A scoping review protocol for evaluating cost questionnaires aimed at measuring the household financial burden of food allergy

Food allergy is a growing public health concern affecting individuals worldwide, with significant economic implications.¹ The increasing prevalence of food allergy in some countries and its sustained high levels in others underscore the urgent need to understand the financial costs associated with this condition.^{2, 3} This understanding is crucial for improving resource allocation and designing meaningful policies to address the impact of food allergy on households and the healthcare system.

To assess the impact of food allergy on household costs, researchers have historically relied on the Food Allergy Economic Questionnaire (FA-EcoQ). The FA-EcoQ is a self-report questionnaire that aims to measure direct and indirect costs of food allergy, including food costs, medical expenses, emergency department visits, medications, travel costs and productivity loss.⁴ While the FA-EcoQ's comprehensiveness can be seen as a strength, it does require a significant time commitment from respondents. Lengthy questionnaires, such as the FA-EcoQ, often face practical challenges, including response burden, reduced completion rates and potential language proficiency issues.⁵ Beyond its length, the FA-EcoQ is also arguably limited by its lack of questions on economic precarity. Given the surge in food prices due to the coronavirus disease 2019 pandemic and the disproportionately high costs of allergen-free foods, individuals managing food allergy have been increasingly shown to be affected by food insecurity.^{6, 7} As such, efforts aimed at assessing the financial burden of food allergy should arguably attempt to capture this important social determinant of health.⁸

In light of these limitations, our research team will undertake a scoping review to evaluate and compare the different questionnaires assessing the household financial costs of food allergy. The choice of a scoping review is driven by its suitability for examining emerging evidence and the lack of clarity regarding more specific questions that could be systematically addressed.⁹

The review will focus on studies utilizing questionnaires designed to measure the household cost of food allergy, including both validated and non-validated instruments. More specifically, our review will include studies that focus on the development, validation, reliability, or applicability of questionnaires specifically designed to measure the household cost of immunoglobulin E (IgE)-mediated food allergy. In the case of non-validated questionnaires, comprehensive documentation regarding their development may not be readily available. Therefore, studies examining the economic burden of food allergy that employ non-validated questionnaires will be considered. In these instances, the primary emphasis will be on elucidating the characteristics of the questionnaire employed, rather than an analysis of the research findings themselves. In the event that multiple studies utilize the same non-validated questionnaire, the first study published using the respective questionnaire will take precedence for inclusion. Our inclusion criteria will not be restricted by the country of study, although articles included will be limited to those published in languages spoken by the research team, namely English, Filipino, Finnish, French, German, Hebrew, Hindi, Italian, Korean, Mandarin, Spanish and Swedish. Conditions such as food intolerance, characterized by non-immunological responses to specific foods and coeliac disease, will be excluded from consideration in this review. Papers lacking sufficient information about questionnaire development or relevance to the research question will also be excluded.

A health sciences librarian will be responsible for developing the search terms and conducting the search of the literature. As part of this process, four scientific databases (MEDLINE [Ovid], Embase [Ovid], Scopus and CINAHL [EBSCOhost]) and the grey literature will be searched. The grey literature search will be restricted to the websites of the five following organizations: Food Allergy Canada (https://foodallergycanada.org), Food Allergy Research & Education (https://www.foodallergy.org), Asthma and Allergy Foundation of America (https://aafa.org), the European Academy of Allergy and Clinical Immunology (https://eaaci.org) and the Australasian Society of Clinical Immunology and Allergy (https://www.allergy.org.au). All search strategies will be made publicly available via a data repository at (URL blinded for review).

The retrieved citations will be uploaded to Covidence (Veritas Health Innovation, Melbourne, Victoria, Australia) after the initial search. Following deduplication, two reviewers will independently conduct title and abstract screening of the remaining studies in a blinded fashion (i.e., each screener will not have access to the inclusions and exclusions made by the other screener).

Once title and abstract screening is complete, full texts of the selected studies will be uploaded to Covidence. The full-text screening will follow the same process as the title and abstract screening described above. Once the screeners have independently screened the full texts, the results will be unblinded. In the event of conflicts regarding the inclusion of an article, the screeners will convene a meeting to discuss the discrepancies. If a consensus cannot be reached, the final decision will be made by the study lead (initials blinded for review).

For all included articles, relevant data will be extracted and organized into tables. During the extraction process, reviewers will be instructed to collect all information that may be pertinent to the review. Extracted data from the articles will be used to provide a detailed overview of the included questionnaires, describing their content, format and key features and an assessment of their practicality in terms of ease of use, administration and data collection. Furthermore, the results will highlight the strengths and limitations of the included studies and the questionnaires assessed. We anticipate that findings from the current review will not only help clinicians and researchers make an informed choice when selecting a food allergy cost questionnaire, but will also inform efforts aimed at improving cost measures by highlighting gaps and limitations of the existing suite of cost measures.

Ayel Luis R. Batac: Conceptualization (equal); data curation (lead); methodology (equal); project administration (supporting); visualization (lead); writing – original draft (lead); writing – review and editing (equal). Michael A. Golding: Conceptualization (equal); data curation (supporting); methodology (equal); project administration (supporting); visualization (supporting); writing – original draft (supporting); writing – review and editing (equal). Andrew T. Fong: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Kaitlyn A. Merrill: Conceptualization (equal); methodology (equal); writing – original draft (supporting); writing – review and editing (equal). Mê-Linh Lê: Data curation (supporting); methodology (equal); writing – review and editing (equal). Priyanka Dadha: Data curation (supporting); methodology (equal); writing – review and editing (equal). Christopher M. Warren: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Elissa M. Abrams: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Edmond S. Chan: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Moshe Ben-Shoshan: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Lucy A. Bilaver: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Peter S. Hsu: Data curation (supporting); methodology (equal); writing – review and editing (equal). Ruchi S. Gupta: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Jodi A. Shroba: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Juho E. Kivistö: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Matthew J. Greenhawt: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Mika J. Mäkelä: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Antonella Muraro: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Staffan Ahlstedt: Conceptualization (equal); methodology (equal); supervision (supporting); writing – review and editing (equal). Jennifer L. P. Protudjer: Conceptualization (equal); funding acquisition (lead); methodology (equal); project administration (lead); supervision (lead); validation (lead); writing – review and editing (equal).

Funding for the development of the rapid review protocol was provided by J Protudjer's Start-up Funds at the Children's Hospital Research Institute of Manitoba. The funding body had no influence on the study design; data collection, analysis and interpretation, writing of the protocol or the decision to submit for publication.

AB serves on the Manitoba and Saskatchewan Steering Committee for ImmUnity Canada, and is a scientist for the Government of Manitoba. The work presented here is conducted in his capacity as a researcher for the University of Manitoba and the Children's Hospital Research Institute of Manitoba. The views expressed herein are solely those of the author and do not represent the views of the Government of Manitoba or any of its departments and agencies. MG: none. AF: none. M-LL: none. PD: none. KM: none. CW: none. EA holds the position of Section Head for Anaphylaxis and Food Allergy and is a Member of the Board for the Canadian Society of Allergy and Clinical Immunology. She is also the Chair of the Allergy Section of the Canadian Paediatrics Society. In addition, she is an employee of the Public Health Agency of Canada. The views expressed are her own and not those of the Public Health Agency of Canada. EC has received research support from DBV Technologies and has served on advisory boards for ALK-Abelló, Alladapt Immunotherapeutics, Allergenis, AstraZeneca, Avir Pharma, Bausch Health, DBV Technologies, Kaléo, LEO Pharma, Medexus Pharmaceuticals, Miravo Healthcare, Pfizer and Sanofi Genzyme. In addition, he holds a position on the Executive Board of the Canadian Society of Allergy and Clinical Immunology and is a member of the healthcare advisory board for Food Allergy Canada. MB-S serves on several advisory boards, including Food Allergy Canada, Novartis, Sanofi and Stallergenes Greer. He also reports personal fees from Bausch Health, Novartis, Sanofi and Stallergenes Greer. Additionally, he has received grants from Stallergenes Greer and has participated in clinical trials conducted by Aimmune Therapeutics, Novartis and Sanofi. LB has received research support from the National Institutes of Health, Novartis, Genentech, Yobee Care, Before Brands, Food Allergy Research and Education, the National Confectioners Association and Thermo Fisher Scientific. PH: none. RG receives research support from the National Institutes of Health (R21 ID # AI135705, R01 ID # AI130348, U01 ID # AI138907), Food Allergy Research & Education, Melchiorre Family Charitable Foundation, Sunshine Charitable Foundation, Walder Foundation, UnitedHealth Group, Thermo Fisher Scientific, Novartis and Genentech. She serves as a medical consultant/advisor for Aimmune Therapeutics, Allergenis, Food Allergy Research & Education, Genentech and Novartis. She has ownership interest in Yobee Care, Inc. Currently, she is employed by Ann & Robert H. Lurie Children's Hospital of Chicago and holds the position of Professor of Paediatrics and Medicine at the Northwestern University Feinberg School of Medicine. JS serves on the Advisory Board for both Genentech and Thermo Fisher Scientific. JK: none. MJG serves as a consultant for Aquestive and is a member of physician/medical advisory boards for various organizations, including ALK-Abelló, Allergy Therapeutics, AstraZeneca, Bryn Pharma, DBV Technologies, Genentech, Novartis and Prota Therapeutics. Additionally, he is an unpaid member of the scientific advisory council for the National Peanut Board and the medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association. Furthermore, he is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group and holds the position of senior associate editor for the Annals of Allergy, Asthma and Immunology. He is also a member of the Joint Taskforce on Allergy Practice Parameters. Moreover, he has received honorariums for lectures from Clinical Care Targeted Communications Group, International Meetings & Science, Medscape, Paradigm Medical Communications, Postgraduate Healthcare Education, Red Nucleus and multiple state/local allergy societies. MM: none. AM has received speaker's fees from Aimmune Therapeutics, DBV Technologies, Nestlé Health Science and Nestlé Purina Petcare. Additionally, she serves on the Advisory Boards of DBV Technologies, Novartis, Sanofi and Viatris. SA: none. JP is the Section Head for Allied Health, Co-Lead of the Research Pillar for the Canadian Society of Allergy and Clinical Immunology; and a member of the steering committee for Canada's National Food Allergy Action Plan. She also reports consultancy work for Ajinomoto Cambrooke, ALK-Abelló, Novartis and Nutricia.