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Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial

Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial
Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial
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: Children will be randomised to either bath emollients plus standard eczema care or standard eczema care only. 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.
Santer, Miriam
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Rumsby, Kate
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Ridd, Matthew J.
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Francis, Nick A.
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Stuart, Beth
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Chorozoglou, Maria
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Wood, Wendy
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Roberts, Amanda
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Thomas, Kim S.
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Williams, Hywel C.
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Little, Paul
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Santer, Miriam
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Rumsby, Kate
2002ee8a-32ac-4119-869d-ed35164c3b51
Ridd, Matthew J.
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Francis, Nick A.
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Stuart, Beth
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Chorozoglou, Maria
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Wood, Wendy
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Roberts, Amanda
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Thomas, Kim S.
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Williams, Hywel C.
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Little, Paul
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Santer, Miriam, Rumsby, Kate, Ridd, Matthew J., Francis, Nick A., Stuart, Beth, Chorozoglou, Maria, Wood, Wendy, Roberts, Amanda, Thomas, Kim S., Williams, Hywel C. and Little, Paul (2015) Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial. BMJ Open, 5 (10), [e009575]. (doi:10.1136/bmjopen-2015-009575). (PMID:26525422)

Record type: Article

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: Children will be randomised to either bath emollients plus standard eczema care or standard eczema care only. 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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More information

Accepted/In Press date: 21 August 2015
e-pub ahead of print date: 1 November 2015
Published date: 1 November 2015
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 391294
URI: http://eprints.soton.ac.uk/id/eprint/391294
PURE UUID: 0cd08ba8-3e45-4aba-89f8-4e5fc80d640d
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260
ORCID for Kate Rumsby: ORCID iD orcid.org/0000-0002-8573-3718
ORCID for Nick A. Francis: ORCID iD orcid.org/0000-0001-8939-7312
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437

Catalogue record

Date deposited: 11 Apr 2016 11:11
Last modified: 10 Jan 2022 03:19

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Contributors

Author: Miriam Santer ORCID iD
Author: Kate Rumsby ORCID iD
Author: Matthew J. Ridd
Author: Nick A. Francis ORCID iD
Author: Beth Stuart ORCID iD
Author: Wendy Wood
Author: Amanda Roberts
Author: Kim S. Thomas
Author: Hywel C. Williams
Author: Paul Little

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