key: cord-0795166-3a3pcf40 authors: Mack, Douglas P.; Chan, Edmond S.; Shaker, Marcus; Abrams, Elissa M.; Wang, Julie; Fleischer, David M.; Hanna, Mariam A.; Greenhawt, Matthew title: Novel approaches to food allergy management during COVID-19 inspire long-term change date: 2020-07-25 journal: J Allergy Clin Immunol Pract DOI: 10.1016/j.jaip.2020.07.020 sha: d7d83464ffb6852473167e0faa9ad789a8832fab doc_id: 795166 cord_uid: 3a3pcf40 nan Prior to the pandemic, international variance already existed regarding pre-emptive screening 130 recommendations for peanut introduction in infants. While the National Institute of Allergy and 131 Infectious Diseases (NIAID) 2017 Addendum Guidelines for the Prevention of Peanut Allergy in 132 the United States recommend that high risk infants (those with severe eczema and/or egg allergy) 133 have screening prior to peanut introduction, 3 this recommendation is not endorsed by the 134 Australian, British or Canadian guidelines, nor has screening been proven to be cost-effective. 4-6 135 Importantly, the Learning Early About Peanut trial (LEAP) showed only that early introduction 136 in a screened population was effective for prevention, but did not evaluate whether screening a 137 population was necessary for early introduction. The constraints of COVID-19 have further 138 highlighted the barriers of significant health service utilization inherent to screening approaches 139 such as referral, testing, and in-office oral food challenges (OFC). All of these procedures are 140 currently reduced and deprioritized during the pandemic. Reliance on such a screening-141 dominated pathway could negate the benefits of early introduction strategies since services have 142 shifted to predominantly virtual clinics. 7-10 143 Limited access to in-person visits will restrict diagnostic testing availability in all but the most 144 urgent circumstances. Regardless, any form of food allergy testing has low specificity in the 145 absence of a clinical reaction (which is the context of an infant being screened) and could 146 inadvertently result in over-diagnosis due to high false positive rates. 11, 12 This would be 147 particularly concerning if combined with poor access to infant OFCs during a pandemic. 13,14 148 Compounding this issue further, recent evidence suggests a 'screening creep' extending to non-at 149 risk groups. This phenomenon was demonstrated in a recent study at a large tertiary care center, 150 8 where less than half of screened infants met NIAID criteria. 15 While home peanut introduction 151 was successful in 93% of those with negative tests, only 50% of those children with a peanut 152 SPT wheal size of 3-7mm were offered supervised OFCs-clearly a deviation from the NIAID 153 guidelines. 15 With the current testing and visit limitations resulting from COVID-19, it is highly 154 likely that even fewer children could be evaluated for food allergy prevention and offered 155 supervised OFCs. 156 Under current financial constraints resulting from the pandemic, cost-effective care is a priority. 157 Pre-emptive screening for food allergy in infants is not cost-effective compared to a non-158 screening approach of careful home introduction. From an American perspective, annual 159 screening prior to introduction costs $654,115,322 when downstream consequences are 160 considered and results in 3,208 additional peanut allergy diagnoses. 14 Moreover, though levers 161 for cost-effectiveness for screening were identified, none were considered feasible. While 162 screening prevents an index reaction in a truly peanut allergy infant, the trade-off is significant 163 and does not outweigh the risk of automobile fatality in traveling to the office for screening and 164 OFC. 16 Indeed, unless a family is willing to trade the equivalent of 21% of a year of life for any 165 peace of mind afforded by in-clinic vs. at-home peanut introduction, screening is not cost-166 effective. 13 These figures are unlikely to improve given the significant access limitations 167 clinicians are currently experiencing. 168 Most importantly, no data have ever shown that a screening strategy is safer, or even necessary, 169 compared to at-home introduction recommended outside the US. Large randomized controlled 170 trials (such as LEAP) and large observational studies (such as the HealthNuts study) 171 demonstrated that early introduction is safe, with low rates of reactions (approximately 2%) that 9 are typically exclusively cutaneous. 19-21 First-ingestion life-threatening reactions with early 173 introduction are unlikely, and no infant fatalities have been reported with early peanut 174 introduction. As a result, ED visits during COVID-19 from home introduction reactions would 175 also be unlikely, and cautious introduction of new foods can be safely recommended in lieu of 176 screening to facilitate food allergy prevention. 22 177 During and beyond COVID-19, at-home vs. in office early introduction should be a preference-178 sensitive care option as more data accumulates. At-home introduction will not be acceptable for 179 some families. An option to consider for these families would be pre-emptively prescribing an 180 epinephrine autoinjector to improve comfort with at-home introduction. 13 Others will prefer a 181 virtually-supported home peanut introduction. 23 The plan recommends that if severe symptoms do not resolve after a second dose of 211 epinephrine, then EMS should be activated. This plan necessitates that the patient/family is 212 capable and willing to follow the modified algorithm and has access to at least 2 epinephrine 213 autoinjectors. Proactive discussion with the patient and family via telehealth is prudent to 214 ensure a clear understanding of the risks and benefits of this approach, and to emphasize that 215 11 immediate activation of EMS after epinephrine administration is still appropriate if there is 216 concern for a severe, life-threatening reaction. 217 Changing the guidance to de-emphasize reflex EMS activation after epinephrine use serves two 219 needs: preventing over-burdening of emergency health care services, and reducing the risk of 220 contracting SARS-CoV-2 while in the ED setting. 2 While the change in recommendation 221 resulted from highly nuanced contextual circumstances of a pandemic, this change should 222 arguably endure once the pandemic risk passes. Prior data demonstrate that 12% or fewer of 223 pediatric patients receiving one dose of epinephrine prior to arrival in the ED receive an 224 additional dose, and no data ever substantiated that immediate ED evaluation after epinephrine 225 use is associated with reduced fatality. 28,29 True biphasic reactions in children are rare, as 226 opposed to needing a second epinephrine dose to effectively treat an initial reaction. 227 Furthermore, studies have suggested that food triggers are a negative predictor for biphasic 228 reactions. 30,31,32 The requirement to reflexively activate EMS after epinephrine use is, ironically, 229 a noted barrier to epinephrine use to treat anaphylaxis. 33 Decoupling the mandatory 230 recommendation for immediate ED assessment after epinephrine treatment may help increase 231 rates of appropriate epinephrine use in the community setting. 232 233 Unfortunately, clinical trials are lacking to confirm the clinical utility of a "watch-and-wait" 234 recommendation but until then the risks and benefits of both approaches need to be recognized 235 by clinicians and families. At minimum, the choice to reflexively activate EMS is preference-236 sensitive, wording should be modified to say this is "not required", and clinicians should discuss 237 values and preferences of the family in emergency situations. Accordingly, given there is no 238 evidence to suggest that reflex activation is necessary, cost-effective, or associated with clear 239 universal health benefits, the instructions on the action plan for the COVID-19 pandemic could 240 become permanent. Ultimately, the decision to implement a watch and wait action plan still 241 depends upon a physician's assessment of the individual patient and an understanding of the 242 family's desires and capabilities. food introduction is in-office due to anxiety or reluctance), and reserving the office for high-risk 278 OFCs. Use of OFC as the initial test, rather than obtaining skin/serum testing in circumstances 279 of low pre-test probability, would further limit misdiagnosis attributable to false positive 280 sensitization. Pathways to use telemedicine visits for patients who have an epinephrine device at 281 home, who understand the signs and symptoms of a reaction and when to treat, could be 282 designed to allow for OFCs to be supervised virtually. This additional support may assist in 283 parental comfort, in particular when expectation is high that the procedure will be tolerated. This 284 14 virtual approach may also help to increase access to OFCs given that space and time have been 285 recurrently cited as major constraints. Shared decision-making should be utilized to the greatest 286 extent possible. Ensuring that patients and families are properly evaluated, prepared and educated is vital before 295 initiating OIT. 35 As part of their evaluation, many patients undergo OFCs prior to initiation of 296 OIT for diagnostic or threshold-determination. Access to OFCs before starting OIT, to ensure 297 that only those that are truly allergic undergo OIT, may not be possible under pandemic 298 ambulatory care constraints. 36 299 300 Once OIT is initiated, ensuring that these families are safely monitored, provided with continued 301 education, and that parental/patient concerns are addressed are essential steps to maintaining 302 safety and long-term success. 35 Recurring and prolonged in-person visits for OIT counselling 303 and updosing during build-up phase or in follow-up during maintenance phase will challenge 304 clinicians facing significant limitations of service. In the setting of clinical practice altered by 305 COVID-19, clinicians who are naïve to the practice of OIT may wish to consider delaying 306 initiating OIT programs until they can ensure they have the capacity to effectively and safely 307 15 support their patients at baseline. This is particularly important for the recently FDA approved 308 product, which is regulated under a stringent regulatory program to be administered by certified 309 allergists in an office-based setting only. 37 310 311 Patient adherence has been an ongoing concern amongst OIT practitioners, and the lack of 312 regular in-office visits during COVID-19 may negatively affect this important aspect of care. 38, 39 313 A lack of adherence may be further exacerbated amongst teens and complicated by psychosocial 314 factors including rising mental health challenges during "stay-at-home" orders. The use of 315 telehealth visits may allow clinicians to monitor individual patients and any reaction-related 316 issues virtually. 2 If such resources are available, referral to a food-allergy counsellor via 317 telehealth to address intercurrent anxiety, distaste or compliance concerns should be considered. 318 Similarly, the use of a dietitian has also been demonstrated to improve adherence and should also 319 be considered during this extended time at home. 40 The incorporation of allied health as an 320 adjunct for OIT practices should persist even after the pandemic. prior to COVID-19 despite patient willingness to use it, due to patient barriers such as inertia and 359 awareness, as well as systemic barriers such as reimbursement. 48 During the pandemic, using 360 telemedicine services helps provide stable access to care while reducing in-office risk of 361 transmitting COVID-19. Our task is to try to maintain these services and integrate telehealth 362 more permanently, in particular to food allergy care. Table 1 peanuts. 55 Similarly, a recent article supports the safety of home-based subcutaneous 400 immunotherapy in select patients. 56 A virtually-supported, home-based approach may be 401 appropriate in areas that are remote or where access to clinicians is limited, but cannot be 402 recommended for the FDA approved product due to its Risk Evaluation and Mitigation Strategy 403 program. 37 Virtually-supported home-based peanut OIT dose escalation may be primarily 404 considered among the following preschoolers: high thresholds of reactivity; low sIgE; absence of 405 asthma; and stable preceding OIT course. 39,54,57 Discussion about whether to utilize the strategy 406 must include a comprehensive discussion about the risks and benefits for this elective procedure. 407 If physicians and parents decide jointly to pursue this option, all efforts must be maintained to 408 evaluate, educate and train patients throughout the process to ensure safety. 409 410 The COVID-19 pandemic has presented many challenges to the practicing allergist. However, 412 as we respond to this international emergency with fresh ideas, medical practice may benefit 413 from a period of rapid evolution. New paradigms of care aimed at delivering lower-risk food 414 allergy procedures via virtual health and incorporating shared decision making will be crucial 415 as we move through and beyond these challenging times. There is reason for renewed 416 optimism for the ability of health care systems to address longstanding implementation 417 inadequacies of prevention and management of food allergy. The time has come for rational, 418 constructive discussion to enable clinician-patient partnerships to deliver contextual care to 419 each food allergy patient. 420 421 Table 1 World Health Organization, WHO Coronavirus Disease (COVID-19) Dashboard COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic Addendum 431 guidelines for the prevention of peanut allergy in the United States National Institute of Allergy and Infectious Diseases-sponsored expert panel An Australian Consensus on Infant Feeding Guidelines to Prevent Food Allergy Outcomes From the Australian Infant Feeding Summit BSACI: Preventing food allergy in higher risk infants: guidance for healthcare 439 professionals Timing of introduction of allergenic 442 solids for infants at high risk Comparison of practice patterns among Canadian allergists before and after NIAID 445 guideline recommendations Challenge Implementation: The First Mixed-Methods Study Exploring Barriers and 448 Pre-emptive screening for peanut allergy before 450 peanut ingestion in infants is not standard of care Association journal = journal de l'Association medicale canadienne. Canada Primum non nocere-first do no harm. And then feed peanut Food allergy Oral food challenges in children with a diagnosis of food allergy Determining Levers of Cost-effectiveness for Screening 462 Infants at High Risk for Peanut Sensitization Before Early Peanut Introduction To screen 465 or not to screen": Comparing the health and economic benefits of early peanut 466 22 introduction strategies in five countries Real-life infant peanut 468 allergy testing in the post-NIAID peanut guideline world Department of Transportation. Traffic Safety Facts The health and economic benefits of 474 approaches for peanut introduction in infants with a peanut allergic sibling The health and economic outcomes of early egg 477 introduction strategies Understanding the feasibility and implications of implementing early peanut introduction 480 for prevention of peanut allergy Randomized Trial of 482 Introduction of Allergenic Foods in Breast-Fed Infants Randomized trial of peanut consumption in infants at risk for peanut allergy Canadian Paediatric Society -Can we continue to recommend 488 Risk Evaluation and Mitigations Strategy Long-term outcome of 536 peanut oral immunotherapy-Real-life experience Community Private Practice Clinical Experience with Peanut Oral Immunotherapy 540 Impact of a dietitian-led counseling program to support transition to whole foods during 544 oral immunotherapy A Phased Approach to Resuming Suspended Allergy Epub ahead of print Outcomes for Oral Immunotherapy-Induced Gastrointestinal Symptoms and Eosinophilic 553 Responses (OITIGER) Long-term sublingual 556 immunotherapy for peanut allergy in children: Clinical and immunologic evidence of 557 desensitization Virtual health care in the era of COVID-19 Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to 563 The Virtual Care Task Force, Virtual Care: Recommendations for Scaling Up 565 Prime Minister announces virtual health care 568 and mental health tools for Canadians Telemedicine in the Era of COVID-19 The Role of Shared Decision Making in 574 Pediatric Food Allergy Management Identification of goals and barriers to treatment from 577 92 consecutive consultations with families considering peanut oral immunotherapy Effectiveness Analysis During Exceptional Times Safety Analysis of Preschool Peanut Oral Immunotherapy OIT follow-up to assess adherence 626 (OFC, Oral Food Challenge; OIT early allergenic food introduction during a pandemic? [Internet] . Available from: 489 https://www.cps.ca/en/blog-blogue/can-we-continue-to-recommend-early-allergenic-490 food-introduction-during-a-pandemic, Accessed Peanut oral immunotherapy protects patients from accidental allergic reactions to peanut, 532 J Allergy Clin Immunol Pract, 2020. 533