Publications by authors named "Paolo Matricardi"

91 Publications

@IT2020: An innovative algorithm for allergen immunotherapy prescription in seasonal allergic rhinitis.

Clin Exp Allergy 2021 Mar 23. Epub 2021 Mar 23.

Department of Pediatric Pneumology, Immunology and Critical Care Medicine, Charité Universitätsmedizin - Berlin, Berlin, Germany.

Background: Allergen immunotherapy (AIT) is the only disease-modifying treatment in patients with seasonal allergic rhinoconjunctivitis (SAR). Its efficacy depends on the precise identification of the triggering allergen. However, diagnostics based on retrospective clinical history and sensitization to whole extracts (SWE) often leads to equivocal results.

Objectives: To assess the usability and impact of a recently established algorithm for a clinical decision support system (@IT2020-CDSS) for SAR and its diagnostic steps [anamnesis, SWE (skin prick test or serum IgE), component resolved diagnosis, CRD, and real-time digital symptom recording, eDiary] on doctor's AIT prescription decisions.

Methods: After educational training on the @IT2020-CDSS algorithm, 46 doctors (18 allergy specialists, AS, and 28 general practitioners, GP) expressed their hypothetical AIT prescription for 10 clinical index cases. Decisions were recorded repeatedly based on different steps of the algorithm. The usability and perceived impact of the algorithm were evaluated.

Results: The combined use of CRD and an eDiary increased the hypothetical AIT prescriptions, both among AS and GP (p < .01). AIT prescription for pollen and Alternaria allergy based on anamnesis and SWE was heterogeneous but converged towards a consensus by integrating CRD and eDiary information. Doctors considered the algorithm useful and recognized its potential in enhancing traditional diagnostics.

Conclusions And Clinical Implications: The implementation of CRD and eDiary in the @IT2020-CDSS algorithm improved consensus on AIT prescription for SAR among AS and GP. The potential usefulness of a CDSS for aetiological diagnosis of SAR and AIT prescription in real-world clinical practice deserves further investigation.
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http://dx.doi.org/10.1111/cea.13867DOI Listing
March 2021

A Novel, Portable MESH Nebulizer-An Alternative to Metered Dose Inhaler: Efficacy and Usability in Preschool Wheezers.

Front Pediatr 2020 10;8:598690. Epub 2020 Dec 10.

Pediatric Pulmonology & Respiratory Intermediate Care Unit, Sleep and Long Term Ventilation Unit, Academic Department of Pediatrics, Research Institute, Bambino Gesù Children Hospital, Rome, Italy.

Wheezing episodes are the first causes of doctor's consultation in preschool age. Treatment is usually administered with a metered dose inhaler (MDI) spacer. At variance, many parents and doctors prefer to use a compressor nebulizer, which cannot be easily carried. The study is aimed at testing whether a pocket mesh nebulizer has similar efficacy and acceptability than a standard MDI device. The IPAC study was a randomized, controlled, non-inferiority trial (number: 1616/2018, Ospedale Pediatrico Bambino Gesu'-IRCCS). The study had two arms: cases, using MicroAIR U100, and controls, using MDI+spacer device. Both devices were adopted for long-term treatment and for exacerbations. Follow-up was organized with clinical visits and a daily e-diary connected to an application for mobile phone. One hundred patients were enrolled. The frequency of asthmatic symptoms showed a non-inferiority for MicroAIR U100 group vs. MDI. Accordingly, no significant difference was found in the average % of days with cough, wheezing, breathlessness after exercise, days lost at school, and not-programmed visits. Considering only patients with >1 day with symptoms, no significant sdifferences were found in the number of exacerbations nor in the cumulative days with symptoms. The acceptance and usability of both devices have been favorable. However, the MDI+AeroChamber® device showed better acceptability. Our study shows that MicroAIR U-100, a mesh nebulizer, has similar clinical efficacy but lower acceptance and usability than an MDI plus Aerochamber® in delivering therapy in preschool wheezers. Therefore, MicroAIR U-100 might be a valuable second choice, when the delivery of medication with an MDI plus Aerochamber® is not accepted, or wrongly used by the parents.
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http://dx.doi.org/10.3389/fped.2020.598690DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7758231PMC
December 2020

A study of longitudinal mobile health data through fuzzy clustering methods for functional data: The case of allergic rhinoconjunctivitis in childhood.

PLoS One 2020 17;15(11):e0242197. Epub 2020 Nov 17.

Department of Pediatric Pneumology and Immunology, Charitè Medical University of Berlin, Berlin, Germany.

The use of mobile communication devices in health care is spreading worldwide. A huge amount of health data collected by these devices (mobile health data) is nowadays available. Mobile health data may allow for real-time monitoring of patients and delivering ad-hoc treatment recommendations. This paper aims at showing how this may be done by exploiting the potentialities of fuzzy clustering techniques. In fact, such techniques can be fruitfully applied to mobile health data in order to identify clusters of patients for diagnostic classification and cluster-specific therapies. However, since mobile health data are full of noise, fuzzy clustering methods cannot be directly applied to mobile health data. Such data must be denoised prior to analyzing them. When longitudinal mobile health data are available, functional data analysis represents a powerful tool for filtering out the noise in the data. Fuzzy clustering methods for functional data can then be used to determine groups of patients. In this work we develop a fuzzy clustering method, based on the concept of medoid, for functional data and we apply it to longitudinal mHealth data on daily symptoms and consumptions of anti-symptomatic drugs collected by two sets of patients in Berlin (Germany) and Ascoli Piceno (Italy) suffering from allergic rhinoconjunctivitis. The studies showed that clusters of patients with similar changes in symptoms were identified opening the possibility of precision medicine.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242197PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7671550PMC
January 2021

Validation study of a new chemiluminescent singleplex IgE assay in a set of Italian allergic rhinitis patients.

Clin Exp Allergy 2021 Apr 20;51(4):604-613. Epub 2020 Dec 20.

Division of Pneumonology, Immunology and Intensive Medicine, Department of Pediatrics, Charité - Universitätsmedizin, Berlin, Germany.

Background: The measurement of specific IgE to allergenic extracts and molecules in patients with allergic rhinitis (AR) is crucial for a precise diagnosis and further immunotherapy. Companies providing in vitro diagnostic methods in allergology continuously strive for the optimization and modernization of such methods. A new generation of automated allergy tests based on chemiluminescence detection and paramagnetic microparticles is now available, with possible advantages in sample volume, cost-effectiveness and avoidance of sample-related interference.

Objectives: To test whether sIgE antibody levels obtained with a new singleplex chemiluminescent method have a good agreement with the corresponding results obtained with a "gold standard" test.

Methods: We tested sera from 368 AR patients. Specific IgE sera levels (kU/L) to a comprehensive panel of 15 allergen extracts and 6 molecules were tested with ImmunoCAP (Thermo Fisher Scientific Inc, Phadia AB, Uppsala, Sweden) and NOVEOS™ (HYCOR Biomedical, Garden Grove, CA, USA). We evaluated the qualitative and quantitative performance of the new NOVEOS system in matching the outcome of ImmunoCAP to each of the examined allergens.

Results: In relation to ImmunoCAP, the overall diagnostic sensitivity and specificity of sIgE tests with NOVEOS were 90.8% (95% CI = 88.6-92.7) and 96.2% (95% CI = 93.9-97.8), respectively. These values were higher when only molecules were considered (sensitivity = 98.7% [95% CI = 96.4%-99.7%]; specificity = 94.2% [95% CI = 88.4%-97.6%]) and lower when only extracts were considered (sensitivity = 87.6% [95% CI = 84.7%-90.2%]; specificity = 97% [95% CI = 94.4%-98.6%]). Spearman's correlation between the data set of both methods for a ≥ 0.1 kU/L cut-off was 0.84 (p < .001).

Conclusions: The new singleplex NOVEOS system presented good results for qualitative and quantitative comparisons when testing specific serum IgE antibodies against a range of 21 allergens. This novel immunoassay system using only 4 µl of sample per test appears to be robust and reliable and can, therefore, be used as an aid in allergy diagnosis.
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http://dx.doi.org/10.1111/cea.13785DOI Listing
April 2021

The Potential of Clinical Decision Support Systems for Prevention, Diagnosis, and Monitoring of Allergic Diseases.

Front Immunol 2020 10;11:2116. Epub 2020 Sep 10.

Department of Pediatric Pulmonology, Immunology and Critical Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.

Clinical decision support systems (CDSS) aid health care professionals (HCP) in evaluating large sets of information and taking informed decisions during their clinical routine. CDSS are becoming particularly important in the perspective of precision medicine, when HCP need to consider growing amounts of data to create precise patient profiles for personalized diagnosis, treatment and outcome monitoring. In allergy care, several CDSS are being developed and investigated, mainly for respiratory allergic diseases. Although the proposed solutions address different stakeholders, the majority aims at facilitating evidence-based and shared decision-making, incorporating guidelines, and real-time clinical data. We offer here an overview on existing tools, new developments and novel concepts and discuss the potential of digital CDSS in improving prevention, diagnosis and monitoring of allergic diseases.
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http://dx.doi.org/10.3389/fimmu.2020.02116DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7511544PMC
September 2020

Use of biologicals in allergic and type-2 inflammatory diseases during the current COVID-19 pandemic: Position paper of Ärzteverband Deutscher Allergologen (AeDA), Deutsche Gesellschaft für Allergologie und Klinische Immunologie (DGAKI), Gesellschaft für Pädiatrische Allergologie und Umweltmedizin (GPA), Österreichische Gesellschaft für Allergologie und Immunologie (ÖGAI), Luxemburgische Gesellschaft für Allergologie und Immunologie (LGAI), Österreichische Gesellschaft für Pneumologie (ÖGP) in co-operation with the German, Austrian, and Swiss ARIA groups, and the European Academy of Allergy and Clinical Immunology (EAACI).

Authors:
Ludger Klimek Oliver Pfaar Margitta Worm Thomas Eiwegger Jan Hagemann Markus Ollert Eva Untersmayr Karin Hoffmann-Sommergruber Alessandra Vultaggio Ioana Agache Sevim Bavbek Apostolos Bossios Ingrid Casper Susan Chan Alexia Chatzipetrou Christian Vogelberg Davide Firinu Paula Kauppi Antonios Kolios Akash Kothari Andrea Matucci Oscar Palomares Zsolt Szépfalusi Wolfgang Pohl Wolfram Hötzenecker Alexander R Rosenkranz Karl-Christian Bergmann Thomas Bieber Roland Buhl Jeroen Buters Ulf Darsow Thomas Keil Jörg Kleine-Tebbe Susanne Lau Marcus Maurer Hans Merk Ralph Mösges Joachim Saloga Petra Staubach Uta Jappe Klaus F Rabe Uta Rabe Claus Vogelmeier Tilo Biedermann Kirsten Jung Wolfgang Schlenter Johannes Ring Adam Chaker Wolfgang Wehrmann Sven Becker Laura Freudelsperger Norbert Mülleneisen Katja Nemat Wolfgang Czech Holger Wrede Randolf Brehler Thomas Fuchs Peter-Valentin Tomazic Werner Aberer Antje-Henriette Fink-Wagner Fritz Horak Stefan Wöhrl Verena Niederberger-Leppin Isabella Pali-Schöll Wolfgang Pohl Regina Roller-Wirnsberger Otto Spranger Rudolf Valenta Mübecell Akdis Paolo M Matricardi François Spertini Nicolai Khaltaev Jean-Pierre Michel Larent Nicod Peter Schmid-Grendelmeier Marco Idzko Eckard Hamelmann Thilo Jakob Thomas Werfel Martin Wagenmann Christian Taube Erika Jensen-Jarolim Stephanie Korn Francois Hentges Jürgen Schwarze Liam O Mahony Edward F Knol Stefano Del Giacco Tomás Chivato Pérez Jean Bousquet Anna Bedbrook Torsten Zuberbier Cezmi Akdis Marek Jutel

Allergol Select 2020 7;4:53-68. Epub 2020 Sep 7.

European Academy of Allergy and Clinical Immunology (EAACI).

Background: Since the beginning of the COVID-19 pandemic, the treatment of patients with allergic and atopy-associated diseases has faced major challenges. Recommendations for "social distancing" and the fear of patients becoming infected during a visit to a medical facility have led to a drastic decrease in personal doctor-patient contacts. This affects both acute care and treatment of the chronically ill. The immune response after SARS-CoV-2 infection is so far only insufficiently understood and could be altered in a favorable or unfavorable way by therapy with monoclonal antibodies. There is currently no evidence for an increased risk of a severe COVID-19 course in allergic patients. Many patients are under ongoing therapy with biologicals that inhibit type 2 immune responses via various mechanisms. There is uncertainty about possible immunological interactions and potential risks of these biologicals in the case of an infection with SARS-CoV-2.

Materials And Methods: A selective literature search was carried out in PubMed, Livivo, and the internet to cover the past 10 years (May 2010 - April 2020). Additionally, the current German-language publications were analyzed. Based on these data, the present position paper provides recommendations for the biological treatment of patients with allergic and atopy-associated diseases during the COVID-19 pandemic.

Results: In order to maintain in-office consultation services, a safe treatment environment must be created that is adapted to the pandemic situation. To date, there is a lack of reliable study data on the care for patients with complex respiratory, atopic, and allergic diseases in times of an imminent infection risk from SARS-CoV-2. Type-2-dominant immune reactions, as they are frequently seen in allergic patients, could influence various phases of COVID-19, e.g., by slowing down the immune reactions. Theoretically, this could have an unfavorable effect in the early phase of a SARS-Cov-2 infection, but also a positive effect during a cytokine storm in the later phase of severe courses. However, since there is currently no evidence for this, all data from patients treated with a biological directed against type 2 immune reactions who develop COVID-19 should be collected in registries, and their disease courses documented in order to be able to provide experience-based instructions in the future.

Conclusion: The use of biologicals for the treatment of bronchial asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, and spontaneous urticaria should be continued as usual in patients without suspected infection or proven SARS-CoV-2 infection. If available, it is recommended to prefer a formulation for self-application and to offer telemedical monitoring. Treatment should aim at the best possible control of difficult-to-control allergic and atopic diseases using adequate rescue and add-on therapy and should avoid the need for systemic glucocorticosteroids. If SARS-CoV-2 infection is proven or reasonably suspected, the therapy should be determined by weighing the benefits and risks individually for the patient in question, and the patient should be involved in the decision-making. It should be kept in mind that the potential effects of biologicals on the immune response in COVID-19 are currently not known. Telemedical offers are particularly desirable for the acute consultation needs of suitable patients.
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http://dx.doi.org/10.5414/ALX02166EDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7480069PMC
September 2020

Personalized medicine for allergy treatment: Allergen immunotherapy still a unique and unmatched model.

Allergy 2021 Apr 19;76(4):1041-1052. Epub 2020 Oct 19.

Personalized Medicine, Asthma & Allergy - Humanitas Clinical and Research Center IRCCS, Rozzano, Italy.

The introduction of personalized medicine (PM) has been a milestone in the history of medical therapy, because it has revolutionized the previous approach of treating the disease with that of treating the patient. It is known today that diseases can occur in different genetic variants, making specific treatments of proven efficacy necessary for a given endotype. Allergic diseases are particularly suitable for PM, because they meet the therapeutic success requirements, including a known molecular mechanism of the disease, a diagnostic tool for such disease, and a treatment blocking the mechanism. The stakes of PM in allergic patients are molecular diagnostics, to detect specific IgE to single-allergen molecules and to distinguish the causative molecules from those merely cross-reactive, pursuit of patient's treatable traits addressing genetic, phenotypic, and psychosocial features, and omics, such as proteomics, epi-genomics, metabolomics, and breathomics, to forecast patient's responsiveness to therapies, to detect biomarker and mediators, and to verify the disease control. This new approach has already improved the precision of allergy diagnosis and is likely to significantly increase, through the higher performance achieved with the personalized treatment, the effectiveness of allergen immunotherapy by enhancing its already known and unique characteristics of treatment that acts on the causes.
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http://dx.doi.org/10.1111/all.14575DOI Listing
April 2021

Digital technologies for an improved management of respiratory allergic diseases: 10 years of clinical studies using an online platform for patients and physicians.

Ital J Pediatr 2020 Jul 25;46(1):105. Epub 2020 Jul 25.

Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.

Background: Digital health technologies carry the great potential of assisting physicians in making well-informed diagnostic and therapeutic decisions. In allergy care, electronic clinical diaries have been recently used to prospectively collect patient data and improve diagnostic precision.

Objective: This review summarizes the clinical and scientific experience we gathered over 10 years of using a digital platform for patients suffering from seasonal allergic rhinitis.

Methods: The mobile application and back-office of AllergyMonitor (TPS software production, Rome, Italy) enable patients to record their daily allergy symptoms as well as drug and immunotherapy intake plus possible side effects in a customizable way. The results can be accessed by the patient and attending physician as concise reports via a smartphone or computer. This technology has been used in several clinical studies and routine practice since 2009.

Results: Our studies showed that A) the etiological diagnosis of SAR may be supported by matching prospectively registered symptoms with pollen counts; B) it is possible to perform a short-term prediction of SAR-symptoms at individual level; C) the adherence to daily symptom monitoring can remain high (> 80%) throughout several weeks when prescribed and thoroughly explained by the treating doctor; D) the use of mobile technology can improve adherence to symptomatic drugs as well as allergen-specific immunotherapy and E) the choice of the correct symptom-severity-score is critical at patient level, but not at group level.

Conclusion: The studies and clinical practice based on the use of AllergyMonitor have proven the reliability and positive impact of a digital platform including an electronic diary (eDiary) on the diagnostic precision of SAR in poly-sensitized patients as well as patient adherence to both, drug therapy and allergen immunotherapy.
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http://dx.doi.org/10.1186/s13052-020-00870-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7382563PMC
July 2020

Allergen immunotherapy in the current COVID-19 pandemic: A position paper of AeDA, ARIA, EAACI, DGAKI and GPA: Position paper of the German ARIA Group in cooperation with the Austrian ARIA Group, the Swiss ARIA Group, German Society for Applied Allergology (AEDA), German Society for Allergology and Clinical Immunology (DGAKI), Society for Pediatric Allergology (GPA) in cooperation with AG Clinical Immunology, Allergology and Environmental Medicine of the DGHNO-KHC and the European Academy of Allergy and Clinical Immunology (EAACI).

Allergol Select 2020 28;4:44-52. Epub 2020 May 28.

German ARIA Group.

No abstract available.
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http://dx.doi.org/10.5414/ALX02147EDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304289PMC
May 2020

Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology.

Clin Chem Lab Med 2020 Oct;58(11):1865-1874

Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps University Marburg, German Center for Lung Research (DZL), Marburg, Germany.

Objectives Detection of allergen-specific immunoglobulin E (sIgE) is important for the diagnosis of allergy. IgE sensitization is commonly demonstrated in vivo by skin prick testing (SPT), or in vitro utilizing automated systems. Recently, HYCOR® Biomedical launched its new system for allergen sIgE testing called the NOVEOS™ Immunoanalyzer. This study aims to evaluate the analytical performance of the NOVEOS system in a bi-center study at Philipps-University Marburg (Site-1) and Charité Medical University Berlin (Site-2), respectively. Methods The analytical performance was evaluated based on the guidelines I/LA20-A3, EP5-A3, EP17-A2, EP6-A, EP7-A3, and EP9-A3 of the Clinical and Laboratory Standards Institute (CLSI). Results The conducted repeatability and within-laboratory precision tests provided acceptable performance with 3.0%-11.9% coefficient of variation across both sites. The limit of blank (LoB) and limit of detection (LoD) were <0.1 kU/L at both centers. A within-parameter linearity for all tested allergens was reported at both sites. Of note, no significant interference was observed for high levels of biotin, methylprednisolone, diphenhydramine, omalizumab, or ranitidine. Method comparison between the NOVEOS calibration and the latest World Health Organization (WHO) reference standard showed good agreement at both sites. Conclusions The results from the analytical performance of the NOVEOS allergen sIgE assay and instrument testing at both sites were comparable. Overall, a good precision and linearity as well as a detection limit <0.1 kU/L were observed, with minimal impact of common interfering substances on patient recoveries. The NOVEOS is calibrated to the latest WHO reference standard and adds benefits like a small sample size and para-magnetic microparticles that improve upon third-generation allergen sIgE assays' design and performance.
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http://dx.doi.org/10.1515/cclm-2020-0535DOI Listing
October 2020

Anwendung von Biologika bei allergischen und Typ-2-entzündlichen Erkrankungen in der aktuellen Covid-19-Pandemie: Positionspapier des Ärzteverbands Deutscher Allergologen (AeDA)A, der Deutschen Gesellschaft für Allergologie und klinische Immunologie (DGAKI)B, der Gesellschaft für Pädiatrische Allergologie und Umweltmedizin (GPA)C, der Österreichischen Gesellschaft für Allergologie und Immunologie (ÖGAI)D, der Luxemburgischen Gesellschaft für Allergologie und Immunologie (LGAI)E, der Österreichischen Gesellschaft für Pneumologie (ÖGP)F in Kooperation mit der deutschen, österreichischen, und schweizerischen ARIA-GruppeG und der Europäischen Akademie für Allergologie und Klinische Immunologie (EAACI)H.

Allergo J 2020 24;29(4):14-27. Epub 2020 Jun 24.

Zentrum für Rhinologie & Allergologie, An den Quellen 10, 65183 Wiesbaden, Germany.

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http://dx.doi.org/10.1007/s15007-020-2553-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7289636PMC
June 2020

COVID-19 pandemic: Practical considerations on the organization of an allergy clinic-An EAACI/ARIA Position Paper.

Allergy 2021 03;76(3):648-676

Transylvania University, Brasov, Romania.

Background: The coronavirus disease 2019 (COVID-19) has evolved into a pandemic infectious disease transmitted by the severe acute respiratory syndrome coronavirus (SARS-CoV-2). Allergists and other healthcare providers (HCPs) in the field of allergies and associated airway diseases are on the front line, taking care of patients potentially infected with SARS-CoV-2. Hence, strategies and practices to minimize risks of infection for both HCPs and treated patients have to be developed and followed by allergy clinics.

Method: The scientific information on COVID-19 was analysed by a literature search in MEDLINE, PubMed, the National and International Guidelines from the European Academy of Allergy and Clinical Immunology (EAACI), the Cochrane Library, and the internet.

Results: Based on the diagnostic and treatment standards developed by EAACI, on international information regarding COVID-19, on guidelines of the World Health Organization (WHO) and other international organizations, and on previous experience, a panel of experts including clinicians, psychologists, IT experts, and basic scientists along with EAACI and the "Allergic Rhinitis and its Impact on Asthma (ARIA)" initiative have developed recommendations for the optimal management of allergy clinics during the current COVID-19 pandemic. These recommendations are grouped into nine sections on different relevant aspects for the care of patients with allergies.

Conclusions: This international Position Paper provides recommendations on operational plans and procedures to maintain high standards in the daily clinical care of allergic patients while ensuring the necessary safety measures in the current COVID-19 pandemic.
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http://dx.doi.org/10.1111/all.14453DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323448PMC
March 2021

IgE to cross-reactive carbohydrate determinants: Origins, functions, and confounding role in nPhl p 4-IgE assays.

J Allergy Clin Immunol 2020 06;145(6):1554-1555

Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.jaci.2020.04.012DOI Listing
June 2020

EAACI Allergen Immunotherapy User's Guide.

Pediatr Allergy Immunol 2020 05;31 Suppl 25:1-101

Department of Paediatrics, Imperial College London, London, UK.

Allergen immunotherapy is a cornerstone in the treatment of allergic children. The clinical efficiency relies on a well-defined immunologic mechanism promoting regulatory T cells and downplaying the immune response induced by allergens. Clinical indications have been well documented for respiratory allergy in the presence of rhinitis and/or allergic asthma, to pollens and dust mites. Patients who have had an anaphylactic reaction to hymenoptera venom are also good candidates for allergen immunotherapy. Administration of allergen is currently mostly either by subcutaneous injections or by sublingual administration. Both methods have been extensively studied and have pros and cons. Specifically in children, the choice of the method of administration according to the patient's profile is important. Although allergen immunotherapy is widely used, there is a need for improvement. More particularly, biomarkers for prediction of the success of the treatments are needed. The strength and efficiency of the immune response may also be boosted by the use of better adjuvants. Finally, novel formulations might be more efficient and might improve the patient's adherence to the treatment. This user's guide reviews current knowledge and aims to provide clinical guidance to healthcare professionals taking care of children undergoing allergen immunotherapy.
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http://dx.doi.org/10.1111/pai.13189DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7317851PMC
May 2020

The first, holistic immunological model of COVID-19: Implications for prevention, diagnosis, and public health measures.

Pediatr Allergy Immunol 2020 07 5;31(5):454-470. Epub 2020 Jun 5.

Unit of Immunology, Dipartimento di Malattie Infettive, Istituto Superiore di Sanità, Rome, Italy.

The natural history of COVID-19 caused by SARS-CoV-2 is extremely variable, ranging from asymptomatic or mild infection, mainly in children, to multi-organ failure, eventually fatal, mainly in the eldest. We propose here the first model explaining how the outcome of first, crucial 10-15 days after infection, depends on the balance between the cumulative dose of viral exposure and the efficacy of the local innate immune response (natural IgA and IgM antibodies, mannose-binding lectin). If SARS-CoV-2 runs the blockade of this innate immunity and spreads from the upper airways to the alveoli in the early phases of the infections, it can replicate with no local resistance, causing pneumonia and releasing high amounts of antigens. The delayed and strong adaptive immune response (high-affinity IgM and IgG antibodies) that follows, causes severe inflammation and triggers mediator cascades (complement, coagulation, and cytokine storm), leading to complications often requiring intensive therapy and being, in some patients, fatal. Low-moderate physical activity can still be recommended. However, extreme physical activity and oral breathing with hyperventilation during the incubation days and early stages of COVID-19 facilitates re-inhalation and early direct penetration of high numbers of own virus particles in the lower airways and the alveoli, without impacting on the airway's mucosae covered by neutralizing antibodies ("viral auto-inhalation" phenomenon). This allows the virus to bypass the efficient immune barrier of the upper airway mucosa in already infected, young, and otherwise healthy athletes. In conclusion, whether the virus or the adaptive immune response reaches the lungs first is a crucial factor deciding the fate of the patient. This "quantitative and time-/sequence-dependent" model has several implications for prevention, diagnosis, and therapy of COVID-19 at all ages.
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http://dx.doi.org/10.1111/pai.13271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267459PMC
July 2020

IgA-Ab response to spike glycoprotein of SARS-CoV-2 in patients with COVID-19: A longitudinal study.

Clin Chim Acta 2020 Aug 25;507:164-166. Epub 2020 Apr 25.

Department of Medicine-DIMED, University of Padova, Italy; Department of Laboratory Medicine, University-Hospital of Padova, Italy. Electronic address:

Validation studies of serological antibody tests must be properly designed for clinical, epidemiological and Public Health objectives such as confirmation of suspected COVID-19 cases, certification of seroconversion after infection, and epidemiological surveillance. We evaluated the kinetics of IgM, IgA and IgG SARS-CoV-2 antibodies in COVID-19 patients with confirmed (rRT-PCR) infection. We found that the IgA response appears and grows early, peaks at week 3, and it is stronger and more persistent than the IgM response. Further longitudinal investigations of virus-specific antibodies functions and of their protective efficacy over time are needed.
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http://dx.doi.org/10.1016/j.cca.2020.04.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7194886PMC
August 2020

Molecular profiling of allergen-specific antibody responses may enhance success of specific immunotherapy.

J Allergy Clin Immunol 2020 11 13;146(5):1097-1108. Epub 2020 Apr 13.

Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria. Electronic address:

Background: House dust mites (HDMs) are among the most important allergen sources containing many different allergenic molecules. Analysis of patients from a double-blind, placebo-controlled allergen-specific immunotherapy (AIT) study indicated that patients may benefit from AIT to different extents depending on their molecular sensitization profiles.

Objective: Our aim was to investigate in a real-life setting whether stratification of patients with HDM allergy according to molecular analysis may enhance AIT success.

Methods: Serum and nasal secretion samples from patients with HDM allergy (n = 24) (at baseline, 7, 15, 33, and 52 weeks) who had received 1 year of treatment with a well-defined subcutaneous AIT form (Alutard SQ 510) were tested for IgE and IgG reactivity to 15 microarrayed HDM allergen molecules with ImmunoCAP Immuno-solid-phase Allergen Chip technology. IgG subclass levels to allergens and peptides were determined by ELISA, and IgG blocking was assessed by basophil activation. In vitro parameters were related to reduction of symptoms determined by combined symptom medication score and visual analog scale score.

Results: Alutard SQ 510 induced protective IgG mainly against Dermatophagoides pteronyssinus (Der p) 1 and Der p 2 and to a lesser extent to Der p 23, but not to the other important allergens such as Der p 5, Der p 7, and Der p 21, showing better clinical efficacy in patients sensitized only to Der p 1 and/or Der p 2 as compared with patients having additional IgE specificities.

Conclusion: Stratification of patients with HDM allergy according to molecular sensitization profiles and molecular monitoring of AIT-induced IgG responses may enhance the success of AIT.
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http://dx.doi.org/10.1016/j.jaci.2020.03.029DOI Listing
November 2020

Adherence to Prescribed E-Diary Recording by Patients With Seasonal Allergic Rhinitis: Observational Study.

J Med Internet Res 2020 03 16;22(3):e16642. Epub 2020 Mar 16.

Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité University Medicine, Berlin, Germany.

Background: Complete diagnosis and therapy of seasonal allergic rhinoconjunctivitis require evidence that exposure to the sensitizing pollen triggers allergic symptoms. Electronic clinical diaries, by recording disease severity scores and pollen exposure, can demonstrate this association. However, patients who spontaneously download an e-diary app show very low adherence to their recording.

Objective: The objective of our study was to assess adherence of patients with seasonal allergic rhinitis to symptom recording via e-diary explicitly prescribed by an allergist within a blended care approach.

Methods: The @IT-2020 project is investigating the diagnostic synergy of mobile health and molecular allergology in patients with seasonal allergic rhinitis. In the pilot phase of the study, we recruited Italian children (Rome, Italy) and adults (Pordenone, Italy) with seasonal allergic rhinitis and instructed them to record their symptoms, medication intake, and general conditions daily through a mobile app (Allergy.Monitor) during the relevant pollen season.

Results: Overall, we recruited 101 Italian children (Rome) and 93 adults (Pordenone) with seasonal allergic rhinitis. Adherence to device use slowly declined during monitoring in 3 phases: phase A: first week, ≥1267/1358, 90%; phase B: second to sixth week, 4992/5884, 80% to 90%; and phase C: seventh week onward, 2063/2606, 70% to 80%. At the individual level, the adherence assessed in the second and third weeks of recording predicted with enough confidence (Rome: Spearman ρ=0.75; P<.001; Pordenone: ρ=0.81; P<.001) the overall patient adherence to recording and was inversely related to postponed reporting (ρ=-0.55; P<.001; in both centers). Recording adherence was significantly higher during the peak grass pollen season in Rome, but not in Pordenone.

Conclusions: Adherence to daily recording in an e-diary, prescribed and motivated by an allergist in a blended care setting, was very high. This observation supports the use of e-diaries in addition to face-to-face visits for diagnosis and treatment of seasonal allergic rhinitis and deserves further investigation in real-life contexts.
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http://dx.doi.org/10.2196/16642DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105930PMC
March 2020

Research Priorities in Pediatric Asthma: Results of a Global Survey of Multiple Stakeholder Groups by the Pediatric Asthma in Real Life (PeARL) Think Tank.

J Allergy Clin Immunol Pract 2020 06 4;8(6):1953-1960.e9. Epub 2020 Mar 4.

Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester, United Kingdom; Allergy Department, 2nd Paediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece. Electronic address:

Background: Pediatric asthma remains a public health challenge with enormous impact worldwide.

Objective: The aim of this study was to identify and prioritize unmet clinical needs in pediatric asthma, which could be used to guide future research and policy activities.

Methods: We first identified unmet needs through an open-question survey administered to international experts in pediatric asthma who were members of the Pediatric Asthma in Real Life Think Tank. Prioritization of topics was then achieved through a second, extensive survey with global reach, of multiple stakeholders (leading experts, researchers, clinicians, patients, policy makers, and the pharmaceutical industry). Differences across responder groups were compared.

Results: A total of 57 unmet clinical need topics identified by international experts were prioritized by 412 participants from 5 continents and 60 countries. Prevention of disease progression and prediction of future risk, including persistence into adulthood, emerged as the most urgent research questions. Stratified care, based on biomarkers, clinical phenotypes, the children's age, and demographics were also highly rated. The identification of minimum diagnostic criteria in different age groups, cultural perceptions of asthma, and best treatment by age group were priorities for responders from low-middle-income countries. There was good agreement across different stakeholder groups in all domains with some notable exceptions that highlight the importance of involving the whole range of stakeholders in formulation of recommendations.

Conclusions: Different stakeholders agree in the majority of research and strategic (eg, prevention, personalized approach) priorities for pediatric asthma. Stakeholder diversity is crucial for highlighting divergent issues that future guidelines should consider.
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http://dx.doi.org/10.1016/j.jaip.2020.01.059DOI Listing
June 2020

Toward personalization of asthma treatment according to trigger factors.

J Allergy Clin Immunol 2020 06 18;145(6):1529-1534. Epub 2020 Feb 18.

Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna, Austria; Laboratory of Immunopathology, Department of Clinical Immunology and Allergy, Sechenov First Moscow State Medical University, Moscow, Russia; NRC Institute of Immunology FMBA of Russia, Moscow, Russia; Division of Immunology and Allergy, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden; Karl Landsteiner University, Krems, Austria. Electronic address:

Asthma is a severe and chronic disabling disease affecting more than 300 million people worldwide. Although in the past few drugs for the treatment of asthma were available, new treatment options are currently emerging, which appear to be highly effective in certain subgroups of patients. Accordingly, there is a need for biomarkers that allow selection of patients for refined and personalized treatment strategies. Recently, serological chip tests based on microarrayed allergen molecules and peptides derived from the most common rhinovirus strains have been developed, which may discriminate 2 of the most common forms of asthma, that is, allergen- and virus-triggered asthma. In this perspective, we argue that classification of patients with asthma according to these common trigger factors may open new possibilities for personalized management of asthma.
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http://dx.doi.org/10.1016/j.jaci.2020.02.001DOI Listing
June 2020

Digital allergology: Towards a clinical decision support system for allergen immunotherapy.

Pediatr Allergy Immunol 2020 02;31 Suppl 24:61-64

Department of Pediatrics, Pediatric Allergy Unit, Sandro Pertini Hospital, Rome, Italy.

Mobile health is the "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices." For example, mobile apps (such as MASK-Air, Allergy.Monitor, Pollen, and others) have proven useful in the management of patients with allergic rhinitis. These apps can be used in the context of broader clinical decision support systems (CDSS) for enhancing allergy-related decisions and actions with pertinent, organized clinical knowledge and patient information to improve allergy care. A CDSS targeted to control rhinitis with drugs and other interventions guiding the patient in his/her self- and doctor-driven management is currently being produced and investigated by the MACVIA network. Another one, called @IT-2020, is targeted to support etiologic diagnostics and allergen immunotherapy (AIT) prescriptions for patients with seasonal allergic rhinitis. Intensive investigation is necessary to better define the advantages and limitations of mobile-health technology in allergology and establish guidelines for their proper use in daily practice in the context of a rapidly evolving European regulatory environment.
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http://dx.doi.org/10.1111/pai.13165DOI Listing
February 2020

"Whole" vs. "fragmented" approach to EAACI pollen season definitions: A multicenter study in six Southern European cities.

Allergy 2020 07 11;75(7):1659-1671. Epub 2020 May 11.

Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.

Background: The adequate definition of pollen seasons is essential to facilitate a correct diagnosis, treatment choice, and outcome assessment in patients with seasonal allergic rhinitis. A position paper by the European Academy of Allergy and Clinical Immunology (EAACI) proposed season definitions for Northern and Middle Europe.

Objective: To test the pollen season definitions proposed by EAACI in six Mediterranean cities for seven pollen taxa.

Methods: As part of the @IT.2020 multi-center study, pollen counts for Poaceae, Oleaceae, Fagales, Cupressaceae, Urticaceae (Parietaria spp.), and Compositae (Ambrosia spp., Artemisia spp.) were collected from January 1 to December 31, 2018. Based on these data, pollen seasons were identified according to EAACI criteria. A unified monitoring period for patients in AIT trials was created and assessed for feasibility.

Results: The analysis revealed a great heterogeneity between the different locations in terms of pattern and length of the examined pollen seasons. Further, we found a fragmentation of pollen seasons in several segments (max. 8) separated by periods of low pollen counts (intercurrent periods). Potential monitoring periods included often many recording days with low pollen exposure (max. 341 days).

Conclusion: The Mediterranean climate leads to challenging pollen exposure times. Monitoring periods for AIT trials based on existing definitions may include many intermittent days with low pollen concentrations. Therefore, it is necessary to find an adapted pollen season definition as individual solution for each pollen and geographical area.
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http://dx.doi.org/10.1111/all.14153DOI Listing
July 2020

IgE antibody repertoire in nasal secretions of children and adults with seasonal allergic rhinitis: A molecular analysis.

Pediatr Allergy Immunol 2020 04 22;31(3):273-280. Epub 2020 Jan 22.

Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.

Background: There is growing interest both in testing IgE in nasal secretions (NS) and in molecular diagnosis of seasonal allergic rhinitis (SAR). Yet, the reliability of nasal IgE detection with the newest molecular assays has never been assessed in a large cohort of pollen allergic patients.

Objective: To investigate with microarray technology and compare the repertoires of specific IgE (sIgE) antibodies in NS and sera of a large population of children and adults with SAR.

Methods: Nasal secretions were collected with an absorbent device (Merocel 2000 , Medtronic) and a minimal dilution procedure from 90 children and 71 adults with SAR. Total IgE (tIgE) (ImmunoCAP, Thermo Fisher Scientific (TFS)) and sIgE antibodies against 112 allergen molecules (ISAC-112, TFS) were measured in NS and serum.

Results: Nasal sIgE was detectable in 68.3% of the patients. The detected nasal sIgE antibodies recognized airborne (88%), vegetable (10%), and animal food or other (<1%) allergen molecules. The prevalence and average levels of sIgE in NS and serum were highly interrelated at population level. A positive nasal sIgE antibody to a given molecule predicted the detection of the same antibody in the patient's serum with a specificity of 99.7% and a sensitivity of 40%.

Conclusions: The concentration of sIgE is much lower in nasal secretions than in the serum. sIgE assays with very high analytical sensitivity and sampling methods with minimal dilution will be therefore needed to validate nasal secretions as alternative to serum in testing the sIgE repertoire.
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http://dx.doi.org/10.1111/pai.13148DOI Listing
April 2020

Component-Resolved Diagnosis in Allergic Rhinitis and Asthma.

J Appl Lab Med 2019 03 12;3(5):883-898. Epub 2018 Nov 12.

Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps Universität Marburg, German Center for Lung Research (DZL), Marburg, Germany;

Background: Allergic rhinitis and asthma are highly prevalent chronic inflammatory diseases leading to restrictions in the patient's quality of life and high costs for healthcare systems. Both diseases are associated with the presence of specific IgE (sIgE) against aeroallergens. This review aims to examine the importance of molecular allergy diagnostics in the assessment and management of these disorders.

Content: The "U-shaped" approach, proposed by the European Academy of Allergy and Clinical Immunology, combines conventional allergy diagnostics with the benefits of component-resolved diagnosis (CRD) and offers important additional information regarding the patient's sensitization pattern, especially in complex clinical cases such as polysensitization or idiopathic reactions, thus avoiding overuse of in vitro and in vivo IgE diagnostics. CRD may help the clinician to identify the cause of an allergy and, in the case of complex polysensitization, uncover possible cross-reactivity. Polysensitization, especially to inhalant allergens, is associated with the clinical appearance of asthma and allergic rhinitis; important risk factors for the latter are the major allergens Fel d 1 and Can f 1. Importantly, information on molecular sensitization patterns significantly influences the choice of specific immunotherapy and reduces its overprescription.

Conclusion: At present, allergy diagnostics largely rely on clinical history, physical examination, and in vivo IgE testing. However, in vitro diagnostics including CRD are currently finding their way into the clinical routine and can offer additional information on the patient's sensitization profile and treatment responsiveness.
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http://dx.doi.org/10.1373/jalm.2018.026526DOI Listing
March 2019

Molecular Diagnosis of Allergy: The Pediatric Perspective.

Front Pediatr 2019 24;7:369. Epub 2019 Sep 24.

Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité University Medicine Berlin, Berlin, Germany.

In times of "Precision Medicine" it is fundamental to identify the individual disease phenotype in order to provide an individualized therapy for every patient. This concept is also becoming increasingly important for the treatment of allergic diseases. Thanks to the biological engineering of recombinant and native allergens for the assessment of allergen-specific IgE antibodies, it is now possible to easily obtain the individual sensitization profile of a patient. This allows the allergist to precisely identify the primary elicitor of an IgE response and, based on this knowledge, to choose the best treatment option. Several studies have observed the longitudinal evolution of sensitization profiles and identified a phenomenon termed "molecular spreading," which describes a broadening of the recognized allergen spectrum from a source over time. Additionally, the identification of marker proteins, which can trigger an IgE response or correlate with an increased risk for certain clinical symptoms, helps to establish an individual risk profile. This information may not only affect the decision-making concerning immunotherapy, but also opens up avenues for future investigations with regard to prevention strategies. We provide here an overview on the role of individual sensitization patterns and their predictive value.
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http://dx.doi.org/10.3389/fped.2019.00369DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6768979PMC
September 2019

Mobile Technology in Allergic Rhinitis: Evolution in Management or Revolution in Health and Care?

J Allergy Clin Immunol Pract 2019 Nov - Dec;7(8):2511-2523. Epub 2019 Aug 21.

Charité-Universitätsmedizin Berlin, Berlin, Germany; Corporate member of Freie Universität Berlin, Humboldt-Uniersität zu Berlin, and Berlin Institute of Health, Comprehensive Allergy-Centre, Department of Dermatology and Allergy, Berlin, Germany; Member of GA(2)LEN, Berlin, Germany.

Smart devices and Internet-based applications (apps) are largely used in allergic rhinitis and may help to address some unmet needs. However, these new tools need to first of all be tested for privacy rules, acceptability, usability, and cost-effectiveness. Second, they should be evaluated in the frame of the digital transformation of health, their impact on health care delivery, and health outcomes. This review (1) summarizes some existing mobile health apps for allergic rhinitis and reviews those in which testing has been published, (2) discusses apps that include risk factors of allergic rhinitis, (3) examines the impact of mobile health apps in phenotype discovery, (4) provides real-world evidence for care pathways, and finally (5) discusses mobile health tools enabling the digital transformation of health and care, empowering citizens, and building a healthier society.
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http://dx.doi.org/10.1016/j.jaip.2019.07.044DOI Listing
October 2020

The role of mobile health technologies in allergy care: An EAACI position paper.

Allergy 2020 02 16;75(2):259-272. Epub 2019 Sep 16.

Transylvania University Brasov, Brasov, Romania.

Mobile health (mHealth) uses mobile communication devices such as smartphones and tablet computers to support and improve health-related services, data and information flow, patient self-management, surveillance, and disease management from the moment of first diagnosis to an optimized treatment. The European Academy of Allergy and Clinical Immunology created a task force to assess the state of the art and future potential of mHealth in allergology. The task force endorsed the "Be He@lthy, Be Mobile" WHO initiative and debated the quality, usability, efficiency, advantages, limitations, and risks of mobile solutions for allergic diseases. The results are summarized in this position paper, analyzing also the regulatory background with regard to the "General Data Protection Regulation" and Medical Directives of the European Community. The task force assessed the design, user engagement, content, potential of inducing behavioral change, credibility/accountability, and privacy policies of mHealth products. The perspectives of healthcare professionals and allergic patients are discussed, underlining the need of thorough investigation for an effective design of mHealth technologies as auxiliary tools to improve quality of care. Within the context of precision medicine, these could facilitate the change in perspective from clinician- to patient-centered care. The current and future potential of mHealth is then examined for specific areas of allergology, including allergic rhinitis, aerobiology, allergen immunotherapy, asthma, dermatological diseases, food allergies, anaphylaxis, insect venom, and drug allergy. The impact of mobile technologies and associated big data sets are outlined. Facts and recommendations for future mHealth initiatives within EAACI are listed.
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http://dx.doi.org/10.1111/all.13953DOI Listing
February 2020