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.
Development and validation of combined symptom-medication scores for allergic rhinitis* / 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.; Melen, E.; Morais-Almeida, M.; Mosges, R.; Mullol, J.; Nadeau, K. C.; Pham-Thi, N.; O'Hehir, R.; Regateiro, F. S.; Reitsma, S.; Samolinski, B.; Sheikh, A.; Stellato, Cristiana; 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.. - In: ALLERGY. - ISSN 1398-9995. - 77:7(2022), pp. 2147-2162. [10.1111/all.15199]
Development and validation of combined symptom-medication scores for allergic rhinitis*
Illario M.;
2022
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
