학술논문
Development and validation of combined symptom-medication scores for allergic rhinitis*
Document Type
Author
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; Kvedariene, 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, Arunas; 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
Source
Allergy. European Journal of Allergy and Clinical Immunology. 77(7):2147-2162
Subject
Language
English
ISSN
0105-4538
1398-9995
1398-9995
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.