Abstract
Background: The ability to perceive bronchial obstruction is variable in asthma. This is one of the main causes of inaccurate asthma control assessment, on which therapeutic strategies are based.
Objective: Primary: To evaluate the ability of a clinical and spirometric telemonitoring device to characterize symptom perception profile in asthmatic children. Secondary: To evaluate its impact on asthma management (control, treatment, respiratory function variability) and the acceptability of this telemonitoring system.
Method: 26 asthmatic children aged 6-18 years equipped with a portable spirometer and a smartphone application were monitored remotely for 3 months. Clinical and spirometric data were automatically transmitted to a secure internet platform. A medical team contacted the patient to optimize management. Three physicians blindly and independently classified the patients according to their perception profile. The impact of telemonitoring on the quantitative data was assessed at the beginning (T0) and end (T3 months) of telemonitoring, using matched statistical tests.
Results: Patients could initially be classified according to their perception profile, with a concordance between the 3 observers of 64% (kappa coefficient: 0.55, 95%CI [0.39; 0.71]). After further discussion, a consensus was reached and resulted in 97% concordance (kappa coefficient: 0.97, 95%CI [0.91; 1.00]). There was a trend towards improvement in the ACT score, and a significant > 40% decrease in FEV1 and PEF variability, with good acceptance of the device.
Conclusion: Clinical and spirometric telehome monitoring is applicable and can help define the perception profile of bronchial obstruction in asthmatic children. The device was generally well accepted.
INTRODUCTION
Telemedicine has been a rapidly growing field over the last twenty years, particularly since the COVID-19 epidemic. Its importance has been recognized both nationally and internationally. The World Health Organization (WHO) published in 2019 its first recommendations on the use of digital health1. In France, the telemedicine deployment plan published by the Haute Autorité de Santé (HAS) in 2013 has defined the management of chronic pathologies using telemedicine as one of the 5 national priorities2. Telemonitoring in particular is increasingly used to monitor chronic patients, and allows the recording of clinical or technical indicators at home with the identification of alerts3. These data are interpreted remotely by a medical team, who can then provide personalized care.
Asthma is the most common chronic pathology in children, and its level of control remains insufficient4. According to international guidelines, the level of asthma control is determined based on symptom control over the last four weeks reported by children and their parents at the time of consultations, and on spirometric examinations performed on an ad hoc basis5. However, according to the AIRE (Asthma Insights and Reality in Europe) study carried out in 2002, the parents’ perception of asthma control is erroneous: in fact, 61% of parents of children with severe persistent asthma considered that their child’s asthma was well controlled6. Moreover, the ability to perceive the onset and severity of symptoms varies among children and depends on multifactorial causes and very complex and largely undefined psycho-physiological mechanisms7,8. The use of peak flow meters is recommended to help the patient objectify the degree of bronchial obstruction, but previous studies have shown that there is only a weak correlation between objective measures of respiratory distress and the subjective dyspnea sensation described by the patient9-11. Some patients will report significant discomfort with minimal bronchoconstriction, leading the clinician to question whether these symptoms are due to bronchospasm, anxiety or other factors12; and others will not report symptoms even in the presence of severe obstruction13.
With this in mind, Brouwer et al. conducted a study in 36 children with mild to moderate persistent asthma who electronically recorded Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) twice daily for 3 months using a home spirometer14. The results showed a poor correlation between the spirometric data and clinical disease activity scores. Importantly, the authors were able to distinguish four perception profiles in the asthmatic child: poor perceivers (no symptoms in the presence of severe obstruction); good perceivers (correlation between symptoms and bronchial obstruction); excessive perceivers (many symptoms with no or minimal obstruction) and anarchic perceivers (no correlation between symptoms and obstruction). Since symptom reporting is an integral part of therapeutic management of asthma (control scores), this may have implications for clinical and therapeutic approaches for these patients. Under-perception may delay the diagnosis and treatment of exacerbations, resulting in a greater risk of morbidity and mortality15,16. Conversely, excessive perception of symptoms may lead to overuse of medication and frequent recourse to consultations17. The lack of precise determination of these profiles could explain why some studies have not demonstrated a net benefit related to the application of telemonitoring in childhood asthma, particularly in terms of reduction of medical treatments18.
Therefore, the current study was conducted to assess whether the perception profile of children with asthma can be routinely identified using home telemonitoring of clinical symptom and FEV1. In addition, we evaluated the impact of home telemonitoring on asthma management (control, therapeutic optimization, spirometric signal variability), as well as the acceptability and barriers to the use of this mobile health care system.
MATERIAL AND METHODS
Context and ethics
This was a retrospective study that analyzed data from asthmatic children and adolescents followed at the Children’s Hospital of the Centre Hospitalier Universitaire (CHU) of Bordeaux and the Seychelles Hospital between December 2018 and January 2021. The children and their parents were informed of the objectives of the study and written informed consent for the use of their data was obtained. In view of the documents at its disposal, the Publication Group of the Ethics Committee of the CHU of Bordeaux issued a favorable opinion on the publication of this research work (Opinion CE-GP-2021/12).
Sample
The study included 26 asthmatic children and adolescents aged 6 to 18 years old. The inclusion criteria were: asthma diagnosed by a physician for more than 6 months, moderate to severe persistent asthma according to the Global Initiative for Asthma (GINA) (treatment level ≥ 3), having a home connected tool (tablet and/or smartphone), being able to perform correct spirometry. The exclusion criteria were any other pathology responsible for respiratory symptoms (cystic fibrosis, primary ciliary dyskinesia, chronic obstructive pulmonary disease…).
Objectives
The primary objective was to evaluate the device’s ability to characterize patients according to Brouwer’s profiles based on data collected by the mobile health platform. The secondary objectives were to study, overall and according to the Brouwer profile of the children: the role of home telemonitoring on asthma control, treatment levels (GINA steps), lung function and its variability, and the satisfaction of children and parents regarding these telemonitoring devices and process.
Conduct of the study
As part of routine care, patients received a free electronic spirometer Spirobank Smart® (MIR company, Langlade, France). It enables the measurement of FEV1, PEF, and FEF25-75 (Forced Expiratory Flow at 25–75% of the vital capacity) which are then transmitted in real time via the free application Pneumotel uploader® (company LAMIRAU Ingénierie, Langlade, France) installed on the patient’s smartphone, to the central and secure Pneumotel® internet platform. The application also allows the patient to enter his/her clinical symptoms. The clinical symptoms monitored were those related to an exacerbation: wheezing in the chest, shortness of breath, difficulty speaking, more coughing than usual; and those of asthma control according to GINA guidelines: activity limitation, taking bronchodilators (e.g. salbutamol), signs of daytime asthma, nocturnal awakening due to asthma. In a subgroup of patients, SpO2 (pulsed oxygen saturation) and heart rate were also monitored.
The monitoring process began with a 10-day observation phase, during which the patient made twice-daily spirometric recordings at home, as well as his/her clinical symptoms. In the absence of signs of exacerbation, the best FEV1 value obtained during this period was taken as a reference. Once the observation phase was over, FEV1 and clinical signs were performed at least twice a week outside of exacerbation phases and daily if the patient thought he had signs of exacerbation. In case of worsening (at least one clinical sign of exacerbation and/or uncontrolled asthma (≥ 3 items of poor GINA control) and/or a drop in FEV1 ≥ 30% compared to the reference value19), the physician received an alert by e-mail and Short Message Service (SMS). They then contacted the patient by phone call or e-mail within 24 hours for a real assessment of the situation and to optimize management. The data analyzed included the recordings made during 3 months of follow-up for each patient.
Personal and family history, asthma characteristics, Asthma Control Test (ACT) score and treatments were collected from the computerized hospital medical records. A semi-structured interview was conducted between the physician and the patient and his/her parents after 3 months of use of the device to assess the acceptability and barriers to the use of Spirobank Smart®. The After Scenario Questionnaire (ASQ) was also completed to qualitatively assess satisfaction with this connected device20.
Statistical analysis
Data are reported as mean + standard deviation or median [interquartile range IQR1; IQR3]. Statistical analysis was performed using PRISM software (GraphPad Software, San Diego, California 92108). Regarding the identification of the perception profile, 3 physicians (observer 1: M.F., 35 years of post-thesis experience; observer 2: F.G., 6 years of post-thesis experience; observer 3: A.F., in thesis year) classified the patients blindly and independently according to 5 categories: ”good perceiver”, ”poor perceiver”, ”anarchic perceiver”, ”excessive perceiver” or ”unclassifiable”. The concordance of this classification between the 3 physicians was then evaluated according to the Randolph’s Kappa coefficient method, before and after a collegial discussion of the cases (Delphi method). Agreement by pairs was assessed using Cohen’s Kappa coefficient. The variability of FEV1 and PEF was calculated for each patient over the first 15 and last 15 days of the study using the following formula: (maximum value - minimum value) / mean of the 2 values. The quantitative variables for the two groups were compared by the Student’s t-test (or Mann and Whitney for non-Gaussian data). The non-continuous variables were compared by the chi-squared test or two-tailed Fischer exact test (non-parametric). A p<0.05 was considered a statistically significant difference for all tests.
The qualitative study regarding the satisfaction with the telemonitoring device was conducted according to a semio-pragmatic phenomenological interpretative method. All the interviews were transcribed word for word, and then analyzed to identify themes. A triangulation of the qualitative data was carried out.