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Cutoff Values of MASK-air Patient-Reported Outcome Measures

B. Sousa-Pinto, A. Sá-Sousa, RJ. Vieira, R. Amaral, AM. Pereira, JM. Anto, L. Klimek, W. Czarlewski, J. Mullol, O. Pfaar, A. Bedbrook, L. Brussino, V. Kvedariene, DE. Larenas-Linnemann, Y. Okamoto, MT. Ventura, IJ. Ansotegui, S....

. 2023 ; 11 (4) : 1281-1289.e5. [pub] 20221222

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc23010583

BACKGROUND: In clinical and epidemiological studies, cutoffs of patient-reported outcome measures can be used to classify patients into groups of statistical and clinical relevance. However, visual analog scale (VAS) cutoffs in MASK-air have not been tested. OBJECTIVE: To calculate cutoffs for VAS global, nasal, ocular, and asthma symptoms. METHODS: In a cross-sectional study design of all MASK-air participants, we compared (1) approaches based on the percentiles (tertiles or quartiles) of VAS distributions and (2) data-driven approaches based on clusters of data from 2 comparators (VAS work and VAS sleep). We then performed sensitivity analyses for individual countries and for VAS levels corresponding to full allergy control. Finally, we tested the different approaches using MASK-air real-world cross-sectional and longitudinal data to assess the most relevant cutoffs. RESULTS: We assessed 395,223 days from 23,201 MASK-air users with self-reported allergic rhinitis. The percentile-oriented approach resulted in lower cutoff values than the data-driven approach. We obtained consistent results in the data-driven approach. Following the latter, the proposed cutoff differentiating "controlled" and "partly-controlled" patients was similar to the cutoff value that had been arbitrarily used (20/100). However, a lower cutoff was obtained to differentiate between "partly-controlled" and "uncontrolled" patients (35 vs the arbitrarily-used value of 50/100). CONCLUSIONS: Using a data-driven approach, we were able to define cutoff values for MASK-air VASs on allergy and asthma symptoms. This may allow for a better classification of patients with rhinitis and asthma according to different levels of control, supporting improved disease management.

Allergy and Clinical Immunology Unit Centro Hospitalar e Universitário de Coimbra Coimbra Portugal

Allergy Center CUF Descobertas Hospital Lisbon Portugal

Allergy Department 2nd Pediatric Clinic University of Athens Athens Greece

Allergy Section Department of Internal Medicine Hospital Vall d'Hebron and ARADyAL research network Barcelona Spain

Allergy Unit D Kalogeromitros 2nd Department of Dermatology and Venereology National and Kapodistrian University of Athens Attikon University Hospital Athens Greece

Center for Rhinology and Allergology Wiesbaden Germany

Center of Excellence in Asthma and Allergy Médica Sur Clinical Foundation and Hospital México City Mexico

CIBER Epidemiología y Salud Pública Barcelona Spain

CINTESIS Center for Health Technology and Services Research University of Porto Porto Portugal

Coimbra Institute for Clinical and Biomedical Research Faculty of Medicine University of Coimbra Coimbra Portugal

Department of Allergology Medical University of Gdańsk Gdansk Poland

Department of Allergy and Immunology Hospital Quironsalud Bizkaia Bilbao Spain

Department of Allergy ARIA and MASK air Montpellier France

Department of Biomedical Sciences Humanitas University Pieve Emanuele Milan Italy

Department of Cardiovascular and Thoracic Sciences Fondazione Policlinico Universitario A Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy

Department of Epidemiology of Asthma Universitat Pompeu Fabra Barcelona Spain

Department of Immunoallergology Cova da Beira University Hospital Centre Covilhã Portugal

Department of Internal Medicine Poltava State Medical University Poltava Ukraine

Department of Medical Research and Environment IMIM Barcelona Spain

Department of Medical Sciences Allergy and Clinical Immunology Unit University of Torino and Mauriziano Hospital Torino Italy

Department of Medical Sciences and Public Health and Unit of Allergy and Clinical Immunology University Hospital Duilio Casula University of Cagliari Cagliari Italy

Department of Otolaryngology Head and Neck Surgery Dar Al Shifa Hospital Salmiya Kuwait

Department of Otolaryngology Head and Neck Surgery Eye and Ear University Hospital Beirut Lebanon

Department of Otolaryngology Head and Neck Surgery Universitätsmedizin Mainz Mainz Germany

Department of Otorhinolaryngology Amsterdam University Medical Centres AMC Amsterdam the Netherlands

Department of Otorhinolaryngology Chiba University Hospital and Chiba Rosai Hospital Chiba Japan

Department of Otorhinolaryngology Head and Neck Surgery Section of Rhinology and Allergy University Hospital Marburg Philipps Universität Marburg Marburg Germany

Department of Otorhinolaryngology Head and Neck Surgery Semmelweis University Budapest Hungary

Department of Pathology Institute of Biomedical Sciences Faculty of Medicine Vilnius University Vilnius Lithuania

Department of Pneumology University Hospital Montpellier France

Department of Prevention of Environmental Hazards Allergology and Immunology Medical University of Warsaw Poland

Department of Pulmonary Diseases Celal Bayar University Faculty of Medicine Manisa Turkey

Department of Pulmonary Diseases Istanbul University Cerrahpasa Cerrahpasa Faculty of Medicine Istanbul Turkey

Department of Pulmonary Medicine CHU Liege and GIGA I3 research group University of Liege Liege Belgium

Department of Research and Development ISGlobal Barcelona Institute for Global Health Barcelona Spain

Department of Respiratory Medicine and Tuberculosis University Hospital Brno Czech Republic

Department Recherches and Développement KYomed INNOV Montpellier France

Division of Allergy and Clinical Immunology Department of Medicine Agency of Health ASL Salerno Santa Maria della Speranza Hospital Battipaglia Salerno Italy

Division of Internal Medicine Asthma and Allergy Barlicki University Hospital Medical University of Lodz Lodz Poland

Ecole Polytechnique Palaiseau IRBA Bretigny France

ENT Department Eskisehir Osmangazi University Medical Faculty Eskisehir Turkey

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP Allergology and Immunology Berlin Germany

Fundaçao ProAR Federal University of Bahia and GARD WHO Planning Group Salvador Bahia Brazil

Fundacion Jimenez Diaz CIBERES Faculty of Medicine Autonoma University of Madrid Madrid Spain

Health Planning Unit Department of Social Medicine Faculty of Medicine University of Crete Heraklion Greece

IMSB Medical Faculty University at Cologne and ClinCompetence Cologne GmbH Cologne Germany

Institute of Allergology Charité Universitätsmedizin Berlin Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin Berlin Germany

Institute of Clinical Medicine and Institute of Health Sciences Vilnius Lithunia

Institute of Clinical Medicine Clinic of Chest Diseases and Allergology Faculty of Medicine Vilnius University Vilnius Lithuania

Institute of Immunology Faculty of Medicine University of Coimbra Coimbra Portugal

International Primary Care Respiratory Group IPCRG Aberdeen Scotland

MEDCIDS Department of Community Medicine Information and Health Decision Sciences Faculty of Medicine University of Porto Porto Portugal

Medical Consulting Czarlewski Levallois and MASK air Montpellier France

Medical Faculty of Vilnius University Vilnius Lithuania

Personalized Medicine Asthma and Allergy Humanitas Clinical and Research Center IRCCS Rozzano Italy

Quality Use of Respiratory Medicines Group Woolcock Institute of Medical Research Sydney Sydney Pharmacy School The University of Sydney Sydney Local Health District Sydney NSW Australia

Rhinology Unit and Smell Clinic ENT Department Hospital Clínic Clinical and Experimental Respiratory Immunoallergy IDIBAPS CIBERES University of Barcelona Barcelona Spain

RISE Health Research Network University of Porto Porto Portugal

School of Medicine University CEU San Pablo Madrid Spain

Servicio de Alergia e Immunologia Clinica Santa Isabel Buenos Aires Argentina

Skin and Allergy Hospital Helsinki University Hospital University of Helsinki Helsinki Finland

SOS Allergology and Clinical Immunology USL Toscana Centro Prato Italy

UBIAir Clinical and Experimental Lung Centre University of Beira Interior Covilhã and CICS Health Sciences Research Centre University of Beira Interior Covilhã Portugal

UCIBIO REQUINTE Faculty of Pharmacy and Competence Center on Active and Healthy Ageing of University of Porto Porto Portugal

Unit of Geriatric Immunoallergology University of Bari Medical School and Institute of Sciences of Food Production National Research Council Bari Italy

University Clinic of Respiratory and Allergic Diseases Golnik and University of Ljubljana Faculty of Medicine Ljubljana Slovenia

Usher Institute the University of Edinburgh Edinburgh UK

VIM Suresnes UMR 0892 Pôle des Maladies des Voies Respiratoires Hôpital Foch Université Paris Saclay Suresnes France

Citace poskytuje Crossref.org

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$a BACKGROUND: In clinical and epidemiological studies, cutoffs of patient-reported outcome measures can be used to classify patients into groups of statistical and clinical relevance. However, visual analog scale (VAS) cutoffs in MASK-air have not been tested. OBJECTIVE: To calculate cutoffs for VAS global, nasal, ocular, and asthma symptoms. METHODS: In a cross-sectional study design of all MASK-air participants, we compared (1) approaches based on the percentiles (tertiles or quartiles) of VAS distributions and (2) data-driven approaches based on clusters of data from 2 comparators (VAS work and VAS sleep). We then performed sensitivity analyses for individual countries and for VAS levels corresponding to full allergy control. Finally, we tested the different approaches using MASK-air real-world cross-sectional and longitudinal data to assess the most relevant cutoffs. RESULTS: We assessed 395,223 days from 23,201 MASK-air users with self-reported allergic rhinitis. The percentile-oriented approach resulted in lower cutoff values than the data-driven approach. We obtained consistent results in the data-driven approach. Following the latter, the proposed cutoff differentiating "controlled" and "partly-controlled" patients was similar to the cutoff value that had been arbitrarily used (20/100). However, a lower cutoff was obtained to differentiate between "partly-controlled" and "uncontrolled" patients (35 vs the arbitrarily-used value of 50/100). CONCLUSIONS: Using a data-driven approach, we were able to define cutoff values for MASK-air VASs on allergy and asthma symptoms. This may allow for a better classification of patients with rhinitis and asthma according to different levels of control, supporting improved disease management.
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$a Anto, Josep M $u Department of Research & Development, ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain; Department of Medical Research & Environment, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain; Department of Epidemiology of Asthma, Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
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$a Klimek, Ludger $u Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany
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$a Czarlewski, Wienczyslawa $u Medical Consulting Czarlewski, Levallois and MASK-air, Montpellier, France
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$a Pfaar, Oliver $u Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany
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$a Bedbrook, Anna $u Department of Allergy, ARIA & MASK-air, Montpellier, France
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$a Brussino, Luisa $u Department of Medical Sciences, Allergy and Clinical Immunology Unit, University of Torino and Mauriziano Hospital, Torino, Italy
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$a Kvedariene, Violeta $u Department of Pathology, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University, Vilnius, Lithuania; Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
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$a Larenas-Linnemann, Desirée E $u Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico
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$a Bosnic-Anticevich, Sinthia $u Quality Use of Respiratory Medicines Group, Woolcock Institute of Medical Research, Sydney, Sydney Pharmacy School, The University of Sydney, Sydney Local Health District, Sydney, NSW, Australia
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$a Canonica, G Walter $u Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy
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$a Cardona, Victoria $u Allergy Section, Department of Internal Medicine, Hospital Vall d'Hebron & ARADyAL research network, Barcelona, Spain
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$a Cecchi, Lorenzo $u SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy
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$a Chivato, Tomas $u School of Medicine, University CEU San Pablo, Madrid, Spain
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$a Cingi, Cemal $u ENT Department, Eskisehir Osmangazi University, Medical Faculty, Eskisehir, Turkey
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$a Costa, Elísio M $u UCIBIO, REQUINTE, Faculty of Pharmacy and Competence Center on Active and Healthy Ageing of University of Porto (Porto4Ageing), Porto, Portugal
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$a Cruz, Alvaro A $u Fundaçao ProAR, Federal University of Bahia and GARD/WHO Planning Group, Salvador, Bahia, Brazil
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$a Del Giacco, Stefano $u Department of Medical Sciences and Public Health and Unit of Allergy and Clinical Immunology, University Hospital "Duilio Casula", University of Cagliari, Cagliari, Italy
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$a Devillier, Philippe $u VIM Suresnes, UMR 0892, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France
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$a Fokkens, Wytske J $u Department of Otorhinolaryngology, Amsterdam University Medical Centres, AMC, Amsterdam, the Netherlands
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$a Gemicioglu, Bilun $u Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Turkey
700    1_
$a Haahtela, Tari $u Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
700    1_
$a Ivancevich, Juan Carlos $u Servicio de Alergia e Immunologia, Clinica Santa Isabel, Buenos Aires, Argentina
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$a Kuna, Piotr $u Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
700    1_
$a Kaidashev, Igor $u Department of Internal Medicine, Poltava State Medical University, Poltava, Ukraine
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$a Kraxner, Helga $u Department of Otorhinolaryngology, Head and Neck Surgery, Semmelweis University, Budapest, Hungary
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$a Laune, Daniel $u Department Recherches & Développement, KYomed INNOV, Montpellier, France
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$a Louis, Renaud $u Department of Pulmonary Medicine, CHU Liege, and GIGA I3 research group, University of Liege, Liege, Belgium
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$a Makris, Michael $u Allergy Unit "D Kalogeromitros", 2nd Department of Dermatology and Venereology, National and Kapodistrian University of Athens, "Attikon" University Hospital, Athens, Greece
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$a Monti, Riccardo $u Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
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$a Morais-Almeida, Mario $u Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal
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$a Mösges, Ralph $u IMSB, Medical Faculty, University at Cologne, and ClinCompetence Cologne GmbH, Cologne, Germany
700    1_
$a Niedoszytko, Marek $u Department of Allergology, Medical University of Gdańsk, Gdansk, Poland
700    1_
$a Papadopoulos, Nikolaos G $u Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece
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$a Patella, Vincenzo $u Division of Allergy and Clinical Immunology, Department of Medicine, Agency of Health ASL Salerno, "Santa Maria della Speranza" Hospital, Battipaglia, Salerno, Italy
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$a Pham-Thi, Nhân $u Ecole Polytechnique Palaiseau, IRBA (Institut de Recherche bio-Médicale des Armées), Bretigny, France
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$a Regateiro, Frederico S $u Allergy and Clinical Immunology Unit, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Institute of Immunology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal; Coimbra Institute for Clinical and Biomedical Research (ICBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal
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$a Reitsma, Sietze $u Department of Otorhinolaryngology, Amsterdam University Medical Centres, AMC, Amsterdam, the Netherlands
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$a Rouadi, Philip W $u Department of Otolaryngology-Head and Neck Surgery, Eye and Ear University Hospital, Beirut, Lebanon; Department of Otolaryngology-Head and Neck Surgery, Dar Al Shifa Hospital, Salmiya, Kuwait
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$a Samolinski, Boleslaw $u Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Poland
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$a Sheikh, Aziz $u Usher Institute, the University of Edinburgh, Edinburgh, UK
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$a Sova, Milan $u Department of Respiratory Medicine and Tuberculosis, University Hospital, Brno, Czech Republic
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$a Taborda-Barata, Luis $u UBIAir-Clinical & Experimental Lung Centre, University of Beira Interior, Covilhã and CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal; Department of Immunoallergology, Cova da Beira University Hospital Centre, Covilhã, Portugal
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$a Toppila-Salmi, Sanna $u Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
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$a Sastre, Joaquin $u Fundacion Jimenez Diaz, CIBERES, Faculty of Medicine, Autonoma University of Madrid, Madrid, Spain
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$a Tsiligianni, Ioanna $u Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Heraklion, Greece; International Primary Care Respiratory Group IPCRG, Aberdeen, Scotland
700    1_
$a Valiulis, Arunas $u Institute of Clinical Medicine and Institute of Health Sciences, Vilnius, Lithunia; Medical Faculty of Vilnius University, Vilnius, Lithuania
700    1_
$a Yorgancioglu, Arzu $u Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Turkey
700    1_
$a Zidarn, Mihaela $u University Clinic of Respiratory and Allergic Diseases, Golnik & University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia
700    1_
$a Zuberbier, Torsten $u Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany
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$a Fonseca, Joao A $u MEDCIDS-Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; CINTESIS-Center for Health Technology and Services Research, University of Porto, Porto, Portugal; RISE-Health Research Network, University of Porto, Porto, Portugal
700    1_
$a Bousquet, Jean $u Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany; Department of Pneumology, University Hospital, Montpellier, France. Electronic address: jean.bousquet@orange.fr
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