McMaster researchers have crafted the first-ever guidelines to help prepare families who plan to build their child’s tolerance to common food allergens.

These international guidelines, published April 8 in the Journal of Allergy and Clinical Immunology, standardize the preparation process for families considering oral immunotherapy, a process that involves giving very small amounts of an allergen, like peanuts, to patients and gradually increasing the amount to build up their tolerance.

Until now, clinicians had little evidence-based guidance to provide parents administering this procedure to their child.

The new guidelines fill an important gap as the therapy is not without its risks — it is administered daily at home to children by their parents, requiring caregivers to act like amateur medical professionals, observing reactions and deciding on necessary treatments.

“This is a landmark paper in our field because it has never been done before and this process has never been standardized,” says Douglas Mack, lead author of the paper and assistant clinical professor in the department of Pediatrics in the Faculty of Health Sciences.

“We’re in dire need of having some kind of guidance on how to approach oral immunotherapy. We simply have not had this before.”

The guidelines include recommendations for:

• A robust standardized education process for patients and caregivers through a detailed consent procedure
• Establishing adequate parental supervision for dosing before beginning treatment
• Identifying inadvisable risk factors, including uncontrolled asthma, an unwillingness to use epinephrine, uncontrolled psychological concerns and pregnancy
• Clearly understanding the patient and caregiver goals
• Developing a structured universal consent form template.

To develop the recommendations, the panel of 36 international oral immunotherapy experts identified more than 250 statements that met consensus as important considerations for clinicians in prescribing oral immunotherapy, and 71 statements that were used to craft a consent form for families.

Using these statements, researchers have put forward a standardized protocol that clinicians can use to prepare patients.

Clinicians can also use the consent form template to ensure patients understand the risks, benefits, and alternatives to this therapy.

“These families must provide the therapy every single day. That’s why these guidelines are so important,” Mack says.

“Safety can be optimized to make sure that they understand what they’re taking on, while ensuring that they are aware of the kinds of side-effects that can be dangerous.”

Before now, as many as one-third of patients were not getting any degree of adequate consent or preparation before starting treatment.

When adequate counselling was performed, the study found the average time to be about 30-60 minutes.

“If families are not prepared for oral immunotherapy, they’re going to fail or it’s going to become unsafe,” Mack says.

“If they decide they want to do it after following these guidelines, they’re prepared for what they’re getting into. They understand the risks and most importantly, it makes it safer because they can anticipate the challenges.  This protocol sets the standard moving forward.”

The U.S. National Institutes of Health provided funding for the study.