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      Risk and safety requirements for diagnostic and therapeutic procedures in allergology: World Allergy Organization Statement

      research-article
      1 , , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 10 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48
      The World Allergy Organization Journal
      BioMed Central

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          Abstract

          One of the major concerns in the practice of allergy is related to the safety of procedures for the diagnosis and treatment of allergic disease. Management (diagnosis and treatment) of hypersensitivity disorders involves often intentional exposure to potentially allergenic substances (during skin testing), deliberate induction in the office of allergic symptoms to offending compounds (provocation tests) or intentional application of potentially dangerous substances (allergy vaccine) to sensitized patients. These situations may be associated with a significant risk of unwanted, excessive or even dangerous reactions, which in many instances cannot be completely avoided. However, adverse reactions can be minimized or even avoided if a physician is fully aware of potential risk and is prepared to appropriately handle the situation.

          Information on the risk of diagnostic and therapeutic procedures in allergic diseases has been accumulated in the medical literature for decades; however, except for allergen specific immunotherapy, it has never been presented in a systematic fashion. Up to now no single document addressed the risk of the most commonly used medical procedures in the allergy office nor attempted to present general requirements necessary to assure the safety of these procedures.

          Following review of available literature a group of allergy experts within the World Allergy Organization (WAO), representing various continents and areas of allergy expertise, presents this report on risk associated with diagnostic and therapeutic procedures in allergology and proposes a consensus on safety requirements for performing procedures in allergy offices. Optimal safety measures including appropriate location, type and required time of supervision, availability of safety equipment, access to specialized emergency services, etc. for various procedures have been recommended.

          This document should be useful for allergists with already established practices and experience as well as to other specialists taking care of patients with allergies.

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          Most cited references231

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          EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists

          The European Position Paper on Rhinosinusitis and Nasal Polyps 2012 is the update of similar evidence based position papers published in 2005 and 2007. The document contains chapters on definitions and classification, we now also proposed definitions for difficult to treat rhinosinusitis, control of disease and better definitions for rhinosinusitis in children. More emphasis is placed on the diagnosis and treatment of acute rhinosinusitis. Throughout the document the terms chronic rhinosinusitis without nasal polyps (CRSsNP) and chronic rhinosinusitis with nasal polyps (CRSwNP) are used to further point out differences in pathophysiology and treatment of these two entities. There are extensive chapters on epidemiology and predisposing factors, inflammatory mechanisms, (differential) diagnosis of facial pain, genetics, cystic fibrosis, aspirin exacerbated respiratory disease, immunodeficiencies, allergic fungal rhinosinusitis and the relationship between upper and lower airways. The chapters on paediatric acute and chronic rhinosinusitis are totally rewritten. Last but not least all available evidence for management of acute rhinosinusitis and chronic rhinosinusitis with or without nasal polyps in adults and children is analyzed and presented and management schemes based on the evidence are proposed. This executive summary for otorhinolaryngologists focuses on the most important changes and issues for otorhinolaryngologists. The full document can be downloaded for free on the website of this journal: http://www.rhinologyjournal.com.
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            Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria.

            Many patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H-antihistamines, even at high doses. In phase 2 trials, omalizumab, an anti-IgE monoclonal antibody [corrected] that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients. In this phase 3, multicenter, randomized, double-blind study, we evaluated the efficacy and safety of omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H-antihistamine therapy (licensed doses). We randomly assigned 323 patients to receive three subcutaneous injections, spaced 4 weeks apart, of omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period. The primary efficacy outcome was the change from baseline in a weekly itch-severity score (ranging from 0 to 21, with higher scores indicating more severe itching). The baseline weekly itch-severity score was approximately 14 in all four study groups. At week 12, the mean (±SD) change from baseline in the weekly itch-severity score was -5.1±5.6 in the placebo group, -5.9±6.5 in the 75-mg group (P=0.46), -8.1±6.4 in the 150-mg group (P=0.001), and -9.8±6.0 in the 300-mg group (P<0.001). Most prespecified secondary outcomes at week 12 showed similar dose-dependent effects. The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300-mg group (6%) than in the placebo group (3%) or in either the 75-mg or 150-mg group (1% for each). Omalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.).
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              Allergen immunotherapy: a practice parameter third update.

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                Author and article information

                Contributors
                kowalsml@csk.umed.lodz.pl
                Iansotegui.bil@quironsalud.es
                werner.aberer@medunigraz.at
                monaalahmad@yahoo.com
                akdism@siaf.uzh.ch
                barbara.ballmer@usz.ch
                kirsten.beyer@charite.de
                mblancago@gmail.com
                simon.brown@uwa.edu.au
                sicbg@mahidol.ac.th
                arnaldocapriles@gmail.com
                mcastells@partners.org
                hiok_hee_chng@ttsh.com.sg
                frederic.deblay@chru-strasbourg.fr
                m-ebisawa@sagamihara-hosp.gr.jp
                SFineman@atlantaallergy.com
                dgolden1@jhmi.edu
                tari.haahtela@hus.fi
                makaliner@aol.com
                chk@allergyimmunol.com.au
                paeleebw@nus.edu.sg
                Joanna.Makowska@umed.lodz.pl
                uelimuel@sunrise.ch
                jmullol@clinic.ub.es
                nallopp@optonline.net
                hspark@ajou.ac.kr
                jparkers@health.usf.edu
                passalacqua@unige.it
                pawankar.ruby@gmail.com
                renzh@med.uni-marburg.de
                Franziska.Rueff@med.uni-muenchen.de
                sanchezbmario@gmail.com
                JSastre@fjd.es
                g.scadding@ucl.ac.uk
                scott.sicherer@mssm.edu
                ptantili@yahoo.com
                jmtracy@cox.net
                kampen@ipa-dguv.de
                barbara.bohle@meduniwien.ac.at
                lcaraballog@unicartagena.edu.co
                gomezmaximiliano@hotmail.com
                koumei_itoh@mx.achmc.pref.aichi.jp
                erika.jensen-jarolim@meduniwien.ac.at
                larche@mcmaster.ca
                giovannimelioli@gmail.com
                lkpallgy@mail.dk
                Rudolf.Valenta@meduniwien.ac.at
                Torsten.Zuberbier@charite.de
                Journal
                World Allergy Organ J
                World Allergy Organ J
                The World Allergy Organization Journal
                BioMed Central (London )
                1939-4551
                12 October 2016
                12 October 2016
                2016
                : 9
                : 1
                : 33
                Affiliations
                [1 ]Department of Immunology, Rheumatology & Allergy, Medical University of Lodz, 251 Pomorska Str, 92-213 Lodz, Poland
                [2 ]Department of Allergy and Immunology, Hospital Quiron Bizkaia, Bilbao, Spain
                [3 ]Department of Dermatology, Medical University of Graz, Graz, Austria
                [4 ]Microbiology Department, Faculty of Medicine, Kuwait University, Kuwait City, Kuwait
                [5 ]Swiss institute of Allergy & Asthma research, Davos, Switzerland
                [6 ]Allergy Unit, Dermatology Clinic, University Hospital Zürich, University Zürich, Zürich, Switzerland
                [7 ]Kirsten Beyer, Charité Universitätsmedizin Berlin, Klinik für Pädiatrie m.S. Pneumologie und Immunologie, Berlin, Germany
                [8 ]Hospital Reg. Univ. Carlos Haya, Allergy Serv, Malaga, Spain
                [9 ]Royal Perth Hospital, Department of Emergency Medicine, Perth, WA Australia
                [10 ]Department of Otolaryngology, Siriraj Hospital, Mahidol University, Bangkok, Thailand
                [11 ]Allergology Unit, Hospital San Juan de Dios, Caracas, Venezuela
                [12 ]Brigham & Women’s Hospital, Harvard Medical School, Boston, MA USA
                [13 ]Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital, Singapore, Singapore
                [14 ]Hôpitaux Universitaires de Strasbourg, Chest Diseases Department, Strasbourg, France
                [15 ]Department of Allergy, Clinical Research Center for Allergology and Rheumatology, Sagamihara National Hospital, Sagamihara, Kanagawa Japan
                [16 ]Emory University School of Medicine, Atlanta Allergy & Asthma, Atlanta, Georgia
                [17 ]Johns Hopkins University, Baltimore, MD USA
                [18 ]Helsinki University Central Hospital, Helsinki, Finland
                [19 ]Institute for Asthma & Allergy, Bethesda, MD USA
                [20 ]Westmead Medical Centre, Westmead, NSW Australia
                [21 ]Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
                [22 ]CSK, Department of Allergy & Clinical Immunology, Lodz, Poland
                [23 ]Spitalnetz, Bern, Switzerland
                [24 ]Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, Clinical & Experimental Respiratory Immunoallergy, IDIBAPS, and CIBERES, Barcelona, Spain
                [25 ]UMDNJ – Rutgers Medical School, c/o Pulmonary and Allergy Associates, Summit, New Jersey, USA
                [26 ]Department of Internal Medicine, Ajou University School of Medicine, Suwon, South Korea
                [27 ]University of South Florida, Tampa, FL USA
                [28 ]Allergy and Respiratory Diseases, IRCCS San Martino Hospital IST, University of Genoa, Genoa, Italy
                [29 ]Department of Pediatrics, Nippon Medical School, Tokyo, Japan
                [30 ]Universitatsklinikum GI & MR GmbH, Institut fur Laboratoriumsmedizin & Path, Standort Marburg, Marburg, Germany
                [31 ]Klinikum der Ludwig-Maximilians-Universitat, Klinik & Poliklinik fur Dermatologie & Allergologie, Munchen, Germany
                [32 ]Allergy and Clinical Immunology Department, Centro Medico-Docente La Trinidadad, Caracas, Venezuela
                [33 ]Allergy Department, Fundacion Jimenez Diaz, Universidad Autonoma de Madrid, CIBER de Enfermedades Respiratorias (CIBERES), Institute Carlos III, Madrid, Spain
                [34 ]RNTNE Hospital, London, UK
                [35 ]Division of Allergy and Immunology, Department of Pediatrics, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY USA
                [36 ]University of Nebraska, Omaha, NE USA
                [37 ]Institute for Prevention and Occupational Medicine, German Social Accident Insurance, Ruhr-University Bochum (IPA), Bochum, Germany
                [38 ]Division of Experimental Allergology, Department of Pathophysiology, Allergy Research Center of Pathophysiology, Infectiology & Immunology, Medical University of Vienna, Vienna, Austria
                [39 ]Allergy & Respiratory Disease Clinic, DIMI – Department Int Med, University of Genoa, IRCCS AOU, San Martino – IST, Genoa, Italy
                [40 ]Immunology Department, Universidad De Cartagena, Cartagena, Colombia
                [41 ]Hospital San Bernardo, Salta, Argentina
                [42 ]Department of Allergy, Aichi Children’s Health and Medical Center, Aichi, Japan
                [43 ]Messerli Research Institute, Medical University Vienna, University Vienna, Vienna, Austria
                [44 ]Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Canada
                [45 ]Istituto Giannina Gaslini, Genoa, Italy
                [46 ]Gentofte University Hospital, Lab for Allergology, Allergy Clinic, Hellerup, Denmark
                [47 ]Department of Pathophysiology, AKH, Wien, Austria
                [48 ]Campus Charite Mitte, Klinik fur Dermatologie & Allergologie, Berlin, Germany
                Article
                122
                10.1186/s40413-016-0122-3
                5062928
                27777642
                4135acd4-c18c-414d-8656-1422c000708b
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 12 March 2016
                : 19 August 2016
                Categories
                WAO Statement
                Custom metadata
                © The Author(s) 2016

                Immunology
                Immunology

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