Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study 'COMFA'.

BACKGROUND: IgE-mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. METHODS: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two-round online-modified Delphi process followed by hybrid consensus meeting to finalize the COS. RESULTS: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in-person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, 'allergic symptoms' and 'quality of life' achieved consensus for inclusion as 'core' outcomes. CONCLUSION: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.

Anthropological and sociological perspectives on food allergy.

This review explores the anthropological and sociological literature on food allergy and identifies four primary areas of research to date. The first explores the relationality and management of risk, uncertainty and stigma among parents and sufferers of food allergies. The second analyses the influence of intersectionality, specifically the effects of class, gender, race/ethnicity and disability on experiences of food allergy. The third discusses diagnostic difficulties and the impact these have on legitimacy and believability, both in the context of clinician-patient relations and in managing food allergies in public spaces. The fourth explores the ethics and uncertainties in food allergy treatments and how scientific knowledge of emerging treatments is constructed. This body of research illustrates that although an individual disease, food allergy experiences are significantly affected by socio-cultural structures, institutions, ideologies and discourses. The review concludes with four primary recommendations. First, there should be more incorporation of anthropological or sociological methodologies and perspectives into studies of food allergy. Second, studies are needed from more countries exploring lived experience of food allergy. Third, research on food allergy needs to incorporate an analysis of intersectional factors such as gender, class and race/ethnicity, and should explore the experiences of minority populations. Fourth, more research is needed on the interactions between biomedicine and local systems of knowledge, as well as the factors that shape what treatments become available, for whom it becomes available, experiences of treatment and aspects (including biases) that influence patient-clinician interactions.

Embodied Memory, Affective Imagination, and Vigilance: Navigating Food Allergies in Japan.

"Food is relationships isn't it," Yamada san stated in 2017, neatly capturing the importance of food in social life. This article, drawing on the experiences of people with severe food allergies in Japan, illustrates the complexities of safely managing allergies when food-and the importance of sharing the same food-is so important to social life. In particular, I argue that individuals develop and practice skills of vigilance and situational awareness to mitigate physical and social risk which emerge through an affective imagination of what they feel could happen in the future, built on embodied memories of what has been experienced prior (e.g., severe allergic reactions and difficult social experiences with food). The development and enactment of these skills of vigilance happen through an 'education of attention' (Gibson in The ecological approach to visual perception, Psychology Press, New York, 1979; Ingold in The perception of the environment: essays on livelihood, dwelling and skill, Routledge, London, 2000) developed over time and in different social settings and constitute a somatic mode of attention (Csordas in Cult Anthropol 8:135-156, 1993) which shapes social interactions and aims to mitigate against any potential perceived social costs for not being able to eat everything.