We would like to thank everyone who have participated in COMFA Consensus Meeting 2023! Very grateful for your kind involvement, for finding time to come to London in person and for spending countless hours in front of your computers, which is very burdensome as all of us know.
Special thanks go to those who made this meeting happen, Daniel Munblit, Christian Apfelbacher, Philipp Drewitz, Anastasia Demidova, Parisut Kimkool and Bob Boyle! You have made this meeting an absolute joy!
We would also like to take this opportunity to gratitude COMFA members and our partners from WAO, the Canadian Society of Allergy and Clinical Immunology (CSACI), the American Academy of Allergy and Immunology (AAAAI), the British Society for Allergy and Immunology (BSACI), and the EAACI Patients Organization Committee (POC). Thanks to their support, we were able to gather almost 800 participants in the Delphi survey, which is a very significant number for a COS development project. We are particularly pleased that over a half of our participants were people with food allergies and their family members and carers.
We would like to remind you that if you require reimbursement, please do not forget to claim it via ‘e-cost’. If you have any further queries, please do not hesitate to contact us. The meeting was very intense and reached its’ original primary goal thanks to your enthusiasm and hard work!
Core Outcome Set
The primary goal of our meeting was to reach a consensus on the outcomes that must be included in the final Core Outcome Set (COS) for food allergy, applicable to all future studies, including clinical trials and observational research. Through careful evaluation of the results from the second round of Delphi and extensive discussions, we have included two outcomes in the final core outcome set: allergic symptoms and quality of life. Additionally, it was agreed upon that quality of life should be more specifically defined in the future at the “how to measure” phase of the project.
Detailed descriptions of these outcomes are available below:
Allergic symptoms – occurrence and frequency of allergic symptoms (e.g. tingling or itching; a raised, itchy red rash (hives); swelling of the face, mouth (angioedema), throat or other areas of the body; difficulty swallowing; wheezing or shortness of breath; hoarse voice; feeling dizzy and lightheaded, fainting; feeling sick (nausea) or vomiting, disphagia; abdominal pain or diarrhoea; anaphylaxis; hay fever-like symptoms, such as sneezing or itchy eyes (allergic conjunctivitis)) due to intended or unintended consumption of a food containing the trigger allergen.
Quality of life – Individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a multi-domain construct and usually encompasses at least a physical, a mental and a social health dimension.
An a priori defined threshold for outcome inclusion in the core outcome set was >80% of participants in each stakeholder group scoring it as ‘critical’ (7 to 9 on a 9-point Likert scale). We have not reached this threshold in all three groups on any of the outcomes during two rounds of Delphi process, but we did reach the consensus on 2 the “most critical” outcomes during the consensus meeting.
We would like to highlight that although only two outcomes formed COS this does not mean that other outcomes are ‘not important’. Researchers will continue studying different outcomes, however, not in every single clinical trial and observational study of interventions. “Allergic symptoms” and “Quality of Life” are recommended to be included into all clinical trials and observational studies of interventions as they consensus was reached for them to be critical to all stakeholder groups.
The development of the core outcome set marks a significant milestone, but it does not signal the conclusion of our project. We aim to widely disseminate the results of our process to enable researchers to implement the core outcome set in their respective practices. Moreover, our next step involves identifying appropriate instruments for measuring these “critical” outcomes.