Skip to content

TEST (Trial of Eczema allergy Screening Tests): protocol for feasibility randomised controlled trial of allergy tests in children with eczema, including economic scoping and nested qualitative study

Research output: Contribution to journalArticle

Original languageEnglish
Article numbere028428
Number of pages10
JournalBMJ Open
Volume9
Issue number5
Early online date9 May 2019
DOIs
DateAccepted/In press - 21 Feb 2019
DateE-pub ahead of print - 9 May 2019
DatePublished (current) - 9 May 2019

Abstract

Background Early onset eczema is associated with food allergy, and allergic reactions to foods can cause acute exacerbations of eczema. Parents often pursue dietary restrictions as a way of managing eczema and seek allergy testing for their children to guide dietary management. However, it is unclear whether test-guided dietary management improves eczema symptoms, and whether the practice causes harm through reduced use of conventional eczema treatment or unnecessary dietary restrictions. The aim of the Trial of Eczema allergy Screening Tests Study is to determine the feasibility of conducting a trial comparing food allergy testing and dietary advice versus usual care, for the management of eczema in children. Methods and analysis Design: A single centre, two-group, individually randomised, feasibility randomised controlled trial (RCT) with economic scoping and a nested qualitative study. Setting: General Practioner (GP) surgeries in the west of England. Participants: children aged over 3 months and less than 5 years with mild to severe eczema. Interventions: allergy testing (structured allergy history and skin prick tests) or usual care. Sample size and outcome measures: we aim to recruit 80 participants and follow them up using 4-weekly questionnaires for 24 weeks. Nested qualitative study: We will conduct ∼20 interviews with parents of participating children, 5-8 interviews with parents who decline or withdraw from the trial and ∼10 interviews with participating GPs. Economic scoping: We will gather data on key costs and outcomes to assess the feasibility of carrying out a cost-effectiveness analysis in a future definitive trial. Ethics and dissemination The study has been reviewed by the Health Research Authority and given a favourable opinion by the NHS REC (West Midlands-South Birmingham Research Ethics Committee, Reference Number 18/WM/0124). Findings will be submitted for presentation at conferences and written up for publication in peer-reviewed journals, which may include mixed-method triangulation and integration of the quantitative and qualitative findings. Trial registration ISRCTN15397185; Pre-results.

Additional information

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

    Structured keywords

  • BRTC

    Research areas

  • allergy, clinical trials, eczema

Download statistics

No data available

Documents

Documents

  • Full-text PDF (final published version)

    Rights statement: This is the final published version of the article (version of record). It first appeared online via BMJ at https://bmjopen.bmj.com/content/9/5/e028428. Please refer to any applicable terms of use of the publisher.

    Final published version, 661 KB, PDF document

    Licence: CC BY

DOI

View research connections

Related faculties, schools or groups