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

P Bégin; E S Chan; H Kim; M Wagner; M S Cellier; C Favron-Godbout; E M Abrams; M Ben-Shoshan; S B Cameron; S Carr; D Fischer; A Haynes; S Kapur; M N Primeau; J Upton; T K Vander Leek; M M Goetghebeur

doi:10.1186/s13223-020-0413-7

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

Allergy Asthma Clin Immunol. 2020 Mar 18:16:20. doi: 10.1186/s13223-020-0413-7. eCollection 2020.

Authors

P Bégin^{1

2

3}, E S Chan⁴, H Kim^{5

6}, M Wagner⁷, M S Cellier³, C Favron-Godbout⁸, E M Abrams⁹, M Ben-Shoshan¹⁰, S B Cameron^{4

11}, S Carr¹², D Fischer⁵, A Haynes¹³, S Kapur¹⁴, M N Primeau¹⁵, J Upton¹⁶, T K Vander Leek¹², M M Goetghebeur⁷

Affiliations

¹ 1Division of Clinical Immunology, Rheumatology and Allergy, Department of Pediatrics, Sainte-Justine University Hospital Centre, Montreal, QC Canada.
² 2Division of Allergy and Clinical Immunology, Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal, QC Canada.
³ 3Research Center of the Sainte-Justine University Hospital Center, Montreal, QC Canada.
⁴ 4Division of Allergy & Immunology, Department of Pediatrics, University of British Columbia, BC Children's Hospital, Vancouver, BC Canada.
⁵ 5Division of Clinical Immunology and Allergy, Department of Medicine, Western University, London, ON Canada.
⁶ 6Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, ON Canada.
⁷ 7Unit Methods, Ethics and Participation, INESSS, National Institute for Excellence in Health and Social Services, Montreal, QC Canada.
⁸ 8Department of Bioethics, School of Public Health of the University of Montreal, Montreal, Canada.
⁹ 9Section of Allergy and Clinical Immunology, Department of Pediatrics, University of Manitoba, Winnipeg, MB Canada.
¹⁰ 10Division of Allergy Immunology and Dermatology, Department of Pediatrics, Montreal Children's Hospital, Montreal, QC Canada.
¹¹ Community Allergy Clinic, Victoria, BC Canada.
¹² 12Department of Pediatrics, University of Alberta, Edmonton, AB Canada.
¹³ 13Discipline of Pediatrics, Memorial University of Newfoundland, St. John's, NL Canada.
¹⁴ 14Department of Pediatrics, Dalhousie University, Halifax, NS Canada.
¹⁵ 15Division of Allergy and Clinical Immunology, Department of Medicine, CISSS Laval, Laval, QC Canada.
¹⁶ 16Division of Immunology and Allergy, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON Canada.

Abstract

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.

Keywords: Avoidance; Clinical practice guidelines; Contraindication; Ethics; Evidence; Food allergy; Indication; Multi-criteria decision analysis; Oral immunotherapy; Patient-centered; Quality of life.

Publication types

Review