Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi Consensus for Procedural Preparation and Consent

Authors

Douglas P Mack
Timothy E Dribin
Paul J Turner
Richard L Wasserman
Mariam A Hanna
Marcus Shaker
Mimi L K Tang
Pablo Rodríguez Del Río
Brad Sobolewski
Elissa M Abrams
Aikaterini Anagnostou
Stefania Arasi
Sakina Bajowala
Philippe Bégin
Scott B Cameron
Edmond S Chan
Sharon Chinthrajah
Andrew T Clark
Paul Detjen
George du Toit
Motohiro Ebisawa
Arnon Elizur
Jeffrey M Factor
Justin Greiwe
Jonathan O'B Hourihane
Sarah W Hughes
Douglas H Jones
Antonella Muraro
Anna Nowak-Wegrzyn
Nandinee B Patel
Amy M Scurlock
Atul N Shah
Sayantani B Sindher
Stephen Tilles
Brian P Vickery
Julie Wang
Hugh H Windom
Matthew Greenhawt

Publication Date

6-1-2024

Journal

Journal of Allergy and Clinical Immunology

DOI

10.1016/j.jaci.2024.02.019

PMID

38597862

PMCID

PMC11461787

PubMedCentral® Posted Date

10-9-2024

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes

Keywords

Humans, Desensitization, Immunologic, Administration, Oral, Informed Consent, Delphi Technique, Consensus, Food Hypersensitivity, Allergy, anaphylaxis, Delphi, food allergy, oral immunotherapy, consent, patient preparation, shared decision making, risk mitigation

Abstract

BACKGROUND: Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process.

OBJECTIVE: We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form.

METHODS: We convened a 36-member Preparing Patients for Oral Immunotherapy (PPOINT) panel of allergy experts to develop a consensus OIT patient preparation, informed consent process, and framework form. Consensus for themes and statements was reached using Delphi methodology, and the consent information form was developed.

RESULTS: The expert panel reached consensus for 4 themes and 103 statements specific to OIT preparatory procedures, of which 76 statements reached consensus for inclusion specific to the following themes: general considerations for counseling patients about OIT; patient- and family-specific factors that should be addressed before initiating OIT and during OIT; indications for initiating OIT; and potential contraindications and precautions for OIT. The panel reached consensus on 9 OIT consent form themes: benefits, risks, outcomes, alternatives, risk mitigation, difficulties/challenges, discontinuation, office policies, and long-term management. From these themes, 219 statements were proposed, of which 189 reached consensus, and 71 were included on the consent information form.

CONCLUSION: We developed consensus recommendations to prepare and counsel patients for safe and effective OIT in clinical practice with evidence-based risk mitigation. Adoption of these recommendations may help standardize clinical care and improve patient outcomes and quality of life.