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*

Brussino L.;Sheikh A.;
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.
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medication score; quality-of-life; rhinitis; symptom score; work
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 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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1863583
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