Development and validation of combined symptom‐medication scores for allergic rhinitis*
Creators: name: Sousa‐Pinto, Bernardo
name: Azevedo, Luís Filipe
name: Jutel, Marek
name: Agache, Ioana
name: Canonica, G. Walter
name: Czarlewski, Wienczyslawa
name: Papadopoulos, Nikolaos G.
name: Bergmann, Karl‐Christian
name: Devillier, Philippe
name: Laune, Daniel
name: Klimek, Ludger
name: Anto, Aram
name: Anto, Josep M.
name: Eklund, Patrik
name: Almeida, Rute
name: Bedbrook, Anna
name: Bosnic‐Anticevich, Sinthia
name: Brough, Helen A.
name: Brussino, Luisa
name: Cardona, Victoria
name: Casale, Thomas
name: Cecchi, Lorenzo
name: Charpin, Denis
name: Chivato, Tomás
name: Costa, Elisio M.
name: Cruz, Alvaro A.
name: Dramburg, Stephanie
name: Durham, Stephen R.
name: De Feo, Giulia
name: Gerth Van Wijk, Roy
name: Fokkens, Wystke J.
name: Gemicioglu, Bilun
name: Haahtela, Tari
name: Illario, Maddalena
name: Ivancevich, Juan Carlos
name: Kvedariene, Violeta
name: Kuna, Piotr
name: Larenas‐Linnemann, Désirée E.
name: Makris, Michael
name: Mathieu‐Dupas, Eve
name: Melén, Erik
name: Morais‐Almeida, Mario
name: Mösges, Ralph
name: Mullol, Joaquim
name: Nadeau, Kari C.
name: Pham‐Thi, Nhân
name: O’Hehir, Robyn
name: Regateiro, Frederico S.
name: Reitsma, Sietze
name: Samolinski, Boleslaw
name: Sheikh, Aziz
name: Stellato, Cristiana
name: Todo‐Bom, Ana
name: Tomazic, Peter Valentin
name: Toppila‐Salmi, Sanna
name: Valero, Antonio
name: Valiulis, Arunas
name: Ventura, Maria Teresa
name: Wallace, Dana
name: Waserman, Susan
name: Yorgancioglu, Arzu
name: De Vries, Govert
name: Van Eerd, Michiel
name: Zieglmayer, Petra
name: Zuberbier, Torsten
name: Pfaar, Oliver
name: Almeida Fonseca, João
name: Bousquet, Jean
Publisher: name: Charité - Universitätsmedizin Berlin
Year: 2022
Subjects: subject: medication score
subject: quality-of-life
subject: rhinitis
subject: symptom score
subject: work
subject: 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit

description: 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.