The TEST (Trial of Eczema Allergy Screening Tests) study: feasibility randomised controlled trial with economic scoping and nested qualitative study
Specialty: Primary Care, Primary sub-specialty: Dermatology; UKCRC code/ Disease: Skin/ Dermatitis and eczema
TEST is a single centre, two-group, individually randomised (1:1) feasibility RCT with economic scoping and nested qualitative study set in primary care in the West of England. The study will recruit children with eczema aged 3 months to 5 years by postal invitation from their GP and opportunistically during appointments at the surgery. INTERVENTION GROUP 'ALLERGY GROUP': The CSO will first take a structured allergy history. Next, the CSO will carry out the SPTs from a standard panel of cow's milk, peanut, hen's egg, codfish, wheat & cashew (allergens commonly associated allergies in young children with eczema with eczema), along with positive (histamine) and negative (saline) controls. Sharp lancets will be used to prick drops of allergen (and one positive and one negative control) into the skin (forearm, outer upper arm or back). The diameter of any wheal reaction will be measured in millimetres after 15 minutes. Depending on the participant’s allergy history and the results of their skin prick test, the parent participant will be either reassured and advised to follow a normal diet; or told to exclude any food(s) to which they have had a “positive” result. Of those children with a “positive” result, some will be invited to repeat their SPT, referred for an OFC and/or to undergo a home dietary trial of exclusion or inclusion. If required, OFCs will usually be undertaken within 1-2 weeks of the baseline appointment as part research study, at a local Clinical Investigation Unit in UHBristol NHS Foundation Trust, by trained and qualified nurses. OFCs will be undertaken as per standard practice at UHBristol, there will be no modification to the procedure for the purposes of the research. Advice will be tailored accordingly for mothers who are breast-feeding and/or babies who have not yet been weaned. Any participants with indeterminate results will be reviewed by an expert allergy panel and advice on food ingestion/avoidance relayed to their family accordingly.
Children must: 1. Be aged between 3 months and less than 5 years 2. Have eczema diagnosed by an appropriately qualified healthcare professional (registered doctor, nurse or health visitor) 3. Mild, moderate or severe eczema (Patient Orientated Eczema Measure (POEM) score>2) The person giving consent must: 1. Have parental responsibility for the participant 2. Be willing for their child to have allergy skin prick tests (SPTs) and oral food challenges
Child: 1. Medically-diagnosed food allergy or awaiting referral/investigations for possible food allergy 2. Previous investigations for food allergy (does not include home testing) The person responsible for consent: 1. Is unable to give informed consent 2. Has insufficient written English to complete outcome measures 3. Has another child in the family already taking part in the trial