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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....
Language English Country United States
Document type Journal Article, Research Support, Non-U.S. Gov't
- MeSH
- Rhinitis, Allergic * diagnosis MeSH
- Asthma * epidemiology therapy MeSH
- Patient Reported Outcome Measures MeSH
- Humans MeSH
- Cross-Sectional Studies MeSH
- Rhinitis * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
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
Center for Rhinology and Allergology Wiesbaden Germany
CIBER Epidemiología y Salud Pública Barcelona Spain
CINTESIS Center for Health Technology and Services Research University of Porto Porto 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 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 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 Semmelweis University Budapest Hungary
Department of Pneumology University Hospital Montpellier France
Department of Pulmonary Diseases Celal Bayar University Faculty of Medicine Manisa Turkey
Department of Respiratory Medicine and Tuberculosis University Hospital Brno Czech Republic
Department Recherches and Développement KYomed INNOV Montpellier France
Ecole Polytechnique Palaiseau IRBA Bretigny France
ENT Department Eskisehir Osmangazi University Medical Faculty Eskisehir Turkey
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
IMSB Medical Faculty University at Cologne and ClinCompetence Cologne GmbH Cologne Germany
Institute of Clinical Medicine and Institute of Health Sciences Vilnius Lithunia
Institute of Immunology Faculty of Medicine University of Coimbra Coimbra Portugal
International Primary Care Respiratory Group IPCRG Aberdeen Scotland
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
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
References provided by Crossref.org
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- $a Sousa-Pinto, Bernardo $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
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- $a Cutoff Values of MASK-air Patient-Reported Outcome Measures / $c 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. Bosnic-Anticevich, GW. Canonica, V. Cardona, L. Cecchi, T. Chivato, C. Cingi, EM. Costa, AA. Cruz, S. Del Giacco, P. Devillier, WJ. Fokkens, B. Gemicioglu, T. Haahtela, JC. Ivancevich, P. Kuna, I. Kaidashev, H. Kraxner, D. Laune, R. Louis, M. Makris, R. Monti, M. Morais-Almeida, R. Mösges, M. Niedoszytko, NG. Papadopoulos, V. Patella, N. Pham-Thi, FS. Regateiro, S. Reitsma, PW. Rouadi, B. Samolinski, A. Sheikh, M. Sova, L. Taborda-Barata, S. Toppila-Salmi, J. Sastre, I. Tsiligianni, A. Valiulis, A. Yorgancioglu, M. Zidarn, T. Zuberbier, JA. Fonseca, J. Bousquet
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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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