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.