TY - JOUR
TI - Development and validation of combined symptom-medication scores for allergic rhinitis*
AU - Sousa-Pinto, B.
AU - Azevedo, L.F.
AU - Jutel, M.
AU - Agache, I.
AU - Canonica, G.W.
AU - Czarlewski, W.
AU - Papadopoulos, N.G.
AU - Bergmann, K.-C.
AU - Devillier, P.
AU - Laune, D.
AU - Klimek, L.
AU - Anto, A.
AU - Anto, J.M.
AU - Eklund, P.
AU - Almeida, R.
AU - Bedbrook, A.
AU - Bosnic-Anticevich, S.
AU - Brough, H.A.
AU - Brussino, L.
AU - Cardona, V.
AU - Casale, T.
AU - Cecchi, L.
AU - Charpin, D.
AU - Chivato, T.
AU - Costa, E.M.
AU - Cruz, A.A.
AU - Dramburg, S.
AU - Durham, S.R.
AU - De Feo, G.
AU - Gerth van Wijk, R.
AU - Fokkens, W.J.
AU - Gemicioglu, B.
AU - Haahtela, T.
AU - Illario, M.
AU - Ivancevich, J.C.
AU - Kvedariene, V.
AU - Kuna, P.
AU - Larenas-Linnemann, D.E.
AU - Makris, M.
AU - Mathieu-Dupas, E.
AU - Melén, E.
AU - Morais-Almeida, M.
AU - Mösges, R.
AU - Mullol, J.
AU - Nadeau, K.C.
AU - Pham-Thi, N.
AU - O’Hehir, R.
AU - Regateiro, F.S.
AU - Reitsma, S.
AU - Samolinski, B.
AU - Sheikh, A.
AU - Stellato, C.
AU - Todo-Bom, A.
AU - Tomazic, P.V.
AU - Toppila-Salmi, S.
AU - Valero, A.
AU - Valiulis, A.
AU - Ventura, M.T.
AU - Wallace, D.
AU - Waserman, S.
AU - Yorgancioglu, A.
AU - De Vries, G.
AU - van Eerd, M.
AU - Zieglmayer, P.
AU - Zuberbier, T.
AU - Pfaar, O.
AU - Almeida Fonseca, J.
AU - Bousquet, J.
JO - Allergy: European Journal of Allergy and Clinical Immunology
PY - 2022
VL - null
TODO - null
SP - null
PB - John Wiley and Sons Inc
SN - null
TODO - 10.1111/all.15199
TODO - null
TODO - 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. © 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
ER -