Health Information Management; Decision Sciences (miscellaneous); Health Informatics; Medicine (miscellaneous)
Abstract :
[en] [en] 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.
Disciplines :
Public health, health care sciences & services
Author, co-author :
Sousa-Pinto, Bernardo; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Jácome, Cristina; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Pereira, Ana Margarida; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal, Patient Centred Innovation and Technology, Centro de Investigação em Tecnologias e Serviços de Saúde, Centre for Health Technology and Services Research, University of Porto, Porto, Portugal
Regateiro, Frederico S; Allergy and Clinical Immunology Unit, Centro Hospitalar e Universitário de Coimbra, Coimbra and Institute of Immunology, and Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, University of Coimbra, Coimbra, Portugal
Almeida, Rute; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Czarlewski, Wienczyslawa; Medical Consulting Czarlewski, Levallois, France
Kulus, Marek; Department of Pediatric Respiratory Diseases and Allergology, Medical University of Warsaw, Warsaw, Poland
Shamji, Mohamed H; National Heart and Lung Institute, Imperial College & National Institutes for Health Imperial Biomedical Research Centre, London, UK
Boulet, Louis-Philippe; Quebec Heart and Lung Institute, Laval University, Québec City, Quebec, Canada
Bonini, Matteo; Department of Cardiovascular and Respiratory Sciences, Università Cattolica del Sacro Cuore, Rome, Italy, Department of Neurological, Ear, Nose, and Throat, and Thoracic Sciences, Fondazione Policlinico Universitario A Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy, National Heart and Lung Institute, Imperial College London, London, UK
Brussino, Luisa; Department of Medical Sciences, Allergy and Clinical Immunology Unit, University of Torino & Mauriziano Hospital, Torino, Italy
Canonica, G Walter; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy, Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy
Cruz, Alvaro A; Fundaçao ProAR, Federal University of Bahia and Global Alliance Against Chronic Respiratory Diseases and WHO Planning Group, Salvador, Bahia, Brazil
Gemicioglu, Bilun; Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Türkiye
Haahtela, Tari; Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
Kupczyk, Maciej; Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
Kvedariene, Violeta; Institute of Biomedical Sciences, Department of Pathology and Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
Larenas-Linnemann, Desirée; Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico
Louis, Renaud ; Centre Hospitalier Universitaire de Liège - CHU > > Service de pneumologie - allergologie
Niedoszytko, Marek; Department of Allergology, Medical University of Gdańsk, Gdansk, Poland
Pham-Thi, Nhân; Institut de Recherche bio-Médicale des Armées, Bretigny sur Orge, France, École Polytechnique de Palaiseau, Palaiseau, France, Université Paris Cité, Paris, France
Puggioni, Francesca; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy
Romantowski, Jan; Department of Allergology, Medical University of Gdańsk, Gdansk, Poland
Sastre, Joaquin; Allergy Service, Fundacion Jimenez Diaz, Faculty of Medicine Universidad Autonoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
Scichilone, Nicola; PROMISE Department, University of Palermo, Palermo, Italy
Taborda-Barata, Luis; University of Beira Interior Air, Clinical & Experimental Lung Centre and Centro de Investigação em Ciências da Saúde-University of Beira Interior Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal, Department of Immunoallergology, Cova da Beira University Hospital Centre, Covilhã, Portugal
Ventura, Maria Teresa; Unit of Geriatric Immunoallergology, University of Bari Medical School, Bari, Italy
Vieira, Rafael José; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Agache, Ioana; Faculty of Medicine, Transylvania University Brasov, Brasov, Romania
Bedbrook, Anna; Allergic Rhinitis and its Impact on Asthma, Montpellier, France
Bergmann, Karl C; Institute of Allergology, Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, Berlin, Germany
Amaral, Rita; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Azevedo, Luís Filipe; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Bosnic-Anticevich, Sinthia; Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, The University of Sydney, and Sydney Local Health District, Sydney, NSW, Australia
Brusselle, Guy; Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium
Buhl, Roland; Department of Pulmonary Medicine, Mainz University Hospital, Mainz, Germany
Cecchi, Lorenzo; Struttura Organizzativa Semplice Allergology and Clinical Immunology Unita Sanitaria Locale, Toscana Centro, Prato, Italy
Charpin, Denis; Clinique des Bronches, Allergie et Sommeil, Hôpital Nord, Marseille, France
Loureiro, Claudia Chaves; Pneumology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
de Blay, Frédéric; Allergy Division, Chest Disease Department, University Hospital of Strasbourg, Strasbourg, France, Federation of Translational Medicine, University of Strasbourg, Strasbourg, France
Del Giacco, Stefano; Department of Medical Sciences and Public Health and Unit of Allergy and Clinical Immunology, University Hospital Duilio Casula, University of Cagliari, Cagliari, Italy
Devillier, Philippe; Virologie et Immunologie Moléculaires Suresnes, Unités Mixtes de Recherche 0892, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France
Jassem, Ewa; Medical University of Gdańsk, Department of Pneumonology, Gdansk, Poland
Joos, Guy; Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium
Jutel, Marek; Department of Clinical Immunology, Wrocław Medical University, Wroclaw, Poland, All-Medicine Medical Research Institute, Wroclaw, Poland
Klimek, Ludger; Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany, Center for Rhinology and Allergology, Wiesbaden, Germany
Kuna, Piotr; Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
Laune, Daniel; KYomed Innovation, Montpellier, France
Luna Pech, Jorge; University of Guadalajara, Guadalajara, Mexico
Makela, Mika; Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
Morais-Almeida, Mario; Allergy Center, Companhia União Fabril Descobertas Hospital, Lisbon, Portugal
Nadif, Rachel; Université Paris-Saclay, Université Versailles-St Quentin, Université Paris-Sud, Paris, France, Inserm, Equipe d'Epidémiologie Respiratoire Intégrative, Villejuif, France
Neffen, Hugo E; Center of Allergy, Immunology and Respiratory Diseases, Santa Fe, Argentina
Ohta, Ken; National Hospital Organization, Tokyo National Hospital, Tokyo, Japan, JATA Fukujuji Hospital, Tokyo, Japan
Papadopoulos, Nikolaos G; Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece
Papi, Alberto; Respiratory Medicine, Department of Translational Medicine, University of Ferrara, Ferrara, Italy
Pétré, Benoît ; Université de Liège - ULiège > Département des sciences de la santé publique > Education thérapeutique du patient au service des soins intégrés
Pfaar, Oliver; Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany
Yeverino, Daniela Rivero; Allergy and Clinical Immunology Department, Hospital Universitario de Puebla, Puebla, Mexico
Cordeiro, Carlos Robalo; Department of Pneumology, Coimbra University Hospital, Coimbra, Portugal
Roche, Nicolas; Pneumologie, Assistance Publique - Hôpitaux de Paris, Centre Université de Paris Cité, Hôpital Cochin, Paris, France
Sá-Sousa, Ana; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal, Patient Centred Innovation and Technology, Centro de Investigação em Tecnologias e Serviços de Saúde, Centre for Health Technology and Services Research, University of Porto, Porto, Portugal
Samolinski, Boleslaw; Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland
Sheikh, Aziz; Usher Institute, The University of Edinburgh, Edinburgh, UK
Ulrik, Charlotte Suppli; Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark, Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
Usmani, Omar S; National Heart and Lung Institute, Imperial College London, London, UK, Royal Brompton Hospital, Airways Disease Section, London, UK
Valiulis, Arunas; Institute of Clinical Medicine and Institute of Health Sciences and Medical Faculty of Vilnius University, Vilnius, Lithuania
Vandenplas, Olivier; Department of Chest Medicine, Centre Hospitalier Universitaire UCL, Namur, Belgium, Université Catholique de Louvain, Yvoir, Belgium
Vieira-Marques, Pedro; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Yorgancioglu, Arzu; Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Türkiye
Zuberbier, Torsten; Institute of Allergology, Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, Berlin, Germany
Anto, Josep M; ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain, Universitat Pompeu Fabra, Barcelona, Spain, Centro de Investigación Biomédica en Red Epidemiología y Salud Pública, Barcelona, Spain
Fonseca, João A; MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal, Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
Bousquet, Jean; Institute of Allergology, Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, Berlin, Germany, Inserm, Equipe d'Epidémiologie Respiratoire Intégrative, Villejuif, France, University Hospital Montpellier, Montpellier, France. Electronic address: jean.bousquet@orange.fr
Global Initiative for Asthma. Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf, 2022. (Accessed 16 November 2022)
McCoy, K, Shade, DM, Irvin, CG, et al. Predicting episodes of poor asthma control in treated patients with asthma. J Allergy Clin Immunol 118 (2006), 1226–1233.
van Dijk, BCP, Svedsater, H, Heddini, A, Nelsen, L, Balradj, JS, Alleman, C, Relationship between the Asthma Control Test (ACT) and other outcomes: a targeted literature review. BMC Pulm Med, 20, 2020, 79.
Juniper, EF, O'Byrne, PM, Guyatt, GH, Ferrie, PJ, King, DR, Development and validation of a questionnaire to measure asthma control. Eur Respir J 14 (1999), 902–907.
Schatz, M, Sorkness, CA, Li, JT, et al. Asthma control test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol 117 (2006), 549–556.
Fonseca, JA, Nogueira-Silva, L, Morais-Almeida, M, et al. Validation of a questionnaire (CARAT10) to assess rhinitis and asthma in patients with asthma. Allergy 65 (2010), 1042–1048.
Santanello, NC, Barber, BL, Reiss, TF, Friedman, BS, Juniper, EF, Zhang, J, Measurement characteristics of two asthma symptom diary scales for use in clinical trials. Eur Respir J 10 (1997), 646–651.
Medical Device Coordination Group. Guidance on classification of medical devices. https://ec.europa.eu/health/system/files/2021-10/mdcg_2021-24_en_0.pdf, October, 2021. (Accessed 16 April 2022)
Sousa-Pinto, B, Azevedo, LF, Jutel, M, et al. Development and validation of combined symptom-medication scores for allergic rhinitis. Allergy 77 (2022), 2147–2162.
Bousquet, J, Bedbrook, A, Czarlewski, W, et al. Guidance to 2018 good practice: ARIA digitally-enabled, integrated, person-centred care for rhinitis and asthma. Clin Transl Allergy, 9, 2019, 16.
Amaral, R, Jácome, C, Almeida, R, et al. Profiling persistent asthma phenotypes in adolescents: a longitudinal diagnostic evaluation from the INSPIRERS studies. Int J Environ Res Public Health, 18, 2021, 1015.
Mokkink, LB, Terwee, CB, Patrick, DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 63 (2010), 737–745.
Bousquet, J, Sousa-Pinto, B, Antó, JM, et al. Identification by cluster analysis of patients with asthma and nasal symptoms using the MASK-air® mHealth app. Pulmonology, 2022 published online November 22. https://doi.org/10.1016/j.pulmoe.2022.10.005.
Sousa-Pinto, B, Eklund, P, Pfaar, O, et al. Validity, reliability, and responsiveness of daily monitoring visual analog scales in MASK-air®. Clin Transl Allergy, 11, 2021, e12062.
Vieira, RJ, Sousa-Pinto, B, Cardoso-Fernandes, A, et al. Control of allergic rhinitis and asthma test: a systematic review of measurement properties and COSMIN analysis. Clin Transl Allergy, 12, 2022, e12194.
Prasad, M, Wahlqvist, P, Shikiar, R, Shih, YC, A review of self-report instruments measuring health-related work productivity: a patient-reported outcomes perspective. PharmacoEconomics 22 (2004), 225–244.
Devlin, NJ, Brooks, R, EQ-5D and the EuroQol group: past, present and future. Appl Health Econ Health Policy 15 (2017), 127–137.
Mouelhi, Y, Jouve, E, Castelli, C, Gentile, S, How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods. Health Qual Life Outcomes, 18, 2020, 136.
Koo, TK, Li, MY, A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med 15 (2016), 155–163.
Husted, JA, Cook, RJ, Farewell, VT, Gladman, DD, Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol 53 (2000), 459–468.
Gater, A, Nelsen, L, Fleming, S, et al. Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the asthma daily symptom diary. Value Health 19 (2016), 440–450.
Sousa-Pinto, B, Fonseca, JA, Gemicioglu, B, et al. Patient-reported outcome measures (PROMs) using the MASK-air® app in severe asthma. Allergy 77 (2022), 1600–1602.
de-Vet, H, Terwee, C, Mokkink, L, Knol, D, Measurement in medicine: a practical guide. 2010, Cambridge University Press, Cambridge.
Sullivan, PW, Ghushchyan, VH, Campbell, JD, Globe, G, Bender, B, Magid, DJ, Measurement of utility in asthma: evidence indicating that generic instruments may miss clinically important changes. Qual Life Res 25 (2016), 3017–3026.
Ferreira, LN, Brito, U, Ferreira, PL, Quality of life in asthma patients. Rev Port Pneumol 16 (2010), 23–55.
Szentes, BL, Schultz, K, Nowak, D, Schuler, M, Schwarzkopf, L, How does the EQ-5D-5L perform in asthma patients compared with an asthma-specific quality of life questionnaire?. BMC Pulm Med, 20, 2020, 168.
Hyland, ME, Lanario, JW, Menzies-Gow, A, et al. Comparison of the sensitivity of patient-reported outcomes for detecting the benefit of biologics in severe asthma. Chron Respir Dis, 2021 published online Sept 25. https://doi.org/10.1177/14799731211043530.
Sousa-Pinto, B, Schünemann, HJ, Sá-Sousa, A, et al. Comparison of rhinitis treatments using MASK-air® data and considering the minimal important difference. Allergy 77 (2022), 3002–3014.
Savouré, M, Bousquet, J, Leynaert, B, et al. Rhinitis phenotypes and multimorbidities in the general population: the CONSTANCES cohort. Eur Respir J, 61, 2023, 2200943.
Paradis, S, Roussel, J, Bosson, J-L, Kern, J-B, Use of smartphone health apps among patients aged 18 to 69 years in primary care: population-based cross-sectional survey. JMIR Form Res, 6, 2022, e34882.
Wynn, R, Oyeyemi, SO, Budrionis, A, Marco-Ruiz, L, Yigzaw, KY, Bellika, JG, Electronic health use in a representative sample of 18,497 respondents in Norway (the Seventh Tromsø Study - part 1): population-based questionnaire study. JMIR Med Inform, 8, 2020, e13106.