CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy.

BACKGROUND

Oral immunotherapy (OIT) is an emerging approach to the treatment of patients with IgE-mediated food allergy and is in the process of transitioning to clinical practice.

OBJECTIVE

To develop patient-oriented clinical practice guidelines on oral immunotherapy based on evidence and ethical imperatives for the provision of safe and efficient food allergy management.

MATERIALS AND METHODS

Recommendations were developed using a reflective patient-centered multicriteria approach including 22 criteria organized in five dimensions (clinical, populational, economic, organizational and sociopolitical). Data was obtained from: (1) a review of scientific and ethic literature; (2) consultations of allergists, other healthcare professionals (pediatricians, family physicians, nurses, registered dieticians, psychologists, peer supporters), patients and caregivers; and patient associations through structured consultative panels, interviews and on-line questionnaire; and (3) organizational and economic data from the milieu of care. All data was synthesized by criteria in a multicriteria deliberative guide that served as a platform for structured discussion and development of recommendations for each dimension, based on evidence, ethical imperatives and other considerations.

RESULTS

The deliberative grid included 162 articles from the literature and media reviews and data from consultations involving 85 individuals. Thirty-eight (38) recommendations were made for the practice of oral immunotherapy for the treatment of IgE mediated food allergy, based on evidence and a diversity of ethical imperatives. All recommendations were aimed at fostering a context conducive to achieving objectives identified by patients and caregivers with food allergy. Notably, specific recommendations were developed to promote a culture of shared responsibility between patients and healthcare system, equity in access, patient empowerment, shared decision making and personalization of OIT protocols to reflect patients' needs. It also provides recommendations to optimize organization of care to generate capacity to meet demand according to patient choice, e.g. OIT or avoidance. These recommendations were made acknowledging the necessity of ensuring sustainability of the clinical offer in light of various economic considerations.

CONCLUSIONS

This innovative CPG methodology was guided by patients' perspectives, clinical evidence as well as ethical and other rationales. This allowed for the creation of a broad set of recommendations that chart optimal clinical practice and define the conditions required to bring about changes to food allergy care that will be sustainable, equitable and conducive to the well-being of all patients in need.

Informations de copyright

© The Author(s) 2020.

Déclaration de conflit d'intérêts

Competing interestsDirect competing interests related to the topic of the guidelines P. Bégin and J. Upton are non-remunerated investigators on an investigator-instigated trial sponsored by the Canadian Institutes of Health on the use of omalizumab in oral immunotherapy (in-kind contribution of investigative drug product by Novartis worth > $100,000 CAD). They were excluded from the room for the discussion and deliberations on recommendations related to the use of omalizumab in oral immunotherapy. M. Ben-Shoshan was a principal investigator on a trial on the use of pharmaceutical peanut flour preparations in OIT sponsored by Aimmune Therapeutics (> $100,000 CAD in grant support). J. Upton was a non-remunerated sub-investigator on clinical trial sponsored by Aimmune Therapeutics on the use of pharmaceutical peanut flour preparations in OIT. They were excluded from the room for the discussion and deliberations on recommendations related to the use of pharmaceutical food products in OIT. Direct competing interests unrelated to the topic of the guidelines P. Begin reports speaker and/or advisor fees from Food Allergy Canada, Novartis, Pfizer, Sanofi, ALK and Aralez Pharmaceuticals, as well as research grant support from Canadian Institutes for Health Research, Fonds de Recherche en Santé du Québec, Canadian Allergy, Asthma and Immunology Foundation, DBV technologies, CHU Ste-Justine Foundation, Regeneron and Sanofi outside the submitted work. M. Ben-Shoshan reports advisor fees from Food Allergy Canada, as well as research grant support from Canadian Institutes for Health Research, Fonds de recherché en Santé du Québec and Canadian Foundation of Allergy and Clinical Immunology outside the submitted work. S. B. Cameron reports an unrestricted educational grant from Pfizer outside the submitted work. S. Carr reports speaker and/or advisor fees from Aralez, Pfizer, Nutricia, Meda (Mylan), Sanofi, GSK, ALK, and Pediapharm. E. S. Chan reports speaker and/or advisor fees from Pfizer, Kaleo, Food Allergy Canada, Pediapharm, Leo and DBV technologies as well as research grant support from DBV Technologies outside the submitted work. D. Fischer reports speaker and/or advisor fees from ALK, AstraZeneca, Aralez, Bausch Health, Merck, Mylan, Pfizer, Novartis, Pediapharm, Sanofi and Teva outside the submitted work. A. Haynes reports advisor fees from Sanofi outside the submitted work. S. Kapur reports speaker and/or advisor fees from Pediapharm and has been a member of advisory boards for, Bausch, Kaleo, Mylan, Novartis, Pediapharm, Pfizer, and Sanofi outside the submitted work. He also holds shares in ABK Biomedical, who are not involved in the field of allergy. H. Kim reports speaker and/or advisor fees for ALK-Abelló, Aralez, Astra Zeneca, CSL Behring, Shire, Novartis, Pediapharm, Stallergenes, Kaleo, Sanofi, Pfizer, and Mylan outside the submitted work. M. N. Primeau reports speaker and/or advisor fees from ALK, Allergie Québec, Aralez, Bausch Health, Food Allergy Canada, Mead Johnson, Mylan, Novartis, Nutricia, Pediapharm and Pfizer outside the submitted work. J. Upton reports advisor fees from Food Allergy Canada, ALK-Abelló, Kaleo, as well as research grant support from Toronto SickKids Foundation, DBV technologies and Regeneron outside the submitted work. T. K. Vander Leek reports speaker and/or advisor fees from Pediapharm, Pfizer and Aralez outside the submitted work. Other authors and members of the deliberative committee declared no financial conflicts of interest. Indirect competing interests related to the topic of the guidelines E. M. Abrams is a pediatric allergist currently offering OIT in clinic. She has contributed to a national cohort study published on the topic. She is on the national advisory board of Food Allergy Canada. P. Begin is an adult-trained allergist currently offering OIT in the academic setting. He pursues clinical research projects on OIT. He is the director of a pilot public OIT program funded through philanthropy and government support. He collaborates with a parent committee doing fundraising for a public-funded OIT program in the province of Quebec. He is a clinician-scientist with a research program including clinical trials, epidemiologic and health technology assessment studies on food allergy and OIT. He has published original research as well as editorials and review articles on the topic of OIT. He is a member of the advisory board for Food Allergy Canada. He has given public and scientific lectures on the topic of OIT. M. Ben-Shoshan is a pediatric allergist currently not offering OIT outside research. He is a clinician-scientist with a research program including clinical trials OIT. He has previously published on the topic of OIT. He is on the national advisory board of Food Allergy Canada. A. Boisvert is a peer-supporter at byebyeallergies.ca and Food Allergy Canada. M. J. Cadieux, is a peer-supporter at Déjouer-les-allergies. S. B. Cameron is a pediatric allergist currently offering OIT in clinic. He has contributed to a national cohort study and a review published and has given scientific lectures on the topic. S. Carr is a pediatric allergist currently offering OIT in clinic. He has contributed to a national cohort study and a review published and has given scientific lectures on the topic. E. S. Chan is a pediatric allergist currently offering OIT in the academic setting. He collaborates with a parent committee doing fundraising for a public-funded OIT program in Vancouver. He as contributed to a national cohort study published on the topic. He is a member of the advisory board for Food Allergy Canada, is an eosinophilic esophagitis guideline member for the Joint Task Force/American Gastroenterological Association, and was an expert panel and coordinating committee member of the National Institute of Allergy and Infectious Diseases–sponsored Guidelines for Peanut Allergy Prevention. D. Fischer is an adult-trained allergist currently not offering OIT in clinic. He has given scientific lectures on the topic. B. Francoeur is a family physician from a region without allergist with a practice focus on allergy. He currently follows patients on OIT but does not initiate treatment himself. H. Kim is an adult-trained allergist currently offering OIT in clinic. He has published an editorial on the topic of OIT. He is the president of Canadian Society of Allergy and Clinical Immunology. A. Haynes is a pediatric allergist currently not offering OIT in clinic. S. Kapur is a pediatric allergist currently offering OIT in clinic. He has previously contributed to a national cohort study published on the topic. G. Parizeault is a pediatrician with a practice focus on allergy in a region without allergist. He is currently offering OIT in clinic. S. Pernice, is a registered dietician practicing in an academic allergy clinic offering OIT. M.N. Primeau is a pediatric allergist currently not offering OIT in clinic. J. Upton is an adult-trained allergists currently not offering OIT outside research. She is a clinician with a research program including clinical trials OIT. She is on the national advisory board of Food Allergy Canada. She has given public and scientific lectures on the topic of OIT. C. Vaillancourt is a family physician with a practice focus on allergy in a region without allergist. He is currently offering OIT in clinic. T. K. Vander Leek is a pediatric allergists currently offering OIT in clinic. He has previously contributed to a national cohort study published on the topic. Other authors and members of the deliberative committee declared no indirect conflicts of interest.