42 results on '"Institute of Medical Statistics, Informatics and Epidemiology (IMSIE)"'
Search Results
2. Adherence to treatment in allergic rhinitis using mobile technology. the mask study
- Author
-
Menditto, E, Costa, E, Midao, L, Bosnic-Anticevich, S, Novellino, E, Bialek, S, Briedis, V, Mair, A, Rajabian-Soderlund, R, Arnavielhe, S, Bedbrook, A, Czarlewski, W, Annesi-Maesano, I, Anto, JM, Devillier, P, De Vries, G, Keil, T, Sheikh, A, Orlando, V, Larenas-Linnemann, D, Cecchi, L, De Feo, G, Stellato, C, Fonseca, J, Malva, J, Morais-Almeida, M, Pereira, AM, Todo-Bom, AM, Kvedariene, V, Valiulis, A, Bergmann, KC, Klimek, L, Mosges, R, Pfaar, O, Zuberbier, T, Cardona, V, Mullol, J, Papadopoulos, NG, Prokopakis, EP, Bewick, M, Ryan, D, Roller-Wirnsberger, RE, Tomazic, PV, Cruz, AA, Kuna, P, Samolinski, B, Fokkens, WJ, Reitsma, S, Bosse, I, Fontaine, JF, Laune, D, Haahtela, T, Toppila-Salmi, S, Bachert, C, Hellings, PW, Melen, E, Wickman, M, Bindslev-Jensen, C, Eller, E, O'Hehir, RE, Cingi, C, Gemicioglu, B, Kalayci, O, Ivancevich, JC, Bousquet, J, Aberer, W, Agache, I, Akdis, CA, Akdis, M, Aliberti, MR, Almeida, R, Amat, F, Angles, R, Ansotegui, IJ, Arnavielle, S, Asayag, E, Asarnoj, A, Arshad, H, Avolio, F, Bacci, E, Baiar-Dini, I, Barbara, C, Barbagallo, M, Baroni, I, Barreto, BA, Basagana, X, Bateman, ED, Bedolla-Barajas, M, Beghe, B, Bel, EH, Bennoor, KS, Benson, M, Bertorello, L, Bialoszewski, AZ, Bieber, T, Bjermer, L, Blain, H, Blasi, F, Blua, A, Marciniak, MB, Bogus-Buczynska, I, Boner, AL, Bonini, M, Bonini, S, Bosnic-Anticevich, CS, Bouchard, J, Boulet, LP, Bourret, R, Bousquet, P, Braido, F, Brightling, CE, Brozek, J, Bucca, C, Buhl, R, Buonaiuto, R, Panaitescu, C, Cabanas, MTB, Burte, E, Bush, A, Caballero-Fonseca, F, Caillaud, D, Caimmi, D, Calderon, MA, Camargos, PAM, Camuzat, T, Canfora, G, Canonica, GW, Carlsen, KH, Carreiro-Martins, P, Carriazo, AM, Carr, W, Cartier, C, Casale, T, Castellano, G, Cepeda, AM, Chavannes, NH, Chen, Y, Chiron, R, Chivato, T, Chkhartishvili, E, Chuchalin, AG, Chung, KF, Ciaravolo, MM, Ciceran, A, Ciprandi, G, Coehlo, ACC, Colas, L, Colgan, E, Coll, J, Conforti, D, De Sousa, JC, Cortes-Grimaldo, RM, Corti, F, Mc Costa-Dominguez, Al Courbis, Cox, L, Crescenzo, M, Custovic, A, Dahlen, SE, D'Amato, Dario, C, da Silva, J, Dauvilliers, Y, Darsow, U, De Blay, F, De Carlo, G, Dedeu, T, Emerson, MDF, De Martino, B, Rubina, NPM, Deleanu, D, Demoly, P, Denburg, J, Ercolano, SDC, Di Carluccio, N, Didier, A, Dokic, D, Dominguez-Silva, MG, Douagui, H, Dray, G, Dubakiene, R, Durham, SR, Du Toit, G, Dykewicz, MS, El-Gamal, Y, Eklund, P, Emuzyte, R, Farrell, J, Farsi, A, De Mello, JF, Ferrero, J, Fink-Wagner, A, Fiocchi, A, Fok-Kens, WJ, Forti, S, Fuentes-Perez, JM, Galvez-Romero, JL, Gamkrelidze, A, Garcia-Aymerich, J, Garcia-Cobas, CY, Garcia-Cruz, MH, Genova, S, Christoff, G, Gereda, JE, Van Wijk, RG, Gomez, RM, Gomez-Vera, J, Diaz, SG, Gotua, M, Grisle, I, Guidacci, M, Guldemond, N, Gutter, Z, Guzman, M, Hajjam, J, Hernandez, L, Houri-Hane, J, Huerta-Villalobos, YR, Humbert, M, Iaccarino, G, Illario, M, Ispayeva, Z, Jares, E, Jassem, E, Johnston, SL, Joos, G, Jung, KS, Just, J, Jutel, M, Kaidashev, I, Kalyoncu, AF, Karjalainen, J, Kardas, P, Keith, PK, Khaitov, M, Khaltaev, N, Kleine-Tebbe, J, Kowalski, ML, Kuitunen, M, Kull, I, Kupczyk, M, Krzych-Falta, E, Lacwik, P, Lauri, D, Lavrut, J, L, TT, Lessa, M, Levato, G, Li, J, Lieberman, P, Liplec, A, Lipworth, B, Carlsen, KCL, Louis, R, Lourenco, O, Luna-Pech, JA, Magnan, A, Mahboub, B, Maier, D, Majer, I, Mandajieva, E, Manning, P, Keenoy, EDM, Marshall, GD, Masjedi, MR, Maspero, JF, Mathieu-Dupas, E, Campos, JJM, Al Matos, Maurer, M, Mavale-Manuel, S, Mayora, O, Medina-Avalos, MA, Melo-Gomes, E, Meltzer, E, Mercier, J, Miculinic, N, Mihaltan, F, Milenkovic, B, Moda, G, Mogica-Martinez, MD, Mohammad, Y, Momas, I, Monte-Fort, S, Monti, R, Bogado, DM, Morato-Castro, Mota-Pinto, A, Santo, PM, Munter, L, Muraro, A, Murray, R, Naclerio, R, Nadif, R, Nalin, M, Napoli, L, Namazova-Baranova, L, Neffen, H, Niedeberger, V, Nekam, K, Neou, A, Nieto, A, Nogueira-Silva, L, Nogues, M, Nyembue, T, O'Hehir, R, Odzhakova, C, Ohta, K, Okamoto, Y, Okubo, K, Onorato, GL, Cisneros, MO, Ouedraogo, S, Pali-Scholl, I, Palkonen, S, Panzner, P, Park, HS, Papi, A, Passalacqua, G, Paulino, E, Pawankar, R, Pedersen, S, Pepin, JL, Persico, M, Phillips, J, Picard, R, Pigearias, B, Pin, I, Pitsios, C, Plavec, D, Pohl, W, Popov, TA, Portejoie, F, Potter, P, Pozzi, AC, Price, D, Puy, R, Pugin, B, Ross, REP, Przemecka, M, Rabe, KF, Raciborski, F, Raja-Bian-Soderlund, R, Ribeirinho, I, Rimmer, J, Riv-Ero-Yeverino, D, Rizzo, JA, Rizzo, MC, Robalo-Cordeiro, C, Rodenas, F, Rodo, X, Gonzalez, MR, Rodriguez-Manas, L, Rolland, C, Valle, SR, Rodriguez, MR, Romano, A, Rodriguez-Zagal, E, Rolla, G, Romano, M, Rosado-Pinto, J, Rosario, N, Rottem, M, Sagara, H, Salimaki, J, Sanchez-Borges, M, Sastre-Dominguez, J, Scadding, GK, Schunemann, HJ, Scichilone, N, Schmid-Grendelmeier, P, Serpa, FS, Shamai, S, Sierra, M, Simons, FER, Sir-Oux, V, Sisul, JC, Skrindo, I, Sole, D, Somekh, D, Sonder-Mann, M, Sooronbaev, T, Sova, M, Sorensen, M, Sorlini, M, Spranger, O, Stelmach, R, Stukas, R, Sunyer, J, Strozek, J, Szylling, A, Tebyrica, J, Thibaudon, M, To, T, Todo-Bom, A, Trama, U, Triggiani, M, Ulrik, CS, Urrutia-Pereira, M, Valenta, R, Valero, A, Valovirta, E, Van Eerd, M, Van Ganse, E, Van Hague, M, Vandenplas, O, Ventura, MT, Vezzani, G, Vasankari, T, Vatrella, A, Verissimo, MT, Viart, F, Viegi, G, Vicheva, D, Vontetsianos, T, Wagenmann, M, Walker, S, Wallace, D, Wang, DY, Waserman, S, Werfel, T, Westman, M, Williams, DM, Williams, S, Wilson, N, Wright, J, Wroczynski, P, Yakovliev, P, Yawn, BP, Yiallouros, PK, Yorgancioglu, A, Yusuf, OM, Zar, HJ, Zhang, L, Zhong, N, Zernotti, ME, Zhanat, I, Zidarn, M, Zubrinich, C, Zurkuhlen, A, MASK Grp, İÜC, Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, Department of Dermatology, Allergology and Venereology, University of Helsinki, Clinicum, Children's Hospital, HUS Children and Adolescents, HUS Inflammation Center, et. al., Universidade do Minho, Internal Medicine, Health Services Management & Organisation (HSMO), Ear, Nose and Throat, AII - Inflammatory diseases, Kyomed, Center for Research in Environmental Epidemiology (CREAL), Universitat Pompeu Fabra [Barcelona] (UPF)-Catalunya ministerio de salud, Università degli Studi di Salerno (UNISA), Center of Research in Health Technologies and Information Systems (CINTESIS), Universidade do Porto, Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, Department of Otorhinolaryngology, Head, and Neck Surgery, University Hospital Leuven, Institute of Environmental Medicine, Karolinska Institutet [Stockholm]-Karolinska University Hospital [Stockholm]-Astrid Lindgren Children's Hospital, Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital-Monash University Building, AMREP, Cerrahpasa Faculty of Medicine, Istanbul University, Hacettepe University = Hacettepe Üniversitesi, Vieillissement et Maladies chroniques : approches épidémiologique et de santé publique (VIMA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Department for Molecular Biomedical Research, Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), Department of Otorhinolaryngology, Head and Neck Surgery, Eskisehir Osmangazi University, Instituto de Biologia Molecular e Celular (IBMC), Laboratoire de Génie Informatique et d'Ingénierie de Production (LGI2P), IMT - MINES ALES (IMT - MINES ALES), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT), UCB Pharma, Colombes, Laboratoire de recherche sur les mécanismes moléculaires et pharmacologiques de l’obstruction bronchique (LOBIP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Department of Dermatology and Allergy Centre, Odense University Hospital, Department of Dermatology, Helsinki University Hospital-Skin and Allergy Hospital, Institute of Social Medicine, Epidemiology and Health Economics-Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], German Society for Otorhinolaryngology HNS, Medical University of Łódź (MUL), Vilnius University [Vilnius], Institut de Recherche en Infectiologie de Montpellier (IRIM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), University of Coimbra [Portugal] (UC), 'Federico II' University of Naples Medical School, Transverse group for research in primary care [Barcelona], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Naples Federico II, University Hospital Mannheim, Allergy and Respiratory Research Group, University of Edinburgh, Department of Prevention of Envinronmental Hazards and Allergology, Medical University of Warsaw - Poland, Asthma UK Centre for Applied Research [Edinburgh, U.K.], University of Edinburgh-Usher Institute of Population Health Sciences and Informatics [Edinburgh, U.K.], Vilnius University Clinic of Children's Diseases, Sachs’ Children and Youth Hospital [Stockholm, Sweden], Secretary General of the Global Allergy and Asthma European Network (GA2LEN), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Menditto, E, Costa, E, Midão, L, Bosnic-Anticevich, S, Novellino, E, Bialek, S, Briedis, V, Mair, A, Rajabian-Soderlund, R, Arnavielhe, S, Bedbrook, A, Czarlewski, W, Annesi-Maesano, I, Anto, Jm, Devillier, P, De Vries, G, Keil, T, Sheikh, A, Orlando, V, Larenas-Linnemann, D, Cecchi, L, De Feo, G, Illario, M, Stellato, C, Fonseca, J, Malva, J, Morais-Almeida, M, Pereira, Am, Todo-Bom, A, Kvedariene, V, Valiulis, A, Bergmann, Kc, Klimek, L, Mösges, R, Pfaar, O, Zuberbier, T, Cardona, V, Mullol, J, Papadopoulos, Ng, Prokopakis, Ep, Bewick, M, Ryan, D, Roller-Wirnsberger, Re, Tomazic, Pv, Cruz, Aa, Kuna, P, Samolinski, B, Fokkens, Wj, Reitsma, S, Bosse, I, Fontaine, Jf, Laune, D, Haahtela, T, Toppila-Salmi, S, Bachert, C, Hellings, Pw, Melén, E, Wickman, M, Bindslev-Jensen, C, Eller, E, O'Hehir, Re, Cingi, C, Gemicioğlu, B, Kalayci, O, Ivancevich, Jc, Bousquet, J, and Iaccarino, Guido
- Subjects
0301 basic medicine ,Male ,Allergy ,Medicina Básica [Ciências Médicas] ,CONTROLLER MEDICATION ,adherence ,mHealth ,mobile technology ,observational study ,rhinitis ,treatment ,THERAPY ,Medical and Health Sciences ,Medical Records ,DISEASE ,0302 clinical medicine ,Surveys and Questionnaires ,Immunology and Allergy ,Middle Aged ,Mobile Applications ,3. Good health ,Medication possession ratio ,rhiniti ,1107 Immunology ,Ciências Médicas::Medicina Básica ,Female ,TRIAL ,Life Sciences & Biomedicine ,Adult ,medicine.medical_specialty ,Immunology ,K-ANONYMITY ,VALIDATION ,1117 Public Health and Health Services ,Medication Adherence ,03 medical and health sciences ,Internal medicine ,Health Sciences ,medicine ,Humans ,Clinical significance ,Mobile technology ,[INFO]Computer Science [cs] ,Asthma ,Aged ,[SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health ,Science & Technology ,Relative efficacy ,business.industry ,PERSISTENCE ,medicine.disease ,Rhinitis, Allergic ,Cell Phone Use ,Patient Outcome Assessment ,030104 developmental biology ,Cross-Sectional Studies ,030228 respiratory system ,3121 General medicine, internal medicine and other clinical medicine ,MASK group ,ASTHMA ,Observational study ,business - Abstract
Pereira, Ana Margarida/0000-0002-5468-0932; Briedis, Vitalis/0000-0002-5106-6638; Johnston, Sebastian Lennox/0000-0003-3009-9200; Orlando, Valentina/0000-0002-8209-8878; Sova, Milan/0000-0002-8542-7841; Chung, Kian Fan/0000-0001-7101-1426; Ciprandi, Giorgio/0000-0001-7016-8421; Yusuf, M Osman/0000-0002-8067-1204; stelmach, rafael/0000-0002-5132-1934; Sunyer, Jordi/0000-0002-2602-4110; Martins, Pedro/0000-0002-4129-133X; Demoly, Pascal/0000-0001-7827-7964; Fonseca, Joao Almeida/0000-0002-0887-8796; Anto, J M/0000-0002-4736-8529; IACCARINO, Guido/0000-0002-8997-835X; Custovic, Adnan/0000-0001-5218-7071; Lourenco, Olga/0000-0002-8401-5976; Pugin, Benoit/0000-0001-7132-9477; Chavannes, Niels/0000-0002-8607-9199; Rodo, Xavier/0000-0003-4843-6180; Nadif, Rachel/0000-0003-4938-9339; Plavec, Davor/0000-0003-2020-8119; Vicheva, Dilyana/0000-0002-6805-3825; Iaccarino, Guido/0000-0002-8997-835X; Annesi-Maesano, Isabella/0000-0002-6340-9300; N.G., Papadopoulos/0000-0002-4448-3468; J, Garcia-Aymerich/0000-0002-7097-4586; Humbert, Marc/0000-0003-0703-2892; Barbara, C./0000-0003-0915-4105; Gemicioglu, Bilun/0000-0001-5953-4881; Caimmi, Davide/0000-0003-4481-6194; Namazova-Baranova, Leyla/0000-0002-2209-7531; Basagana, Xavier/0000-0002-8457-1489; Midao, Luis/0000-0003-1981-2554; Sheikh, Aziz/0000-0001-7022-3056; O'Hehir, Robyn/0000-0002-3489-7595; Cardona, Victoria/0000-0003-2197-9767; Mota-Pinto, Anabela/0000-0002-0820-9568; Cecchi, Lorenzo/0000-0002-0658-2449; Bindslev-Jensen, Carsten/0000-0002-8940-038X; Costa, Elisio/0000-0003-1158-1480; Kuna, Piotr/0000-0003-2401-0070; Malva, Joao/0000-0002-5438-4447; Zuberbier, Torsten/0000-0002-1466-8875; Toppila-Salmi, Sanna/0000-0003-0890-6686; Nogueira-Silva, Luis/0000-0002-5519-707X; Ivancevich, Juan Carlos/0000-0001-8713-6258 WOS:000463761700007 PubMed ID: 30597673 Background: Mobile technology may help to better understand the adherence to treatment. MASK-rhinitis (Mobile Airways Sentinel NetworK for allergic rhinitis) is a patient-centred ICT system. A mobile phone app (the Allergy Diary) central to MASK is available in 22 countries. Objectives: To assess the adherence to treatment in allergic rhinitis patients using the Allergy Diary App. Methods: An observational cross-sectional study was carried out on all users who filled in the Allergy Diary from 1 January 2016 to 1 August 2017. Secondary adherence was assessed by using the modified Medication Possession Ratio (MPR) and the Proportion of days covered (PDC) approach. Results: A total of 12143 users were registered. A total of 6949 users reported at least one VAS data recording. Among them, 1887 users reported >= 7 VAS data. About 1195 subjects were included in the analysis of adherence. One hundred and thirty-six (11.28%) users were adherent (MPR >= 70% and PDC = 70% and PDC = 1.50) and 176 (14.60%) were switchers. On the other hand, 832 (69.05%) users were non-adherent to medications (MPR
- Published
- 2019
3. Mobile technology offers novel insights into the control and treatment of allergic rhinitis: The MASK study
- Author
-
Niels H. Chavannes, Oliver Pfaar, Peter Valentin Tomazic, Antonio Valero, Jean-François Fontaine, Sara Shamai, Gabrielle L. Onorato, Jane da Silva, Ralph Mösges, I. Annesi-Maesano, Piotr Kuna, Violeta Kvedariene, Sanna Toppila-Salmi, Arunas Valiulis, Rute Almeida, Philippe Devillier, Rafael Stelmach, Regina Roller-Wirnsberger, Sietze Reitsma, Tari Haahtela, Ioana Agache, Ruth Murray, Claus Bachert, Gert De Vries, Michael Makris, Esben Eller, Carsten Bindslev-Jensen, Josep M. Antó, João O. Malva, R. Emuzyte, Benoit Pugin, Arzu Yorgancioglu, Ana Todo-Bom, Enrica Menditto, Wienczyslawa Czarlewski, Isabelle Bosse, Ana Margarida Pereira, Mário Morais-Almeida, Cemal Cingi, Emmanuel P. Prokopakis, Ingrid Kull, José Miguel Fuentes-Pérez, Mike Bewick, João Fonseca, Alvaro A. Cruz, Aziz Sheikh, Annabelle Bédard, Mark S. Dykewicz, Xavier Basagaña, Anna Bedbrook, Sinthia Bosnic-Anticevich, Ludger Klimek, Jean Bousquet, Magnus Wickman, Joaquim Mullol, Susan Waserman, Cristiana Stellato, Dermot Ryan, Judith Garcia-Aymerich, Erik Melén, Dana Wallace, Yunuen Rocío Huerta-Villalobos, Thomas B. Casale, Sylvie Arnavielhe, Bilun Gemicioglu, Daniel Laune, Fotis Psarros, Nikos G. Papadopoulos, Bolesław Samoliński, Maria Teresa Ventura, Erkka Valovirta, Robyn E O'Hehir, Peter Hellings, V. Cardona, Michiel van Eerd, Pascal Demoly, Wytske Fokkens, Elísio Costa, Ignacio J. Ansotegui, Désirée Larenas-Linnemann, ISGlobal, Barcelona, Spain, Universitat Pompeu Fabra (UPF), Barcelona, Spain, CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain, UPRES EA220, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France, KYomed INNOV, Montpellier, France, MACVIA-France, Fondation partenariale FMC VIA-LR, Montpellier, France, Medical Consulting Czarlewski, Levallois, France, Medical Communications Consultant, MedScript, Dundalk, and OPC, Cambridge, United Kingdom, Center for Health Technology and Services Research–CINTESIS, Faculdade de Medicina, Universidade do Porto, and Medida, Porto, Portugal, UCIBIO, REQUINTE, Faculty of Pharmacy and Competence Center on Active and Healthy Ageing of University of Porto (Porto4Ageing), Porto, Portugal, Institute of Biomedical Imaging and Life Sciences (IBILI), Faculty of Medicine, University of Coimbra, and the Ageing@Coimbra EIP-AHA Reference Site, Coimbra, Portugal, Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal, Allergy Unit, CUF-Porto Hospital and Institute, and the Center for Research in Health Technologies and information systems CINTESIS, Universidade do Porto, Porto, Portugal, Imunoalergologia, Centro Hospitalar Universitário de Coimbra and Faculty of Medicine, University of Coimbra, Coimbra, Portugal, CIRFF, Federico II University, Naples, Italy, Department of Medicine, Surgery and Dentistry 'Scuola Medica Salernitana', University of Salerno, Salerno, Italy, Unit of Geriatric Immunoallergology, University of Bari Medical School, Bari, Italy, ProAR–Nucleo de Excelencia em Asma, Federal University of Bahia, and the WHO GARD Planning Group, Brazil, Pulmonary Division, Heart Institute (InCor), Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil, Department of Internal Medicine and Allergy Clinic of Professor Polydoro Ernani de São Thiago University Hospital, Federal University of Santa Catarina (UFSC), Florianopolis, Brazil, Center of Excellence in Asthma and Allergy, Hospital Médica Sur, México City, Mexico, Hospital General Region 1, Dr Carlos Mc Gregor Sanchez Navarro' IMSS, Mexico City, Mexico, Clinic of Children's Diseases, Faculty of Medicine, Vilnius University, Vilnius, Lithuania, Faculty of Medicine, Vilnius University, Vilnius, Lithuania, Vilnius University Institute of Clinical Medicine, Clinic of Children's Diseases, and the Institute of Health Sciences, Department of Public Health, Vilnius, Lithuania, European Academy of Paediatrics (EAP/UEMS-SP), Brussels, Belgium, Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland, Department of Prevention of Environmental Hazards and Allergology, Medical University of Warsaw, Warsaw, Poland, Center for Rhinology and Allergology, Wiesbaden, Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany, Institute of Medical Statistics, and Computational Biology, Medical Faculty, University of Cologne, and CRI-Clinical Research International, Hamburg, Germany, University Hospital, Montpellier, France, Department of Otorhinolaryngology, Head and Neck Surgery, Section for Rhinology and Allergy, University Hospital Marburg, Phillipps-Universität, Marburg, Germany, Epidemiology of Allergic and Respiratory Diseases, Department Institute Pierre Louis of Epidemiology and Public Health, INSERM and UPMC Sorbonne Université, Medical School Saint Antoine, Paris, France, Allergist, La Rochelle, France, Department of Respiratory Diseases, Montpellier University Hospital, Montpellier, France, Allergist, Reims, France, Allergy Section, Department of Internal Medicine, Hospital Vall'dHebron & ARADyAL Research Network, Barcelona, Spain, Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, and Clinical & Experimental Respiratory Immunoallergy, IDIBAPS, CIBERES, University of Barcelona, Barcelona, Spain, Pneumology and Allergy Department CIBERES and Clinical & Experimental Respiratory Immunoallergy, IDIBAPS, University of Barcelona, Barcelona, Spain, Department of Internal Medicine, Medical University of Graz, Graz, Austria, Department of ENT, Medical University of Graz, Graz, Austria, Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands, Department of Otorhinolaryngology, Amsterdam University Medical Centres, AMC, Amsterdam, Netherlands, iQ4U Consultants, London, United Kingdom, Allergy and Respiratory Research Group, University of Edinburgh, Edinburgh, United Kingdom, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom, Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland, Department of Lung Diseases and Clinical Immunology, University of Turku and Terveystalo allergy clinic, Turku, Finland, Allergy Unit 'D Kalogeromitros', 2nd Department of Dermatology and Venereology, National & Kapodistrian University of Athens, 'Attikon' University Hospital, Athens, Greece, Center for Pediatrics and Child Health, Institute of Human Development, Royal Manchester Children's Hospital, University of Manchester, and UK Allergy Department, 2nd Pediatric Clinic, Athens General Children's Hospital 'P&A Kyriakou', University of Athens, Athens, Greece, Department of Otorhinolaryngology University of Crete School of Medicine, Heraklion, Greece, Allergy Department, Athens Naval Hospital, Athens, Greece, Eskisehir Osmangazi University, Medical Faculty, ENT Department, Eskisehir, Turkey, Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Turkey, Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa (and the GARD Executive Committee), Manisa, Turkey, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia, Woolcock Emphysema Centre and Local Health District, Glebe, Australia, Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Central Clinical School, and the Department of Immunology, Monash University, Melbourne, Australia, Upper Airways Research Laboratory, ENT Department, Ghent University Hospital, Ghent, Belgium, Department of Otorhinolaryngology, University Hospitals Leuven, and the Academic Medical Center, University of Amsterdam, and Euforea, Brussels, Belgium, European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA), Brussels, Belgium, Department of Dermatology and Allergy Centre, Odense University Hospital, Odense Research Center for Anaphylaxis (ORCA), Odense, Denmark, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and Sach's Children and Youth Hospital, Södersjukhuset, Stockholm, Sweden, Sachs' Children and Youth Hospital, Södersjukhuset, Stockholm and Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden, Peercode BV, Geldermalsen, Netherlands, Transylvania University Brasov, Brasov, Romania, Department of Allergy and Immunology, Hospital Quirón Bizkaia, Erandio, Spain, Section of Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, Mo, United States, Division of Allergy/Immunology, University of South Florida, Tampa, Fla, United States, Nova Southeastern University, Fort Lauderdale, Fla, United States, Department of Medicine, Clinical Immunology and Allergy, McMaster University, Hamilton, Ontario, Canada, INSERM U 1168, VIMA: Ageing and chronic diseases Epidemiological and Public Health Approaches, Villejuif, Université Versailles St-Quentin-en-Yvelines, Montigny le Bretonneux, and Euforea, Brussels, Belgium, İÜC, Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Global - Institute For Global Health [Barcelona] (ISGlobal), Universitat Pompeu Fabra [Barcelona] (UPF), Hôpital Foch [Suresnes], Kyomed, Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), MedScript Ltd, Universidade do Porto, Centre for Research in Health Technologies and Information Systems (CINTESIS), Instituto de Biologia Molecular e Celular (IBMC), University of Coimbra [Portugal] (UC), Allergy and Clinical Immunology Department, Hospital CUF-Descobertas, 'Federico II' University of Naples Medical School, Università degli studi di Bari Aldo Moro (UNIBA), Universidade Federal da Bahia (UFBA), Hospital Medica Sur, Vilnius University [Vilnius], Vilnius University Clinic of Children's Diseases, Medical University of Łódź (MUL), Medical University of Warsaw - Poland, Center for Rhinology and Allergology, Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), Vall d'Hebron University Hospital [Barcelona], Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Medical University Graz, iQ4U consultants Ltd, University of Edinburgh, University of Helsinki, Suomen Terveystalo Allergy Clinic, Eskisehir Osmangazi University, Cerrahpasa Faculty of Medicine, Istanbul University, Department of Pulmonology, Manisa Celal Bayar University, Woolcock Institute of Medical Research [Sydney], The University of Sydney, Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital-Monash University Building, AMREP, Ghent University Hospital, University Hospitals Leuven [Leuven], Department of Dermatology and Allergy Centre, Odense University Hospital, Institute of Environmental Medicine [Stockholm, Sweden], Karolinska Institutet [Stockholm]-Karolinska University Hospital [Stockholm]-Astrid Lindgren Children's Hospital, Peercode (Développement de l'application) Oudenhof 4c 4191 NW Geldermalsen, Pays-Bas., Department of Allergy and Clinical Immunology, Transylvania University of Brasov, Department of Allergy and Immunology, Hospital Quiròn Bizkaia Erandio, Saint Louis University School of Medicine [St Louis], University of South Florida [Tampa] (USF), Nova Southeastern University (NSU), McMaster University [Hamilton, Ontario], Hôpital Arnaud de Villeneuve [CHRU Montpellier], Department of Dermatology, Allergology and Venereology, HUS Inflammation Center, Ear, Nose and Throat, AII - Inflammatory diseases, Bedard, A., Basagana, X., Anto, J. M., Garcia-Aymerich, J., Devillier, P., Arnavielhe, S., Bedbrook, A., Onorato, G. L., Czarlewski, W., Murray, R., Almeida, R., Fonseca, J., Costa, E., Malva, J., Morais-Almeida, M., Pereira, A. M., Todo-Bom, A., Menditto, E., Stellato, C., Ventura, M. T., Cruz, A. A., Stelmach, R., da Silva, J., Larenas-Linnemann, D., Fuentes-Perez, J. M., Huerta-Villalobos, Y. R., Emuzyte, R., Kvedariene, V., Valiulis, A., Kuna, P., Samolinski, B., Klimek, L., Mosges, R., Pfaar, O., Shamai, S., Annesi-Maesano, I., Bosse, I., Demoly, P., Fontaine, J. -F., Cardona, V., Mullol, J., Valero, A., Roller-Wirnsberger, R. E., Tomazic, P. V., Chavannes, N. H., Fokkens, W. J., Reitsma, S., Bewick, M., Ryan, D., Sheikh, A., Haahtela, T., Toppila-Salmi, S., Valovirta, E., Makris, M., Papadopoulos, N. G., Prokopakis, E. P., Psarros, F., Cingi, C., Gemicioglu, B., Yorgancioglu, A., Bosnic-Anticevich, S., O'Hehir, R. E., Bachert, C., Hellings, P. W., Pugin, B., Bindslev-Jensen, C., Eller, E., Kull, I., Melen, E., Wickman, M., De Vries, G., van Eerd, M., Agache, I., Ansotegui, I. J., Dykewicz, M. S., Casale, T., Wallace, D., Waserman, S., Laune, D., and Bousquet, J.
- Subjects
Male ,Allergy ,Lydia Becker Institute ,Visual Analog Scale ,IMPACT ,Efficiency ,THERAPY ,Allergic rhinitis ,law.invention ,corticosteroids ,FLUTICASONE ,0302 clinical medicine ,Randomized controlled trial ,law ,Adrenal Cortex Hormones ,conjunctiviti ,conjunctivitis ,Immunology and Allergy ,AZELASTINE ,030212 general & internal medicine ,[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology ,Child ,Aged, 80 and over ,treatment ,Middle Aged ,WORK PRODUCTIVITY ,Mobile Applications ,3. Good health ,Child, Preschool ,GUIDED SELF-MANAGEMENT ,Histamine H1 Antagonists ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,Female ,Symptom Assessment ,medicine.drug ,Adult ,corticosteroid ,medicine.medical_specialty ,antihistamines ,MASK ,Adolescent ,Visual analogue scale ,Immunology ,Mometasone furoate ,antihistamine ,Fluticasone propionate ,03 medical and health sciences ,Young Adult ,ResearchInstitutes_Networks_Beacons/lydia_becker_institute_of_immunology_and_inflammation ,asthma ,mobile health ,Allergic rhiniti ,medicine ,QUALITY ,Humans ,Asthma ,Aged ,business.industry ,Infant, Newborn ,Infant ,medicine.disease ,Azelastine ,Rhinitis, Allergic ,030228 respiratory system ,3121 General medicine, internal medicine and other clinical medicine ,Physical therapy ,Observational study ,business ,TRADITIONAL TREATMENT - Abstract
Demoly, Pascal/0000-0001-7827-7964; Chavannes, Niels/0000-0002-8607-9199; Basagana, Xavier/0000-0002-8457-1489; N.G., Papadopoulos/0000-0002-4448-3468; Almeida, Rute/0000-0001-7755-5002; Pereira, Ana Margarida/0000-0002-5468-0932; Gemicioglu, Bilun/0000-0001-5953-4881; Bedard, Annabelle/0000-0002-7842-8889; Anto, J M/0000-0002-4736-8529; Fonseca, Joao Almeida/0000-0002-0887-8796; Rodo, Xavier/0000-0003-4843-6180; stelmach, rafael/0000-0002-5132-1934; J, Garcia-Aymerich/0000-0002-7097-4586; orlando, valentina/0000-0002-8209-8878; Cardona, Victoria/0000-0003-2197-9767; yorgancioglu, arzu/0000-0002-4032-0944; Bindslev-Jensen, Carsten/0000-0002-8940-038X; VENTURA, Maria Teresa/0000-0002-2637-4583; O'Hehir, Robyn/0000-0002-3489-7595; Costa, Elisio/0000-0003-1158-1480; Malva, Joao/0000-0002-5438-4447; Pugin, Benoit/0000-0001-7132-9477; Psarros, Fotis/0000-0002-2928-150X; Kuna, Piotr/0000-0003-2401-0070 WOS:000473432800017 PubMed ID: 30951790 Background: Mobile health can be used to generate innovative insights into optimizing treatment to improve allergic rhinitis (AR) control. Objectives: A cross-sectional real-world observational study was undertaken in 22 countries to complement a pilot study and provide novel information on medication use, disease control, and work productivity in the everyday life of patients with AR. Methods: A mobile phone app (Allergy Diary, which is freely available on Google Play and Apple stores) was used to collect the data of daily visual analogue scale (VAS) scores for (1) overall allergic symptoms; (2) nasal, ocular, and asthma symptoms; (3) work; and (4) medication use by using a treatment scroll list including all allergy medications (prescribed and over-the-counter) customized for 22 countries. The 4 most common intranasal medications containing intranasal corticosteroids and 8 oral H-1-antihistamines were studied. Results: Nine thousand one hundred twenty-two users filled in 112,054 days of VASs in 2016 and 2017. Assessment of days was informative. Control of days with rhinitis differed between no (best control), single (good control for intranasal corticosteroid-treated days), or multiple (worst control) treatments. Users with the worst control increased the range of treatments being used. The same trend was found for asthma, eye symptoms, and work productivity. Differences between oral H-1-antihistamines were found. Conclusions: This study confirms the usefulness of the Allergy Diary in accessing and assessing behavior in patients with AR. This observational study using a very simple assessment tool (VAS) on a mobile phone had the potential to answer questions previously thought infeasible. Sanofi AventisSanofi-Aventis; GlaxoSmithKlineGlaxoSmithKline; North Portugal Regional Operational Programme; European Regional Development Fund (ERDF)European Union (EU); Mundipharm; Teva Pharma; AstraZenecaAstraZeneca; Boehringer IngelheimBoehringer Ingelheim; Chiesi; MEDA Pharma; Sao Paulo Research FoundationFundacao de Amparo a Pesquisa do Estado de Sao Paulo (FAPESP); NovartisNovartis; Chiesi, DBV Technologies; UCBUCB Pharma SA; SanofiSanofi-Aventis; Adamed; FAES, Berlin Chemie; ALK-Abello; Allergopharma, Allergy Therapeutics; ServierServier; ASIT biotech; Hulka; Leti and Stallergenes; Roxall, Atmos, Bionorica; ALK-Abello, Allergopharma, Stallergenes Greer, HAL Allergy Holding B.V./HAL Allergie GmbH, Bencard Allergie GmbH/Allergy Therapeutics; Biomay, Nuvo, Circassia; Novartis Pharma; Mundipharma; RocheRoche Holding; Erkko Foundation; Hal Allergy B. V.; Teva; Meda, Stallergenes; Cipla; Mundipharma, Mylan; Sanofi-AventisSanofi-Aventis P. Devillier reports personal fees from Sanofi Aventis, GlaxoSmithKline, AstraZeneca, Chiesi, Meda Pharma, and Menarini outside the submitted work. R. Almeida reports grants from Project NORTE-01-0145-FEDER-000016 (NanoSTIMA) by the North Portugal Regional Operational Programme (NORTE 2020) under the Portugal 2020 Partnership Agreement and through the European Regional Development Fund (ERDF) during the conduct of the study. A. Todo-Bom reports grants and personal fees from GlaxoSmithKline, Mundipharm, and Novartis; personal fees from Teva Pharma and AstraZeneca; and grants from Leti and Bial outside the submitted work. A. A. Cruz reports grants and personal fees from AstraZeneca; grants from GlaxoSmithKline; personal fees from Boehringer Ingelheim, Chiesi, Novartis, Eurofarma, MEDA Pharma, and Boston Scientific outside the submitted work. R. Stelmach reports grants from the Sao Paulo Research Foundation and MSD; grants and personal fees from Novartis, grants, personal fees, and nonfinancial support from AstraZeneca and Chiesi; and personal fees and nonfinancial support from Boehringer Ingelheim outside the submitted work. D. Larenas-Linnemann reports personal fees from Armstrong, AstraZeneca, Boehringer Ingelheim, Chiesi, DBV Technologies, Grunenthal, GlaxoSmithKline, MEDA, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, and UCB and grants from Sanofi, AstraZeneca, Novartis, UCB, GlaxoSmithKline, TEVA, Boehringer Ingelheim, and Chiesi outside the submitted work. V. Kvedariene has received payment for consultancy from GlaxoSmithKline and for lectures from StallergensGreer and Berlin-Chemie outside the submitted work. P. Kuna reports personal fees from Adamed, Boehringer Ingelheim, AstraZeneca, Chiesi, FAES, Berlin Chemie, Novartis, Polpharma, and Allergopharma outside the submitted work. R. Mosges reports personal fees from ALK-Abello, Allergopharma, Allergy Therapeutics, Hexal, Servier, Klosterfrau, Stada, UCB, and Friulchem; grants from ASIT biotech, Nuvo, Bayer, FAES, GlaxoSmithKline, MSD, Johnson & Johnson, Meda, Optima, Ursapharm, BitopAG, and Hulka; grants and personal fees from Bencard; grants from Leti and Stallergenes; grants, personal fees and nonfinancial support from Lofarma; nonfinancial support from Roxall, Atmos, Bionorica, Otonomy, and Ferrero; and personal fees and nonfinancial support from Novartis outside the submitted work. O. Pfaar reports grants and personal fees from ALK-Abello, Allergopharma, Stallergenes Greer, HAL Allergy Holding B.V./HAL Allergie GmbH, Bencard Allergie GmbH/Allergy Therapeutics, and Lofarma; grants from Biomay, Nuvo, Circassia, and GlaxoSmithKline; and personal fees from Novartis Pharma, MEDA Pharma, Indoor Biotechnologies, and Pohl-Boskamp outside the submitted work. T. Haahtela reports personal fees from Mundipharma, Novartis, and Orion Pharma outside the submitted work. S. Toppila-Salmi reports other support from Biomedical Systems and Roche and grants from the Erkko Foundation outside the submitted work. N. G. Papadopoulos reports grants from Gerolymatos and personal fees from Hal Allergy B. V., Novartis Pharma AG, Menarini, Hal Allergy B. V., and Mylan outside the submitted work. S. Bosnic-Anticevich reports personal fees from Teva, Boehringer Ingelheim, Sanofi, GlaxoSmithKline, and AstraZeneca outside the submitted work. C. Bachert reports personal fees from Meda, Stallergenes, and ALK-Abello (speaker). I. J. Ansotegui reports personal fees from Hikma, Roxall, AstraZeneca, Menarini, UCB, Faes Farma, Sanofi, and Mundipharma outside the submitted work. D.; Wallace reports other from Mylan Pharmaceutical Company outside the submitted work being co-chair of the AAAAI/ACAAI Joint Task Force on Practice Parameters. J. Bousquet reports personal fees and other support from Chiesi, Cipla, Hikma, Menarini, Mundipharma, Mylan, Novartis, Sanofi-Aventis, Takeda, Teva, and Uriach outside the submitted work and other support from Kyomed. The rest of the authors declare that they have no relevant conflicts of interest.
- Published
- 2018
4. Allergy immunotherapy across the life cycle to promote active and healthy ageing: from research to policies: An AIRWAYS Integrated Care Pathways (ICPs) programme item (Action Plan B3 of the European Innovation Partnership on active and healthy ageing) and the Global Alliance against Chronic Respiratory Diseases (GARD), a World Health Organization GARD research demonstration project
- Author
-
Oliver Pfaar, Luciana Kase Tanno, Antonella Muraro, M. Bewick, G.W. Canonica, Pascal Demoly, Mohamed H. Shamji, Cezmi A. Akdis, T. Zuberbier, Dirceu Solé, H.-J. Malling, J Mullol, Alain Didier, Gunter J. Sturm, B. Samolinski, Claus Bachert, G. Passalacqua, Carmen Vidal, Andrew Bush, L. Cox, Stephen R. Durham, Anca-Mirela Chiriac, V. Cardona, Ana I. Tabar, M. T. Ventura, P. Devillier, G. Du Toit, Eva-Maria Varga, David Price, Thomas B. Casale, P. Rodriguez del Rio, Barbara Bohle, D. Larenas-Linnemann, Aziz Sheikh, G. Di Lorenzo, Margitta Worm, R. Rueff, R. van Ree, Susanne Halken, Davide Caimmi, Alessandro Fiocchi, J. C. Sisul, F. de Blay, Piotr Kuna, R. Gerth van Wijk, M. Matricardi, Moises A. Calderon, Ludger Klimek, Sergio Bonini, R. M. Gomez, Gabriela Senti, G. K. Scadding, Peter Eng, Nikolaos G. Papadopoulos, Adam T. Fox, Jean Bousquet, B. M. Bilo, Elideanna Pastorello, Edward F. Knol, Jörg Kleine-Tebbe, T. Haathela, Lars Jacobsen, R. Moesges, Adnan Custovic, Allan Linneberg, Peter Hellings, J. Just, Imperial College London, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'allergologie et de pneumologie [Hôpital Arnaud de Villeneuve], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), University of South Florida [Tampa] (USF), Universität Zürich [Zürich] = University of Zurich (UZH), Ghent University Hospital, iQ4U consultants Ltd, University hospital Ospedali Riuniti, Medizinische Universität Wien = Medical University of Vienna, National Research Council of Italy | Consiglio Nazionale delle Ricerche (CNR), University of Naples Federico II = Università degli studi di Napoli Federico II, Università degli studi di Genova = University of Genoa (UniGe), Vall d'Hebron University Hospital [Barcelona], Nova Southeastern University (NSU), Pôle de pathologie thoracique, CHU Strasbourg-Hopital Civil, Laboratoire de recherche sur les mécanismes moléculaires et pharmacologiques de l’obstruction bronchique (LOBIP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Pôle Clinique des Voies respiratoires [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), King‘s College London, Università degli studi di Palermo - University of Palermo, Children's hospital Aarau, IRCCS Ospedale Pediatrico Bambino Gesù [Roma], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Hospital San Bernardo, Helsinki University Hospital, Odense University Hospital, University Hospitals Leuven [Leuven], Allergy Learning and Consulting, CHU Montpellier, Hospital Sírio Libanês, Allergy and Asthma Center Westend, German Society for Otorhinolaryngology HNS, University Medical Center [Utrecht], Medical University of Łódź (MUL), Hospital Medica Sur, ARIA, University of Copenhagen = Københavns Universitet (UCPH), Research Centre for Prevention and Health (RCPH), Department of Public Health [Copenhagen], Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (UCPH)-University of Copenhagen = Københavns Universitet (UCPH)-Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (UCPH)-University of Copenhagen = Københavns Universitet (UCPH)-Capital Region of Denmark, Rigshospitalet [Copenhagen], Copenhagen University Hospital, Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Gentofte University Hospital, Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), Università degli Studi di Padova = University of Padua (Unipd), ASST Grande Ospedale Metropolitano Niguarda, Universität Mannheim, Center for Rhinology and Allergology, University Medical Centre Mannheim, Heidelberg University, University of Aberdeen, Research in Real Life (RiRL), Optimum Patient Care Ltd, Singapore, Hospital Infantil Universitario Niño Jesús (HIUNJ), Ludwig-Maximillians University, Medical University of Warsaw - Poland, University College of London [London] (UCL), Royal National Throat, Nose and Ear Institute, University hospital of Zurich [Zurich], MRC and Asthma UK Centre in Allergic Mechanisms of Asthma, University of Edinburgh, Sociedad Latinoamericana de alergia, asma e inmunolgia (SLaai), Federal University of Sao Paulo (Unifesp), Medical University Graz, Allergy Outpatient Clinic Reumannplatz, Complejo Hospitalario de Navarra, University of Amsterdam [Amsterdam] (UvA), Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), Universidade de Santiago de Compostela [Spain] (USC ), Vieillissement et Maladies chroniques : approches épidémiologique et de santé publique (VIMA), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), European Innovation Partnership on Active and Healthy Ageing Reference Site MACVIA-France, European Structural and Development Funds of Region Languedoc Roussillon., Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), Consiglio Nazionale delle Ricerche (CNR), Centre de l'Asthme et des Allergies [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Unité Asthme et allergologie [CHU Trousseau], Service d'Allergologie pédiatrique [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University of Mannheim, Universidade Federal de São Paulo (UNIFESP), BMC, BMC, University of Naples Federico II, University of Genoa (UNIGE), Service des maladies respiratoires [Rangueil-Larrey], CHU Toulouse [Toulouse], Unité Asthme et allergologie, University of Copenhagen = Københavns Universitet (KU), University of Copenhagen = Københavns Universitet (KU)-University of Copenhagen = Københavns Universitet (KU)-Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (KU)-University of Copenhagen = Københavns Universitet (KU)-Capital Region of Denmark, Universita degli Studi di Padova, Hospital Infantil Universitario Niño Jesús, Università degli studi di Bari Aldo Moro (UNIBA), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), and Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)
- Subjects
Pulmonary and Respiratory Medicine ,Gerontology ,Allergen immunotherapy ,medicine.medical_specialty ,Allergy ,Al·lèrgia ,EIP on AHA ,[SDV]Life Sciences [q-bio] ,Immunology ,Alternative medicine ,Immunoteràpia ,Review ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Journal Article ,Immunology and Allergy ,030212 general & internal medicine ,Asthma ,Rhinitis ,business.industry ,Precision medicine ,medicine.disease ,3. Good health ,Integrated care ,[SDV] Life Sciences [q-bio] ,Ageing ,AIRWAYS ICPs ,030228 respiratory system ,General partnership ,Action plan ,Immunotherapy ,business - Abstract
Allergic diseases often occur early in life and persist throughout life. This life-course perspective should be considered in allergen immunotherapy. In particular it is essential to understand whether this al treatment may be used in old age adults. The current paper was developed by a working group of AIRWAYS integrated care pathways for airways diseases, the model of chronic respiratory diseases of the European Innovation Partnership on active and healthy ageing (DG CONNECT and DG Santé). It considered (1) the political background, (2) the rationale for allergen immunotherapy across the life cycle, (3) the unmet needs for the treatment, in particular in preschool children and old age adults, (4) the strategic framework and the practical approach to synergize current initiatives in allergen immunotherapy, its mechanisms and the concept of active and healthy ageing. ispartof: Clinical and Translational Allergy vol:6 issue:1 pages:41-47 ispartof: location:England status: published
- Published
- 2016
5. EAACI: A European Declaration on Immunotherapy. Designing the future of allergen specific immunotherapy
- Author
-
Erkka Valovirta, Hans Jørgen Malling, Oliver Pfaar, Jean Bousquet, Montserrat Fernandez-Rivas, Ludger Klimek, Marek Jutel, Pascal Demoly, Gianenrico Senna, Gabriela Senti, Carmen Vidal, Giovanni Battista Pajno, Victoria Cardona, Ralph Mösges, Jocelyne Just, Antonio Nieto, Cezmi A. Akdis, Aziz Sheikh, Claus Bachert, Sabina Rak, Lars Jacobsen, Anthony J. Frew, Antonella Muraro, Albrecht Bufe, Peter Eng, Rudolph Valenta, Nikolaos G. Papadopoulos, Stephen R. Durham, Moises A. Calderon, Marianne van Hage, Roy Gerth van Wijk, Eva M. Varga, Ulrich Wahn, Jan Lötvall, B. M. Bilo, Johannes C Virchow, Alain Didier, Barbara Bohle, Ronald Dahl, Giovanni Passalacqua, Walter Canonica, Jörg Kleine-Tebbe, Glenis Scadding, Carmen Moreno, Emilio Alvarez-Cuesta, Bodo Niggemann, Internal Medicine, Section of Allergy and Clinical Immunology, Imperial College London-National Heart and Lung Institute [UK], Pneumologie et allergologie, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Pharmacoepidemiologie et évaluation de l'impact des produits de santé sur les populations, Université Bordeaux Segalen - Bordeaux 2-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Allergology, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Centre for Population Health Sciences, University of Edinburgh, Department of Respiratory Medicine, Royal Sussex County Hospital, The Royal National Throat, Nose and Ear Hospital, Upper Airway Research Laboratory (URL), Ghent University Hospital, Allergy Clinic, National University Hospital, Division of Immunopathology, Department of Pathophysiology and Allergy Research, Medizinische Universität Wien = Medical University of Vienna, Department of Internal Medicine, Immunology, Allergy & Respiratory Diseases, University Hospital-Ospedali Riuniti di Ancona, Pediatric Allergy and Pneumology Unit, Children's Hospital La Fe, Swiss Institute of Allergy and Asthma Research (SIAF), Universität Zürich [Zürich] = University of Zurich (UZH), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Department of Allergy, Hospital Clínico Universitario, Department of Paediatrics, Respiratory and Allergic Disease Division, Medical University Graz, Allergy Division, Universidad de Alcalá - University of Alcalá (UAH)-Ramon & Cajal University Hospital, Department of Pathophysiology and Allergy Research, Medizinische Universität Wien = Medical University of Vienna-Christian Doppler Laboratory for Immunomodulation, Department of Experimental Pneumology, Ruhr University Bochum (RUB), Allergy and Respiratory Diseases Clinic, Department of Internal Medicine, University of Genoa (UNIGE), Allergy Section, Department of Internal Medicine, Vall d'Hebron University Hospital [Barcelona], Department of Respiratory Diseases, Aarhus University Hospital, Service de Pneumologie-Allergologie, CHU Toulouse [Toulouse]-Hôpital Larrey [Toulouse], CHU Toulouse [Toulouse], Imperial College London-Royal Brompton Hospital-National Heart and Lung Institute [UK], Allergy Unit, Children's Hospital-Kantonsspital Aarau, Facultad de Medicina-UCM, Hospital Clínico San Carlos-IdISSC, Research Centre for Prevention and Health (RCPH), Department of Public Health [Copenhagen], Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (KU)-University of Copenhagen = Københavns Universitet (KU)-Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (KU)-University of Copenhagen = Københavns Universitet (KU)-Capital Region of Denmark, Department of Clinical Immunology, Wroclaw Medical University, Allergy & Asthma Center Westend, Outpatient Clinic Hanf, Center for Rhinology and Allergology, Krefting Research Centre, Department of Internal Medicine and Clinical Nutrition, University of Gothenburg (GU), Seccion de Alergia, Hospital Reina Sofía, Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, Department of Pediatrics, Padua General Hospital, Pediatric Allergology and Pneumology, German Red Cross Clinic Westend, Department of Pediatrics, Allergy Unit, University of Messina, Allergy and Respiratory Diseases, Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital [Gothenburg], Allergy Service, Verona General Hospital, Clinical Trials Center, University hospital of Zurich [Zurich], Suomen Terveystalo Allergy Clinic, Division of Respiratory Medicine, Department of Medicine, Karolinska Institutet [Stockholm], Department of Pulmonology, Intensive Care Medicine, Zentrum f. Innere Medizin, Klinik I-University Clinic Rostock, Department for Pediatric Pneumology and Immunology, Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], UPC Research Laboratories, Allergy Department, Università degli studi di Genova = University of Genoa (UniGe), Service Pneumologie-Allergologie [CHU Toulouse], Pôle Clinique des Voies respiratoires [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), University of Copenhagen = Københavns Universitet (UCPH)-University of Copenhagen = Københavns Universitet (UCPH)-Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (UCPH)-University of Copenhagen = Københavns Universitet (UCPH)-Capital Region of Denmark, Wrocław Medical University, and BMC, Ed.
- Subjects
Pulmonary and Respiratory Medicine ,Quality of life ,medicine.medical_specialty ,Allergy ,[SDV.IMM] Life Sciences [q-bio]/Immunology ,Immunology ,Alternative medicine ,Declaration ,03 medical and health sciences ,0302 clinical medicine ,Quality of life (healthcare) ,Position Article and Guidelines ,Epidemiology ,Pandemic ,medicine ,Immunology and Allergy ,030212 general & internal medicine ,Rhinitis ,Health economics ,business.industry ,Public health ,RC581-607 ,medicine.disease ,Asthma ,3. Good health ,030228 respiratory system ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Family medicine ,Immunotherapy ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Immunologic diseases. Allergy ,business - Abstract
Allergy today is a public health concern of pandemic proportions, affecting more than 150 million people in Europe alone. In view of epidemiological trends, the European Academy of Allergy and Clinical Immunology (EAACI) predicts that within the next few decades, more than half of the European population may at some point in their lives experience some type of allergy. Not only do allergic patients suffer from a debilitating disease, with the potential for major impact on their quality of life, career progression, personal development and lifestyle choices, but they also constitute a significant burden on health economics and macroeconomics due to the days of lost productivity and underperformance. Given that allergy triggers, including urbanization, industrialization, pollution and climate change, are not expected to change in the foreseeable future, it is imperative that steps are taken to develop, strengthen and optimize preventive and treatment strategies. Allergen specific immunotherapy is the only currently available medical intervention that has the potential to affect the natural course of the disease. Years of basic science research, clinical trials, and systematic reviews and meta-analyses have convincingly shown that allergen specific immunotherapy can achieve substantial results for patients, improving the allergic individuals’ quality of life, reducing the long-term costs and burden of allergies, and changing the course of the disease. Allergen specific immunotherapy not only effectively alleviates allergy symptoms, but it has a long-term effect after conclusion of the treatment and can prevent the progression of allergic diseases. Unfortunately, allergen specific immunotherapy has not yet received adequate attention from European institutions, including research funding bodies, even though this could be a most rewarding field in terms of return on investments, translational value and European integration and, a field in which Europe is recognized as a worldwide leader. Evaluation and surveillance of the full cost of allergic diseases is still lacking and further progress is being stifled by the variety of health systems across Europe. This means that the general population remains unaware of the potential use of allergen specific immunotherapy and its potential benefits. We call upon Europe’s policy-makers to coordinate actions and improve individual and public health in allergy by: Promoting awareness of the effectiveness of allergen specific immunotherapy Updating national healthcare policies to support allergen specific immunotherapy Prioritising funding for allergen specific immunotherapy research Monitoring the macroeconomic and health economic parameters of allergy Reinforcing allergy teaching in medical disciplines and specialties The effective implementation of the above policies has the potential for a major positive impact on European health and well-being in the next decade.
- Published
- 2012
6. Immunologic mechanisms of a short-course of Lolium perenne peptide immunotherapy: A randomized, double-blind, placebo-controlled trial.
- Author
-
Sharif H, Singh I, Kouser L, Mösges R, Bonny MA, Karamani A, Parkin RV, Bovy N, Kishore U, Robb A, Katotomichelakis M, Holtappels G, Derycke L, Corazza F, von Frenckell R, Wathelet N, Duchateau J, Legon T, Pirotton S, Durham SR, Bachert C, and Shamji MH
- Subjects
- Adult, Asthma immunology, B-Lymphocytes, Regulatory immunology, Conjunctivitis immunology, Desensitization, Immunologic, Double-Blind Method, Female, Humans, Immunoglobulin E blood, Immunoglobulin G blood, Male, Peptides immunology, Rhinitis, Allergic, Seasonal immunology, T-Lymphocytes, Helper-Inducer immunology, T-Lymphocytes, Regulatory immunology, Young Adult, Allergens immunology, Asthma therapy, Conjunctivitis therapy, Lolium immunology, Peptides therapeutic use, Pollen immunology, Rhinitis, Allergic, Seasonal therapy
- Abstract
Background: A 3-week short-course of adjuvant-free hydrolysates of Lolium perenne peptide (LPP) immunotherapy for rhinoconjunctivitis with or without asthma over 4 physician visits is safe, well tolerated, and effective., Objective: We sought to investigate immunologic mechanisms of LPP immunotherapy in a subset of patients who participated in a phase III, multicenter, randomized, double-blind, placebo-controlled trial (clinical.govNCT02560948)., Methods: Participants were randomized to receive LPP (n = 21) or placebo (n = 11) for 3 weeks over 4 visits. Grass pollen-induced basophil, T-cell, and B-cell responses were evaluated before treatment (visit [V] 2), at the end of treatment (V6), and after the pollen season (V8)., Results: Combined symptom and rescue medication scores (CSMS) were lower during the peak pollen season (-35.1%, P = .03) and throughout the pollen season (-53.7%, P = .03) in the LPP-treated group compared with those in the placebo-treated group. Proportions of CD63
+ and CD203cbright CRTH2+ basophils were decreased following LPP treatment at V6 (10 ng/mL, P < .0001) and V8 (10 ng/mL, P < .001) compared to V2. No change in the placebo-treated group was observed. Blunting of seasonal increases in levels of grass pollen-specific IgE was observed in LPP-treated but not placebo-treated group. LPP immunotherapy, but not placebo, was associated with a reduction in proportions of IL-4+ TH 2 (V6, P = .02), IL-4+ (V6, P = .003; V8, P = .004), and IL-21+ (V6, P = .003; V8, P = .002) follicular helper T cells. Induction of FoxP3+ , follicular regulatory T, and IL-10+ regulatory B cells were observed at V6 (all P < .05) and V8 (all P < .05) in LPP-treated group. Induction of regulatory B cells was associated with allergen-neutralizing IgG4 -blocking antibodies., Conclusion: For the first time, we demonstrate that the immunologic mechanisms of LPP immunotherapy are underscored by immune modulation in the T- and B-cell compartments, which is necessary for its effect., (Copyright © 2019. Published by Elsevier Inc.)- Published
- 2019
- Full Text
- View/download PDF
7. EAACI Guidelines on Allergen Immunotherapy: House dust mite-driven allergic asthma.
- Author
-
Agache I, Lau S, Akdis CA, Smolinska S, Bonini M, Cavkaytar O, Flood B, Gajdanowicz P, Izuhara K, Kalayci O, Mosges R, Palomares O, Papadopoulos NG, Sokolowska M, Angier E, Fernandez-Rivas M, Pajno G, Pfaar O, Roberts GC, Ryan D, Sturm GJ, van Ree R, Varga EM, van Wijk RG, Yepes-Nuñez JJ, and Jutel M
- Subjects
- Animals, Asthma diagnosis, Humans, Allergens immunology, Antigens, Dermatophagoides immunology, Asthma immunology, Asthma therapy, Desensitization, Immunologic methods, Pyroglyphidae immunology
- Abstract
Allergen immunotherapy (AIT) has been in use for the treatment of allergic disease for more than 100 years. Asthma treatment relies mainly on corticosteroids and other controllers recommended to achieve and maintain asthma control, prevent exacerbations, and improve quality of life. AIT is underused in asthma, both in children and in adults. Notably, patients with allergic asthma not adequately controlled on pharmacotherapy (including biologics) represent an unmet health need. The European Academy of Allergy and Clinical Immunology has developed a clinical practice guideline providing evidence-based recommendations for the use of house dust mites (HDM) AIT as add-on treatment for HDM-driven allergic asthma. This guideline was developed by a multi-disciplinary working group using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. HDM AIT was separately evaluated by route of administration and children and adults: subcutaneous (SCIT) and sublingual AIT (SLIT), drops, and tablets. Recommendations were formulated for each. The important prerequisites for successful treatment with HDM AIT are (a) selection of patients most likely to respond to AIT and (b) use of allergen extracts and desensitization protocols of proven efficacy. To date, only AIT with HDM SLIT-tablet has demonstrated a robust effect in adults for critical end points (exacerbations, asthma control, and safety). Thus, it is recommended as an add-on to regular asthma therapy for adults with controlled or partially controlled HDM-driven allergic asthma (conditional recommendation, moderate-quality evidence). HDM SCIT is recommended for adults and children, and SLIT drops are recommended for children with controlled HDM-driven allergic asthma as the add-on to regular asthma therapy to decrease symptoms and medication needs (conditional recommendation, low-quality evidence)., (© 2019 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.)
- Published
- 2019
- Full Text
- View/download PDF
8. Lolium perenne peptide immunotherapy is well tolerated and elicits a protective B-cell response in seasonal allergic rhinitis patients.
- Author
-
Mösges R, Koch AF, Raskopf E, Singh J, Shah-Hosseini K, Astvatsatourov A, Hauswald B, Yarin Y, Corazza F, Haazen L, Pirotton S, Allekotte S, Zadoyan G, Legon T, Durham SR, and Shamji MH
- Subjects
- Adolescent, Adult, Allergens immunology, B-Lymphocytes metabolism, Child, Child, Preschool, Female, Humans, Immunoglobulin E immunology, Male, Middle Aged, Nasal Provocation Tests, Pollen immunology, Rhinitis, Allergic, Seasonal diagnosis, Young Adult, B-Lymphocytes immunology, Desensitization, Immunologic adverse effects, Desensitization, Immunologic methods, Immune Tolerance, Lolium immunology, Peptides immunology, Rhinitis, Allergic, Seasonal immunology, Rhinitis, Allergic, Seasonal therapy
- Abstract
Background: Systemic allergic reactions are a risk for allergen immunotherapy that utilizes intact allergen preparations. We evaluated the safety, efficacy and immune mechanisms of short-course treatment with adjuvant-free Lolium perenne peptides (LPP) following a 6-week dose-escalation protocol., Methods: In a prospective, dose-escalation study, 61 grass pollen-allergic patients received 2 subcutaneous injections of LPP once weekly for 6 weeks. Safety was assessed evaluating local reactions, systemic reactions and adverse events. The clinical effect of LPP was determined by reactivity to the conjunctival provocation test (CPT). Specific IgE, IgG
4 and blocking antibodies were measured at baseline (V1), during (V6) and after treatment (V8)., Results: No fatality, serious adverse event or epinephrine use was reported. Mean wheal diameters after injections were <0.6 cm and mean redness diameters <2.5 cm, independent of dose. Transient and mostly mild adverse events were reported in 33 patients. Two patients experienced a grade I and 4 patients a grade II reaction (AWMF classification). At V8, 69.8% of patients became nonreactive to CPT. sIgG4 levels were higher at V6 (8.1-fold, P < .001) and V8 (12.2-fold, P < .001) than at V1. The sIgE:sIgG4 ratio decreased at V6 (-54.6%, P < .001) and V8 (-71.6%, P < .001) compared to V1. The absolute decrease in IgE-facilitated allergen binding was 18% (P < .001) at V6 and 25% (P < .001) at V8., Conclusion: Increasing doses of subcutaneous LPP appeared safe, substantially diminished reactivity to CPT and induced blocking antibodies as early as 4 weeks after treatment initiation. The benefit/risk balance of LPP immunotherapy remains to be further evaluated in large studies., (© 2018 The Authors. Allergy Published by John Wiley & Sons Ltd.)- Published
- 2018
- Full Text
- View/download PDF
9. A randomized, double-blind, placebo-controlled, dose-finding trial with Lolium perenne peptide immunotherapy.
- Author
-
Mösges R, Kasche EM, Raskopf E, Singh J, Sohlich L, Astvatsatourov A, Shah-Hosseini K, Pirotton S, Haazen L, Durham SR, Legon T, Zadoyan G, and Shamji MH
- Subjects
- Adult, Allergens administration & dosage, Allergens immunology, Antigens, Plant administration & dosage, Antigens, Plant immunology, Double-Blind Method, Female, Humans, Injections, Subcutaneous, Lolium, Male, Peptides administration & dosage, Peptides immunology, Conjunctivitis, Allergic prevention & control, Desensitization, Immunologic methods, Rhinitis, Allergic, Seasonal prevention & control
- Abstract
Background: A novel subcutaneous allergen immunotherapy formulation (gpASIT+™) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen-induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety., Methods: This prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen-allergic adults to receive placebo or cumulative doses of 70, 170 or 370 μg LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen-specific immunoglobulins were analysed before and after treatment., Results: Conjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 μg; P = .023), 46.3% (370 μg), and 38.6% (70 μg) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per-protocol set). Also, 39% of patients in the 170-μg group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen-binding assays revealed a highly significant (P < .001) dose-dependent reduction in IgE allergen binding across all treatment groups (70 μg: 17.1%; 170 μg: 18.8%; 370 μg: 26.4%). Specific IgG
4 levels increased to 1.6-fold (70 μg), 3.1-fold (170 μg) and 3.9-fold (370 μg) (mPP)., Conclusion: Three-week immunotherapy with 170 μg LPP reduced CPT reactivity significantly and increased protective specific antibodies., (© 2017 The Authors. Allergy Published by John Wiley & Sons Ltd.)- Published
- 2018
- Full Text
- View/download PDF
10. Incidence and risk factors of anaesthesia-related perioperative cardiac arrest: A 6-year observational study from a tertiary care university hospital.
- Author
-
Hohn A, Machatschek JN, Franklin J, and Padosch SA
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Critical Care methods, Critical Care statistics & numerical data, Female, Germany epidemiology, Health Status, Heart Arrest etiology, Hospitals, University statistics & numerical data, Humans, Incidence, Infant, Male, Middle Aged, Retrospective Studies, Risk Factors, Risk Management statistics & numerical data, Tertiary Care Centers statistics & numerical data, Young Adult, Anesthesia adverse effects, Heart Arrest epidemiology, Perioperative Period statistics & numerical data, Surgical Procedures, Operative adverse effects
- Abstract
Background: In recent decades, the incidences of anaesthesia-related perioperative mortality and adverse outcomes have decreased drastically. However, to date, data on perioperative cardiac arrest and risk factors of perioperative cardiac arrest from European countries are scarce., Objectives: To determine the incidences of perioperative cardiac arrest and rates of anaesthesia-related and anaesthesia-contributory cardiac arrest. Identification of pre-existing risk factors leading to perioperative cardiac arrest., Design: Retrospective cohort study., Setting: Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Cologne, Germany., Interventions: Perioperative critical incident reports between 2007 and 2012 were screened, and reports on cardiac arrest within 24 h postoperatively were identified. Cardiac arrests were classified as 'anaesthesia-related', 'anaesthesia-contributory' or 'anaesthesia-unrelated' by two reviewers independently. Univariate and multi-variate logistic regression analysis was used to identify risk factors associated with perioperative cardiac arrest., Results: Analysis of 318 critical incidents from 169 500 anaesthetics revealed 99 perioperative cardiac arrests. This is an overall incidence of perioperative cardiac arrest of 5.8/10 000 anaesthetics [95% confidence interval (CI), 4.7 to 7.0]. The rate of anaesthesia-related cardiac arrest was 0.7/10 000 (95% CI, 0.3 to 1.1), and the rate of anaesthesia-contributory cardiac arrest was 1.7/10 000 (95% CI, 1.1 to 2.3). Most cardiac arrests related to anaesthesia were due to respiratory events. From the multi-variate analysis, American Society of Anesthesiologists physical status grade at least 3 [P = 0.007, odds ratio (OR) 2.59 (95% CI, 1.29 to 5.19)], emergency surgery [P < 0.001, OR 4.00 (95% CI, 2.15 to 7.54)] and pre-existing cardiomyopathy [P < 0.001, OR 17.48 (95% CI, 6.18 to 51.51)] emerged as predictors of cardiac arrest., Conclusion: These first available European data on perioperative cardiac arrest from a large unselected cohort indicate that the overall perioperative incidence of cardiac arrest at our institution was slightly lower than published in the literature, whereas rates of anaesthesia-related and anaesthesia-contributory cardiac arrest were comparable. Most cardiac arrests related to anaesthesia were due to respiratory events. American Society of Anesthesiologists physical status grade at least 3, emergency surgery and pre-existing cardiomyopathy appear to be relevant risk factors for cardiac arrest.
- Published
- 2018
- Full Text
- View/download PDF
11. Ultra-short-course booster is effective in recurrent grass pollen-induced allergic rhinoconjunctivitis.
- Author
-
Pfaar O, Lang S, Pieper-Fürst U, Astvatsatourov A, Gerich F, Klimek L, Kramer MF, Reydelet Y, Shah-Hosseini K, and Mösges R
- Subjects
- Adult, Antigens, Plant, Desensitization, Immunologic, Female, Humans, Immunization, Secondary, Male, Middle Aged, Allergens immunology, Conjunctivitis, Allergic immunology, Conjunctivitis, Allergic prevention & control, Pollen immunology, Rhinitis, Allergic, Seasonal immunology, Rhinitis, Allergic, Seasonal prevention & control
- Abstract
Background: A relevant proportion of allergic rhinoconjunctivitis (ARC) patients experience recurrent symptoms after successfully completing allergen immunotherapy (AIT). This prospective, controlled, noninterventional study used internationally standardized instruments to determine the clinical effects of a preseasonal, ultra-short-course booster AIT on clinical outcome parameters., Methods: This two-arm study included patients aged ≥12 years with recurrent grass pollen-induced seasonal AR who had completed a successful course of any grass pollen AIT at least 5 years before enrolment. Overall, 56 patients received one preseasonal short-course booster AIT using tyrosine-absorbed grass pollen allergoids containing the adjuvant monophosphoryl lipid A (MPL
® ); 51 control patients received symptomatic medication. The combined symptom and medication score (CSMS) was recorded in the (peak) grass pollen season. Furthermore, concomitant (antiallergic) medication use, the patients' state of health, Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) results and safety/tolerability of the treatment were assessed., Results: The CSMS in the peak grass pollen season was significantly lower in the booster AIT group (Δ=38.4%, P<.01). Moreover, significantly more patients in this group used no concomitant antiallergic medication throughout the peak grass pollen season. Twice as many patients in the booster AIT group as in the control group reported having a better state of health than in the preceding season. MiniRQLQ results showed significant differences favouring the booster AIT. The booster AIT was generally well tolerated, with only two patients reporting mild, grade 1 systemic adverse events., Conclusion: Booster AIT using tyrosine-absorbed allergoids containing the adjuvant MPL® effectively prevents re-occurrence of symptoms in patients with grass pollen-induced ARC., (© 2017 The Authors. Allergy Published by John Wiley & Sons Ltd.)- Published
- 2018
- Full Text
- View/download PDF
12. Prevalence of hyponatremia in inpatients with incurable and life-limiting diseases and its association with physical symptoms-a retrospective descriptive study.
- Author
-
Kremeike K, Wetter RML, Burst V, Voltz R, Kuhr K, and Simon ST
- Subjects
- Adult, Aged, Female, Hospitalization statistics & numerical data, Humans, Hyponatremia diagnosis, Inpatients statistics & numerical data, Male, Middle Aged, Prevalence, Prospective Studies, Retrospective Studies, Hyponatremia epidemiology, Palliative Care statistics & numerical data
- Abstract
Purpose: Hyponatremia is a common electrolyte abnormality seen in hospitalized patients. It may cause a variety of symptoms and is associated with longer hospitalizations and higher mortality. However, to date, only little is known about the extent of hyponatremia in patients with incurable diseases and whether it is associated with physical symptoms in this patient group. This study aims to describe the prevalence of hyponatremia, associated symptoms, and symptom intensity in inpatients with hyponatremia receiving specialist palliative care (SPC)., Methods: This is a retrospective study. Demographic and clinical data as well as symptoms, scored symptom intensity, and laboratory values were collected. All inpatients of a large German University Hospital receiving SPC in 2013 with documented sodium values were included., Results: In 2013, 789 inpatients received SPC of which 710 had documented sodium values. The prevalence of hyponatremia was 38.7% (275/710). A mild degree showed 220 (31,0%), 44 (6.2%) had a moderate, and 11 (1.6%) a severe form. Hyponatremia patients experienced significantly more symptoms than normonatremic patients (mean = 7.71 vs 6.63; p < 0.001). Breathlessness, depressiveness, nausea, vomiting, poor appetite, constipation, and weakness were significantly more frequent in patients with hyponatremia. Furthermore, hyponatremia severity was associated with higher symptom intensity (mean = 13.29 vs 11.28; p < 0.001)., Conclusions: More than one third of all SPC patients showed a hyponatremia, and the hyponatremia grade was associated with symptom burden and symptom intensity. A prospective analysis is needed to further examine this association and the possible influence of hyponatremia correction on symptom burden reduction.
- Published
- 2018
- Full Text
- View/download PDF
13. Allergen immunotherapy for allergic asthma: A systematic review and meta-analysis.
- Author
-
Dhami S, Kakourou A, Asamoah F, Agache I, Lau S, Jutel M, Muraro A, Roberts G, Akdis CA, Bonini M, Cavkaytar O, Flood B, Gajdanowicz P, Izuhara K, Kalayci Ö, Mosges R, Palomares O, Pfaar O, Smolinska S, Sokolowska M, Asaria M, Netuveli G, Zaman H, Akhlaq A, and Sheikh A
- Subjects
- Asthma diagnosis, Cost-Benefit Analysis, Humans, Injections, Subcutaneous, Quality of Life, Randomized Controlled Trials as Topic, Respiratory Function Tests, Sublingual Immunotherapy, Symptom Assessment, Time Factors, Treatment Outcome, Allergens immunology, Asthma immunology, Asthma therapy, Desensitization, Immunologic adverse effects, Desensitization, Immunologic methods
- Abstract
Background: To inform the development of the European Academy of Allergy and Clinical Immunology's (EAACI) Guidelines on Allergen Immunotherapy (AIT) for allergic asthma, we assessed the evidence on the effectiveness, cost-effectiveness and safety of AIT., Methods: We performed a systematic review, which involved searching nine databases. Studies were screened against predefined eligibility criteria and critically appraised using established instruments. Data were synthesized using random-effects meta-analyses., Results: 98 studies satisfied the inclusion criteria. Short-term symptom scores were reduced with a standardized mean difference (SMD) of -1.11 (95% CI -1.66, -0.56). This was robust to a prespecified sensitivity analyses, but there was evidence suggestive of publication bias. Short-term medication scores were reduced SMD -1.21 (95% CI -1.87, -0.54), again with evidence of potential publication bias. There was no reduction in short-term combined medication and symptom scores SMD 0.17 (95% CI -0.23, 0.58), but one study showed a beneficial long-term effect. For secondary outcomes, subcutaneous immunotherapy (SCIT) improved quality of life and decreased allergen-specific airway hyperreactivity (AHR), but this was not the case for sublingual immunotherapy (SLIT). There were no consistent effects on asthma control, exacerbations, lung function, and nonspecific AHR. AIT resulted in a modest increased risk of adverse events (AEs). Although relatively uncommon, systemic AEs were more frequent with SCIT; however no fatalities were reported. The limited evidence on cost-effectiveness was mainly available for sublingual immunotherapy (SLIT) and this suggested that SLIT is likely to be cost-effective., Conclusions: AIT can achieve substantial reductions in short-term symptom and medication scores in allergic asthma. It was however associated with a modest increased risk of systemic and local AEs. More data are needed in relation to secondary outcomes, longer-term effectiveness and cost-effectiveness., (© 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.)
- Published
- 2017
- Full Text
- View/download PDF
14. Cognitive interventions in patients with dementia living in long-term care facilities: Systematic review and meta-analysis.
- Author
-
Folkerts AK, Roheger M, Franklin J, Middelstädt J, and Kalbe E
- Subjects
- Activities of Daily Living, Dementia psychology, Humans, Quality of Life, Cognitive Behavioral Therapy, Dementia therapy, Long-Term Care
- Abstract
Background: Previous reviews and meta-analyses demonstrated effects of cognitive interventions in dementia, but none specifically considered residents with dementia in long-term care (LTC) facilities., Objective: To analyse the efficacy of cognitive interventions in institutionalised individuals with dementia., Methods: After identifying 27 articles, a systematic review was performed. A meta-analysis was calculated for 15 studies of the randomized controlled trials regarding effects on relevant outcomes. Fixed-effects meta-analyses were conducted using standardized mean differences (SMD) of changes from baseline pooled using the inverse variance method., Results: When comparing cognitive interventions to passive control groups, the meta-analysis revealed significant moderate effects on global cognition (SMD=0.47, 95% CI 0.27-0.67), autobiographical memory (0.67, 0.02-1.31), and behavioral and psychological symptoms in dementia (BPSD; 0.71, 0.06-1.36). Significant small effects were detected for quality of life (QoL; 0.37, 0.05-0.70). Moderate effects on activities of daily living (0.28; -0.02 to 0.58) failed to reach significance; no effects were found on depression (0.22; -0.08 to 0.51). Significant moderate effects of global cognition (0.55; 0.22-0.89) and depression (0.64; 0.21-1.07) were also found for cognitive interventions contrasting active control groups. No harmful events related to the participation in the interventions were observed., Conclusion: Cognitive interventions are safe and effective for residents with dementia in LTC. However, while it seems clear that cognitive benefits can specifially be assigned to these forms of intervention, further research is necessary to clarify whether the effects on BPSD and QoL reflect unspecific changes due to additional attention. Furthermore, future studies will have to determine which intervention type yields the largest benefits., (Copyright © 2017 Elsevier B.V. All rights reserved.)
- Published
- 2017
- Full Text
- View/download PDF
15. Renal function following xenon anesthesia for partial nephrectomy-An explorative analysis of a randomized controlled study.
- Author
-
Stevanovic A, Schaefer P, Coburn M, Rossaint R, Stoppe C, Boor P, Pfister D, Heidenreich A, Christ H, Hellmich M, and Fahlenkamp AV
- Subjects
- Anesthetics, Inhalation adverse effects, Female, Humans, Kidney surgery, Kidney Neoplasms physiopathology, Kidney Neoplasms surgery, Male, Middle Aged, Nephrectomy adverse effects, Perioperative Period, Time Factors, Xenon adverse effects, Anesthetics, Inhalation pharmacology, Kidney drug effects, Kidney physiopathology, Nephrectomy methods, Xenon pharmacology
- Abstract
Background: Perioperative preservation of renal function has a significant impact on morbidity and mortality in kidney surgery. Nephroprotective effects of the anesthetic xenon on ischemia-reperfusion injury were found in several experimental studies., Objective: We aimed to explore whether xenon anesthesia can reduce renal damage in humans undergoing partial nephrectomy and to gather pilot data of possible nephroprotection in these patients., Design: A prospective randomized, single-blinded, controlled study., Setting: Single-center, University Hospital of Aachen, Germany between July 2013-October 2015., Patients: Forty-six patients with regular renal function undergoing partial nephrectomy., Interventions: Patients were randomly assigned to receive xenon- (n = 23) or isoflurane (n = 23) anesthesia., Main Outcome Measures: Primary outcome was the maximum postoperative glomerular filtration rate (GFR) decline within seven days after surgery. Secondary outcomes included intraoperative and tumor-related data, assessment of further kidney injury markers, adverse events and optional determination of renal function after 3-6 months., Results: Unexpected radical nephrectomy was performed in 5 patients, thus they were excluded from the per-protocol analysis, but included in the intention-to-treat analysis. The maximum postoperative GFR decline was attenuated by 45% in the xenon-group (10.9 ml min-1 1.73 cm-2 versus 19.7 ml min-1 1.73 cm-2 in the isoflurane group), but without significance (P = 0.084). Occurrence of adverse events was reduced (P = 0.003) in the xenon group. Renal function was similar among the groups after 3-6 months., Conclusion: Xenon anesthesia was feasible and safe in patients undergoing partial nephrectomy with regard to postoperative renal function. We found no significant effect on early renal function but less adverse events in the xenon group. Larger randomized controlled studies in more heterogeneous collectives are required, to confirm or refute the possible clinical benefit on renal function by xenon., Trial Registration: ClinicalTrials.gov NCT01839084 and EudraCT 2012-005698-30.
- Published
- 2017
- Full Text
- View/download PDF
16. Allergen exposure chambers: harmonizing current concepts and projecting the needs for the future - an EAACI Position Paper.
- Author
-
Pfaar O, Calderon MA, Andrews CP, Angjeli E, Bergmann KC, Bønløkke JH, de Blay F, Devillier P, Ellis AK, Gerth van Wijk R, Hohlfeld JM, Horak F, Jacobs RL, Jacobsen L, Jutel M, Kaul S, Larché M, Larenas-Linnemann D, Mösges R, Nolte H, Patel P, Peoples L, Rabin RL, Rather C, Salapatek AM, Sigsgaard T, Thaarup S, Yang J, Zieglmayer P, Zuberbier T, and Demoly P
- Subjects
- Desensitization, Immunologic standards, Desensitization, Immunologic trends, Health Policy, Humans, Hypersensitivity immunology, Hypersensitivity therapy, Reproducibility of Results, Allergens immunology, Desensitization, Immunologic methods, Environment, Controlled, Inhalation Exposure adverse effects
- Abstract
Background: Allergen exposure chambers (AECs) are clinical facilities allowing for controlled exposure of subjects to allergens in an enclosed environment. AECs have contributed towards characterizing the pathophysiology of respiratory allergic diseases and the pharmacological properties of new therapies. In addition, they are complementary to and offer some advantages over traditional multicentre field trials for evaluation of novel therapeutics. To date, AEC studies conducted have been monocentric and have followed protocols unique to each centre. Because there are technical differences among AECs, it may be necessary to define parameters to standardize the AECs so that studies may be extrapolated for driving basic immunological research and for marketing authorization purposes by regulatory authorities., Methods: For this task force initiative of the European Academy of Allergy and Clinical Immunology (EAACI), experts from academia and regulatory agencies met with chamber operators to list technical, clinical and regulatory unmet needs as well as the prerequisites for clinical validation., Results: The latter covered the validation process, standardization of challenges and outcomes, intra- and interchamber variability and reproducibility, in addition to comparability with field trials and specifics of paediatric trials and regulatory issues., Conclusion: This EAACI Position Paper aims to harmonize current concepts in AECs and to project unmet needs with the intent to enhance progress towards use of these facilities in determining safety and efficacy of new therapeutics in the future., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
- Published
- 2017
- Full Text
- View/download PDF
17. EffenDys-Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial.
- Author
-
Simon ST, Kloke M, Alt-Epping B, Gärtner J, Hellmich M, Hein R, Piel M, Cornely OA, Nauck F, and Voltz R
- Subjects
- Administration, Buccal, Analgesics, Opioid adverse effects, Cross-Over Studies, Disease Progression, Dyspnea etiology, Feasibility Studies, Female, Fentanyl adverse effects, Humans, Male, Middle Aged, Morphine administration & dosage, Patient Dropouts, Pilot Projects, Severity of Illness Index, Time Factors, Treatment Outcome, Analgesics, Opioid administration & dosage, Dyspnea drug therapy, Fentanyl administration & dosage, Neoplasms complications
- Abstract
Context: Episodic breathlessness is a frequent and burdensome symptom in cancer patients but pharmacological treatment is limited., Objectives: To determine time to onset, efficacy, feasibility, and safety of transmucosal fentanyl in comparison to immediate-release morphine for the relief of episodic breathlessness., Methods: Phase II, investigator-initiated, multicenter, open-label, randomized, morphine-controlled, crossover trial with open-label titration of fentanyl buccal tablet (FBT) in inpatients with incurable cancer. The primary outcome was time to onset of meaningful breathlessness relief. Secondary outcomes were efficacy (breathlessness intensity difference at 10 and 30 minutes; sum of breathlessness intensity difference at 15 and 60 minutes), feasibility, and safety. Study was approved by local ethics committees., Results: Twenty-five of 1341 patients were eligible, 10 patients agreed to participate (four female, mean age 58 ± 11, mean Karnofsky score 67 ± 11). Two patients died before final visits and two patients dropped-out because of disease progression leaving six patients for analysis with 61 episodes of breathlessness. Mean time to onset was for FBT 12.7 ± 10.0 and for immediate-release morphine 23.6 ± 15.1 minutes with a mean difference of -10.9 minutes (95% CI = -24.5 to 2.7, P = 0.094). Efficacy measures were predominately in favor for FBT. Both interventions were safe. Feasibility failed because of too much study demands for a very ill patient group., Conclusion: The description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial., (Copyright © 2016. Published by Elsevier Inc.)
- Published
- 2016
- Full Text
- View/download PDF
18. Peyton's 4-Steps-Approach in comparison: Medium-term effects on learning external chest compression - a pilot study.
- Author
-
Münster T, Stosch C, Hindrichs N, Franklin J, and Matthes J
- Subjects
- Adult, Clinical Competence, Female, Humans, Male, Pilot Projects, Prospective Studies, Young Adult, Chest Wall Oscillation, Heart Arrest therapy, Learning, Students, Medical
- Abstract
Introduction: The external chest compression is a very important skill required to maintain a minimum of circulation during cardiac arrest until further medical procedures can be taken. Peyton's 4-Steps-Approach is one method of skill training, the four steps being: Demonstration, Deconstruction, Comprehension and Execution. Based on CPR skill training, this method is widely, allegedly predominantly used, although there are insufficient studies on Peyton's 4-Steps-Approach for skill training in CPR in comparison with other methods of skill training. In our study, we compared the medium- term effects on learning external chest compression with a CPR training device in three different groups: PEY (Peyton's 4-Steps-Approach), PMOD (Peyton's 4-Steps-Approach without Step 3) and STDM, the standard model, according to the widely spread method "see one, do one" (this is equal to Peyton's step 1 and 3)., Material and Methods: This prospective and randomised pilot study took place during the summer semester of 2009 at the SkillsLab and Simulation Centre of the University of Cologne (Kölner interprofessionelles Skills Lab und Simulationszentrum - KISS). The subjects were medical students (2(nd) and 3(rd) semester). They volunteered for the study and were randomised in three parallel groups, each receiving one of the teaching methods mentioned above. One week and 5/6 months after the intervention, an objective, structured single assessment was taken. Compression rate, compression depth, correct compressions, and the sum of correct checklist items were recorded. Additionally, we compared cumulative percentages between the groups based on the correct implementation of the resuscitation guidelines during that time., Results: The examined sample consisted of 134 subjects (68% female; age 22±4; PEY: n=62; PMOD: n=31; STDM: n=41). There was no difference between the groups concerning age, gender, pre-existing experience in CPR or time of last CPR course. The only significant difference between the groups was the mean compression rate (bpm): Group 1 (PEY) with 99±17 bpm, Group 2 (PMOD) with 101±16 bpm and Group 3 (STDM) with 90±16 bpm (p=0,007 for Group 3 vs. Group 1 and Group 3 vs. Group 2, Mann-Whitney- U-Test). We observed no significant differences between the groups after the second assessment., Conclusion: Our study showed that there are no essential differences in external chest compression during CPR performed by medical students dependent on the teaching method (Peyton vs. "Non-Peyton") implemented with regard to the medium-term effects. The absence of benefits could possibly be due to the simplicity of external chest compression.
- Published
- 2016
- Full Text
- View/download PDF
19. Priority Setting and Influential Factors on Acceptance of Pharmaceutical Recommendations in Collaborative Medication Reviews in an Ambulatory Care Setting - Analysis of a Cluster Randomized Controlled Trial (WestGem-Study).
- Author
-
Rose O, Mennemann H, John C, Lautenschläger M, Mertens-Keller D, Richling K, Waltering I, Hamacher S, Felsch M, Herich L, Czarnecki K, Schaffert C, Jaehde U, and Köberlein-Neu J
- Subjects
- Aged, Aged, 80 and over, Ambulatory Care, Cardiovascular Diseases epidemiology, Female, Geriatrics, Humans, Male, Medical Records, Pharmacists, Physicians, Cardiovascular Diseases drug therapy, Drug Interactions, Medication Therapy Management
- Abstract
Background: Medication reviews are recognized services to increase quality of therapy and reduce medication risks. The selection of eligible patients with potential to receive a major benefit is based on assumptions rather than on factual data. Acceptance of interprofessional collaboration is crucial to increase the quality of medication therapy., Objective: The research question was to identify and prioritize eligible patients for a medication review and to provide evidence-based criteria for patient selection. Acceptance of the prescribing general practitioner to implement pharmaceutical recommendations was measured and factors influencing physicians' acceptance were explored to obtain an impression on the extent of collaboration in medication review in an ambulatory care setting., Methods: Based on data of a cluster-randomized controlled study (WestGem-study), the correlation between patient parameters and the individual performance in a medication review was calculated in a multiple logistic regression model. Physician's acceptance of the suggested intervention was assessed using feedback forms. Influential factors were analyzed., Results: The number of drugs in use (p = 0.001), discrepancies between prescribed and used medicines (p = 0.014), the baseline Medication Appropriateness Index score (p<0.001) and the duration of the intervention (p = 0.006) could be identified as influential factors for a major benefit from a medication review, whereas morbidity (p>0.05) and a low kidney function (p>0.05) do not predetermine the outcome. Longitudinal patient care with repeated reviews showed higher interprofessional acceptance and superior patient benefit. A total of 54.9% of the recommendations in a medication review on drug therapy were accepted for implementation., Conclusions: The number of drugs in use and medication reconciliation could be a first rational step in patient selection for a medication review. Most elderly, multimorbid patients with polymedication experience a similar chance of receiving a benefit from a medication review. Longitudinal patient care should be preferred over confined medication reviews. The acceptance of medication reviews by physicians supports further implementation into health care systems., Trial Registration: ISRCTN ISRCTN41595373.
- Published
- 2016
- Full Text
- View/download PDF
20. Prescription errors in geriatric patients can be avoided by means of a computerized physician order entry (CPOE).
- Author
-
Frisse S, Röhrig G, Franklin J, Polidori MC, and Schulz RJ
- Subjects
- Aged, Aged, 80 and over, Deglutition Disorders epidemiology, Germany epidemiology, Humans, Male, Renal Insufficiency epidemiology, Retrospective Studies, Deglutition Disorders drug therapy, Drug Prescriptions statistics & numerical data, Medical Order Entry Systems statistics & numerical data, Medication Errors prevention & control, Medication Errors statistics & numerical data, Renal Insufficiency drug therapy
- Abstract
Background: The implementation of a computerized physician order entry (CPOE) can help reduce prescription errors in clinical practice., Objective: The aim of this study was to evaluate the effects of a CPOE for geriatric patients with the two most common conditions for drug-induced iatrogenic diseases, dysphagia and renal failure., Subjects and Methods: A retrospective analysis of actual drug prescriptions versus CPOE recommendations in the geriatric department of the St. Marien Hospital in Cologne, Germany was carried out. Actual drug prescriptions were collected for 26 patients with dysphagia (15 female, 11 male, average age 82.3 ± 8.0 years) and 35 patients with renal failure (23 female, 12 male, average age 80.5 ± 6.7 years) which were compared with recommended prescriptions by means of a CPOE and discrepancies were statistically analyzed., Results: Prescription errors for at least 1 drug were detected in 46 % of patients with renal failure and the administration of at least 1 drug with inadequate crushing was observed in 77 % of dysphagia patients., Conclusion: Prescription errors appear to be frequent to highly frequent in the medical routine even in a highly specialized geriatric setting. Inaccuracies might be reduced by the implementation of a CPOE and even more if coupled to a decision support system. Drug-drug or drug-disease interactions, which are particularly high risks in patients with multimorbidities, multidrug therapy, renal failure or malnutrition, might be kept under control through careful verification of medication indications, organ function status as well as drug administration and preparation in cases of tube feeding.
- Published
- 2016
- Full Text
- View/download PDF
21. Vitrectomy with or without encircling band for pseudophakic retinal detachment: a multi-centre, three-arm, randomised clinical trial. VIPER Study Report No. 1--design and enrolment.
- Author
-
Mazinani B, Baumgarten S, Schiller P, Agostini H, Helbig H, Limburg E, Hellmich M, and Walter P
- Subjects
- Adult, Female, Humans, Male, Prospective Studies, Pseudophakia physiopathology, Retina physiology, Retinal Detachment physiopathology, Visual Acuity physiology, Patient Selection, Pseudophakia surgery, Research Design, Retinal Detachment surgery, Scleral Buckling, Vitrectomy
- Abstract
Purpose: Scleral buckling is currently used in addition to vitrectomy for the treatment of pseudophakic retinal detachment (PRD) to better support the vitreous base and better visualisation of the periphery., Aims: The aims of this study are to evaluate (1) whether the combination of 20 G vitrectomy and scleral buckling is superior to 20 G vitrectomy alone (control) (confirmatory), and (2) whether transconjunctival 23/25 G vitrectomy is non-inferior to 20 G vitrectomy (both without scleral buckling) regarding operation success (exploratory)., Methods: The VIPER (Vitrectomy Plus Encircling Band Vs. Vitrectomy Alone For The Treatment Of Pseudophakic Retinal Detachment) study is an unmasked, multi-centre, three-arm randomised trial. Patients with PRD were eligible, excluding complicated retinal detachment or otherwise severe ophthalmologic impairment. Patients were randomised to one of three interventions: 20 G vitrectomy alone (control C), combination of 20 G vitrectomy and circumferential scleral buckling (experimental treatment E1) or 23/25 G vitrectomy alone (experimental treatment E2). The primary endpoint is the absence of any indication for a retina re-attaching procedure during 6 months of follow-up. Secondary endpoints include best corrected visual acuity, retina re-attaching procedures, complications and adverse events., Results: From June 2011 to August 2013, 257 patients were enrolled in the study. The internet randomisation service assigned 100 patients each to the treatment arms C and E1, and 57 patients to treatment E2. The imbalance is due to the fact that several retinal surgeons did not qualify for performing E2. The random assignment was stratified and balanced (ie, 1:1 or 1:1:1 ratio) by surgeon., Conclusions: The described study represents a methodologically rigorous protocol evaluating the benefits of three different vitrectomy approaches to PRD. The projected results will help to establish their overall efficacy and will permit conclusions regarding their relative value., Trial Registration Number: DRKS00003158 (German Clinical Trials Register, DRKS)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
- Published
- 2016
- Full Text
- View/download PDF
22. Limitations in Ankle Dorsiflexion Range of Motion, Gait, and Walking Efficiency in Childhood Cancer Survivors.
- Author
-
Beulertz J, Bloch W, Prokop A, Rustler V, Fitzen C, Herich L, Streckmann F, and Baumann FT
- Subjects
- Adolescent, Case-Control Studies, Child, Child, Preschool, Cross-Sectional Studies, Female, Humans, Male, Neoplasms nursing, Neoplasms therapy, Ankle Joint physiopathology, Gait physiology, Neoplasms physiopathology, Range of Motion, Articular physiology, Survivors statistics & numerical data, Walking physiology
- Abstract
Background: Improvements in survival rates in pediatric oncology have resulted in a growing need to identify adverse effects and improve rehabilitation in this population., Objective: This cross-sectional study aimed to investigate active ankle dorsiflexion (DF) range of motion (ROM), gait, walking efficiency, and motor performance in a mixed childhood cancer survivor population in comparison to healthy peers., Methods: Active ankle DF-ROM (goniometer), gait (Microgate Optogait 2D Gait Analysis), walking efficiency (6-minute walk test), and motor performance (German Motor Test 6-18) were assessed in a mixed childhood cancer survivor population after cessation of medical treatment (n = 13) in comparison to healthy children matched for age and gender (n = 13)., Results: Active ankle DF-ROM, gait (stance, swing, and preswing phase), and walking efficiency were significantly impaired in survivors compared with control subjects. No significant difference between groups was found in motor performance., Conclusion: Despite sufficient total motor performance levels, specific limitations in physical functioning were identified in a mixed childhood cancer survivor sample. This highlights the importance of the present findings., Implication for Practice: The results from this study highlight the potential significance of limited ankle DF function, inhibited gait, and reduced walking efficiency as adverse effects of various types of childhood cancer. It is hoped this enhanced recognition by pediatric cancer patients, parents, and exercise professionals will initiate specific supportive strategies and potentially prevent further limitations.
- Published
- 2016
- Full Text
- View/download PDF
23. Study of the effectiveness of hippotherapy on the symptoms of multiple sclerosis - Outline of a randomised controlled multicentre study (MS-HIPPO).
- Author
-
Wollenweber V, Drache M, Schickendantz S, Gerber-Grote A, Schiller P, and Pöhlau D
- Abstract
Background: Hippotherapy is a form of therapeutic riding which is used in the treatment of neurological and muscular disorders. Until now there has not been any high-quality randomised study that has proven its effectiveness., Objective: The aims of this study are to evaluate whether hippotherapy (as add-on to physiotherapy and/or pharmacotherapy) is superior to the standard treatment (physiotherapy and/or pharmacotherapy as prior to the study) in terms of balance function and other patient relevant outcomes in patients with multiple sclerosis., Methods: The MS-HIPPO study is a prospective, randomised, examiner-blinded, controlled multicentre study. Patients were randomised to one of two groups: 12 weeks of hippotherapy accompanied by physiotherapy and/or pharmacotherapy (intervention) or 12 weeks of physiotherapy and/or pharmacotherapy as prior to the study (control). The primary endpoint is the change in balance function, as measured by the Berg Balance Scale (BBS). The treatment comparison is evaluated using a covariance analysis with baseline BBS, centre, age, gender and EDSS as covariates. Secondary endpoints include fatigue, quality of life, pain intensity and spasticity., Results and Conclusions: The described study is the first randomised study evaluating the benefits of hippotherapy for patients with multiple sclerosis. In 5 national centres ten study physicians will screen potential participants. The expected results will help to improve the knowledge on non-pharmaceutical therapeutic options in this field.
- Published
- 2016
- Full Text
- View/download PDF
24. Recent pharmacological developments in the treatment of perennial and persistent allergic rhinitis.
- Author
-
Klimek L, Mullol J, Hellings P, Gevaert P, Mösges R, and Fokkens W
- Subjects
- Adrenal Cortex Hormones therapeutic use, Cholinergic Antagonists therapeutic use, Histamine Antagonists therapeutic use, Humans, Immunotherapy, Leukotriene Antagonists therapeutic use, Quality of Life, Rhinitis, Allergic, Perennial drug therapy, Toll-Like Receptors agonists, Anti-Allergic Agents therapeutic use, Rhinitis, Allergic drug therapy
- Abstract
Introduction: Allergic rhinitis (AR) has a major negative impact on patients' quality of life (QoL) and carries a high socio economic burden. This is particularly the case for patients who experience symptoms for extended periods of time (i.e. those with perennial (PAR) or persistent AR (PER), depending on the classification system used). This review covers available pharmacological advances and recent developments in the treatment of PAR or PER., Areas Covered: Pharmacological AR treatment is used to reduce symptom burden and help restore patients' normal daily routine. Traditionally, non-sedating antihistamines and intranasal corticosteroids (INS) were the two drug classes recommended for use first line. These, along with antileukotrienes, decongestants, mast cell stabilizers and anticholinergics, constituted the bulk of the AR treatment arsenal. MP-AzeFlu (Dymista®, Meda, Solna, Sweden) is the most recent addition to that arsenal. It is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) delivered in a single spray and has surpassed available therapies in terms of symptom control and treatment response. Other relatively new treatments for PAR or PER include H3 antihistamines, toll-like receptor (TLR) agonists, cellulose powders and micro-emulsions, novel biomolecular formulations and omalizumab. Each of these new additions is reviewed here., Expert Opinion: A new AR drug class has recently been introduced (i.e. RO1AD58). Currently MP-AzeFlu is the only treatment option within this drug class. It can be estimated that combination treatments like MP-AzeFlu will become the mainstay of PAR and PER therapy since use will result in better compliance, improved efficacy over INS and a faster response together with good levels of tolerability. The challenge is to find other equally, or more effective, combination treatments, as has been the therapeutic standard in bronchial asthma for decades. The potential of biologics, as well as TLR-agonists and other new treatment options needs to be further evaluated.
- Published
- 2016
- Full Text
- View/download PDF
25. Exploratory study of long-term health-related quality of life in patients with surgically treated primary parotid gland cancer.
- Author
-
Stenner M, Beenen F, Hahn M, Koopmann M, Weiss D, and Hüttenbrink KB
- Subjects
- Cross-Sectional Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neck Dissection methods, Neoplasm Staging, Parotid Neoplasms diagnosis, Parotid Neoplasms radiotherapy, Risk Factors, Surveys and Questionnaires, Time Factors, Treatment Outcome, Parotid Neoplasms surgery, Quality of Life
- Abstract
Background: Health-related quality of life (HRQOL) has received more and more attention as an outcome in cancer therapy. In this exploratory study, we assessed the long-term HRQOL among 77 surgically treated patients with parotid gland cancer., Methods: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-questions (EORTC-QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (EORTC-QLQ-C30-H&N35) questionnaires were used in a cross-sectional design. The mean time-lag between initial diagnosis and completion of the questionnaire was 89.7 months., Results: The HRQOL significantly increased with the time-lag to surgery and decreased with the patients' age. Factors with clinically significant effects in several areas of long-term HRQOL (ie, more than 4 scores) were age, type of neck dissection, preoperative facial nerve palsy, and postoperative radiation therapy., Conclusion: In parotid gland cancer surgery, factors, such as sex, age, type of surgery, facial nerve palsy, and radiation therapy, seem to be associated with clinically meaningful differences in long-term HRQOL scores., (© 2015 Wiley Periodicals, Inc.)
- Published
- 2016
- Full Text
- View/download PDF
26. Effects of a 6-Month, Group-Based, Therapeutic Exercise Program for Childhood Cancer Outpatients on Motor Performance, Level of Activity, and Quality of Life.
- Author
-
Beulertz J, Prokop A, Rustler V, Bloch W, Felsch M, and Baumann FT
- Subjects
- Adolescent, Child, Child, Preschool, Emotions, Female, Group Processes, Humans, Male, Outpatients, Prospective Studies, Exercise, Neoplasms therapy, Psychomotor Performance, Quality of Life
- Abstract
Background: Exercise interventions in pediatric oncology are feasible and safe. However, scarce data are available with regard to the effectiveness of outpatient, group-based exercise interventions. As well, the potential role of exercise to improve motor performance has not been adequately explored despite being a meaningful outcome during childhood with important implications for physical activity behavior. No study has yet demonstrated significant changes in motor performance after an exercise intervention., Procedures: This explorative, prospective study was designed to evaluate the effects of a 6-month, group-based, therapeutic exercise program for a mixed childhood cancer population on motor performance, level of activity, and quality of life. After cessation of inpatient medical treatment, childhood cancer outpatients aged 4-17 years exercised once a week during a 6-month period (IG). Comparison groups included childhood cancer outpatients receiving care as usual (CG(1)), as well as healthy peers (matched to IG by age and gender) (CG(2))., Results: Overall motor performance, various motor dimensions, activity in sport clubs and school sports, as well as physical and emotional well-being were significantly reduced in the IG at baseline. Significant differences between the IG and CG(1) and/or CG(2) were identified in the change of overall motor performance, single motor dimensions, overall level of activity, and emotional well-being from baseline to post-intervention., Conclusions: The exercise intervention was beneficial in terms of motor performance, level of activity, and emotional well-being. As such, this study provides support for group-based exercise as a potential strategy to improve these outcomes after inpatient medical treatment., (© 2015 Wiley Periodicals, Inc.)
- Published
- 2016
- Full Text
- View/download PDF
27. Optimum treatment strategies for polyallergic patients - analysis of a large observational trial.
- Author
-
Shah-Hosseini K, Mioc K, Hadler M, Karagiannis E, and Mösges R
- Subjects
- Adolescent, Adult, Aged, Allergens immunology, Child, Child, Preschool, Conjunctivitis, Allergic therapy, Female, Humans, Male, Middle Aged, Poaceae immunology, Pollen immunology, Prospective Studies, Retrospective Studies, Seasons, Sublingual Immunotherapy adverse effects, Tablets administration & dosage, Young Adult, Rhinitis, Allergic, Seasonal therapy, Sublingual Immunotherapy methods
- Abstract
Objectives: To document the effectiveness and safety of sublingual allergen immunotherapy (SLIT) with a five-grass pollen tablet (Oralair ) and compare different treatment options in a broad, non-selected population of patients in a real-world clinical setting., Research Design and Methods: This was a 2 year, open, prospective, multicenter, single-arm, non-interventional study. Patients with a history of clinically relevant allergic symptoms caused by grass pollen, confirmed by skin prick testing, received treatment with the five-grass pollen tablet. Concomitant treatment with symptomatic medication and/or additional SLIT or subcutaneous immunotherapy (SCIT) was permitted. Twelve-month data are presented here. Effectiveness was assessed comparing a combined rhinoconjunctivitis (RC) score derived from the severity of rhinitis and conjunctivitis symptoms under treatment with retrospective data of the previous year., Results: A total of 1408 patients participated in the study, of whom 434 were children/adolescents and 962 polyallergic. Compared with the grass pollen season preceding five-grass pollen tablet treatment, a statistically significant reduction of 49.9% was achieved in RC score for the total population (p < 0.001), and an improvement in overall health was perceived by 90.9% of patients. The overall population of polyallergic patients derived similar benefits from treatment with the five-grass pollen tablet as monoallergic patients. The percentage reduction in RC score was larger in polyallergic patients taking no additional therapy (60.2%) than in those taking concomitant symptomatic medication (38.1%) or allergen immunotherapy (AIT) (50.8%). Within the last of these groups, RC score improved by 47.6% among patients receiving additional SCIT, versus 54.8% with additional SLIT. Adverse drug reactions, reported in 15.3% of study participants, were mostly local in nature and mild or moderate in intensity., Conclusions: After 1 year of treatment, polyallergic patients responded similarly to the five-grass pollen tablet as monoallergic patients. For polyallergic patients in whom additional treatment was needed, a second SLIT may be more beneficial than a SCIT or symptomatic co-medication.
- Published
- 2015
- Full Text
- View/download PDF
28. The correlation between ECochG parameters and early auditory behavior after cochlear implantation in children.
- Author
-
Stuermer KJ, Beutner D, Streicher B, Foerst A, Felsch M, Lang-Roth R, and Walger M
- Subjects
- Age Factors, Child, Child, Preschool, Disabled Children psychology, Female, Hearing Loss, Central diagnosis, Hearing Loss, Central physiopathology, Hearing Loss, Central psychology, Hearing Loss, Sensorineural diagnosis, Hearing Loss, Sensorineural physiopathology, Hearing Loss, Sensorineural psychology, Humans, Infant, Male, Persons With Hearing Impairments psychology, Predictive Value of Tests, Recovery of Function, Retrospective Studies, Surveys and Questionnaires, Treatment Outcome, Audiometry, Evoked Response, Auditory Perception, Child Behavior, Cochlear Implantation instrumentation, Cochlear Implants, Disabled Children rehabilitation, Hearing Loss, Central rehabilitation, Hearing Loss, Sensorineural rehabilitation, Persons With Hearing Impairments rehabilitation
- Abstract
Objective: The individual outcome after cochlear implantation in children with auditory synaptopathy/neuropathy (AS/AN) is difficult to predict. A tool for preoperative assessment would be helpful for counseling parents. This study evaluates the outcome after CI in children with AS/AN and with sensorineural hearing loss (SNHL), and correlates it with the preoperative ECochG results in order to find specific parameters of prognostic value., Design: The improvement of auditory behavior after CI was retrospectively assessed using the LittlEARS questionnaire and quantified in a score (LS). This score was correlated with the CAP/SP ratio in the preoperative ECochG. The score was further correlated with the patient's age six months following CI., Study Sample: Nine children with AS/AN were compared to nine children with SNHL., Results: Both groups showed a significant improvement in LS following CI. There was a significant positive correlation between the CAP/SP ratio and the improvement in LS in all children. The correlation between age and LS was significantly negative in the SNHL group and positive in the AS/AN group., Conclusion: All children with AS/AN and SNHL benefit to a similar extent from CI. The preoperatively assessed CAP/SP ratio has a prognostic value for the development of auditory behavior following CI.
- Published
- 2015
- Full Text
- View/download PDF
29. Characteristics of episodic breathlessness as reported by patients with advanced chronic obstructive pulmonary disease and lung cancer: Results of a descriptive cohort study.
- Author
-
Weingärtner V, Scheve C, Gerdes V, Schwarz-Eywill M, Prenzel R, Otremba B, Mühlenbrock J, Bausewein C, Higginson IJ, Voltz R, Herich L, and Simon ST
- Subjects
- Adult, Aged, Aged, 80 and over, Dyspnea epidemiology, Dyspnea physiopathology, Female, Germany epidemiology, Humans, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Dyspnea etiology, Lung Neoplasms complications, Pulmonary Disease, Chronic Obstructive complications
- Abstract
Background: Episodic breathlessness is one form of refractory breathlessness. Better understanding of the symptom is necessary for effective management., Aim: The aim was to describe the characteristics of episodic breathlessness in patients with advanced chronic obstructive pulmonary disease or lung cancer., Design: This is a longitudinal cohort study. Outcomes were assessed monthly by up to 13 telephone interviews: peak severity (modified Borg scale: 0-10), duration, frequency, and timing of breathlessness episodes. Data from each episode were pooled and analyzed using descriptive statistics. Associations between outcomes were explored by correlation coefficients., Setting/participants: Patients with chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease classification stage III or IV) or primary lung cancer (any stage) were recruited in two inpatient units (internal medicine) and two outpatient clinics in Oldenburg, Germany., Results: A total of 82 patients (50 chronic obstructive pulmonary disease, 32 lung cancer), mean age (standard deviation) 67 years (8 years) and 36% female, were included reporting on 592 breathlessness episodes (chronic obstructive pulmonary disease: 403, lung cancer: 189). Peak severity was perceived significantly higher in chronic obstructive pulmonary disease patients than in lung cancer patients (mean (standard deviation) Borg scale: 6.2 (2.1) vs 4.2 (1.9); p < 0.001). Episodes described by chronic obstructive pulmonary disease patients were longer than those described by lung cancer patients (median (range): 7 min (0-600) vs 5 min (0.3-120), p = 0.002)). Frequency was similar and most often daily in both groups. Severity and frequency of episodes were correlated in lung cancer patients (r = 0.324, p = 0.009)., Conclusion: Most breathlessness episodes are short (minutes) and severe with significant differences between chronic obstructive pulmonary disease and lung cancer patients. Effective management strategies are warranted to improve symptom relief and coping., (© The Author(s) 2015.)
- Published
- 2015
- Full Text
- View/download PDF
30. Electrocochleography in children with auditory synaptopathy/neuropathy: diagnostic findings and characteristic parameters.
- Author
-
Stuermer KJ, Beutner D, Foerst A, Hahn M, Lang-Roth R, and Walger M
- Subjects
- Acoustic Stimulation, Action Potentials physiology, Audiometry, Evoked Response, Child, Child, Preschool, Humans, Infant, Matched-Pair Analysis, Retrospective Studies, Cochlear Microphonic Potentials physiology, Evoked Potentials, Auditory, Brain Stem physiology, Hearing Loss, Central diagnosis, Hearing Loss, Central physiopathology
- Abstract
Introduction: The early diagnosis of AS/AN in children remains challenging because it exclusively relies on the detection of OAE and/or CM, while ABR are pathologically changed or missing. The aim of our study was to ensure the diagnosis of AS/AN, demarcate it to an outer hair cell damage and possibly differentiate between pre- and postsynaptic pathologies., Methods: We retrospectively evaluated the transtympanic ECochG results of ten children with AS/AN and compared them to a matched group with SNHL and without any signs of AS/AN. We analyzed the thresholds, latencies and - as a new parameter - the amplitude ratio between CAP and SP., Results: CM and SP thresholds were significantly lower than CAP thresholds in AS/AN patients and significantly lower than SP and CM thresholds in SNHL patients with comparable CAP thresholds. The CAP/SP ratio of amplitudes in SNHL children was more than three times (significantly) higher than in AS/AN children. The cutoff value was set at 1.0 in order to differentiate between both groups with a 80-90% sensitivity and specificity. It was not possible to differentiate between a pre- and postsynaptic type of AS/AN in our collective., Summary and Conclusion: The ECochG can add valuable information for a precise differential diagnosis of AS/AN, especially in babyhood. We identified the CAP/SP ratio as a new parameter for differentiation between AS/AN and SNHL. When the CAP/SP ratio falls below 1.0, patients can be diagnosed AS/AN with high specificity and sensitivity. Significantly smaller SPL are needed to evoke SP and CM in the AS/AN group, thus showing the preserved hair cell function., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2015
- Full Text
- View/download PDF
31. Allergen sensitization linked to climate and age, not to intermittent-persistent rhinitis in a cross-sectional cohort study in the (sub)tropics.
- Author
-
Larenas-Linnemann D, Michels A, Dinger H, Shah-Hosseini K, Mösges R, Arias-Cruz A, Ambriz-Moreno M, Barajas MB, Javier RC, de la Luz Cid Del Prado M, Moreno MA, Almaráz RG, García-Cobas CY, Garcia Imperial DA, Muñoz RG, Hernández-Colín D, Linares-Zapien FJ, Luna-Pech JA, Matta-Campos JJ, Jiménez NM, Medina-Ávalos MA, Hernández AM, Maldonado AM, López DN, Pizano Nazara LJ, Sanchez ER, Ramos-López JD, Rodríguez-Pérez N, and Rodríguez-Ortiz PG
- Abstract
Background: Allergen exposure leads to allergen sensitization in susceptible individuals and this might influence allergic rhinitis (AR) phenotype expression. We investigated whether sensitization patterns vary in a country with subtropical and tropical regions and if sensitization patterns relate to AR phenotypes or age., Methods: In a national, cross-sectional study AR patients (2-70 y) seen by allergists underwent blinded skin prick testing with a panel of 18 allergens and completed a validated questionnaire on AR phenotypes., Results: 628 patients were recruited. The major sensitizing allergen was house dust mite (HDM) (56%), followed by Bermuda grass (26%), ash (24%), oak (23%) and mesquite (21%) pollen, cat (22%) and cockroach (21%). Patients living in the tropical region were almost exclusively sensitized to HDM (87%). In the central agricultural zones sensitization is primarily to grass and tree pollen. Nationwide, most study subjects had perennial (82.2%), intermittent (56.5%) and moderate-severe (84.7%) AR. Sensitization was not related to the intermittent-persistent AR classification or to AR severity; seasonal AR was associated with tree (p < 0.05) and grass pollen sensitization (p < 0.01). HDM sensitization was more frequent in children (0-11 y) and adolescents (12-17 y) (subtropical region: p < 0.0005; tropical region p < 0.05), but pollen sensitization becomes more important in the adult patients visiting allergists (Adults vs children + adolescents for tree pollen: p < 0.0001, weeds: p < 0.0005)., Conclusions: In a country with (sub)tropical climate zones SPT sensitization patterns varied according to climatological zones; they were different from those found in Europe, HDM sensitization far outweighing pollen allergies and Bermuda grass and Ash pollen being the main grass and tree allergens, respectively. Pollen sensitization was related to SAR, but no relation between sensitization and intermittent-persistent AR or AR severity could be detected. Sensitization patterns vary with age (child HDM, adult pollen). Clinical implications of our findings are dual: only a few allergens -some region specific- cover the majority of sensitizations in (sub)tropical climate zones. This is of major importance for allergen manufacturers and immunotherapy planning. Secondly, patient selection in clinical trials should be based on the intermittent-persistent and severity classifications, rather than on the seasonal-perennial AR subtypes, especially when conducted in (sub)tropical countries.
- Published
- 2014
- Full Text
- View/download PDF
32. Nucleoplasty, a minimally invasive procedure for disc decompression: a systematic review and meta-analysis of published clinical studies.
- Author
-
Eichen PM, Achilles N, Konig V, Mosges R, Hellmich M, Himpe B, and Kirchner R
- Subjects
- Databases, Factual statistics & numerical data, Humans, Treatment Outcome, Visual Analog Scale, Decompression, Surgical methods, Intervertebral Disc Displacement surgery, Minimally Invasive Surgical Procedures methods
- Abstract
Background: Nucleoplasty, based on Coblation® technology, is a minimally invasive procedure used to decompress herniated discs. Reviews to date--exclusively systematic reviews--recommend nucleoplasty for treating chronic back pain, although with the restriction of limited to fair evidence. We therefore aimed to summarize and interpret our calculated results, where possible comprehensively and quantitatively, using statistical methods in the context of a meta-analysis supplementing a systematic review. In the process, the central question was to statistically determine whether, and to what extent, nucleoplasty can positively affect pain relief and functional mobility as well as lower the complication rate., Objective: Newly published studies made it possible to conduct a meta-analysis of the visual analog scale (VAS), a measuring instrument used to determine pain intensity, and the Oswestry Disability Index (ODI), a scale that reflects the degree of impairment in percent. In addition to having clearly sound evidence for analyzing VAS/NPS data, the present, newly compiled meta-analysis was able to summarize VAS and ODI data quantitatively and to calculate a total complication rate for the first time. It was thereby possible to make a first comparison between nucleoplasty and conservative therapy (including epidural steroid injection)., Study Design: This meta-analysis examined all study data published in clinical trials involving the nucleoplasty procedure for plasma disc decompression., Methods: A systematic search using the terms nucleoplasty and/or plasma disc decompression was conducted for literature listed in MEDLINE. Twenty-seven eligible studies (22 prospective trials and 5 retrospective trials) were included, and pooled analyses as well as various subgroup analyses (differentiation between cervical and lumbar disc herniations, comparisons with alternative treatments such as epidural steroid injection) were performed based on their data., Results: Pain decreased from a baseline VAS value of 7.27 to 2.12 (postop/first day), 2.50 (one week), 2.70 (2 weeks), 3.23 (one month), 2.66 (6 weeks), 2.84 (3 months), 3.06 (6 months), 3.03 (12 months), 1.54 (18 months), and 3.69 (24 months) after nucleoplasty. The ODI value (baseline: 58.95) dropped to 28.60 (one week), 29.00 (2 weeks), 23.21 (one month), 30.00 (6 weeks), 18.30 (3 months), 22.54 (6 months), 24.43 (12 months), 12.82 (18 months), and 36.98 (24 months). Compared to baseline, significant pain reduction and improvement in functional mobility after nucleoplasty were observed at every time point. Nucleoplasty showed a total complication rate of 1.5%, with the individual rates being 0.8% for cervical and 1.8% for lumbar nucleoplasty. Nucleoplasty was superior to conservative therapy at every time point and for all 3 included parameters, at some measurement time points even significantly., Conclusions: Nucleoplasty reduces pain in the long term and improves patients' functional mobility. It is an effective, low-complication, minimally invasive procedure used to treat disc herniations.
- Published
- 2014
33. Nonpharmacological treatment of rhinoconjunctivitis and rhinosinusitis.
- Author
-
Mösges R, Baena-Cagnani CE, and Passali D
- Published
- 2014
- Full Text
- View/download PDF
34. Thermal water applications in the treatment of upper respiratory tract diseases: a systematic review and meta-analysis.
- Author
-
Keller S, König V, and Mösges R
- Abstract
Background. Thermal water inhalations and irrigations have a long tradition in the treatment of airway diseases. Currently there exists no systematic review or meta-analysis on the effectiveness of thermal water treatment in upper respiratory tract diseases. Methods. A systematic search in the databases of MEDLINE, EMBASE, CENTRAL, ISI Web of Science, and MedPilot was accomplished. Results. Eight evaluable outcome parameters from 13 prospective clinical studies were identified for 840 patients. Mucociliary clearance time improves significantly (P < 0.01) for the pooled thermal water subgroup and the sulphurous subgroup after 2 weeks (-6.69/minutes) and after 90 days (-8.33/minutes), not for isotonic sodium chloride solution (ISCS). Nasal resistance improved significantly after 2 weeks (Radon, ISCS, and placebo), after 30 days (sulphur and ISCS), and after 90 days (sulphur). Nasal flow improved significantly with the pooled thermal water, radon alone, and ISCS subgroups. For the IgE parameter only sulphurous thermal water (P < 0.01) and ISCS (P > 0.01) were analyzable. Adverse events of minor character were only reported for sulphurous treatment (19/370). Conclusion. Thermal water applications with radon or sulphur can be recommended as additional nonpharmacological treatment in upper airway diseases. Also in comparison to isotonic saline solution it shows significant improvements and should be investigated further.
- Published
- 2014
- Full Text
- View/download PDF
35. Tolerability and effects on quality of life of liposomal nasal spray treatment compared to nasal ointment containing dexpanthenol or isotonic NaCl spray in patients with rhinitis sicca.
- Author
-
Hahn C, Böhm M, Allekotte S, and Mösges R
- Subjects
- Administration, Intranasal, Adult, Aerosols administration & dosage, Aerosols adverse effects, Aged, Aged, 80 and over, Female, Humans, Liposomes administration & dosage, Liposomes adverse effects, Male, Middle Aged, Pantothenic Acid administration & dosage, Pantothenic Acid adverse effects, Prospective Studies, Severity of Illness Index, Sodium Chloride adverse effects, Treatment Outcome, Nasal Mucosa pathology, Nasal Sprays, Ointments, Pantothenic Acid analogs & derivatives, Quality of Life, Rhinitis drug therapy, Sodium Chloride administration & dosage
- Abstract
This study aimed to investigate symptom reduction via the liposomal nasal spray LipoNasal (LN) in patients with rhinitis sicca. Tolerability and the impact on quality of life were also examined. The same parameters were established in parallel for treatment approaches with Bepanthen (BP) nasal ointment containing dexpanthenol and the Rhinomer (RH) nasal spray containing NaCl. This prospective, controlled, open-label observation study was a multicenter trial. 92 patients with rhinitis sicca were allocated to three arms according to their symptoms: LN: n = 33; BP: n = 32 and RH: n = 27. The study comprised three visits at an interval of 14 days. Efficacy was examined by the Rhinitis Sicca Symptom Score (RSSS) documented daily and at the visits based on an endoscopic evaluation. The nasal spray sensory scale was used to investigate the tolerability. Quality of life (QoL) was measured by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the "Short Form 12" of the "Impact on Health-Related Quality of Life (HRQL)" questionnaire on general quality of life. Nasal symptoms improved significantly (p = 0.001) under all three treatment approaches, reflected by the reduction in the RSSS and the Endoscopy Sum Score. A comparison of the three groups showed that no therapy was significantly superior to any of the others (p = 0.410). The tolerability of all treatments was good. Concerning the nasal moisturization, LipoNasal was evaluated better than Bepanthen and Rhinomer. Quality of life improved in all groups, but not significantly. The results show good efficacy and tolerability of the liposomal nasal spray compared to generally recognized treatments of rhinitis sicca with dexpanthenol nasal ointment and NaCl nasal spray. LipoNasal therefore constitutes a good treatment for patients suffering from dry nose.
- Published
- 2013
- Full Text
- View/download PDF
36. The effectiveness of modern antihistamines for treatment of allergic rhinitis - an IPD meta-analysis of 140,853 patients.
- Author
-
Mösges R, König V, and Köberlein J
- Subjects
- Humans, Nasal Obstruction drug therapy, Prospective Studies, Rhinitis, Allergic, Treatment Outcome, Anti-Allergic Agents therapeutic use, Cetirizine administration & dosage, Cetirizine therapeutic use, Histamine Antagonists administration & dosage, Histamine Antagonists therapeutic use, Histamine H1 Antagonists, Non-Sedating administration & dosage, Histamine H1 Antagonists, Non-Sedating therapeutic use, Rhinitis, Allergic, Perennial drug therapy
- Abstract
Background: Allergic rhinitis represents a worldwide health problem. The prevalence is increasing. The aim of this study was to analyse the correlation between the severity of allergic rhinitis and an adequate treatment dose of modern oral antihistamines., Methods: From a comprehensive databank containing data from ten different open-label prospective observational studies including raw data of 140,853 patients with allergic rhinitis, symptomatology variables were analysed and scored to study the effects of treatment with four antihistamines (Desloratadine, Ebastine, Fexofenadine, Levocetirizine) alone or in combination with intranasal corticosteroids. The patient data were collected in 23,606 study centres from Germany, mostly medical specialist and some primary care physicians in private practice. The analyses were performed via individual patient data meta-analysis techniques., Results: Finally 92,900 patient data from nine of ten studies could be analysed. One study with data of 47,953 patients was excluded due to incomplete treatment documentation. Both monotherapy analysis subgroups (Total Symptom Score and Total Nasal Symptom Score) were significantly better than those of their combinations with intranasal steroids. Monotherapy with levocetirizine was determined to be significantly more effective in lowering the Total Symptom Score (p < 0.001) and the Total Nasal Symptom Score (p < 0.05) than the other antihistamines. In the next stage, a greater positive effect of levocetirizine was demonstrated in relation to the severity of the clinical symptoms of allergic rhinitis (Total Nasal Symptom Score in cases with severe symptomatology [effect size = -0.09])., Conclusions: Levocetirizine asserted itself as the only antihistamine compared with the others as significant in this analysis. The study authors recommend monotherapy with the new-generation antihistamine levocetirizine, especially in severe cases of allergic rhinitis.
- Published
- 2013
- Full Text
- View/download PDF
37. Computational fluid dynamics: a suitable assessment tool for demonstrating the antiobstructive effect of drugs in the therapy of allergic rhinitis.
- Author
-
Achilles N, Pasch N, Lintermann A, Schröder W, and Mösges R
- Subjects
- Diagnosis, Computer-Assisted, Humans, Hydrodynamics, Imaging, Three-Dimensional, Nasal Obstruction etiology, Nasal Obstruction physiopathology, Rhinitis, Allergic, Rhinitis, Allergic, Perennial complications, Rhinitis, Allergic, Perennial physiopathology, Anti-Allergic Agents therapeutic use, Nasal Obstruction diagnosis, Nasal Obstruction drug therapy, Rhinitis, Allergic, Perennial diagnosis, Rhinitis, Allergic, Perennial drug therapy
- Abstract
This systematic review aims first to summarize the previous areas of application of computational fluid dynamics (CFD) and then to demonstrate that CFD is also a suitable instrument for generating three-dimensional images that depict drug effects on nasal mucosa. Special emphasis is placed on the three-dimensional visualization of the antiobstructive effect of nasal steroids and antihistamines in the treatment of allergic rhinitis. In the beginning, CFD technology was only used to demonstrate physiological and pathophysiological airflow conditions in the nose and to aid in preoperative planning and postoperative monitoring of surgical outcome in the field of rhinosurgery. The first studies using CFD examined nasal respiratory physiology, important functions of the nose, such as conditioning and warming of inspired air, and the influence of pathophysiological changes on nasal breathing. Also, postoperative outcome of surgical procedures could be "predicted" using the nasal airflow model. Later studies focused on the three-dimensional visualization of the effect of nasal sprays in healthy subjects and postoperative patients. A completely new approach, however, was the use of CFD in the area of allergic rhinitis and the treatment of its cardinal symptom of nasal obstruction. In two clinical trials, a suitable patient with a positive history of allergic rhinitis was enrolled during a symptom-free period after the pollen season. The patient developed typical allergic rhinitis symptoms after provocation with birch pollen. The 3-D visualization showed that the antiallergic treatment successfully counteracted the effects of nasal allergen provocation on nasal airflow. These observations were attributed to the antiobstructive effect of a nasal steroid (mometasone furoate) and a systemic antihistamine (levocetirizine), respectively. CFD therefore constitutes a non-invasive, precise, reliable and objective examination procedure for generating three-dimensional images that depict the effects of drugs used in the treatment of allergic rhinitis.
- Published
- 2013
38. Liposomes: a new non-pharmacological therapy concept for seasonal-allergic-rhinoconjunctivitis.
- Author
-
Böhm M, Avgitidou G, El Hassan E, and Mösges R
- Subjects
- Adolescent, Adult, Aged, Anti-Asthmatic Agents administration & dosage, Conjunctivitis, Allergic, Cromolyn Sodium administration & dosage, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Nasal Sprays, Ophthalmic Solutions, Rhinitis, Allergic, Seasonal, Time Factors, Treatment Outcome, Young Adult, Liposomes administration & dosage
- Abstract
Mucosal barrier disorders play an important role in the pathomechanism of the allergic disease. A new approach for their treatment uses liposomes, which consist of phospholipids that make up 75% of the protective nasal surfactant layer. Our aim was to investigate the efficacy of liposomal-based therapy, as a comprehensive treatment alternative to guideline cromoglycate-based therapy, in the treatment of seasonal allergic rhinoconjunctivitis (SAR). We compared nasal and conjunctival symptom reduction with LipoNasal n nasal spray used as monotherapy (LNM), or LipoNasal n nasal spray and Tears Again eye spray combination therapy (LTC), against standard cromoglycate combination therapy (CGC). This prospective, controlled, open observational study was conducted monocentrically. According to their symptoms and preferences 72 patients with SAR were distributed in three equal groups. The study comprised two visits at an interval of 7 days. The efficacy was examined by daily documenting nasal and conjunctival symptom scores. The Nasal-Spray-Sensory-Scale and the Eye-Drops/Spray-Sensory-Scale were used to investigate the tolerability. Quality of life (QoL) was evaluated, using the RHINASTHMA QoL German adapted version. LNM achieved significant improvement in nasal (p < 0.001) and conjunctival symptoms (p = 0.050). The symptom reduction using CGC was equally significant. LTC led to significant nasal symptom relief (p = 0.045). QoL did not improve significantly in all groups (p > 0.05). The tolerability of all treatments was good and no adverse reactions were observed. In all treatment groups the improvement of the nasal and conjunctival symptom scores exceeds the minimal clinically important difference (MCID). The results demonstrate good tolerability and efficacy of non-pharmaceutical liposomal-based treatment (LipoNasal n and Tears Again), given as monotherapy or combination therapy, for nasal and conjunctival symptoms caused by SAR. This study indicates that liposomal-based treatment for SAR may be a comparable alternative to cromoglycate therapy. Further studies are needed to verify these findings.
- Published
- 2012
- Full Text
- View/download PDF
39. The effectiveness of levocetirizine in comparison with loratadine in treatment of allergic rhinitis--a meta-analysis.
- Author
-
Mösges R, König V, and Köberlein J
- Subjects
- Humans, Treatment Outcome, Anti-Allergic Agents therapeutic use, Cetirizine therapeutic use, Loratadine therapeutic use, Rhinitis, Allergic, Perennial drug therapy, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Background: Oral antihistamines are considered the gold standard therapy for allergic rhinitis to date. The goal of this investigation is to make an indirect comparison between loratadine, an oral antihistamine available over-the-counter (OTC) in the USA, and the more modern antihistamine levocetirizine. Only double-blind, placebo-controlled (DBPC) studies involving monotherapy with the active substances levocetirizine and loratadine were included in the meta-analysis., Methods: The medical databases EMBASE and Medline were searched systematically for all relevant studies completed by the end of 2009. Only DBPC studies conducted in normal environmental settings were included. Furthermore, the Jadad scale was used to guarantee the quality of the studies involved. The "standardized mean difference" (SMD) method was applied for calculating the study-specific effects to neutralize the variability between studies., Results: The results of a total of seven published DBPC studies met all criteria for inclusion in meta-analysis. The meta-analysis showed that levocetirizine was significantly more effective than loratadine in improving the total symptom score (TSS) (p < 0.01). The effect sizes were calculated as -0.59 (95% confidence interval -0.89, -0.29) for levocetirizine and -0.21 (95% confidence interval -0.31, -0.1) for loratadine when compared to placebo., Conclusions: The results of this meta-analysis illustrate greater effectiveness for treatment with the active substance levocetirizine as monotherapy in reducing allergic symptoms when compared to treatment with loratadine.
- Published
- 2011
- Full Text
- View/download PDF
40. What Google® knows about the pollen season.
- Author
-
Mösges R, Adrian M, El Hassan E, and König V
- Subjects
- Data Collection, Internet, Pollen, Search Engine
- Published
- 2011
- Full Text
- View/download PDF
41. Carbamylated monomeric allergoids as a therapeutic option for sublingual immunotherapy of dust mite- and grass pollen-induced allergic rhinoconjunctivitis: a systematic review of published trials with a meta-analysis of treatment using Lais® tablets.
- Author
-
Mösges R, Ritter B, Kayoko G, and Allekotte S
- Subjects
- Administration, Sublingual, Allergoids, Animals, Anti-Asthmatic Agents therapeutic use, Antigens, Plant therapeutic use, Humans, Immunotherapy methods, Mites immunology, Pollen immunology, Treatment Outcome, Allergens administration & dosage, Anti-Allergic Agents therapeutic use, Conjunctivitis, Allergic drug therapy, Desensitization, Immunologic methods, Plant Extracts administration & dosage, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Lais® allergoid tablets contain allergens that are modified by carbamylation. Due to their modified chemical structure, they are suitable for sublingual immunotherapy (SLIT) (13, 16, 17, 24). Based on their small molecule size of 12 to 40 kDa, they can be easily absorbed via the oral mucosa (1). In this review, we studied the efficacy of SLIT with carbamylated monomeric allergoid tablets in the treatment of grass pollen- and dust mite-induced allergic rhinoconjunctivitis on the basis of symptom and medication score improvements. Following a selective internet and databank search, six trials-some placebo-controlled-regarding the treatment of grass pollen- (n = 266) and dust mite-induced (n = 241) allergic rhinoconjunctivitis were used to draw conclusions regarding the clinical efficacy of allergoid tablets. The primary endpoints in these trials were decreases in the need for allergy medications and/or reductions in the occurrence of rhinoconjunctivitis symptoms. Data was recorded from patient diaries regarding their symptoms and medications used and conclusions were then drawn about the effectiveness and tolerabieity of Lais® tablets. The average improvement in symptom score in three trials of grass pollen allergy treatment was 34% in comparison to the placebo group. The treatment of dust mite-induced rhinoconjunctivitis produced an average symptom score improvement of 22% compared to the placebo or control groups. The intake of symptomatic rescue medication during allergoid tablet therapy declined. Treatment of grass pollen allergies and dust mite-induced rhinoconjunctivitis showed an average medication score improvement of 49% and 24%, respectively. Few side effects were documented in the trials and predominantly local effects were observed. Severe systemic side effects did not occur. On the basis of the trial results summarized in this review, we suggest that SLIT using Lais® sublingual tablets is an effective and well-tolerated form of treatment.
- Published
- 2010
42. Glycerol lidocaine eardrops for the treatment of acute abacterial otitis externa.
- Author
-
Mösges R, Kaatz V, Schmalz P, Meiser P, and Eschmann K
- Subjects
- Acute Disease, Adolescent, Adult, Aged, Anesthetics, Local therapeutic use, Double-Blind Method, Germany, Glycerol therapeutic use, Humans, Middle Aged, Patient Satisfaction, Random Allocation, Treatment Outcome, Young Adult, Lidocaine therapeutic use, Otitis Externa drug therapy
- Abstract
Inflammations of the external auditory canal number among the most frequently occurring ear-nose-throat diseases. For local treatment, substances from various groups of active ingredients are used as combinations and as single-agent drugs, e.g. antibiotics, glucocorticoids or analgesics [1]. In the case of acute otitis externa, treatment measures focus on the reduction of pain and swelling. The study described here investigates the efficacy and safety of glycerol lidocaine eardrops for the treatment of acute abacterial otitis externa (CAS No. for glycerol: 56-81-5, lidocaine-HCl: 73-78-9). In this double-blind, three-arm study, 105 patients diagnosed with acute abacterial otitis externa were included and randomized to receive either glycerol eardrops, glycerol eardrops with 0.5% lidocaine, or glycerol eardrops with 2% lidocaine for seven days. The primary outcome parameter was the change of the five typical clinical symptoms, earache, itching, otorrhea, hearing impairment, and "clogged ear" at Visit 2 (Day 7) based on the initial examination on Day 0. Both therapy groups treated with a combination of glycerol and lidocaine exhibited definite improvement in overall symptoms after seven days. This improvement differed from the mild reduction of symptoms under treatment with glycerol eardrops alone. Overall improvement of symptoms, expressed by the area under the curve of the baseline-adjusted symptom sum score, yielded a mean value of 10.95 (standard deviation 27.4) for the morning survey of the groups receiving eardrops containing only glycerol; in comparison, for eardrops containing glycerol and 2% lidocaine it was 15.71 (+/- 23.6) and for glycerol with 0.5% lidocaine, 23.16 (+/- 19.4). No severe adverse events occurred. Five adverse events were documented during the clinical investigation, none of which was considered by the investigators to be related to the study medication. Local therapy with glycerol lidocaine eardrops is a safe, and cost-effective treatment for the widely spread clinical picture of acute abacterial otitis externa. The advantage regarding efficacy of this combination compared with glycerol eardrops must be demonstrated in an adequately powered clinical trial.
- Published
- 2010
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.