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西澳大利亚偏远地区儿童脓疱疮控制的三模式皮肤健康方案(SToP):一项集群随机、阶梯式楔形试验。

Trimodal skin health programme for childhood impetigo control in remote Western Australia (SToP): a cluster randomised, stepped-wedge trial.

机构信息

Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia (formerly Telethon Kids Institute), University of Western Australia, Nedlands, WA, Australia.

Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia (formerly Telethon Kids Institute), University of Western Australia, Nedlands, WA, Australia; The Marshall Centre for Infectious Diseases Research and Training, School of Biomedical Sciences, University of Western Australia, Perth, WA, Australia.

出版信息

Lancet Child Adolesc Health. 2024 Nov;8(11):809-820. doi: 10.1016/S2352-4642(24)00229-3. Epub 2024 Oct 9.

DOI:10.1016/S2352-4642(24)00229-3
PMID:39393383
Abstract

BACKGROUND

Skin infections affect physical health and, through stigma, social-emotional health. When untreated, they can cause life-threatening conditions. We aimed to assess the effect of a holistic, co-designed, region-wide skin control programme on the prevalence of impetigo.

METHODS

The SToP (See, Treat, and Prevent Skin Sores and Scabies) trial is a pragmatic, open-cohort, stepped-wedge cluster randomised trial involving participants aged 0-18 years in nine remote communities of the Kimberley, Western Australia. The trial involves programmatic interventions in three domains: See (skin checks and skin infection recognition training), Treat (skin infection treatment training, sulfamethoxazole-trimethoprim for impetigo, and ivermectin for scabies), and Prevent (co-designed health promotion and environmental health). Four clusters, defined as pragmatic aggregations of communities, were randomised in two steps to progressively receive the activities during ten visits. The primary outcome was the proportion of school-aged children (aged 5-9 years) with impetigo. We adopted an intention-to-treat analysis and compared the intervention with the control (usual care before the start of intervention) states to derive a time and cluster averaged effect using Bayesian modelling. This study is registered with Australian New Zealand Clinical Trials Registry, ACTRN12618000520235.

FINDINGS

Between Sept 19, 2018, and Nov 22, 2022, 915 children were consented and 777 (85%) had skin checks performed on at least one of ten possible visits between May 5, 2019, and Nov 22, 2022. Of the participants, 448 (58%) of 777 were aged 5-9 years at one or more of the visit timepoints and were eligible for primary outcome assessment. A decline in impetigo occurred across all clusters, with the greatest decline during the observational period of baseline skin checks before commencement of the interventional trial activities activities. The mean (95% credible interval) for the conditional posterior odds ratio for observing impetigo in the intervention compared with the control period was 1·13 (0·71-1·70). The probability that the intervention reduced the odds of observing impetigo was 0·33.

INTERPRETATION

A decreased prevalence of impetigo during the observational period before the commencement of trial activities was sustained across the trial, attributable to the trimodal skin health initiative. Although the prevalence of impetigo reduced, there is no direct evidence to attribute this to the individual effects of the trial activities. The wholistic approach inclusive of skin checks collectively contributed to the sustained reduction in impetigo.

FUNDING

Western Australia Department of Health, Australian National Health and Medical Research Council, and Healthway.

摘要

背景

皮肤感染会影响身体健康,并通过污名化影响社会情感健康。如果不加以治疗,它们可能会导致危及生命的状况。我们旨在评估一项整体的、共同设计的、区域范围的皮肤控制计划对脓疱病流行率的影响。

方法

SToP(观察、治疗和预防皮肤溃疡和疥疮)试验是一项实用的、开放性队列、阶梯式楔形集群随机试验,涉及西澳大利亚金伯利地区 9 个偏远社区的 0-18 岁参与者。该试验涉及三个领域的方案干预:观察(皮肤检查和皮肤感染识别培训)、治疗(皮肤感染治疗培训、治疗脓疱病的磺胺甲噁唑-甲氧苄啶和治疗疥疮的伊维菌素)和预防(共同设计的健康促进和环境卫生)。四个聚类被定义为社区的实用聚合,以两步随机方式分配,在十次访问中逐步接受活动。主要结局是 5-9 岁学龄儿童脓疱病的比例。我们采用意向治疗分析,并比较了干预组和对照组(干预开始前的常规护理)的情况,使用贝叶斯建模得出时间和聚类平均效应。本研究在澳大利亚新西兰临床试验注册处注册,ACTRN12618000520235。

结果

2018 年 9 月 19 日至 2022 年 11 月 22 日,915 名儿童同意参加,其中 777 名(85%)在 2019 年 5 月 5 日至 2022 年 11 月 22 日的 10 次可能访问中的至少一次进行了皮肤检查。在参与者中,448 名(58%)的 777 名在一个或多个访视点的年龄为 5-9 岁,有资格进行主要结局评估。所有聚类的脓疱病发生率均有所下降,在开始干预试验活动之前进行的基线皮肤检查的观察期内下降最大。与对照期相比,观察到干预组中脓疱病的条件后验比值比的平均值(95%可信区间)为 1.13(0.71-1.70)。干预降低观察到脓疱病的可能性的概率为 0.33。

解释

在试验活动开始前的观察期内,脓疱病的流行率持续下降,这归因于三模式皮肤健康倡议。尽管脓疱病的流行率有所下降,但没有直接证据将其归因于试验活动的个别影响。包括皮肤检查在内的整体方法共同促成了脓疱病的持续减少。

资金

西澳大利亚州卫生部、澳大利亚国家卫生和医学研究委员会以及健康路。

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