13331013/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148359261","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
Maternal asthma activity and offspring asthma: a linked-data population study in Australia and Sweden. 母亲哮喘活动和后代哮喘:澳大利亚和瑞典的相关数据人口研究。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-06-28 DOI: 10.1136/bmjresp-2025-004010
Bronwyn K Brew, Vanessa E Murphy, Cecilia Lundholm, Helga Zoega, Alys Havard, Annelies L Robijn, Tong Gong, Awad I Smew, Gustaf Rejnö, Georgina Chambers, Catarina Almqvist
{"title":"Maternal asthma activity and offspring asthma: a linked-data population study in Australia and Sweden.","authors":"Bronwyn K Brew, Vanessa E Murphy, Cecilia Lundholm, Helga Zoega, Alys Havard, Annelies L Robijn, Tong Gong, Awad I Smew, Gustaf Rejnö, Georgina Chambers, Catarina Almqvist","doi":"10.1136/bmjresp-2025-004010","DOIUrl":"10.1136/bmjresp-2025-004010","url":null,"abstract":"<p><strong>Background: </strong>Inhaled corticosteroid (ICS) use in pregnancy has shown associations with decreased offspring asthma in childhood, whereas exacerbations in pregnancy may increase the risk. However, these findings have not been tested in population-based cohorts with rigorous assessment of confounding structures. The aim was to describe asthma exacerbations and ICS utilisation during pregnancy and to assess causal pathways between pregnancy exacerbations, ICS use and offspring asthma.</p><p><strong>Methods: </strong>Register-based cohort study of pregnancies in New South Wales (NSW), Australia and Sweden. Maternal monthly asthma exacerbations (hospital visits and/or oral corticosteroid (OCS) dispensings) and ICS dispensing rates were calculated 12 months prepregnancy to 12 months post partum. Among mothers with asthma (35 194 NSW, 102 248 Sweden), Hazard Ratios (HR)s were calculated for pregnancy exacerbations or ICS use and offspring asthma adjusting for confounders including asthma severity. Associations between paternal exposures and offspring asthma and sibling analyses assessed the likelihood of unmeasured confounding.</p><p><strong>Results: </strong>Maternal asthma prevalence was 8.6% in NSW and 7.1% in Sweden. While ICS use was maintained over the course of pregnancy, a postpartum decline was observed, accompanied by a rise in OCS use. Adjusted HRs for offspring asthma were 1.47 (95% CI 1.32 to 1.64, NSW) and 1.30 (95% CI 1.24 to 1.36, Sweden) following maternal exacerbations, and 1.37 (95% CI 1.26 to 1.49, NSW) and 1.23 (95% CI 1.19 to 1.27, Sweden) following maternal ICS use. Paternal exposures were also associated with offspring asthma, while associations in sibling analyses were not significant.</p><p><strong>Conclusions: </strong>Observed associations between maternal exacerbations, ICS use and offspring asthma appear to be due to unmeasured confounding. Management of maternal asthma remains a priority in pregnancy and post partum.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13331117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148350597","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 RApid PrednIsolone Dose reduction for acute exacerbation of Idiopathic Pulmonary Fibrosis (RAPID-IPF Trial): a study protocol for a randomised controlled trial. 快速泼尼松龙减剂量治疗特发性肺纤维化急性加重的疗效和安全性(RApid - ipf试验):一项随机对照试验的研究方案
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-06-28 DOI: 10.1136/bmjresp-2025-003818
Keisuke Anan, Yuki Kataoka, Masataka Taguri, Kazuya Ichikado, Ryo Tachikawa, Kazunori Tobino, Kodai Kawamura, Chigusa Shirakawa, Takafumi Kawabata, Yosuke Yamamoto
{"title":"Efficacy and safety of RApid PrednIsolone Dose reduction for acute exacerbation of Idiopathic Pulmonary Fibrosis (RAPID-IPF Trial): a study protocol for a randomised controlled trial.","authors":"Keisuke Anan, Yuki Kataoka, Masataka Taguri, Kazuya Ichikado, Ryo Tachikawa, Kazunori Tobino, Kodai Kawamura, Chigusa Shirakawa, Takafumi Kawabata, Yosuke Yamamoto","doi":"10.1136/bmjresp-2025-003818","DOIUrl":"10.1136/bmjresp-2025-003818","url":null,"abstract":"<p><strong>Introduction: </strong>Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a life-threatening event with high mortality. While systemic corticosteroids are commonly used in clinical practice for AE-IPF despite the absence of randomised evidence, the optimal tapering strategy is uncertain. Early corticosteroid tapering reduces adverse events in other inflammatory diseases. However, the efficacy and safety of this approach in AE-IPF have not been established. This study aims to determine if an early corticosteroid tapering regimen is non-inferior to a conventional regimen for 90-day mortality in patients with AE-IPF.</p><p><strong>Methods and analysis: </strong>The RApid PrednIsolone Dose reduction for acute exacerbation of Idiopathic Pulmonary Fibrosis (RAPID-IPF) trial is a multicentre, parallel-group, open-label, randomised controlled non-inferiority trial conducted in Japan. A total of 70 patients (up to 130) hospitalised for AE-IPF will be randomly assigned in a 1:1 ratio to either an accelerated 6-week prednisolone tapering regimen (early tapering group) or a conventional 12-week tapering regimen (standard tapering group). The primary outcome is all-cause mortality at 90 days. The non-inferiority margin is set at a 10% risk difference. Key secondary outcomes include 28-day mortality, mortality due to respiratory causes, time to respiratory worsening or death, protocol adherence and the proportion of patients lost to follow-up. The trial incorporates two interim analyses for feasibility and sample size re-estimation.</p><p><strong>Ethics and dissemination: </strong>This study will be conducted in compliance with the Declaration of Helsinki and Japanese ethical guidelines. The protocol was approved by the institutional review boards of all participating hospitals (lead approval: Saiseikai Kumamoto Hospital, #1367). Written informed consent will be obtained from all participants or their legally acceptable representatives. Findings will be disseminated through scientific conferences and publication in a peer-reviewed journal.</p><p><strong>Trial registration number: </strong>Japan Registry of Clinical Trials (jRCT1071250015).</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13331100/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148350645","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
Economic impact of initiation of home mechanical ventilation: a budget impact analysis from the Netherlands. 家庭机械通气的经济影响:来自荷兰的预算影响分析。
IF 4 3区 医学
BMJ Open Respiratory Research Pub Date : 2026-06-25 DOI: 10.1136/bmjresp-2025-003162
Ries van den Biggelaar, Marieke Duiverman, Anda Hazenberg, J F M van Boven, Karin Vermeulen, Peter J Wijkstra
{"title":"Economic impact of initiation of home mechanical ventilation: a budget impact analysis from the Netherlands.","authors":"Ries van den Biggelaar, Marieke Duiverman, Anda Hazenberg, J F M van Boven, Karin Vermeulen, Peter J Wijkstra","doi":"10.1136/bmjresp-2025-003162","DOIUrl":"10.1136/bmjresp-2025-003162","url":null,"abstract":"<p><strong>Objective: </strong>In addition to the already positive outcomes of initiating home mechanical ventilation (HMV) at home, we aimed to explore the economic impact of implementation of initiating HMV at home versus traditional clinical settings, focusing on the Dutch healthcare system.</p><p><strong>Methods: </strong>An Excel-based cost calculator model was used adhering to International Society of Pharmacoeconomics and Outcomes Research (ISPOR) budget impact analysis guidelines and based on the estimated population of HMV patients from 2023 to 2027 in the Netherlands. We compared home initiation of HMV against inpatient initiation in two scenarios based on patient eligibility and assessed financial impact from both health payer and societal perspectives.</p><p><strong>Results: </strong>Substantial cost savings in both scenarios were observed, with significant reductions in hospital admission days and in waiting time among patients who initiated treatment at home. The main scenario (55% of patients initiated at home) indicated savings of €8.4 million for health payers and €10.0 million from a societal perspective over 5 years. The high-uptake scenario (85% of patients initiated at home) showed even greater savings: €13.8 million for health payers and €16.4 million from a societal perspective over 5 years. Tornado diagrams highlighted the low risk of unsuccessful implementation and potential for greater benefits than projected.</p><p><strong>Conclusion: </strong>Initiating HMV at home yields substantial budget savings for payers and society in the Netherlands without compromising previously demonstrated clinical outcomes. These findings support broader implementation of home-based HMV initiation and may inform reimbursement reform and wider adoption of home-based HMV initiation.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13311772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148326706","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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