Development and validation of combined symptom‐medication scores for allergic rhinitis*
Bernardo Sousa‐Pinto, Luís Filipe Azevedo, Marek Jutel, Ioana Agache, Giorgio Walter Canonica, W. Czarlewski, Nikolaos G. Papadopoulos, Karl‐Christian Bergmann, Philippe Devillier, Daniel Laune, Ludger Klimek, Aram Antó, Josep M. Antó, Patrik Eklund, Rute Almeida, Anna Bedbrook, Sinthia Bosnic‐Anticevich, Helen A. Brough, Luisa Brussino, Victória Cardona, Thomas B. Casale, Lorenzo Cecchi, D. Charpin, Tomás Chivato, Elı́sio Costa, Álvaro A. Cruz, Stephanie Dramburg, Stephen R. Durham, Giulia De Feo, Roy Gerth van Wijk, Wystke J. Fokkens, Bilun Gemicioğlu, Tari Haahtela, Maddalena Illario, Juan Carlos Ivancevich, Violeta Kvedarienė, Piotr Kuna, Désirée Larenas‐Linnemann, Μichael Μakris, Eve Mathieu‐Dupas, Erik Melén, Mário Morais‐Almeida, Ralph Mösges, Joaquim Mullol, Kari C. Nadeau, N. Pham‐Thi, Robyn E. O’Hehir, Frederico S. Regateiro, Sietze Reitsma, Bolesław Samoliński, Aziz Sheikh, Cristiana Stellato, Ana Todo‐Bom, Peter Valentin Tomazic, Sanna Toppila‐Salmi, Antonio Valero, Arūnas Valiulis, Maria Teresa Ventura, Dana Wallace, Susan Waserman, Arzu Yorgancıoğlu, Govert de Vries, M. van Eerd, Petra Zieglmayer, Torsten Zuberbier, Oliver Pfaar, João Fonseca, Jean Bousquet
Abstract
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.