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 Cardona; Thomas 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

doi:10.1111/all.15199

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

Danube ARC

Publikation: Beitrag in Fachzeitschrift (peer-reviewed) › Artikel in Fachzeitschrift

9 Zitate (Scopus)

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.

Originalsprache	Englisch
Seiten (von - bis)	2147-2162
Seitenumfang	16
Fachzeitschrift	Allergy: European Journal of Allergy and Clinical Immunology
Jahrgang	77
Ausgabenummer	7
DOIs	https://doi.org/10.1111/all.15199
Publikationsstatus	Veröffentlicht - Juli 2022

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10.1111/all.15199

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Sousa-Pinto, B., Azevedo, L. F., Jutel, M., Agache, I., Canonica, G. W., Czarlewski, W., Papadopoulos, N. G., Bergmann, K-C., Devillier, P., Laune, D., Klimek, L., Anto, A., Anto, J. M., Eklund, P., Almeida, R., Bedbrook, A., Bosnic-Anticevich, S., Brough, H. A., Brussino, L., ... Bousquet, J. (2022). Development and validation of combined symptom-medication scores for allergic rhinitis. Allergy: European Journal of Allergy and Clinical Immunology, 77(7), 2147-2162. https://doi.org/10.1111/all.15199

@article{06795faf008940d3939b5454f398b49a,

title = "Development and validation of combined symptom-medication scores for allergic rhinitis",

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{\textregistered} app to generate and validate hypothesis- and data-driven CSMSs.METHODS: We used MASK-air{\textregistered} 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{\textregistered} 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{\textregistered} , 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{\textregistered} 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 = "Asthma/drug therapy, Humans, Quality of Life, Reproducibility of Results, Rhinitis, Rhinitis, Allergic/diagnosis",

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

note = "Funding Information: RA reports personal fees from operation POCI‐01–0145–36 FEDER‐029130 ({\textquoteleft}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{\textquoteright}) cofunded by ERDF (European Regional Development Fund), COMPETE2020 (Programa Operacional Competitividade e Internacionaliza{\c c}{\~a}o), Portugal 2020 and by Portuguese Funds through FCT (Funda{\c c}{\~a}o para a Ci{\^e}ncia 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‐Abell{\'o}, 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 {\textquoteleft}Allergic Rhinitis and Its Impact on Asthma{\textquoteright} (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. {\textregistered} 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 {\textregistered} Publisher Copyright: {\textcopyright} 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.",

year = "2022",

month = jul,

doi = "10.1111/all.15199",

language = "English",

volume = "77",

pages = "2147--2162",

journal = "Allergy: European Journal of Allergy and Clinical Immunology",

issn = "0105-4538",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "7",

}

Sousa-Pinto, B, Azevedo, LF, Jutel, M, Agache, I, Canonica, GW, Czarlewski, W, Papadopoulos, NG, Bergmann, K-C, Devillier, P, Laune, D, Klimek, L, Anto, A, Anto, JM, Eklund, P, Almeida, R, Bedbrook, A, Bosnic-Anticevich, S, Brough, HA, Brussino, L, Cardona, V, Casale, T, Cecchi, L, Charpin, D, Chivato, T, Costa, EM, Cruz, AA, Dramburg, S, Durham, SR, De Feo, G, Gerth van Wijk, R, Fokkens, WJ, Gemicioglu, B, Haahtela, T, Illario, M, Ivancevich, JC, Kvedariene, V, Kuna, P, Larenas-Linnemann, DE, Makris, M, Mathieu-Dupas, E, Melén, E, Morais-Almeida, M, Mösges, R, Mullol, J, Nadeau, KC, Pham-Thi, N, O'Hehir, R, Regateiro, FS, Reitsma, S, Samolinski, B, Sheikh, A, Stellato, C, Todo-Bom, A, Tomazic, PV, Toppila-Salmi, S, Valero, A, Valiulis, A, Ventura, MT, Wallace, D, Waserman, S, Yorgancioglu, A, De Vries, G, van Eerd, M, Zieglmayer, P, Zuberbier, T, Pfaar, O, Almeida Fonseca, J & Bousquet, J 2022, 'Development and validation of combined symptom-medication scores for allergic rhinitis', Allergy: European Journal of Allergy and Clinical Immunology, Jg. 77, Nr. 7, S. 2147-2162. https://doi.org/10.1111/all.15199

TY - JOUR

T1 - Development and validation of combined symptom-medication scores for allergic rhinitis

AU - Sousa-Pinto, Bernardo

AU - Azevedo, Luís Filipe

AU - Jutel, Marek

AU - Agache, Ioana

AU - Canonica, G Walter

AU - Czarlewski, Wienczyslawa

AU - Papadopoulos, Nikolaos G

AU - Bergmann, Karl-Christian

AU - Devillier, Philippe

AU - Laune, Daniel

AU - Klimek, Ludger

AU - Anto, Aram

AU - Anto, Josep M

AU - Eklund, Patrik

AU - Almeida, Rute

AU - Bedbrook, Anna

AU - Bosnic-Anticevich, Sinthia

AU - Brough, Helen A

AU - Brussino, Luisa

AU - Cardona, Victoria

AU - Casale, Thomas

AU - Cecchi, Lorenzo

AU - Charpin, Denis

AU - Chivato, Tomás

AU - Costa, Elisio M

AU - Cruz, Alvaro A

AU - Dramburg, Stephanie

AU - Durham, Stephen R

AU - De Feo, Giulia

AU - Gerth van Wijk, Roy

AU - Fokkens, Wystke J

AU - Gemicioglu, Bilun

AU - Haahtela, Tari

AU - Illario, Maddalena

AU - Ivancevich, Juan Carlos

AU - Kvedariene, Violeta

AU - Kuna, Piotr

AU - Larenas-Linnemann, Désirée E

AU - Makris, Michael

AU - Mathieu-Dupas, Eve

AU - Melén, Erik

AU - Morais-Almeida, Mario

AU - Mösges, Ralph

AU - Mullol, Joaquim

AU - Nadeau, Kari C

AU - Pham-Thi, Nhân

AU - O'Hehir, Robyn

AU - Regateiro, Frederico S

AU - Reitsma, Sietze

AU - Samolinski, Boleslaw

AU - Sheikh, Aziz

AU - Stellato, Cristiana

AU - Todo-Bom, Ana

AU - Tomazic, Peter Valentin

AU - Toppila-Salmi, Sanna

AU - Valero, Antonio

AU - Valiulis, Arunas

AU - Ventura, Maria Teresa

AU - Wallace, Dana

AU - Waserman, Susan

AU - Yorgancioglu, Arzu

AU - De Vries, Govert

AU - van Eerd, Michiel

AU - Zieglmayer, Petra

AU - Zuberbier, Torsten

AU - Pfaar, Oliver

AU - Almeida Fonseca, João

AU - Bousquet, Jean

N1 - 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.

PY - 2022/7

Y1 - 2022/7

N2 - 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.

AB - 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.

KW - Asthma/drug therapy

KW - Humans

KW - Quality of Life

KW - Reproducibility of Results

KW - Rhinitis

KW - Rhinitis, Allergic/diagnosis

UR - http://www.scopus.com/inward/record.url?scp=85122740548&partnerID=8YFLogxK

U2 - 10.1111/all.15199

DO - 10.1111/all.15199

M3 - Journal article

C2 - 34932829

SN - 0105-4538

VL - 77

SP - 2147

EP - 2162

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

IS - 7

ER -

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

Abstract

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