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

Bernardo Sousa-Pinto, Luís Filipe Azevedo, Marek Jutel, Ioana Agache, G. Walter Canonica, Wienczyslawa Czarlewski, Nikolaos G. Papadopoulos, Karl Christian Bergmann, Philippe Devillier, Daniel Laune, Ludger Klimek, Aram Anto, Josep M. Anto, Patrik Eklund, Rute Almeida, Anna Bedbrook, Sinthia Bosnic-Anticevich, Helen A. Brough, Luisa Brussino, Victoria CardonaThomas Casale, Lorenzo Cecchi, Denis Charpin, Tomás Chivato, Elisio M. Costa, Alvaro A. Cruz, Stephanie Dramburg, Stephen R. Durham, Giulia De Feo, Roy Gerth van Wijk, Wystke J. Fokkens, Bilun Gemicioglu, Tari Haahtela, Maddalena Illario, Juan Carlos Ivancevich, Violeta Kvedariene, Piotr Kuna, Désirée E. Larenas-Linnemann, Michael Makris, Eve Mathieu-Dupas, Erik Melén, Mario Morais-Almeida, Ralph Mösges, Joaquim Mullol, Kari C. Nadeau, Nhân Pham-Thi, Robyn O’Hehir, Frederico S. Regateiro, Sietze Reitsma, Boleslaw Samolinski, Aziz Sheikh, Cristiana Stellato, Ana Todo-Bom, Peter Valentin Tomazic, Sanna Toppila-Salmi, Antonio Valero, Arunas Valiulis, Maria Teresa Ventura, Dana Wallace, Susan Waserman, Arzu Yorgancioglu, Govert De Vries, Michiel van Eerd, Petra Zieglmayer, Torsten Zuberbier, Oliver Pfaar, João Almeida Fonseca, Jean Bousquet*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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.

Original languageEnglish
Pages (from-to)2147-2162
Number of pages16
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume77
Issue number7
DOIs
Publication statusAccepted/In press - 21 Dec 2021

Bibliographical note

Funding Information:
RA reports personal fees from operation POCI‐01–0145–36 FEDER‐029130 (‘mINSPIRE‐mHealth to measure and improve adherence to medication in chronic respiratory diseases—generalisation and evaluation of gamification, peer support and advanced image processing technologies’) cofunded by ERDF (European Regional Development Fund), COMPETE2020 (Programa Operacional Competitividade e Internacionalização), Portugal 2020 and by Portuguese Funds through FCT (Fundação para a Ciência e a Tecnologia). JB reports personal fees from Chiesi, Cipla, Hikma, Menarini, Mundipharma, Mylan, Novartis, Sanofi‐Aventis, Takeda, Teva, Uriach, other from KYomed Innov, personal fees from Purina. Share holder of Kyomed Innov and MASK‐air‐SAS. VC reports personal fees from ALK, LETI, Thermo Fisher, Merck. AC reports grants and personal fees from GlaxoSmithKline, SANOFI, AstraZeneca, personal fees from Novartis, CHIESI, Mylan, Glenmark, Eurofarma. BG reports grants from AstraZeneca, MSD, Novartis, Deva, Abdi İbrahim. JCI reports personal fees from Laboratorios Casasco Argentina, Abbott Ecuador, Faes Farma, Sanofi. VK reports non‐financial support from AstraZeneca, Dimuna, personal fees from GSK. D LL reports personal fees from Allakos, Amstrong, Astrazeneca, DBV Technologies, Grunenthal, GSK, Mylan, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, UCB, Alakos, Gossamer, grants from Sanofi, Astrazeneca, Novartis, Circassia, UCB, GSK, TEVA, Purina institute. MM reports personal fees from Novartis Hellas, Astra Zeneca, GSK, Menarini, Mylan, Sanofi Genzyme, Pfizer, Chiesi Hellas. RM reports personal fees from ALK, Allergopharma, from Allergy Therapeutics, Friulchem, Hexal, Servier, Klosterfrau, Bayer, FAES, GSK, Johnson&Johnson, Meda, Stada, UCB, Nuvo, Menarini, Mundipharma, Pohl‐Boskamp, grants from ASIT biotech, Leti, Optima, BitopAG, Hulka, Ursapharm, Inmunotek, grants and personal fees from Bencard, Stallergenes, personal fees and non ‐financial support from Lofarma, Novartis, non‐financial support from Roxall, Atmos, Bionorica, Otonomy, Ferrero. JM reports personal fees and other from SANOFI GENZYME & REGENERON, NOVARTIS, grants and personal fees from MYLAN Pharma, URIACH Group, Mitsubishi‐Tanabe, Menarini, UCB, AstraZeneca, GSK, MSD, KC N reports grants from National Institute of Allergy and Infectious Diseases (NIAID), National Heart, Lung and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS), Food Allergy Research & Education (FARE), other from World Allergy Organization (WAO), Cour Pharma, Before Brands, Alladapt, Latitude, IgGenix, Immune Tolerance Network (ITN), National Institutes of Health (NIH) clinical research centres; In addition, and has a patent Inhibition of Allergic Reaction to Peanut Allergen using an IL −33 Inhibitor pending, a patent Special Oral Formula for Decreasing Food Allergy Risk and Treatment for Food Allergy pending, a patent Basophil Activation Based Diagnostic Allergy Test pending, a patent Granulocyte‐based methods for detecting and monitoring immune system disorders pending, a patent Methods and Assays for Detecting and Quantifying Pure Subpopulations of White Blood Cells in Immune System Disorders pending, a patent Mixed Allergen Compositions and Methods for Using the Same pending, and a patent Microfluidic Device and Diagnostic Methods for Allergy Testing Based on Detection of Basophil Activation pending. NGP reports personal fees from Novartis, Nutricia, HAL, MENARINI/FAES FARMA, SANOFI, MYLAN/MEDA, BIOMAY, AstraZeneca, GSK, MS D, ASIT BIOTECH, Boehringer Ingelheim, grants from Gerolymatos International SA, Capricare. OP reports grants and personal fees from ALK‐Abelló, Allergopharma, from Stallergenes Greer, HAL Allergy Holding B.V./HAL Allergie GmbH, from Bencard Allergie GmbH/Allergy Therapeutics, Lofarma, ASIT Biotech Tools S.A., Laboratorios LETI/LETI Pharma, Anergis S.A., Glaxo Smith Kline, personal fees from Astellas Pharma Global, grants from Biomay, Pohl‐Boskamp, Inmunotek S.L., personal fees from MEDA Pharma/MYLAN, Mobile Chamber Experts (a GA2LEN Partner), Indoor Biotechnologies, EUFOREA, ROXALL Medizin, Novartis, Sanofi‐Aventis and Sanofi Genzyme, Med Update Europe GmbH, streamedup! GmbH, John Wiley and Sons, AS, Paul‐Martini‐Stiftung (PMS). SR reports that her department has received grants from ALK, Allergy Therapeutics and Mylan BV and acted as consultant for Sanofi Genzyme and Novartis. ATB reports grants and personal fees from AstraZeneca, GSK (GlaxoSmithKline), Novartis, Sanofi, Teva, Mundipharma, personal fees from Bial, grants from Leti. SW reports other from GSK, AZ, ALK, SANOFI, PEDIAPHARM, MEDEXAS, NOVARTIS, COVIS and President Canadian Allergy Asthma and Immunology Foundation Board of Asthma Canada. TZ reports and Organizational affiliations: Commitee member: WHO‐Initiative ‘Allergic Rhinitis and Its Impact on Asthma’ (ARIA), Member of the Board: German Society for Allergy and Clinical Immunology (DGAKI), Board Chairman: European Centre for Allergy Research Foundation (E CARF)—President: Global Allergy and Asthma European Network (GA2LEN), Member: Committee on Allergy Diagnosis and Molecular Allergology, World Allergy Organization (WAO).

Funding Information:
This study was funded by ARIA. MASK‐air has been supported by EU grants (EU Structural and Development grant, POLLAR: EIT Health and Structural and Development Funds) and educational grants from Mylan‐Viatris, ALK, GSK, Novartis and Uriach. ®

Funding Information:
ARIA. MASK‐air has been supported by EU grants (EU Structural and Development Grant, POLLAR: EIT Health and Structural and Development Funds) and educational grants from Mylan‐Viatris, ALK, GSK, Novartis and Uriach ®

Publisher Copyright:
© 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

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