Sousa-Pinto, BAzevedo, LFJutel, MAgache, ICanonica, GWCzarlewski, WPapadopoulos, NGBergmann, KCDevillier, PLaune, DKlimek, LAnto, AAnto, JMEklund, PAlmeida, RBedbrook, ABosnic-Anticevich, SBrough, HABrussino, LCardona, VCasale, TCecchi, LCharpin, DChivato, TCosta, EMCruz, AADramburg, SDurham, SRDe Feo, Gvan Wijk, RGFokkens, WJGemicioglu, BHaahtela, TIllario, MIvancevich, JCKvedariene, VKuna, PLarenas-Linnemann, DEMakris, MMathieu-Dupas, EMelén, EMorais-Almeida, MMösges, RMullol, JNadeau, KCNhan, PHO'Hehir, RRegateiro, FSReitsma, SSamolinski, BSheikh, AStellato, CTodo-Bom, ATomazic, PVToppila-Salmi, SValero, AValiulis, AVentura, MTWallace, DWaserman, SYorgancioglu, AVries, GEerd, MZieglmayer, PZuberbier, TPfaar, OFonseca, JABousquet, J2024-07-182024-07-180105-45381398-9995http://akademikarsiv.cbu.edu.tr:4000/handle/123456789/11124Background 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(R) app to generate and validate hypothesis- and data-driven CSMSs. Methods We used MASK-air(R) 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(R) 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(R), 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(R) 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.EnglishWORK PRODUCTIVITYIMMUNOTHERAPYQUESTIONNAIRERESPONSIVENESSRELIABILITYIMPAIRMENTTRIALSASTHMAEQ-5DArticle