Title: BATHE (Bath Emollients for Treatment of cHildhood Eczema)
Funder: Department of Health (England)

Abstract: DESIGN: Pragmatic 2-arm randomised controlled trialSETTING: Primary CareTARGET POPULATIONChildren aged 1 to 11 years with atopic eczema. We will exclude children with inactive or very mild eczema (5 or less on the Nottingham Eczema Severity Scale) and those who usually have a bath less than once per week.HEALTH TECHNOLOGIES BEING ASSESSEDBath emollients as they are currently used in primary care along with standard management. It will not be possible to create a convincing placebo so standard care will be used as the comparator. Children will be randomised using remote randomisation to either standard care plus a GP prescription of regular bath emollients or to standard care alone. Both groups will be provided with general advice regarding eczema care in line with NICE guidance.MEASUREMENT OF COST AND OUTCOMESPrimary outcome measureWe will measure weekly eczema severity by administering POEM questionnaires weekly for 16 weeks. POEM (Patient-Oriented Eczema Measure) is a patient reported outcome based on symptoms over the previous week which can be completed by the child’s carer. POEM is the only patient reported outcome that demonstrated sufficient validity and repeatability in a systematic review of outcome measures for eczema. POEM captures symptoms on a weekly basis and there is no other well validated measure of well controlled weeks or patient-reported exacerbations in eczema. We are currently piloting use of text reminders and online data collection in a similar study population and will include a pilot phase with clear progression criteria based on recruitment and retention.Secondary outcome measures1.Number of eczema exacerbations resulting in a primary healthcare consultation over 1 year. This will be assessed by a review of participants’ primary care records at 1 year and exacerbations will be defined as consultations where there is mention of eczema and topical steroid has been advised or prescribed. 2.Eczema severity over 1 year by administering POEM every 4 weeks from 16 weeks to 12 months. Weekly measures over the course of 1 year are unlikely to be feasible so we propose to seek POEM monthly after the first 16 weeks.3.Disease-specific QoL at baseline 16 weeks and 1 year measured by DFI (Dermatitis Family Impact) IDQoL (Infants Dermatitis Quality of Life index) and CDLQI (Childrens Dermatology Life Quality Index). DFI is a validated instrument measuring impact of eczema on the family’s quality of life. IDQoL and CDLQI are validated measures in children aged 4 or less and 5 or over respectively.4.Generic QoL as measured by the Child Health Utility 9D (CHU 9D) a paediatric health related quality of life measure for use in economic evaluations and the Health Utility Index II (HUI2) a utility measure that has been widely used in paediatric research (the UK valuation tariff will be used). 5.Type (strength) and quantity of topical steroid/calcineurin inhibitors prescribed measured by GP record review at 12 months6.Amount of leave-on emollient prescribed (i.e. emollient directly applied to the skin and left on) measured by GP record review at 12 months. 7.Adherence to bath emollient reported by carers in bath emollient group. Contamination reported by carers in standard care group.8.Adverse effects from bath emollients reported by carer.9.Assessment of cost-effectiveness (prescriptions GP appointments dermatology referrals).SAMPLE SIZEThe sample size was calculated for repeated measures ANOVA in weekly POEM scores over the 16 week observation period. Using data from a similar population in the SWET trial we aim to detect a mean difference of 2.0 (sd 7.0) between intervention and control groups. An alpha of 0.05 and power 0.9 gives a sample size of 338. Allowing for 20 per cent loss to follow-up this gives a total sample size 405 i.e. 135 for each of the three participating regions.ANALYSISWe will use repeated measures analysis of variance to analyse POEM scores over the first 16 weeks or if there is missing data a mixed model to allow for this. We will control for possible confounding effects such as baseline eczema severity and age of child. Primary analyses will be carried out on an intention to treat basis. HEALTH ECONOMIC ANALYSISThe within trial economic analysis adherent to guidelines for good economic evaluation practice will include the primary economic evaluation which will be in the form of cost-effectiveness analysis (CEA) and a secondary economic evaluation in the form of cost-utility analysis (CUA). As part of the study resource use data in primary and secondary care associated with eczema will be collected. The main viewpoint of the study will be that of the NHS. However other resource use data will be collected to allow for a secondary analysis from a societal perspective. All cost-effectiveness results will be presented on the cost-effectiveness plane and cost-effectiveness acceptability curves.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: SKIN