| Authors |
Sousa-Pinto, Bernardo ; Azevedo, Luís Filipe ; Jutel, Marek ; Agache, Ioana ; Canonica, G. Walter ; Czarlewski, Wienczyslawa ; Papadopoulos, Nikolaos G ; Bergmann, Karl-Christian ; Devillier, Philippe ; Laune, Daniel ; Klimek, Ludger ; Anto, Aram ; Anto, Josep M ; Eklund, Patrik ; Almeida, Rute ; Bedbrook, Anna ; Bosnic-Anticevich, Sinthia ; Brough, Helen A ; Brussino, Luisa ; Cardona, Victoria ; Casale, Thomas ; Cecchi, Lorenzo ; Charpin, Denis ; Chivato, Tomás ; Costa, Elisio M ; Cruz, Alvaro A ; Dramburg, Stephanie ; Durham, Stephen R ; De Feo, Giulia ; Gerth van Wijk, Roy ; Fokkens, Wystke J ; Gemicioglu, Bilun ; Haahtela, Tari ; Illario, Maddalena ; Ivancevich, Juan Carlos ; Kvedarienė, Violeta ; Kuna, Piotr ; Larenas-Linnemann, Désirée E ; Makris, Michael ; Mathieu-Dupas, Eve ; Melén, Erik ; Morais-Almeida, Mario ; Mösges, Ralph ; Mullol, Joaquim ; Nadeau, Kari C ; Pham-Thi, Nhân ; O’Hehir, Robyn ; Regateiro, Frederico S ; Reitsma, Sietze ; Samolinski, Boleslaw ; Sheikh, Aziz ; Stellato, Cristiana ; Todo-Bom, Ana ; Tomazic, Peter Valentin ; Toppila-Salmi, Sanna ; Valero, Antonio ; Valiulis, Arūnas ; Ventura, Maria Teresa ; Wallace, Dana ; Waserman, Susan ; Yorgancioglu, Arzu ; De Vries, Govert ; van Eerd, Michiel ; Zieglmayer, Petra ; Zuberbier, Torsten ; Pfaar, Oliver ; Almeida Fonseca, João ; Bousquet, Jean |
| Abstract [eng] |
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. |
