BMJ OpenPub Date : 2025-10-15DOI: 10.1136/bmjopen-2024-096665
Fengyi Jiang, Song Zhou, Tao Liang, Jiao Jiang, Xiaoyue Yang, Yanxia Huang
{"title":"Ideal cardiovascular health and its associated factors among young people in Zhuhai, China: a cross-sectional study.","authors":"Fengyi Jiang, Song Zhou, Tao Liang, Jiao Jiang, Xiaoyue Yang, Yanxia Huang","doi":"10.1136/bmjopen-2024-096665","DOIUrl":"10.1136/bmjopen-2024-096665","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the status of ideal cardiovascular health (CVH) among young individuals in Zhuhai, China, and analyse the factors that affect it, providing a basis for formulating prevention strategies for cardiovascular diseases in young people.</p><p><strong>Design: </strong>A cross-sectional study.</p><p><strong>Setting: </strong>The Health Management Centre of the Fifth Affiliated Hospital of Sun Yat-sen University in Zhuhai, China.</p><p><strong>Participants: </strong>944 young individuals aged between 18 and 40 years were included.</p><p><strong>Inclusion criteria: </strong>at least a primary school education, the ability to communicate effectively in the local language and willingness to provide informed consent.</p><p><strong>Exclusion criteria: </strong>a history of cardiovascular and cerebrovascular diseases, cognitive impairment, previous tumour diagnoses, prior mental illnesses, severe liver, kidney and lung diseases and pregnancy.</p><p><strong>Outcome measures: </strong>Ideal CVH Scale scores and factors associated with ideal CVH among young populations.</p><p><strong>Results: </strong>The median score for ideal CVH among young individuals in Zhuhai was found to be 10 (9, 11), with 0.5% having all seven ideal CVH items, 1.6% exhibiting four ideal CVH behaviours and 45.1% possessing three ideal CVH physiological and biochemical factors. The proportions of seven CVH factors in an ideal state were as follows: physical activity, 13.3%; healthy diet, 30.9%; Body Mass Index, 54.6%; smoking, 81.1%; blood pressure, 56.2%; total cholesterol, 76.7% and blood sugar, 96.6%. Multiple linear regression analysis revealed that gender (β=-0.328, p=0.001, 95% CI -1.447 to -0.996), education level (β=0.068, p=0.046, 95% CI 0.004 to 0.451) and per capita monthly household income (β=0.092, p=0.007, 95% CI 0.050 to 0.320) were the main influencing factors on ideal CVH, explaining 12.3% of the variance.</p><p><strong>Conclusions: </strong>The ideal CVH status of young individuals in Zhuhai is not optimistic. Young males with low education levels and lower per capita family income are particularly lacking in ideal CVH behaviours. Therefore, these individuals should be targeted for interventions in the prevention and treatment of cardiovascular diseases.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e096665"},"PeriodicalIF":2.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298461","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}
BMJ OpenPub Date : 2025-10-15DOI: 10.1136/bmjopen-2025-101030
Shelly Melissa Pranic, Jasna Karačić Zanetti, Anika Pulumati, Josipa Bukic, Doris Rušić, Ana Seselja Perisin, Dario Leksur, Darko Modun
{"title":"Quality and readability of drug fact sheets for FDA-approved and emergency use authorised drug products for COVID-19 treatment: an observational study.","authors":"Shelly Melissa Pranic, Jasna Karačić Zanetti, Anika Pulumati, Josipa Bukic, Doris Rušić, Ana Seselja Perisin, Dario Leksur, Darko Modun","doi":"10.1136/bmjopen-2025-101030","DOIUrl":"10.1136/bmjopen-2025-101030","url":null,"abstract":"<p><strong>Objectives: </strong>To determine the quality of drug manufacturers' fact sheets for patients for COVID-19 therapeutics for baricitinib, convalescent plasma, anakinra, molnupiravir, nirmatrelvir/ritonavir, remdesivir, tocilizumab and vilobelimab, and fact sheet readability.</p><p><strong>Design: </strong>Cross-sectional document analysis.</p><p><strong>Setting: </strong>Fact sheets on COVID-19 drugs approved by the US Food and Drug Administration from 2020 to 2023.</p><p><strong>Primary and secondary outcome measures: </strong>Quality assessments with the 16-item DISCERN tool scored 16-80 points and 36-item Ensuring Quality of Information for Patients (EQIP) tool scored 0-36, where lower scores indicate low-quality information. We assessed readability with Flesch-Kincaid Reading Ease (ranges from 0 to 100 where higher scores correspond to reading ease). Higher grades indicated hard-to-read information: Flesch-Kincaid grade level (ranges from grades 0 to 18 (college graduate)), Gunning-Fog score (ranges from grades 0 to 20 (college graduate)), Coleman-Liau index (ranges from grade 4 to college graduate), automated readability index (ranging from grades 5 to 22 (college graduate)), Dale-Chall Readability (ranges from grade 4 to college graduate) and simple measure of gobbledygook (ranges from grade 3 to college graduate). Secondary outcomes were word, syllable and sentence counts. We reported percentages and the median (IQR).</p><p><strong>Results: </strong>We found 18 fact sheets that described 11 (63.5%) anti-virals (remdesivir (n=4), molnupiravir (n=4) and nirmatrelvir/ritonavir (n=3)) and 7 (37.5%) immune modulators (tocilizumab (n=2), baricitinib (n=2), convalescent plasma (n=1), anakinra (n=1) and vilobelimab (n=1)). DISCERN (median (IQR)) reliability was 4 (IQR 3-4) and 5 (1-5), while DISCERN treatment information was 3 (1-5) and 5 (1-5) for anti-virals and immune modulators, respectively. EQIP (median (IQR)) content was 12 (11-13) and 11 (11-13), identification of information was 4 (3-4) and 3 (3-3) and structure was 9 (8-9) and 9 (9-9) for anti-virals and immune modulators, respectively. Overall, fact sheets had median readability grade levels that ranged from 6.2 to 12.4. Anti-viral and immune modulator fact sheets had median readability grade levels from 6.1 to 12.5. Median (IQR) word, >4 syllable words and sentence counts were 1646.5 (1318.3-1934.8), 25.0 (21.3-29.8) and 118.0 (92.0-152.5) overall; 1758.00 (1200.0-2181.0), 23.0 (15.0-27.0) and 134.0 (82.0-185.0) for anti-virals; and 1461.0 (1341.0-1776.0), 29.0 (23.0-46.0) and 107.0 (105.0-122.0) for immune modulators, respectively.</p><p><strong>Conclusions: </strong>Although of fair quality, the fact sheet reading level was high, and the transparency of sources used was low. Regulatory officials should enforce readable resources from drug manufacturers to guide patients' decision-making surrounding COVID-19 therapeutics.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e101030"},"PeriodicalIF":2.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298479","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}
BMJ OpenPub Date : 2025-10-15DOI: 10.1136/bmjopen-2024-093538
Xipeng Wang, Chengqiang Li, Yuqin Cao, Xiaozheng Kang, Xuefeng Leng, Yan Zheng, Bin Zheng, Wei Guo, Hui Jing, Yongtao Han, Chun Chen, Yin Li, Hecheng Li
{"title":"Neoadjuvant camrelizumab combined with chemoradiotherapy and watch-and-wait strategy versus neoadjuvant chemoradiotherapy followed by surgery in locally advanced oesophageal squamous cell carcinoma: study protocol of a randomised controlled trial (PALACE-3).","authors":"Xipeng Wang, Chengqiang Li, Yuqin Cao, Xiaozheng Kang, Xuefeng Leng, Yan Zheng, Bin Zheng, Wei Guo, Hui Jing, Yongtao Han, Chun Chen, Yin Li, Hecheng Li","doi":"10.1136/bmjopen-2024-093538","DOIUrl":"10.1136/bmjopen-2024-093538","url":null,"abstract":"<p><strong>Introduction: </strong>Combining immunotherapy with neoadjuvant chemoradiotherapy (neoCRT) has been shown to be safe, achieving a pathological complete response (pCR) rate of 56% in patients with locally advanced oesophageal squamous cell carcinoma (ESCC) in the PALACE-1 trial. This high pCR rate encourages us to explore the feasibility of postponing surgery after immunotherapy combined with neoCRT under active surveillance. This study aims to assess the efficacy, safety and patient-reported quality of life (QOL) of camrelizumab combined with neoCRT and watch-and-wait strategy versus neoCRT followed by surgery in locally advanced resectable ESCC.</p><p><strong>Methods and analysis: </strong>The PALACE-3 trial is a multicentre, open-label, randomised non-inferiority trial expected to recruit 356 patients from six high-volume centres in China. The study is planned to start in May 2024 and end in December 2028. Eligible patients will be randomly assigned (1:1 ratio) to either camrelizumab combined with neoCRT and watch-and-wait strategy or neoCRT followed by surgery (standard surgery). In the active surveillance group, patients achieving a clinical complete response (cCR) to camrelizumab combined with neoCRT will undergo active surveillance, while those with residual disease or locoregional recurrence will undergo immediate surgery. Patients in the standard surgery group will proceed to surgery after neoCRT. The primary endpoint is the 3-year overall survival (OS) rate. The secondary endpoints include cCR rate, salvage surgery incidence, objective response rate, adverse events during the neoadjuvant therapy, pCR, tumour regression grade, R0 resection rate, lymph node ratio, perioperative complications, disease-free survival (DFS) and 3-year DFS rate, OS and health-related QOL.</p><p><strong>Ethics and dissemination: </strong>This study has been approved by the Ethics Committee of Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital (Shanghai, China), as well as the ethics committees of the following participating centres: National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (Beijing, China); Sichuan Cancer Hospital and Institute, Sichuan Cancer Centre, School of Medicine, University of Electronic Science and Technology of China (Chengdu, China); The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital (Zhengzhou, China); Fujian Medical University Union Hospital (Fuzhou, China). Complete information about the study status, relevant events and results will be regularly updated on the project's webpage on ClinicalTrials.gov. Written informed consent (Supplemental Material) will be obtained from each participant. All research outputs will be published in peer-reviewed journals and presented at national or international conferences.</p><p><strong>Trial registration number: </strong>The trial was metic","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e093538"},"PeriodicalIF":2.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530390/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298527","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}
BMJ OpenPub Date : 2025-10-15DOI: 10.1136/bmjopen-2024-097144
Katherine A McDermott, Clara C Vonderheide, Alexandria E Cronin, Ana-Maria Vranceanu, Evan Plys
{"title":"Community advisory boards to inform behavioural health research in primary care: protocol for a scoping review.","authors":"Katherine A McDermott, Clara C Vonderheide, Alexandria E Cronin, Ana-Maria Vranceanu, Evan Plys","doi":"10.1136/bmjopen-2024-097144","DOIUrl":"10.1136/bmjopen-2024-097144","url":null,"abstract":"<p><strong>Introduction: </strong>Most patients receive behavioural healthcare (BH) in a primary care setting, yet much of the BH research was not developed to account for eventual implementation. Areas of research and intervention that are considered priorities to patients may be absent from our existing knowledge base. Engaging the community in the research process can facilitate translation and uptake. A key strategy for community engagement is to employ a Community Advisory Board (CAB). CABs can assist in a number of research processes, including guiding research questions to fit the priorities of the community and creating research materials that are tailored to the patient population and healthcare setting. There is variability in practices and reporting standards for CABs. The field would benefit from a summary of the state of the current literature on CAB utilisation for BH research in primary care. To fill this gap, we will conduct a scoping review to answer the question, 'What is known about the use of CABs in behavioural health studies in primary care?'.</p><p><strong>Methods and analysis: </strong>We will use the guidelines for scoping reviews outlined by Arksey and O'Malley: (1) identifying the research question; (2) identifying relevant studies; (3) study selection; (4) charting the data and (5) collating, summarising and reporting the results. Our reporting of the results will be guided by the Arnos and colleagues Toolkit for Project-Based Community Advisory Boards, a set of practical guidelines for employing a CAB. To this end, we will report on how well CABs currently employed in BH primary care research match existing guidelines and what gaps need to be filled by future research.</p><p><strong>Ethics and dissemination: </strong>This review does not require ethics board approval, as no patient data will be collected. We will disseminate findings primarily through journal publications and conference presentations.</p><p><strong>Trial registration number: </strong>This scoping review protocol was registered on the Open Science Framework (https://osf.io/pa3rz/?view_only=31c558eb395a4a9482ee9c5b57ca1c4c).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e097144"},"PeriodicalIF":2.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298272","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}
BMJ OpenPub Date : 2025-10-15DOI: 10.1136/bmjopen-2025-100024
Natalia Petka-Nosal, Iwona A Bielska, Katarzyna Badora-Musiał, Katarzyna Nowak-Zając, Alicja Domagała, Małgorzata Gałązka-Sobotka, Iwona Kowalska-Bobko
{"title":"Skill mix changes in healthcare professions during the COVID-19 pandemic: a scoping review.","authors":"Natalia Petka-Nosal, Iwona A Bielska, Katarzyna Badora-Musiał, Katarzyna Nowak-Zając, Alicja Domagała, Małgorzata Gałązka-Sobotka, Iwona Kowalska-Bobko","doi":"10.1136/bmjopen-2025-100024","DOIUrl":"10.1136/bmjopen-2025-100024","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of the scoping review was to systematise the existing knowledge about skill mix changes among the healthcare workforce during the COVID-19 pandemic.</p><p><strong>Design: </strong>Scoping review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review.</p><p><strong>Data sources: </strong>Five databases including CINAHL Ultimate, Web of Science, Medline, Embase and Scopus were searched in August 2024.</p><p><strong>Eligibility criteria: </strong>The review encompassed original research studies published from January 2020 to August 2024, on the skill mix of healthcare workers during the COVID-19 pandemic. Quantitative and qualitative studies were included without geographical or linguistic restrictions.</p><p><strong>Data extraction and synthesis: </strong>Data were independently extracted by two researchers, capturing details such as publication year, study title, country, target population, study purpose and methodology, sample size, analysed variables, results and recommendations.</p><p><strong>Results: </strong>A total of 13 563 records were identified in the databases of which 3962 remained for abstract review. 32 articles were included in the final analysis. 17 of the 32 papers were from Western and Southern Europe. The healthcare professions which were described in the studies were physicians, nurses, midwives, paramedics, pharmacists, physiotherapists, occupational therapists and medical assistants, of which the majority of the studies were conducted among nurses (n=16), pharmacists (n=11) and physicians (n=6). Most studies (n=9) concerned the adding of new tasks/roles and reallocating tasks in combination with teamwork (n=8). Research covered a range of topics, including psychological aspects of work, patient safety, work reorganisation, training and collaboration. Many studies focused on the challenges related to skill mix, such as the blurring of responsibilities and role ambiguity.</p><p><strong>Conclusions: </strong>The research summarised in this review demonstrates the impact of implementing skill mix changes on healthcare workers during the COVID-19 pandemic, particularly in the area of mental health. The research highlights the importance of adaptation in response to pressures among healthcare professions and the entire system. Further research is needed to examine the long-term impact of skill mix on healthcare workers across regions and professions in crisis situations.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e100024"},"PeriodicalIF":2.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530391/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298311","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}
{"title":"Effectiveness of primary care-led low-carbohydrate diet and self-management advice on glycaemic control in individuals with type 2 diabetes mellitus: protocol of a cluster randomised controlled trial.","authors":"Joshua Chadwick, Parasuraman Ganeshkumar, Kathiresan Jeyashree, Hemant Deepak Shewade, Madhanraj Kalyanasundaram, Devika Shanmugasundaram, Lokesh Shanmugam","doi":"10.1136/bmjopen-2025-100310","DOIUrl":"10.1136/bmjopen-2025-100310","url":null,"abstract":"<p><strong>Introduction: </strong>Dietary modification, particularly low-carbohydrate diet, and diabetes self-management education (DSME) have shown promise in improving glycaemic control among persons with type 2 diabetes mellitus (T2DM). However, real-world evidence from India is limited. This protocol describes the methods of a cluster randomised trial to determine the effectiveness and feasibility of adopting a low-carbohydrate diet among persons with T2DM.</p><p><strong>Methods and analysis: </strong>Our cluster-randomised trial with a mixed-method process evaluation will use computer-generated block randomisation sequence to randomise Urban Primary Health Centres (UPHCs) (n=16) to either continue delivering the usual guideline-based care under the National Programme for Prevention and Control of Non-Communicable Diseases (NPNCD) or our study intervention. The study intervention will comprise a personalised nutrition counselling focusing on (i) low-carbohydrate diet (<130 g/day) (ii) diabetes self-management principles. A primary care nurse will deliver the intervention at baseline, 3, 6, 9 and 12 months.We will include persons with T2DM, over the age of 30 years and above, irrespective of comorbidities, registered in the selected UPHC under care for diabetes for at least a month and with an glycated haemoglobin (HbA1c) level ≥6.5% during the screening test. We will collect data electronically using semistructured questionnaires and measure HbA1c, blood pressure, lipid profile, serum creatinine and body weight at baseline, 3, 6, 9 and 12 months after enrolment. We will use a difference in difference analysis, adjusted for clustering, to compare the change in HbA1c at the follow-up visits compared with baseline across the two study arms. We will conduct both intention-to-treat and per-protocol analysis, exploring reasons for differences in effect size.</p><p><strong>Ethics and dissemination: </strong>The study protocol was reviewed and approved by the Scientific Advisory Committee/Institutional Human Ethics Committee of the research institution (NIE/IHEC/202302-03). The findings of this study will be disseminated through publication in peer-reviewed journals.</p><p><strong>Trial registration number: </strong>Clinical Trials Registry-India (CTRI/2024/02/062202).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e100310"},"PeriodicalIF":2.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298422","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}
BMJ OpenPub Date : 2025-10-15DOI: 10.1136/bmjopen-2025-101289
Juan José Castón, Clara Aparicio, Aurora Paez-Vega, Lorena Pozo López, Estefanía García, Carmen Martín, Elisa Ruiz-Arabi, María Ángeles Cuesta-Casas, María Aránzazu Bermúdez-Rodriguez, Juan Manuel Cerezo-Martín, Pedro Antonio González-Sierra, Isabel Machuca, Francisco Manuel Martín Domínguez, Raquel Saldaña-Moreno, Concepción Herrera, Julian Torre-Cisneros
{"title":"Impact of CMV-specific immune reconstitution at the end of letermovir prophylaxis on the development of late cytomegalovirus infection in haematopoietic stem cell transplant recipients (INMUNOEND): a protocol for a prospective, observational, multicentre study.","authors":"Juan José Castón, Clara Aparicio, Aurora Paez-Vega, Lorena Pozo López, Estefanía García, Carmen Martín, Elisa Ruiz-Arabi, María Ángeles Cuesta-Casas, María Aránzazu Bermúdez-Rodriguez, Juan Manuel Cerezo-Martín, Pedro Antonio González-Sierra, Isabel Machuca, Francisco Manuel Martín Domínguez, Raquel Saldaña-Moreno, Concepción Herrera, Julian Torre-Cisneros","doi":"10.1136/bmjopen-2025-101289","DOIUrl":"10.1136/bmjopen-2025-101289","url":null,"abstract":"<p><strong>Introduction: </strong>Cytomegalovirus (CMV) infection is a common complication in patients undergoing haematopoietic stem cell transplantation (SCT). Letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, a study is needed to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualisation of CMV prophylaxis duration in these patients.</p><p><strong>Methods and analysis: </strong>INMUNOEND is a multicentre, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post SCT. Immunological and virological monitoring will be conducted until day+200 post-SCT. The primary outcome is the percentage of patients who develop clinically significant CMV infection up to day+200 post-SCT after completing LTV prophylaxis. Data collected will include baseline characteristics of the haematological diseases and comorbidities, variables related to SCT (ie, engrafment, graft-versus-host disease, use of LTV and CMV replication) and variables related to CMV-specific immune reconstitution.</p><p><strong>Ethics and dissemination: </strong>Ethical approval has been obtained from the institutional review board (Comité de Ética de la Investigación de Córdoba; SICEIA-2024-0 01 762). The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.</p><p><strong>Trial registration number: </strong>NCT06814301.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e101289"},"PeriodicalIF":2.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298478","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}
BMJ OpenPub Date : 2025-10-14DOI: 10.1136/bmjopen-2025-100684
Christine Tricia Kulabako, Linda Madsen
{"title":"<i>If the pain is too much, you go to a hospital</i>: a qualitative study on health-seeking behaviour for human brucellosis in Nakasongola cattle corridor, Uganda.","authors":"Christine Tricia Kulabako, Linda Madsen","doi":"10.1136/bmjopen-2025-100684","DOIUrl":"10.1136/bmjopen-2025-100684","url":null,"abstract":"<p><strong>Objective: </strong>Brucellosis ranks fourth among the top seven priority zoonotic diseases for control in Uganda. The effect of individual actions on controlling the spread of infectious diseases in humans and the choices people make regarding symptoms and suspicions must be given a critical role in the management of zoonotic diseases. Understanding the experiences that shape response to brucellosis is crucial if we are to effectively control the spread of brucellosis in the human population. This study aimed to explore people's experiences and health-seeking behaviour for human brucellosis and elucidate any challenges as perceived by the affected population. This study involved exploring the facilitating factors for seeking healthcare from the perspectives of the affected population and the potential barriers in accessing health services in Nakasongola.</p><p><strong>Design: </strong>Descriptive qualitative study.</p><p><strong>Setting: </strong>The study was conducted in the cattle corridor of Nakasongola District within three sub-counties of Nabiswera, Wabinyonyi and Nakitoma, which were purposively selected because of the large herd number (150 cattle per square km and 30-50 cattle per household), high prevalence of brucellosis in humans, thus extensive human-animal interaction, and the community's susceptibility to brucellosis. Data were collected from November 2023 to January 2024.</p><p><strong>Participants: </strong>Semi-structured, face-to-face interviews were conducted by the first author with 15 participants for in-depth interviews, who included the people who were recovering/had recovered and their caretakers, and 20 key informants including medical personnel, village health team members and social leaders who were purposively selected.</p><p><strong>Analysis: </strong>Thematic analysis was conducted to group themes originating in the data into higher-order themes using inductive and deductive approaches.</p><p><strong>Results: </strong>Key themes were identified in line with literature and the healthcare systems model. The findings highlighted a series of factors that influence and inhibit health-seeking behaviour for human brucellosis. Participants identified the role of sex and religion as some of the social factors, barriers to health information and perceptions of healthcare quality, accessibility and availability of treatment. These insights show the importance of understanding broader social norms and health system constraints to improve timely diagnosis, treatment adherence and overall disease control.</p><p><strong>Conclusion: </strong>Addressing the factors identified requires a diverse approach that includes improving the quality of health services, promoting health education, challenging societal norms around gender and illness and leveraging the role of religious communities in health promotion. Such efforts could ultimately improve health outcomes in the affected community.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e100684"},"PeriodicalIF":2.3,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12519722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291078","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}
{"title":"Prevalence and risk of adverse intrapartum-related outcomes in Uganda: a cross-sectional study with nested case-control.","authors":"Phillip Wanduru, Manuela Straneo, Samantha Sadoo, Cally J Tann, Angelina Mwesige Kakooza, Rolland Mutumba, Kristi Sidney Annerstedt, Peter Waiswa, Claudia Hanson","doi":"10.1136/bmjopen-2025-099256","DOIUrl":"10.1136/bmjopen-2025-099256","url":null,"abstract":"<p><strong>Introduction: </strong>Intrapartum-related complications are a leading cause of adverse perinatal outcomes, including stillbirths, neonatal deaths and intrapartum-related neonatal encephalopathy (IP-NE). We assessed the prevalence of adverse intrapartum-related outcomes, evaluated the association between IP-NE and obstetric and fetal risk factors, and examined whether emergency referral and emergency caesarean section (CS) modified this association through interaction effects.</p><p><strong>Design: </strong>Cross-sectional with a nested case-control study.</p><p><strong>Setting: </strong>Two hospitals in rural Eastern Uganda.</p><p><strong>Population: </strong>Women giving birth to a live or stillborn baby weighing >2000 g between June and December 2022.</p><p><strong>Methods: </strong>We used prospectively collected perinatal e-registry data to assess the prevalence of adverse perinatal outcomes. Logistic regression with interaction with postregression margins analysis was used to determine the association between IP-NE and emergency referral and emergency CS across risk groups of hypertensive disorders, antepartum haemorrhage, prolonged/obstructed labour and birth weight.</p><p><strong>Main outcome measures: </strong>Adverse perinatal outcomes were stillbirths, 24-hour neonatal deaths and IP-NE (defined as Apgar score <7 at 5 min, cord blood lactate ≥5.5 mmol/L and Thompson score ≥5).</p><p><strong>Results: </strong>Of 6550 births, 10.2% had an adverse perinatal outcome: 3.8% stillbirths, 0.6% neonatal deaths and 5.7% IP-NE. Adverse outcomes were higher among neonates whose mothers had antepartum haemorrhage (31.3%) or prolonged/obstructed labour (27.2%) compared with those whose mothers had no complications. Emergency referral and CS did not change the association between IP-NE and obstetric risk, except in prolonged/obstructed labour. Without emergency CS, the predicted probability of IP-NE was 0.73 (95% CI 0.51 to 0.95); with CS, it decreased to 0.45 (95% CI 0.39 to 0.50).</p><p><strong>Conclusions: </strong>Neonates born to mothers with obstetric complications had low healthy survival rates. Emergency referral and CS did not alter the risks of IP-NE in women with obstetric complications except for obstructed or prolonged labour, highlighting that these interventions may not be implemented with sufficient timeliness or quality, and/or that additional, more targeted strategies beyond referral and CS are needed to address IP-NE.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e099256"},"PeriodicalIF":2.3,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12519689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291103","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}
BMJ OpenPub Date : 2025-10-14DOI: 10.1136/bmjopen-2025-102742
Jingya Yu, Xuemei Yang, Lixia Kuang, Yu Zhang, Lu Bai, Yajun Li, Xiaoqin Bi
{"title":"Design and evaluation of the pulmonary rehabilitation programme for patients with oral and maxillofacial cancer: a randomised controlled trial protocol.","authors":"Jingya Yu, Xuemei Yang, Lixia Kuang, Yu Zhang, Lu Bai, Yajun Li, Xiaoqin Bi","doi":"10.1136/bmjopen-2025-102742","DOIUrl":"10.1136/bmjopen-2025-102742","url":null,"abstract":"<p><strong>Introduction: </strong>Postoperative pulmonary complications are a common and significant concern following head and neck surgeries. Patients with oral and maxillofacial cancer are particularly susceptible to reduced pulmonary function, impaired exercise capacity and diminished quality of life. Pulmonary rehabilitation (PR) has been widely validated as an effective intervention for managing respiratory diseases, improving functional capacity and enhancing health-related quality of life. However, a critical gap persists in developing PR programmes specifically tailored to the distinct physiological and functional challenges faced by patients with oral and maxillofacial cancer. This protocol introduces an innovative PR intervention uniquely designed to address these challenges, bridging the gap in current rehabilitation practices and offering a comprehensive approach to improve recovery outcomes.</p><p><strong>Methods and analysis: </strong>This single-blind, two-arm, randomised controlled trial will enrol 144 patients with oral and maxillofacial malignancies from a tertiary hospital in China. Participants will be randomly assigned to either the intervention group (n=72), receiving routine care alongside a tailored PR programme designed by the research team, or the control group (n=72), receiving routine care alone. The primary outcome is pulmonary function, which is assessed using pulmonary function tests. Secondary outcomes include exercise capacity, quality of life and cancer-related fatigue. Outcomes will be assessed at three time points: baseline (T0), before discharge and 2 months postdischarge (T1), allowing for evaluation of both immediate and sustained intervention effects.</p><p><strong>Ethics and dissemination: </strong>The trial has received ethical approval from the Ethics Committee of West China Hospital of Stomatology, Sichuan University (WCHSIRB-D-2025-025). Study findings will be disseminated through peer-reviewed journals and conference presentations.</p><p><strong>Trial registration number: </strong>ChiCTR2500099236.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e102742"},"PeriodicalIF":2.3,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12519653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291032","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}