NIHR open research最新文献_第10页

Early special educational needs provision and its impact on unplanned hospital utilisation and school absences in children with isolated cleft lip and/or palate: a demonstration target trial emulation study protocol using ECHILD 早期特殊教育需求的提供及其对孤立性唇裂和/或腭裂儿童计划外医院使用和缺课的影响:使用ECHILD的示范目标试验模拟研究方案

NIHR open research

Pub Date : 2023-10-24 DOI: 10.3310/nihropenres.13472.1

Vincent Nguyen, Kate M Lewis, Ruth Gilbert, Lorraine Dearden, Bianca De Stavola

Background Special educational needs (SEN) provision is designed to help pupils with additional educational, behavioural or health needs; for example, pupils with cleft lip and/or palate may be offered SEN provision to improve their speech and language skills. Our aim is to contribute to the literature and assess the impact of SEN provision on health and educational outcomes for a well-defined population. Methods We will use the ECHILD database, which links educational and health records across England. Our target population consists of children identified within ECHILD to have a specific congenital anomaly: isolated cleft lip and/or palate. We will apply a trial emulation framework to reduce biases in design and analysis of observational data to investigate the causal impact of SEN provision (including none) by the start of compulsory education (Year One – age five year on entry) on the number of unplanned hospital utilisation and school absences by the end of primary education (Year Six – age ten/eleven). We will use propensity score-based estimators (inverse probability weighting (IPW) and IPW regression adjustment IPW) to compare categories of SEN provision in terms of these outcomes and to triangulate results obtained using complementary estimation methods (Naïve estimator, multivariable regression, parametric g-formula, and if possible, instrumental variables), targeting a variety of causal contrasts (average treatment effect/in the treated/in the not treated) of SEN provision. Conclusions This study will evaluate the impact of reasonable adjustments at the start of compulsory education on health and educational outcomes in the isolated cleft lip and palate population by triangulating complementary methods under a target-trial framework.

背景:特殊教育需要条款旨在帮助有额外教育、行为或健康需要的学生;例如，唇裂和/或腭裂的学生可以接受特殊教育，以提高他们的语言和语言技能。我们的目标是为文献做出贡献，并评估特殊教育对明确人群的健康和教育成果的影响。方法我们将使用ECHILD数据库，该数据库将整个英格兰的教育和健康记录联系起来。我们的目标人群包括在ECHILD中确定有特定先天性异常的儿童:孤立性唇裂和/或腭裂。我们将采用试验模拟框架来减少观察数据设计和分析中的偏差，以调查义务教育开始时(一年级-入学时的五岁)提供SEN(包括无SEN)对初等教育结束时(六年级-十岁/十一岁)意外医院使用和缺课人数的因果影响。我们将使用基于倾向评分的估计器(逆概率加权(IPW)和IPW回归调整IPW)，根据这些结果比较SEN提供的类别，并使用互补估计方法(Naïve估计器、多变量回归、参数g公式，如果可能的话，还有工具变量)对结果进行三角测量，针对SEN提供的各种因果对比(平均治疗效果/治疗/未治疗)。结论本研究将在目标-试验框架下，采用三角互补法评估义务教育开始时的合理调整对孤立性唇腭裂人群健康和教育结果的影响。

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引用次数: 0

Covariates of success in quitting smoking: a systematic review of studies from 2008 to 2021 conducted to inform the statistical analyses of quitting outcomes of a hospital-based tobacco dependence treatment service in the United Kingdom. 戒烟成功的协变量：对2008年至2021年的研究进行的系统回顾，该研究旨在为英国一家医院烟草依赖治疗服务的戒烟结果统计分析提供信息。

NIHR open research

Pub Date : 2023-10-20 eCollection Date: 2023-01-01 DOI: 10.3310/nihropenres.13427.2

Emma S Hock, Matthew Franklin, Susan Baxter, Mark Clowes, James Chilcott, Duncan Gillespie

Background: Smoking cessation interventions are being introduced into routine secondary care in the United Kingdom (UK), but there are person and setting-related factors that could moderate their success in quitting smoking. This review was conducted as part of an evaluation of the QUIT hospital-based tobacco dependence treatment service ( https://sybics-quit.co.uk). The aim of the review was to identify a comprehensive set of variables associated with quitting success among tobacco smokers contacting secondary healthcare services in the UK who are offered support to quit smoking and subsequently set a quit date. The results would then be used to inform the development of a statistical analysis plan to investigate quitting outcomes.

Methods: Systematic literature review of five electronic databases. Studies eligible for inclusion investigated quitting success in one of three contexts: (a) the general population in the UK; (b) people with a mental health condition; (c) quit attempts initiated within a secondary care setting. The outcome measures were parameters from statistical analysis showing the effects of covariates on quitting success with a statistically significant (i.e., p-value <0.05) association.

Results: The review identified 29 relevant studies and 14 covariates of quitting success, which we grouped into four categories: demographics (age; sex; ethnicity; socio-economic conditions; relationship status, cohabitation and social network), individual health status and healthcare setting (physical health, mental health), tobacco smoking variables (current tobacco consumption, smoking history, nicotine dependence; motivation to quit; quitting history), and intervention characteristics (reduction in amount smoked prior to quitting, the nature of behavioural support, tobacco dependence treatment duration, pharmacological aids).

Conclusions: In total, 14 data fields were identified that should be considered for inclusion in datasets and statistical analysis plans for evaluating the quitting outcomes of smoking cessation interventions initiated in secondary care contexts in the UK.

Prospero registration: CRD42021254551 (13/05/2021).

背景：在英国，戒烟干预措施正在被引入常规的二级护理，但有一些与个人和环境相关的因素可能会影响他们戒烟的成功。这篇综述是作为对QUIT医院烟草依赖治疗服务（https://sybics-quit.co.uk)。这项审查的目的是在英国联系二级医疗服务的吸烟者中确定一组与戒烟成功相关的综合变量，这些吸烟者得到了戒烟支持，并随后确定了戒烟日期。然后，这些结果将用于制定统计分析计划，以调查戒烟结果。方法：对五个电子数据库进行系统的文献综述。符合入选条件的研究调查了三种情况之一的戒烟成功率：（a）英国的普通人群；（b）有心理健康状况的人；（c）退出在二级护理环境中启动的尝试。结果测量是来自统计分析的参数，显示协变量对戒烟成功的影响具有统计学意义（即p值）。结果：该综述确定了29项相关研究和14项戒烟成功的协变量，我们将其分为四类：人口统计学（年龄；性别；种族；社会经济条件；关系状况、同居和社会网络）、个人健康状况和医疗环境（身体健康、心理健康）、吸烟变量（当前烟草消费、吸烟史、尼古丁依赖；戒烟动机；戒烟史），以及干预特征（戒烟前吸烟量的减少、行为支持的性质、烟草依赖治疗的持续时间、药物辅助），确定了14个数据字段，应考虑将其纳入数据集和统计分析计划，以评估在英国二级护理环境中启动的戒烟干预措施的戒烟结果。Prospero注册：CRD42021254551（2021年5月13日）。

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引用次数: 0

Doctoral research, COVID-19, and political crisis in Ethiopia, Sudan, Rwanda, and the UK: challenges, responses, and recommendations 埃塞俄比亚、苏丹、卢旺达和英国的博士研究、COVID-19和政治危机:挑战、应对措施和建议

NIHR open research

Pub Date : 2023-10-11 DOI: 10.3310/nihropenres.13470.1

Jean Paul Bikorimana, Corinna Thellmann, Tseganesh Mulugeta, Dereje Wonde, Addisu Tsegaye, Badraldeen Ali Bashir Alnoor Ahmed, Ursin Bayisenge, Jeffrey Pocock

Background Conducting doctoral research is a challenging endeavour, a challenge which as the growing literature on the subject has shown, the COVD-19 pandemic has made even more so. For some doctoral researchers, however, the pandemic has also been accompanied by political unrest and military conflict, putting them and their networks at risk and making their research especially difficult to sustain. Methods We have used a collaborative auto-ethnography, and we, a group of seven doctoral researchers based in Ethiopia, Rwanda, Sudan and UK have written our experiences. Results Drawing upon the results of a collaborative auto-ethnography (CAE), this article records and discusses the experiences of a group of doctoral researchers who with the support of their organisation, the Social Science for Severe Stigmatised Skin Diseases (5S) Foundation, have been attempting to cope with both the pandemic and internal instability and strife. After firstly setting the context, the article explains why for the purposes of this paper CAE was adopted as our method, and then documents and discusses the experiences of seven doctoral researchers based in Ethiopia, Sudan, Rwanda, and the UK, doing so in terms of four different themes: New Ways of Working and Its Impact, Change and Delay, Mental Health and Well-Being Impact, and Qualities and Capacities. Conclusion What these experiences tell us is that this group of doctoral researchers have found themselves in extremely challenging situations, which have placed exceptionally high demands on them and their support networks, and this has had an impact on their health and well-being although also been the catalyst for some more positive development. Given their lived experiences, the article finishes with a series of recommendations for future research projects of this kind.

开展博士研究是一项具有挑战性的工作，越来越多关于这一主题的文献表明，covid -19大流行使这一挑战更加严峻。然而，对于一些博士研究人员来说，大流行还伴随着政治动荡和军事冲突，使他们及其网络面临风险，使他们的研究特别难以维持。我们使用了协作式的自动人种志，我们，一个由来自埃塞俄比亚、卢旺达、苏丹和英国的七名博士研究人员组成的小组，写下了我们的经验。根据合作自动人种志(CAE)的结果，本文记录并讨论了一组博士研究人员的经历，他们在他们的组织——严重耻辱性皮肤病社会科学基金会(5S)的支持下，一直试图应对疫情和内部不稳定与冲突。在首先设定背景之后，文章解释了为什么采用CAE作为本文的目的，然后记录和讨论了来自埃塞俄比亚，苏丹，卢旺达和英国的七位博士研究人员的经验，他们在四个不同的主题上这样做:新的工作方式及其影响，变化和延迟，心理健康和福祉影响，素质和能力。这些经历告诉我们，这群博士研究人员发现自己处于极具挑战性的环境中，这对他们和他们的支持网络提出了极高的要求，这对他们的健康和福祉产生了影响，尽管这也成为一些更积极发展的催化剂。鉴于他们的生活经历，文章最后对未来这类研究项目提出了一系列建议。

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引用次数: 0

Effectiveness and cost-effectiveness of offering a chair-based yoga programme in addition to usual care in older adults with multiple long-term conditions: a pragmatic, parallel group, open label, randomised controlled trial 在有多种长期疾病的老年人的常规护理之外，提供椅子瑜伽项目的有效性和成本效益:一项实用的、平行的、开放标签的、随机对照试验

NIHR open research

Pub Date : 2023-10-11 DOI: 10.3310/nihropenres.13465.1

Garry Tew, Laura Wiley, Lesley Ward, Jess Hugill-Jones, Camila Maturana, Caroline Fairhurst, Kerry Bell, Laura Bissell, Alison Booth, Jenny Howsam, Valerie Mount, Tim Rapley, Sarah Ronaldson, Fiona Rose, David Torgerson, David Yates, Catherine Hewitt

Background People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple long-term conditions. Methods In this pragmatic, multi-site, open, randomised controlled trial, we recruited older adults aged ≥65 years with ≥2 long-term conditions from 15 primary care practices in England and Wales. Participants were randomly assigned to usual care control or a 12-week, group-based, GYY programme delivered face-to-face or online by qualified yoga teachers. The primary outcome was HRQOL (assessed with EQ-5D-5L) over 12 months. Secondary outcomes included anxiety, depression, falls, loneliness, healthcare resource use, and adverse events. Results Between October 2019 and October 2021, 454 participants were randomly assigned to the intervention (n=240) and control (n=214) groups. Seven GYY courses were delivered face-to-face and 12 courses were delivered online. The mean number of classes attended among all intervention participants was nine (SD 4, median 10). In our intention-to-treat analysis (n=422), there was no statistically significant difference between trial groups in the primary outcome of HRQOL (adjusted difference in mean EQ-5D-5L = 0.020 [favouring intervention]; 95% CI -0.006 to 0.045, p=0.14). There were also no statistically significant differences in key secondary outcomes. No serious, related adverse events were reported. The incremental cost-effectiveness ratio was £4,546 per quality-adjusted life-year (QALY) and the intervention had a 79% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Conclusions The offer of a 12-week chair-based yoga programme in addition to usual care did not improve HRQOL in older adults with multiple long-term conditions. However, the intervention was safe, acceptable, and probably cost-effective.

患有多种长期疾病的人更有可能具有较差的健康相关生活质量(HRQOL)。瑜伽有改善HRQOL的潜力。温柔岁月瑜伽©(GYY)是一个以椅子为基础的老年人瑜伽课程。我们调查了GYY计划在患有多种长期疾病的老年人中的有效性和成本效益。在这项实用的、多地点的、开放的、随机对照试验中，我们从英格兰和威尔士的15个初级保健诊所招募了年龄≥65岁且有≥2种长期疾病的老年人。参与者被随机分配到常规护理控制组，或参加由合格瑜伽老师面对面或在线授课的为期12周的以小组为基础的GYY课程。主要终点是12个月的HRQOL(用EQ-5D-5L评估)。次要结局包括焦虑、抑郁、跌倒、孤独、医疗资源使用和不良事件。在2019年10月至2021年10月期间，454名参与者被随机分配到干预组(n=240)和对照组(n=214)。7门GYY课程为面对面授课，12门课程为在线授课。所有干预参与者参加课程的平均数量为9个(标准差4，中位数10)。在我们的意向治疗分析(n=422)中，试验组之间HRQOL的主要结局无统计学意义差异(EQ-5D-5L平均校正差= 0.020[有利于干预];95% CI -0.006 ~ 0.045, p=0.14)。在关键的次要结局上也没有统计学上的显著差异。未见严重的相关不良事件报道。增量成本效益比为每个质量调整生命年(QALY) 4,546英镑，在每个QALY 20,000英镑的支付意愿阈值下，干预措施具有成本效益的概率为79%。结论:在常规护理之外，提供12周的椅子瑜伽计划并不能改善患有多种长期疾病的老年人的HRQOL。然而，干预是安全的，可接受的，并且可能具有成本效益。

{"title":"Effectiveness and cost-effectiveness of offering a chair-based yoga programme in addition to usual care in older adults with multiple long-term conditions: a pragmatic, parallel group, open label, randomised controlled trial","authors":"Garry Tew, Laura Wiley, Lesley Ward, Jess Hugill-Jones, Camila Maturana, Caroline Fairhurst, Kerry Bell, Laura Bissell, Alison Booth, Jenny Howsam, Valerie Mount, Tim Rapley, Sarah Ronaldson, Fiona Rose, David Torgerson, David Yates, Catherine Hewitt","doi":"10.3310/nihropenres.13465.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13465.1","url":null,"abstract":"<ns3:p>Background People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple long-term conditions. Methods In this pragmatic, multi-site, open, randomised controlled trial, we recruited older adults aged ≥65 years with ≥2 long-term conditions from 15 primary care practices in England and Wales. Participants were randomly assigned to usual care control or a 12-week, group-based, GYY programme delivered face-to-face or online by qualified yoga teachers. The primary outcome was HRQOL (assessed with EQ-5D-5L) over 12 months. Secondary outcomes included anxiety, depression, falls, loneliness, healthcare resource use, and adverse events. Results Between October 2019 and October 2021, 454 participants were randomly assigned to the intervention (n=240) and control (n=214) groups. Seven GYY courses were delivered face-to-face and 12 courses were delivered online. The mean number of classes attended among all intervention participants was nine (SD 4, median 10). In our intention-to-treat analysis (n=422), there was no statistically significant difference between trial groups in the primary outcome of HRQOL (adjusted difference in mean EQ-5D-5L = 0.020 [favouring intervention]; 95% CI -0.006 to 0.045, p=0.14). There were also no statistically significant differences in key secondary outcomes. No serious, related adverse events were reported. The incremental cost-effectiveness ratio was £4,546 per quality-adjusted life-year (QALY) and the intervention had a 79% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Conclusions The offer of a 12-week chair-based yoga programme in addition to usual care did not improve HRQOL in older adults with multiple long-term conditions. However, the intervention was safe, acceptable, and probably cost-effective.</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136211654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Propranolol reduces risk of knee or hip replacement due to osteoarthritis: A propensity score matched cohort study-using data from the Clinical Practice Research Datalink 心得安降低因骨关节炎导致的膝关节或髋关节置换术的风险:一项倾向评分匹配的队列研究-使用临床实践研究数据链的数据

NIHR open research

Pub Date : 2023-10-06 DOI: 10.3310/nihropenres.13462.1

Georgina Nakafero, Matthew J Grainge, Ana M Valdes, Nick P Townsend, Christian Mallen, Weiya Zhang, Michael Doherty, Mamas A Mamas, Abhishek Abhishek

Background: There is paucity of safe and effective analgesic drugs for osteoarthritis (OA). β-adrenoreceptor blockers have demonstrated anti-nociceptive effects in several painful conditions. We investigated whether β-blockers are associated with a reduced risk of total joint replacement (TJR) at the knee or the hip in people with incident knee or hip OA. Methods: This was a cohort study. We used data from the Clinical Practice Research Datalink. Participants aged 40 years or older with incident knee or hip OA, prescribed β-blockers following OA diagnosis (new-user design) and their age, sex, OA location and propensity score (PS) for β-blocker prescription matched controls were included in the study. Cox-proportional hazard ratios (HRs) and 95% confidence intervals (CI) were calculated. The analyses were adjusted for factors that influence health-seeking behaviour, progression of OA, and stratified according to β-blocker classification. Data analysis was conducted using STATA-MP v15. Results: Data for 6,970 PS-matched β-blocker exposed and unexposed participants were included. Any β-blocker prescription was not associated with knee or hip TJR (aHR 1.11; 95 % CI 0.98 – 1.25). However, prescription of lipophilic non-selective β-blockers with membrane stabilising effect associated with reduced risk of knee or hip TJR (aHR 0.69; 95 % CI 0.52 – 0.93). Of these, there was a protective effect for propranolol (aHR 0.71; 95 % CI 0.53 – 0.95), the commonest prescribed drug in this class. The number needed to treat (95%CI) with propranolol for two years, in order to prevent one TJR was 32 (23-52). Conclusions: The non-selective β-blocker propranolol reduces the risk of knee or hip TJR, consistent with its analgesic effects demonstrated in other conditions. A randomised controlled trial is required to further evaluate the analgesic potential of propranolol in OA.

背景:目前缺乏安全有效的骨关节炎镇痛药物。β-肾上腺素受体阻滞剂在几种疼痛条件下显示出抗伤害性作用。我们研究了β受体阻滞剂是否与偶发性膝关节或髋关节OA患者膝关节或髋关节全关节置换术(TJR)风险降低相关。方法:这是一项队列研究。我们使用的数据来自临床实践研究数据链。年龄≥40岁的膝关节或髋关节骨性关节炎患者，在骨性关节炎诊断后服用β受体阻滞剂(新用户设计)，以及他们的年龄、性别、骨性关节炎位置和β受体阻滞剂处方匹配对照的倾向评分(PS)被纳入研究。计算Cox-proportional hazard ratio (hr)和95% confidence intervals (CI)。对影响求医行为、骨性关节炎进展的因素进行调整，并根据β受体阻滞剂分类进行分层。使用STATA-MP v15进行数据分析。结果:6970名ps匹配β受体阻滞剂暴露和未暴露的参与者的数据被纳入。任何β受体阻滞剂处方与膝关节或髋关节TJR无关(aHR 1.11;95% ci 0.98 - 1.25)。然而，具有膜稳定作用的亲脂性非选择性β受体阻滞剂处方与降低膝关节或髋关节TJR风险相关(aHR 0.69;95% ci 0.52 - 0.93)。其中，心得安有保护作用(aHR 0.71;95% CI 0.53 - 0.95)，这类药物中最常见的处方药。为了预防1例TJR，需要使用心得安治疗2年(95%CI)的人数为32(23-52)。结论:非选择性β受体阻滞剂心得安可降低膝关节或髋关节TJR的风险，这与其在其他情况下的镇痛效果一致。需要一项随机对照试验来进一步评估心得安对OA的镇痛潜力。

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引用次数: 0

Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia 埃塞俄比亚皮肤利什曼病的前瞻性观察队列研究方案

NIHR open research

Pub Date : 2023-10-05 DOI: 10.3310/nihropenres.13432.1

Amel Beshir Mohammed, Fewzia Dhikur Mohammed, Feleke Tilahun Zewdu, Shimelis Doni Nigusse, Yohannes Hailemichael, Teklu Cherkose, Abebaw Yeshambel Alemu, Eshetu Molla, Kidist Bobosha, Vanessa Yardley, Iris Mosweu, Mirgissa Kaba, Catherine Pitt, Elizabeth Allen, Saba Maria Lambert, Michael Marks, Stephen L. Walker, Endalamaw Gadisa

Background: Cutaneous leishmaniasis (CL) is a skin neglected tropical disease, with an estimated 40,000 new cases each year in Ethiopia. CL causes ulcers, nodules, and plaques on the skin, and in some instances the destruction of the nasopharyngeal mucosa and cartilage. Some CL lesions may heal spontaneously, whilst other lesions may require therapies which are associated with discomfort, adverse effects, prolonged treatment, and a frequent lack of a complete response. Scarring, a sequela of CL, causes permanent disfigurement and is associated with stigma linked with a reduction in health-related quality of life. The choice of treatment for CL is based upon factors including the causative species; the number, extent, size, and location of lesions; and the availability of treatments. The development of robust evidence for CL treatment is hindered by a lack of validated and appropriate outcome measures and few data to support hypothesis-generation and trial design. There is a paucity of prospective data with well-defined treatment outcomes for CL caused by L. aethiopica. Aim: The overall aim of this study is to improve the understanding of the health and economic burden of CL. Methods: We have designed an observational, multi-centre cohort study to examine treatment outcomes for CL in Ethiopia which includes clinical outcomes, laboratory outcomes, patient reported outcome measures, scar assessments and cost effectiveness. We aim to recruit up to 750 participants across two hospital sites. We present here the protocol for this cohort study with a 12-month follow up period for each participant. Conclusions: These data will inform the design of randomized controlled trials to evaluate new treatment strategies, with appropriate economic evaluations. This will help improve evidence-based guidelines and support evidence-led policy decisions, not only in Ethiopia but also globally.

背景:皮肤利什曼病(CL)是一种被忽视的皮肤热带病，埃塞俄比亚每年估计有4万例新病例。CL引起皮肤溃疡、结节和斑块，在某些情况下还会破坏鼻咽黏膜和软骨。一些CL病变可以自发愈合，而其他病变可能需要治疗，这与不适、不良反应、长期治疗和经常缺乏完全反应有关。结疤是恶性淋巴瘤的后遗症，可导致永久性毁容，并与与健康相关的生活质量下降相关的耻辱感有关。CL的治疗选择是基于各种因素，包括致病物种;病变的数量、范围、大小和位置;以及治疗的可用性。缺乏经过验证和适当的结果测量，以及支持假设生成和试验设计的数据很少，阻碍了CL治疗的有力证据的发展。埃塞俄比亚乳杆菌引起的CL缺乏明确的治疗结果的前瞻性数据。目的:本研究的总体目的是提高对慢性阻塞性肺病的健康和经济负担的认识。方法:我们设计了一项观察性、多中心队列研究，以检查埃塞俄比亚CL的治疗结果，包括临床结果、实验室结果、患者报告的结果测量、疤痕评估和成本效益。我们的目标是在两家医院招募750名参与者。我们在此提出了这项队列研究的方案，并对每位参与者进行了12个月的随访。结论:这些数据将为随机对照试验的设计提供信息，以评估新的治疗策略，并进行适当的经济评估。这将有助于改进以证据为基础的指导方针，支持以证据为主导的决策，不仅在埃塞俄比亚，而且在全球。

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引用次数: 0

Local authority variation in primary school-recorded special educational needs provision among children with major congenital anomalies: A research protocol 地方当局在主要先天性畸形儿童中提供小学记录的特殊教育需求方面的差异:一项研究方案

NIHR open research

Pub Date : 2023-10-05 DOI: 10.3310/nihropenres.13466.1

Kate Lewis, Vincent Nguyen, Ania Zylbersztejn, Ruth Gilbert, Bianca De Stavola, Lorraine Dearden

Introduction: Special educational needs (SEN) provision has been called a 'postcode lottery’ in England, but the extent to which this represents underlying inequities has not been sufficiently investigated. This study will focus on children with similar underlying health characteristics to explore sources of systematic variation in SEN provision by local authority (LA) in England. Methods and analysis: We will use linked individual-level state-funded hospital and school records from the Education and Health Insights from Linked Data (ECHILD) database, alongside open-source school-level data. Our cohort will be defined as singleton children with major congenital anomalies born in England between 1 September 2003 and 31 August 2012. We will identify major congenital anomalies from diagnoses in hospital records in the first year of life using European Surveillance of Congenital Anomalies (EUROCAT) guidelines. LA (152 in total) will be defined by child’s residential address reported in education records at entry into year one of school (aged five years old). SEN provision will be defined by a recording of an educational health and care plan or SEN support in any census in Reception, year one or two of primary school (ages four/five to six/seven). To quantify variation in SEN provision we will fit multilevel logistic regression models to the individual records, with a-priori selected individual-, school- and LA-level characteristics. We will report the estimated intraclass correlation coefficient at each stage of the model, signifying the percentage of remaining variation in the odds of recorded SEN provision that is due to differences between LAs. Ethics and dissemination: We have existing research ethics approval for analyses of the ECHILD database described in this protocol. We will disseminate our findings to diverse audiences (academics, relevant government departments, service users and providers) through seminars, peer-reviewed publications, short briefing reports and infographics for non-academics (published on the study website).

简介:特殊教育需求(SEN)条款在英国被称为“邮政编码彩票”，但这在多大程度上代表了潜在的不平等尚未得到充分的调查。本研究将重点关注具有相似潜在健康特征的儿童，以探索英格兰地方当局(LA)提供特殊教育的系统性差异的来源。方法和分析:我们将使用关联数据教育与健康洞察(ECHILD)数据库中的关联个人级别的国家资助医院和学校记录，以及开源的学校级别数据。我们的队列将被定义为2003年9月1日至2012年8月31日期间在英格兰出生的患有重大先天性异常的单胎儿童。我们将根据欧洲先天性异常监测(EUROCAT)指南，从医院第一年的诊断记录中识别出主要的先天性异常。LA(总共152个)将根据儿童在入学第一年(5岁)时在教育记录中报告的居住地址来定义。特殊教育环境的提供将通过在小学一年级或二年级(4 / 5岁至6 / 7岁)接待处的任何普查中记录教育卫生和护理计划或特殊教育环境支持来确定。为了量化特殊教育条件的变化，我们将根据先验选择的个人、学校和洛杉矶水平特征，对个人记录进行多层逻辑回归模型拟合。我们将在模型的每个阶段报告估计的类内相关系数，表示由于LAs之间的差异而记录的SEN提供的几率中剩余变化的百分比。伦理和传播:我们对本协议中描述的ECHILD数据库的分析有现有的研究伦理批准。我们会透过研讨会、经同行评审的刊物、简短的简报及供非学术界人士使用的资讯图表(刊登于研究网站)，向不同的受众(学术界人士、相关政府部门、服务使用者及供应商)传播研究结果。

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引用次数: 0

A Randomised Controlled Trial of Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis (EVIAN study): study protocol for a feasibility trial 早期玻璃体切除术和玻璃体内抗生素治疗术后外源性眼内炎的随机对照试验(EVIAN研究):可行性试验的研究方案

NIHR open research

Pub Date : 2023-09-28 DOI: 10.3310/nihropenres.13469.1

Mahiul Muhammed Khan Muqit, Carlos Pavesio, Hayley Boston, Keerththika Sriharan, Yanzhong Wang, Elena Pizzo, Stephen Cobb, Christopher Spink, James Bainbridge

Postoperative bacterial endophthalmitis is an infection of the eye's internal tissues resulting from an intraocular procedure. The condition is uncommon but can cause severe and irreversible impairment of sight. Standard management involves administration of antibiotics with or without subsequent removal of the infected vitreous gel by vitrectomy surgery. Surgical intervention is typically reserved for infections that persist despite a period of medical management alone. We aim to determine whether outcomes can be improved by performing surgery without delay. To explore the feasibility of a definitive randomised controlled trial and to determine the number of participants required, we will conduct a multicentre feasibility trial. This trial will include 40 affected individuals, allocated randomly to either standard of care, being intravitreal antibiotic administration alone, or to early vitrectomy surgery in addition to antibiotic administration. We will determine the feasibility and size of a definitive trial by evaluating the participants and the outcomes for their sight. Research Ethics Committee approval (REC 20/WM/0264). Here we describe the trial protocol. Trial registration number:ClinicalTrials.gov NCT04522661

术后细菌性眼内炎是眼内手术引起的眼睛内部组织感染。这种情况并不常见，但会导致严重的、不可逆转的视力损害。标准的治疗包括使用抗生素，并或不随后通过玻璃体切割手术去除受感染的玻璃体凝胶。手术干预通常保留在感染持续，尽管一段时间的医疗管理单独。我们的目的是确定是否可以通过立即进行手术来改善预后。为了探索一项明确的随机对照试验的可行性，并确定所需的参与者人数，我们将进行一项多中心可行性试验。该试验将包括40名受影响的个体，随机分配到标准护理组，单独给予玻璃体内抗生素，或早期玻璃体切除手术加上抗生素。我们将通过评估参与者和他们视力的结果来确定最终试验的可行性和规模。研究伦理委员会批准(REC 20/WM/0264)。这里我们描述试验方案。试验注册号:ClinicalTrials.gov NCT04522661

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引用次数: 0

Deprivation, essential and non-essential activities and SARS-CoV-2 infection following the lifting of national public health restrictions in England and Wales 英格兰和威尔士取消国家公共卫生限制后的贫困、必要和非必要活动以及SARS-CoV-2感染

NIHR open research

Pub Date : 2023-09-28 DOI: 10.3310/nihropenres.13445.1

Susan Hoskins, Sarah Beale, Vincent Nguyen, Yamina Boukari, Alexei Yavlinsky, Jana Kovar, Thomas Byrne, Wing Lam Erica Fong, Cyril Geismar, Parth Patel, Anne Johnson, Robert Aldridge, Andrew Hayward

Background: Individuals living in deprived areas in England and Wales undertook essential activities more frequently and experienced higher rates of SARS-CoV-2 infection than less deprived communities during periods of restrictions aimed at controlling the Alpha (B.1.1.7) variant. We aimed to understand whether these deprivation-related differences changed once restrictions were lifted. Methods: Among 11,231 adult Virus Watch Community Cohort Study participants multivariable logistic regressions were used to estimate the relationships between deprivation and self-reported activities and deprivation and infection (self-reported lateral flow or PCR tests and linkage to National Testing data and Second Generation Surveillance System (SGSS)) between August – December 2021, following the lifting of national public health restrictions. Results: Those living in areas of greatest deprivation were more likely to undertake essential activities (leaving home for work (aOR 1.56 (1.33 – 1.83)), using public transport (aOR 1.33 (1.13 – 1.57)) but less likely to undertake non-essential activities (indoor hospitality (aOR 0.82 (0.70 – 0.96)), outdoor hospitality (aOR 0.56 (0.48 – 0.66)), indoor leisure (aOR 0.63 (0.54 – 0.74)), outdoor leisure (aOR 0.64 (0.46 – 0.88)), or visit a hairdresser (aOR 0.72 (0.61 – 0.85))). No statistical association was observed between deprivation and infection (P=0.5745), with those living in areas of greatest deprivation no more likely to become infected with SARS-CoV-2 (aOR 1.25 (0.87 – 1.79). Conclusion: The lack of association between deprivation and infection is likely due to the increased engagement in non-essential activities among the least deprived balancing the increased work-related exposure among the most deprived. The differences in activities highlight stark disparities in an individuals’ ability to choose how to limit infection exposure.

背景:在旨在控制Alpha (B.1.1.7)变异的限制期间，生活在英格兰和威尔士贫困地区的个人比贫困地区的人更频繁地进行基本活动，并且经历了更高的SARS-CoV-2感染率。我们的目的是了解一旦限制解除，这些与剥夺相关的差异是否会发生变化。方法:在解除国家公共卫生限制后的2021年8月至12月期间，对11,231名成年病毒监测社区队列研究参与者进行多变量logistic回归，估计剥夺与自我报告活动之间的关系，以及剥夺与感染之间的关系(自我报告的横向流动或PCR检测以及与国家检测数据和第二代监测系统(SGSS)的联系)。结果:生活在最贫困地区的人更有可能从事必要的活动(离家上班(aOR 1.56(1.33 - 1.83))，乘坐公共交通工具(aOR 1.33(1.13 - 1.57))，但不太可能从事非必要的活动(aOR 0.82(0.70 - 0.96))，户外招待(aOR 0.56(0.48 - 0.66))，室内休闲(aOR 0.63(0.54 - 0.74))，户外休闲(aOR 0.64(0.46 - 0.88))，或去理发店(aOR 0.72(0.61 - 0.85))。贫困与感染之间无统计学关联(P=0.5745)，生活在最贫困地区的人不太可能感染SARS-CoV-2 (aOR 1.25(0.87 - 1.79))。结论:贫困和感染之间缺乏联系可能是由于最贫困的人群增加了非必要活动的参与，平衡了最贫困的人群增加的与工作相关的接触。活动的差异突出了个人选择如何限制感染暴露的能力的明显差异。

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引用次数: 0

The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol. 早期局部利多卡因贴剂在因肋骨骨折入院的老年患者中的随机评价：可行性试验方案。

NIHR open research

Pub Date : 2023-09-25 eCollection Date: 2023-01-01 DOI: 10.3310/nihropenres.13438.2

Amanda Lewis, Madeleine Clout, Jonathan Benger, Philip Braude, Nicholas Turner, James Gagg, Emma Gendall, Simon Holloway, Jenny Ingram, Rebecca Kandiyali, Nick Maskell, David Shipway, Jason E Smith, Jodi Taylor, Alia Darweish-Medniuk, Edward Carlton

Background: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible.

Methods: RELIEF is an open label, multicentre, parallel group, individually randomised, feasibility randomised controlled trial with economic scoping and nested qualitative study. Patients aged ≥ 65 years presenting to the ED with traumatic rib fracture(s) requiring admission will be randomised 1:1 to lidocaine patches (intervention), in addition to standard clinical management, or standard clinical management alone. Lidocaine patches will be applied immediately after diagnosis in ED and continued daily for 72 hours or until discharge. Feasibility outcomes will focus on recruitment, adherence and follow-up data with a total sample size of 100. Clinical outcomes, such as 30-day pulmonary complications, and resource use will be collected to understand feasibility of data collection. Qualitative interviews will explore details of the trial design, trial acceptability and recruitment processes. An evaluation of the feasibility of measuring health economics outcomes data will be completed.

Discussion: Interventions to improve outcomes in elderly patients with rib fractures are urgently required. This feasibility trial will test a novel early intervention which has the potential of fulfilling this unmet need. The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF) feasibility trial will determine whether a definitive trial is feasible.

Isrctn registration: ISRCTN14813929 (22/04/2021).

背景：局部利多卡因贴用于肋骨骨折，被认为是一种非侵入性的局部麻醉方法，可以改善呼吸功能，减少阿片类药物的消耗，从而减少肺部并发症。老年患者可能会从改进的镇痛方案中获益最多，但利多卡因贴作为急诊科的早期干预措施尚未经过测试。本试验的目的是调查试验设计和实施的不确定性，以确定在老年肋骨骨折患者中进行局部利多卡因贴剂的最终随机试验是否可行。方法：RELEF是一项开放标签、多中心、平行组、个体随机、可行性随机对照试验，具有经济范围和嵌套定性研究。除标准临床管理或单独标准临床管理外，年龄≥65岁的急诊科创伤性肋骨骨折患者将以1:1的比例随机接受利多卡因贴（干预）治疗。诊断为ED后立即使用利多卡因贴片，每天持续使用72小时或直至出院。可行性结果将侧重于招募、依从性和随访数据，总样本量为100。将收集临床结果，如30天肺部并发症和资源使用，以了解数据收集的可行性。定性访谈将探讨试验设计、试验可接受性和招募过程的细节。将完成对衡量卫生经济学结果数据的可行性的评估。讨论：迫切需要采取干预措施来改善老年肋骨骨折患者的预后。这项可行性试验将测试一种新型的早期干预措施，该干预措施有可能满足这一未满足的需求。对因肋骨骨折入院的老年患者早期局部利多卡因贴剂的随机评估（RELIEF）可行性试验将确定最终试验是否可行。以色列注册号：ISRCTN14813929（2021年4月22日）。

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引用次数: 0