Περίληψη:
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.
Συγγραφείς:
Sousa-Pinto, B.
Azevedo, L.F.
Jutel, M.
Agache, I.
Canonica, G.W.
Czarlewski, W.
Papadopoulos, N.G.
Bergmann, K.-C.
Devillier, P.
Laune, D.
Klimek, L.
Anto, A.
Anto, J.M.
Eklund, P.
Almeida, R.
Bedbrook, A.
Bosnic-Anticevich, S.
Brough, H.A.
Brussino, L.
Cardona, V.
Casale, T.
Cecchi, L.
Charpin, D.
Chivato, T.
Costa, E.M.
Cruz, A.A.
Dramburg, S.
Durham, S.R.
De Feo, G.
Gerth van Wijk, R.
Fokkens, W.J.
Gemicioglu, B.
Haahtela, T.
Illario, M.
Ivancevich, J.C.
Kvedariene, V.
Kuna, P.
Larenas-Linnemann, D.E.
Makris, M.
Mathieu-Dupas, E.
Melén, E.
Morais-Almeida, M.
Mösges, R.
Mullol, J.
Nadeau, K.C.
Pham-Thi, N.
O’Hehir, R.
Regateiro, F.S.
Reitsma, S.
Samolinski, B.
Sheikh, A.
Stellato, C.
Todo-Bom, A.
Tomazic, P.V.
Toppila-Salmi, S.
Valero, A.
Valiulis, A.
Ventura, M.T.
Wallace, D.
Waserman, S.
Yorgancioglu, A.
De Vries, G.
van Eerd, M.
Zieglmayer, P.
Zuberbier, T.
Pfaar, O.
Almeida Fonseca, J.
Bousquet, J.
