Development and validation of combined symptom-medication scores for allergic rhinitis

Bernardo Sousa-Pinto^{1

2}, Luís Filipe Azevedo^{1

2}, Marek Jutel^{3

4}, Ioana Agache⁵, G Walter Canonica^{6

7}, Wienczyslawa Czarlewski^{8

9}, Nikolaos G Papadopoulos¹⁰, Karl-Christian Bergmann^{11

12}, Philippe Devillier¹³, Daniel Laune¹⁴, Ludger Klimek^{15

16}, Aram Anto⁹, Josep M Anto^{17

18

19

20}, Patrik Eklund²¹, Rute Almeida^{1

2}, Anna Bedbrook²², Sinthia Bosnic-Anticevich^{23

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 Kvedariene^{42

43}, Piotr Kuna⁴⁴, Désirée E Larenas-Linnemann⁴⁵, Michael Makris⁴⁶, Eve Mathieu-Dupas¹⁴, Erik Melén^{47

48}, Mario Morais-Almeida⁴⁹, Ralph Mösges⁵⁰, Joaquim Mullol^{51

52}, Kari C Nadeau⁵³, Nhân Pham-Thi⁵⁴, Robyn O'Hehir⁵⁵, Frederico S Regateiro^{56

57

58}, Sietze Reitsma⁵⁹, Boleslaw Samolinski⁶⁰, Aziz Sheikh⁶¹, Cristiana Stellato³⁵, Ana Todo-Bom⁶², Peter Valentin Tomazic⁶³, Sanna Toppila-Salmi⁶⁴, Antonio Valero⁶⁵, Arunas Valiulis^{66

67}, Maria Teresa Ventura⁶⁸, Dana Wallace⁶⁹, Susan Waserman⁷⁰, Arzu Yorgancioglu⁷¹, Govert De Vries⁷², Michiel van Eerd⁷², Petra Zieglmayer^{73

74}, Torsten Zuberbier^{11

12}, Oliver Pfaar⁷⁵, João Almeida Fonseca^{76

77

78}, Jean Bousquet^{11

12

22

79}

Affiliations

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.

PMID: 34932829
DOI: 10.1111/all.15199

Free article

Development and validation of combined symptom-medication scores for allergic rhinitis

Bernardo Sousa-Pinto et al. Allergy. 2022 Jul.

Free article

. 2022 Jul;77(7):2147-2162.

doi: 10.1111/all.15199. Epub 2022 Jan 15.

Authors

Affiliations

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.

PMID: 34932829
DOI: 10.1111/all.15199

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.

Keywords: medication score; quality-of-life; rhinitis; symptom score; work.

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References

REFERENCES

1. Godicke V, Hundt F. Registration trials for specific immunotherapy in Europe: advanced guidance from the new European Medical Agency guideline. Allergy. 2010;65(12):1499-1505.
1. Bousquet J, Pfaar O, Togias A, et al. 2019 ARIA Care pathways for allergen immunotherapy. Allergy. 2019;74(11):2087-2102.
1. Pfaar O, Demoly P, Gerth van Wijk R, et al. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014;69(7):854-867.
1. Pfaar O, Agache I, Blay F, et al. Perspectives in allergen immunotherapy: 2019 and beyond. Allergy. 2019;74(Suppl 108):3-25.
1. Bousquet JJ, Schünemann HJ, Togias A, et al. Next-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases. Clin Transl Allergy. 2019;9:44.

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Development and validation of combined symptom-medication scores for allergic rhinitis

Affiliations

Development and validation of combined symptom-medication scores for allergic rhinitis

Authors

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical

Research Materials