. 2024 Sep;14(9):e12390.

doi: 10.1002/clt2.12390.

Concurrent validity, cut-offs and ability to change of patient-reported outcome measures for rhinitis and asthma in MASK-air^®

Jean Bousquet^{1

2

3}, Bernardo Sousa-Pinto^{4

5}, Josep M Anto^{6

7

8}, Anna Bedbrook³, Wienczyslawa Czarlewski^{3

9}, Ignacio J Ansotegui¹⁰, Karl-C Bergmann^{1

2}, Fulvio Braido¹¹, Luisa Brussino^{12

13}, Lorenzo Cecchi¹⁴, Claudia Chaves Loureiro^{15

16}, Alvaro A Cruz¹⁷, Philippe Devillier¹⁸, Alessandro Fiocchi¹⁹, Bilun Gemicioglu²⁰, Tari Haahtela²¹, Juan Carlos Ivancevich²², Ludger Klimek^{23

24}, Marek Kulus²⁵, Piotr Kuna²⁶, Maciej Kupczyk²⁶, Violeta Kvedariene^{27

28}, Desiree E Larenas-Linnemann²⁹, Gilles Louis³⁰, Renaud Louis^{31

32}, Michael Makris³³, Mario Morais-Almeida³⁴, Marek Niedoszytko³⁵, Ken Ohta^{36

37}, Markus Ollert^{38

39}, Nikolaos Papadopoulos⁴⁰, Vincenzo Patella^{41

42

43}, Benoit Pétré³⁰, Oliver Pfaar⁴⁴, Francesca Puggioni⁴⁵, Santiago Quirce⁴⁶, Frederico S Regateiro^{47

48

49}, Nicolas Roche^{50

51}, Philip W Rouadi^{52

53}, Boleslaw Samolinski⁵⁴, Joaquin Sastre⁵⁵, Florence Schleich^{31

32}, Nicola Scichilone⁵⁶, Luis Taborda-Barata^{57

58}, Sanna Toppila-Salmi^{59

60}, Arunas Valiulis^{61

62}, Ilgim Vardaloglu Koyuncu²⁰, Maria Teresa Ventura^{63

64}, Arzu Yorgancioglu⁶⁵, Joao A Fonseca^{4

5}, Torsten Zuberbier^{1

2}

Affiliations

¹ Institute of Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
² Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
³ ARIA, Montpellier, France.
⁴ MEDCIDS - Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal.
⁵ CINTESIS@RISE- Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal.
⁶ ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain.
⁷ Universitat Pompeu Fabra (UPF), Barcelona, Spain.
⁸ CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
⁹ Medical Consulting Czarlewski, Levallois, France.
¹⁰ Department of Allergy and Immunology, Hospital Quironsalud Bizkaia, Bilbao, Spain.
¹¹ Respiratory and Allergy Clinic, IRCCS - Policlinico San Martino and Department of Internal Medicine (DIMI), University of Genoa, Genoa, Italy.
¹² Department of Medical Sciences, University of Torino, Torino, Italy.
¹³ Allergy and Clinical Immunology Unit, Mauriziano Hospital, Torino, Italy.
¹⁴ SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy.
¹⁵ Department of Pneumology and University of Coimbra, Medicine Faculty, Coimbra, Portugal.
¹⁶ Coimbra Institute for Clinical and Biomedical Research, CIBB, Coimbra, Portugal.
¹⁷ Fundaçao ProAR, Federal University of Bahia and GARD/WHO Planning Group, Salvador, Bahia, Brazil.
¹⁸ VIM Suresnes, UMR 0892, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France.
¹⁹ Allergy, Bambino Gesù Children's Hospital, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
²⁰ Department of Pulmonary Diseases and Institute of Pulmonology and Tuberculosis, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey.
²¹ Skin and Allergy Hospital, Helsinki University Hospital, and University of Helsinki, Helsinki, Finland.
²² Servicio de Alergia e Immunologia, Clinica Santa Isabel, Buenos Aires, Argentina.
²³ Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany.
²⁴ Center for Rhinology and Allergology, Wiesbaden, Germany.
²⁵ Department of Pediatric Respiratory Diseases and Allergology, Medical University of Warsaw, Warsaw, Poland.
²⁶ Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.
²⁷ Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
²⁸ Department of Pathology, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
²⁹ Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico.
³⁰ Department of Public Health, University of Liège, Liège, Belgium.
³¹ Department of Pulmonary Medicine, CHU Liège, Liège, Belgium.
³² GIGA I3 Research Group, University of Liège, Liège, Belgium.
³³ Allergy Unit "D Kalogeromitros", 2nd Department of Dermatology and Venereology, National & Kapodistrian University of Athens, "Attikon" University Hospital, Athens, Greece.
³⁴ Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal.
³⁵ Department of Allergology, Medical University of Gdańsk, Gdansk, Poland.
³⁶ Japan Antituberculosis Association (JATA) Fukujuji Hospital, Tokyo, Japan.
³⁷ National Hospital Organization Tokyo National Hospital, and JATA Fukujuji Hospital, Tokyo, Japan.
³⁸ Department of Infection and Immunity, Luxembourg Institute of Health, Esch-sur-Alzette, Luxembourg.
³⁹ Department of Dermatology and Allergy Center, Odense Research Center for Anaphylaxis (ORCA), Odense University Hospital, Odense, Denmark.
⁴⁰ Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.
⁴¹ Division of Allergy and Clinical Immunology, Department of Medicine, "Santa Maria della Speranza" Hospital, Salerno, Italy.
⁴² Agency of Health ASL, Salerno, Italy.
⁴³ Postgraduate Programme in Allergy and Clinical Immunology, University of Naples Federico II, Naples, Italy.
⁴⁴ Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.
⁴⁵ IRCCS Humanitas Research Center, Personalized Medicine Asthma & Allergy, Milan, Italy.
⁴⁶ Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.
⁴⁷ Allergy and Clinical Immunology Department, Hospitais da Universidade de Coimbra, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.
⁴⁸ Center for Innovative Biomedicine and Biotechnology (CIBB), Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
⁴⁹ Institute of Immunology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
⁵⁰ Pneumologie, AP-HP Centre Université de Paris Cité, Hôpital Cochin, Paris, France.
⁵¹ UMR 1016, Institut Cochin, Paris, France.
⁵² Department of Otolaryngology-Head and Neck Surgery, Eye and Ear University Hospital, Beirut, Lebanon.
⁵³ Department of Otorhinolaryngology-Head and Neck Surgery, Dar Al Shifa Hospital, Salmiya, Kuwait.
⁵⁴ Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland.
⁵⁵ Allergy Service, Fundacion Jimenez Diaz, Autonoma University of Madrid, CIBERES-ISCIII, Madrid, Spain.
⁵⁶ PROMISE Department, University of Palermo, Palermo, Italy.
⁵⁷ Department of Immunoallergology, Cova da Beira University Hospital Centre, Covilhã, Portugal.
⁵⁸ UBIAir - Clinical & Experimental Lung Centre and CICS-UBI Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal.
⁵⁹ Department of Otorhinolaryngology, University of Eastern Finland and the North Savo Wellbeing Services County, Kuopio, Finland.
⁶⁰ Department of Allergy, Inflammation Center, Skin and Allergy Hospital, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
⁶¹ Clinic of Asthma, Allergy, and Chronic Lung Diseases, Vilnius, Lithuania.
⁶² Interdisciplinary Research Group of Human Ecology, Institute of Clinical Medicine, Institute of Health Sciences, and Clinic of Children's Diseases, Medical Faculty of Vilnius University, Vilnius, Lithuania.
⁶³ University of Bari Medical School, Bari, Italy.
⁶⁴ Institute of Sciences of Food Production, National Research Council (ISPA-CNR), Bari, Italy.
⁶⁵ Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Turkey.

PMID: 39313483
PMCID: PMC11419846
DOI: 10.1002/clt2.12390

Concurrent validity, cut-offs and ability to change of patient-reported outcome measures for rhinitis and asthma in MASK-air^®

Jean Bousquet et al. Clin Transl Allergy. 2024 Sep.

. 2024 Sep;14(9):e12390.

doi: 10.1002/clt2.12390.

Authors

Affiliations

¹ Institute of Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
² Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
³ ARIA, Montpellier, France.
⁴ MEDCIDS - Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal.
⁵ CINTESIS@RISE- Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal.
⁶ ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain.
⁷ Universitat Pompeu Fabra (UPF), Barcelona, Spain.
⁸ CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
⁹ Medical Consulting Czarlewski, Levallois, France.
¹⁰ Department of Allergy and Immunology, Hospital Quironsalud Bizkaia, Bilbao, Spain.
¹¹ Respiratory and Allergy Clinic, IRCCS - Policlinico San Martino and Department of Internal Medicine (DIMI), University of Genoa, Genoa, Italy.
¹² Department of Medical Sciences, University of Torino, Torino, Italy.
¹³ Allergy and Clinical Immunology Unit, Mauriziano Hospital, Torino, Italy.
¹⁴ SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy.
¹⁵ Department of Pneumology and University of Coimbra, Medicine Faculty, Coimbra, Portugal.
¹⁶ Coimbra Institute for Clinical and Biomedical Research, CIBB, Coimbra, Portugal.
¹⁷ Fundaçao ProAR, Federal University of Bahia and GARD/WHO Planning Group, Salvador, Bahia, Brazil.
¹⁸ VIM Suresnes, UMR 0892, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France.
¹⁹ Allergy, Bambino Gesù Children's Hospital, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
²⁰ Department of Pulmonary Diseases and Institute of Pulmonology and Tuberculosis, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey.
²¹ Skin and Allergy Hospital, Helsinki University Hospital, and University of Helsinki, Helsinki, Finland.
²² Servicio de Alergia e Immunologia, Clinica Santa Isabel, Buenos Aires, Argentina.
²³ Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany.
²⁴ Center for Rhinology and Allergology, Wiesbaden, Germany.
²⁵ Department of Pediatric Respiratory Diseases and Allergology, Medical University of Warsaw, Warsaw, Poland.
²⁶ Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.
²⁷ Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
²⁸ Department of Pathology, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
²⁹ Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico.
³⁰ Department of Public Health, University of Liège, Liège, Belgium.
³¹ Department of Pulmonary Medicine, CHU Liège, Liège, Belgium.
³² GIGA I3 Research Group, University of Liège, Liège, Belgium.
³³ Allergy Unit "D Kalogeromitros", 2nd Department of Dermatology and Venereology, National & Kapodistrian University of Athens, "Attikon" University Hospital, Athens, Greece.
³⁴ Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal.
³⁵ Department of Allergology, Medical University of Gdańsk, Gdansk, Poland.
³⁶ Japan Antituberculosis Association (JATA) Fukujuji Hospital, Tokyo, Japan.
³⁷ National Hospital Organization Tokyo National Hospital, and JATA Fukujuji Hospital, Tokyo, Japan.
³⁸ Department of Infection and Immunity, Luxembourg Institute of Health, Esch-sur-Alzette, Luxembourg.
³⁹ Department of Dermatology and Allergy Center, Odense Research Center for Anaphylaxis (ORCA), Odense University Hospital, Odense, Denmark.
⁴⁰ Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.
⁴¹ Division of Allergy and Clinical Immunology, Department of Medicine, "Santa Maria della Speranza" Hospital, Salerno, Italy.
⁴² Agency of Health ASL, Salerno, Italy.
⁴³ Postgraduate Programme in Allergy and Clinical Immunology, University of Naples Federico II, Naples, Italy.
⁴⁴ Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.
⁴⁵ IRCCS Humanitas Research Center, Personalized Medicine Asthma & Allergy, Milan, Italy.
⁴⁶ Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.
⁴⁷ Allergy and Clinical Immunology Department, Hospitais da Universidade de Coimbra, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.
⁴⁸ Center for Innovative Biomedicine and Biotechnology (CIBB), Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
⁴⁹ Institute of Immunology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
⁵⁰ Pneumologie, AP-HP Centre Université de Paris Cité, Hôpital Cochin, Paris, France.
⁵¹ UMR 1016, Institut Cochin, Paris, France.
⁵² Department of Otolaryngology-Head and Neck Surgery, Eye and Ear University Hospital, Beirut, Lebanon.
⁵³ Department of Otorhinolaryngology-Head and Neck Surgery, Dar Al Shifa Hospital, Salmiya, Kuwait.
⁵⁴ Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland.
⁵⁵ Allergy Service, Fundacion Jimenez Diaz, Autonoma University of Madrid, CIBERES-ISCIII, Madrid, Spain.
⁵⁶ PROMISE Department, University of Palermo, Palermo, Italy.
⁵⁷ Department of Immunoallergology, Cova da Beira University Hospital Centre, Covilhã, Portugal.
⁵⁸ UBIAir - Clinical & Experimental Lung Centre and CICS-UBI Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal.
⁵⁹ Department of Otorhinolaryngology, University of Eastern Finland and the North Savo Wellbeing Services County, Kuopio, Finland.
⁶⁰ Department of Allergy, Inflammation Center, Skin and Allergy Hospital, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
⁶¹ Clinic of Asthma, Allergy, and Chronic Lung Diseases, Vilnius, Lithuania.
⁶² Interdisciplinary Research Group of Human Ecology, Institute of Clinical Medicine, Institute of Health Sciences, and Clinic of Children's Diseases, Medical Faculty of Vilnius University, Vilnius, Lithuania.
⁶³ University of Bari Medical School, Bari, Italy.
⁶⁴ Institute of Sciences of Food Production, National Research Council (ISPA-CNR), Bari, Italy.
⁶⁵ Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Turkey.

PMID: 39313483
PMCID: PMC11419846
DOI: 10.1002/clt2.12390

Abstract

Patient-reported outcome measures (PROMs) are used to assess a patient's health status at a particular point in time. They are essential in the development of person-centred care. This paper reviews studies performed on PROMs for assessing AR and asthma control, in particular VAS scales that are included in the app MASK-air^® (Mobile Airways Sentinel networK) for asthma and rhinitis. VASs were initially developed on paper and pencil and tested for their criterion validity, cut-offs and responsiveness. Then, a multicentric, multinational, double-blind, placebo-controlled, randomised control trial (DB-PC-RCT) using an electronic VAS form was carried out. Finally, with the development of MASK-air^® in 2015, previously validated VAS questions were adapted to the digital format and further methodologic evaluations were performed. VAS for asthma, rhinitis, conjunctivitis, work and EQ-5D are included in the app. Additionally, two control-medication scores for allergic symptoms of asthma (e-DASTHMA) were validated for their criterion validity, cut-offs and responsiveness.

Keywords: EQ‐5D; asthma; digital health; rhinitis; visual analogue scale.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

**FIGURE 1**
VAS, RQLQ and TNSS before and after treatment (from ¹⁴ ).

**FIGURE 2**
Distribution of GINA control categories relative to VAS levels.

**FIGURE 3**
Correlation between ACT and VAS asthma (SACRA) (from ²⁰ ).

**FIGURE 4**
(A) Evolution of T5SS and VAS global allergy symptoms in patients with intermittent allergic rhinitis treated with desloratadine or placebo. (B) Evolution of T5SS and VAS global allergy symptoms in patients with persistent allergic rhinitis treated with desloratadine or placebo.

**FIGURE 6**
Correlation between VAS asthma and dysponea in two studies on severe asthma (from ³¹ , ³² ).

**FIGURE 7**
Allergy e‐CSMS compared to VAS work (from ²⁶ ). BR, Brazil; FR, France; GE, Germany; IT, Italy; LT, Lithuania; ME, Mexico; POL,Poland; POR, Portugal; SP, Spain.

**FIGURE 8**
Results between the best performing e‐DASTHMA and comparators (from ⁴⁸ ).

**FIGURE 9**
Correlation between VAS work and global allergy symptoms (from N = 16,925 days).

**FIGURE 10**
Association of VAS or CSMS with EQ‐5D‐5L domains in a multivariate analysis (from ⁶⁶ ).

See this image and copyright information in PMC

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Concurrent validity, cut-offs and ability to change of patient-reported outcome measures for rhinitis and asthma in MASK-air^®

Affiliations

Concurrent validity, cut-offs and ability to change of patient-reported outcome measures for rhinitis and asthma in MASK-air^®

Authors

Affiliations

Abstract

Conflict of interest statement

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