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

Scientific Working Group Allergology and Immunology

Research output: Journal article (peer-reviewed) › Journal article

45 Citations (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.

Original language	English
Pages (from-to)	2147-2162
Number of pages	16
Journal	Allergy: European Journal of Allergy and Clinical Immunology
Volume	77
Issue number	7
DOIs	https://doi.org/10.1111/all.15199
Publication status	Published - Jul 2022

Keywords

Asthma/drug therapy
Humans
Quality of Life
Reproducibility of Results
Rhinitis
Rhinitis, Allergic/diagnosis

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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 = "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, vol. 77, no. 7, pp. 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

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

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