Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent.

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.

Age-Related Food Aversion and Anxiety Represent Primary Patient Barriers to Food Oral Immunotherapy.

BACKGROUND: Although oral immunotherapy (OIT) for food allergy is a reasonable treatment option, barriers to this procedure's implementation have not been extensively evaluated from a patient perspective. OBJECTIVE: We evaluated the barriers patients face during OIT administration, including anxiety and taste aversion, and the role of health care professionals, especially dietitians. METHODS: A survey in Canada and the United States involved families currently enrolled in food OIT programs. RESULTS: Of responses from 379 participants, fear of reaction was the most common barrier to OIT initiation, with 45.6% reporting it being a "very significant" barrier with other fears reported. However, taste aversion represented the prominent obstacle to continuation. Taste aversion was associated with a slower buildup (P = .02) and a reduction in dose (P = .002). Taste aversion was a strongly age-dependent barrier for initiation (P < .001) and continuation (P < .002), with older children over 6 years of age reporting it as a very significant barrier (P < .001). Boredom was reported as a concern for specific allergens such as peanut, egg, sesame, and hazelnuts (P < .05), emphasizing the need for diverse food options. Notably, 59.9% of respondents mixed OIT foods with sweet items. Despite these dietary concerns, dietitians were underutilized, with only 9.5% of respondents having seen a dietitian and the majority finding dietitian support helpful with greater certainty about the exact dose (P < .001). CONCLUSIONS: Taste aversion and anxiety represent primary patient-related barriers to OIT. Taste aversion was highly age dependent, with older patients being more affected. Dietitians and psychology support were underutilized, representing a critical target to improve adherence and OIT success.

Information needs of patients considering oral immunotherapy for food allergy.

While the historic management of food allergy includes avoidance strategies and allergic reaction treatment, oral immunotherapy (OIT) approaches have become more commonly integrated into therapeutic approaches. International guidelines, phase 3 trials and real-world experience have supported the implementation of this procedure. However, OIT is an elective, rarely curative procedure with inherent risks that necessitates an increased degree of health literacy for the patients and families. Families assume the responsibility of amateur healthcare providers to ensure the daily safe administration of the allergenic food. As such, it is incumbent upon physicians to ensure that families are prepared for this role. A thorough educational and shared decision-making approach is necessary during the counselling and consent process to adequately inform the families. Educated discussion about the efficacy and patient-centred effectiveness, therapeutic alternatives and family goals is required to align physician and patient expectations. A frank discussion about the struggles, practical challenges, risks and contraindications can help to develop an understanding of the risk mitigation strategies employed to maintain safety. Physicians should develop a proactive approach to educate families about this, at times, burdensome procedure. This educational approach should encourage ongoing support starting prior to consent through the maintenance visits. By preparing families for their unique management role, physicians can help ensure the safe and successful integration of OIT into the therapeutic offering for the management of food allergies.

A High Proportion of Canadian Allergists Offer Oral Immunotherapy but Barriers Remain.

BACKGROUND: Limited data on clinical implementation of oral immunotherapy (OIT) have been reported with incomplete evaluation of barriers. OBJECTIVE: To survey Canadian allergists on their current practice of OIT and barriers to implementation and expansion of OIT. METHODS: A survey investigating current practice and logistical and clinical barriers to offering or expanding OIT was distributed to all Canadian Society of Allergy and Clinical Immunology allergists. RESULTS: Of 90 responding allergists, 52.2% reported offering OIT, most commonly to peanut. Food sublingual immunotherapy was offered by 7% of allergists. Having received training for OIT was associated with currently performing OIT (P = .008); 44.7% of allergists offering OIT had received training on OIT, and 81.4% not offering OIT had no training. A total of 87% of allergists performing OIT reported lack of efficacy data and lack of support staff and clinic space, and concerns about increased oral challenges (84%) were "moderately" to "extremely" important barriers to expanding OIT. For clinicians not offering OIT, concerns about safety (95%), after-hours support (95%), efficacy (93%), medicolegal risk (93%), and long-term practice implications (93%) were prioritized as significant barriers. Qualitative assessment suggested concerns about the practical challenges associated with OIT, the need for increased safety and efficacy data, and a desire for OIT guidelines and training. CONCLUSION: The implementation of OIT faces many barriers, both clinical and logistical. Increasing high-quality safety and efficacy data may support those hesitant to offer OIT, and improving funding may address the practical infrastructure challenges. In addition, training will help expand access for allergists interested in performing OIT.

A counseling video with pre- and posttesting and checklist for oral immunotherapy consent improves participant knowledge.

BACKGROUND: The use of oral immunotherapy (OIT) for food allergies has been expanding in North America. Although families are interested in this therapeutic approach, misconceptions are common; therefore, education of these families is essential before obtaining informed consent. OBJECTIVE: To improve parent and patient knowledge about OIT by investigating the use of a counseling video (CV) and checklist. METHODS: This retrospective review was conducted in a pediatric outpatient clinic. After consultation and review of the information package, 467 parents and patients (>12 years old) performed pre- and posttests in conjunction with a CV during a checklist-based 2-hour counseling session for OIT. RESULTS: The evaluation of pre- and posttest performance suggested an improvement in the ability of patients to answer relevant questions pertaining to OIT. This was statistically significant for all groups, including mothers, fathers, and children (P < .001). Mothers performed better than fathers and patients in mean number of correct responses in both pre- and posttest scores and in posttest scores after adjustment for pretest scores. Fathers performed better than patients in both pre- and posttest scores but not on posttest scores after adjustment for pretest scores. A checklist-based format resulted in 100% of all major topics being discussed in a 1-hour discussion. Reported satisfaction was high among the participants. CONCLUSION: This is the first study to evaluate the use of a CV in conjunction with pre- and posttesting to educate families about the key principles of OIT. We suggest that as part of extensive counseling for OIT, an educational video is beneficial in a pediatric outpatient clinic.

Novel Approaches to Food Allergy Management During COVID-19 Inspire Long-Term Change.

The SARS-CoV2 pandemic has prompted a re-evaluation of our current practice of medicine. The seemingly abrupt worldwide spread of this disease resulted in immediate changes and a reduction in many allergy-focussed services and procedures. The reality of the long-term circulation of this virus in our communities requires us to evolve as a specialty. In this article, we outline current and future challenges in the management of food allergy in light of coronavirus disease 2019 (COVID-19). We focus on infant food allergy prevention, management of anaphylaxis, accurate diagnosis with oral food challenges, and active management of food allergy with oral immunotherapy. This article identifies the challenges of conflicting guidelines, shortcomings of acute management approaches, and inherent system deficiencies. We offer perspectives and strategies that can be implemented now, including an evaluation of virtual care and telemedicine for the management of food allergy. The use of a shared decision-making model results in novel approaches that can benefit our patients and our specialty for years to come. COVID-19 has forced us to re-evaluate our current way of thinking about food allergy management to better treat our patients.

Discussion topic and observed behavior in couples' problem-solving conversations: do problem severity and topic choice matter?

Communication behavior is an integral part of relationship functioning and, therefore, a common target of relationship interventions. Between-couple variability in observed behaviors is commonly interpreted as reflecting their underlying skill in communication, but other factors, including perceived difficulty of the problem and the topic being discussed, may also covary with communication behavior. The current study examined this possibility by testing whether these two aspects of discussion topics were associated with communication behavior. Ethnically diverse newlywed couples (N = 402 couples) were observed in their homes as they engaged in conflict resolution tasks. Resulting behavioral codes were examined in relation to perceived difficulty of the problem and the topic of the discussion. Higher levels of husband-reported problem difficulty were associated with higher levels of husband and wife negativity, independent of relationship satisfaction. After controlling for problem difficulty and relationship satisfaction, the topic of the discussion was associated with husband and wife positivity, husband and wife negativity, and wife effectiveness, indicating that some topics elicited better or worse communication than others. The substantive focus of couples' conflicts may play an important role in how they communicate, suggesting that the topic of discussion merits close attention in studies of couples and in relationship interventions.