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

Miriam Santer; Kate Rumsby; Matthew J Ridd; Nick A Francis; Beth Stuart; Maria Chorozoglou; Wendy Wood; Amanda Roberts; Kim S Thomas; Hywel C Williams; Paul Little

doi:10.1136/bmjopen-2015-009575

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

Miriam Santer, Kate Rumsby, Matthew J Ridd, Nick A Francis, Beth Stuart, Maria Chorozoglou, Wendy Wood, Amanda Roberts, Kim S Thomas, Hywel C Williams, Paul Little

Research output: Contribution to journal › Article (Academic Journal) › peer-review

10 Citations (Scopus)

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.

Original language	English
Pages (from-to)	e009575
Journal	BMJ Open
Volume	5
Issue number	10
DOIs	https://doi.org/10.1136/bmjopen-2015-009575
Publication status	Published - 1 Nov 2015

Keywords

Baths
Child
Child, Preschool
Clinical Protocols
Eczema
Emollients
Humans
Infant
Quality of Life
Research Design
Severity of Illness Index
Skin
Standard of Care
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

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@article{8d68ae29ee6149dabc8580191d1515e7,

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

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 childrenMETHODS 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.",

keywords = "Baths, Child, Child, Preschool, Clinical Protocols, Eczema, Emollients, Humans, Infant, Quality of Life, Research Design, Severity of Illness Index, Skin, Standard of Care, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",

author = "Miriam Santer and Kate Rumsby and Ridd, {Matthew J} and Francis, {Nick A} and Beth Stuart and Maria Chorozoglou and Wendy Wood and Amanda Roberts and Thomas, {Kim S} and Williams, {Hywel C} and Paul Little",

year = "2015",

month = nov,

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doi = "10.1136/bmjopen-2015-009575",

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TY - JOUR

T1 - Bath additives for the treatment of childhood eczema (BATHE)

T2 - protocol for multicentre parallel group randomised trial

AU - Santer, Miriam

AU - Rumsby, Kate

AU - Ridd, Matthew J

AU - Francis, Nick A

AU - Stuart, Beth

AU - Chorozoglou, Maria

AU - Wood, Wendy

AU - Roberts, Amanda

AU - Thomas, Kim S

AU - Williams, Hywel C

AU - Little, Paul

PY - 2015/11/1

Y1 - 2015/11/1

N2 - 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 childrenMETHODS 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.

AB - 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 childrenMETHODS 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.

KW - Baths

KW - Child

KW - Child, Preschool

KW - Clinical Protocols

KW - Eczema

KW - Emollients

KW - Humans

KW - Infant

KW - Quality of Life

KW - Research Design

KW - Severity of Illness Index

KW - Skin

KW - Standard of Care

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1136/bmjopen-2015-009575

DO - 10.1136/bmjopen-2015-009575

M3 - Article (Academic Journal)

C2 - 26525422

SN - 2044-6055

VL - 5

SP - e009575

JO - BMJ Open

JF - BMJ Open

IS - 10

ER -

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

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