Abstract | INTRODUCTION: 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 METHODS AND ANALYSIS: DESIGN: Pragmatic open 2-armed parallel group randomised controlled trial. SETTING: General practitioner (GP) practices in England and Wales. PARTICIPANTS: 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). INTERVENTIONS: OUTCOME MEASURES: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN84102309.
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Authors | Miriam Santer, Kate Rumsby, Matthew J Ridd, Nick A Francis, Beth Stuart, Maria Chorozoglou, Wendy Wood, Amanda Roberts, Kim S Thomas, Hywel C Williams, Paul Little |
Journal | BMJ open
(BMJ Open)
Vol. 5
Issue 10
Pg. e009575
(Nov 01 2015)
ISSN: 2044-6055 [Electronic] England |
PMID | 26525422
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ |
Chemical References |
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Topics |
- Baths
- Child
- Child, Preschool
- Clinical Protocols
- Eczema
(therapy)
- Emollients
(pharmacology, therapeutic use)
- Humans
- Infant
- Quality of Life
- Research Design
- Severity of Illness Index
- Skin
(drug effects, pathology)
- Standard of Care
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