National Institute of Health Research

HTA - 11/153/01: BATHE (Bath Emollients for Treatment of cHildhood Eczema)

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Project title BATHE (Bath Emollients for Treatment of cHildhood Eczema)
Research type Primary Research
Status Research in progress
Start date May 2014
Publication date

May 2018

This is the estimated publication date for this report, but please note that delays in the editorial review process can cause the forecast publication date to be delayed.

Cost £ 959,035.00
Chief Investigator Dr Miriam Santer
Co-investigators Dr Nick Francis (Cardiff University), Professor Paul Little (University of Southampton), Dr Matthew Ridd (University of Bristol), Mrs Amanda Roberts (Centre for Evidence Based Dermatology), Dr Beth Stuart (University of Southampton), Professor Kim Thomas (University of Nottingham), Professor Hywel Williams (University of Nottingham), Dr Wendy Wood (University of Southampton), Ms Maria Chorozoglou (University of Southampton), Mrs Louise Stanton (University of Southampton)
Contractor University of Southampton
Plain English summary Eczema is a skin condition that is very common in young children. It causes itching and sleep problems which lead to distress for the child and the rest of the family and can also impact on schooling and everyday tasks. The main treatments are emollients which moisturise the skin and steroid creams/ointments to treat flare-ups caused by skin inflammation. A NICE guideline on childhood eczema has recommended complete emollient therapy a care package that includes leave-on emollient (non-cosmetic moisturiser directly applied to the skin and left on), soap substitute emollient and bath emollient (a liquid added to the bath). However, the guideline highlighted that there is little research evidence on whether adding a bath emollient is helpful. While health professionals agree about the benefits of leave-on emollients and avoiding soap for children with eczema, there is less confidence in the possible additional benefits of bath emollients. It is possible that they do help because they are easy to pour in the bath and it is likely that they come into contact with most of the skin. But it is also possible that the emollient effect is too little to be effective compared with direct application of leave-on emollients onto the skin. Bath emollients can have side effects as they sometimes cause stinging and redness of the skin and potentially cause accidents through leaving the bath slippery. They may rot bath mats and lead to increased time spent cleaning the bath. There is also concern that some families view bath emollients as an alternative to leave-on emollients and are therefore using a less effective therapy. Bath emollients cost the NHS over £16 million per year, a large sum given the lack of evidence for their benefit. This trial will measure whether bath emollients help children with eczema. Children aged 1 to 11 years will be randomly allocated to 2 groups: (1) standard eczema management with bath emollient and (2) standard eczema management without bath emollient. We will ask parents or carers to complete weekly diaries including a short questionnaire about eczema severity for the first 16 weeks, the time period during which the greatest effect is likely, and will ask them to complete monthly questionnaires for a further 8 months to assess longer term outcomes. We will also ask parents and carers about any side effects or difficulties they have using the treatment (adherence to treatment). We will also look at use of additional treatments, such as leave-on emollients, from GP prescribing. The cost of the study reflects the organisation required to collect high quality data for over 400 children over a 1 year time period, the training of nurses for recruiting participants into the trial and the employment of staff to run the trial, including specialists in trial management, statistics, health economics, dermatology, primary care (General Practice), and patient and participant representation. NHS costs include time spent by practice staff in carrying out recruitment and notes review, as well as the costs of bath emollient prescribing within the study. The majority of children with eczema are managed in primary care and this study will therefore identify participants through a number of different general practices, both by practices posting invitations to eligible families and also by GPs and health visitors inviting families during routine clinics. The combined expertise within this team covers extensive experience in successfully carrying out dermatology trials and also in carrying out large trials in primary care.
Scientific summary DESIGN: Pragmatic 2-arm randomised controlled trial SETTING: Primary Care TARGET POPULATION Children 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 ASSESSED Bath 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 OUTCOMES Primary outcome measure We 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 measures 1. 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 months 6. 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 SIZE The 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. ANALYSIS We 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 ANALYSIS The 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.
Documents

Protocol (PDF File - 632.1 KB)

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