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.

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.

Informations de copyright

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

Déclaration de conflit d'intérêts

Competing interests: MJR: No financial interests; convenes the NIHR SPCR Allergy working group; and was a member of the NICE Quality Standard 44 for Atopic eczema in under 12s and RCPCH “Care pathway for children with eczema” groups. LW: Direct – financial: write articles, attend round table infant formula company meetings and present at sponsored lectures relating to food allergy; received infant formula company sponsorship to attend national/international allergy related conferences/ meetings. Runs a private practice (Food Allergy Nottingham Service Ltd, 2013-) in addition to NHS role (Feb 2012-). BDA cow’s milk allergy course facilitator (2018-). Direct – non-financial: member of RCPCH faculty for tier 3 paediatric allergy course (2018-); member of Allergy UK health advisory board (2015-); member of iMAP implementation team (2017-); produce food allergy related dietary information for BDA food allergy group (2014-); NICE Expert adviser relating to paediatric food allergy and gastro-oesophageal reflux (2017-2020); previous member of NICE food allergy guidelines GDG and RCPCH food allergy care pathway (2010-2011). RJB has received honoraria for participating in advisory boards for ALK-Abello who manufacture allergy diagnostics and treatments, and DBV technologies who manufacture a food allergy treatment.