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, 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

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.

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

References

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