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Sleep disturbance and risk of incident incontinence in middle-aged and older Chinese adults: a 4-year national cohort study. 中国中老年人睡眠障碍与尿失禁风险:一项为期4年的国家队列研究
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-09 DOI: 10.1136/bmjopen-2025-108424
Yuefan Shen, Weixin Zhang, Jianguo Gao, Sihai Shao

Objectives: This study aimed to investigate the longitudinal association between sleep disturbance and the risk of new-onset incontinence in middle-aged and older Chinese adults and to explore whether chronic lung diseases mediate this relationship.

Design: A prospective cohort study based on a nationally representative survey.

Setting: Data were obtained from the China Health and Retirement Longitudinal Study, a national survey of middle-aged and elderly community-dwelling Chinese adults.

Participants: A total of 7098 participants aged ≥50 years who were continent at baseline in 2011 and completed follow-up in 2015 were included in the analysis.

Measures: Sleep disturbance was assessed via self-report and categorised into good versus poor quality. Incident incontinence was defined as a new onset of difficulty in controlling urination or defecation. Multivariable logistic regression models were used to estimate the association between baseline sleep disturbance and incident incontinence, adjusting for sociodemographic, behavioural and health-related covariates. Mediation analysis was conducted to evaluate the indirect role of chronic lung disease in the sleep-incontinence pathway. Subgroup and interaction analyses assessed whether key demographic or health factors influenced the sleep-incontinence association.

Results: Sleep disturbance at baseline was significantly associated with a higher risk of developing incontinence over 4 years (adjusted OR 1.34, p=0.040). This association remained robust across subgroups, particularly among participants aged ≥65 years, rural residents, those with higher education and those with chronic lung disease. Mediation analysis revealed that chronic lung disease partially mediated the relationship between sleep disturbance and incontinence, accounting for 7.59% of the total effect (indirect effect: 0.00104, 95% CI 0.00012 to 0.00170). Subgroup and interaction analyses confirmed the consistency of the findings across various demographic and health strata.

Conclusion: Sleep disturbance was associated with higher odds of incident incontinence among middle-aged and older Chinese adults. Chronic lung disease contributed modestly to this association. These findings underscore the potential importance of sleep health and comorbidity management in continence care for ageing populations.

目的:本研究旨在探讨中国中老年成人睡眠障碍与新发尿失禁风险之间的纵向关联,并探讨慢性肺部疾病是否介导了这种关系。设计:基于全国代表性调查的前瞻性队列研究。背景:数据来自中国健康与退休纵向研究,这是一项针对中国中老年社区居民的全国性调查。参与者:共有7098名年龄≥50岁的参与者被纳入分析,他们在2011年基线时处于大陆状态,并在2015年完成随访。测量方法:通过自我报告对睡眠障碍进行评估,并将其分为质量好与质量差。偶发性尿失禁被定义为控制排尿或排便困难的新发作。多变量logistic回归模型用于估计基线睡眠障碍与事件性尿失禁之间的关联,并对社会人口统计学、行为和健康相关协变量进行调整。通过中介分析评估慢性肺部疾病在睡眠失禁通路中的间接作用。亚组分析和相互作用分析评估了关键的人口统计学或健康因素是否影响睡眠失禁的关联。结果:基线睡眠障碍与4年内发生尿失禁的高风险显著相关(调整OR为1.34,p=0.040)。这种关联在各个亚组中仍然很强,特别是在年龄≥65岁、农村居民、受过高等教育和患有慢性肺病的参与者中。中介分析显示,慢性肺部疾病部分介导了睡眠障碍与尿失禁的关系,占总效应的7.59%(间接效应:0.00104,95% CI 0.00012 ~ 0.00170)。亚组分析和相互作用分析证实了不同人口和健康阶层调查结果的一致性。结论:睡眠障碍与中国中老年人群尿失禁发生率增高有关。慢性肺部疾病对这种关联有一定影响。这些发现强调了睡眠健康和合并症管理在老年人失禁护理中的潜在重要性。
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引用次数: 0
Effect of enhanced support for coping with side effects during medication counselling on the nocebo effect in patients with advanced lung cancer receiving initial chemotherapy: protocol for a multicentre exploratory open-label randomised controlled trial. 在接受初始化疗的晚期肺癌患者中,在药物咨询期间加强应对副作用的支持对反安慰剂效应的影响:一项多中心探索性开放标签随机对照试验方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-09 DOI: 10.1136/bmjopen-2025-103580
Ryohei Fujii, Yoshinobu Matsuda, Miyuki Okada, Haruka Ishikura, Yusuke Imai, Risako Muraoka, Hideaki Hasuo

Introduction: Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in cancer, and it is one of the distressing symptoms in patients with cancer receiving chemotherapy. Information about side effects may exacerbate CINV due to the nocebo effect. This study aims to examine the efficacy of pharmacist-led enhanced support for coping with side effects during medication counselling, which includes providing information about side effects, with the goal of mitigating the nocebo effect and reducing CINV.

Methods and analysis: This multicentre exploratory open-label randomised controlled trial will examine the efficacy of pharmacist-led enhanced support for coping with the side effects of treatments during medication counselling in patients with advanced lung cancer. The control group will receive medication counselling as usual. The study population will consist of patients with advanced lung cancer who have not received chemotherapy and are receiving highly emetogenic chemotherapy or equivalent chemotherapy. The primary endpoint is the prevention of nausea, and the secondary endpoints include complete response (no vomiting event and no rescue medication), stress (objectively assessed using the salivary cortisol and immunoglobulin A), coping strategies and quality of life.

Ethics and dissemination: This study received approval from the medical ethics committee of Kansai Medical University. The results will be submitted for publication in an international peer-reviewed journal, and the findings will be presented at international scientific conferences.

Protocol version: 1.0, 18 Mar 2025 TRIAL REGISTRATION NUMBER: Registration number: UMIN000056068.

化疗引起的恶心和呕吐(CINV)是癌症患者常见的症状,是癌症患者接受化疗的痛苦症状之一。由于反安慰剂效应,有关副作用的信息可能会加剧CINV。本研究旨在检验在药物咨询期间,药剂师主导的强化支持对应对副作用的有效性,包括提供有关副作用的信息,以减轻反安慰剂效应和减少CINV。方法和分析:这项多中心探索性开放标签随机对照试验将检验药师主导的增强支持在晚期肺癌患者药物咨询期间应对治疗副作用的有效性。对照组照常接受药物咨询。研究人群将包括未接受化疗且正在接受高致吐性化疗或同等化疗的晚期肺癌患者。主要终点是恶心的预防,次要终点包括完全缓解(无呕吐事件和无抢救药物)、压力(使用唾液皮质醇和免疫球蛋白A客观评估)、应对策略和生活质量。伦理与传播:本研究获得关西医科大学医学伦理委员会的批准。研究结果将在国际同行评议期刊上发表,研究结果将在国际科学会议上发表。协议版本:1.0,2025年3月18日试验注册号:注册号:UMIN000056068。
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引用次数: 0
Azithromycin use in labour to prevent sepsis among pregnant women undergoing vaginal delivery in Nigeria (AZIN-V): a study protocol for a hybrid type 2 effectiveness-implementation trial. 在尼日利亚阴道分娩的孕妇中使用阿奇霉素预防败血症(AZIN-V):一项混合型2有效性实施试验的研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-110719
Bosede Bukola Afolabi, Christian Chigozie Makwe, Esther Oluwakemi Oluwole, Chisom Obi-Jeff, Eleanor J Mitchell, Aduragbemi Banke-Thomas, Titilope Adenike Adeyemo, Ajibola Ibraheem Abioye, Ejemai Amaize Eboreime, Abdulhadi Diyo Saidu, Udo Abali Okoro, Patricia Akintan, Chioma Stella Osuagwu, Chisom Florence Chieme, Teniola Lawanson, Anower Hossain, Kate Walker
<p><strong>Introduction: </strong>Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%-60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.</p><p><strong>Methods and analysis: </strong>This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria's unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care-the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.</p><p><strong>Ethics and dissemination: </strong>This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Commi
导言:尼日利亚是全球孕产妇死亡率最高的国家,产妇围产期败血症是孕产妇死亡的主要原因之一。单次口服阿奇霉素(AZM; 2g)是安全的,可有效减少低收入和中等收入国家计划阴道分娩期间33%-60%的产妇败血症。然而,在尼日利亚,由于抗菌素管理做法不佳、抗菌素耐药性严重和卫生保健筹资,阴道分娩期间口服AZM的临床和成本效益仍然未知。在尼日利亚进行阴道分娩的孕妇中,预防产妇败血症的标准护理也缺乏证据。AZIN-V试验是一项混合型有效性实施试验,旨在确定产时口服AZM与常规护理在预防围产期产妇败血症方面的安全性、临床和成本效益。该试验还将检查实施策略对提高计划阴道分娩期间口服AZM方案的依从性的影响,并确定在实际低收入和中等收入国家环境中提高对方案的依从性(保真度)的有效策略。方法和分析:这是一项在尼日利亚六个州进行的多中心混合型2型试验:埃邦伊、埃多、贡贝、卡诺、夸拉和拉各斯。该研究旨在同时测试AZM的临床和成本效益(临床试验)以及实施战略(实施研究)在尼日利亚独特的医疗保健环境中的影响。该临床试验是一项在48家卫生机构进行的两组、集群随机对照试验,随机(1:1)分配到分娩时口服AZM(干预组)或常规护理-目前的常规做法(对照组)。共有5040名研究参与者(每组2520人)将被纳入临床试验。实施试验是一项两组非随机对照试验,在12个卫生设施中进行(1:1),分为采用计划-执行-研究-行动周期的自下而上方法或采用采用一次性培训讲习班和分发临床指南的通常自上而下方法,两组在阴道分娩期间口服AZM,同时评估保真度(主要结果)。对于临床试验,数据将使用意向治疗统计方法进行分析。成本效益结果将使用增量成本效益比进行分析。将使用描述性统计和专题方法分析执行结果。伦理与传播:本研究已获得尼日利亚国家卫生研究伦理委员会(NHREC/01/01/2007-30/09/2024)、参与卫生机构伦理委员会(拉各斯大学教学医院卫生研究伦理委员会:ADM/DSCST/HREC/APP/6325;伊洛林大学教学医院卫生研究伦理委员会:ERC/PAN/2025/03/0581;贝宁大学教学医院卫生研究伦理委员会:ADM/E22/A/VOL)批准。七世/ 483117141;Aminu Kano教学医院研究伦理委员会:AKTH/MAC/SUB/12 A/P-3/VI/2509和Irrua专科教学医院研究伦理委员会:ISTH/HREC/20241507/605)、六个州的卫生部和国家食品药品监督管理局。在入组前,将获得所有符合条件的研究参与者的书面知情同意。研究结果将通过同行评议的期刊与社区和政策利益攸关方分享,并将在会议上发表。试验注册号:ISRCTN16415327。
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引用次数: 0
Deep phenotyping of suicidal ideation after discharge from psychiatric inpatient care: study protocol for an interdisciplinary, multicentre prospective observational study in Psychiatric University Hospitals. 精神科住院病人出院后自杀意念的深度表型:精神科大学医院跨学科、多中心前瞻性观察研究的研究方案
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-111273
Anna Monn, Stephanie Homan, Jacopo Mocellin, Schwarna Maria Raja, Lara Kirchhofer, Vivienne Walser, Eyal Liron Dolev, Marcia Nißen, Tobias Kowatsch, Guido Seiler, Katharina Schultebraucks, Sebastian Olbrich, Birgit Kleim

Introduction: Suicidal thoughts and behaviours (STB) are a critical public health concern, with 700 000 deaths by suicide each year. The period immediately following hospital discharge is associated with an elevated risk for suicide. Monitoring suicidal ideations throughout this period is therefore critical. However, its highly dynamic nature limits the utility of traditional risk assessments through infrequent outpatient visits. Recent advancements in ambulatory assessments and multimodal predictive approaches offer a promising new avenue. Hence, the present study aims to examine how psychological, linguistic, neurobiological and smartphone-based characteristics relate to suicidal ideation and to improve STB monitoring through a deep phenotyping approach.

Methods and analysis: In this interdisciplinary, multicentre, prospective observational study, we plan to recruit a total of 200 inpatients with current and/or past STB. The study comprises the following components: (1) a baseline assessment, conducted while participants are still in the hospital. This includes interviews, an electroencephalography recording, a video-recorded verbal task and self-report questionnaires; (2) data collection through a smartphone application during the first 4 weeks after hospital discharge with two active collection weeks of five daily ecological momentary assessments and two 1 min video diaries every other day, as well as smartphone passive sensing for 28 consecutive days and (3) two follow-up assessments, 4 weeks and 3 months after discharge. The primary outcome is self-reported suicidal ideation after hospital discharge.

Ethics and dissemination: The Ethics Committee of the Faculty of Arts and Social Sciences of the University of Zurich, Switzerland, approved the study for the Zurich and Basel sites (Ref: 22.09.19). Approval for the New York Site was granted by the Institutional Review Board of NYU Langone Health (i23-00366). Study findings will be disseminated via peer-reviewed, open-access publications, conference presentations, patient and public events, and dedicated social media outlets.

Trial registration number: CRSII5_205913.

导言:自杀念头和行为(STB)是一个严重的公共卫生问题,每年有70万人死于自杀。出院后的一段时间与自杀风险升高有关。因此,在此期间监测自杀意念至关重要。然而,其高度动态的性质限制了通过不频繁的门诊就诊进行传统风险评估的效用。动态评估和多模式预测方法的最新进展提供了一个有希望的新途径。因此,本研究旨在研究心理、语言、神经生物学和基于智能手机的特征如何与自杀意念相关,并通过深度表型方法改善STB监测。方法和分析:在这项跨学科、多中心、前瞻性观察性研究中,我们计划招募200名目前和/或过去患有STB的住院患者。该研究包括以下部分:(1)基线评估,在参与者仍在医院时进行。这包括访谈、脑电图记录、视频录制的口头任务和自我报告问卷;(2)出院后前4周通过智能手机应用程序收集数据,包括2周主动收集,每天5次生态瞬间评估和每隔一天2次1分钟视频日记,以及连续28天的智能手机被动感知。(3)出院后4周和3个月两次随访评估。主要结局是出院后自我报告的自杀意念。伦理与传播:瑞士苏黎世大学艺术与社会科学学院伦理委员会批准了苏黎世和巴塞尔地点的研究(参考文献:22.09.19)。纽约大学朗格尼健康中心的机构审查委员会(i23-00366)批准了纽约站点。研究结果将通过同行评审、开放获取的出版物、会议报告、患者和公共活动以及专门的社交媒体渠道传播。试验注册号:CRSII5_205913。
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引用次数: 0
Psychological recovery of nurses after emergencies and disasters: a systematic review protocol. 突发事件和灾害后护士的心理恢复:系统评价方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-105202
Yousof Akbari Shahrestanaki, Faranak Sadat Hosseini, Erfaneh Kashiha, Shaghayegh Norouzi, Fatemeh Mirzaei Jirandehi, Mehdi Beyrami Jam

Introduction: With the increasing frequency and intensity of disasters globally-and their profound effects on the mental well-being of healthcare professionals, particularly nurses-the psychological distress experienced by nurses following natural disasters has become a pressing issue. This study aims to explore prevalent patterns and effective interventions for supporting nurses' psychological recovery after disaster exposure, ultimately aiming to propose an optimal recovery model.

Methods and analysis: This systematic review will include qualitative, quantitative and mixed-methods studies, as well as relevant systematic reviews, published in English between 2010 and 2025. A comprehensive search will be conducted in PubMed, Web of Science, Scopus and Google Scholar. Study selection, data extraction and quality assessment will be performed independently by multiple reviewers, with methodological quality and risk of bias evaluated using the Mixed Methods Appraisal Tool. Due to anticipated heterogeneity, findings will be synthesised using thematic analysis.

Ethics and dissemination: This study protocol raises no ethical issues. The results will be shared through publication in peer-reviewed journals and presentations at appropriate academic conferences.

Prospero registration number: CRD420251014914.

导读:随着全球灾害频率和强度的增加,以及它们对医疗保健专业人员,特别是护士的心理健康的深刻影响,护士在自然灾害后所经历的心理困扰已成为一个紧迫的问题。本研究旨在探讨灾害暴露后护士心理恢复的流行模式和有效干预措施,最终提出最优的恢复模式。方法和分析:本系统综述将包括定性、定量和混合方法研究,以及相关的系统综述,在2010年至2025年期间以英文发表。将在PubMed, Web of Science, Scopus和b谷歌Scholar中进行全面搜索。研究选择、数据提取和质量评估将由多位审稿人独立完成,方法学质量和偏倚风险使用混合方法评估工具进行评估。由于预期的异质性,调查结果将采用专题分析加以综合。伦理与传播:本研究方案不涉及伦理问题。研究结果将在同行评议的期刊上发表,并在适当的学术会议上发表。普洛斯彼罗注册号:CRD420251014914。
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引用次数: 0
Perceptions of best practice, pain science and structure-focused education for rotator cuff-related shoulder pain: a content analysis of qualitative data from a randomised experiment. 对肩袖相关肩痛的最佳实践、疼痛科学和以结构为重点的教育的认识:一项随机实验定性数据的内容分析。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-107032
Zixin Zhang, Giovanni E Ferreira, Ryan Muller, Fernando Sousa, Peter Malliaras, Courtney A West, Mary O'Keeffe, Chris Maher, Joshua Zadro

Objectives: To explore how people perceive different forms of education for rotator cuff-related shoulder pain in terms of words or feelings evoked by the education and treatments they feel are needed.

Setting: We performed a content analysis of qualitative data collected in a randomised experiment.

Participants: 2237 participants with rotator cuff-related shoulder pain were randomly assigned to receive three forms of education: best practice education, best practice education plus pain science messages and structure-focused education.

Primary and secondary outcomes: After receiving the education, participants answered two questions regarding (1) words or feelings evoked by the education and (2) treatments they felt were needed.

Results: 2232 responses for each question were analysed (99.7% response rate). Participants who received best practice education more frequently expressed feelings of unhappiness/frustration. The addition of pain science messages to best practice education resulted in slightly more emotional responses and a greater sense of being validated or cared for. In contrast, participants who received structure-focused education more frequently expressed trust in the clinician's expertise and the need for medication, activity modification, rest, diagnostic imaging, injections and surgery. These participants also less frequently considered exercise as a viable treatment option.

Conclusion: Participants with rotator cuff-related shoulder pain expressed generally similar emotional responses across groups, with small differences in treatment preferences favouring self-management in the best practice education groups compared with those who received structure-focused education. Those in the best practice education also less frequently reported needing potentially unnecessary treatments (eg, imaging, injections and surgery).

Trial registration number: Australia New Zealand Clinical Trials Registry (ACTRN12623000197639).

目的:探讨人们对肩袖相关性肩痛不同形式的教育的感知,包括教育和治疗所唤起的语言或感觉。背景:我们对随机实验中收集的定性数据进行内容分析。参与者:2237名肩袖相关肩痛的参与者被随机分配接受三种形式的教育:最佳实践教育、最佳实践教育加疼痛科学信息和以结构为重点的教育。主要和次要结果:在接受教育后,参与者回答了两个问题,关于(1)教育引起的词语或感觉,以及(2)他们认为需要的治疗。结果:每个问题共分析2232份问卷,答复率99.7%。接受最佳实践教育的参与者更频繁地表达不快乐/沮丧的感觉。在最佳实践教育中加入疼痛科学信息,会产生更多的情绪反应,以及更大的被认可或被关心的感觉。相比之下,接受以结构为中心的教育的参与者更频繁地表达了对临床医生专业知识的信任,以及对药物治疗、活动调整、休息、诊断成像、注射和手术的需求。这些参与者也很少把运动作为一种可行的治疗选择。结论:与肩袖相关的肩部疼痛的参与者在各组中表达了大致相似的情绪反应,与接受结构关注教育的患者相比,最佳实践教育组在治疗偏好上倾向于自我管理方面存在微小差异。那些接受最佳实践教育的人也较少报告需要可能不必要的治疗(例如成像、注射和手术)。试验注册号:澳大利亚新西兰临床试验注册中心(ACTRN12623000197639)。
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引用次数: 0
Patient perspectives on harmonica playing as an intervention for chronic obstructive pulmonary disease: a qualitative study. 口琴演奏作为慢性阻塞性肺疾病干预的病人观点:一项定性研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-112115
Wenli Chen, Jingye Huang, Qiuxuan Zeng, Zeng Jie Ye, Junxin Li, Jiaying Li

Objectives: To qualitatively explore the lived experiences and perceptions of patients with chronic obstructive pulmonary disease (COPD) using the harmonica as a therapeutic intervention.

Design: A qualitative study.

Setting: The study was conducted at a tertiary hospital in Guangzhou, China.

Participants: Patients with COPD who had participated in supervised harmonica playing for at least 12 weeks. (clinical trial registration: NCT05995847).

Primary and secondary outcome measures: The study focused on patients' experiences, including perceived facilitators, barriers and needs regarding the intervention.

Results: We interviewed 19 patients with COPD between September and December 2024, with interviews lasting an average of 54 min (range: 36-77 min). Five primary themes were identified. Participants reported better physical functioning, including better breathing control, enhanced functional capacity and improved sleep quality. Psychological well-being improved with increased relaxation, emotional improvement and mental engagement. Patients also experienced increased social engagement and role shift, such as expanded social connections, family support and restored family roles. Harmonica playing promoted enhanced self-reliance and personal development, with increased self-management confidence, mastery of the harmonica and encouragement for lifelong learning. Barriers and challenges included physical limitations, breathing difficulties, adherence issues and concerns about the sustainability of long-term benefits.

Conclusions: Our study indicates that harmonica playing could improve physical health, psychological well-being, social participation and self-reliance, although barriers persist. Tailored programmes could enhance benefits and adherence, and future research should evaluate durability within comprehensive COPD care.

Trial registration number: NCT05995847.

目的:定性地探讨慢性阻塞性肺疾病(COPD)患者使用口琴作为治疗干预手段的生活体验和认知。设计:定性研究。环境:本研究在中国广州的一家三级医院进行。参与者:参与监督口琴演奏至少12周的COPD患者。(临床试验注册号:NCT05995847)。主要和次要结果测量:该研究侧重于患者的经历,包括对干预的感知促进因素、障碍和需求。结果:我们在2024年9月至12月期间采访了19名COPD患者,访谈平均持续54分钟(范围:36-77分钟)。确定了五个主要主题。参与者报告说,他们的身体机能得到了改善,包括更好的呼吸控制、功能能力的增强和睡眠质量的改善。心理健康随着放松、情绪改善和精神投入的增加而改善。患者也经历了更多的社会参与和角色转变,如扩大社会联系,家庭支持和恢复家庭角色。吹口琴可以增强自立和个人发展,增强自我管理的信心,掌握口琴,鼓励终身学习。障碍和挑战包括身体限制、呼吸困难、坚持问题和对长期利益可持续性的关注。结论:本研究表明,尽管存在障碍,但吹奏口琴可以改善身体健康、心理健康、社会参与和自力更生。量身定制的方案可以提高疗效和依从性,未来的研究应评估COPD综合治疗的持久性。试验注册号:NCT05995847。
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引用次数: 0
Multicentre international observational study on airway management for anaesthesia: the STARGATE study protocol. 麻醉气道管理的多中心国际观察研究:STARGATE研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-109038
Vincenzo Russotto, Chiara Sansovini, Massimo Muraccini, Francesca Collino, Sheila Nainan Myatra, Andrew Higgs, David Brewster, Renata Curić Radivojević, Matteo Parotto, Kunal Karamchandani, Giovanni Landoni, Massimiliano Sorbello, Mattia Monfroglio, Giulia Rovescala, Pietro Martinelli, Ornella Tinelli, Jennifer Meessen, Giacomo Bellani, John G Laffey, Olivier Langeron, Pietro Caironi

Introduction: More than 300 million major surgical procedures are carried out under general anaesthesia each year worldwide, and advanced airway management remains one of the leading daily challenges for clinicians. Data from large international prospective cohort studies on adverse events such as cardiovascular collapse, cardiac arrest and severe hypoxaemia during advanced airway management to facilitate anaesthesia are lacking.

Methods and analysis: The International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE) study will be an international prospective observational cohort study describing the incidence of major adverse events associated with advanced airway management (tracheal intubation or supraglottic airway device placement) for general anaesthesia in the operating and non-operating room for surgery and medical procedures. The secondary aim will be to describe the practice of airway management in a large international cohort. Critically ill patients will be excluded from this study. Data on patients' characteristics, type of procedure and the adopted airway management strategy, post-procedure adverse events, operator characteristics and in-hospital mortality will be prospectively collected. The study aims to enrol 10 500 patients.

Ethics and dissemination: The study has been approved by the Ethics Committee of the coordinating centre (Comitato Etico Interaziendale AOU San Luigi Gonzaga, N° 25/2023). Each of the participating centres will then seek approval of their local Ethics Committee before enrolment. Data will be disseminated to the scientific community by original articles submitted to international peer-reviewed journals.

Trial registration number: NCT05759299.

全球每年有超过3亿例重大外科手术是在全身麻醉下进行的,先进的气道管理仍然是临床医生每天面临的主要挑战之一。缺乏来自大型国际前瞻性队列研究的数据,这些研究涉及高级气道管理期间促进麻醉的心血管衰竭、心脏骤停和严重低氧血症等不良事件。方法和分析:国际手术室和非手术室麻醉气道管理观察研究(STARGATE)研究将是一项国际前瞻性观察队列研究,描述手术和医疗程序中手术和非手术室全身麻醉的高级气道管理(气管插管或声门上气道装置放置)相关的主要不良事件发生率。第二个目的是描述一个大型国际队列的气道管理实践。危重患者将被排除在本研究之外。前瞻性收集患者特征、手术类型和采用的气道管理策略、手术后不良事件、操作人员特征和住院死亡率等数据。这项研究的目标是招募10500名患者。伦理和传播:该研究已得到协调中心伦理委员会的批准(Comitato Etico Interaziendale AOU San Luigi Gonzaga, N°25/2023)。每个参与中心将在报名前获得当地道德委员会的批准。数据将通过提交给国际同行评议期刊的原创文章传播给科学界。试验注册号:NCT05759299。
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引用次数: 0
Perioperative intravenous fluid management in paediatric surgery: a scoping review protocol. 儿科外科围手术期静脉输液管理:范围审查方案
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-112113
Viviana Leidy Sanchez, Valentina Pinzon Rodas, Ginna Cabra-Bautista, Ivan D Florez, Markus Klimek, Jose A Calvache

Introduction: Intravenous fluids are essential components of perioperative care, supporting intravascular volume, acid-base balance and electrolyte homeostasis. Despite extensive research in adult surgical populations, paediatric-specific evidence remains limited, and clinical practice frequently relies on extrapolated adult-based recommendations. This gap is particularly relevant in paediatric non-cardiac surgery, where fluid choice may influence key physiological outcomes such as acid-base status, electrolyte balance, renal function and haemodynamic stability. Given the heterogeneity of study designs, perioperative phases, age groups and reported outcomes in the paediatric literature, a comprehensive synthesis of the existing evidence is needed before a systematic review can be undertaken.

Methods and analysis: We will conduct this scoping review following the methodological guidance of the Joanna Briggs Institute Manual for Evidence Synthesis, and the reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guideline.This scoping review will map existing evidence on perioperative intravenous fluid management in paediatric patients (<18 years) undergoing elective non-cardiac surgery in outpatient and inpatient settings. Eligible study designs will include randomised trials, observational studies and systematic reviews. A comprehensive search will be developed with a medical librarian and applied to MEDLINE (PubMed), Ovid, Embase, Web of Science, CENTRAL, Google Scholar and ClinicalTrials.gov, with no date restrictions and limited to English, Spanish and German.Eligibility is framed using participants, concept and context: paediatric patients (<18 years) undergoing non-cardiac surgery; concepts related to preoperative fasting/replacement period, intraoperative period and postoperative period up to 24 hours, intravenous fluid management for maintenance/replacement; and hospital/outpatient surgical settings. Study selection and data charting will follow established scoping review methodology. Data will be synthesised descriptively using narrative and tabular formats. No meta-analysis or formal risk-of-bias appraisal is planned, consistent with scoping review methodology.

Ethics and dissemination: This scoping review involves no primary data collection and relies exclusively on published literature; therefore, formal ethical approval is not required. The protocol received administrative approval from the Comité de Ética para la Investigación Científica of Universidad del Cauca (approval no. 6553, 11 June 2025). Findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with paediatric anaesthesia and surgical communities.

静脉输液是围手术期护理的重要组成部分,支持血管内容积、酸碱平衡和电解质稳态。尽管在成人手术人群中进行了广泛的研究,但儿科特异性证据仍然有限,临床实践经常依赖于推断的成人建议。这一差距在儿科非心脏手术中尤为重要,因为在这些手术中,液体的选择可能会影响关键的生理结果,如酸碱状态、电解质平衡、肾功能和血流动力学稳定性。鉴于研究设计、围手术期、年龄组和儿科文献报道结果的异质性,在进行系统评价之前,需要对现有证据进行全面综合。方法和分析:我们将按照乔安娜布里格斯研究所证据综合手册的方法指导进行范围审查,报告将遵循范围审查指南的系统审查和元分析扩展的首选报告项目。这项范围审查将绘制儿科患者围手术期静脉输液管理的现有证据(伦理和传播:这项范围审查不涉及原始数据收集,完全依赖于已发表的文献;因此,不需要正式的伦理批准。议定书已获得考卡大学 Ética para Investigación Científica委员会的行政批准(批准号:6553, 2025年6月11日)。研究结果将通过同行评议的出版物、会议报告以及与儿科麻醉和外科社区进行有针对性的交流来传播。
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引用次数: 0
Development of a resilience assessment tool for cardiac care pathways in Europe: a mixed-methods study. 欧洲心脏护理途径弹性评估工具的发展:一项混合方法研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-110266
Ana Sofia V Carvalho, Óscar Brito Fernandes, Jan J Piek, Josepa Mauri, Ariadna Sanz Escartin, William Wijns, Niek Klazinga, Dionne Kringos

Objectives: To develop a resilience assessment tool for cardiac care pathways in Europe, informed by stakeholder insights on the impact of COVID-19, emerging innovations and recommendations to enhance resilience.

Design: Mixed-methods study comprising three phases: (1) survey among European cardiac care providers; (2) five multistakeholder focus groups and (3) participatory tool development. Quantitative data were analysed using descriptive statistics, and qualitative data were analysed thematically.

Setting: The survey targeted cardiology professionals from the 27 European Union Member States and Ukraine who worked during the COVID-19 pandemic. Focus group participants were purposefully sampled to represent clinical, organisational and policy perspectives.

Participants: A total of 177 survey respondents and 40 informants in focus groups.

Results: Six key resilience dimensions of cardiac care pathways were identified: workforce, organisation of care delivery, governance and trust, communication and cooperation, medical devices and products, and data collection and use. Staff shortages and infrastructure capacity were key challenges during the pandemic. The most frequent measures were the reallocation of health staff (75%; n=133) and repurposing infrastructures (38%; n=32). Participants discussed the six resilience dimensions around a total of 17 subdimensions and 39 recommended actions to enhance resilience were identified. The resulting resilience assessment tool included four components: (1) mapping a context-specific cardiac care pathway; (2) stakeholder identification critical to participate in collective self-assessment; (3) a preparedness checklist generating a visual heat map and (4) a resource toolkit.

Conclusions: The resilience assessment tool offers step-by-step guidance to strengthening cardiac care pathways across six key resilience dimensions, supported by actionable recommendations. The tool enables the identification of context-specific vulnerabilities and improvement priorities, thereby supporting healthcare professionals and policymakers in enhancing preparedness and ensuring care continuity before, during and after crises. Its implementation is currently being piloted in European hospitals to evaluate and refine its practical applicability.

目标:根据利益相关者对COVID-19影响的见解、新兴创新和增强韧性的建议,开发欧洲心脏护理途径的复原力评估工具。设计:混合方法研究包括三个阶段:(1)对欧洲心脏护理提供者的调查;(2)五个多利益相关者焦点小组;(3)参与式工具开发。定量数据采用描述性统计分析,定性数据采用主题分析。背景:调查对象是来自27个欧盟成员国和乌克兰的心脏病学专业人员,他们在COVID-19大流行期间工作。焦点小组参与者有目的地抽样,以代表临床、组织和政策观点。参与者:共有177名调查对象和40名焦点小组的信息提供者。结果:确定了心脏护理途径的六个关键弹性维度:劳动力、护理服务组织、治理和信任、沟通和合作、医疗设备和产品以及数据收集和使用。工作人员短缺和基础设施能力是大流行期间的主要挑战。最常见的措施是重新分配卫生工作人员(75%;n=133)和重新利用基础设施(38%;n=32)。参与者讨论了六个弹性维度,共涉及17个子维度,并确定了39项增强弹性的建议行动。复原力评估工具包括四个组成部分:(1)绘制特定环境的心脏护理路径;(2)利益相关者识别对参与集体自我评估至关重要;(3)生成可视化热图的准备检查表和(4)资源工具包。结论:弹性评估工具通过六个关键弹性维度为加强心脏护理途径提供了逐步指导,并提供了可操作的建议。该工具能够确定具体情况下的脆弱性和改进重点,从而支持卫生保健专业人员和政策制定者加强准备,并确保危机之前、期间和之后的护理连续性。目前正在欧洲各医院试行其实施情况,以评估和完善其实际适用性。
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引用次数: 0
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