The University of Southampton
University of Southampton Institutional Repository

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
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
Rumsby, Kate
2002ee8a-32ac-4119-869d-ed35164c3b51
Ridd, Matthew J.
de8b7ad0-5afa-4231-99f6-d6778744ddd4
Francis, Nick A.
9b610883-605c-4fee-871d-defaa86ccf8e
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Roberts, Amanda
c4a5d206-49c3-4a07-8cfd-5bccf8c93b3b
Thomas, Kim S.
f21619f9-467f-45dd-b9d4-be4014f11f3b
Williams, Hywel C.
3914e691-2348-4704-a044-e8d2af92444e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
Rumsby, Kate
2002ee8a-32ac-4119-869d-ed35164c3b51
Ridd, Matthew J.
de8b7ad0-5afa-4231-99f6-d6778744ddd4
Francis, Nick A.
9b610883-605c-4fee-871d-defaa86ccf8e
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Roberts, Amanda
c4a5d206-49c3-4a07-8cfd-5bccf8c93b3b
Thomas, Kim S.
f21619f9-467f-45dd-b9d4-be4014f11f3b
Williams, Hywel C.
3914e691-2348-4704-a044-e8d2af92444e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777

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.

Text
BMJ Open-2015-Santer-.pdf - Version of Record
Available under License Creative Commons Attribution.
Download (892kB)

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
ORCID for Maria Chorozoglou: ORCID iD orcid.org/0000-0001-5070-4653
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873

Catalogue record

Date deposited: 11 Apr 2016 11:11
Last modified: 12 Jul 2024 02:05

Export record

Altmetrics

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 ORCID iD

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×