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.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.# Background
IgE-mediated food allergy is a condition that imposes food-related restrictions on patients and their caregivers in order to prevent allergic reactions. The burden of disease stems from both the actual and perceived risks of accidental ingestion, including the possibility of a lifethreatening allergic reaction. This burden manifests itself in variable levels of anxiety and social limitations and significantly impacts quality of life. The current standard management for food allergy is complete avoidance of the offending allergen in the diet, combined with training on how to recognize and treat allergic reactions. And while avoidance is currently recognized as a safe approach, it has a limited ability to improve a patients' perception of safety or sense of control over the condition and its associated limitations-this leads many to seek alternative management options .
Oral immunotherapy (OIT) consists of daily ingestion of the offending food allergen (food dosing), starting below a patient's threshold dose (i.e. the minimum amount that would elicit a reaction), and increasing the dose over time with a goal of increasing clinical tolerance to that food. It had been proposed as a potential alternative to avoidance throughout the 20th and into the early 21st centuries , yet its development had been limited until recently. This is mainly due to the risk of allergic reactions associated with OIT, which is difficult to reconcile with current practice standards that focus on the avoidance of reactions at all cost and are arguably rooted in a culture of fear.
OIT can be viewed as a disruptive innovation as it challenges the current paradigm of care in food allergy and highlights its limitations in responding to patient needs. There is a need for patient-centered ethical clinical practice guidelines (CPGs) that include patients and caregivers as well as other stakeholders in the consultation and deliberation process, in order to develop best practice recommendations for providing OIT for food allergy. It is essential to understand patient and caregiver perspectives to ensure proper interpretation of published evidence and understand the ethical issues involved.
Previous CPGs on OIT  have used more traditional approaches, focusing mainly on quantitative clinical evidence. However, in order to ensure a clear vision of all that OIT entails and to benefit all patients with food allergy in need of care, CPGs must not only be based on experimental data (e.g., clinical trials) but also on observational, economic and sociopolitical data, as well as experiential narrative data from both patients and healthcare professionals. The optimal provision of OIT must also account for ethical and organizational data to promote the equitable, sustainable and responsible development of this treatment. In fact, evidence-based medicine has been defined as "the application of the best available research to clinical care, which requires the integration of evidence with clinical expertise and patient values . " The development of these CPGs on OIT followed the Guidelines International Network 2015 recommendations including a policy for the management of conflicts of interests . They were commissioned by the Canadian Society of Allergy and Clinical Immunology (CSACI), and was developed through a collaboration with the University Hospital Center Sainte-Justine and the methodological support of the Institut National d'Excellence en Sante et Services Sociaux (INESSS). CSACI acted as the sponsor and was responsible for creating a diversified Working Group. This working group and the executive team opted for a reflective multicriteria methodology, which has been used in the past to develop CPGs  using the EVIDEM (Evidence and Values Impact on Decision Making) ethical framework . This approach encourages the collection of data from diverse sources, including both the scientific literature and consultations, thus offering a 360 view of the subject. This framework was also used to organize, analyze and ultimately integrate the data into a deliberation guide, providing an efficient and consistent approach throughout the project.

# Materials and methods

# Multidisciplinary team
A multidisciplinary team comprised of experts from a diversity of fields was assembled, including allergists and other healthcare professionals, ethicists, and those with expertise in multicriteria deliberation methodology, literature review, consultations and sociology. Begin et al. Allergy Asthma Clin Immunol (2020) 16:20 

# Multicriteria methodology
The aim of the methodological approach was to support reflection by all stakeholders during the development of fair and reasonable recommendations. To this end, a patient-centered and ethics-based multicriteria framework was used throughout the process. The framework was adapted from EVIDEM, included three additional patient focused criteria and organized 22 criteria into five dimensions defined to cover all relevant aspects of OIT. The framework also builds on the Accountability for reasonableness (A4R) conditions set forth by Daniels and Sabin  and the Triple Aim of healthcare systems set forth by Berwick and colleagues . The five dimensions of the framework include:
- How the use of OIT can contribute to a sociopolitico-cultural context conducive to The Common Good (sociopolitical dimension), - How OIT contributes to a fair and equitable distribution of services (populational dimension), - How OIT responds to a need for health and wellbeing in an adequate way (clinical dimension), - How the use of OIT can contribute to improve the quality, organization and governance of healthcare services (organizational dimension), and - How OIT optimizes the use of resources and the associated costs to ensure sustainability of healthcare systems (economic dimension).
Each dimension contains criteria for operationalization, organized into a multicriteria grid. Data from the literature review and consultations were collected and organized per criterion to allow for a comprehensive assessment of OIT and provide a knowledge platform for the development of the CPG recommendations.
All documentation was compiled using a data management software program (CITAVI), which was adapted to organize data by criteria and provided an interactive interface for review by the working group.