Characteristics of Peanut Allergy Diagnosis in a US Health Care Claims Database (2011-2017).

BACKGROUND: Peanut allergy is the most common food allergy among children. Studies assessing the burden of peanut allergy in a real-world setting are limited. OBJECTIVE: To estimate annual incidence and prevalence of peanut allergy cases among children aged 4 to 17 years and assess severe reaction and associated health care utilization rates. METHODS: Patient longitudinal data between January 2011 and December 2017 from a geographically and payer-type representative US health care claims database were used. Peanut allergy cases were identified using diagnostic codes and/or services indicating peanut-allergy-associated severe reactions/anaphylaxis. Estimated annual incidence was defined as peanut-allergic births as a proportion of all 1-year-olds and adjusted for less than 100% data set capture, undercoding, patient underpresenting rates, and spontaneous outgrowth. Prevalence was calculated on the basis of incidence. To assess rates of severe reactions to peanut and associated health care utilization, the cohort of 720,490 peanut allergy cases identified in 2011 was evaluated over a 6-year period from 2011 to 2017. RESULTS: Annual incidence increased from 1.7% to 5.2% between 2001 and 2017. Estimated prevalence in 4- to 17-year-olds was 1.25 million (2.2%) in 2017. Atopic comorbidities (asthma, 60.8%; atopic dermatitis, 61.7%) and other food allergies (35.3%) were common. Severe reactions (≥1) were observed in more than half (n = 399,806) the patients, and 37.9% were triggered by an accidental exposure. One in 5 patients (n = 144,883) visited the emergency department due to peanut exposure. CONCLUSIONS: Claims data suggest that the incidence and prevalence of peanut allergy in the United States may be increasing. Estimated severe reaction rates and health care utilization were high, suggesting that the burden of peanut allergy may be considerable.

A Proposal from the Montpellier World Health Organization Collaborating Centre for Better Management and Prevention of Anaphylaxis.

Since the first description of anaphylaxis in 1902, its clinical importance as an emergency condition has been recognized worldwide. Anaphylaxis is a severe, potentially life-threatening systemic hypersensitivity reaction characterized by rapid onset and the potential to endanger life through respiratory or circulatory compromise. It is usually, although not always, associated with skin and mucosal changes. Although the academic/scientific communities have advocated to promote greater awareness and protocols for the management of anaphylaxis based on best evidence, there are few efforts documenting feedback as to the success of these efforts. In this article, we review the key unmet needs related to the diagnosis and management of anaphylaxis, and propose a public health initiative for prevention measures and a timetable action plan that intends to strengthen the collaboration among health professionals and especially primary care physicians dealing with anaphylaxis, which can encourage enhanced quality of care of patients with anaphylaxis. More than calling for a harmonized action for the best management of anaphylaxis to prevent undue morbidity and mortality, the Montpellier World Health Organization Collaborating Centre here proposes an action plan as a baseline for a global initiative against anaphylaxis. We strongly believe that these collaborative efforts are a strong public health and societal priority that is consistent with the overarching goals of providing optimal care of allergic patients and best practices of allergology.

Consensus report from the Food Allergy Research & Education (FARE) 2019 Oral Immunotherapy for Food Allergy Summit.

Food allergy is a major health problem affecting 5% to 10% of the population in developed nations, including an estimated 32 million Americans. Despite the large number of patients suffering from food allergies, up until the end of January 2020, no treatment for food allergies had been approved by the US Food and Drug Administration. The only options were avoidance of food allergen triggers and acute management of allergic reactions. A considerable body of data exists supporting oral immunotherapy (OIT) as a promising, novel treatment option, including that for the now Food and Drug Administration-approved peanut OIT product Palforzia (Aimmune Therapeutics, Brisbane, Calif). However, data for long-term quality-of-life improvement with OIT varies, depending on the measures used for analysis. Like many therapies, OIT is not without potential harms, and burdens, and the evaluation of patient-specific risk-benefit ratio of food OIT produces challenges for clinicians and patients alike, with many unanswered questions. Food Allergy Research & Education organized the Oral Immunotherapy for Food Allergy Summit on November 6, 2019, modeled after the PRACTALL sessions between the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology to address these critical issues. Health care providers, patient representatives, researchers, regulators, and food allergy advocates came together to discuss OIT and identify areas of common ground as well as gaps in existing research and areas of uncertainty and disagreement. The purpose of this article was to summarize that discussion and facilitate collaboration among clinicians and patients to help them make better-informed decisions about offering and accepting OIT, respectively, as a therapeutic option.

Global implementation of the world health organization's International Classification of Diseases (ICD)-11: The allergic and hypersensitivity conditions model.

The International Classification of Diseases (ICD) provides a common language for use worldwide as a diagnostic and classification tool for epidemiology, clinical purposes and health management. Since its first edition, the ICD has maintained a framework distributing conditions according to topography, with the result that some complex conditions, such as allergies and hypersensitivity disorders (A/H) including anaphylaxis, have been poorly represented. The change in hierarchy in ICD-11 permitted the construction of the pioneer section addressed to A/H, which may result in more accurate mortality and morbidity statistics, including more accurate accounting for mortality due to anaphylaxis, strengthen classification, terminology and definitions. The ICD-11 was presented and adopted by the 72nd World Health Assembly in May 2019, and the implementation is ongoing worldwide. We here present the outcomes from an online survey undertaken to reach out the allergy community worldwide in order to peer review the terminology, classification and definitions of A/H introduced into ICD-11 and to support their global implementation. Data are presented here for 406 respondents from 74 countries. All of the subsections of the new A/H section of the ICD-11 had been considered with good accuracy by the majority of respondents. We believe that, in addition to help during the implementation phase, all the comments provided will help to improve the A/H classification and to increase awareness by different disciplines of what actions are needed to ensure more accurate epidemiological data and better clinical management of A/H patients.

Closed-loop electronic referral to SmokefreeTXT for smoking cessation support: a demonstration project in outpatient care.

Too few smokers who present for outpatient healthcare receive evidence-based interventions to stop smoking. Referral to nationally available smoking cessation support may enhance tobacco intervention reach during healthcare visits. This study evaluated the feasibility of outpatient electronic health record (EHR)-enabled, closed-loop referral (eReferral) to SmokefreeTXT, a National Cancer Institute text message smoking cessation program. SmokefreeTXT eReferral for adult patients who smoke was implemented in a family medicine clinic and an allergy and asthma clinic in an integrated Midwestern healthcare system. Interoperable, HIPAA-compliant eReferral returned referral outcomes to the EHR. In Phase 1 of implementation, clinicians were responsible for eReferral; in Phase 2 this responsibility shifted to Medical Assistants and/or nurses. EHR data were extracted to compute eReferral rates among adult smokers and compare demographics among those eReferred versus not referred. SmokefreeTXT data were used to compute SmokefreeTXT enrollment rates among those eReferred. Descriptive analyses of clinic staff surveys assessed implementation context and staff attitudes toward and adaptations of eReferral processes. During clinician implementation, 43 of 299 adult smokers (14.4%) were eReferred. During medical assistant (MA) implementation, 36 of 401 adult smokers (9.0%) were eReferred. Overall, among those eReferred, 25.7% completed SmokefreeTXT enrollment (3.1% of patients eligible for eReferral). Staff survey responses indicated that eReferral was efficient and easy. eReferral rates and relevant attitudes varied meaningfully by clinic. Thus, interoperable eReferral via outpatient EHR to SmokefreeTXT is feasible and acceptable to clinic staff and enrolls roughly 3.0% of smokers. Clinic context and implementation approach may influence reach.

An electronic health record-based interoperable eReferral system to enhance smoking Quitline treatment in primary care.

OBJECTIVE: The study sought to determine whether interoperable, electronic health record-based referral (eReferral) produces higher rates of referral and connection to a state tobacco quitline than does fax-based referral, thus addressing low rates of smoking treatment delivery in health care. MATERIALS AND METHODS: Twenty-three primary care clinics from 2 healthcare systems (A and B) in Wisconsin were randomized, unblinded, over 2016-2017, to 2 smoking treatment referral methods: paper-based fax-to-quit (system A =6, system B = 6) or electronic (eReferral; system A = 5, system B = 6). Both methods referred adult patients who smoked to the Wisconsin Tobacco Quitline. A total of 14 636 smokers were seen in the 2 systems (system A: 54.5% women, mean age 48.2 years; system B: 53.8% women, mean age 50.2 years). RESULTS: Clinics with eReferral, vs fax-to-quit, referred a higher percentage of adult smokers to the quitline: system A clinic referral rate = 17.9% (95% confidence interval [CI], 17.2%-18.5%) vs 3.8% (95% CI, 3.5%-4.2%) (P < .001); system B clinic referral rate = 18.9% (95% CI, 18.3%-19.6%) vs 5.2% (95% CI, 4.9%-5.6%) (P < .001). Average rates of quitline connection were higher in eReferral than F2Q clinics: system A = 5.4% (95% CI, 5.0%-5.8%) vs 1.3% (95% CI, 1.1%-1.5%) (P < .001); system B = 5.3% (95% CI, 5.0%-5.7%) vs 2.0% (95% CI, 1.8%-2.2%) (P < .001). DISCUSSION: Electronic health record-based eReferral provided an effective, closed-loop, interoperable means of referring patients who smoke to telephone quitline services, producing referral rates 3-4 times higher than the current standard of care (fax referral), including especially high rates of referral of underserved individuals. CONCLUSIONS: eReferral may help address the challenge of providing smokers with treatment for tobacco use during busy primary care visits.ClinicalTrials.gov; No. NCT02735382.

Inflammometry in pediatric asthma: a review of fractional exhaled nitric oxide in clinical practice.

The burden of pediatric asthma remains high with one-third of patients being under- or overtreated because of the unique challenges in the assessment and management of childhood asthma. Until recently, there has been no point of care tool for assessing the underlying airway inflammation (i.e., inflammometry) in asthma. Recently, fractional exhaled nitric oxide (FeNO) has emerged as an important biomarker for the assessment and management of asthma. Recent evidence indicates that FeNO identifies T-helper cell type 2 (Th2)­mediated airway inflammation with a high positive and negative predictive value for identifying corticosteroid responsive airway inflammation. This article examines the evidence for FeNO as a predictor of Th2-mediated inhaled corticosteroid (ICS) responsive airway inflammation and reviews recent studies evaluating the role of FeNO, whether helpful or not, in the assessment and management of pediatric asthma. FeNO is a reliable adjunct to traditional tests in the assessment of suspected asthma. Importantly, it is useful for identifying and for excluding ICS-responsive airway inflammation. Although individual study results have varied, collectively, asthma managed using FeNO is associated with lower exacerbation rates compared with clinical algorithms alone. Finally, FeNO may be useful in identifying patients at risk for future impairment or loss of asthma control during reduction/cessation of ICS treatment. FeNO testing has an important role in the assessment of pediatric patients with suspected asthma and in the management of pediatric patients with established asthma. Additional studies will continue to define the exact role of FeNO testing in pediatric asthma.

Management of food allergy in the school setting.

Food allergy is estimated to affect approximately 1 in 25 school-aged children and is the most common trigger of anaphylaxis in this age group. School food-allergy management requires strategies to reduce the risk of ingestion of the allergen as well as procedures to recognize and treat allergic reactions and anaphylaxis. The role of the pediatrician or pediatric health care provider may include diagnosing and documenting a potentially life-threatening food allergy, prescribing self-injectable epinephrine, helping the child learn how to store and use the medication in a responsible manner, educating the parents of their responsibility to implement prevention strategies within and outside the home environment, and working with families, schools, and students in developing written plans to reduce the risk of anaphylaxis and to implement emergency treatment in the event of a reaction. This clinical report highlights the role of the pediatrician and pediatric health care provider in managing students with food allergies.

The Childhood Asthma Control Test: retrospective determination and clinical validation of a cut point to identify children with very poorly controlled asthma.

BACKGROUND: The Childhood Asthma Control Test (C-ACT) has demonstrated validity in classifying children aged 4 to 11 years as having either "well-controlled" or "not well-controlled" asthma. However, new asthma management guidelines distinguish 3 levels of asthma control. OBJECTIVE: We sought to determine a second cut point on the C-ACT to identify children with "very poorly controlled" asthma. METHODS: Binomial logistic regression was performed on data from 671 children. The specialist's rating of control was the criterion measure. Specialists' severity ratings, specialists' assessment of therapy, and FEV(1) percent predicted were used to assess the clinical validity of the cut point. RESULTS: A cut point of 12 was selected because it correctly classified the highest percentage of participants (66.3%) as having "very poorly controlled" (vs "not well controlled") asthma and demonstrated high specificity (89.8%) and moderate positive predictive value (69.1%). Children scoring 12 or less versus 13 to 19 had lower mean FEV(1) percent predicted (79.8% vs 92.6%, P = .0002) and were more frequently stepped up in therapy (72.9% vs 53.6%, P = .0131) and rated as having severe asthma (13.6% vs 4.5%, P = .0005). One month later, significant differences in C-ACT scores and lung function between these 2 groups persisted. The mean C-ACT score of participants classified as "very poorly controlled" was significantly lower than that of participants classified as "not well-controlled" (17.2 vs 20.3, respectively; P = .0001). CONCLUSION: A second cut point of 12 or less on the C-ACT identifies children with the lowest level of control, who are at risk for poorer outcomes, and is conceptually consistent with the classification of "very poorly controlled" asthma adopted by asthma management guidelines.

Burden of allergic rhinitis: results from the Pediatric Allergies in America survey.

Allergic rhinitis (AR), a chronic inflammatory disease of the upper airway, is one of the most common chronic diseases in the United States and is estimated to affect up to 60 million people. Pediatric Allergies in America is the largest and most comprehensive survey to date of pediatric patients and parents of patients with allergy, as well as health care providers (HCPs), regarding AR in children and its treatment. The goals of the survey were to determine the prevalence of AR in the US pediatric population and to collect information on what effect the condition has on patients in terms of symptom burden, quality of life, productivity, disease management, and pharmacologic treatment. This national survey screened 35,757 households to identify 500 children with HCP-diagnosed nasal allergies and 504 children without nasal allergies who were between the ages of 4 and 17 years. Parents of young children, as well as children 10 to 17 years of age, were questioned about the condition and its treatment. In parallel, 501 HCPs were interviewed. This survey has captured previously unavailable data on the prevalence of nasal allergies and their most common and most bothersome symptoms, on the effect of nasal allergies on the quality of life of children, and on medication use, including both over-the-counter and prescription medications, and has identified factors affecting satisfaction with treatment. The Pediatric Allergies in America survey also identifies distinct areas for improvement in the management of AR in children. In fact, based on the results of this survey, it appears that HCPs overestimate patients' and parents' satisfaction with disease management and the benefit of medications used for the treatment of nasal allergies in children. Findings from this national survey have identified important challenges to the management of AR, suggesting that its burden on children in the United States has been significantly underestimated.

A comparison of olopatadine 0.2% ophthalmic solution versus fluticasone furoate nasal spray for the treatment of allergic conjunctivitis.

Allergic conjunctivitis is an inflammatory condition of the ocular surface characterized by ocular itching, redness, tearing, chemosis, and eyelid swelling. The purpose of this study was to assess the comparative efficacy of an ophthalmic antihistamine/mast cell stabilizer solution and an intranasal steroid at reducing the signs and symptoms of allergic conjunctivitis induced by the conjunctival allergen challenge (CAC) model. Sixty subjects were enrolled in a single center, randomized, placebo-controlled, parallel-treatment, four-visit CAC study. After titration and confirmation of the allergic reaction at visits 1 and 2, subjects were randomized at visit 3 into one of 4 treatment groups (olopatadine 0.2% ophthalmic solution, fluticasone furoate nasal spray, a tear substitute, or saline nasal spray), dosed with study medication, and challenged 15 minutes later, after which ocular allergic signs and symptoms were assessed. Subjects continued treatment of the assigned medication for 6 days. At visit 4, subjects underwent similar procedures to those performed at visit 3. Fifty-nine subjects completed the study. Olopatadine 0.2% ophthalmic solution showed statistical and clinical superiority over fluticasone furoate nasal spray at all post-CAC time points after a single dose (p < 0.001) and after a 1-week loading period (p < 0.01) for ocular itching, the primary end point. Similarly, olopatadine 0.2% showed statistical and clinical superiority over fluticasone furoate for the majority of time points for ocular redness, tearing, chemosis, and eyelid swelling. Olopatadine 0.2% ophthalmic solution was statistically and clinically superior to fluticasone furoate nasal spray for the relief of signs and symptoms of allergic conjunctivitis.

Therapy in allergic rhinoconjunctivitis: new horizons.

Allergic Rhinitis (AR) is a common disease that impacts productivity and has significant patient morbidity. We have a variety of agents available for the treatment of AR, but numerous patients still lack good control of symptoms and some are tolerating undesired side effects. Surveys have shown 1/5 of patients with AR are not fully satisfied with their AR medications and almost 1/2 feel they receive insufficient attention from their physicians. Newer agents for the treatment of AR are in development, and an overview of some of these are presented here.

Development and cross-sectional validation of the Childhood Asthma Control Test.

BACKGROUND: For children younger than 12 years old with asthma, there are several quality-of-life instruments, clinical diaries, and questionnaires assessing symptoms; however, a validated tool for assessing asthma control is currently lacking. OBJECTIVE: To develop and validate the Childhood Asthma Control Test (C-ACT), a self-administered tool for identifying children aged 4-11 years whose asthma is inadequately controlled. METHODS: A 21-item questionnaire was administered to 343 patients with asthma and their caregivers, randomly assigning 75% (n = 257) for development and cross-sectional validation of the tool and 25% (n = 86) to a confirmatory sample. Stepwise logistic regression was used to reduce the 21 items to those best able to discriminate control as defined by the specialist's rating of asthma control. RESULTS: Seven items were selected from regression analyses of the development sample to comprise the C-ACT. The scores of each item were summed for a total score (0-27), with lower scores indicating poorer control. Summed scores discriminated between groups of patients differing in the specialists' rating of asthma control (F = 36.89; P < .0001), the need for change in patients' therapy (F = 20.07; P < .0001), and % predicted FEV(1) (F = 2.66; P = .0494). A score of 19 indicated inadequately controlled asthma (specificity 74%, sensitivity 68%). These analyses were confirmed in the confirmatory sample. CONCLUSION: The C-ACT is a validated tool to assess asthma control and identify children with inadequately controlled asthma. CLINICAL IMPLICATIONS: The C-ACT can be valuable in clinical practice and research based on its validation, ease of use, input from the child and caregiver, and alignment with asthma guidelines.

Expanding choices in intranasal steroid therapy: summary of a roundtable meeting.

Intranasal steroids (INSs) are recommended as first-line treatment for allergic rhinitis (AR) and a wealth of data exist supporting them as safe and effective. Our goal was to develop a consensus to help physicians choose between INSs by focusing on clinical profiles and patient preferences and providing expert advice on choosing the appropriate INS for each patient. Experts from specialties that manage patients with AR attended a roundtable meeting to discuss INS therapy. Besides comparisons with other pharmacologic agents, they examined the effects of INS on nasal anatomy, patient preferences for INS, and benefits of product selection based on patient profile. The literature on INSs in AR was reviewed, examining properties of the various drugs, delivery devices, formulations, and patient preference data. Nasal anatomy and physiology must be considered to optimize INS deposition in the nose. Teaching patients proper technique for using INS devices is important to prevent nasal injury and may help concentrate drug effect on affected tissues. INS therapies differ somewhat in biological properties and specific formulation; however, all are considered safe and effective treatment for AR. Patients exhibit different clinical profiles, which play a role in INS selection. Patients can clearly identify sensory characteristics of INS and therefore establish product preference. Patient preference also can guide physicians in choosing the appropriate agent for each patient. Control of AR requires a systematic approach to treatment selection and follow-up. Treatment selection should be matched with clinical profile and patient preferences.