Food Allergy in Children Research PSP protocol

  • Published: 31 October 2024
  • Version: V1 - June 2024
  • 11 min read

Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Food Allergy in Children Priority Setting Partnership (PSP) in line with James Lind Alliance (JLA) principles. The Protocol is a JLA requirement and will be published on the PSP’s page of the JLA website. The Steering Group will review the Protocol regularly and any updated versions will be sent to the JLA.

The JLA is a non-profit making initiative, established in 2004.  It brings patients, carers and clinicians together in PSPs. These PSPs identify and prioritise the evidence uncertainties, or ‘unanswered questions’, that they agree are the most important for research in their topic area. Traditionally PSPs have focused on uncertainties about the effects of treatments, but some PSPs have chosen to broaden their scope beyond that. The aim of a PSP is to help ensure that those who fund health research are aware of what really matters to patients, carers and clinicians. The National Institute for Health and Care Research (NIHR) coordinates the infrastructure of the JLA to oversee the processes for PSPs, based at the NIHR Coordinating Centre (NIHRCC), University of Southampton.

Background to the Food Allergy in Children PSP  

This PSP focuses on food allergy in children. 1 in 5 children have a food allergy. As well as concerns about the effect of excluding food(s) from the diet of the child on their growth and health, food allergy has a significant psychological and social impact on both the affected child and their family. There are many unanswered questions about the prevention, diagnosis and care of food allergy in children, and we do not know which are the most important to children, parents and health care professionals.

This PSP is part of a wider programme of research called TOPIC (Transforming Outcomes for Paediatric allergy in Primary Care) and is funded through Professor Matthew Ridd’s NIHR Research Professorship to accelerate work on the diagnosis and management of childhood skin conditions and allergy. It will be run through the Centre for Applied Excellence in Skin & Allergy Research (CAESAR), University of Bristol.

Aims, objectives and scope of the PSP

The aim of the Food Allergy in Children PSP is to identify the unanswered questions about food allergy in children from patient, carer and clinical perspectives and then prioritise those that patients, carers and clinicians agree are the most important for research to address.

The objectives of the PSP are to:

  • Identify unanswered questions about food allergy in children from birth to 19 years of age, thereby prioritising what future research in this area (prevention, diagnosis, care, treatment, configuration of health services) should be prioritised.
  • to agree by consensus how to rank in importance a list of priority areas and unanswered questions for research. 
  • to publicise the results of the PSP and process
  • to take the results to research commissioning bodies to be considered for funding.

The scope of the Food Allergy in Children PSP includes questions about:

  • All types of food allergy in children aged 0-19 years at onset.
  • Primary prevention of food allergy in children e.g through pregnancy, breastfeeding, early introduction of foods or eczema prevention and treatment.
  • Any aspect of causes, diagnosis, referral, treatment and management or care of children who have or have had a food allergy.
  • Aspects of spontaneous resolution or outgrowing of allergies.
  • The impact of food allergy on the child as well as their parent/carer and families.
  • Physical, developmental, psychological, emotional, quality of life, cultural and social aspects of food allergy in children.
  • Any aspect of the care pathway:
    • Preventions
    • Symptoms
    • Diagnosis
    • Treatment and management
    • Follow up
    • Transition to adult services
    • Living with an allergy
  • Configuration of and access to health services such as information provision in primary care, referral to allergy teams or transition to adult services.

The PSP will exclude from its scope questions about:

  • Food allergy in people who are older than 19 years at the time of initial diagnosis 
  • Intolerances, auto-immune and other “non-allergy” food problems
  • Airborne and contact allergies
  • Food labelling
  • Issues not relevant to the UK
  • Access to private services or unconventional tests/therapies.

The Steering Group is responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process.  Resources and expertise will be put in place to do this evidence checking.

The Steering Group

The Steering Group includes membership of patients and carers and clinicians, as individuals or representatives from a relevant group.

The Food Allergy in Children PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s: 

  • Holly Shaw, Allergy UK
  • Mary Kelly, Anaphylaxis UK
  • Alicia Kennedy, Natasha Allergy Research Foundation
  • Suzi Holland, Eczema Outreach Support 
  • Gail Jackson, Parent of young person with allergies
  • Lauren Gluyas, Parent of child with allergies
  • Farzana Kausir, Parent of children with allergies
  • Liliana Jackson, Young person with allergies
  • Eden Byrne, Young person with allergies

Clinical representative/s: 

  • Graham Roberts, Consultant Paediatric Allergist, Professor in Paediatric Allergy & Respiratory Medicine, University of Southampton
  • Mary Feeney, Paediatric Allergy Dietitian, Kings College London
  • Joanne Walsh, General Practitioner with interest in allergy, Castle Partnership, Norwich
  • Deborah Marriage, Consultant Nurse in Asthma and Allergy, Bristol Children's Hospital 
  • Hora Soltani, Midwife, Professor in Maternal and Infant Health, Sheffield Hallam University
  • Sara Brown, Consultant Dermatologist, Professor of Dermatology, The University of Edinburgh & NHS Lothian
  • Emma Vaughan, Pharmacist, Allcare Pharmacy Ireland
  • Amy Dobson, Health Visitor, University of Southampton  

Project lead:

  • Matthew Ridd, General Practitioner & Professor of Primary Care, University of Bristol

Project coordinator:

  • Roxanne Parslow, Research Fellow, University of Bristol

Project support:

  • Alyson Huntley, Senior Research Fellow, University of Bristol
  • Farhad Shokraneh, Senior Research Associate, University of Bristol

James Lind Alliance Adviser and Chair of the Steering Group:

  • Jonathan Gower, James Lind Alliance

The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process, with input and advice from the JLA. 

Partners

Organisations and individuals will be invited to be involved with the PSP as partners.  Partners are organisations or groups who will commit to supporting the PSP, promoting the process and encouraging their represented groups or members to participate. Organisations which can reach and advocate for these groups will be invited to become involved in the PSP. Partners represent the following groups:

  • People who have been diagnosed with a food allergy in childhood.
  • Carers of people who have been diagnosed with a food allergy in childhood.
  • Health and social care professionals with experience of the diagnosis and management of food allergy in children.
  • Allergy charities
  • Eczema charities

Exclusion criteria

Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest.  These may be perceived to potentially cause unacceptable bias as a member of the Steering Group.  As this is likely to affect the ultimate findings of the PSP, those organisations will not be invited to participate.  It is possible, however, that interested parties may participate in a purely observational capacity when the Steering Group considers it may be helpful.

The methods the PSP will use

This section describes a schedule of proposed steps through which the PSP aims to meet its objectives.  The process is iterative and dependent on the active participation and contribution of different groups.  The methods used in any step will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives.  More details of the method are in the Guidebook section of the JLA website where examples of the work of other JLA PSPs can be seen. 

Step 1: Identification and invitation of potential partners

Potential partner organisations will be identified through a process of peer knowledge and consultation, through the Steering Group members’ networks.  Potential partners will be contacted and informed of the establishment and aims of the food allergy in children research PSP.

Step 2: Awareness raising 

PSPs will need to raise awareness of their proposed activity among their patient, carer and clinician communities, in order to secure support and participation.  Depending on budget, this may be done by a face-to-face meeting, or there may be other ways in which the process can be launched, e.g. via social media.  It may be carried out as part of steps 1 and/or 3.  The Steering Group should advise on when to do this.  Awareness raising has several key objectives:

  • to present the proposed plan for the PSP
  • to generate support for the process
  • to encourage participation in the process
  • to initiate discussion, answer questions and address concerns.

Step 3: Identifying evidence uncertainties

The Food Allergy in Children PSP will carry out a consultation to gather uncertainties from patients, carers and clinicians. A period of 3 months will be given to complete this exercise (which may be revised by the Steering Group if required). We plan to use primarily online surveys to reach different groups: children/young people, carers/parents and health and care professionals.

The Food Allergy in Children PSP recognises that the following groups may require additional consideration: 

  • Those without access to the internet
  • Younger children
  • Ethnic minorities

The Steering Group will collaborate with partner organisations in order to target the survey at particular groups. For example, paper/ tablet questionnaire may be completed in community group settings. Organisations that aim to amplify the voices of Black and Brown skin individuals will be approached to publicise the survey.

Existing sources of evidence uncertainties may also be searched. For example, NICE Food allergy in under 19s (CG116) “Recommendations for research”

Step 4: Refining questions and uncertainties

The consultation process will produce ‘raw’ questions and comments indicating patients’, carers’ and clinicians’ areas of uncertainty.  These raw questions will be categorised and refined by Roxanne Parslow, Farhad Shokraneh and Alyson Huntley into summary questions which are clear, addressable by research, and understandable to all.  Similar or duplicate questions will be combined where appropriate.  Out-of-scope and ‘answered’ submissions will be compiled separately. The Steering Group will have oversight of this process to ensure that the raw data is being interpreted appropriately and that the summary questions are being worded in a way that is understandable to all audiences.  The JLA Adviser will observe to ensure accountability and transparency.

This will result in a long list of in-scope summary questions. These are not research questions and to try and word them as such may make them too technical for a non-research audience. They will be framed as researchable questions that capture the themes and topics that people have suggested. 

The summary questions will then be checked against evidence to determine whether they have already been answered by research. This will be done by Roxanne Parslow, Farhad Shokraneh and Alyson Huntley. The PSP will complete the JLA Question Verification Form, which clearly describes the process used to verify the uncertainty of the questions, before starting prioritisation. The Question Verification Form includes details of the types and sources of evidence used to check uncertainty. The Question Verification Form should be published on the JLA website as soon as it has been agreed to enable researchers and other stakeholders to understand how the PSP has decided that its questions are unanswered, and any limitations of this.

Questions that are not adequately addressed by previous research will be collated and recorded on a standard JLA template by Roxanne Parslow, Farhad Shokraneh and Alyson Huntley. This will show the checking undertaken to make sure that the uncertainties have not already been answered. The data should be submitted to the JLA for publication on its website on completion of the priority setting exercise, taking into account any changes made at the final workshop, in order to ensure that PSP results are publicly available.  

The Steering Group will also consider how it will deal with submitted questions that have been answered, and questions that are out of scope.

Step 5: Prioritisation – interim and final stages 

The aim of the final stage of the priority setting process is to prioritise through consensus the identified uncertainties about food allergy in children. This will involve input from patients, carers and clinicians. The JLA encourages PSPs to involve as wide a range of people as possible, including those who did and did not contribute to the first consultation. There are usually two stages of prioritisation. 

  1. Interim prioritisation is the stage where the long list of questions is reduced to a shorter list that can be taken to the final priority setting workshop. This is aimed at a wide audience and is done using similar methods to the first consultation. With the JLA’s guidance, the Steering Group will agree the method and consider how best to reach and engage patients, carers and clinicians in the process. The most highly ranked questions (around 25) will be taken to a final priority setting workshop. Where the interim prioritisation does not produce a clear ranking or cut off point, the Steering Group will decide which questions are taken forwards to the final prioritisation.
  2. The final priority setting stage is generally a one-day workshop facilitated by the JLA. With guidance from the JLA and input from the Steering Group, up to 30 patients, carers and clinicians will be recruited to participate in a day of discussion and ranking, to determine the top 10 questions for research. All participants will declare their interests. The Steering Group will advise on any adaptations needed to ensure that the process is inclusive and accessible.

Dissemination of results

The Steering Group will identify audiences with which it wants to engage when disseminating the results of the priority setting process, such as researchers, funders and the patient and clinical communities. They will need to determine how best to communicate the results and who will take responsibility for this. Previous PSPs’ outputs have included academic papers, lay reports, infographics, conference presentations and videos for social media. 

It should be noted that the priorities are not worded as research questions. The Steering Group should discuss how they will work with researchers and funders to establish how to address the priorities and to work out what the research questions are that will address the issues that people have prioritised. The dissemination of the results of the PSP will be led by Matthew Ridd and the University of Bristol’s Centre for Applied Excellence in Skin & Allergy Research. Dissemination will be supported by the steering group and partners who helped distribute the survey.

The JLA encourages PSPs to report back about any activities that have come about because of the PSP, including funded research.  Please send any details to jla@soton.ac.uk.  

Agreement of the Steering Group

The Food Allergy in Children PSP Steering Group agreed the content and direction of this Protocol on 27/06/2024.