Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study.

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.

Informations de copyright

Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests IA is an associate editor for Allergy and Clinical and Translational Allergy journals. RAl reports personal fees from operation POCI-01–0145–36 FEDER-029130 (titled “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”), co-funded by European Regional Development Fund, Programa Operacional Competitividade e Internacionalização, Portugal 2020, and by Portuguese Funds through Fundação para a Ciência e a Tecnologia, outside the submitted work. SB-A reports grants from TEVA, and personal fees from Teva, AstraZeneca, Boehringer Ingelheim, GSK, Sanofi, and Mylan, outside the submitted work. L-PB reports grants from Amgen, AstraZeneca, GlaxoSmithKline, Merck, Novartis, and Sanofi-Regeneron; personal fees from AstraZeneca, Novartis, GlaxoSmithKline, Merck, Sanofi-Regeneron, Covis, and Sanofi, outside the submitted work; and is a member of the Chair of Global Initiative for Asthma (GINA) Board of Directors, President of the Global Asthma Organisation (Interasma), and is a member of the Canadian Thoracic Society Respiratory Guidelines Committee and Laval University Chair on Knowledge Transfer, and Prevention and Education in Respiratory and Cardiovascular Health. JB reports personal fees from Chiesi, Cipla, Hikma, Menarini, Mundipharma, Mylan, Novartis, Purina, Sanofi-Aventis, Takeda, Teva, and Uriach; and other from Kyomed-Innov, outside the submitted work. GB reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Sanofi, outside the submitted work. RB 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. LC reports personal fees from Thermofisher, Sanofi, Novartis, and AstraZeneca, outside the submitted work. AAC reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Eurofarma, GSK, Novartis, and Sanofi, outside the submitted work. FdB reports other grants from Novartis, ALK, Stallergenes, Regeneron, DBV, Sanofi, Boehringer, and AstraZeneca, outside the submitted work. PD reports non-financial support from AstraZeneca, Boehringer Ingelheim, Stallergenes, and ALK Abelló; and personal fees from AstraZeneca, Chiesi, Boehringer Ingelheim, GlaxoSmithKline, Menarini, Stallergenes, ALK Abelló, and IQVIA, outside the submitted work. JAF reports grants from Astrazeneca and Mundipharma; and personal fees from AstraZeneca, Mundipharma, Sanofi, GSK, and Teva, outside the submitted work; and is co-founder of a company that develops mobile health technologies and has the copyright of the Control of Allergic Rhinitis and Asthma Test Patient-Reported Outcome Measurement. BG reports grants from AstraZeneca, Sanofi, Deva, Abdi Ibrahim, and Sandoz, outside the submitted work. TH reports personal fees from Orion Pharma, outside the submitted work. GJ reports personal fees from AstraZeneca, GSK, Chiesi, Novartis, and Laparcon; support from GSK, outside the submitted work; and is a member of European Respiratory Society Chair of Operational Committee International Respiratory Coalition. MJ reports personal fees from ALK-Abello, Allergopharma, Stallergenes, Anergis, Allergy Therapeutics, Leti, and HAL, during the conduct of the study; and personal fees from GSK, Novartis, Teva, Takeda, and Chiesi, outside the submitted work. LK reports grants from Allergopharma, MEDA/Mylan, ALK Abelló, LETI Pharma, Stallergenes, Sanofi, ASIT biotech, Lofarma Quintiles, AstraZeneca, GSK, and Inmunotk; and personal fees from Allergopharma, MEDA/Mylan, HAL Allergie, LETI Pharma, Sanofi, Allergy Therapeut, and Cassella Med, outside the submitted work; and is a member of Ärzteverband Deutscher Allergologen, Deutsche Gesellschaft für Hals-Nasen-Ohren, Deutsche Akademie für Allergologie und klinische Immunologie, Berufsverband der Hals-Nasen-Ohrenärzte, Gesellschaft für Pädiatrische Allergologie, andEuropean Academy of Allergy and Clinical Immunology. PK reports personal fees from Adamed, AstraZeneca, Berlin Chemie Menarini, FAES, Glenmark, Novartis, Polpharma, Boehringer Ingelheim, Teva, and Zentiva, outside the submitted work. MKup reports personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Novartis, Lekam, Alvogen, Emma, Nexter, Teva, Sanofi Aventis, and Berlin Chemie, outside the submitted work. VK reports non-financial support from Norameda and Berlin Chemie Menarini, outside the submitted work. DL-L 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, and Carnot; and grants from Sanofi, Astrazeneca, Lilly, Pfizer, Novartis, Circassia, UCB, GSK, and Purina institute, outside the submitted work. RL reports personal fees from GSK and AZ; and grants from GSK, AZ, and Chiesi, outside the submitted work. NGP reports personal fees from Novartis, Nutricia, HAL, MENARINI/FAES FARMA, SANOFI, MYLAN/MEDA, BIOMAY, AstraZeneca, GSK, MSD, ASIT BIOTECH, and Boehringer Ingelheim; and grants from Gerolymatos International SA and Capricare, outside the submitted work. AP reports grants from Chiesi, Astrazeneca, GSK, BI, Pfizer, Teva, and Sanofi; personal fees from CHIESI, Astrazeneca, GSK, Novartis, Sanofi, Iqvia, Avillion, Elpen Pharmaceuticals, BI, Menarini, Zambon, Mundipharma, Teva, Edmon Pharma, and MSD, outside the submitted work. OP reports grants from ALK Abelló, Allergopharma, Stallergenes Greer, HAL Allergy Holding BV/HAL Allergie, Bencard Allergie/Allergy Therapeutics, Lofarma, Biomay, Circassia, ASIT Biotech Tools SA, Laboratorios LETI/LETI Pharma, Anergis SA, GlaxoSmithKline, Pohl-Boskamp, Inmunotek SL, and AstraZeneca; and personal fees from ALK-Abelló, Allergopharma, Stallergenes Greer, HAL Allergy Holding BV/HAL Allergie, Bencard Allergie/Allergy Therapeutics, Lofarma, ASIT Biotech Tools SA, Laboratorios LETI/LETI Pharma, MEDA Pharma/MYLAN, Anergis SA, AstraZeneca, Mobile Chamber Experts (a GA2LEN Partner), Indoor Biotechnologies, GlaxoSmithKline, Astellas Pharma Global, EUFOREA, ROXALL Medizin, Novartis, Sanofi-Aventis and Sanofi-Genzyme, Med Update Europe, streamedup!, John Wiley and Sons, AS, Paul-Martini-Stiftung, Regeneron Pharmaceuticals, RG Aerztefortbildung, Institut für Disease Management, Springer, IQVIA Commercial, Ingress Health, Wort & Bild Verlag, Verlag ME, and Procter & Gamble, outside the submitted work; and is a member of EAACI Excom, member of external board of directors Deutsche Gesellschaft für Allergologie und klinische Immunologie; and is a coordinator, main author, or coauthor of different position papers and guidelines in rhinology, allergology, and allergen immunotherapy. FSR reports speaker and advisory fees from AstraZeneca, Novartis, Sanofi, GSK, Teva, Kedrion, Takeda, LEO Pharma, and Lusomedicamenta, all outside the submitted work. NR reports grants from Boehringer Ingelheim, Novartis, GSK, and Pfizer; and personal fees from Boehringer Ingelheim, Novartis, GSK, AstraZeneca, Chiesi, Pfizer, Sanofi, Zambon, and MSD, outside the submitted work. JS reports grants from Sanofi; and personal fees from Sanofi, GSK, Novartis, AstraZeneca, MundiPharma, and Faes Farma, outside the submitted work. CSU reports personal fees from GSK, AZ, TEVA, Novartis, BI, Chiesi, Sanofi, Orion Pharma, and Covis Pharma; and grants from AZ, Novartis, BI, Sanofi, Orion Pharma, and Covis Pharma, outside the submitted work. OV reports grants from Astrazeneca and Chiesi, outside the submitted work. TZ reports grants from Novartis and 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, and L'Oréal, outside the submitted work. All other authors declare no competing interests.