Development and validation of combined symptom‐medication scores for allergic rhinitis*
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 , 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 
Published: December 2021

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.