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Bath Additives for the Treatment of Childhood Eczema (BATHE): Protocol for Multicentre Parallel Group Randomised Trial

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Bath Additives for the Treatment of Childhood Eczema (BATHE): Protocol for Multicentre Parallel Group Randomised Trial Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2015-009575 on 1 November 2015. Downloaded from Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial Miriam Santer,1 Kate Rumsby,1 Matthew J Ridd,2 Nick A Francis,3 Beth Stuart,1 Maria Chorozoglou,4 Wendy Wood,5 Amanda Roberts,6 Kim S Thomas,6 Hywel C Williams,6 Paul Little1 To cite: Santer M, ABSTRACT Strengths and limitations of this study Rumsby K, Ridd MJ, et al. Introduction: Bath emollients are widely prescribed Bath additives for the for childhood eczema, yet evidence of their benefits ▪ treatment of childhood We are carrying out the first large trial to provide over direct application of emollients is lacking. eczema (BATHE): protocol for evidence about the clinical and cost-effectiveness multicentre parallel group Objectives To determine the clinical and cost- of bath emollients in the treatment of childhood randomised trial. BMJ Open effectiveness of adding bath emollient to the standard eczema. 2015;5:e009575. management of eczema in children ▪ Children will be randomised to either bath emol- doi:10.1136/bmjopen-2015- Methods and analysis: Design: Pragmatic open lients plus standard eczema care or standard 009575 2-armed parallel group randomised controlled trial. eczema care only. Setting: General practitioner (GP) practices in England ▪ Primary outcome is long-term eczema severity, ▸ Prepublication history for and Wales. Participants: Children aged over 12 months measured by the Patient-Oriented Eczema this paper is available online. and less than 12 years with eczema, excluding inactive Measure repeated weekly for 16 weeks. To view these files please or very mild eczema (5 or less on Nottingham Eczema ▪ The trial is ‘open label’ as it would not be pos- visit the journal online Severity Scale). Interventions: Children will be sible to create a convincing placebo for bath (http://dx.doi.org/10.1136/ randomised to either bath emollients plus standard emollients, which many carers and children are bmjopen-2015-009575). eczema care or standard eczema care only. Outcome already familiar with. measures: Primary outcome is long-term eczema Received 30 July 2015 Revised 12 August 2015 severity, measured by the Patient-Oriented Eczema http://bmjopen.bmj.com/ Accepted 21 August 2015 Measure (POEM) repeated weekly for 16 weeks. Secondary outcomes include: number of eczema BACKGROUND exacerbations resulting in healthcare consultations over Childhood eczema is very common, affecting 1 year; eczema severity over 1 year; disease-specific over 20% of children aged 5 years or under and generic quality of life; medication use and at some point.1 Eczema can cause significant healthcare resource use; cost-effectiveness. Aiming to distress to children and their families due to detect a mean difference between groups of 2.0 (SD sleep disturbance and itch.23Health and 7.0) in weekly POEM scores over 16 weeks societal costs of eczema are thought to cause (significance 0.05, power 0.9), allowing for 20% loss a similar economic burden to that for on October 2, 2021 by guest. Protected copyright. to follow-up, gives a total sample size of 423 children. asthma.45The term atopic eczema (syn- We will use repeated measures analysis of covariance, onymous with atopic dermatitis) is widely or a mixed model, to analyse weekly POEM scores. used to denote a clinical phenotype, rather We will control for possible confounders, including fi baseline eczema severity and child’s age. Cost- than those who are truly atopic de ned by fi effectiveness analysis will be carried out from a the presence of IgE-speci c antibodies to National Health Service (NHS) perspective. common environmental allergens. In this Ethics and dissemination: This protocol was study, we use the term ‘eczema’ throughout approved by Newcastle and North Tyneside to refer to the ‘atopic eczema’ clinical For numbered affiliations see 1 NRES committee 14/NE/0098. Follow-up will be phenotype, in accordance with the recom- end of article. completed in 2017. Findings will be disseminated to mended nomenclature of the World Allergy participants and carers, the public, dermatology and Organisation.6 Correspondence to primary care journals, guideline developers and Guidelines suggest that emollients form Dr Miriam Santer; decision-makers. the mainstay of treatment for eczema and [email protected], Trial registration number: ISRCTN84102309. [email protected], http:// should be used regularly by all patients with www.southampton.ac.uk/ other treatments, such as topical corticoster- bathe oids, used in addition where necessary.7 Santer M, et al. BMJ Open 2015;5:e009575. doi:10.1136/bmjopen-2015-009575 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2015-009575 on 1 November 2015. Downloaded from Emollients are thought to act by providing a protective the most appropriate design to address the question of layer over the skin, decreasing moisture loss and occlud- the effectiveness of bath emollients in addition to stand- ing against irritants. There are three methods of applica- ard eczema care in everyday care. We chose an ‘open tion of emollients: (1) leave-on (directly applied) label’ design as it would not be possible to create a con- emollients, where emollients are applied to the skin and vincing placebo for bath emollients, which make the left to soak in; (2) soap substitutes, where emollients are bath feel ‘greasy’. We wished to design a trial with a clin- used instead of soap or other washing products; and (3) ical outcome relevant to participants. In eczema, the bath emollients (or bath additives), which are oil and/ appearance of the skin does not always closely reflect or emulsifiers designed to disperse in the bath. All three symptoms causing a major impact on the child and approaches are often used together. family, such as sleep disturbance and itch.19 It was there- While there is widespread clinical consensus on the fore particularly important to design a trial with a vali- need for leave-on emollients and soap substitutes, there dated participant-reported primary outcome. is less agreement regarding the additional benefits of We aim to determine the clinical and cost-effectiveness bath emollients. Despite this, they are widely prescribed of adding bath emollient to the standard management at a cost of nearly £25 million per year to the National of atopic eczema in children, which includes regular Health Service (NHS) in England.8 A previous system- application of leave-on emollients with use of topical cor- atic review has revealed no convincing evidence for the ticosteroids as required. The BATHE trial is a pragmatic use of bath emollients in the treatment of eczema.910 randomised open-label multicentre superiority trial with Available data consist of isolated case series and case two parallel groups and a primary outcome of long-term reports, with no controlled studies. No relevant trials control as measured by Patient-Oriented Eczema have been published since 200711 and trial registries Measure (POEM) weekly scores over 16 weeks. Children reveal no ongoing studies. will be randomised in a 1:1 ratio to either bath emolli- In addition to concerns about cost-effectiveness, ents plus standard eczema care or standard eczema care potential harms from using bath emollients include skin only. This paper outlines the study protocol, in accord- irritation and greasier bath surfaces that can increase ance with the SPIRIT guidelines (Standard protocol the risk of slips and accidents (listed in the Summary of items; recommendations for interventional trials).20 Product Characteristics of leading brands). There is also a concern that people who use bath emollients in place of leave-on emollients are receiving substandard emolli- METHODS ent therapy.10 Study setting The effectiveness of adding antiseptic agents to bath The BATHE study will recruit participants registered at emollients has also not been demonstrated. Two small approximately 100 general practices in Wales, West of randomised studies12 13 compared ‘bath emollient’ with England and South-West England (list of practices will ‘bath emollient plus antiseptic’ on a range of outcomes, be on study website when available). Practices will be http://bmjopen.bmj.com/ but there were no significant differences between recruited through the local Clinical Research Networks groups, including colony counts of Staphylococcus in England and The National Institute for Social Care aureus.14 For this reason, we chose to exclude bath emol- and Health Research in Wales. We aim to recruit prac- lients which incorporate an antiseptic, because of the tices that are broadly representative of UK primary care absence of benefit and possible increased risk of skin in terms of practice size and sociodemographics. irritation.15 Pragmatic clinical trials aim to test the effectiveness of Eligibility an intervention in a real-life setting in order to recruit a Children are eligible to participate in the study if they on October 2, 2021 by guest. Protected copyright. study population that is as similar as possible to the are aged over 12 months and less than 12 years with population on which the intervention is meant to be eczema according to UK Diagnostic Criteria for Atopic used. Whereas an explanatory clinical trial aims to Eczema.21 We will exclude children with inactive or very answer the question, ‘Can this intervention work under mild eczema, defined as a score of 5 or less on ideal conditions?’ a pragmatic approach
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