RESULTS
Study flow diagram
The flow chart is shown in Figure 1.
Demographic characteristics of the study population
Demographic characteristics of the study population are shown in Table
1.
Main objective: Brouwer’s asthma profile
After evaluating each patient’s profile independently and blindly, based
on the criteria reported by Brouwer et al., the overall
concordance between the 3 observers was 64%. Randolph’s kappa
coefficient was 0.55 [0.39; 0.71]. When assessed in pairs, Cohen’s
kappa coefficient ranged from 0.33 to 0.61 (Figure 2, E-Table 1).
After the Delphi approach (consensus among observers), the final overall
agreement was 97% with a Randolph’s kappa coefficient of 0.97 [0.91;
1.00]. The percentage of patients that could be classifiable into a
specific profile was 88% (23/26). 38% were anarchic perceivers
(10/26), 27% were poor perceivers (7/26), 15% were good perceivers
(4/26) and 8% were excessive perceivers (2/26). Two patients were
defined as ”unclassifiable” because the first patient did not provide
enough data, and the quality of the spirometry recordings of the second
patient was considered to be poor. There was no consensus for one child
(E-Figure 1 ; E-Table 2).
Secondary objectives
Asthma control
There was a non-significant trend towards improvement in the ACT score
between baseline (median 16 [14; 20]) and the end of the study
(median 20 [15; 23]) (Figure 3). The change in the ACT scores
according to the patients’ perception profile is represented in E-Figure
2.
Therapeutic optimization
The distribution of treatment steps from the beginning to the end of the
study is shown in Figure 4. The distribution according to the patients’
perception profile is represented in E- Figure 3.
FEV1 and PEF variability
The mean FEV1 for the first 15 days (1.49 L/s + 0.64) did not
differ significantly from the mean for the last 15 days (1.48 L/s+ 0.66). The mean PEF for the first 15 days (3.15 L/s +1.42) did not differ significantly from the mean for the last 15 days
(3.22 L/s + 1.61).
FEV1 variability decreased from a median of 75.6% [42.6; 87.9] at
the beginning of the study to 35.6% [22.7; 73.4] at the end of the
study (p=0.006) (Figure 5a). PEF variability decreased from a median of
90.2% [49.6; 112.7] at baseline to 44.4% [19.3; 97.5] at the
end of the study (p=0.03) (Figure 5b).
Tool observance and acceptability
During the first 10 days, 73% of patients (19/26) recorded at least
half of the 20 expected measurements (E-Figure 4). After these 10 days,
73% of patients (19/26) achieved the expected minimum of 2 weekly
recordings.
Children and their parents were generally very satisfied with Spirobank
Smart® follow-up according to the ASQ (After Scenario Questionnaire)
(E-Figure 5).
Qualitative analysis
A total of 15 children and 17 parents were included in the qualitative
analysis at the end of the study. When asked, ”Were you satisfied with
the Spirobank Smart®?”, the entire sample was satisfied with the tool
and the follow-up. Regarding the positive points reported by children
and parents, the system was particularly appreciated for its playful and
intuitive aspect. In addition, some children and parents reported a
better perception of the severity of asthma exacerbations thanks to the
FEV1 and PEF values displayed on the mobile application. Parents
expressed a feeling of comfort and reassurance thanks to the
telemonitoring. They felt that the monitoring was close without
appearing over-medicalized. To the question: ”Did you find the device
too medicalized?” all but one of the parents answered in the negative.
Nevertheless, some parents expressed their anxiety whenever the medical
team did not respond quickly enough or if the child left home without
his portable spirometer. Half of the parents surveyed did not find the
device constraining, but the need to perform the measurement daily was
experienced as a constraint by some children. The length of the expired
breaths required to record technically good spirometric tests also
discouraged some children.