Uniform standards for food allergy research

Europe-wide initiative defines criteria to improve the comparability of study results on IgE-mediated food allergies

13-Mar-2024

In the European research network COMFA, together with the team led by healthcare researcher Prof. Dr. Dr. Christian Apfelbacher from Otto von Guericke University Magdeburg, internationally valid criteria for observational and intervention studies on IgE-mediated food allergies were defined for the first time. To this end, the researchers developed a so-called Core Outcome Set (COS), a compilation of relevant outcome parameters for a clinical picture, in order to make studies more comparable. The results of the Delphi consensus study were published in the journal Allergy and lay the foundation for a standardized evaluation of scientific studies on food allergies worldwide.

Food allergies are a growing health problem, especially in industrialized countries. Between 1960 and 2020, the global incidence rose from 3 to 7 percent. In Germany, around 2-3 percent of adults and 4 percent of infants are affected. In the case of a food allergy, the body reacts to food proteins by releasing antibodies such as immunoglobulin E (IgE), which can lead to severe immune reactions such as rashes, itching, swelling and inflammation of the mucous membranes.

In order to assess and improve the effectiveness of existing treatment strategies, the comparability of studies is crucial. "Many studies on food allergies cannot be compared despite asking similar questions, as different research groups set different outcome parameters.This is particularly problematic as it makes it considerably more difficult to summarize knowledge about this clinical picture," explains Professor Apfelbacher, Director of the Institute of Social Medicine and Health Systems Research (ISMG) at the University of Magdeburg.

According to Apfelbacher, the development of a core outcome set for IgE-mediated food allergies as part of the COMFA project is therefore an important step for research and for practice in order to establish standardized outcome parameters for clinical trials and observational studies on interventions. "It enables research into food allergies to be harmonized and improved and helps to accelerate the development of effective therapies," says Apfelbacher.

Following a comprehensive literature review and a multi-stage qualitative survey process using the Delphi method, the research initiative agreed on "allergic symptoms" and "quality of life" as the key outcome parameters for studies on food allergies. A total of 778 people from 52 countries took part in the consensus process. "It is very important that this consensus has such a broad basis, because the discussions among patient representatives, doctors and researchers have shown us how controversial some outcome parameters are viewed," says co-study author Prof. Dr. Jon Genuneit from the University of Leipzig.

Apfelbacher emphasizes: "These identified core outcomes will help to facilitate the comparability of studies and increase the quality of the results.They also make it possible for study results to be incorporated into meta-analyses in order to benefit from new findings as quickly as possible."

COMFA's further work will now focus on determining the optimal measurement instruments for assessing symptoms and quality of life for the Core Outcome Set in a further consensus process.At the same time, an intensive exchange with study institutions, drug authorities, manufacturers and other interest groups will take place. This serves the acceptance and long-term implementation of the COS and thus the improvement of research in the field of food allergies.

Original publication

Anastasia Demidova et al. ; "Core Outcome Set for IgE‐mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study ‘COMFA’"; Allergy, 2024-3-3

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