Development and validation of combined symptom‐medication scores for allergic rhinitis*

  • Bernardo Sousa‐Pinto
    MEDCIDS ‐ Department of Community Medicine, Information and Health Decision Sciences Faculty of Medicine University of Porto Porto Portugal
  • Luís Filipe Azevedo
    MEDCIDS ‐ Department of Community Medicine, Information and Health Decision Sciences Faculty of Medicine University of Porto Porto Portugal
  • Marek Jutel
    Department of Clinical Immunology Wrocław Medical University Wroclaw Poland
  • Ioana Agache
    Faculty of Medicine Transylvania University Brasov Romania
  • G. Walter Canonica
    Department of Biomedical Sciences Humanitas University Milan Italy
  • Wienczyslawa Czarlewski
    Medical Consulting Czarlewski Levallois France
  • Nikolaos G. Papadopoulos
    Allergy Department 2nd Pediatric Clinic Athens General Children's Hospital “P&A Kyriakou” University of Athens Athens Greece
  • Karl‐Christian Bergmann
    Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology Berlin Germany
  • Philippe Devillier
    UPRES EA220 Pôle des Maladies des Voies Respiratoires Hôpital Foch Université Paris‐Saclay Suresnes France
  • Daniel Laune
    KYomed INNOV Montpellier France
  • Ludger Klimek
    Department of Otolaryngology, Head and Neck Surgery Universitätsmedizin Mainz Mainz Germany
  • Aram Anto
    ARIA Montpellier France
  • Josep M. Anto
    ISGlobAL Barcelona Institute for Global Health Barcelona Spain
  • Patrik Eklund
    Computing Science Department Umeå University Umeå Finland
  • Rute Almeida
    MEDCIDS ‐ Department of Community Medicine, Information and Health Decision Sciences Faculty of Medicine University of Porto Porto Portugal
  • Anna Bedbrook
    MACVIA‐France Montpellier France
  • Sinthia Bosnic‐Anticevich
    Quality Use of Respiratory Medicine Group Woolcock Institute of Medical Research The University of Sydney Sydney New South Wales Australia
  • Helen A. Brough
    Division of Allergy/Immunology University of South Florida Tampa Florida USA
  • Luisa Brussino
    Department of Medical Sciences Allergy and Clinical Immunology Unit University of Torino & Mauriziano Hospital Torino Italy
  • Victoria Cardona
    Allergy Section Department of Internal Medicine Hospital Vall d'Hebron & ARADyAL Research Network Barcelona Spain
  • Thomas Casale
    Division of Allergy/Immunology University of South Florida Tampa Florida USA
  • Lorenzo Cecchi
    SOS Allergology and Clinical Immunology USL Toscana Centro Prato Italy
  • Denis Charpin
    Clinique des Bronches Allergie et Sommeil Hôpital Nord Marseille France
  • Tomás Chivato
    School of Medicine University CEU San Pablo Madrid Spain
  • Elisio M. Costa
    Faculty of Pharmacy and Competence Center on Active and Healthy Ageing University of Porto (Porto4Ageing) UCIBIO REQUINTE Porto Portugal
  • Alvaro A. Cruz
    Fundaçao ProAR Federal University of Bahia and GARD/WHO Planning Group Salvador Brazil
  • Stephanie Dramburg
    Department of Pediatric Pneumology, Immunology and Intensive Care Medicine Charité Medical University Berlin Germany
  • Stephen R. Durham
    Allergy and Clinical Immunology National Heart and Lung Institute Imperial College London London UK
  • Giulia De Feo
    Department of Medicine, Surgery and Dentistry “Scuola Medica Salernitana” University of Salerno Salerno Italy
  • Roy Gerth van Wijk
    Section of Allergology Department of Internal Medicine Erasmus MC Rotterdam The Netherlands
  • Wystke J. Fokkens
    Department of Otorhinolaryngology Amsterdam University Medical Centres Amsterdam The Netherlands
  • Bilun Gemicioglu
    Department of Pulmonary Diseases Cerrahpasa Faculty of Medicine Istanbul University‐Cerrahpasa Istanbul Turkey
  • Tari Haahtela
    Skin and Allergy Hospital Helsinki University Hospital University of Helsinki Helsinki Finland
  • Maddalena Illario
    Department of Public Health and Research and Development Unit Federico II University and Hospital Naples Italy
  • Juan Carlos Ivancevich
    Servicio de Alergia e Immunologia Clinica Santa Isabel Buenos Aires Argentina
  • Violeta Kvedariene
    Department of Pathology Faculty of Medicine Institute of Biomedical Sciences Vilnius University Vilnius Lithuania
  • Piotr Kuna
    Division of Internal Medicine, Asthma and Allergy Barlicki University Hospital Medical University of Lodz Poland
  • Désirée E. Larenas‐Linnemann
    Center of Excellence in Asthma and Allergy Médica Sur Clinical Foundation and Hospital México City Mexico
  • Michael Makris
    Allergy Unit “D Kalogeromitros” 2nd Department of Dermatology and Venereology National & Kapodistrian University of Athens, “Attikon” University Hospital Athens Greece
  • Eve Mathieu‐Dupas
    KYomed INNOV Montpellier France
  • Erik Melén
    Sachs’ Children and Youth Hospital Södersjukhuset Stockholm Sweden
  • Mario Morais‐Almeida
    Allergy Center CUF Descobertas Hospital Lisbon Portugal
  • Ralph Mösges
    CRI‐Clinical Research International‐Ltd Hamburg Germany
  • Joaquim Mullol
    Rhinology Unit & Smell Clinic ENT Department Hospital Clínic Barcelona Spain
  • Kari C. Nadeau
    Sean N. Parker Center for Allergy and Asthma Research Stanford University School of Medicine Stanford California USA
  • Nhân Pham‐Thi
    IRBA (Institut de Recherche bio‐Médicale des Armées) Ecole Polytechnique Palaiseau Bretigny France
  • Robyn O’Hehir
    Department of Allergy, Immunology and Respiratory Medicine Central Clinical School Monash University and Alfred Health Melbourne Victoria Australia
  • Frederico S. Regateiro
    Allergy and Clinical Immunology Unit Centro Hospitalar e Universitário de Coimbra Coimbra Portugal
  • Sietze Reitsma
    Department of Otorhinolaryngology Amsterdam University Medical Centres AMC Amsterdam The Netherlands
  • Boleslaw Samolinski
    Department of Prevention of Environmental Hazards, Allergology and Immunology Medical University of Warsaw Warsaw Poland
  • Aziz Sheikh
    Usher Institute The University of Edinburgh Edinburgh UK
  • Cristiana Stellato
    Department of Medicine, Surgery and Dentistry “Scuola Medica Salernitana” University of Salerno Salerno Italy
  • Ana Todo‐Bom
    Imunoalergologia Centro Hospitalar Universitário de Coimbra and Faculty of Medicine University of Coimbra Coimbra Portugal
  • Peter Valentin Tomazic
    Department of General ORL, H&NS Medical University of Graz ENT‐University Hospital Graz Austria
  • Sanna Toppila‐Salmi
    Skin and Allergy Hospital Helsinki University Hospital and University of Helsinki Helsinki Finland
  • Antonio Valero
    Pneumology and Allergy Department CIBERES and Clinical & Experimental Respiratory Immunoallergy IDIBAPS University of Barcelona Spain
  • Arunas Valiulis
    Faculty of Medicine Institute of Clinical Medicine & Institute of Health Sciences Vilnius University Vilnius Lithuania
  • Maria Teresa Ventura
    Unit of Geriatric Immunoallergology University of Bari Medical School Bari Italy
  • Dana Wallace
    Nova Southeastern University Fort Lauderdale Florida USA
  • Susan Waserman
    Department of Medicine Clinical Immunology and Allergy McMaster University Hamilton Ontario Canada
  • Arzu Yorgancioglu
    Department of Pulmonary Diseases Faculty of Medicine Celal Bayar University Manisa Turkey
  • Govert De Vries
    Peercode BV Geldermalsen The Netherlands
  • Michiel van Eerd
    Peercode BV Geldermalsen The Netherlands
  • Petra Zieglmayer
    Vienna Challenge Chamber Vienna Austria
  • Torsten Zuberbier
    Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology Berlin Germany
  • Oliver Pfaar
    Section of Rhinology and Allergy Department of Otorhinolaryngology, Head and Neck Surgery University Hospital Marburg Philipps‐Universität Marburg Marburg Germany
  • João Almeida Fonseca
    Departamento Medicina da Comunidade Informaçao e Decisao em Saude (MEDCIDS) Faculdada de Medicina da Universidade do Porto Porto Portugal
  • Jean Bousquet
    Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology Berlin Germany

抄録

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Validated combined symptom‐medication scores (CSMSs) are needed to investigate the effects of allergic rhinitis treatments. This study aimed to use real‐life data from the MASK‐air<jats:sup>®</jats:sup> app to generate and validate hypothesis‐ and data‐driven CSMSs.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We used MASK‐air<jats:sup>®</jats:sup> data to assess the concurrent validity, test‐retest reliability and responsiveness of one hypothesis‐driven CSMS (modified CSMS: mCSMS), one mixed hypothesis‐ and data‐driven score (mixed score), and several data‐driven CSMSs. The latter were generated with MASK‐air<jats:sup>®</jats:sup> data following cluster analysis and regression models or factor analysis. These CSMSs were compared with scales measuring (i) the impact of rhinitis on work productivity (visual analogue scale [VAS] of work of MASK‐air<jats:sup>®</jats:sup>, and Work Productivity and Activity Impairment: Allergy Specific [WPAI‐AS]), (ii) quality‐of‐life (EQ‐5D VAS) and (iii) control of allergic diseases (Control of Allergic Rhinitis and Asthma Test [CARAT]).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>We assessed 317,176 days of MASK‐air<jats:sup>®</jats:sup> use from 17,780 users aged 16‐90 years, in 25 countries. The mCSMS and the factor analyses‐based CSMSs displayed poorer validity and responsiveness compared to the remaining CSMSs. The latter displayed moderate‐to‐strong correlations with the tested comparators, high test‐retest reliability and moderate‐to‐large responsiveness. Among data‐driven CSMSs, a better performance was observed for cluster analyses‐based CSMSs. High accuracy (capacity of discriminating different levels of rhinitis control) was observed for the latter (AUC‐ROC = 0.904) and for the mixed CSMS (AUC‐ROC = 0.820).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The mixed CSMS and the cluster‐based CSMSs presented medium‐high validity, reliability and accuracy, rendering them as candidates for primary endpoints in future rhinitis trials.</jats:p></jats:sec>

収録刊行物

  • Allergy

    Allergy 77 (7), 2147-2162, 2022-01-15

    Wiley

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