Evidence map›Paper›PMID 26525422›Full record

Trial reportBMJ open2015

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 and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Emollients and moisturisers for eczema.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Miriam SanterDepartment of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
Kate RumsbyDepartment of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
Matthew J RiddDepartment of School of Social & Community Medicine, University of Bristol, Bristol, UK.
Nick A FrancisWales School of Primary Care Research, Cardiff University, Cardiff, UK.
Beth StuartDepartment of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
Maria ChorozoglouSouthampton Health Technology Assessment Centre (SHTAC), University of Southampton, Southampton, UK.
Wendy WoodSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Amanda RobertsCentre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
Kim S ThomasCentre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.ORCID http://orcid.org/0000-0001-7785-7465
Hywel C WilliamsCentre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
Paul LittleDepartment of Primary Care and Population Sciences, University of Southampton, Southampton, UK.
University of Southampton · GBUniversity of Nottingham · GBCardiff University · GBDesignability · GBUniversity of Bristol · GB

Funding

Department of Health 11/153/01Department of Health CTF-01-12-06
6 · The paper itself

Abstract

introductionBath 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:

designPragmatic open 2-armed parallel group randomised controlled trial.

settingGeneral practitioner (GP) practices in England and Wales.

participantsChildren 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).

interventionsChildren 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.

Indexed as

BathsSeverity of Illness IndexChildChild, PreschoolClinical ProtocolsEczemaEmollientsHumansInfantQuality of LifeResearch DesignSkinStandard of CareEmollientsDERMATOLOGYPRIMARY CARE

Identifiers

PMID26525422
PMCPMC4636671
OpenAlexW2190690175

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.