Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent - 05/06/24

Doi : 10.1016/j.jaci.2024.02.019

Douglas P. Mack, MD, MSc ^a,^⁎ , Timothy E. Dribin, MD ^b, Paul J. Turner, FRCPCH, PhD ^c, Richard L. Wasserman, MD, PhD ^d, Mariam A. Hanna, MD ^e, Marcus Shaker, MD, MSc ^f, Mimi L.K. Tang, MBBS, PhD, FRACP, FRCPA, FAAAI ^g, Pablo Rodríguez del Río, MD, PhD ^h, Brad Sobolewski, MD, MEd ⁱ, Elissa M. Abrams, MD, MPH ^j, Aikaterini Anagnostou, MD, PhD ^k, Stefania Arasi, MD, PhD ^l, Sakina Bajowala, MD ^m, Philippe Bégin, MD, PhD ⁿ, Scott B. Cameron, MD, PhD ^o, Edmond S. Chan, MD, FRCPC ^p, Sharon Chinthrajah, MD ^q, Andrew T. Clark, MB, BS, DM ^r, Paul Detjen, MD ^s, George du Toit, MBBCh, RCPCH ^t, Motohiro Ebisawa, MD, PhD ^u, Arnon Elizur, MD ^v, Jeffrey M. Factor, MD ^w, Justin Greiwe, MD ^x, Jonathan O’B Hourihane, MB, DM ^y, Sarah W. Hughes, MPAS, PA-C ^z, Douglas H. Jones, MD ^aa, Antonella Muraro, MD, PhD ^bb, Anna Nowak-Wegrzyn, MD, PhD ^cc, Nandinee B. Patel, MD, PhD ^dd, Amy M. Scurlock, MD ^ee, Atul N. Shah, MD, FACAAI, FAAAAI ^ff, Sayantani B. Sindher, MD ^gg, Stephen Tilles, MD ^hh, Brian P. Vickery, MD ⁱⁱ, Julie Wang, MD ^jj, Hugh H. Windom, MD ^kk, Matthew Greenhawt, MD, MBA, MSc ^ll
^a Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
^b Division of Emergency Medicine, Cincinnati Children’s Hospital Medical Center; and the Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio
^c National Heart & Lung Institute, Imperial College London, London, United Kingdom
^d Medical City Children’s Hospital, Dallas, Tex
^e McMaster University, Hamilton, Ontario, Canada
^f Dartmouth-Hitchcock Medical Center; and Geisel School of Medicine at Dartmouth, Lebanon, NH
^g Department of Allergy Immunology, Murdoch Children’s Research Institute; the Department of Paediatrics, University of Melbourne, Australia; and the Department of Allergy and Immunology, the Royal Children’s Hospital Melbourne, Melbourne, Australia
^h Hospital Infantil Universitario Niño Jesús, Madrid, Spain
ⁱ Department of Pediatrics, Division of Emergency Medicine, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio
^j Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, Canada
^k Texas Children’s Hospital, Baylor College of Medicine, Houston, Tex
^l Pediatric Allergology Unit of the Allergy Diseases Research Area, Bambino Gesù Children’s Hospital IRCCS, Rome, Italy
^m Kaneland Allergy and Asthma Center, North Aurora, Ill
ⁿ Department of Pediatrics, Section of Allergy, CHU Sainte-Justine; and the Department of Medicine, Section of Allergy, CHUM, Montreal, Canada
^o Department of Pediatrics, Division of Allergy and Immunology, University of British Columbia, Vancouver, Canada
^p Department of Pediatrics, Division of Allergy, University of British Columbia, BC Children’s Hospital, Vancouver, Canada
^q Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, Calif
^r Cambridge University Hospitals NHS Trust, Cambridge, United Kingdom
^s Kenilworth Medical, Kenilworth, Ill
^t Department of Paediatric Allergy, Division of Asthma, Allergy and Lung Biology, MRC and Asthma UK Centre in Allergic Mechanisms of Asthma, King’s College London; and the Evelina London Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom
^u National Hospital Organization, Sagamihara National Hospital, Yokosuka, Japan
^v Institute of Allergy, Immunology and Pediatric Pulmonology, Yitzhak Shamir Medical Center; and the Department of Pediatrics, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
^w Department of Pediatrics, University of Connecticut School of Medicine, Farmington, Conn
^x Bernstein Allergy Group; the Department of Internal Medicine, Division of Immunology/Allergy Section, the University of Cincinnati College of Medicine, Cincinnati, Ohio
^y Paediatrics and Child Health, Royal College of Surgeons in Ireland; and Children’s Health Ireland, Dublin, Ireland
^z Dartmouth-Hitchcock Medical Center, Lebanon, NH
^aa Global Food Initiative, Clearfield, Utah
^bb Food Allergy Referral Centre Padua, University Hospital, Padua, Italy
^cc NYU Grossman School of Medicine, Hassenfeld Children’s Hospital, New York; and the Department of Pediatrics, Gastroenterology, and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland
^dd National Heart & Lung Institute, Imperial College London, London, United Kingdom
^ee Department of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children’s Hospital and Research Institute, Little Rock, Ark
^ff Center for Asthma & Allergy, New York Food Allergy & Wellness, New York, NY
^gg Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif
^hh Aimmune Therapeutics, Brisbane; and the University of Washington, Seattle, Wash
ⁱⁱ Emory University School of Medicine; and Children’s Healthcare of Atlanta, Atlanta, Ga
^jj Department of Pediatrics, Division of Allergy & Immunology, Icahn School of Medicine at Mount Sinai, New York, NY
^kk Windom Asthma Allergy & Sinus, Sarasota, Fla
^ll Children’s Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo

^∗Corresponding author: Douglas Paul Mack, MD, MSc, Halton Pediatric Allergy, 5500 N Service Rd, Ste 106, Burlington, Ontario, L7L 6W6, Canada.Halton Pediatric Allergy5500 N Service RdSte 106BurlingtonOntarioL7L 6W6Canada

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.

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Key words : Allergy, anaphylaxis, Delphi, food allergy, oral immunotherapy, consent, patient preparation, shared decision making, risk mitigation

Abbreviations used : EoE, OIT, PPOINT, SDM, SU

Plan

Methods

Defining consensus

Prioritizing statements to include in template OIT consent form

Results

OIT Delphi panel participants and overview of Delphi voting process

General considerations for counseling patients about OIT

Patient- and family-specific factors to be addressed before and during OIT

Indications for initiating OIT

Potential contraindications and precautions for OIT

Defining potential benefits of OIT

Defining potential risks associated with OIT

Defining potential outcomes of OIT

Alternative therapies and options to OIT to consider

Practical risk mitigation strategies (including protocol modifications) for OIT

Difficulties and challenges during OIT

OIT discontinuation

Options for long-term management of OIT

Ranked importance of OIT consent information

Discussion

Patient selection and preparation approach for OIT

Contraindications, risk mitigation, and OIT discontinuation

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Vol 153 - N° 6

P. 1621-1633 - juin 2024 Retour au numéro

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Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent - 05/06/24

Abstract

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Results

Conclusion

Plan

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