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Langerhans Cell Histiocytosis of the Nose and Maxilla: A Rare Presentation. 朗格汉斯细胞组织细胞增生症的鼻子和上颌骨:一个罕见的表现。
IF 0.6 Pub Date : 2023-12-01 Epub Date: 2023-07-23 DOI: 10.1007/s12070-023-04075-8
Raghul Sekar, Kalaiarasi Raja

Langerhans cell histiocytosis (LCH) is a disease characterized by localized and generalized proliferation of the histiocytes. It is a locally aggressive condition. The clinical presentation is highly variable and can range from isolated, self-healing skin or bone lesions to life-threatening multisystem disease. It can present as a unifocal or multifocal disease. The majority are present in the head and neck region, but the involvement of Paranasal sinuses is rare. Here we describe a 64-years-old female who presented with a slow-growing left nasal mass for 1 year. Evaluation of the patient was suggestive of malignancy, but the biopsy report turned out to be Langerhans cell histiocytosis; subsequently left, total maxillectomy was done. We hereby present a unique case of LCH with isolated nose and paranasal sinus involvement.

朗格汉斯细胞组织细胞增生症(LCH)是一种以组织细胞局部和全身性增生为特征的疾病。这是一种局部侵袭性疾病。临床表现变化很大,从孤立的、自愈的皮肤或骨骼病变到危及生命的多系统疾病。它可以表现为单灶性或多灶性疾病。大多数出现在头颈部,但鼻窦的累及是罕见的。这里我们描述了一位64岁的女性,她表现为缓慢增长的左鼻肿块1年。对患者的评估提示恶性肿瘤,但活检报告结果是朗格汉斯细胞组织细胞增多症;随后行上颌全切除术。我们在此提出一个独特的LCH病例与孤立的鼻子和副鼻窦受累。
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引用次数: 0
Behavioural intervention to reduce sexually transmitted infections in people aged 16–24 years in the UK: the safetxt RCT 英国16-24岁人群减少性传播感染的行为干预:安全随机对照试验
Pub Date : 2023-01-01 DOI: 10.3310/dane8826
Caroline Free, Melissa J Palmer, Kimberley Potter, Ona L McCarthy, Lauren Jerome, Sima Berendes, Anasztazia Gubijev, Megan Knight, Zahra Jamal, Farandeep Dhaliwal, James R Carpenter, Tim P Morris, Phil Edwards, Rebecca French, Louis Macgregor, Katy ME Turner, Paula Baraitser, Ford CI Hickson, Kaye Wellings, Ian Roberts, Julia V Bailey, Graham Hart, Susan Michie, Tim Clayton, Karen Devries
Background The prevalence of genital chlamydia and gonorrhoea is higher in the 16–24 years age group than those in other age group. With users, we developed the theory-based safetxt intervention to reduce sexually transmitted infections. Objectives To establish the effect of the safetxt intervention on the incidence of chlamydia/gonorrhoea infection at 1 year. Design A parallel-group, individual-level, randomised superiority trial in which care providers and outcome assessors were blinded to allocation. Setting Recruitment was from 92 UK sexual health clinics. Participants Inclusion criteria were a positive chlamydia or gonorrhoea test result, diagnosis of non-specific urethritis or treatment started for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks; owning a personal mobile phone; and being aged 16–24 years. Allocation Remote computer-based randomisation with an automated link to the messaging system delivering intervention or control group messages. Intervention The safetxt intervention was designed to reduce sexually transmitted infection by increasing partner notification, condom use and sexually transmitted infection testing before sex with new partners. It employed educational, enabling and incentivising content delivered by 42–79 text messages over 1 year, tailored according to type of infection, gender and sexuality. Comparator A monthly message regarding trial participation. Main outcomes The primary outcome was the incidence of chlamydia and gonorrhoea infection at 12 months, assessed using nucleic acid amplification tests. Secondary outcomes at 1 and 12 months included self-reported partner notification, condom use and sexually transmitted infection testing prior to sex with new partner(s). Results Between 1 April 2016 and 23 November 2018, we assessed 20,476 people for eligibility and consented and randomised 6248 participants, allocating 3123 to the safetxt intervention and 3125 to the control. Primary outcome data were available for 4675 (74.8%) participants. The incidence of chlamydia/gonorrhoea infection was 22.2% (693/3123) in the intervention group and 20.3% (633/3125) in the control group (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). There was no evidence of heterogeneity in any of the prespecified subgroups. Partner notification was 85.6% in the intervention group and 84.0% in the control group (odds ratio 1.14, 95% confidence interval 0.99 to 1.33). At 12 months, condom use at last sex was 33.8% in the intervention group and 31.2% in the control group (odds ratio 1.14, 95% confidence interval 1.01 to 1.28) and condom use at first sex with most recent new partner was 54.4% in the intervention group and 48.7% in the control group (odds ratio 1.27, 95% confidence interval 1.11 to 1.45). Testing before sex with a new partner was 39.5% in the intervention group and 40.9% in the control group (odds ratio 0.95, 95% confidence interval 0.82 to 1.10). Having two or more partners since joining the trial wa
背景16-24岁年龄组生殖道衣原体和淋病患病率高于其他年龄组。与用户一起,我们开发了基于理论的安全干预措施,以减少性传播感染。目的探讨安全干预对1年衣原体/淋病感染发生率的影响。设计一项平行组、个体水平的随机优势试验,在该试验中,护理提供者和结果评估者对分配采取盲法。招募人员来自英国92家性健康诊所。纳入标准为衣原体或淋病检测结果阳性,诊断为非特异性尿道炎或在过去2周内开始治疗衣原体/淋病/非特异性尿道炎;拥有个人移动电话;年龄在16-24岁。分配远程计算机随机化,自动链接到传递干预或控制组消息的消息系统。安全干预的目的是通过增加伴侣通知、使用避孕套和在与新伴侣发生性行为前进行性传播感染检测来减少性传播感染。根据感染类型、性别和性行为,在1年内通过42-79条短信提供教育、激励和激励内容。关于参加试验的每月消息。主要结局:主要结局是12个月时衣原体和淋病感染的发生率,采用核酸扩增试验评估。第1个月和第12个月的次要结果包括自我报告的性伴侣通知、避孕套使用和与新伴侣发生性行为前的性传播感染检测。在2016年4月1日至2018年11月23日期间,我们评估了20,476人的资格,同意并随机分配了6248名参与者,将3123名分配到安全干预组,3125名分配到对照组。4675名(74.8%)参与者获得了主要结局数据。干预组衣原体/淋病感染率为22.2%(693/3123),对照组为20.3%(633/3125)(优势比1.13,95%可信区间0.98 ~ 1.31)。没有证据表明在任何预先指定的亚组中存在异质性。干预组伴侣告知率为85.6%,对照组为84.0%(优势比1.14,95%可信区间0.99 ~ 1.33)。12个月时,干预组最后一次性行为使用避孕套的比例为33.8%,对照组为31.2%(优势比1.14,95%可信区间1.01 ~ 1.28);干预组最近一次与新伴侣发生性行为时使用避孕套的比例为54.4%,对照组为48.7%(优势比1.27,95%可信区间1.11 ~ 1.45)。与新伴侣发生性行为前的检测在干预组为39.5%,对照组为40.9%(优势比0.95,95%可信区间0.82 ~ 1.10)。干预组自参加试验以来有两个或两个以上性伴侣的比例为56.9%,对照组为54.8%(优势比1.11,95%可信区间1.00 ~ 1.24);干预组自参加试验以来与新人发生性行为的比例为69.7%,对照组为67.4%(优势比1.13,95%可信区间1.00 ~ 1.28)。在安全结果上没有差异。额外的敏感性和协议分析也显示了类似的结果。我们对意外效应的作用机制的理解是有限的。结论安全干预并没有减少衣原体和淋病感染,干预组感染人数略多。干预措施增加了避孕套的使用,但也增加了性伴侣和新伴侣的数量。随机对照试验对于评估卫生传播干预措施至关重要,因为这些干预措施可能产生意想不到的效果。未来的工作需要随机对照试验来评估这一复杂领域的新干预措施。本试验注册号为ISRCTN64390461。该项目由国家卫生和保健研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第11卷第1期请参阅NIHR期刊图书馆网站了解更多项目信息。
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引用次数: 1
A group-based exercise and behavioural maintenance intervention for adults over 65 years with mobility limitations: the REACT RCT 一项针对65岁以上行动受限成年人的基于群体的锻炼和行为维持干预:REACT随机对照试验
Pub Date : 2022-12-01 DOI: 10.3310/mqbw6832
A. Stathi, J. Withall, C. Greaves, J. Thompson, G. Taylor, A. Medina-Lara, C. Green, T. Snowsill, H. Johansen-Berg, J. Bilzon, S. Gray, Rosina Cross, M. Western, J. D. Koning, P. Ladlow, Jessica C Bollen, Sarah J Moorlock, J. Guralnik, W. Rejeski, M. Hillsdon, K. Fox
Mobility limitation in older age reduces quality of life, generates substantial health- and social-care costs, and increases mortality. The REtirement in ACTion (REACT) trial aimed to establish whether or not a community-based active ageing intervention could prevent decline in physical functioning in older adults already at increased risk of mobility limitation. A multicentre, pragmatic, two-arm, parallel-group randomised controlled trial with parallel process and health economic evaluations. Urban and semi-rural locations across three sites in England. Physically frail or pre-frail older adults (aged ≥ 65 years; Short Physical Performance Battery score of 4–9). Recruitment was primarily via 35 primary care practices. Participants were randomly assigned to receive brief advice (three healthy ageing education sessions) or a 12-month, group-based, multimodal exercise and behavioural maintenance programme delivered in fitness and community centres. Randomisation was stratified by site and used a minimisation algorithm to balance age, sex and Short Physical Performance Battery score. Data collection and analyses were blinded. The primary outcome was change in lower limb physical function (Short Physical Performance Battery score) at 24 months, analysed using an intention-to-treat analysis. The economic evaluation adopted the NHS and Personal Social Services perspective. Between June 2016 and October 2017, 777 participants (mean age 77.6 years, standard deviation 6.8 years; 66% female; mean Short Physical Performance Battery score 7.37, standard deviation 1.56) were randomised to the intervention arm (n = 410) or the control arm (n = 367). Data collection was completed in October 2019. Primary outcome data at 24 months were provided by 628 (80.8%) participants. At the 24-month follow-up, the Short Physical Performance Battery score was significantly greater in the intervention arm (mean 8.08, standard deviation 2.87) than in the control arm (mean 7.59, standard deviation 2.61), with an adjusted mean difference of 0.49 (95% confidence interval 0.06 to 0.92). The difference in lower limb function between intervention and control participants was clinically meaningful at both 12 and 24 months. Self-reported physical activity significantly increased in the intervention arm compared with the control arm, but this change was not observed in device-based physical activity data collected during the trial. One adverse event was related to the intervention. Attrition rates were low (19% at 24 months) and adherence was high. Engagement with the REACT intervention was associated with positive changes in exercise competence, relatedness and enjoyment and perceived physical, social and mental well-being benefits. The intervention plus usual care was cost-effective compared with care alone over the 2 years of REACT; the price year was 2019. In the base-case scenario, the intervention saved £103 per participant, w
老年人的行动限制降低了生活质量,产生了大量的健康和社会护理成本,并增加了死亡率。行动中的再疲劳(REACT)试验旨在确定基于社区的积极老龄化干预是否可以防止行动受限风险增加的老年人身体功能下降。一项多中心、务实、两臂、平行组的随机对照试验,具有平行过程和健康经济评估。英格兰三个地区的城市和半农村地区。身体虚弱或前期虚弱的老年人(年龄≥ 65岁;短物理性能电池得分为4-9)。招聘主要通过35家初级保健机构进行。参与者被随机分配接受简短的建议(三次健康老龄化教育)或在健身和社区中心提供的为期12个月的基于小组的多模式锻炼和行为维持计划。随机分组按地点分层,并使用最小化算法来平衡年龄、性别和短期身体表现电池得分。数据收集和分析是盲目的。主要结果是24个月时下肢身体功能的变化(短期身体表现电池评分),使用意向治疗分析进行分析。经济评估采用了国民保健服务和个人社会服务的观点。在2016年6月至2017年10月期间,777名参与者(平均年龄77.6岁,标准差6.8岁;66%为女性;平均短期体能测试得分7.37,标准差1.56)被随机分配到干预组(n = 410)或控制臂(n = 367)。数据收集工作于2019年10月完成。628名(80.8%)参与者提供了24个月时的主要结果数据。在24个月的随访中,干预组的短期身体性能电池得分(平均值8.08,标准偏差2.87)显著高于对照组(平均值7.59,标准偏差2.61),调整后的平均差异为0.49(95%置信区间0.06-0.92)。干预和对照参与者之间的下肢功能差异在12个月和24个月时都具有临床意义。与对照组相比,干预组的自我报告体力活动显著增加,但在试验期间收集的基于设备的体力活动数据中没有观察到这种变化。一个不良事件与干预有关。损耗率低(24个月时为19%),依从性高。参与REACT干预与运动能力、相关性和乐趣以及感知的身体、社会和心理健康益处的积极变化有关。在REACT的2年中,与单独护理相比,干预加常规护理具有成本效益;价格年为2019年。在基本情况下,干预为每位参与者节省了103英镑,在2年的试验窗口内,质量调整后的生命年增加了0.04(95%置信区间0.006至0.074)。寿命期建模估计,在随机化后的15年内,可以进一步节省成本和质量调整后的寿命年收益。资源相对较低的1年多模式运动和行为维持干预可以帮助老年人在24个月内保持身体功能。研究结果表明,老年人身体机能下降的既定轨迹是可以改变的。参与者没有对研究臂的分配视而不见。然而,主要结果是由盲法数据采集者独立评估的。次要结果分析是探索性的,没有对多次测试进行调整,应进行相应的解释。在过程评估结果的指导下进行改进后,REACT干预适合大规模实施。进一步的研究将优化REACT的大规模实施。本试验注册号为ISRCTN45627165。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第14期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 1
Feasibility of a theory-based intervention to reduce sedentary behaviour among contact centre staff: the SUH stepped-wedge cluster RCT 基于理论的干预措施减少联络中心工作人员久坐行为的可行性:SUH阶梯楔形群随机对照试验
Pub Date : 2022-12-01 DOI: 10.3310/iexp0277
R. Jepson, G. Baker, Divya Sivaramakrishnan, Jillian Manner, R. Parker, Scott Lloyd, A. Stoddart
Sedentary behaviour is linked to increased risk of type 2 diabetes, cardiovascular disease, musculoskeletal issues and poor mental well-being. Contact (call) centres are associated with higher levels of sedentary behaviour than other office-based workplaces. Stand Up for Health is an adaptive intervention designed to reduce sedentary behaviour in contact centres. The objectives were to test the acceptability and feasibility of implementing the intervention; to assess the feasibility of the study design and methods; to scope the feasibility of a future health economic evaluation; and to consider the impact of COVID-19 on the intervention. All sites received no intervention for between 3 and 12 months after the start of the study, as a waiting list control. This was a cluster-randomised stepped-wedge feasibility design. The trial was set in 11 contact centres across the UK. Eleven contact centres and staff. Stand Up for Health involved two workshops with staff in which staff developed activities for their context and culture. Activities ranged from using standing desks to individual goal-setting, group walks and changes to workplace policies and procedures. The primary outcome was accelerometer-measured sedentary time. The secondary outcomes were subjectively measured sedentary time, overall sedentary behaviour, physical activity, productivity, mental well-being and musculoskeletal health. Stand Up for Health was implemented in 7 out of 11 centres and was acceptable, feasible and sustainable (objective 1). The COVID-19 pandemic affected the delivery of the intervention, involvement of contact centres, data collection and analysis. Organisational factors were deemed most important to the success of Stand Up for Health but also the most challenging to change. There were also difficulties with the stepped-wedge design, specifically maintaining contact centre interest (objective 2). Feasible methods for estimating cost-efficiency from an NHS and a Personal Social Services perspective were identified, assuming that alternative feasible effectiveness methodology can be applied. Detailed activity-based costing of direct intervention costs was achieved and, therefore, deemed feasible (objective 3). There was significantly more sedentary time spent in the workplace by the centres that received the intervention than those that did not (mean difference 84.06 minutes, 95% confidence interval 4.07 to 164.1 minutes). The other objective outcomes also tended to favour the control group. There were significant issues with the stepped-wedge design, including difficulties in maintaining centre interest and scheduling data collection. Collection of accelerometer data was not feasible during the pandemic. Stand Up for Health is an adaptive, feasible and sustainable intervention. However, the stepped-wedge study design was not feasible. The effectiveness of Stand Up for H
久坐行为与2型糖尿病、心血管疾病、肌肉骨骼问题和精神健康状况不佳的风险增加有关。与其他办公室工作场所相比,联络(呼叫)中心与更高水平的久坐行为有关。“维护健康”是一种适应性干预措施,旨在减少联络中心的久坐行为。目标是测试实施干预措施的可接受性和可行性;评估研究设计和方法的可行性;确定未来卫生经济评估的可行性;并考虑新冠肺炎对干预措施的影响。在研究开始后的3至12个月内,所有研究点均未接受干预,作为等待名单对照。这是一个集群随机阶梯楔形可行性设计。试验在英国的11个联络中心进行。11个联络点和工作人员。“为健康挺身而出”包括两次与工作人员的研讨会,工作人员在研讨会上为自己的背景和文化制定了活动。活动包括使用立式办公桌、设定个人目标、集体散步以及改变工作场所政策和程序。主要结果是加速度计测量的久坐时间。次要结果是主观测量的久坐时间、整体久坐行为、身体活动、生产力、心理健康和肌肉骨骼健康。11个中心中有7个实施了“为健康挺身而出”,这是可以接受的、可行的和可持续的(目标1)。新冠肺炎大流行影响了干预措施的实施、联络中心的参与、数据收集和分析。组织因素被认为是“为健康挺身而出”成功的最重要因素,但也是最具挑战性的变革因素。阶梯式楔形设计也存在困难,特别是保持接触中心的兴趣(目标2)。确定了从NHS和个人社会服务角度估计成本效率的可行方法,假设可以应用其他可行的有效性方法。直接干预费用的详细作业成本计算已经实现,因此被认为是可行的(目标3)。接受干预的中心在工作场所久坐的时间明显多于未接受干预的(平均差异84.06分钟,95%置信区间4.07-164.1分钟)。其他客观结果也倾向于有利于对照组。阶梯式楔形设计存在重大问题,包括难以保持中心兴趣和安排数据收集。在疫情期间,收集加速度计数据是不可行的。维护健康是一种适应性的、可行的和可持续的干预措施。然而,阶梯式楔形研究设计是不可行的。“站起来维护健康”的有效性尚未得到证实,在一项更大规模的研究中可能无法看到久坐行为的临床重要减少。然而,将与混合工作场所更相关的活动纳入“为健康挺身而出”的有效性研究可能仍然值得。未来的工作可能包括为“为健康挺身而出”制定混合(办公室和/或在家工作)活动;进行更大规模的有效性研究和后续经济分析(视成功与否而定);以及探索联络中心的组织特征,这些特征会影响诸如“为健康挺身而出”等干预措施的实施。本试验注册号为ISRCTN11580369。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第13期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 0
Evaluation of water fluoridation scheme in Cumbria: the CATFISH prospective longitudinal cohort study 坎布里亚郡水氟化方案的评价:CATFISH前瞻性纵向队列研究
Pub Date : 2022-11-01 DOI: 10.3310/shmx1584
M. Goodwin, R. Emsley, M. Kelly, M. Sutton, M. Tickle, T. Walsh, W. Whittaker, I. Pretty
Water fluoridation was introduced in the UK against a background of high dental decay within the population. Levels of decay have dramatically reduced over the last 40 years following widespread use of fluoride toothpaste. The aim of the CATFISH (Cumbrian Assessment of Teeth a Fluoride Intervention Study for Health) study was to address the question of whether or not the addition of fluoride to community drinking water, in a contemporary population, lead to a reduction in the number of children with caries and, if so, is this reduction cost-effective? A longitudinal prospective cohort design was used in two distinct recruited populations: (1) a birth cohort to assess systemic and topical effects of water fluoridation and (2) an older school cohort to assess the topical effects of drinking fluoridated water. The study was conducted in Cumbria, UK. Broadly, the intervention group (i.e. individuals receiving fluoridated drinking water) were from the west of Cumbria and the control group were from the east of Cumbria. Children who were lifetime residents of Cumbria were recruited. For the birth cohort, children were recruited at birth (2014–15), and followed until age 5 years. For the older school cohort, children were recruited at age 5 years (2013–14) and followed until the age of 11 years. The provision of a ‘reintroduced fluoridated water scheme’. The primary outcome measure was the presence or absence of decay into dentine in the primary teeth (birth cohort) and permanent teeth (older school cohort). The cost per quality-adjusted life-year was also assessed. In the birth cohort (n = 1444), 17.4% of children in the intervention group had decay into dentine, compared with 21.4% of children in the control group. The evidence, after adjusting for deprivation, age and sex, with an adjusted odds ratio of 0.74 (95% confidence interval 0.56 to 0.98), suggested that water fluoridation was likely to have a modest beneficial effect. There was insufficient evidence of difference in the presence of decay in children in the older school cohort (n = 1192), with 19.1% of children in the intervention group having decay into dentine, compared with 21.9% of children in the control group (adjusted odds ratio 0.80, 95% confidence interval 0.58 to 1.09). The intervention was found to be likely to be cost-effective for both the birth cohort and the older school cohort at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year. There was no significant difference in the performance of water fluoridation on caries experience across deprivation quintiles. The prevalence of caries and the impact of water fluoridation was much smaller than previous studies have reported. The intervention was effective in the birth cohort group; however, the importance of the modest absolute reduction in caries (into dentine) needs to be considered against the use of other dental caries preventative measures. Longe
在英国,针对人口中蛀牙率高的背景,引入了水氟化处理。在过去的40年里,由于氟化物牙膏的广泛使用,蛀牙的程度大大降低了。CATFISH(坎布里亚牙齿评估-健康氟化物干预研究)研究的目的是解决在当代人口中向社区饮用水中添加氟化物是否会导致龋齿儿童数量减少的问题,如果是这样,这种减少是否具有成本效益?纵向前瞻性队列设计在两个不同的招募人群中使用:(1)出生队列评估水氟化的全身和局部影响;(2)老年学校队列评估饮用氟化水的局部影响。这项研究是在英国坎布里亚郡进行的。总的来说,干预组(即接受含氟饮用水的个体)来自坎布里亚郡西部,对照组来自坎布里亚郡东部。招募了坎布里亚郡终身居民的儿童。对于出生队列,儿童在出生时(2014-15年)被招募,并随访至5岁。对于年龄较大的学校队列,儿童在5岁(2013-14)时被招募,并随访至11岁。提供“重新引入的氟化水计划”。主要结局指标是乳牙(出生队列)和恒牙(学龄队列)是否存在牙本质龋坏。还评估了每个质量调整生命年的成本。在出生队列(n = 1444)中,干预组有17.4%的儿童出现牙本质龋坏,对照组为21.4%。在对贫困、年龄和性别进行调整后,经调整的优势比为0.74(95%可信区间为0.56至0.98),证据表明,水氟化可能具有适度的有益效果。在学龄较大的队列中,没有足够的证据表明龋齿在儿童中存在差异(n = 1192),干预组中有19.1%的儿童龋齿进入牙本质,而对照组中有21.9%的儿童龋齿进入牙本质(校正优势比0.80,95%可信区间0.58 ~ 1.09)。研究发现,在每个质量调整生命年的支付意愿阈值为2万英镑的情况下,这项干预措施对出生队列和学龄较长的队列都可能具有成本效益。在剥夺五分位数中,水氟化对龋齿经历的影响没有显著差异。龋齿患病率和水氟化的影响比以前的研究报告要小得多。干预在出生队列组有效;然而,适度绝对减少龋齿(进入牙本质)的重要性需要与使用其他预防龋齿的措施相比较。需要进行长期随访,以充分了解当代低龋人群用水加氟的益处和潜在风险(例如氟中毒)之间的平衡。问卷的低回复率降低了其概括的价值。观察到的患有龋齿的儿童人数和各组之间的假设差异远小于预期,因此,研究的效力受到影响(即增加了置信区间中显示的不确定性)。本研究注册号为综合研究申请系统131824和149278。该项目由国家卫生和保健研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第10卷第11期请参阅NIHR期刊图书馆网站了解更多项目信息。
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引用次数: 2
A multicomponent structured health behaviour intervention to improve physical activity in long-distance HGV drivers: the SHIFT cluster RCT 一项多组分结构化健康行为干预以改善长途HGV驾驶员的身体活动:SHIFT集群随机对照试验
Pub Date : 2022-11-01 DOI: 10.3310/pnoy9785
S. Clemes, V. Varela-Mato, D. Bodicoat, C. Brookes, Yu-Ling Chen, Edward Cox, C. Edwardson, L. Gray, A. Guest, Vicki Johnson, F. Munir, Nicola J. Paine, G. Richardson, K. Ruettger, Mohsen Sayyah, A. Sherry, Ana Suazo Di Paola, J. Troughton, Simon Walker, T. Yates, James A King
Long-distance heavy goods vehicle drivers are exposed to a multitude of risk factors associated with their occupation. The working environment of heavy goods vehicle drivers provides limited opportunities for a healthy lifestyle, and, consequently, heavy goods vehicle drivers exhibit higher than nationally representative rates of obesity and obesity-related comorbidities, and are underserved in terms of health promotion initiatives. The aim of this trial was to test the effectiveness and cost-effectiveness of the multicomponent Structured Health Intervention For Truckers (SHIFT) programme, compared with usual care, at both 6 months and 16–18 months. A two-arm cluster randomised controlled trial, including a cost-effectiveness analysis and process evaluation. Transport depots throughout the Midlands region of the UK. Heavy goods vehicle drivers. The 6-month SHIFT programme included a group-based interactive 6-hour education session, health coach support and equipment provision [including a Fitbit® (Fitbit Inc., San Francisco, CA, US) and resistance bands/balls to facilitate a ‘cab workout’]. Clusters were randomised following baseline measurements to either the SHIFT arm or the control arm. Outcome measures were assessed at baseline, with follow-up assessments occurring at both 6 months and 16–18 months. The primary outcome was device-measured physical activity, expressed as mean steps per day, at 6-month follow-up. Secondary outcomes included device-measured sitting, standing, stepping, physical activity and sleep time (on any day, workdays and non-workdays), along with adiposity, biochemical measures, diet, blood pressure, psychophysiological reactivity, cognitive function, functional fitness, mental well-being, musculoskeletal symptoms and work-related psychosocial variables. Cost-effectiveness and process evaluation data were collected. A total of 382 participants (mean ± standard deviation age: 48.4 ± 9.4 years; mean ± standard deviation body mass index: 30.4 kg/m2 ± 5.1 kg/m2; 99% male) were recruited across 25 clusters. Participants were randomised (at the cluster level) to either the SHIFT arm (12 clusters, n = 183) or the control arm (13 clusters, n = 199). At 6 months, 209 (54.7%) participants provided primary outcome data. Significant differences in mean daily steps were found between arms, with participants in the SHIFT arm accumulating 1008 more steps per day than participants in the control arm (95% confidence interval 145 to 1871 steps; p = 0.022), which was largely driven by the maintenance of physical activity levels in the SHIFT arm and a decline in physical activity levels in the control arm. Favourable differences at 6 months were also seen in the SHIFT arm, relative to the control arm, in time spent sitting, standing and stepping, and time in moderate or vigorous activity. No differences between arms were observed at 16–18 months’ follow-up. No differences were observed betw
长途重型货车司机会接触到与其职业相关的多种风险因素。重型货车司机的工作环境为健康生活方式提供了有限的机会,因此,重型货车司机表现出比全国代表性更高的肥胖和肥胖相关合并症发病率,在健康促进举措方面服务不足。该试验的目的是测试卡车司机多组分结构化健康干预(SHIFT)计划在6个月和16-18个月时与常规护理相比的有效性和成本效益。一项双臂集群随机对照试验,包括成本效益分析和过程评估。遍布英国中部地区的运输站。重型货车司机。为期6个月的SHIFT计划包括6小时的小组互动教育课程、健康教练支持和设备供应[包括Fitbit®(美国加利福尼亚州旧金山Fitbit股份有限公司)和阻力带/球,以促进“驾驶室锻炼”]。集群在基线测量后被随机分配到SHIFT臂或对照臂。结果测量在基线时进行评估,随访评估在6个月和16-18个月进行。主要结果是在6个月的随访中,设备测量的体力活动,表示为每天的平均步数。次要结果包括设备测量的坐、站、步、身体活动和睡眠时间(在任何一天、工作日和非工作日),以及肥胖、生物化学测量、饮食、血压、心理生理反应、认知功能、功能健康、心理健康、肌肉骨骼症状和与工作相关的心理社会变量。收集成本效益和工艺评估数据。共有382名参与者(平均 ± 标准差年龄:48.4 ± 9.4年;意思是 ± 标准偏差体重指数:30.4 kg/m2 ± 5.1 kg/m2;99%的男性)在25个集群中被招募。参与者被随机分配到SHIFT组(12组,n = 183)或控制臂(13个簇 = 199)。在6个月时,209名(54.7%)参与者提供了主要结果数据。两组之间的平均每日步数存在显著差异,SHIFT组的参与者每天比对照组多累积1008步(95%置信区间145至1871步;p = 0.022),这在很大程度上是由SHIFT臂中的体力活动水平的维持和控制臂中的体能活动水平的下降所驱动的。在6个月时,相对于对照组,SHIFT组在坐、站和走的时间以及中等或剧烈活动的时间方面也出现了有利的差异。在16–18个月的随访中,未观察到两组之间的差异。在任何一次随访(即6个月和16-18个月)中,在其他次要结果方面,各组之间均未观察到差异。过程评估表明,干预措施受到了参与者的好评,据报道,干预措施对他们的健康行为产生了积极影响。实施SHIFT方案的平均总成本为每位驾驶员369.57英镑,由此产生的质量调整生命年在试验组中相似(SHIFT组:1.22,95%置信区间1.19至1.25;对照组:1.25,95%置信间隔1.22至1.27)。6个月时的随访损失(31.4%)高于预期,在6个月时提供有效主要结果数据的参与者较少(54.7%)。新冠肺炎大流行是一个主要的混淆因素,这限制了我们就SHIFT计划的可持续性得出坚定结论的能力。SHIFT方案在一定程度上成功地对体力活动水平产生了积极影响,并将重型货车司机的坐着时间减少了6个月;然而,这些差异在16-18个月时没有保持。需要利益相关者参与的进一步工作,以根据当前的调查结果完善该计划的内容,然后将SHIFT计划转化为可扩展的驾驶员培训资源。本试验注册号为ISRCTN10483894。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第12期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 1
The Problem Management Plus psychosocial intervention for distressed and functionally impaired asylum seekers and refugees: the PROSPER feasibility RCT 问题管理加心理社会干预对痛苦和功能受损的寻求庇护者和难民:PROSPER可行性随机对照试验
Pub Date : 2022-10-01 DOI: 10.3310/nzxa0081
C. Dowrick, A. Rosala-Hallas, Rebecca Rawlinson, Naila Khan, E. Winrow, A. Chiumento, G. Burnside, Rabeea'h W Aslam, L. Billows, Malena Eriksson-Lee, Daniel Lawrence, Rachel McCluskey, A. Mackinnon, Tracy Moitt, L. Orton, Ewan Roberts, A. Rahman, Grahame Smith, R. Tudor Edwards, P. Uwamaliya, Ross G. White
The prevalence of psychological morbidity among asylum seekers and refugees is high, but these groups encounter extensive barriers to accessing health and social care. The aim of the PROSPER study was to assess the feasibility of conducting a randomised controlled trial in the UK of Problem Management Plus (PM+), an evidence-based psychosocial intervention delivered by lay therapists for distressed and functionally impaired asylum seekers and refugees. We undertook a feasibility study of PM+, which included a pilot study of the design features of a future definitive randomised controlled trial and economic evaluation. The feasibility study involved the adaptation of PM+ based on evidence drawn from literature synthesis and local stakeholder engagement, and a two-stage training procedure for lay therapists. These were followed by a pilot trial designed to assess the feasibility of conducting a three-arm randomised controlled trial of five 90-minute sessions of PM+, delivered individually or in groups, with 105 participants randomised 1 : 1 : 1 to individual PM+, group PM+ or a control intervention. Primary health outcomes were anxiety and depressive symptoms at 3 months; other outcomes included post-traumatic stress disorder symptoms, quality of life, progress with identified goals and service use. We demonstrated that the form and content of PM+ could be adapted to meet the needs of asylum seekers and refugees. Twelve people with lived experience of the asylum process were successfully trained as lay therapists to deliver this targeted, low-intensity psychosocial intervention in local asylum seeker and refugee communities. The pilot trial was affected by governance issues. It began in December 2019 and was cut short by the COVID-19 pandemic. We were not able to complete recruitment and follow-up as planned; 11 out of 105 (10%) participants were recruited to the pilot trial (individual PM+, n = 4; group PM+, n = 3; control, n = 4); 8 out of 11 participants were followed up at 13 weeks and 7 out of 11 participants were followed up at 26 weeks. (Preliminary data were gathered on recruitment and retention, intervention fidelity and acceptability of study measures, including service use measures.) Protracted delays due to governance issues, followed by the COVID-19 pandemic, meant that we were unable to complete the pilot trial or to provide evidence regarding the feasibility of group PM+. The complexities of working with multiple languages and cultural groups were noted. There were mixed views on how successful PM+ might prove, and we had insufficient evidence to provide clear conclusions. Future research could explore how technology can be used to improve the acceptability, feasibility, efficacy and potential cost-effectiveness of scalable mental health interventions and well-being support for distressed asylum seekers and refugees. The use of mobile phone and/or app-based forms of support may help to increase asylum seek
寻求庇护者和难民的心理发病率很高,但这些群体在获得保健和社会护理方面遇到了广泛的障碍。PROSPER研究的目的是评估在英国进行Problem Management Plus(PM+)随机对照试验的可行性,这是一种由非专业治疗师为痛苦和功能受损的寻求庇护者和难民提供的循证心理社会干预。我们对PM+进行了可行性研究,其中包括对未来决定性随机对照试验的设计特征和经济评估的试点研究。可行性研究包括根据文献综合和当地利益相关者参与的证据对PM+进行调整,以及对非专业治疗师进行两阶段培训。随后进行了一项试点试验,旨在评估进行一项三组随机对照试验的可行性,该试验包括五次90分钟的PM+治疗,分别或分组进行,105名参与者随机1 : 1. : 1至个体PM+、组PM+或对照干预。主要健康结果为3个月时出现焦虑和抑郁症状;其他结果包括创伤后应激障碍症状、生活质量、确定目标的进展和服务使用。我们证明,PM+的形式和内容可以进行调整,以满足寻求庇护者和难民的需求。12名有庇护过程经历的人成功地接受了非专业治疗师的培训,在当地寻求庇护者和难民社区提供这种有针对性的、低强度的心理社会干预。试点试验受到治理问题的影响。它始于2019年12月,因新冠肺炎大流行而缩短。我们未能按计划完成招聘和后续工作;105名参与者中有11名(10%)被招募到试点试验中(个体PM+ = 4.PM+组,n = 3.控制,n = 4) ;11名参与者中的8名在13周时进行了随访,11名参与者的7名在26周时进行随访。(收集了关于招募和保留、干预忠诚度和研究措施(包括服务使用措施)的可接受性的初步数据。)由于治理问题以及随后的新冠肺炎大流行而导致的长期延误,意味着我们无法完成试点试验,也无法提供有关团体PM+可行性的证据。与会者注意到与多种语言和文化群体合作的复杂性。关于PM+如何成功,人们众说纷纭,我们没有足够的证据来提供明确的结论。未来的研究可以探索如何利用技术来提高可扩展的心理健康干预措施的可接受性、可行性、疗效和潜在的成本效益,并为陷入困境的寻求庇护者和难民提供福祉支持。使用基于手机和/或应用程序的支持形式可能有助于提高寻求庇护者和难民参与此类研究的意愿。尽管无法具体说明针对英国寻求庇护者和难民的PM+完全随机对照试验的参数,但我们的研究结果为未来此类性质的研究提供了可能有价值的策略指导。该试验注册为ISRCTN15214107。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷,第10期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 2
Developing and implementing 20-mph speed limits in Edinburgh and Belfast: mixed-methods study 在爱丁堡和贝尔法斯特制定和实施时速20英里的限速:混合方法研究
Pub Date : 2022-09-01 DOI: 10.3310/xazi9445
R. Jepson, G. Baker, C. Cleland, A. Cope, N. Craig, Charlie Foster, R. Hunter, F. Kee, M. Kelly, P. Kelly, K. Milton, Glenna F. Nightingale, K. Turner, A. Williams, J. Woodcock
Transport initiatives such as 20-mph (≈30-km/h) speed limits are anticipated to result in fewer road casualties and improve perceptions of safety, leading to increases in active travel. Lower speeds may also lead to more pleasant environments in which to live, work and play. The main objective was to evaluate and understand the processes and effects of developing and implementing 20-mph speed limits in Edinburgh and Belfast. The focus was on health-related outcomes (casualties and active travel) that may lead to public health improvements. An additional objective was to investigate the political and policy factors (conditions) that led to the decision to introduce the new speed limits. This was a mixed-methods study that comprised an outcome, process, policy and economic evaluation of two natural experiments. The study was set in Edinburgh, Scotland, and Belfast, Northern Ireland, from 2000 to 2018. The whole population of each city were participants, as well as stakeholders involved in implementation and decision-making processes. The intervention was the implementation of 20-mph legislation, signage, enforcement, and education and awareness-raising in Edinburgh (citywide) and Belfast (city centre). The main outcomes measured were speed; number, type and severity of road collisions; perceptions; and liveability. The following data sources were used – routinely and locally collected quantitative data for speed, volume of traffic, casualties and collisions, and costs; documents and print media; surveys; interviews and focus groups; and Google Street View (Google Inc., Mountain View, CA, USA). Collisions and casualties – the overall percentage reduction in casualty rates was 39% (the overall percentage reduction in collision rates was 40%) in Edinburgh. The percentage reduction for each level of severity was 23% for fatal casualties, 33% for serious casualties and 37% for minor casualties. In Belfast there was a 2% reduction in casualties, reflecting differences in the size, reach and implementation of the two schemes. Perceptions – in Edinburgh there was an increase in two factors (support for 20 mph and rule-following after implementation) supported by the qualitative data. Liveability – for both cities, there was a small statistical increase in liveability. Speed – mean and median speeds reduced by 1.34 mph and 0.47 mph, respectively, at 12 months in Edinburgh, with no statistically significant changes in Belfast. History, political context, local policy goals, local priorities and leadership influenced decision-making and implementation in the two cities. There was no analysis of active travel outcomes because the available data were not suitable. The pre-implementation period is important. It helps frame public and political attitudes. The scale of implementation and additional activities in the two cities had a bearing on the impacts. The citywide approach adopted by Ed
预计限速20英里/小时(≈30公里/小时)等交通举措将减少道路伤亡,提高安全意识,从而增加主动出行。较低的速度也可能带来更舒适的生活、工作和娱乐环境。主要目的是评估和了解在爱丁堡和贝尔法斯特制定和实施20英里/小时限速的过程和效果。重点关注可能导致公共卫生改善的健康相关结果(伤亡和积极旅行)。另一个目标是调查导致决定引入新限速的政治和政策因素(条件)。这是一项混合方法研究,包括两个自然实验的结果、过程、政策和经济评估。这项研究于2000年至2018年在苏格兰爱丁堡和北爱尔兰贝尔法斯特进行。每个城市的全体居民以及参与执行和决策过程的利益攸关方都是参与者。干预措施是在爱丁堡(全市)和贝尔法斯特(市中心)实施时速20英里的立法、标识、执法、教育和提高认识。测量的主要结果是速度;道路碰撞的数量、类型和严重程度;感知;以及宜居性。使用了以下数据来源——常规和本地收集的速度、交通量、伤亡和碰撞以及成本的定量数据;文件和印刷媒体;调查;访谈和焦点小组;和谷歌街景(谷歌股份有限公司,山景,加利福尼亚州,美国)。碰撞和伤亡——爱丁堡的伤亡率总体下降了39%(碰撞率总体下降40%)。每种严重程度的致命伤亡减少23%,严重伤亡减少33%,轻微伤亡减少37%。贝尔法斯特的伤亡人数减少了2%,这反映出两个计划在规模、范围和实施方面的差异。感知——在爱丁堡,有两个因素(支持20 mph和实施后的规则遵循)。宜居性——这两个城市的宜居性都有小幅的统计增长。速度-平均速度和中间速度降低1.34 英里/小时和0.47 爱丁堡在12个月时分别为每小时12英里,贝尔法斯特没有统计上的显著变化。历史、政治背景、地方政策目标、地方优先事项和领导力影响了这两个城市的决策和实施。由于现有数据不合适,因此没有对积极旅行结果进行分析。实施前阶段很重要。它有助于形成公众和政治态度。这两个城市的实施规模和额外活动对影响产生了影响。爱丁堡采取的全市范围的方法有效地降低了速度,并对一系列公共卫生结果产生了积极影响。贝尔法斯特市中心的方法(那里的速度已经很低)效果较差。然而,这些计划的主要成果是减少了各级严重程度的道路伤亡。未来的工作应该制定一种纳入多种结果变量的公共卫生干预统计方法。在这项研究中,对每种结果进行了独立分析。此外,应该制定可以简单、廉价和大规模管理的积极旅行的人口指标。本研究注册号为ISRCTN10200526。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷,第9期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 0
How public health teams navigate their different roles in alcohol premises licensing: ExILEnS multistakeholder interview findings 公共卫生团队如何在酒精场所许可中定位他们的不同角色:ExILEnS多利益相关者访谈结果
Pub Date : 2022-08-01 DOI: 10.3310/xcuw1239
R. O’Donnell, A. Mohan, R. Purves, N. Maani, M. Egan, N. Fitzgerald
In England and Scotland, local governments regulate the sale of alcohol by awarding licences to premises to permit the sale of alcohol for consumption on or off the premises, under certain conditions; without such a licence, alcohol cannot be legally sold. In recent years, many local public health teams have become proactive in engaging with alcohol licensing, encouraging licensing authorities to act in ways intended to improve population health. This research aimed to explore and understand the approaches and activities of public health stakeholders (i.e. NHS staff and other public health professionals) in seeking to influence local alcohol licensing policy and decisions, and the views of licensing stakeholders (i.e. licensing officers/managers, police staff with a licensing remit, elected members and licensing lawyers/clerks) on the acceptability and effectiveness of these approaches. Local public health teams in England and Scotland were directly informed about this multisite study. Scoping calls were conducted with interested teams to explore their level of activity in alcohol licensing from 2012 across several categories. Twenty local authority areas with public health teams active in licensing matters were recruited purposively in England (n = 14) and Scotland (n = 6) to vary by region and rurality. Fifty-three in-depth telephone interviews (28 with public health stakeholders and 25 with licensing stakeholders outside health, such as local authority licensing teams/lawyers or police) were conducted. Interview transcripts were analysed thematically in NVivo 12 (QSR International, Warrington, UK) using inductive and deductive approaches. Public health stakeholders’ approaches to engagement varied, falling into three main (and sometimes overlapping) types. (1) Many public health stakeholders in England and all public health stakeholders in Scotland took a ‘challenging’ approach to influencing licensing decisions and policies. Reducing health harms was felt to necessitate a focus on reducing availability and generating longer-term culture change, citing international evidence on the links between availability and alcohol-related harms. Some of these stakeholders viewed this as being a narrow, ‘nanny state’ approach, whereas others welcomed public health expertise and its evidence-based approach and input. (2) Some public health stakeholders favoured a more passive, ‘supportive’ approach, with some reporting that reducing availability was unachievable. They reported that, within the constraints of current licensing systems, alcohol availability may be contained (at least in theory) but cannot be reduced, because existing businesses cannot be closed on availability grounds. In this ‘supportive’ approach, public health stakeholders supplied licensing teams with data on request or waited for guidance from licensing teams on when and how to get involved. Therefore, public health action supported the licensing team in their a
在英格兰和苏格兰,地方政府通过向场所颁发许可证来规范酒精销售,允许在某些条件下在场所内或场所外销售酒精;没有这样的许可证,酒类就不能合法销售。近年来,许多地方公共卫生小组积极参与发放酒类许可证的工作,鼓励发放许可证的当局采取旨在改善人口健康的行动。本研究旨在探索和了解公共卫生利益攸关方(即NHS工作人员和其他公共卫生专业人员)在寻求影响当地酒精许可政策和决定方面的方法和活动,以及许可利益攸关方(即许可官员/经理、负责许可的警察工作人员、民选成员和许可律师/办事员)对这些方法的可接受性和有效性的看法。英格兰和苏格兰的当地公共卫生团队被直接告知这项多地点研究。与感兴趣的团队进行了范围界定电话会议,以探索他们从2012年起在几个类别的酒类许可方面的活动水平。在英格兰(n = 14)和苏格兰(n = 6)有目的地招募了20个地方当局地区的公共卫生小组,这些小组积极参与许可证事宜,因地区和农村而异。进行了53次深度电话访谈(28次与公共卫生利益攸关方访谈,25次与卫生部门以外的发放许可证利益攸关方访谈,如地方当局发放许可证小组/律师或警察)。访谈记录在NVivo 12 (QSR国际,沃灵顿,英国)中使用归纳和演绎方法进行了主题分析。公共卫生利益攸关方参与的方法各不相同,可分为三种主要(有时相互重叠)类型。(1)英格兰的许多公共卫生利益相关者和苏格兰的所有公共卫生利益相关者采取了一种“具有挑战性”的方法来影响许可决定和政策。与会者认为,要减少对健康的危害,就必须把重点放在减少可得性和促成长期文化变革上,并引用了有关可得性与酒精相关危害之间联系的国际证据。其中一些利益攸关方认为这是一种狭隘的“保姆国家”方法,而另一些利益攸关方则欢迎公共卫生专业知识及其基于证据的方法和投入。(2)一些公共卫生利益相关者倾向于采取一种更被动的“支持性”方法,一些人报告说,减少可得性是不可能实现的。他们报告说,在目前许可制度的限制下,酒精供应可以得到控制(至少在理论上),但不能减少,因为现有的企业不能以供应为理由关闭。在这种“支持性”方法中,公共卫生利益攸关方应请求向许可团队提供数据,或等待许可团队就何时以及如何参与提供指导。因此,公共卫生行动支持许可小组的目标,即促进"安全"和"负责任"的酒类零售和/或侧重于健康以外的短期结果,如犯罪。(3)一些公共卫生利益攸关方倾向于与许可团队密切合作的“协作”方式;这可能包括侧重于控制酒精的可得性或负责任的零售,或两者兼而有之。在涉及酒精许可问题时,公共卫生利益攸关方调整了他们的做法,有时导致对公共卫生目标的关注减少。抽样不包括低活动区域,在那里体验可能不同。目前的许可制度在多大程度上能够实现公共卫生目标值得怀疑,公共卫生工作的有效性值得定量评估。该研究在研究登记处注册为researchregistry6162。该项目由国家卫生和保健研究所(NIHR)公共卫生研究方案资助,将发表在《公共卫生研究》上。请参阅NIHR期刊图书馆网站了解更多项目信息。
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引用次数: 0
A proportionate, universal parenting programme to enhance social-emotional well-being in infants and toddlers in England: the E-SEE Steps RCT 一个比例,普遍的育儿方案,以提高社会情感福祉婴幼儿在英格兰:E-SEE步骤随机对照试验
Pub Date : 2022-06-01 DOI: 10.3310/bcfv2964
T. Bywater, V. Berry, S. Blower, M. Bursnall, Edward Cox, A. Mason-Jones, S. McGilloway, Kirsty McKendrick, Siobhan B. Mitchell, K. Pickett, G. Richardson, K. Solaiman, M. Teare, S. Walker, K. Whittaker
Mental disorders have become a public health crisis. Early prevention is key. Parenting programmes are effective for children aged ≥ 3 years; however, there is a lack of evidence of their effectiveness for children aged ≤ 2 years. To establish if the model named Enhancing Social–Emotional Health and Well-being in the Early Years (E-SEE) Steps can (1) enhance child social emotional well-being and establish whether or not it is cost-effective at 20 months of age when compared with services as usual; and (2) be delivered as a proportionate universal model with fidelity. A pragmatic two-arm randomised controlled trial and economic appraisal, with an embedded process evaluation to examine the outcomes, implementation and cost-effectiveness of the intervention, and intervention uptake, compared with services as usual. The study had an external pilot phase (which was originally planned as an internal pilot). The intervention was delivered in community settings by early years children’s services and/or public health staff in four sites. A total of 341 parents of infants aged ≤ 8 weeks were randomised in a ratio of 5 : 1 (intervention, n = 285; control, n = 56). The target sample was 606 parents. Two Incredible Years® parenting programmes (i.e. infant and toddler) delivered in a proportionate universal model with three levels [one universal (book) and two targeted group-based parenting programmes]. Child social and emotional well-being (primary outcome) was assessed using the Ages and Stages Questionnaire: Social and Emotional, 2nd edition, at 2, 9 and 18 months after randomisation. Parent depression (secondary key outcome) was assessed using the Patient Health Questionnaire-9 items. Both questionnaires were eligibility screeners for targeted groups. The primary outcome analysis provided no evidence that the E-SEE Steps model was effective in enhancing child social and emotional well-being. The adjusted mean difference was 3.02 on the original Ages and Stages Questionnaire: Social and Emotional, 2nd edition, in favour of the control [95% confidence interval –0.03 to 6.08; p = 0.052; N = 321 (intervention, n = 268; control, n = 53)]. Analysis of the key secondary outcome (i.e. parent depression levels as assessed by the Patient Health Questionnaire-9 items) provided weak evidence on the Patient Health Questionnaire-9 items in favour of the intervention (adjusted mean difference –0.61, 95% confidence interval –1.34 to 0.12; p = 0.1). Other secondary outcomes did not differ between arms. The economic analysis showed that the E-SEE Steps model was associated with higher costs and was marginally more effective (0.031 quality-adjusted life-years gained from E-SEE Steps compared with SAU, 95% confidence interval –0.008 to 0.071) than services as usual, resulting in an incremental cost-effectiveness ratio of approximately £20,062 per quality-adjusted life-year compared with services as usual. Overall take-up of
精神障碍已经成为一场公共卫生危机。早期预防是关键。育儿计划对年龄≥ 3年;然而,缺乏证据表明它们对≤ 2年。确定名为“增强早期社会-情感健康和幸福”(E-SEE)步骤的模型是否可以(1)增强儿童的社会-情感幸福感,并确定与通常的服务相比,它在20个月大时是否具有成本效益;以及(2)作为具有保真度的比例通用模型来递送。一项实用的双臂随机对照试验和经济评估,与常规服务相比,采用嵌入式过程评估来检查干预的结果、实施和成本效益,以及干预的接受情况。该研究有一个外部试点阶段(最初计划作为内部试点)。干预措施由四个地点的早期儿童服务和/或公共卫生工作人员在社区环境中进行。共有341名≤ 8周随机分组,比例为5 : 1(干预,n = 285;控制,n = 56)。目标样本为606名父母。两个不可思议的岁月®育儿计划(即婴儿和学步儿童)以三个层次的比例通用模式提供[一个通用(书籍)和两个有针对性的基于群体的育儿计划]。随机分组后2、9和18个月,使用《年龄和阶段问卷:社会和情感》第2版评估儿童的社会和情感幸福感(主要结果)。使用患者健康问卷-9项评估父母抑郁(次要关键结果)。两份调查问卷都是目标群体的资格筛选者。主要结果分析没有提供证据表明E-SEE Steps模型在增强儿童社交和情绪健康方面是有效的。原始《年龄和阶段问卷:社会和情感》第2版的调整后平均差异为3.02,有利于对照[95%置信区间-0.03至6.08;p = 0.052;N = 321(干预,n = 268;控制,n = 53)]。对关键次要结果的分析(即通过患者健康问卷-9项评估的父母抑郁水平)在患者健康问卷.9项上提供了支持干预的微弱证据(调整后的平均差异-0.61,95%置信区间-1.34至0.12;p = 0.1)。其他次要结果在各组之间没有差异。经济分析表明,E-SEE步骤模型与更高的成本相关,并且比通常的服务稍微有效(与SAU相比,E-SSE步骤获得0.031个质量调整寿命年,95%置信区间-0.008至0.071),与正常服务相比,每个质量调整生命年的成本效益比增加了约20062英镑。有针对性的育儿方案总体接受率较低。网站虽然热情高涨,但发现了实施干预的障碍。未达到目标样本量,该研究无法探索每种干预水平的有效性。样本中的大多数父母都受过良好的教育,因此,结果不太可能是普遍的,尤其是对于那些社会和情绪健康状况不佳的风险最大的人。E-SEE步骤比例通用模型并没有提高儿童的社会和情感幸福感,但在父母健康结果方面没有显著改善,导致干预的成本效益存在相当大的不确定性。主要和关键的次要结果给出了不一致的信号。尽管随着系统的变化、资源的增加和对干预的适应,该模型可以实施,但E-SEE步骤模型的积极结果证据不足。来自外部试点的通用级E-SEE步骤数据(即《不可思议的岁月》一书)将与主要试验数据合并,用于进一步探索,直到随访1,这是观察到大多数变化的时间点。本试验注册号为ISRCTN11079129。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷,第8期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 1
期刊
Public Health Research
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