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Economic evaluation protocol for the PRevention Of sudden cardiac death aFter myocardial Infarction by Defibrillator implantation: the PROFID EHRA trial. 除颤器植入预防心肌梗死后心源性猝死的经济评价方案:PROFID EHRA试验
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-08 DOI: 10.1136/bmjopen-2024-097495
Yirui Qian, Carlos Rojas Roque, Beth Woods, Cynthia P Iglesias Urrutia, Vijay S Gc, Maria Gur Arie, Daniela Fischer, Nikolaos Dagres, Gerhard Hindricks, Andrea Manca
<p><strong>Introduction: </strong>The implantable cardioverter defibrillator (ICD) is a cardiac device recommended for use to prevent the occurrence of sudden cardiac death (SCD) in post-myocardial infarction (MI) patients with reduced left ventricular ejection fraction (LVEF). The evidence informing this guidance comes from landmark trials that are now more than 20 years old. The risk-benefit profile of ICD for the contemporary target population may have changed substantially since then, which raises the question of whether there is evidence for sparing patients a procedure associated with potentially severe complications and high healthcare costs. A main part of the PRevention Of sudden cardiac death aFter myocardial Infarction by Defibrillator implantation (PROFID) project is the PROFID EHRA trial, which is supported by the European Heart Rhythm Association. PROFID EHRA is a European Union-funded, prospective, randomised, multi-centre, non-inferiority study designed to compare optimal medical therapy (OMT) alone to ICD with OMT, for post-MI patients with reduced LVEF. The study also describes economic evaluation methods to quantify the cost and health implications of using OMT alone in place of ICD implantation plus OMT in this group of patients.</p><p><strong>Methods and analysis: </strong>The economic evaluation has been designed to conduct a pre-trial cost-effectiveness analysis (CEA) prior to the availability of trial data, followed by a within-trial cost-consequences analysis (CCA) and a long-term post-trial CEA, conducted from the National Health Service and Personal Social Service perspective in England. The pre-trial CEA uses simulation modelling informed by available evidence to assess the lifetime costs and quality-adjusted life years of OMT alone and ICD+OMT in post-MI patients with reduced LVEF at risk of SCD, as defined in the PROFID EHRA trial. The within-trial CCA is intended to summarise the health-related quality of life (HRQoL), healthcare resource use and associated costs observed during the PROFID EHRA trial follow-up period. The post-trial CEA updates the pre-trial model by incorporating contemporary evidence about the HRQoL and costs observed during the trial and the occurrence of those events and outcomes accruing during the trial follow-up period and projecting them into the expected lifetime of the patients. Sensitivity analyses are performed to assess the robustness of the CEA results with respect to both model assumptions and uncertainty in the value of the model input parameters. Finally, a value of information analysis will identify the key drivers of uncertainty surrounding the model conclusions regarding the optimal treatment strategy, establishing if further research may be required.</p><p><strong>Ethics and dissemination: </strong>The PROFID EHRA trial, under legal sponsorship of Charité-Universitätsmedizin Berlin, Germany, received its first ethics approval by the Medicine Research Ethics Committee of the La P
植入式心律转复除颤器(ICD)是一种推荐用于心肌梗死(MI)后左室射血分数(LVEF)降低的患者预防心源性猝死(SCD)发生的心脏装置。为该指南提供依据的证据来自已有20多年历史的具有里程碑意义的试验。自那时以来,ICD对当代目标人群的风险-收益状况可能发生了重大变化,这就提出了一个问题,即是否有证据表明可以使患者免受与潜在严重并发症和高医疗费用相关的手术。除颤器植入预防心肌梗死后心脏性猝死(PROFID)项目的一个主要部分是PROFID EHRA试验,该试验由欧洲心律协会支持。PROFID EHRA是一项欧盟资助的前瞻性、随机、多中心、非劣效性研究,旨在比较最佳药物治疗(OMT)单独与ICD联合OMT治疗心肌梗死后LVEF降低的患者。该研究还描述了经济评估方法,以量化在这组患者中单独使用OMT代替ICD植入+ OMT的成本和健康影响。方法和分析:经济评估的目的是在获得试验数据之前进行试验前成本效益分析(CEA),然后从英国国家卫生服务和个人社会服务的角度进行试验内成本后果分析(CCA)和长期试验后成本效益分析(CEA)。试验前CEA使用仿真模型,根据现有证据,评估LVEF降低的心肌梗死后SCD风险患者单独使用OMT和ICD+OMT的终身成本和质量调整生命年(PROFID EHRA试验中定义)。试验内CCA旨在总结PROFID EHRA试验随访期间观察到的与健康相关的生活质量(HRQoL)、医疗资源使用和相关成本。试验后CEA通过纳入有关HRQoL和试验期间观察到的成本的当代证据,以及在试验随访期间产生的这些事件和结果的发生,并将其预测到患者的预期寿命,从而更新了试验前模型。进行敏感性分析以评估CEA结果在模型假设和模型输入参数值的不确定性方面的稳健性。最后,信息分析的价值将确定围绕关于最佳治疗策略的模型结论的不确定性的关键驱动因素,确定是否需要进一步的研究。伦理和传播:PROFID EHRA试验在德国Charité-Universitätsmedizin Berlin的法律赞助下,获得了西班牙马德里La Paz大学医院医学研究伦理委员会的首次伦理批准(参考编号LHS-2019-0209)。在纳入患者之前,所有参与研究中心都必须获得所需的地方、中央和/或国家伦理批准。截至2025年11月13日,以下国家至少有一个参与研究中心已获得相关伦理委员会的伦理批准:奥地利、比利时、捷克共和国、丹麦、法国、德国、英国、匈牙利、以色列、荷兰、波兰和西班牙。研究结果将通过各种媒体渠道与公众分享,此外还将通过科学会议、会议和出版物与卫生保健专业人员和科学界分享。试验注册号:NCT05665608。
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引用次数: 0
Patients' lived experiences and coping mechanisms following mitral valve replacement at the National Cardiac Institute in Tanzania: a qualitative study. 坦桑尼亚国家心脏研究所二尖瓣置换术后患者的生活经历和应对机制:一项定性研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-08 DOI: 10.1136/bmjopen-2025-107455
Jinasa Peter Kisangija, Salome E Buluba, Menti Lastone Ndile

Objective: To qualitatively explore patients' lived experiences and coping mechanisms following mitral valve replacement (MVR) at the National Cardiac Institute in Tanzania.

Design: A descriptive qualitative study using in-depth interviews and thematic analysis.

Setting: The study was conducted at the National Cardiac Institute, located in Dar es Salaam, the sole tertiary cardiac centre in Tanzania offering open-heart surgery.

Participants: 17 participants were purposively sampled. Inclusion criteria were as follows: patients aged ≥18 years, had at least 28 days post-MVR, without chronic conditions (eg, diabetes and HIV) and attending postoperative cardiac clinics.

Main outcome measures: Semi-structured interviews conducted in May 2024 using an interviewer guide explored post-MVR challenges, daily life adjustments, patient-provider interactions and coping strategies. Thematic analysis was employed to identify key themes.

Results: Three primary themes emerged: (1) Quality of life after MVR, encompassing physical, social, economic and psychological challenges; (2) Quality of care after MVR, highlighting patient-provider interactions and access to services; and (3) Adapting to post-MVR life, including psychological adaptation and lifestyle modification. Participants reported improved quality of life through shared experiences and support.

Conclusion: Patients experienced physical, socio-economic and psychological challenges post-MVR. However, quality of life improved through access to care, peer support and adaptive coping. Adaptation to life with an artificial valve is feasible with robust support systems, even in resource-limited settings.

目的:定性探讨坦桑尼亚国家心脏研究所二尖瓣置换术(MVR)后患者的生活经历和应对机制。设计:采用深度访谈和专题分析的描述性定性研究。环境:这项研究是在位于达累斯萨拉姆的国家心脏研究所进行的,该研究所是坦桑尼亚唯一提供心脏直视手术的三级心脏中心。参与者:17名参与者有意抽样。纳入标准如下:患者年龄≥18岁,mvr后至少28天,无慢性疾病(如糖尿病和HIV),并参加术后心脏诊所。主要结果测量:在2024年5月使用采访者指南进行的半结构化访谈探讨了mvr后的挑战,日常生活调整,患者与提供者的互动和应对策略。采用专题分析来确定关键主题。结果表明:MVR后的生活质量,包括身体、社会、经济和心理方面的挑战;(2) MVR后的护理质量,强调患者与提供者的互动和服务的可及性;(3)适应mvr后的生活,包括心理适应和生活方式的改变。参与者报告说,通过分享经验和支持,他们的生活质量得到了改善。结论:mvr后患者经历了身体、社会经济和心理方面的挑战。然而,通过获得护理、同伴支持和适应性应对,生活质量得到了改善。即使在资源有限的环境中,只要有强大的支持系统,人工阀门也能适应生活。
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引用次数: 0
Clinical characteristics, treatments and outcomes of hospitalised COVID-19 patients across pandemic waves at a tertiary acute care hospital in Narita, Japan: a single-centre retrospective observational study. 日本成田一家三级急症医院COVID-19住院患者在大流行期间的临床特征、治疗和结果:一项单中心回顾性观察研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-08 DOI: 10.1136/bmjopen-2025-109380
Ryota Hase, Rika Kurata, Yu Niiyama, Naoya Matsuda, Hideki Ueda, Koki Kikuchi, Keiko Ishida, Yoshifumi Kubota, Motoki Fujii, Takashi Kurita, Emiri Muranaka, Hiroki Sasazawa, Haruki Mito, Yudai Yano, Reiko Oku, Yoshihisa Tateishi, Satoshi Toishi, Shintaro Obata, Yasushi Noguchi, Kazuya Nakanishi, Shosuke Sunami

Objective: This study aims to describe the characteristics of hospitalised COVID-19 patients in a tertiary care hospital close to an international airport in Japan and to compare these characteristics among different waves during the pandemic.

Design: Retrospective observational study.

Setting: Tertiary care centre in Japan.

Participants: All patients diagnosed with COVID-19 who were hospitalised between January 2020 and April 2022 were included.

Measurements: Clinical characteristics, characteristics of admission, treatments and outcomes were investigated and compared among six pandemic waves.

Results: A total of 827 patients were included. The median age was 58.0 years. More than half of the patients (58.3%) had at least one comorbidity. The majority of patients (89.0%) were domestically infected patients admitted under the Infectious Diseases Law, while the remaining patients (11.0%) were those diagnosed during airport quarantine and admitted under the Quarantine Act. Hospital-acquired COVID-19 infection occurred in 7.0% of cases, and mainly during the sixth wave. Overall, some form of oxygen therapy, high-flow oxygen devices, invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation was provided in 46.3%, 10.4%, 4.5% and 1.5% of cases, respectively. Only 1.8% of patients were treated in the intensive care unit (ICU), and 59.5% of patients on IMV were managed in the non-ICU ward. The in-hospital mortality rate was 5.8%. Median age, percentages of some comorbidities, vaccination coverage, medications for COVID-19, types of supportive care and ICU admissions differed significantly among waves.

Conclusions: This study suggests that patient characteristics, vaccination coverage, standard of treatment and severity of illness changed across waves during the COVID-19 pandemic. Intensive care delivery in non-ICU wards was unavoidable due to limited ICU capacity, which may be a key consideration when preparing for future pandemics.

目的:本研究旨在描述在日本靠近国际机场的三级医院住院的COVID-19患者的特征,并比较大流行期间不同波的这些特征。设计:回顾性观察性研究。环境:日本的三级保健中心。参与者:包括2020年1月至2022年4月期间住院的所有诊断为COVID-19的患者。测量方法:对六次大流行波的临床特征、入院特征、治疗和结果进行调查和比较。结果:共纳入827例患者。中位年龄为58.0岁。超过一半的患者(58.3%)至少有一种合并症。大部分患者(89.0%)是根据《传染病法》入境的国内感染患者,其余患者(11.0%)是在机场检疫过程中确诊并根据《检疫法》入境的患者。医院获得性COVID-19感染发生率为7.0%,主要发生在第六波。总体而言,分别有46.3%、10.4%、4.5%和1.5%的病例采用了某种形式的氧疗、高流量氧气装置、有创机械通气(IMV)和体外膜氧合。只有1.8%的患者在重症监护病房(ICU)接受治疗,59.5%的IMV患者在非ICU病房接受治疗。住院死亡率为5.8%。中位年龄、某些合并症的百分比、疫苗接种覆盖率、COVID-19药物治疗、支持性护理类型和ICU入院情况在各波之间存在显著差异。结论:本研究提示,在2019冠状病毒病大流行期间,患者特征、疫苗接种覆盖率、治疗标准和疾病严重程度发生了跨波变化。由于ICU容量有限,在非ICU病房提供重症监护是不可避免的,这可能是为未来大流行做准备时的一个关键考虑因素。
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引用次数: 0
Integrating the Common Elements Treatment Approach and motivational interviewing to improve HIV pre-exposure prophylaxis engagement among women who use drugs in Tanzania: protocol for a pilot randomised controlled trial. 整合共同要素治疗方法和动机性访谈,以改善坦桑尼亚吸毒妇女接触艾滋病毒前预防的参与:一项试点随机对照试验方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-08 DOI: 10.1136/bmjopen-2025-114522
Haneefa Saleem, Kaitlyn Atkins, Stephanie Skavenski, Bareng Aletta Nonyane, Frank Chitamwebwa, Sifaely Mtaita, David Mwansa, Adela Luswetula, Laura K Murray, Samuel Likindikoki

Introduction: Women who use drugs in Tanzania face a disproportionately high burden of HIV and mental health disorders. Despite the availability of pre-exposure prophylaxis (PrEP), uptake remains low, highlighting the need for integrated, scalable interventions that address co-occurring substance use and mental health challenges. Motivational interviewing (MI) and cognitive-behavioural approaches, such as the Common Elements Treatment Approach (CETA), show promise for enhancing HIV prevention outcomes in this population. This study presents the protocol for a pilot feasibility trial assessing the acceptability, feasibility and preliminary efficacy of MI for PrEP (MI-PrEP) and a combined CETA and MI-PrEP intervention (CETA + MI-PrEP) to improve PrEP engagement among women who use drugs in Tanzania.

Methods and analysis: This individually randomised, parallel-group pilot trial will be conducted in Dar es Salaam, Tanzania, guided by the situated Information, Motivation and Behavioral Skills model. Eligible participants are adult women who use heroin, report recent drug-related or sex-related HIV risk behaviours, are HIV-negative and exhibit symptoms of depression, anxiety or post-traumatic stress disorder. Participants are randomised to one of three arms: MI-PrEP, CETA + MI-PrEP or enhanced treatment as usual. Interventions are delivered face-to-face by trained counsellors. Feasibility and acceptability will be assessed using recruitment and retention data, surveys and qualitative interviews. Preliminary effects will be measured for PrEP initiation, symptoms of common mental disorders and substance use.

Ethics and dissemination: Ethical approval has been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4830). Results will be disseminated through ClinicalTrials.gov, peer-reviewed publications, conferences, presentations and research briefings to community stakeholders.

Trial registration: ClinicalTrials.gov ID: NCT06835751. Initially registered 14 February 2025, https://clinicaltrials.gov/study/NCT06835751, last updated 5 December 2025.

导言:坦桑尼亚使用毒品的妇女面临着不成比例的艾滋病毒和精神健康障碍的高负担。尽管有接触前预防(PrEP),但使用率仍然很低,这突出表明需要采取综合、可扩展的干预措施,以解决同时发生的药物使用和精神卫生挑战。动机访谈(MI)和认知行为方法,如共同要素治疗方法(CETA),显示出在这一人群中加强艾滋病毒预防结果的希望。本研究提出了一项试点可行性试验方案,评估MI用于PrEP (MI-PrEP)的可接受性、可行性和初步疗效,以及CETA和MI-PrEP联合干预(CETA + MI-PrEP),以提高坦桑尼亚吸毒妇女的PrEP参与度。方法和分析:这项单独随机、平行组的试点试验将在坦桑尼亚的达累斯萨拉姆进行,以情境信息、动机和行为技能模型为指导。合格的参与者是使用海洛因的成年妇女,最近报告了与毒品有关或与性有关的艾滋病毒风险行为,艾滋病毒阴性,并表现出抑郁、焦虑或创伤后应激障碍的症状。参与者随机分为三组:MI-PrEP、CETA + MI-PrEP或常规强化治疗。干预措施由训练有素的咨询师面对面提供。可行性和可接受性将通过招聘和保留数据、调查和定性访谈来评估。将测量PrEP开始、常见精神障碍症状和物质使用的初步影响。伦理和传播:已获得约翰霍普金斯大学彭博公共卫生学院机构审查委员会(25580)、Muhimbili卫生和相关科学大学伦理审查委员会(MUHAS-REC-12-2023-1994)和坦桑尼亚国家医学研究所国家卫生研究伦理委员会(NIMR/HQ/R.8a/Vol.IX/4830)的伦理批准。结果将通过ClinicalTrials.gov、同行评审的出版物、会议、演讲和研究简报向社区利益相关者传播。试验注册:ClinicalTrials.gov ID: NCT06835751。最初注册于2025年2月14日,https://clinicaltrials.gov/study/NCT06835751,最后更新于2025年12月5日。
{"title":"Integrating the Common Elements Treatment Approach and motivational interviewing to improve HIV pre-exposure prophylaxis engagement among women who use drugs in Tanzania: protocol for a pilot randomised controlled trial.","authors":"Haneefa Saleem, Kaitlyn Atkins, Stephanie Skavenski, Bareng Aletta Nonyane, Frank Chitamwebwa, Sifaely Mtaita, David Mwansa, Adela Luswetula, Laura K Murray, Samuel Likindikoki","doi":"10.1136/bmjopen-2025-114522","DOIUrl":"10.1136/bmjopen-2025-114522","url":null,"abstract":"<p><strong>Introduction: </strong>Women who use drugs in Tanzania face a disproportionately high burden of HIV and mental health disorders. Despite the availability of pre-exposure prophylaxis (PrEP), uptake remains low, highlighting the need for integrated, scalable interventions that address co-occurring substance use and mental health challenges. Motivational interviewing (MI) and cognitive-behavioural approaches, such as the Common Elements Treatment Approach (CETA), show promise for enhancing HIV prevention outcomes in this population. This study presents the protocol for a pilot feasibility trial assessing the acceptability, feasibility and preliminary efficacy of MI for PrEP (MI-PrEP) and a combined CETA and MI-PrEP intervention (CETA + MI-PrEP) to improve PrEP engagement among women who use drugs in Tanzania.</p><p><strong>Methods and analysis: </strong>This individually randomised, parallel-group pilot trial will be conducted in Dar es Salaam, Tanzania, guided by the situated Information, Motivation and Behavioral Skills model. Eligible participants are adult women who use heroin, report recent drug-related or sex-related HIV risk behaviours, are HIV-negative and exhibit symptoms of depression, anxiety or post-traumatic stress disorder. Participants are randomised to one of three arms: MI-PrEP, CETA + MI-PrEP or enhanced treatment as usual. Interventions are delivered face-to-face by trained counsellors. Feasibility and acceptability will be assessed using recruitment and retention data, surveys and qualitative interviews. Preliminary effects will be measured for PrEP initiation, symptoms of common mental disorders and substance use.</p><p><strong>Ethics and dissemination: </strong>Ethical approval has been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4830). Results will be disseminated through ClinicalTrials.gov, peer-reviewed publications, conferences, presentations and research briefings to community stakeholders.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06835751. Initially registered 14 February 2025, https://clinicaltrials.gov/study/NCT06835751, last updated 5 December 2025.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 1","pages":"e114522"},"PeriodicalIF":2.3,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145932078","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
Association of rubella and parvovirus B19 IgM positivity and suspected rheumatoid arthritis: a retrospective analysis from a large US national reference laboratory (2014-2023). 风疹和细小病毒B19 IgM阳性与疑似类风湿关节炎的关联:来自美国大型国家参考实验室的回顾性分析(2014-2023)。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-07 DOI: 10.1136/bmjopen-2025-103683
Min Kyung Lee, David Alfego, Stanley J Naides

Objective: Rubella and parvovirus B19 (B19V) infections can present with arthritis-like symptoms in adults instead of typical dermatological symptoms. We quantify associations between rubella and B19V, respectively, with arthritis-like complications using real-world diagnostic testing.

Design: Cross-sectional and retrospective cohort study.

Setting: Reference laboratories across the USA.

Participants: Participants with IgM tests for rubella (N=211 917) or B19V (N=644 473) performed at Labcorp from 2014 to 2023. Among these participants, participants with IgM tests for rubella (N=1867) or B19V (N=22 683) and longitudinal laboratory testing through Labcorp were followed for diagnostic tests for rheumatoid arthritis (RA) up to 1.5 years after the viral IgM tests.

Primary and secondary outcome measures: Primary outcomes were arthritis-like suspicions by providers and diagnostic testing for RA-associated biomarkers.

Results: Higher proportions of suspicions of arthritis (1.4%, p<0.001) and same-day RA-associated diagnostic testing (1.3%, p<0.001) and positivity (26.4%, p=0.003) were identified in rubella IgM-positive adults compared with rubella IgM-negative adults. A higher proportion of B19V IgM-positive adults had suspected arthritis (12.6%) compared with B19V IgM-negative adults (8.1%, p<0.001). While a higher proportion of B19V IgM-positive adults (21.3%) received RA-associated diagnostic testing compared with B19V IgM-negative adults (14.3%, p<0.001), a lower proportion of B19V IgM-positive adults with RA-associated diagnostic testing (12.8%) tested positive (B19V IgM-negative: 15.5%, p<0.001). There was a 33% increased risk of a suspected RA diagnosis in B19V IgM-positive participants compared with B19V IgM-negative participants (HR=1.33, 95% CI 1.10 to 1.61).

Conclusions: Increased awareness of non-typical RA symptoms may facilitate differential diagnosis between rubella, B19V and RA. Recent B19V infections do not occur concurrently with RA; recent B19V infections should be considered in the differential diagnosis for RA when patients present with polyarticular joint symptoms.

目的:成人风疹和细小病毒B19 (B19V)感染可表现为关节炎样症状,而不是典型的皮肤症状。我们量化风疹和B19V之间的关联,分别与关节炎样并发症使用真实世界的诊断测试。设计:横断面和回顾性队列研究。环境:美国各地的参考实验室。参与者:2014年至2023年在Labcorp进行风疹(N=211 917)或B19V (N=644 473) IgM测试的参与者。在这些参与者中,进行风疹(N=1867)或B19V (N=22 683) IgM测试并通过Labcorp进行纵向实验室测试的参与者在病毒IgM测试后进行类风湿关节炎(RA)诊断测试长达1.5年。主要和次要结果测量:主要结果是提供者的关节炎样怀疑和ra相关生物标志物的诊断测试。结论:提高对非典型RA症状的认识可能有助于风疹、B19V和RA的鉴别诊断。近期B19V感染不与类风湿性关节炎同时发生;当患者出现多关节症状时,应考虑近期B19V感染作为RA的鉴别诊断。
{"title":"Association of rubella and parvovirus B19 IgM positivity and suspected rheumatoid arthritis: a retrospective analysis from a large US national reference laboratory (2014-2023).","authors":"Min Kyung Lee, David Alfego, Stanley J Naides","doi":"10.1136/bmjopen-2025-103683","DOIUrl":"10.1136/bmjopen-2025-103683","url":null,"abstract":"<p><strong>Objective: </strong>Rubella and parvovirus B19 (B19V) infections can present with arthritis-like symptoms in adults instead of typical dermatological symptoms. We quantify associations between rubella and B19V, respectively, with arthritis-like complications using real-world diagnostic testing.</p><p><strong>Design: </strong>Cross-sectional and retrospective cohort study.</p><p><strong>Setting: </strong>Reference laboratories across the USA.</p><p><strong>Participants: </strong>Participants with IgM tests for rubella (N=211 917) or B19V (N=644 473) performed at Labcorp from 2014 to 2023. Among these participants, participants with IgM tests for rubella (N=1867) or B19V (N=22 683) and longitudinal laboratory testing through Labcorp were followed for diagnostic tests for rheumatoid arthritis (RA) up to 1.5 years after the viral IgM tests.</p><p><strong>Primary and secondary outcome measures: </strong>Primary outcomes were arthritis-like suspicions by providers and diagnostic testing for RA-associated biomarkers.</p><p><strong>Results: </strong>Higher proportions of suspicions of arthritis (1.4%, p<0.001) and same-day RA-associated diagnostic testing (1.3%, p<0.001) and positivity (26.4%, p=0.003) were identified in rubella IgM-positive adults compared with rubella IgM-negative adults. A higher proportion of B19V IgM-positive adults had suspected arthritis (12.6%) compared with B19V IgM-negative adults (8.1%, p<0.001). While a higher proportion of B19V IgM-positive adults (21.3%) received RA-associated diagnostic testing compared with B19V IgM-negative adults (14.3%, p<0.001), a lower proportion of B19V IgM-positive adults with RA-associated diagnostic testing (12.8%) tested positive (B19V IgM-negative: 15.5%, p<0.001). There was a 33% increased risk of a suspected RA diagnosis in B19V IgM-positive participants compared with B19V IgM-negative participants (HR=1.33, 95% CI 1.10 to 1.61).</p><p><strong>Conclusions: </strong>Increased awareness of non-typical RA symptoms may facilitate differential diagnosis between rubella, B19V and RA. Recent B19V infections do not occur concurrently with RA; recent B19V infections should be considered in the differential diagnosis for RA when patients present with polyarticular joint symptoms.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 1","pages":"e103683"},"PeriodicalIF":2.3,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12781989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145916745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Meanings and practices of solidarity in global health: a qualitative investigation - study protocol. 全球卫生团结的意义和实践:一项定性调查研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-07 DOI: 10.1136/bmjopen-2024-095243
Elysee Nouvet, Mary Ndu, Bridget Pratt, Gabriela Arguedas Ramirez, Barbara Prainsack, Unni Karunakara, Jantina DeVries, Samuel Asiedu Owusu, Caesar Atuire

Introduction: Solidarity in global health is often invoked as an ethical imperative to guide responses to global health challenges. Its meanings and practices across diverse contexts, however, remain under-explored. Deepening an understanding of how solidarity is conceptualised, enacted and perceived by a diverse array of actors within the global health ecosystem is crucial to advancing meaningful and measurable application of this commitment in global health.

Methods and analysis: This qualitative study uses interpretive research methodology to explore perspectives on solidarity among key global health stakeholders: community-level leaders in civil society organisations working on global health issues; research institute directors in the Global South; and individuals with experience of funding decision-making with major global health funding and agenda setting organisations ('global health influencers'). Data will be gathered through semi-structured interviews and analysed using inductive and deductive reflexive thematic analysis, to identify patterns and differences in how these global health stakeholders recognise and define solidarity or its absence in their day-to-day work, while remaining attentive to conceptual tensions, participant interpretations of solidarity that may be unfamiliar to our team, and our role as researchers in shaping what we register and emphasise as significant in our reporting of findings.

Ethics and dissemination: Ethics approval was obtained from the Western University Health Sciences Research Ethics Board (HSREB) in Ontario, Canada # 2024-123965-87873 and the Ethics Committee for the Humanities, University of Ghana # ECH 163/23-24 and University of Oxford, Oxford Tropical Research Ethics Committee (OxTREC) waiver dated 10 April 2024. Study results will be submitted for peer-reviewed publication. Results will also be summarised in an open access report and presented at various stakeholder meetings and in online webinars.

Protocol registration: The final protocol was registered with Open Science Framework on 28 October 2023. View only link: https://osf.io/gryp5/?view_only=8baff435a35847f09a342408d38ee35b.

导言:在全球卫生方面的团结经常被援引为指导应对全球卫生挑战的道德要求。然而,它在不同背景下的意义和实践仍未得到充分探索。加深对全球卫生生态系统内各种行为体如何概念化、制定和感知团结的理解,对于推动这一承诺在全球卫生领域得到有意义和可衡量的应用至关重要。方法和分析:本定性研究使用解释性研究方法来探索全球卫生主要利益相关者之间团结的观点:致力于全球卫生问题的民间社会组织的社区一级领导人;全球南方的研究机构主任;以及具有资助主要全球卫生资助和议程制定组织决策经验的个人(“全球卫生影响者”)。将通过半结构化访谈收集数据,并使用归纳和演绎反身性专题分析进行分析,以确定这些全球卫生利益攸关方在日常工作中如何认识和定义团结或缺乏团结方面的模式和差异,同时继续注意概念上的紧张关系,以及我们团队可能不熟悉的参与者对团结的解释,作为研究人员,我们的角色是塑造我们在报告发现时所记录和强调的重要内容。伦理和传播:获得了加拿大安大略省西部大学健康科学研究伦理委员会(HSREB) # 2024-123965-87873的伦理批准,以及加纳大学人文伦理委员会# ECH 163/23-24和牛津大学牛津热带研究伦理委员会(OxTREC)于2024年4月10日的豁免。研究结果将提交同行评审出版。研究结果还将总结在一份开放获取报告中,并在各种利益相关者会议和在线网络研讨会上进行介绍。方案注册:最终方案于2023年10月28日在开放科学框架注册。仅限查看链接:https://osf.io/gryp5/?view_only=8baff435a35847f09a342408d38ee35b。
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引用次数: 0
Challenges of multicultural healthcare practice in type 2 diabetes care: a qualitative study of Australian healthcare professionals. 2型糖尿病护理中多元文化医疗实践的挑战:澳大利亚医疗保健专业人员的定性研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-07 DOI: 10.1136/bmjopen-2025-108187
Diane Gargya, Vincent Chan, Thilini Thrimawithana, Ieva Stupans, Kimmi Keum Hee Ko, Barbora de Courten, Chiao Xin Lim

Objectives: This study explores the challenges experienced by Australian healthcare professionals (HCPs) in delivering type 2 diabetes care to people of culturally and linguistically diverse (CALD) backgrounds. We examined how sociocultural, linguistic and health systems factors influence their clinical practice.

Design: A qualitative study employing semi-structured interviews was conducted from April to October 2024. Data were analysed using Braun and Clarke's reflexive thematic analysis to identify patterns and themes in HCPs' experiences, guided by a constructivist perspective.

Settings: The study was conducted in metropolitan Melbourne, Australia, across primary and tertiary healthcare settings.

Participants: A purposive sample of 11 Australian HCPs from diverse disciplines, including general practice, pharmacy, nursing, endocrinology, dietetics and podiatry, participated. All had provided type 2 diabetes care to people of CALD backgrounds within the previous 12 months. Participants included both male and female professionals, many from ethnically diverse backgrounds.

Results: Three overarching themes were identified, reflecting HCPs' perceived challenges to providing culturally responsive type 2 diabetes care to people of CALD backgrounds. These themes illustrated the multilevel challenges encountered by HCPs at the patient, organisational and provider levels, namely: (1) healthcare provision across diverse health literacy and cultural contexts, (2) navigating system gaps in multicultural clinical practice and (3) workforce preparedness gaps in culturally responsive care.

Conclusions: HCPs remain committed to providing culturally responsive type 2 diabetes care but continue to face constraints, including limited cross-cultural training and exposure, inadequate interpreter access, time pressures and insufficient culturally adapted resources. Effective care in multicultural settings requires recognising patients' culturally shaped beliefs about health and illness and embedding cultural humility, reflexivity and competence within professional practice, essential steps towards advancing equitable type 2 diabetes care across Australia's diverse communities.

目的:本研究探讨了澳大利亚医疗保健专业人员(HCPs)在向文化和语言多样化(CALD)背景的人提供2型糖尿病护理时所面临的挑战。我们研究了社会文化、语言和卫生系统因素如何影响他们的临床实践。设计:采用半结构化访谈的定性研究于2024年4月至10月进行。数据分析采用Braun和Clarke的反身性主题分析,在建构主义观点的指导下,确定HCPs经验中的模式和主题。环境:该研究在澳大利亚墨尔本大都会进行,涉及初级和三级医疗保健机构。参与者:来自不同学科的11名澳大利亚HCPs有目的的样本,包括全科医生、药学、护理、内分泌学、营养学和足部。在过去的12个月里,所有人都为CALD背景的人提供过2型糖尿病护理。参与者包括男性和女性专业人士,许多人来自不同的种族背景。结果:确定了三个总体主题,反映了HCPs在为CALD背景的人提供文化响应型2型糖尿病护理方面所面临的挑战。这些主题说明了HCPs在患者、组织和提供者层面遇到的多层次挑战,即:(1)跨越不同健康素养和文化背景的医疗保健服务;(2)在多元文化临床实践中导航系统差距;(3)在文化响应性护理中劳动力准备差距。结论:HCPs仍然致力于提供文化响应型2型糖尿病护理,但仍然面临限制,包括有限的跨文化培训和接触,口译人员不足,时间压力和文化适应资源不足。在多元文化环境中,有效的护理需要认识到患者对健康和疾病的文化观念,并在专业实践中嵌入文化谦逊、反思和能力,这是在澳大利亚不同社区推进公平的2型糖尿病护理的重要步骤。
{"title":"Challenges of multicultural healthcare practice in type 2 diabetes care: a qualitative study of Australian healthcare professionals.","authors":"Diane Gargya, Vincent Chan, Thilini Thrimawithana, Ieva Stupans, Kimmi Keum Hee Ko, Barbora de Courten, Chiao Xin Lim","doi":"10.1136/bmjopen-2025-108187","DOIUrl":"10.1136/bmjopen-2025-108187","url":null,"abstract":"<p><strong>Objectives: </strong>This study explores the challenges experienced by Australian healthcare professionals (HCPs) in delivering type 2 diabetes care to people of culturally and linguistically diverse (CALD) backgrounds. We examined how sociocultural, linguistic and health systems factors influence their clinical practice.</p><p><strong>Design: </strong>A qualitative study employing semi-structured interviews was conducted from April to October 2024. Data were analysed using Braun and Clarke's reflexive thematic analysis to identify patterns and themes in HCPs' experiences, guided by a constructivist perspective.</p><p><strong>Settings: </strong>The study was conducted in metropolitan Melbourne, Australia, across primary and tertiary healthcare settings.</p><p><strong>Participants: </strong>A purposive sample of 11 Australian HCPs from diverse disciplines, including general practice, pharmacy, nursing, endocrinology, dietetics and podiatry, participated. All had provided type 2 diabetes care to people of CALD backgrounds within the previous 12 months. Participants included both male and female professionals, many from ethnically diverse backgrounds.</p><p><strong>Results: </strong>Three overarching themes were identified, reflecting HCPs' perceived challenges to providing culturally responsive type 2 diabetes care to people of CALD backgrounds. These themes illustrated the multilevel challenges encountered by HCPs at the patient, organisational and provider levels, namely: (1) healthcare provision across diverse health literacy and cultural contexts, (2) navigating system gaps in multicultural clinical practice and (3) workforce preparedness gaps in culturally responsive care.</p><p><strong>Conclusions: </strong>HCPs remain committed to providing culturally responsive type 2 diabetes care but continue to face constraints, including limited cross-cultural training and exposure, inadequate interpreter access, time pressures and insufficient culturally adapted resources. Effective care in multicultural settings requires recognising patients' culturally shaped beliefs about health and illness and embedding cultural humility, reflexivity and competence within professional practice, essential steps towards advancing equitable type 2 diabetes care across Australia's diverse communities.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 1","pages":"e108187"},"PeriodicalIF":2.3,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12781978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145916769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mixed-methods, participatory action research study exploring palliative and end-of-life care for LGBTIQ+ people in Switzerland: a protocol for the TRUST-PALL study. 探讨瑞士LGBTIQ+人群的姑息治疗和临终关怀的混合方法参与性行动研究:TRUST-PALL研究的协议。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-07 DOI: 10.1136/bmjopen-2025-106641
Michael J Deml, Clément Meier, Catarina Letras, Nina Canova, Paolo Martinelli, Laura Jones, Gaé Colussi, Philip J Larkin, Léïla Eisner, Tabea Hässler, Francesca Bosisio, Claudia Gamondi

Introduction: Lesbian, gay, bisexual, trans, intersex, queer/questioning and other sexual and gender minorities (LGBTIQ+) face systemic barriers and discrimination in healthcare settings, leading to significant health disparities. These challenges persist in palliative and end-of-life care (PEOLC), where older LGBTIQ+ people often lack family support and experience social isolation. Despite the increasing ageing of the LGBTIQ+ population in Switzerland, there is limited evidence on their specific PEOLC needs. Additionally, healthcare providers' knowledge and practices regarding LGBTIQ+ inclusivity in these settings remain understudied. This study aims to address these gaps by co-creating knowledge and developing best practice recommendations for inclusive PEOLC in Switzerland.

Methods and analysis: This study employs a mixed-methods participatory action research approach across three work packages (WPs). WP0 ensures participatory engagement through advisory boards, workshops and co-design processes across Switzerland's four linguistic regions. WP1 investigates the palliative and PEOLC needs of LGBTIQ+ people and their (chosen) families through qualitative interviews (n≈30) and a quantitative survey embedded in the Swiss LGBTIQ+ Panel. WP2 explores healthcare providers' perceptions and practices regarding LGBTIQ+ patients through qualitative interviews (n≈30) and a nationwide quantitative survey among palliative and PEOLC professionals. Data will be analysed using reflexive thematic analysis for qualitative data and multivariate regression models for quantitative data. Findings will be synthesised through a specific data integration framework, integrating community and healthcare perspectives.

Ethics and dissemination: This study has received ethical approval from the relevant Swiss Ethics Committees. The participatory approach promotes inclusivity, empowering LGBTIQ+ people and healthcare providers in shaping recommendations. Findings will be disseminated via peer-reviewed publications, policy briefs, stakeholder workshops and the co-created Rainbow Book, a best-practice guide for LGBTIQ+ inclusive palliative and PEOLC in Switzerland.

女同性恋、男同性恋、双性恋、变性人、双性人、酷儿/质疑和其他性少数群体(LGBTIQ+)在卫生保健环境中面临系统性障碍和歧视,导致严重的健康差距。这些挑战在姑息治疗和临终关怀(PEOLC)中仍然存在,LGBTIQ+老年人往往缺乏家庭支持并经历社会孤立。尽管瑞士LGBTIQ+人口日益老龄化,但关于他们具体的PEOLC需求的证据有限。此外,医疗保健提供者在这些环境中关于LGBTIQ+包容性的知识和实践仍未得到充分研究。本研究旨在通过共同创造知识和制定瑞士包容性PEOLC的最佳实践建议来解决这些差距。方法和分析:本研究采用混合方法的参与性行动研究方法,涉及三个工作包(wp)。WP0通过咨询委员会、研讨会和瑞士四个语言区域的共同设计过程确保参与性参与。WP1通过定性访谈(n≈30)和瑞士LGBTIQ+小组的定量调查,调查LGBTIQ+人群及其(选定)家庭的姑息治疗和PEOLC需求。WP2通过定性访谈(n≈30)和全国范围内姑息治疗和PEOLC专业人员的定量调查,探讨医疗服务提供者对LGBTIQ+患者的看法和做法。将对定性数据使用反身性专题分析,对定量数据使用多元回归模型来分析数据。研究结果将通过具体的数据整合框架进行综合,整合社区和医疗保健观点。伦理与传播:本研究已获得瑞士相关伦理委员会的伦理批准。参与性方法促进了包容性,增强了LGBTIQ+人群和医疗保健提供者制定建议的权能。研究结果将通过同行评议出版物、政策简报、利益相关者研讨会和共同编写的彩虹书(Rainbow Book)进行传播,彩虹书是瑞士LGBTIQ+包容性姑息治疗和PEOLC的最佳实践指南。
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引用次数: 0
Evaluating the delivery of trauma and orthopaedic education in UK medical schools: a national cross-sectional survey protocol (TENDON study). 评估英国医学院创伤和骨科教育的交付:一项全国横断面调查协议(肌腱研究)。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-07 DOI: 10.1136/bmjopen-2025-109530
Naadir Nazar, Ciaran O'Hanlon, Shivam Kolhe, Matthew Bellamy, Marie Barberon, Apoorva Khajuria, Wen X Low, Rahul Geetala, Kayden Chahal, Paul Banaszkiewicz, Andrew McCaskie, Stephen McDonnell

Introduction: Musculoskeletal (MSK) conditions account for up to one-third of general practice consultations and over one-fifth of emergency department attendances in the UK. Postpandemic, the elective orthopaedic surgery backlog remains one of the most substantial across surgical specialties. Despite this burden, undergraduate exposure to trauma and orthopaedics (T&O) remains limited and inconsistent. Most UK medical students receive only 2-3 weeks of T&O teaching, with up to 40% of foundation doctors feeling underprepared to manage MSK conditions. The Evaluation of Trauma and Orthopaedic Teaching in Medical Schools Nationally (TENDON Study) aims to evaluate the current state of undergraduate T&O education in UK medical schools from both student and educator perspectives.

Methods and analysis: This national, prospective, cross-sectional survey will be conducted between 25 July and 27 October 2025. A dual-instrument electronic survey was developed through Qualtrics, informed by the British Orthopaedic Association (BOA) Undergraduate Curriculum and UK Medical Licensing Assessment content map. Participants will include medical students (Years 1-6), foundation doctors and orthopaedic educators recruited through British Orthopaedic Medical Students Association and BOA networks, and designated school representatives. Survey domains include curriculum coverage, teaching methods, clinical exposure and self-reported competence. Quantitative data will be analysed using descriptive and inferential statistics; qualitative data will undergo thematic analysis. Reporting will follow the Checklist for Reporting Of Survey Studies framework, with relevant elements drawn from the Checklist for Reporting Results of Internet E-Surveys checklist.

Ethics and dissemination: Ethical approval was obtained from the Human Biology Research Ethics Committee, University of Cambridge. Findings will be disseminated via peer-reviewed publication, conference presentations and summary reports to curriculum leads and relevant educational bodies.

简介:肌肉骨骼(MSK)条件占三分之一的全科咨询和超过五分之一的急诊科出席在英国。大流行后,择期骨科手术的积压仍然是外科专业中最重要的积压之一。尽管有这种负担,大学生接触创伤和骨科(T&O)仍然有限和不一致。大多数英国医学生只接受了2-3周的T&O教学,高达40%的基础医生觉得自己对管理MSK状况准备不足。全国医学院创伤与骨科教学评估(肌腱研究)旨在从学生和教育者的角度评估英国医学院本科创伤与骨科教育的现状。方法和分析:这项全国性、前瞻性、横断面调查将于2025年7月25日至10月27日进行。在英国骨科协会(BOA)本科课程和英国医学许可评估内容图的指导下,通过qualics开发了一项双仪器电子调查。参与者将包括医学生(1-6年级)、基金会医生和通过英国骨科医学生协会和BOA网络招募的骨科教育者,以及指定的学校代表。调查领域包括课程覆盖、教学方法、临床表现和自我报告能力。定量数据将使用描述性和推断性统计进行分析;将对定性数据进行专题分析。报告将遵循“调查研究报告核对表”框架,并从“互联网电子调查报告结果核对表”中提取相关元素。伦理与传播:已获得剑桥大学人类生物学研究伦理委员会的伦理批准。研究结果将通过同行评审的出版物、会议报告和总结报告传播给课程负责人和相关教育机构。
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引用次数: 0
Online Remote Behavioural Intervention for Tics (ORBIT-UK): protocol of a single cohort usability study. tic的在线远程行为干预(ORBIT-UK):单队列可用性研究的协议。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-07 DOI: 10.1136/bmjopen-2025-110121
Olivia Hastings, Beverley J Brown, Kelly-Marie Prentice, Camilla May Babbage, E Bethan Davies, Joseph Kilgariff, Tara Murphy, Glenn McGarry, Boliang Guo, Chris Greenhalgh, Chris Hollis, Charlotte Lucy Hall

Introduction: Tourette syndrome is a common, disabling childhood-onset condition. Exposure and response prevention (ERP) is an effective treatment for tics, yet access remains limited due to a shortage of trained therapists and uneven geographical distribution of services. The ORBIT trial demonstrated that internet-delivered ERP is both clinically and cost-effective, but was developed on a university research platform, not suitable for widescale roll-out. To enable adoption by the National Health Service (NHS) in England, ORBIT has been redeveloped on an NHS compliant platform. This study will evaluate the usability, acceptability and preliminary outcomes of ORBIT on the new platform within an NHS tic disorder service.

Methods and analysis: This single-cohort usability study will recruit 20 children and young people (aged 9-17) with tics and their chosen supporters (parents/carers). Participants will receive a 10-week online ERP intervention supported by trained coaches. Outcomes include uptake, adherence, system usability, satisfaction and clinical measures such as the Yale Global Tic Severity Scale, Parent Tic Questionnaire and Goal-Based Outcomes. Qualitative feedback will be collected via semi-structured exit interviews. Usability metrics and adverse events will be monitored throughout.

Ethics and dissemination: The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref: 25/NW/0107). The findings from the study will inform future NHS adoption. The results will be submitted for publication in peer-reviewed journals.

Trial registration number: ISRCTN82718960. Registered 10 July 2025. https://doi.org/10.1186/ISRCTN82718960.

图雷特综合征是一种常见的致残性儿童期发病疾病。暴露和反应预防(ERP)是一种有效的治疗抽动症,但由于缺乏训练有素的治疗师和服务的地理分布不均匀,获取仍然有限。ORBIT试验表明,互联网提供的ERP在临床和成本效益上都很好,但它是在大学研究平台上开发的,不适合大规模推广。为了使英国国家医疗服务体系(NHS)能够采用,ORBIT已经在符合NHS标准的平台上重新开发。本研究将评估ORBIT在NHS抽动障碍服务新平台上的可用性、可接受性和初步结果。方法和分析:这项单队列可用性研究将招募20名患有抽动症的儿童和青少年(9-17岁)及其选择的支持者(父母/照顾者)。参与者将在训练有素的教练的支持下接受为期10周的在线ERP干预。结果包括吸收、依从性、系统可用性、满意度和临床测量,如耶鲁全球抽动严重程度量表、家长抽动问卷和基于目标的结果。定性反馈将通过半结构化的离职面谈收集。可用性指标和不良事件将全程监控。伦理和传播:该研究已获得西北大曼彻斯特研究伦理委员会的伦理批准(参考:25/NW/0107)。这项研究的结果将为未来NHS的采用提供信息。研究结果将在同行评议的期刊上发表。试验注册号:ISRCTN82718960。2025年7月10日注册。https://doi.org/10.1186/ISRCTN82718960。
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引用次数: 0
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