Trial of eczema allergy screening tests
| ISRCTN | ISRCTN15397185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15397185 |
| Protocol serial number | 37831 |
| Sponsor | University of Bristol |
| Funder | NIHR School for Primary Care Research; Grant Codes: 383 |
- Submission date
- 23/07/2018
- Registration date
- 30/07/2018
- Last edited
- 23/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Many parents worry that food allergies cause eczema. If a food causes sudden, severe reactions then that food should be avoided. However, for children who “just” have eczema, it is not known whether avoiding certain foods makes any difference to eczema symptoms. Allergy tests are imperfect and experts disagree whether they should be offered. Patients and doctors agree that this problem is a research priority. This study will help decide whether routine allergy tests for children with eczema are helpful or not. The best way to do this is in a clinical trial. Because of the lack of research in this area, the researchers want to first run a smaller version of what the main study might look like.
Who can participate?
Children aged between 3 months and 5 years with eczema
What does the study involve?
Participants are randomly allocated to receive either usual care from their GP or to be asked extra questions and offered skin prick allergy tests. This involves “pricking” small drops of six common allergy-causing foods (cow's milk, peanut, hen's egg, codfish, wheat and cashew) into the skin and noting any local reaction (swelling). If the results are unclear, some children need to be observed eating some of the food(s) at their local hospital or a trial of exclusion/introduction at home. Depending on what the tests show, parents are told what foods are "safe" or should be avoided. Children are followed up for 6 months and some parents and GPs are interviewed to find out what they think about the tests and the study itself.
What are the possible benefits and risks of participating?
The results of this study will be used to design a bigger study. The researchers will also have a better understanding of what parents and GPs think about food allergies and tests in children with eczema. It may be that food allergy testing is not helpful. In addition, the child may experience side effects or have a reaction to either the skin prick tests or the oral food challenges. Parents/carers can decide to stop taking part in the study at any time. By taking part in the study, parents/carers are asked to give up time to meet with a researcher twice over a period of 6 months for the assessments. At the first visit, they are asked to meet the researcher at the child’s GP Practice. At the second and final visit the researcher will try to meet them at a time and place which is convenient (at home, for example). Parents/carers will also be asked to complete monthly surveys regarding their child’s eczema symptoms and use of other eczema treatments.
Where is the study run from?
United Hospitals Bristol NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2018 to November 2019
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Dr Kirsty Roberts
test-study@bristol.ac.uk
2. Dr Matthew Ridd
m.ridd@bristol.ac.uk
Contact information
Scientific
Centre for Academic Primary Care
Population Health Sciences, Bristol Medical School
University of Bristol, Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| Phone | +44 (0)117 928 7351 |
|---|---|
| test-study@bristol.ac.uk |
Scientific
Centre for Academic Primary Care
Population Health Sciences, Bristol Medical School
University of Bristol, Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-7954-8823 |
|---|---|
| Phone | +44 (0)117 331 4557 |
| m.ridd@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Diagnosis, Process of Care, Dietary, Other |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The TEST (Trial of Eczema Allergy Screening Tests) study: feasibility randomised controlled trial with economic scoping and nested qualitative study |
| Study acronym | TEST |
| Study objectives | What is the clinical (disease severity) and cost-effectiveness of routine food allergy testing plus advice compared to current standard practice for the management of eczema in children? |
| Ethics approval(s) | West Midlands - South Birmingham Research Ethics Committee, 05/06/2018, ref: 18/WM/0124 |
| Health condition(s) or problem(s) studied | Specialty: Primary Care, Primary sub-specialty: Dermatology; UKCRC code/ Disease: Skin/ Dermatitis and eczema |
| Intervention | 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. CONTROL GROUP 'USUAL CARE': Participants in the control group will not receive any additional assessments or tests. Care after allocation will be as usual, described in the NICE eczema and allergy in children guidelines. Any allergy tests and subsequent advice will be monitored as part of this feasibility study. Regardless of allocation, all management after randomisation, including investigations and/or referrals for possible new, incident food allergies, will remain under the care of the participant's GP. Intervention and control groups will complete and monthly parent reported diary every 4 weeks for 24 weeks of the state and bother of their eczema, quality of life, food ingestion and allergy symptoms and adverse events. Parents will be given the option of completing follow-up questionnaires either online or on paper (freepost). Those who choose to provide data online will receive email prompts, while those who opt to complete on paper will be offered SMS reminders when their questionnaire is due. All parents will receive SMS and/or telephone reminders when questionnaires are overdue. For those parents who struggle to complete the questionnaires or for those returned with missing data, an option to complete these over the telephone will be offered. Both groups will have a final face-to-face follow-up assessment at 24 weeks with participant and their carer at a venue of their choosing, usually their home. QUALITATIVE INTERVIEWS (participants and GPs): In-depth, cross-sectional qualitative interviews will be conducted either by telephone or face-to-face, depending on the preference of the interviewee. All parents and GPs at participating surgeries will be asked whether they are willing to be contacted to take part in an interview. Purposive sampling will be used to help ensure maximum variation of the parent and GP samples. Parents will be sampled from both intervention and control groups, with the former over-sampled to explore the acceptability of the intervention across parent groups. Further purposive criteria for parent interviews are mild/moderate (<17) vs severe (≥17) POEM symptom score (using most recent data available), socio-economic status (assessed via postcode, using the Index of Multiple Deprivation Database (categories: high (8-10)/medium (5-7)/low (1-4)), and length of time in the trial (shortly after baseline visit or OFC, or later in the trial). For participants in the intervention group, we will seek to speak to parents of children with negative, positive and (in the case of SPTs) ambiguous test results. Sampling of GPs will capture diverse populations served by practices and length of time in the trial (baseline, during, after). The number of interviews will be guided by the research questions, and sampling will stop when we have sufficient “information power” relevant to the study aims. We anticipate a total of 20 parent and 10 GP interviews. In addition, we will conduct brief telephone interviews with ~5-8 parents who have decided to decline to take part in response to the initial invitation letter or later withdrawal from the trial, but indicate that they are willing to discuss reasons why. Parents will be informed about the qualitative component of the study in the trial information sheet provided with the invitation to participate. Parents declining to take part in the trial will have the option to agree to be contacted for possible interview as part of the invitation and response letter. At the baseline assessment and consent visit, parents will be asked to indicate whether they are happy to be approached regarding participating in an interview, and if so the best way to contact them and to send them further information. This will generate a pool of potential interviewees for sampling for the qualitative interviews. Once parents have been selected for invitation for an interview, the qualitative researcher will send the parent an invitation to participate, information sheet and consent form via email or post. The researcher will then contact the parent by email or phone to determine consent and arrange the interview. GPs will be invited to participate in an interview by an initial email from the research team with an information sheet and consent form. GPs willing to be approached will be contacted by the research team by email or phone to determine consent and arrange the interview. All interviewees will have received an information sheet and consent form to read in advance of the interview. Written informed consent will be taken in face-to-face interviews, and verbal consent will be taken for telephone interviews. The researcher will verbally explain consent to the participant before the interview starts and, if the participant confirms their agreement to the interview, the verbal consent agreement will be repeated, and audio recorded. Verbal consent is considered standard practice in studies where telephone interviews are conducted and has been used previously in several HRA-approved BRTC-portfolio trials across a range of clinical populations, e.g. UPSTREAM, CEDAR, HepCATT and RADAR. Verbal consent reduces burden and is resource-efficient, as it removes the need to send and return paperwork. Topic guides have been developed, based on the focus of the trial and existing research literature, and refined with input from the study’s Public and Patient Involvement (PPI) group. However, flexibility will be maintained, and topic guides modified over the course of different interviews (where appropriate) to enable exploration of new issues that arise throughout this process. |
| Intervention type | Other |
| Primary outcome measure(s) |
The feasibility of conducting the trial (recruitment, retention, contamination) and collecting the required data: |
| Key secondary outcome measure(s) |
1. Eczema symptoms, measured using POEM at baseline and weeks 4, 8, 12, 16, 20 & 24 |
| Completion date | 31/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 84 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/09/2018 |
| Date of final enrolment | 28/02/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
BS1 3NU
United Kingdom
-
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Requests for anonymised, individual participant level data should be made to Dr Matthew Ridd (m.ridd@bristol.ac.uk) (Chief Investigator) after November 2020. Access for secondary analyses (e.g. individual patient data meta-analyses) must be within the remit of parent/carer consent for data re-use. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2021 | 04/01/2021 | Yes | No |
| Protocol article | protocol | 09/05/2019 | 13/05/2019 | Yes | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Other publications | qualitative interview study within the Trial of Eczema allergy Screening Tests (TEST) feasibility trial | 18/11/2020 | 23/08/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/08/2023: Publication reference added.
04/01/2021: Publication reference added.
13/05/2019: Publication reference added.
21/03/2019: The following changes were made to the trial record:
1. The total final enrollment was added.
2. The overall end date was changed from 30/11/2019 to 31/01/2020
3. The intention to publish date was changed from 30/11/2020 to 31/01/2021
21/08/2018: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/07/2018 to 01/09/2018.
2. The recruitment end date was changed from 31/12/2018 to 28/02/2019.
