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

Bernardo Sousa-Pinto, Cristina Jácome, Ana Margarida Pereira, Frederico S Regateiro, Rute Almeida, Wienczyslawa Czarlewski, Marek Kulus, Mohamed H Shamji, Louis-Philippe Boulet, Matteo Bonini, Luisa Brussino, G Walter Canonica, Alvaro A Cruz, Bilun Gemicioglu, Tari Haahtela, Maciej Kupczyk, Violeta Kvedariene, Desirée Larenas-Linnemann, Renaud Louis, Marek Niedoszytko, Nhân Pham-Thi, Francesca Puggioni, Jan Romantowski, Joaquin Sastre, Nicola Scichilone, Luis Taborda-Barata, Maria Teresa Ventura, Rafael José Vieira, Ioana Agache, Anna Bedbrook, Karl C Bergmann, Rita Amaral, Luís Filipe Azevedo, Sinthia Bosnic-Anticevich, Guy Brusselle, Roland Buhl, Lorenzo Cecchi, Denis Charpin, Claudia 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 Makela, Mario Morais-Almeida, Rachel Nadif, Hugo E Neffen, Ken Ohta, Nikolaos G Papadopoulos, Alberto Papi, Benoit Pétré, Oliver Pfaar, Daniela Rivero Yeverino, Carlos Robalo Cordeiro, Nicolas Roche, Ana Sá-Sousa, Boleslaw Samolinski, Aziz Sheikh, Charlotte Suppli Ulrik, Omar S Usmani, Arunas Valiulis, Olivier Vandenplas, Pedro Vieira-Marques, Arzu Yorgancioglu, Torsten Zuberbier, Josep M Anto, João A Fonseca, Jean Bousquet

Journal: The Lancet. Digital health 2023;5(4):e227-e238

PMID: 36872189

Free Full Text on Elsevier Science View on PubMed

Abstract

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.

Address: 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.; 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.; 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.; Medical Consulting Czarlewski, Levallois, France.; Department of Pediatric Respiratory Diseases and Allergology, Medical University of Warsaw, Warsaw, Poland.; National Heart and Lung Institute, Imperial College & National Institutes for Health Imperial Biomedical Research Centre, London, UK.; Quebec Heart and Lung Institute, Laval University, Québec City, Quebec, Canada.; 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.; Department of Medical Sciences, Allergy and Clinical Immunology Unit, University of Torino & Mauriziano Hospital, Torino, Italy.; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy.; Fundaçao ProAR, Federal University of Bahia and Global Alliance Against Chronic Respiratory Diseases and WHO Planning Group, Salvador, Bahia, Brazil.; Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Türkiye.; Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.; Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.; 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.; Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico.; Department of Pulmonary Medicine, Centre Hospitalier Universitaire Liege, and GIGA Infection, Immunity, Inflammation Laboratories research group, University of Liege, Liege, Belgium.; Department of Allergology, Medical University of Gdańsk, Gdansk, Poland.; Institut de Recherche bio-Médicale des Armées, Bretigny sur Orge, France; École Polytechnique de Palaiseau, Palaiseau, France; Université Paris Cité, Paris, France.; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy.; Allergy Service, Fundacion Jimenez Diaz, Faculty of Medicine Universidad Autonoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain.; PROMISE Department, University of Palermo, Palermo, Italy.; 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.; Unit of Geriatric Immunoallergology, University of Bari Medical School, Bari, Italy.; Faculty of Medicine, Transylvania University Brasov, Brasov, Romania.; Allergic Rhinitis and its Impact on Asthma, Montpellier, France.; 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.; Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, The University of Sydney, and Sydney Local Health District, Sydney, NSW, Australia.; Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.; Department of Pulmonary Medicine, Mainz University Hospital, Mainz, Germany.; Struttura Organizzativa Semplice Allergology and Clinical Immunology Unita Sanitaria Locale, Toscana Centro, Prato, Italy.; Clinique des Bronches, Allergie et Sommeil, Hôpital Nord, Marseille, France.; Pneumology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.; Allergy Division, Chest Disease Department, University Hospital of Strasbourg, Strasbourg, France; Federation of Translational Medicine, University of Strasbourg, Strasbourg, France.; Department of Medical Sciences and Public Health and Unit of Allergy and Clinical Immunology, University Hospital Duilio Casula, University of Cagliari, Cagliari, Italy.; Virologie et Immunologie Moléculaires Suresnes, Unités Mixtes de Recherche 0892, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France.; Medical University of Gdańsk, Department of Pneumonology, Gdansk, Poland.; Department of Clinical Immunology, Wrocław Medical University, Wroclaw, Poland; All-Medicine Medical Research Institute, Wroclaw, Poland.; Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany.; KYomed Innovation, Montpellier, France.; University of Guadalajara, Guadalajara, Mexico.; Allergy Center, Companhia União Fabril Descobertas Hospital, Lisbon, Portugal.; Université Paris-Saclay, Université Versailles-St Quentin, Université Paris-Sud, Paris, France; Inserm, Equipe d'Epidémiologie Respiratoire Intégrative, Villejuif, France.; Center of Allergy, Immunology and Respiratory Diseases, Santa Fe, Argentina.; National Hospital Organization, Tokyo National Hospital, Tokyo, Japan; JATA Fukujuji Hospital, Tokyo, Japan.; Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.; Respiratory Medicine, Department of Translational Medicine, University of Ferrara, Ferrara, Italy.; Department of Public Health, University of Liege, Liege, Belgium.; Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.; Allergy and Clinical Immunology Department, Hospital Universitario de Puebla, Puebla, Mexico.; Department of Pneumology, Coimbra University Hospital, Coimbra, Portugal.; Pneumologie, Assistance Publique - Hôpitaux de Paris, Centre Université de Paris Cité, Hôpital Cochin, Paris, France.; Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland.; Usher Institute, The University of Edinburgh, Edinburgh, UK.; Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark; Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.; National Heart and Lung Institute, Imperial College London, London, UK; Royal Brompton Hospital, Airways Disease Section, London, UK.; Institute of Clinical Medicine and Institute of Health Sciences and Medical Faculty of Vilnius University, Vilnius, Lithuania.; Department of Chest Medicine, Centre Hospitalier Universitaire UCL, Namur, Belgium; Université Catholique de Louvain, Yvoir, Belgium.; Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Türkiye.; 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.; 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: [email protected].

DOI: 10.1016/S2589-7500(23)00020-1