Santer Miriam, Rumsby Kate, Ridd Matthew J, Francis Nick A, Stuart Beth, Chorozoglou Maria, Wood Wendy, Roberts Amanda, Thomas Kim S, Williams Hywel C, Little Paul
Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
Department of School of Social & Community Medicine, University of Bristol, Bristol, UK.
BMJ Open. 2015 Nov 1;5(10):e009575. doi: 10.1136/bmjopen-2015-009575.
Bath emollients are widely prescribed for childhood eczema, yet evidence of their benefits over direct application of emollients is lacking. Objectives To determine the clinical and cost-effectiveness of adding bath emollient to the standard management of eczema in children
Pragmatic open 2-armed parallel group randomised controlled trial.
General practitioner (GP) practices in England and Wales.
Children aged over 12 months and less than 12 years with eczema, excluding inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale).
Children will be randomised to either bath emollients plus standard eczema care or standard eczema care only.
Primary outcome is long-term eczema severity, measured by the Patient-Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Secondary outcomes include: number of eczema exacerbations resulting in healthcare consultations over 1 year; eczema severity over 1 year; disease-specific and generic quality of life; medication use and healthcare resource use; cost-effectiveness. Aiming to detect a mean difference between groups of 2.0 (SD 7.0) in weekly POEM scores over 16 weeks (significance 0.05, power 0.9), allowing for 20% loss to follow-up, gives a total sample size of 423 children. We will use repeated measures analysis of covariance, or a mixed model, to analyse weekly POEM scores. We will control for possible confounders, including baseline eczema severity and child's age. Cost-effectiveness analysis will be carried out from a National Health Service (NHS) perspective.
This protocol was approved by Newcastle and North Tyneside 1 NRES committee 14/NE/0098. Follow-up will be completed in 2017. Findings will be disseminated to participants and carers, the public, dermatology and primary care journals, guideline developers and decision-makers.
ISRCTN84102309.
沐浴润肤剂在儿童湿疹治疗中应用广泛，但相较于直接涂抹润肤剂，其益处缺乏证据支持。目的：确定在儿童湿疹标准治疗方案中添加沐浴润肤剂的临床疗效及成本效益。
实用开放性双臂平行组随机对照试验。
英格兰和威尔士的全科医生诊所。
年龄超过12个月且小于12岁的湿疹患儿，排除非活动性或非常轻度的湿疹（诺丁汉湿疹严重程度量表评分5分及以下）。
将患儿随机分为两组，一组接受沐浴润肤剂加标准湿疹护理，另一组仅接受标准湿疹护理。
主要观察指标为长期湿疹严重程度，采用以患者为导向的湿疹量表（POEM）每周重复测量，共16周。次要观察指标包括：1年内因湿疹加重导致就医的次数；1年内的湿疹严重程度；疾病特异性和一般生活质量；药物使用及医疗资源利用情况；成本效益。为检测16周内两组每周POEM评分的平均差异为2.0（标准差7.0）（显著性0.05，检验效能0.9），并考虑20%的失访率，共需纳入423名患儿。我们将采用重复测量协方差分析或混合模型分析每周的POEM评分。我们将控制可能的混杂因素，包括基线湿疹严重程度和患儿年龄。成本效益分析将从英国国家医疗服务体系（NHS）的角度进行。
本研究方案已获纽卡斯尔和北泰恩赛德1号国家研究伦理委员会批准（14/NE/0098）。随访将于2017年完成。研究结果将向参与者及其护理人员、公众、皮肤科和初级保健期刊、指南制定者及决策者公布。
ISRCTN84102309。
