TY - JOUR

T1 - Development and validation of an electronic daily control score for asthma (e-DASTHMA)

T2 - a real-world direct patient data study

AU - Sousa-Pinto, Bernardo

AU - Jácome, Cristina

AU - Pereira, Ana Margarida

AU - Regateiro, Frederico S.

AU - Almeida, Rute

AU - Czarlewski, Wienczyslawa

AU - Kulus, Marek

AU - Shamji, Mohamed H.

AU - Boulet, Louis-Philippe

AU - Bonini, Matteo

AU - Brussino, Luisa

AU - Canonica, G. Walter

AU - Cruz, Alvaro A.

AU - Gemicioglu, Bilun

AU - Haahtela, Tari

AU - Kupczyk, Maciej

AU - Kvedariene, Violeta

AU - Larenas-Linnemann, Desirée

AU - Louis, Renaud

AU - Niedoszytko, Marek

AU - Pham-Thi, Nhân

AU - Puggioni, Francesca

AU - Romantowski, Jan

AU - Sastre, Joaquin

AU - Scichilone, Nicola

AU - Taborda-Barata, Luis

AU - Ventura, Maria Teresa

AU - Vieira, Rafael José

AU - Agache, Ioana

AU - Bedbrook, Anna

AU - Bergmann, Karl C.

AU - Amaral, Rita

AU - Azevedo, Luís Filipe

AU - Bosnic-Anticevich, Sinthia

AU - Brusselle, Guy

AU - Buhl, Roland

AU - Cecchi, Lorenzo

AU - Charpin, Denis

AU - Loureiro, Claudia Chaves

AU - de Blay, Frédéric

AU - Del Giacco, Stefano

AU - Devillier, Philippe

AU - Jassem, Ewa

AU - Joos, Guy

AU - Jutel, Marek

AU - Klimek, Ludger

AU - Kuna, Piotr

AU - Laune, Daniel

AU - Pech, Jorge Luna

AU - Makela, Mika

AU - Morais-Almeida, Mario

AU - Nadif, Rachel

AU - Neffen, Hugo E.

AU - Ohta, Ken

AU - Papadopoulos, Nikolaos G.

AU - Papi, Alberto

AU - Pétré, Benoit

AU - Pfaar, Oliver

AU - Yeverino, Daniela Rivero

AU - Cordeiro, Carlos Robalo

AU - Roche, Nicolas

AU - Sá-Sousa, Ana

AU - Samolinski, Boleslaw

AU - Sheikh, Aziz

AU - Ulrik, Charlotte Suppli

AU - Usmani, Omar S.

AU - Valiulis, Arunas

AU - Vandenplas, Olivier

AU - Vieira-Marques, Pedro

AU - Yorgancioglu, Arzu

AU - Zuberbier, Torsten

AU - Anto, Josep M.

AU - Fonseca, João A.

AU - Bousquet, Jean

N1 - Publisher Copyright: © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

U2 - 10.1016/S2589-7500(23)00020-1

DO - 10.1016/S2589-7500(23)00020-1

M3 - Journal article

C2 - 36872189

AN - SCOPUS:85150395888

VL - 5

SP - e227-e238

JO - The Lancet Digital Health

JF - The Lancet Digital Health

SN - 2589-7500

IS - 4

ER -