Produção Nacional
Development and Validation of an Electronic Daily Control Score for Asthma (e-DASTHMA)
2022; RELX Group (Netherlands); Linguagem: Inglês
10.2139/ssrn.4168884
ISSN1556-5068
AutoresBernardo Sousa‐Pinto, Cristina Jácome, Ana Margarida Pereira, Frederico S. Regateiro, Rute Almeida, Heather J. Zar, Marek Kulus, Mohamed H. Shamji, Louis Philippe Boulet, Matteo Bonini, Luisa Brussino, G. Walter Canonica, Álvaro A. Cruz, Bilun Gemicioğlu, Tari Haahtela, Maciej Kupczyk, Violeta Kvedarienė, Désirée Larenas‐Linnemann, Renaud Louis, Marek Niedoszytko, N. Pham‐Thi, Francesca Puggioni, Jan Romantowski, J. Sastre, Nicola Scichilone, Luís Taborda‐Barata, Maria Teresa Ventura, Rafael José Vieira, Ioana Agache, Anna Bedbrook, Karl‐Christian Bergmann, Rita Amaral, Luís Filipe Azevedo, Sinthia Bosnic‐Anticevich, Guy Brusselle, Roland Buhl, Lorenzo Cecchi, D. Charpin, Cláudia Chaves Loureiro, Frédéric de Blay, Stefano Del Giacco, Philippe Devillier, Ewa Jassem, Guy Joos, Marek Jutel, Ludger Klimek, Piotr Kuna, Daniel Laune, Jorge Luna Pech, Mika J. Mäkelä, Mário Morais‐Almeida, Rachel Nadif, Hugo Neffen, Ken Ohta, Nikolaos G. Papadopoulos, Alberto Papi, Benoît Pétré, Oliver Pfaar, Daniela Rivero‐Yeverino, Carlos Robalo Cordeiro, Nicolás Roche, Ana Sá‐Sousa, Bolesław Samoliński, Aziz Sheikh, Charlotte Suppli Ulrik, Omar S. Usmani, Arūnas Valiulis, Olivier Vandenplas, Pedro Vieira‐Marques, Arzu Yorgancıoğlu, Torsten Zuberbier, Josep M. Antó, João Fonseca, Jean Bousquet,
Tópico(s)Respiratory and Cough-Related Research
ResumoBackground: Validated questionnaires are used to assess asthma control over the previous 1-4 weeks. These do not however adequately capture asthma control in patients with fluctuating symptoms. Using the MASK-air ® app, we developed and validated an electronic daily asthma control score.Methods: Data-driven control scores were based on (i) asthma symptoms reported by a visual analogue scale (VAS) and (ii) reported asthma medication use. For each score, we assessed construct validity, test-retest reliability and responsiveness. We used VASs on dyspnoea and work disturbance, EQ-5D VAS, CARAT (Control of Allergic Rhinitis and Asthma Test), CARAT-asthma and WPAI:AS (Work Productivity and Activity Impairment: Allergy Specific) as comparators. We performed an external validation using a cohort of patients with physician-diagnosed asthma (INSPIRERS).Findings: We studied 135,635 days of MASK-air ® data from 1,662 users. The scores (i) were strongly correlated with VAS dyspnoea (Spearman RHO range = 0·57 to 0·99) and moderately correlated with work- and quality-of-life-related comparators (RHO=0·33 to 0·68) and (ii) displayed high test-retest reliability and moderate-to-high responsiveness. The best-performing score displayed strong correlation with the impact of asthma on work/school activities in INSPIRERS (RHO=0·70; 95%CI=0·61;0·78) and good accuracy for the identification of patients with uncontrolled/partly-controlled asthma according to GINA (AUC-ROC=0·73; 95%CI=0·68;0·78).Interpretation: e-DASTHMA is a good candidate for the daily assessment of asthma control. In line with the harmonisation of trial designs and outcomes in asthma, this study is important for optimising the assessment and care of asthma patients, especially those with fluctuating symptoms.Funding Information: None for this study.Declaration of Interests: Dr. Agache reports and Associate Editor for Allergy and CTA journals. Dr. Almeida reports personal fees from operation POCI-01-0145-36 FEDER-029130 (“mINSPIRE-mHealth to measure and improve adherence to medication in chronic respiratory diseases—generalisation and evaluation of gamification, peer support and advanced image processing technologies”) cofunded by ERDF (European Regional Development Fund) , COMPETE2020 (Programa Operacional Competitividade e Internacionalização), Portugal 2020 and by Portuguese Funds through FCT (Fundação para a Ciência e a Tecnologia), outside the submitted work.Dr. Amaral has nothing to disclose., Dr. Antó has nothing to disclose. Dr. Azevedo has nothing to disclose. Ms Bedbrook has nothing to disclose. Dr. Bonini has nothing to disclose. Dr. Bosnic-Anticevich reports grants from TEVA, personal fees from TEVA, personal fees from TEVA, personal fees from AstraZeneca, personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Boehringer Ingelheim, personal fees from GSK, personal fees from Sanofi, personal fees from Mylan, outside the submitted work. Dr. Boulet reports grants from Amgen, AstraZeneca, GlaxoSmithKline, Merck, Novartis, Sanofi-Regeneron, personal fees from Astra Zeneca, Novartis, GlaxoSmithKline, Merck, Sanofi-Regeneron, Covis, Sanofi, outside the submitted work; and member of Chair of Global Initiative for Asthma (GINA) Board of Directors, President of the Global Asthma Organisation (Interasma), member of the Canadian Thoracic Society Respiratory Guidelines Committee Laval University Chair on Knowledge Transfer, Prevention and Education in Respiratory and Cardiovascular Health. Dr. Bousquet reports personal fees from Chiesi, Cipla, Hikma, Menarini, Mundipharma, Mylan, Novartis, Purina, Sanofi-Aventis, Takeda, Teva, Uriach, other from KYomed-Innov, outside the submitted work. Dr. Brusselle reports personal fees from Astra Zeneca, personal fees from Boehringer-Ingelheim, personal fees from Chiesi, personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from Sanofi, outside the submitted work. Dr. Brussino has nothing to disclose. Dr. Buhl reports grants to Mainz University Hospital from Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Roche, and personal fees from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Novartis, Roche, Sanofi, and Teva, all outside the submitted work. Dr. Canonica has nothing to disclose. Dr. Cecchi reports personal fees from Thermofisher, personal fees from Sanofi, personal fees from Novartis, personal fees from Astra Zeneca, outside the submitted work. Dr. Charpin has nothing to disclose. Dr. Chaves Loureiro has nothing to disclose. Dr. Cruz reports personal fees from AstraZeneca, personal fees from Boeahringer-Ingelheim, personal fees from Chiesi, personal fees from Eurofarma, personal fees from GSK, personal fees from Novartis, personal fees from Sanofi, outside the submitted work. Dr. Czarlewski has nothing to disclose. Dr. de BLAY reports other from Novartis, other from ALK, other from Stallergènes, other from Regeneron, other from DBV, other from Sanofi, other from Boehringer, other from AstraZeneca, outside the submitted work. Dr. Devillier reports personal fees and non-financial support from Astra Zeneca, personal fees from Chiesi, personal fees and non-financial support from Boehringer Ingelheim, personal fees from GlaxoSmithKline, personal fees from Menarini, personal fees and non-financial support from Stallergenes, personal fees and non-financial support from ALK Abello, personal fees from IQVIA, outside the submitted work. Dr. Fonseca reports grants and personal fees from Astrazeneca, grants and personal fees from Mundipharma, personal fees from Sanofi, personal fees from GSK, personal fees from Teva, outside the submitted work and is co-founder of a company that develops mHealth technologies and has the copyright of the CARAT PROM. Dr. Gemicioglu reports grants from AstraZeneca, grants from Sanofi, grants from Deva, grants from Abdi Ibrahim, grants from Sandoz, outside the submitted work. Dr. Haahtela reports personal fees from Orion Pharma, outside the submitted work. Dr. Jassem has nothing to disclose. Dr. Joos reports personal fees from AstraZeneca, GSK, Chiesi, Novartis, Laparcon, support from GSK, outside the submitted work; and member of ERS Chair of Operational Committee IRC (International Respiratory Coalition). Dr. Jutel reports personal fees from ALK-Abello, personal fees from Allergopharma , personal fees from Stallergenes, personal fees from Anergis, personal fees from Allergy Therapeutics , personal fees from Leti , personal fees from HAL, during the conduct of the study; personal fees from GSK, personal fees from Novartis, personal fees from Teva, personal fees from Takeda, personal fees from Chiesi, outside the submitted work. Dr. Klimek reports grants and personal fees from Allergopharma, grants and personal fees from MEDA/Mylan, personal fees from HAL Allergie, grants from ALK Abelló, grants and personal fees from LETI Pharma, grants from Stallergenes, grants from Quintiles, grants and personal fees from Sanofi, grants from ASIT biotech, grants from Lofarma, personal fees from Allergy Therapeut., grants from AstraZeneca, grants from GSK, grants from Inmunotk, personal fees from Cassella med, outside the submitted work; and Membership: AeDA, DGHNO, Deutsche Akademie für Allergologie und klinische Immunologie, HNO-BV, GPA, EAACI. Dr. Kulus has nothing to disclose. Dr. Kuna reports personal fees from Adamed, personal fees from AstraZeneca, personal fees from Berlin Chemie Menarini, personal fees from FAES, personal fees from Glenmark, personal fees from Novartis, personal fees from Polpharma, personal fees from Boehringer Ingelheim, personal fees from Teva, personal fees from Zentiva, outside the submitted work. Dr. Kupczyk reports personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Novartis, Lekam, Alvogen, Emma, Nexter, Teva, Sanofi Aventis and Berlin Chemie, outside the submitted work. Dr. Kvedariene reports non-financial support from Norameda, non-financial support from BerlinCHemie Menarini, outside the submitted work. Dr. Larenas Linnemann reports personal fees from ALK, Allakos, Amstrong, Astrazeneca national and global, Chiesi, DBV Technologies, Grunenthal, GSK national and global, Mylan/Viatris, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, UCB, Alakos, Gossamer, Carnot, grants from Sanofi, Astrazeneca, Lilly, Pfizer, Novartis, Circassia, UCB, GSK, Purina institute., outside the submitted work. Dr. Laune has nothing to disclose. Dr. Louis reports grants and personal fees from GSK, grants and personal fees from AZ, grants from Chiesi, outside the submitted work. Dr. Luna-Pech has nothing to disclose. Dr. Mäkelä has nothing to disclose. Dr. Morais Almeida has nothing to disclose. Dr. NADIF has nothing to disclose. Dr. Neffen has nothing to disclose. Dr. Niedoszytko has nothing to disclose. Dr. Papadopoulos reports personal fees from Novartis, personal fees from Nutricia, personal fees from HAL, personal fees from MENARINI/FAES FARMA, personal fees from SANOFI, personal fees from MYLAN/MEDA, personal fees from BIOMAY, personal fees from AstraZeneca, personal fees from GSK, personal fees from MSD, personal fees from ASIT BIOTECH, personal fees from Boehringer Ingelheim, grants from Gerolymatos International SA, grants from Capricare, outside the submitted work. Dr. Ohta has nothing to disclose. Dr. Oliveira Jácome has nothing to disclose. Dr. Papi reports grants from Chiesi, Astrazeneca, GSK, BI, Pfizer, Teva, Sanofi, personal fees from CHIESI, Astrazeneca, GSK, Novartis, Sanofi, Iqvia, Avillion, Elpen Pharmaceuticals, BI, Menarini, Zambon, Mundipharma, Teva, Edmon Pharma, MSD, outside the submitted work. Dr. Pereira has nothing to disclose. Dr. Pétré has nothing to disclose. Dr. Pfaar reports grants and personal fees from ALK-Abelló, grants and personal fees from Allergopharma, grants and personal fees from Stallergenes Greer, grants and personal fees from HAL Allergy Holding B.V./HAL Allergie GmbH, grants and personal fees from Bencard Allergie GmbH/Allergy Therapeutics, grants and personal fees from Lofarma, grants from Biomay, grants from Circassia, grants and personal fees from ASIT Biotech Tools S.A., grants and personal fees from Laboratorios LETI/LETI Pharma, personal fees from MEDA Pharma/MYLAN, grants and personal fees from Anergis S.A., personal fees from Mobile Chamber Experts (a GA2LEN Partner), personal fees from Indoor Biotechnologies, grants and personal fees from GlaxoSmithKline, personal fees from Astellas Pharma Global, personal fees from EUFOREA, personal fees from ROXALL Medizin, personal fees from Novartis, personal fees from Sanofi-Aventis and Sanofi-Genzyme, personal fees from Med Update Europe GmbH, personal fees from streamedup! GmbH, grants from Pohl-Boskamp, grants from Inmunotek S.L., personal fees from John Wiley and Sons, AS, personal fees from Paul-Martini-Stiftung (PMS), personal fees from Regeneron Pharmaceuticals Inc., personal fees from RG Aerztefortbildung, personal fees from Institut für Disease Management, personal fees from Springer GmbH, grants and personal fees from AstraZeneca, personal fees from IQVIA Commercial, personal fees from Ingress Health, personal fees from Wort&Bild Verlag, personal fees from Verlag ME, personal fees from Procter&Gamble, outside the submitted work; and member of EAACI Excom, member of ext. board of directors DGAKI; coordinator, main- or co-author of different position papers and guidelines in rhinology, allergology and allergen-immunotherapy. Dr. Pham-Thi has nothing to disclose. Dr. Puggioni has nothing to disclose. Dr. Regateiro reports speaker and advisory fees from AstraZeneca, Novartis, Sanofi, GSK, Teva, Kedrion, Takeda, LEO Pharma and Lusomedicamenta, all outside the submitted work.Dr. Rivero has nothing to disclose. Dr. Robalo Cordeiro has nothing to disclose. Dr. Roche reports grants and personal fees from Boehringer Ingelheim, grants and personal fees from Novartis, grants and personal fees from GSK, personal fees from AstraZeneca, personal fees from Chiesi, grants and personal fees from Pfizer, personal fees from Sanofi, personal fees from Zambon, personal fees from MSD, outside the submitted work. Dr. Romantowski has nothing to disclose. Dr. Sá-Sousa has nothing to disclose.Dr. Samolińśki has nothing to disclose. Dr. SASTRE reports grants and personal fees from SANOFI, personal fees from GSK, personal fees from NOVARTIS, personal fees from ASTRA ZENECA, personal fees from MUNDIPHARMA, personal fees from FAES FARMA, outside the submitted work. Dr. Scichilone has nothing to disclose. Dr. Shamji has nothing to disclose. Dr. Sheikh has nothing to disclose. Dr. Sousa-Pinto has nothing to disclose. Dr. Taborda-Barata has nothing to disclose. Dr. Ulrik reports personal fees from GSK, grants and personal fees from AZ, personal fees from TEVA, grants and personal fees from Novartis, grants and personal fees from BI, personal fees from Chiesi, grants and personal fees from Sanofi, personal fees from Orion Pharma, personal fees from Covis Pharma, outside the submitted work. Dr. Usmani has nothing to disclose. Dr. Valiulis has nothing to disclose. Dr. Vandenplas reports grants from Astrazeneca, Chiesi, outside the submitted work. Dr. Ventura has nothing to disclose. Dr. Vieira has nothing to disclose. Dr. Vieira-Marques has nothing to disclose. Dr. Yorgancıoğlu has nothing to disclose. Dr. Zuberbier reports grants from Novartis, Henkel, personal fees from Bayer Health Care, FAES, Novartis, Henkel, AstraZeneca, AbbVie, ALK, Almirall, Astellas, Bencard, Berlin Chemie, HAL, Leti, Meda, Menarini, Merck, MSD, Pfizer, Sanofi, Stallergenes, Takeda, Teva, UCB, Kryolan, L'Oréal, outside the submitted work.Ethics Approval Statement: MASK-air® is CE-registered and follows the European Union General Data Protection Regulation (GDPR). An independent review board approval was not required for this specific study as (i) the use of MASK-air® secondary data for research purposes has been approved by an independent review board (Köln-Bonn, Germany), (ii) all data were anonymised before the study using k-anonymity and (iii) users agreed to the analysis of their data in the terms of use (translated into all languages and customised according to the legislation of each country, allowing the use of the results for research purposes). The INSPIRERS studies involved a physician evaluation and had an ethics committee approval from all participating centres.
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