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Changes in rehabilitation service utilisation during COVID-19 bed surges in Japan: a seasonal autoregressive integrated moving average (SARIMA) analysis of care utilisation with 10-year claims data. 日本COVID-19床位激增期间康复服务利用的变化:基于10年索赔数据的护理利用的季节性自回归综合移动平均(SARIMA)分析
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-106742
Yuki Egashira, Ryo Watanabe

Objective: To explore the association between COVID-19 bed utilisation and changes in rehabilitation service provision in Japan, focusing on cerebrovascular, musculoskeletal and respiratory rehabilitation in the pre-COVID-19, during-COVID-19 and post-COVID-19 periods.

Design: Retrospective study using seasonal autoregressive integrated moving average model to predict expected values, which were compared with actual values to calculate observed-to-expected (OE) ratios.

Setting: Acute care hospitals in Kanagawa Prefecture, which has the second largest population in Japan after Tokyo, covering April 2014 to March 2024.

Participants: Patients aged 0-74 years who were enrolled in the National Health Insurance of Kanagawa Prefecture and underwent the studied types of rehabilitation.

Exposure: COVID-19 pandemic waves and associated bed utilisation rates, with multiple distinct peaks.

Outcome measures: The difference between the predicted and actual values of the volume of rehabilitation services provided and the number of patients per insured person calculated as OE ratios during periods of peak bed utilisation for COVID-19.

Results: The OE ratio of inpatient rehabilitation services for cerebrovascular showed a significant decrease after five waves at -14.3%, and musculoskeletal conditions showed a similar decline during periods of high COVID-19 bed utilisation. Outpatient services experienced sharp declines initially but showed differential recovery patterns. Respiratory rehabilitation displayed unique patterns, with inpatient services increasing up to 62.4% above expected levels until September 2021, before sharply declining. By March 2024, musculoskeletal rehabilitation demonstrated complete recovery, cerebrovascular rehabilitation showed partial recovery, while respiratory rehabilitation exhibited mixed patterns with persistent outpatient deficits.

Conclusions: Rehabilitation services in Japan showed substantial changes associated with the COVID-19 pandemic, with inpatient services for cerebrovascular and musculoskeletal conditions being particularly vulnerable to disruptions during high COVID-19 bed utilisation periods. The differential recovery patterns across rehabilitation types, with some structural changes persisting beyond the acute pandemic phase, indicate the need for flexible healthcare systems to deal with future healthcare crises. These findings underscore the importance of developing strategies to maintain essential rehabilitation services during public health emergencies, especially considering the ageing global population and rising demand for rehabilitation.

目的:探讨日本COVID-19床位利用与康复服务提供变化的关系,重点关注COVID-19前、中、后时期的脑血管、肌肉骨骼和呼吸康复。设计:回顾性研究采用季节性自回归综合移动平均模型预测期望值,并将其与实际值进行比较,计算观察到的期望(OE)比。地点:2014年4月至2024年3月,日本人口仅次于东京的神奈川县急症护理医院。参与者:0-74岁的神奈川县国民健康保险登记患者,接受研究类型的康复。暴露:COVID-19大流行浪潮和相关的床位使用率,有多个明显的高峰。结果测量:在COVID-19床位使用高峰期间,提供的康复服务量的预测值与实际值之间的差异,以及以OE比率计算的每个参保人的患者数量。结果:脑血管住院康复服务的OE率在五波后显著下降,为-14.3%,肌肉骨骼疾病在COVID-19高床位利用率期间也出现类似的下降。门诊服务最初经历了急剧下降,但表现出不同的恢复模式。呼吸康复显示出独特的模式,到2021年9月,住院服务比预期水平增加了62.4%,然后急剧下降。到2024年3月,肌肉骨骼康复为完全康复,脑血管康复为部分康复,呼吸康复为混合模式,门诊持续不足。结论:日本的康复服务出现了与COVID-19大流行相关的重大变化,脑血管和肌肉骨骼疾病的住院服务在COVID-19床位使用率高的时期特别容易受到干扰。不同康复类型的不同恢复模式,以及在急性大流行阶段之后持续存在的一些结构性变化,表明需要灵活的卫生保健系统来应对未来的卫生保健危机。这些调查结果强调了在突发公共卫生事件期间制定战略以维持基本康复服务的重要性,特别是考虑到全球人口老龄化和康复需求不断增加。
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引用次数: 0
Exploring the multifactorial reasons for treatment-seeking delays among young and middle-aged stroke patients: a qualitative study. 探讨中青年脑卒中患者延迟求诊的多因素原因:一项质性研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-111267
Qing Yang, Chenyuan Fang, Xiangrong Wang, Shu Huang, Ling Li, Chong Tian

Objectives: To identify multifactorial contributors to treatment-seeking delays among Chinese young and middle-aged stroke patients using socioecological model.

Design: Descriptive phenomenological interview study.

Setting: A tertiary hospital in China.

Participants: Twenty acute stroke patients with treatment-seeking delays and 16 family members were recruited for dyadic semistructured interviews.

Primary and secondary outcome measures: Barriers influencing treatment-seeking delays across individual, interpersonal and systemic levels. And how do interlevel interactions shape decision-making trajectories?

Results: Data analysis revealed 5 overarching themes encompassing 12 subthemes: (1) limited stroke-specific health literacy; (2) psychological barriers at symptom onset; (3) inadequate interpersonal support systems; (4) structural impediments to timely care; (5) decision-making dynamics across levels. Delay was characterised as a sequential cascade mediated by cognitive misattribution, emotional paralysis, relational dependency, institutional constraints and cross-level feedback loops. Two dominant pathways, silent progression and diverted seeking, were identified.

Conclusion: Treatment-seeking delay among young and middle-aged stroke patients arises through dynamic interactions across socioecological strata rather than isolated factors. Integrated interventions targeting public awareness, familial preparedness, workplace policies and healthcare accessibility are required to disrupt this cascade.

目的:利用社会生态学模型确定中国中青年脑卒中患者寻求治疗延迟的多因素影响因素。设计:描述性现象学访谈研究。单位:国内三级医院。参与者:20名寻求治疗延迟的急性中风患者和16名家庭成员被招募进行二元半结构化访谈。主要和次要结果测量:影响个体、人际和系统层面寻求治疗延迟的障碍。层次间的互动是如何塑造决策轨迹的?结果:数据分析揭示了5个总体主题,包括12个次级主题:(1)有限的中风特定健康素养;(2)出现症状时的心理障碍;(3)人际支持系统不足;(4)及时护理的结构性障碍;(5)跨层级决策动态。延迟表现为由认知错误归因、情绪麻痹、关系依赖、制度约束和跨层次反馈循环介导的顺序级联反应。我们确定了两种主要的途径,无声的进步和转向的寻求。结论:中青年脑卒中患者寻求治疗的延迟是由社会生态各阶层的动态相互作用而非孤立因素引起的。需要针对公众意识、家庭准备、工作场所政策和医疗保健可及性的综合干预措施来破坏这一连锁反应。
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引用次数: 0
Reporting completeness and outcomes of the diet- and nutrition-related systematic review planning process: protocol for a meta-epidemiological study. 报告饮食和营养相关系统评价计划过程的完整性和结果:一项荟萃流行病学研究的方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-108561
Judit Németh, Daniela Küllenberg de Gaudry, László Czina, Szimonetta Lohner

Introduction: Dietary recommendations should be based on scientific evidence, and ideally, systematic reviews (SRs) are conducted as part of the guideline development process. The usability of SRs for decision-making is primarily determined by the quality of the evidence from available primary studies, as well as the quality of the SRs themselves. A comprehensive SR protocol ensures high-quality implementation and minimises bias, while making these protocols publicly accessible, promotes transparency and prevents redundancy. The PROSPERO database offers valuable insights into planned methodologies. The aim of this study is to investigate the completeness of reporting in SR protocols for diet- or nutrition-related trials, determine how this has changed over time, and examine the publication of completed SRs by comparing their content with those described in the corresponding protocols.

Methods and analysis: We developed a systematic search strategy for PROSPERO to identify nutrition- or diet-related SR protocols registered at two different time points (2019 and 2024). Following a screening process to identify eligible protocols, relevant predefined data will be extracted. Subsequently, a structured search will be conducted to identify potential journal publications of the selected protocols, as well as publications describing the results of the SRs, from which relevant predefined data will be also extracted. The methodology of the published articles will be compared with the corresponding a priori protocols registered in PROSPERO. The PROSPERO records registered in 2019 will be compared with those registered in 2024. The results will be evaluated by descriptive statistics, the reporting completeness of PROSPERO records will be assessed based on Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P), the planned use of any approaches to assess certainty of evidence will be investigated, and the adherence of published SRs to the methodological details outlined in their corresponding PROSPERO entries will be examined.

Ethics and dissemination: Since both databases and publications used in this study are publicly available, ethical approval is not required. Results of the study will be submitted for publication in an international, peer-reviewed journal.

Prospero registration number: The present study has previously been registered with the Open Science Framework (https://osf.io/8fsx7).

饮食建议应以科学证据为基础,理想情况下,系统评价(SRs)是指南制定过程的一部分。可持续发展指标对决策的可用性主要取决于现有初步研究证据的质量,以及可持续发展指标本身的质量。一个全面的SR协议确保了高质量的实施,并最大限度地减少了偏见,同时使这些协议公开访问,促进了透明度,防止了冗余。普洛斯彼罗数据库为计划方法提供了宝贵的见解。本研究的目的是调查饮食或营养相关试验SR协议中报告的完整性,确定其随时间的变化情况,并通过将已完成的SR的内容与相应协议中描述的内容进行比较,检查其发表情况。方法和分析:我们为PROSPERO制定了一个系统的搜索策略,以识别在两个不同时间点(2019年和2024年)注册的营养或饮食相关的SR协议。在筛选过程中确定合格的协议后,将提取相关的预定义数据。随后,将进行结构化搜索,以确定所选方案的潜在期刊出版物,以及描述SRs结果的出版物,并从中提取相关的预定义数据。发表的文章的方法将与在普洛斯彼罗登记的相应的先验议定书进行比较。2019年注册的普洛斯彼罗记录将与2024年注册的记录进行比较。结果将通过描述性统计进行评估,报告的普洛斯彼罗记录的完整性将根据系统审查和荟萃分析协议的首选报告项目(PRISMA-P)进行评估,计划使用的任何方法来评估证据的确定性将进行调查,并检查已发布的SRs是否符合相应普洛斯彼罗条目中概述的方法细节。伦理和传播:由于本研究中使用的数据库和出版物都是公开的,因此不需要伦理批准。研究结果将在国际同行评议的期刊上发表。普洛斯彼罗注册号:本研究已在开放科学框架(https://osf.io/8fsx7)注册。
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引用次数: 0
PRECISION study: impact of personalised cardiac anaesthesia and cerebral autoregulation on neurological outcomes in patients undergoing cardiac surgery - protocol for an international, multicentre, prospective cohort study. PRECISION研究:个体化心脏麻醉和大脑自动调节对心脏手术患者神经预后的影响——一项国际、多中心、前瞻性队列研究方案
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-115288
Nuno V Gomes, Harry Edgar-Whelan, Erta Beqiri, Jim Young, Christian Schindler, Michael Gregor, Joachim M Erb, Martin Siegemund, Jens Kuhle, Aleksandra Maleska Maceski, Edward Needham, Sven Cichon, Bettina Burger, Andreas U Monsch, Wolfgang Hasemann, Alexandra Wüest, Jens Fassl, Heiko A Kaiser, Darren Hight, Anja Levis, Dominik Günsch, David K Menon, Marek Czosnyka, Peter Smielewski, Andrew A Klein, Salome Dell-Kuster, Luzius A Steiner

Introduction: Adverse neurological complications, including postoperative delirium (POD) and stroke, remain one of the major risks after cardiac surgery. A lack of comprehensive knowledge about their causes and neuroprotective strategies has hindered the development of effective interventions to reduce these events. Personalised cerebral autoregulation (CA)-oriented blood pressure monitoring aims to identify blood pressure targets tailored to each individual patient, thereby reducing brain injury. The PRECISION study aims to assess whether perioperative duration and magnitude of mean arterial pressure (MAP) deviation from an individual's CA limits are associated with adverse neurological complications.

Methods and analysis: This international, multicentre, prospective cohort study is conducted at two Swiss and one British hospital. Patients aged 65 years or older undergoing elective primary or re-operative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass are included. Preoperatively, the patient's baseline of physical, cognitive and mental status is established. Intraoperatively, near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are recorded in real-time to generate NIRS-derived and TCD-derived CA indices. The primary endpoint is POD, assessed daily on postoperative days 0 to 7 or up to discharge, whichever occurs earlier with the 3D-Confusion Assessment Method (3D-CAM) or CAM-Intensive Care Unit. Secondary endpoints include a composite neurological outcome of POD and overt stroke, postoperative neurocognitive disorders, major morbidity and mortality. Associations between neurologic outcomes, neurobiomarkers and genetic variation will be explored.A total of 500 participants is required to achieve 90% power to find a statistically significant effect of the area under the curve MAP

Ethics and dissemination: Ethical approval has been obtained from all responsible ethics committees (Swiss lead ethics committee EKNZ 2022-01457 and Health Research Authority and Health and Care Research Wales, UK, REC 23/SW/0076). Results will be disseminated at national and international conferences and published in peer-reviewed journals.

Trial registration number: NCT05595954.

不良的神经系统并发症,包括术后谵妄(POD)和中风,仍然是心脏手术后的主要风险之一。缺乏对其原因和神经保护策略的全面了解阻碍了有效干预措施的发展,以减少这些事件。以个性化脑自动调节(CA)为导向的血压监测旨在为每位患者确定量身定制的血压目标,从而减少脑损伤。PRECISION研究旨在评估围手术期时间和平均动脉压(MAP)偏离个体CA极限的程度是否与不良神经系统并发症相关。方法和分析:这项国际、多中心、前瞻性队列研究在两家瑞士医院和一家英国医院进行。年龄在65岁或以上的患者接受择期首次或再手术冠状动脉旁路移植术和/或瓣膜和/或升主动脉手术需要体外循环。术前建立患者的身体、认知和精神状态基线。术中实时记录近红外光谱(NIRS)和经颅多普勒(TCD),生成NIRS衍生和TCD衍生的CA指数。主要终点是POD,每天在术后0 - 7天或直到出院时进行评估,以较早发生的3d -混乱评估方法(3D-CAM)或cam -重症监护病房为准。次要终点包括POD和明显中风的复合神经预后、术后神经认知障碍、主要发病率和死亡率。将探讨神经系统预后、神经生物标志物和遗传变异之间的联系。总共需要500名参与者达到90%的功率才能发现曲线map下面积的统计显着影响伦理和传播:已获得所有负责伦理委员会的伦理批准(瑞士领导伦理委员会EKNZ 2022-01457和英国卫生研究管理局和卫生与护理研究威尔士,REC 23/SW/0076)。结果将在国家和国际会议上传播,并在同行评议的期刊上发表。试验注册号:NCT05595954。
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引用次数: 0
How to measure the effectiveness of healthcare providers acting as an 'anchor institution': a case study of the NHS in Greater Manchester, England. 如何衡量医疗服务提供者作为一个“锚机构”的有效性:在英格兰大曼彻斯特的NHS案例研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-111328
Vasudha Wattal, Christine Camacho, Anna Gkiouleka, John Alexander Ford, Luke Aaron Munford

Objectives: To improve social determinants of health, healthcare organisations can support societal and economic goals in their role as anchor institutions (large organisations with an important presence and ties to a place). In England, the National Health Service (NHS) Long Term Plan highlighted the role of the NHS as an Anchor. Despite a clear policy mandate on this, less is known about specific indicators to measure and benchmark anchor performance. A set of metrics was developed to quantify anchor activity using the Greater Manchester (GM) region in England as a case study.

Design: Descriptive cross-sectional study.

Setting: Data were received on employment and procurement for the financial year 2022/2023 from NHS trusts located in GM.

Primary and secondary outcome measures: Performance against two anchor metrics, local spending and employment, was assessed. 'Local' was defined as the Integrated Care Board (ICB) footprint in which the trusts are located. The proportion of procurement spend to the local economy was derived from procurement data. Employment data was aggregated by ethnicity codes and deprivation levels and compared with ICB-level ethnicity and deprivation profiles using the Index of Multiple Deprivation based on 2021 Census data.

Results: The included trusts employed 65 597 residents of GM and spent £389 million on local procurement, demonstrating their importance as anchor organisations. Considerable variation was observed between trusts in local spending, ranging from 6.4% (95% CI 6.4% to 6.41%) to 52.7% (95% CI 52.69% to 52.72%) (with the mean at 21%). The percentage of locally employed staff ranged from 82.7% (95% CI 81.45% to 83.90%) to 89.5% (95% CI 89.12% to 89.95%). All trusts demonstrate strong workforce representation from minoritised ethnic groups, but most employed a lower proportion of staff from the most deprived areas than expected based on the local population profile.

Conclusions: It is feasible to quantify aspects of anchor activity using routine NHS data, and meaningful variation exists across trusts, even within a single health system. GM provides a useful case study, but further work is needed to embed anchor metrics in routine reporting and to extend measurement to other domains such as estates and sustainability.

目标:为了改善健康的社会决定因素,医疗保健组织可以作为锚定机构(具有重要存在和与地方联系的大型组织)支持社会和经济目标。在英格兰,《国民保健服务长期计划》强调了国民保健服务作为支柱的作用。尽管在这方面有明确的政策要求,但人们对衡量和基准锚的具体指标知之甚少。以英格兰大曼彻斯特(GM)地区为例,开发了一套指标来量化锚定活动。设计:描述性横断面研究。背景:从位于gm的NHS信托机构收到了关于2022/2023财政年度就业和采购的数据。主要和次要结果测量:根据两个锚定指标,当地支出和就业,评估了绩效。“本地”被定义为信托所在的综合护理委员会(ICB)足迹。采购支出占当地经济的比例是根据采购数据得出的。就业数据按族裔代码和贫困程度汇总,并使用基于2021年人口普查数据的多重贫困指数与国际清算银行的族裔和贫困概况进行比较。结果:纳入的信托机构雇佣了65597名GM居民,在当地采购上花费了3.89亿英镑,表明了它们作为锚定组织的重要性。各信托机构在地方支出方面存在相当大的差异,范围从6.4% (95% CI 6.4%至6.41%)到52.7% (95% CI 52.69%至52.72%)(平均值为21%)。本地雇员的百分比从82.7% (95% CI 81.45%至83.90%)到89.5% (95% CI 89.12%至89.95%)不等。所有信托基金都显示出来自少数民族群体的强大劳动力代表性,但大多数信托基金雇用的来自最贫困地区的员工比例低于基于当地人口概况的预期比例。结论:使用常规NHS数据量化锚点活动的各个方面是可行的,并且即使在单个卫生系统内,也存在不同信托的有意义的变化。通用汽车提供了一个有用的案例研究,但需要进一步的工作来将锚定指标嵌入到日常报告中,并将测量扩展到其他领域,如房地产和可持续性。
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引用次数: 0
Using flow cytometry for paediatric leukaemia diagnosis in Kenya: a protocol for mixed methods study. 使用流式细胞术诊断肯尼亚儿童白血病:一项混合方法研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2026-117499
Tyler Severance, Teresa Lotodo, Enock Serem, Festus Njuguna, Beatrice Melly, Millicent Orido, Ronald Tonui, Gilbert Olbara, Raphael Koima, Nicholas Kigen, Steven Kussick, Vicki Ratliff, Eda Holl, Patrick O Monahan, Tony Boova, Terry Vik

Introduction: Each year, an estimated 1700 children should be diagnosed with cancer in western Kenya, with leukaemia making up nearly one-third of cases. However, far fewer are actually diagnosed, highlighting significant delays or errors in diagnosis. Flow cytometry, which the WHO considers essential for leukaemia diagnosis, remains underused across sub-Saharan Africa due to high costs, outdated equipment and a lack of trained personnel. In Kenya, decades-old cytometers have been adapted for leukaemia detection, but these systems are now outdated. Newer platforms, such as simplified single-tube multiparametric assays, provide a scalable and sustainable alternative. This study presents a protocol to evaluate the accuracy of diagnosis and the potential for implementing a streamlined flow cytometry assay using peripheral blood, supported by a regional educational initiative.

Methods and analysis: This prospective, mixed-methods implementation study has three aims: (1) to assess the concordance between the Beckman Coulter ClearLLab 10C gold standard 4-tube assay and the streamlined ClearLLab LS 1-tube assay using paired bone marrow and peripheral blood samples; (2) to evaluate the feasibility of peripheral facility referrals and transport logistics with couriered peripheral blood samples from referring sites across western Kenya; and (3) to measure training effectiveness and knowledge gain through a multimodal educational programme using the Project ECHO (Extension for Community Healthcare Outcomes) model. Up to 300 patients at Moi Teaching and Referral Hospital in Eldoret, Kenya, will be enrolled in Aim 1. A separate sample of 100 patients from peripheral facilities will be included in Aim 2. Surveys, knowledge assessments and structured interviews will be used to evaluate training impact under Aim 3. Diagnostic concordance, sensitivity, specificity and knowledge gain will be measured through appropriate quantitative and qualitative methods.

Ethics and dissemination: The protocol has received approval from institutional ethics committees at Moi University, MTRH and Indiana University. De-identified data will be analysed and shared through peer-reviewed publications, stakeholder presentations and educational platforms.

简介:在肯尼亚西部,每年估计有1700名儿童被诊断出患有癌症,其中白血病占病例的近三分之一。然而,真正得到诊断的人数要少得多,这凸显了诊断中的严重延误或错误。世卫组织认为流式细胞术对于白血病诊断至关重要,但由于成本高昂、设备过时以及缺乏训练有素的人员,流式细胞术在撒哈拉以南非洲地区仍未得到充分利用。在肯尼亚,已有几十年历史的细胞仪已被用于白血病检测,但这些系统现在已经过时。较新的平台,如简化的单管多参数分析,提供了可扩展和可持续的替代方案。本研究提出了一个方案,以评估诊断的准确性和潜力,实施流线型流式细胞术检测使用外周血,由区域教育倡议的支持。方法和分析:本前瞻性、混合方法实施研究有三个目的:(1)评估使用配对骨髓和外周血样本的Beckman Coulter ClearLLab 10C金标准4管法和流线型ClearLLab LS 1管法之间的一致性;(2)评估周边设施转诊和运输物流的可行性,并从肯尼亚西部的转诊地点运送外周血样本;(3)利用社区卫生保健成果扩展项目(ECHO)模式,通过多模式教育计划衡量培训效果和知识增益。在肯尼亚埃尔多雷特的Moi教学和转诊医院,将有多达300名患者参加目标1。目标2将包括来自外围设施的100名患者的单独样本。调查、知识评估和结构化访谈将用于评估目标3下的培训影响。诊断一致性、敏感性、特异性和知识增益将通过适当的定量和定性方法进行测量。伦理和传播:该议定书已获得莫伊大学、MTRH和印第安纳大学机构伦理委员会的批准。去识别数据将通过同行评审的出版物、利益相关者演讲和教育平台进行分析和共享。
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引用次数: 0
Transcranial direct current stimulation (tDCS) over the dorso-lateral-prefrontal cortex in combination with exercises for the treatment of individuals with chronic low back pain (STOP-Low Back Pain Trial): study protocol for a randomised controlled trial. 经颅直流电刺激(tDCS)在背外侧前额叶皮质结合运动治疗慢性腰痛(停止腰痛试验):一项随机对照试验的研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-111649
Thomas Pourchet, Stéphane Armand, Cristiano Martins, Simon Barrué-Belou, Stéphane Genevay, Pierre Nicolo

Introduction: Chronic low back pain (CLBP) remains a leading cause of disability worldwide and imposes a substantial personal and socioeconomic burden. Despite exercise being the first-line recommended intervention in clinical guidelines, its efficacy on pain relief remains modest and the hypoalgesia induced by exercise seems to be limited in individuals with musculoskeletal pain. Previous transcranial direct current stimulation (tDCS) studies have mainly targeted the motor cortex, yielding heterogeneous results, underscoring the need to evaluate alternative brain areas. Recently, tDCS studies targeting the dorsolateral prefrontal cortex (DLPFC) may enhance endogenous pain modulation and thereby potentiate the response to exercise. This study aims to compare the effects of adjunctive anodal DLPFC tDCS combined with a standardised exercise programme versus sham tDCS combined with the same exercise programme on pain and function in adults with CLBP.

Methods and analysis: This is a single-centre, triple-blinded, parallel-group randomised controlled trial. 48 participants with CLBP will be randomly assigned to receive either anodal tDCS over the left PFC combined with exercises, or sham tDCS combined with the same exercise programme, over nine sessions during a 3-week period. The primary outcome is the change in the multidimensional impact of CLBP, assessed using the Core Outcome Measures Index, from baseline to postintervention (week 4). Secondary outcomes include pain intensity, disability, psychological factors (fear-avoidance beliefs, catastrophising, anxiety, depression), measured at baseline, postintervention and at 12- and 24-week follow-up. Functional brain connectivity via electroencephalography and neuromuscular function of the erector spinae (flexion-relaxation phenomenon) will be measured at baseline and postintervention.

Ethics and dissemination: This study was approved by the Commission Cantonale d'Ethique de la Recherche sur l'être humain (CCER) in December 2022 (reference number: 2022-D0077). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Trial registration number: NCT05757609.

慢性腰痛(CLBP)仍然是世界范围内致残的主要原因,并造成了巨大的个人和社会经济负担。尽管运动是临床指南中推荐的第一线干预措施,但其缓解疼痛的功效仍然有限,运动引起的痛觉减退在肌肉骨骼疼痛患者中似乎有限。先前的经颅直流电刺激(tDCS)研究主要针对运动皮层,结果不一致,强调需要评估其他脑区域。最近,针对背外侧前额叶皮层(DLPFC)的tDCS研究可能会增强内源性疼痛调节,从而增强对运动的反应。本研究旨在比较辅助淋巴结DLPFC tDCS联合标准化运动方案与假tDCS联合相同运动方案对CLBP成人疼痛和功能的影响。方法与分析:这是一项单中心、三盲、平行组随机对照试验。48名CLBP患者将被随机分配,在3周的时间内接受左PFC的负极tDCS结合锻炼,或假tDCS结合相同的锻炼计划,共9次。主要结果是CLBP多维影响的变化,使用核心结果测量指数评估,从基线到干预后(第4周)。次要结果包括疼痛强度、残疾、心理因素(恐惧回避信念、灾难、焦虑、抑郁),在基线、干预后以及12周和24周随访时测量。在基线和干预后,通过脑电图和竖脊肌的神经肌肉功能(屈曲-松弛现象)测量脑功能连接。伦理与传播:本研究于2022年12月获得être人类研究伦理委员会(CCER)批准(参考编号:2022- d0077)。所有参与者均需获得书面知情同意。研究结果将通过同行评议的出版物和在国家和国际会议上的发言加以传播。试验注册号:NCT05757609。
{"title":"Transcranial direct current stimulation (tDCS) over the dorso-lateral-prefrontal cortex in combination with exercises for the treatment of individuals with chronic low back pain (STOP-Low Back Pain Trial): study protocol for a randomised controlled trial.","authors":"Thomas Pourchet, Stéphane Armand, Cristiano Martins, Simon Barrué-Belou, Stéphane Genevay, Pierre Nicolo","doi":"10.1136/bmjopen-2025-111649","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-111649","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic low back pain (CLBP) remains a leading cause of disability worldwide and imposes a substantial personal and socioeconomic burden. Despite exercise being the first-line recommended intervention in clinical guidelines, its efficacy on pain relief remains modest and the hypoalgesia induced by exercise seems to be limited in individuals with musculoskeletal pain. Previous transcranial direct current stimulation (tDCS) studies have mainly targeted the motor cortex, yielding heterogeneous results, underscoring the need to evaluate alternative brain areas. Recently, tDCS studies targeting the dorsolateral prefrontal cortex (DLPFC) may enhance endogenous pain modulation and thereby potentiate the response to exercise. This study aims to compare the effects of adjunctive anodal DLPFC tDCS combined with a standardised exercise programme versus sham tDCS combined with the same exercise programme on pain and function in adults with CLBP.</p><p><strong>Methods and analysis: </strong>This is a single-centre, triple-blinded, parallel-group randomised controlled trial. 48 participants with CLBP will be randomly assigned to receive either anodal tDCS over the left PFC combined with exercises, or sham tDCS combined with the same exercise programme, over nine sessions during a 3-week period. The primary outcome is the change in the multidimensional impact of CLBP, assessed using the Core Outcome Measures Index, from baseline to postintervention (week 4). Secondary outcomes include pain intensity, disability, psychological factors (fear-avoidance beliefs, catastrophising, anxiety, depression), measured at baseline, postintervention and at 12- and 24-week follow-up. Functional brain connectivity via electroencephalography and neuromuscular function of the erector spinae (flexion-relaxation phenomenon) will be measured at baseline and postintervention.</p><p><strong>Ethics and dissemination: </strong>This study was approved by the Commission Cantonale d'Ethique de la Recherche sur l'être humain (CCER) in December 2022 (reference number: 2022-D0077). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed publications and presentations at national and international conferences.</p><p><strong>Trial registration number: </strong>NCT05757609.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 3","pages":"e111649"},"PeriodicalIF":2.3,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147484687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cluster randomised controlled trial for service delivery redesign of primary care for people with diabetes: study protocol. 重新设计糖尿病患者初级保健服务的聚类随机对照试验:研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-111459
Agustina Mazzoni, Javier Roberti, Marina Guglielmino, Facundo Jorro-Baron, Yanina Mazzaresi, Andrea Falaschi, Jorgelina Alvarez, Luz Gibbons, Hannah H Leslie, Cecilia Silva, Patricia J Garcia, Ezequiel Garcia-Elorrio
<p><strong>Introduction: </strong>Strong primary healthcare enhances resource efficiency and resilience. Type 2 diabetes poses a growing global health challenge, with Argentina's healthcare system struggling to detect and manage the disease effectively. Many patients bypass primary healthcare for secondary facilities, undermining continuity of care and increasing costs. Following a diagnostic process in collaboration with policymakers, we propose evaluating a redesigned primary care model consisting of codesigned evidence-based implementation strategies to improve type 2 diabetes management in Mendoza, Argentina.</p><p><strong>Methods and analysis: </strong>This is an efficient, parallel-arm cluster randomised controlled Hybrid Type II trial with 12 clusters (administrative areas with 2-3 health facilities) allocated 1:1 to control (usual care) or intervention. In phase I, we will codesign, pilot and refine an implementation strategy package. In phase II, we will conduct the trial: 9-month baseline data collection, 15-month intervention and 6-month sustainability period. We will enrol a cohort of 396 patients with type 2 diabetes at primary healthcare centres and follow them for 12 months during the intervention and 6 months sustainment using routine clinical records and patient surveys. In phase III, we will conduct analysis, report and disseminate findings. The primary outcome will be a composite outcome including glycaemic control (glycated haemoglobin (HbA1c) <8%); blood pressure control (<140/90 mm Hg) and statin prescription (limited to patients ≥40 years) from clinical records. The primary analysis will compare the proportion of patients achieving this composite clinical outcome between the trial arms at the end of the study. Secondary analyses include assessing patient experience and primary healthcare engagement; testing the implementation strategies' impact on service use patterns, system competence, user confidence and cost per visit; exploring inequalities by sociodemographic factors; and assessing patient empowerment. We will use all available data from all randomised clusters and conduct all analyses on the intention-to-treat population, regardless of intervention adherence.</p><p><strong>Ethics and dissemination: </strong>All study activities will comply with national and international ethics guidelines, presenting minimal risk to participants. The protocol was submitted and approved by the local independent ethics committee at the Mendoza Ministry of Health (Consejo Provincial de Evaluación ética en investigación en Salud-Provincial Health Research Ethics Review Board, Reference number: 149/2024). Facility-level permission will be obtained for participation and sharing of deidentified data. Written informed consent will be required from study participants, who will receive information on the study's purpose, procedures, risks and benefits. Dissemination activities and outputs will include writing and submitting manuscripts for pub
导言:强大的初级卫生保健可提高资源效率和复原力。2型糖尿病对全球健康构成了日益严峻的挑战,阿根廷的医疗保健系统正在努力有效地发现和管理这种疾病。许多患者绕过初级保健设施而前往二级设施,破坏了护理的连续性并增加了费用。在与政策制定者合作进行诊断过程后,我们建议评估重新设计的初级保健模式,该模式由共同设计的循证实施策略组成,以改善阿根廷门多萨的2型糖尿病管理。方法和分析:这是一项有效的平行分组随机对照混合II型试验,共有12个分组(行政区域,拥有2-3个卫生机构),按1:1分配给对照(常规护理)或干预。在第一阶段,我们将共同设计、试验和完善实施战略包。在第二阶段,我们将进行试验:9个月的基线数据收集,15个月的干预和6个月的可持续性。我们将在初级保健中心招募396名2型糖尿病患者,在干预期间随访12个月,并使用常规临床记录和患者调查随访6个月。在第三阶段,我们将进行分析、报告和传播研究结果。主要结局将是综合结局,包括血糖控制(糖化血红蛋白(HbA1c))。伦理和传播:所有研究活动将遵守国家和国际伦理准则,对参与者的风险最小。该议定书由门多萨卫生部当地独立伦理委员会(Consejo Provincial de Evaluación tica en investigación en salud -省卫生研究伦理审查委员会,参考编号:149/2024)提交并批准。参与和共享未识别数据将获得设施级别的许可。研究参与者需要书面知情同意,他们将收到有关研究目的、程序、风险和益处的信息。传播活动和产出将包括编写和提交稿件供出版;撰写政策简报,以支持其他地区或国家的战略实施;为患者、临床医生和研究人员量身定制产出。我们预计,疾病管理和患者体验的改善将带来与减少二级和三级设施的使用、降低每次就诊成本和减少与糖尿病相关的临床事件数量相关的临床和经济效益。试验注册号:ISRCTN63277390。
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引用次数: 0
Random-effects modelling of timely initiation of breastfeeding in Tanzania: What predicts the practice? 坦桑尼亚及时开始母乳喂养的随机效应模型:如何预测这种做法?
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-104272
Jovin R Tibenderana, Kelvin M Musa, Alfres G Pius, Jacob N Kagasyeko, Sanun Ally Kessy

Objective: To determine individual and community-level predictors associated with timely initiation of breastfeeding among women in Tanzania.

Design: Analytical cross-sectional study.

Setting: This was an analytical cross-sectional study that used the 2022 Tanzania Demographic and Health Survey, which was conducted across all regions of Tanzania.

Participants: Data from 4308 women were included.

Primary outcome: The outcome variable was timely initiation of breastfeeding, defined as starting breastfeeding within the first hour after birth, coded as 1 if timely and 0 otherwise. Mixed-effects generalised linear model (family- Binomial and link-logit) approach was used to account for the hierarchical structure of the data. Four models were constructed to assess individual and community-level predictors. Adjusted prevalence ratios (APRs) with 95% CIs were reported.

Results: Women aged 25-34 years were significantly more likely to initiate breastfeeding within 1 hour (APR=1.40; 95% CI 1.18 to 1.65). Vaginal delivery was strongly associated with the timely initiation of breastfeeding (TIBF) (APR=10.13; 95% CI 7.84 to 13.09), whereas home delivery (APR=0.29; 95% CI 0.24 to 0.36) was negatively associated with TIBF. Multiparity (APR=1.22; 95% CI 1.04 to 1.43) increased the likelihood of TIBF. Women in the richest wealth category were less likely to practise TIBF (APR=0.70; 95% CI 0.51 to 0.96). Approximately 12.3% of the variation in TIBF was explained by cluster-level differences.

Conclusions: Both individual and community-level factors influence TIBF in Tanzania, highlighting the need for strong communication between mothers and healthcare providers to consistently promote its importance across all ages and wealth groups.

目的:确定坦桑尼亚妇女及时开始母乳喂养的个人和社区水平的预测因素。设计:分析性横断面研究。环境:这是一项分析性横断面研究,使用了2022年坦桑尼亚人口与健康调查,该调查在坦桑尼亚所有地区进行。参与者:数据来自4308名女性。主要结局:结局变量为及时开始母乳喂养,定义为出生后1小时内开始母乳喂养,及时为1,不及时为0。采用混合效应广义线性模型(族-二项和链-logit)方法来解释数据的层次结构。构建了四个模型来评估个人和社区水平的预测因子。报告了95% ci的校正患病率(APRs)。结果:25-34岁的女性更有可能在1小时内开始母乳喂养(APR=1.40; 95% CI 1.18至1.65)。阴道分娩与及时开始母乳喂养(TIBF)密切相关(APR=10.13; 95% CI 7.84至13.09),而在家分娩(APR=0.29; 95% CI 0.24至0.36)与TIBF负相关。多胎(APR=1.22; 95% CI 1.04 ~ 1.43)增加了TIBF的可能性。最富有的女性不太可能实践TIBF (APR=0.70; 95% CI 0.51至0.96)。大约12.3%的TIBF变化可以用集群水平差异来解释。结论:在坦桑尼亚,个人和社区层面的因素都影响着生育基准,突出表明需要在母亲和医疗保健提供者之间进行强有力的沟通,以不断提高其在所有年龄和财富群体中的重要性。
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引用次数: 0
Gender differences in clinical profiles, management and outcomes of valvular heart disease in China: insights from a nationwide cohort. 中国瓣膜性心脏病的临床概况、管理和结局的性别差异:来自全国队列的见解
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1136/bmjopen-2025-108331
Hongli Ma, Qianhong Lu, Zhe Li, Yunqing Ye, Bin Zhang, Weiwei Wang, Qingrong Liu, Junxing Lv, Zhenyan Zhao, Zhenya Duan, Bincheng Wang, Zikai Yu, Shuai Guo, Yanyan Zhao, Runlin Gao, Yongjian Wu, Haiyan Xu

Objective: To compare the distribution, aetiology, treatment patterns and 2-year outcomes of moderate to severe valvular heart disease (VHD) between men and women in China.

Design: Nationwide, prospective, multicentre cohort study.

Setting: 46 tertiary hospitals across China, representing a mix of primary and secondary care settings.

Participants: A total of 13 917 adult patients with moderate-to-severe VHD were enrolled between April and June 2018. Of these, 6296 (45.24%) were women. Inclusion criteria included moderate or severe native valve disease, infective endocarditis or prior valve intervention.

Interventions: Patients received either conservative therapy or valve interventions, including surgical repair/replacement or transcatheter procedures. Intervention decisions were based on clinical assessment.

Main outcome measures: 2-year all-cause mortality, cardiovascular mortality, heart failure hospitalisation and major adverse cardiovascular events. Multivariable Cox and logistic regression analyses were conducted to identify outcome predictors.

Results: The overall intervention rate was 31.72%, with no gender difference (men: 31.26% vs women: 32.27%). Among the 5427 patients with severe symptomatic VHD, 49.11% received interventional therapy. The sex-specific pattern was particularly significant in severe symptomatic multiple valvular heart disease, where women had a higher propensity for intervention (p<0.001, OR: 1.19-1.66). In severe symptomatic aortic regurgitation patients, women were less likely to receive valve replacement (p=0.03, OR: 0.39-0.95).The 2-year survival rate was 90.85% with no gender difference (men: 90.41% vs women: 91.38%, p=0.086). Valve intervention improved survival to 97.0%, with no gender disparity (men: 96.92% vs women: 97.01%, p=0.87). Multivariate Cox regression confirmed no significant gender effect (p>0.05).

Conclusions: Significant gender differences exist in VHD aetiology and subtypes in China. Women had more rheumatic VHD, while men had more degenerative and functional VHD. Intervention improved survival, with no gender disparity. Age and VHD subtype influenced intervention rates and prognosis, supporting individualised, sex- and age-stratified management strategies.

Trial registration number: NCT03484806.

目的:比较中国男性和女性中重度瓣膜性心脏病(VHD)的分布、病因、治疗模式和2年转归。设计:全国性、前瞻性、多中心队列研究。环境:全国46家三级医院,代表初级和二级医疗机构的混合。参与者:2018年4月至6月期间,共有13917名中度至重度VHD成年患者入组。其中,女性6296人(45.24%)。纳入标准包括中度或重度先天性瓣膜疾病、感染性心内膜炎或既往瓣膜干预。干预措施:患者接受保守治疗或瓣膜干预,包括手术修复/置换或经导管手术。干预决定基于临床评估。主要结局指标:2年全因死亡率、心血管死亡率、心力衰竭住院率和主要心血管不良事件。进行多变量Cox和logistic回归分析以确定预后预测因子。结果:总干预率为31.72%,无性别差异(男性为31.26%,女性为32.27%)。5427例重度症状性VHD患者中,49.11%接受了介入治疗。性别特异性模式在严重症状性多瓣膜性心脏病中尤为显著,女性有更高的干预倾向(p0.05)。结论:中国VHD的病因和亚型存在显著的性别差异。女性患风湿性VHD较多,而男性患退行性和功能性VHD较多。干预提高了生存率,没有性别差异。年龄和VHD亚型影响干预率和预后,支持个体化、性别和年龄分层的管理策略。试验注册号:NCT03484806。
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