title: Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial.
abstract: BACKGROUND
  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
  
  
  
  METHODS
  Pragmatic open 2-armed parallel group randomised controlled trial.
  
  
  METHODS
  General practitioner (GP) practices in England and Wales.
  
  
  METHODS
  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).
  
  
  METHODS
  Children will be randomised to either bath emollients plus standard eczema care or standard eczema care only.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN84102309.
authors.affiliation: Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Miriam
authors.initials: M
authors.lastname: Santer
authors.affiliation: Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Rumsby
authors.affiliation: Department of School of Social & Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Ridd
authors.affiliation: Wales School of Primary Care Research, Cardiff University, Cardiff, UK.
authors.forename: Nick A
authors.initials: NA
authors.lastname: Francis
authors.affiliation: Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Beth
authors.initials: B
authors.lastname: Stuart
authors.affiliation: Southampton Health Technology Assessment Centre (SHTAC), University of Southampton, Southampton, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Chorozoglou
authors.affiliation: Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Wood
authors.affiliation: Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Roberts
authors.affiliation: Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
authors.forename: Kim S
authors.identifier: http://orcid.org/0000-0001-7785-7465
authors.initials: KS
authors.lastname: Thomas
authors.affiliation: Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
authors.forename: Hywel C
authors.initials: HC
authors.lastname: Williams
authors.affiliation: Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Little
mesh_terms: D001494:Baths; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D004485:Eczema / Q000628:therapy*; D004643:Emollients / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D059039:Standard of Care
chemical_list: D004643:Emollients
keywords: DERMATOLOGY; PRIMARY CARE