Bernardo Sousa-Pinto1,2, Luís Filipe Azevedo1,2, Marek Jutel3,4, Ioana Agache5, G Walter Canonica6,7, Wienczyslawa Czarlewski8,9, Nikolaos G Papadopoulos10, Karl-Christian Bergmann11,12, Philippe Devillier13, Daniel Laune14, Ludger Klimek15,16, Aram Anto9, Josep M Anto17,18,19,20, Patrik Eklund21, Rute Almeida1,2, Anna Bedbrook22, Sinthia Bosnic-Anticevich23,24, Helen A Brough25, Luisa Brussino26, Victoria Cardona27, Thomas Casale25, Lorenzo Cecchi28, Denis Charpin29, Tomás Chivato30, Elisio M Costa31, Alvaro A Cruz32, Stephanie Dramburg33, Stephen R Durham34, Giulia De Feo35, Roy Gerth van Wijk36, Wystke J Fokkens37, Bilun Gemicioglu38, Tari Haahtela39, Maddalena Illario40, Juan Carlos Ivancevich41, Violeta Kvedariene42,43, Piotr Kuna44, Désirée E Larenas-Linnemann45, Michael Makris46, Eve Mathieu-Dupas14, Erik Melén47,48, Mario Morais-Almeida49, Ralph Mösges50, Joaquim Mullol51,52, Kari C Nadeau53, Nhân Pham-Thi54, Robyn O'Hehir55, Frederico S Regateiro56,57,58, Sietze Reitsma59, Boleslaw Samolinski60, Aziz Sheikh61, Cristiana Stellato35, Ana Todo-Bom62, Peter Valentin Tomazic63, Sanna Toppila-Salmi64, Antonio Valero65, Arunas Valiulis66,67, Maria Teresa Ventura68, Dana Wallace69, Susan Waserman70, Arzu Yorgancioglu71, Govert De Vries72, Michiel van Eerd72, Petra Zieglmayer73,74, Torsten Zuberbier11,12, Oliver Pfaar75, João Almeida Fonseca76,77,78, Jean Bousquet11,12,22,79. 1. MEDCIDS - Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal. 2. CINTESIS - Center for Health Technology and Services Research, University of Porto, Porto, Portugal. 3. Department of Clinical Immunology, Wrocław Medical University, Wroclaw, Poland. 4. ALL-MED Medical Research Institute, Wroclaw, Poland. 5. Faculty of Medicine, Transylvania University, Brasov, Romania. 6. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 7. Personalized Medicine, Asthma & Allergy -Humanitas Clinical & Research Centre, IRCCS, Rozzano, Italy. 8. Medical Consulting Czarlewski, Levallois, France. 9. ARIA, Montpellier, France. 10. Allergy Department, 2nd Pediatric Clinic, Athens General Children's Hospital "P&A Kyriakou", University of Athens, Athens, Greece. 11. Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany. 12. Institute for Allergology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany. 13. UPRES EA220, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France. 14. KYomed INNOV, Montpellier, France. 15. Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany. 16. Center for Rhinology and Allergology, Wiesbaden, Germany. 17. ISGlobAL, Barcelona Institute for Global Health, Barcelona, Spain. 18. IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. 19. Universitat Pompeu Fabra (UPF), Barcelona, Spain. 20. CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. 21. Computing Science Department, Umeå University, Umeå, Finland. 22. MACVIA-France, Montpellier, France. 23. Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia. 24. Sydney Local Health District, Sydney, New South Wales, Australia. 25. Division of Allergy/Immunology, University of South Florida, Tampa, Florida, USA. 26. Department of Medical Sciences, Allergy and Clinical Immunology Unit, University of Torino & Mauriziano Hospital, Torino, Italy. 27. Allergy Section, Department of Internal Medicine, Hospital Vall d'Hebron & ARADyAL Research Network, Barcelona, Spain. 28. SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy. 29. Clinique des Bronches, Allergie et Sommeil, Hôpital Nord, Marseille, France. 30. School of Medicine, University CEU San Pablo, Madrid, Spain. 31. Faculty of Pharmacy and Competence Center on Active and Healthy Ageing, University of Porto (Porto4Ageing), UCIBIO, REQUINTE, Porto, Portugal. 32. Fundaçao ProAR, Federal University of Bahia and GARD/WHO Planning Group, Salvador, Brazil. 33. Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Medical University, Berlin, Germany. 34. Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College London, London, UK. 35. Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Salerno, Italy. 36. Section of Allergology, Department of Internal Medicine, Erasmus MC, Rotterdam, The Netherlands. 37. Department of Otorhinolaryngology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. 38. Department of Pulmonary Diseases, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey. 39. Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. 40. Department of Public Health and Research and Development Unit, Federico II University and Hospital, Naples, Italy. 41. Servicio de Alergia e Immunologia, Clinica Santa Isabel, Buenos Aires, Argentina. 42. Department of Pathology, Faculty of Medicine, Institute of Biomedical Sciences, Vilnius University, Vilnius, Lithuania. 43. Faculty of Medicine, Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Vilnius University, Vilnius, Lithuania. 44. Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Poland. 45. Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico. 46. Allergy Unit "D Kalogeromitros", 2nd Department of Dermatology and Venereology, National & Kapodistrian University of Athens, "Attikon" University Hospital, Athens, Greece. 47. Sachs' Children and Youth Hospital, Södersjukhuset, Stockholm, Sweden. 48. Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden. 49. Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal. 50. CRI-Clinical Research International-Ltd, Hamburg, Germany. 51. Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, Barcelona, Spain. 52. Clinical & Experimental Respiratory Immunoallergy, IDIBAPS, CIBERES, University of Barcelona, Barcelona, Spain. 53. Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, California, USA. 54. IRBA (Institut de Recherche bio-Médicale des Armées), Ecole Polytechnique Palaiseau, Bretigny, France. 55. Department of Allergy, Immunology and Respiratory Medicine, Central Clinical School, Monash University and Alfred Health, Melbourne, Victoria, Australia. 56. Allergy and Clinical Immunology Unit, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal. 57. Institute of Immunology, Faculty of Medicine, University of Coimbra, Portugal. 58. ICBR - Coimbra Institute for Clinical and Biomedical Research, CIBB, Coimbra, Portugal. 59. Department of Otorhinolaryngology, Amsterdam University Medical Centres, AMC, Amsterdam, The Netherlands. 60. Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland. 61. Usher Institute, The University of Edinburgh, Edinburgh, UK. 62. Imunoalergologia, Centro Hospitalar Universitário de Coimbra and Faculty of Medicine, University of Coimbra, Coimbra, Portugal. 63. Department of General ORL, H&NS, Medical University of Graz, ENT-University Hospital Graz, Austria. 64. Skin and Allergy Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 65. Pneumology and Allergy Department CIBERES and Clinical & Experimental Respiratory Immunoallergy, IDIBAPS, University of Barcelona, Spain. 66. Faculty of Medicine, Institute of Clinical Medicine & Institute of Health Sciences, Vilnius University, Vilnius, Lithuania. 67. European Academy of Paediatrics (EAP/UEMS-SP), Brussels, Belgium. 68. Unit of Geriatric Immunoallergology, University of Bari Medical School, Bari, Italy. 69. Nova Southeastern University, Fort Lauderdale, Florida, USA. 70. Department of Medicine, Clinical Immunology and Allergy, McMaster University, Hamilton, Ontario, Canada. 71. Department of Pulmonary Diseases, Faculty of Medicine, Celal Bayar University, Manisa, Turkey. 72. Peercode BV, Geldermalsen, The Netherlands. 73. Vienna Challenge Chamber, Vienna, Austria. 74. Competence Center for Allergology and Immunology, Karl Landsteiner University, Krems, Austria. 75. Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany. 76. Departamento Medicina da Comunidade, Informaçao e Decisao em Saude (MEDCIDS), Faculdada de Medicina da Universidade do Porto, Porto, Portugal. 77. Medicina, EDucaçao, I&D e Avaliaçao, Lda (MEDIDA), Porto, Portugal. 78. Imunoalergologia, CUF, Porto, Portugal. 79. University Hospital Montpellier, Montpellier, France.
Abstract
BACKGROUND: 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® app to generate and validate hypothesis- and data-driven CSMSs. METHODS: We used MASK-air® 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® 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® , 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]). RESULTS: We assessed 317,176 days of MASK-air® 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). CONCLUSION: 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.
BACKGROUND: 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® app to generate and validate hypothesis- and data-driven CSMSs. METHODS: We used MASK-air® 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® 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® , 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]). RESULTS: We assessed 317,176 days of MASK-air® 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). CONCLUSION: 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.
Authors: Maria-Magdalena Balp; Anna C Halliday; Thomas Severin; Saoirse A Leonard; Gautam Partha; Manik Kalra; Alexander M Marsland Journal: Dermatol Ther (Heidelb) Date: 2021-11-22
Authors: Bernardo Sousa-Pinto; Luís Filipe Azevedo; Ana Sá-Sousa; Rafael José Vieira; Rita Amaral; Ludger Klimek; Wienczyslawa Czarlewski; Josep M Anto; Anna Bedbrook; Violeta Kvedariene; Maria Teresa Ventura; Ignacio J Ansotegui; Karl-Christian Bergmann; Luisa Brussino; G Walter Canonica; Victoria Cardona; Pedro Carreiro-Martins; Thomas Casale; Lorenzo Cecchi; Tomás Chivato; Derek K Chu; Cemal Cingi; Elisio M Costa; Alvaro A Cruz; Giulia De Feo; Philippe Devillier; Wytske J Fokkens; Mina Gaga; Bilun Gemicioğlu; Tari Haahtela; Juan Carlos Ivancevich; Zhanat Ispayeva; Marek Jutel; Piotr Kuna; Igor Kaidashev; Helga Kraxner; Désirée E Larenas-Linnemann; Daniel Laune; Brian Lipworth; Renaud Louis; Michaël Makris; Riccardo Monti; Mario Morais-Almeida; Ralph Mösges; Joaquim Mullol; Mikaëla Odemyr; Yoshitaka Okamoto; Nikolaos G Papadopoulos; Vincenzo Patella; Nhân Pham-Thi; Frederico S Regateiro; Sietze Reitsma; Philip W Rouadi; Boleslaw Samolinski; Milan Sova; Ana Todo-Bom; Luis Taborda-Barata; Peter Valentin Tomazic; Sanna Toppila-Salmi; Joaquin Sastre; Ioanna Tsiligianni; Arunas Valiulis; Dana Wallace; Susan Waserman; Arzu Yorgancioglu; Mihaela Zidarn; Torsten Zuberbier; João Almeida Fonseca; Jean Bousquet; Oliver Pfaar Journal: Clin Transl Allergy Date: 2022-03 Impact factor: 5.871