Browsing by Author "Azevedo L.F."

Now showing 1 - 3 of 3
  • No Thumbnail Available
    Item
    Development and validation of combined symptom-medication scores for allergic rhinitis*
    (John Wiley and Sons Inc, 2022) 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.
    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.
  • No Thumbnail Available
    Item
    Allergen immunotherapy in MASK-air users in real-life: Results of a Bayesian mixed-effects model
    (John Wiley and Sons Inc, 2022) Sousa-Pinto B.; Azevedo L.F.; Sá-Sousa A.; Vieira R.J.; Amaral R.; Klimek L.; Czarlewski W.; Anto J.M.; Bedbrook A.; Kvedariene V.; Ventura M.T.; Ansotegui I.J.; Bergmann K.-C.; Brussino L.; Canonica G.W.; Cardona V.; Carreiro-Martins P.; Casale T.; Cecchi L.; Chivato T.; Chu D.K.; Cingi C.; Costa E.M.; Cruz A.A.; De Feo G.; Devillier P.; Fokkens W.J.; Gaga M.; Gemicioğlu B.; Haahtela T.; Ivancevich J.C.; Ispayeva Z.; Jutel M.; Kuna P.; Kaidashev I.; Kraxner H.; Larenas-Linnemann D.E.; Laune D.; Lipworth B.; Louis R.; Makris M.; Monti R.; Morais-Almeida M.; Mösges R.; Mullol J.; Odemyr M.; Okamoto Y.; Papadopoulos N.G.; Patella V.; Pham-Thi N.; Regateiro F.S.; Reitsma S.; Rouadi P.W.; Samolinski B.; Sova M.; Todo-Bom A.; Taborda-Barata L.; Tomazic P.V.; Toppila-Salmi S.; Sastre J.; Tsiligianni I.; Valiulis A.; Wallace D.; Waserman S.; Yorgancioglu A.; Zidarn M.; Zuberbier T.; Fonseca J.A.; Bousquet J.; Pfaar O.
    Background: Evidence regarding the effectiveness of allergen immunotherapy (AIT) on allergic rhinitis has been provided mostly by randomised controlled trials, with little data from real-life studies. Objective: To compare the reported control of allergic rhinitis symptoms in three groups of users of the MASK-air® app: those receiving sublingual AIT (SLIT), those receiving subcutaneous AIT (SCIT), and those receiving no AIT. Methods: We assessed the MASK-air® data of European users with self-reported grass pollen allergy, comparing the data reported by patients receiving SLIT, SCIT and no AIT. Outcome variables included the daily impact of allergy symptoms globally and on work (measured by visual analogue scales—VASs), and a combined symptom-medication score (CSMS). We applied Bayesian mixed-effects models, with clustering by patient, country and pollen season. Results: We analysed a total of 42,756 days from 1,093 grass allergy patients, including 18,479 days of users under AIT. Compared to no AIT, SCIT was associated with similar VAS levels and CSMS. Compared to no AIT, SLIT-tablet was associated with lower values of VAS global allergy symptoms (average difference = 7.5 units out of 100; 95% credible interval [95%CrI] = −12.1;−2.8), lower VAS Work (average difference = 5.0; 95%CrI = −8.5;−1.5), and a lower CSMS (average difference = 3.7; 95%CrI = −9.3;2.2). When compared to SCIT, SLIT-tablet was associated with lower VAS global allergy symptoms (average difference = 10.2; 95%CrI = −17.2;−2.8), lower VAS Work (average difference = 7.8; 95%CrI = −15.1;0.2), and a lower CSMS (average difference = 9.3; 95%CrI = −18.5;0.2). Conclusion: In patients with grass pollen allergy, SLIT-tablet, when compared to no AIT and to SCIT, is associated with lower reported symptom severity. Future longitudinal studies following internationally-harmonised standards for performing and reporting real-world data in AIT are needed to better understand its ‘real-world’ effectiveness. © 2022 The Authors. Clinical and Translational Allergy published by John Wiley & Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology.
  • No Thumbnail Available
    Item
    Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study
    (Elsevier Ltd, 2023) Sousa-Pinto B.; Jácome C.; Pereira A.M.; Regateiro F.S.; Almeida R.; Czarlewski W.; Kulus M.; Shamji M.H.; Boulet L.-P.; Bonini M.; Brussino L.; Canonica G.W.; Cruz A.A.; Gemicioglu B.; Haahtela T.; Kupczyk M.; Kvedariene V.; Larenas-Linnemann D.; Louis R.; Niedoszytko M.; Pham-Thi N.; Puggioni F.; Romantowski J.; Sastre J.; Scichilone N.; Taborda-Barata L.; Ventura M.T.; Vieira R.J.; Agache I.; Bedbrook A.; Bergmann K.C.; Amaral R.; Azevedo L.F.; Bosnic-Anticevich S.; Brusselle G.; Buhl R.; Cecchi L.; Charpin D.; Loureiro C.C.; de Blay F.; Del Giacco S.; Devillier P.; Jassem E.; Joos G.; Jutel M.; Klimek L.; Kuna P.; Laune D.; Luna Pech J.; Makela M.; Morais-Almeida M.; Nadif R.; Neffen H.E.; Ohta K.; Papadopoulos N.G.; Papi A.; Pétré B.; Pfaar O.; Yeverino D.R.; Cordeiro C.R.; Roche N.; Sá-Sousa A.; Samolinski B.; Sheikh A.; Ulrik C.S.; Usmani O.S.; Valiulis A.; Vandenplas O.; Vieira-Marques P.; Yorgancioglu A.; Zuberbier T.; Anto J.M.; Fonseca J.A.; Bousquet J.
    Background: Validated questionnaires are used to assess asthma control over the past 1–4 weeks from reporting. However, they do not adequately capture asthma control in patients with fluctuating symptoms. Using the Mobile Airways Sentinel Network for airway diseases (MASK-air) app, we developed and validated an electronic daily asthma control score (e-DASTHMA). Methods: We used MASK-air data (freely available to users in 27 countries) to develop and assess different daily control scores for asthma. Data-driven control scores were developed based on asthma symptoms reported by a visual analogue scale (VAS) and self-reported asthma medication use. We included the daily monitoring data from all MASK-air users aged 16–90 years (or older than 13 years to 90 years in countries with a lower age of digital consent) who had used the app in at least 3 different calendar months and had reported at least 1 day of asthma medication use. For each score, we assessed construct validity, test–retest reliability, responsiveness, and accuracy. We used VASs on dyspnoea and work disturbance, EQ-5D-VAS, Control of Allergic Rhinitis and Asthma Test (CARAT), CARAT asthma, and Work Productivity and Activity Impairment: Allergy Specific (WPAI:AS) questionnaires as comparators. We performed an internal validation using MASK-air data from Jan 1 to Oct 12, 2022, and an external validation using a cohort of patients with physician-diagnosed asthma (the INSPIRERS cohort) who had had their diagnosis and control (Global Initiative for Asthma [GINA] classification) of asthma ascertained by a physician. Findings: We studied 135 635 days of MASK-air data from 1662 users from May 21, 2015, to Dec 31, 2021. The scores were strongly correlated with VAS dyspnoea (Spearman correlation coefficient range 0·68–0·82) and moderately correlated with work comparators and quality-of-life-related comparators (for WPAI:AS work, we observed Spearman correlation coefficients of 0·59–0·68). They also displayed high test–retest reliability (intraclass correlation coefficients range 0·79–0·95) and moderate-to-high responsiveness (correlation coefficient range 0·69–0·79; effect size measures range 0·57–0·99 in the comparison with VAS dyspnoea). The best-performing score displayed a strong correlation with the effect of asthma on work and school activities in the INSPIRERS cohort (Spearman correlation coefficients 0·70; 95% CI 0·61–0·78) and good accuracy for the identification of patients with uncontrolled or partly controlled asthma according to GINA (area under the receiver operating curve 0·73; 95% CI 0·68–0·78). Interpretation: e-DASTHMA is a good tool for the daily assessment of asthma control. This tool can be used as an endpoint in clinical trials as well as in clinical practice to assess fluctuations in asthma control and guide treatment optimisation. Funding: None. © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license