1.4 Study method
We designed a two-steps, pilot study to compare home-based virtual care
vs. in-person physical evaluation. Two different units: a “bed-side”
and a “remote” evaluation team were recruited.
The study was divided in three phases:
1. Identification of the auscultatory landmarks in SMA patients
and concordance with the standard landmarks
Children were first assessed during one of the routine consultations by
a pediatric neurologist with expertise in SMA, one pediatrician expert
in digital health and one pediatric ultrasonographer who were in charge
of locating optimal lung auscultation landmarks for each child with
different methodologies. Each of them examined the children separately
and located what she/he believed to be optimal chest auscultation
landmarks after evaluating with either traditional stethoscope or lung
ultrasound point of care (Fig. 2). According to her/his expertise, each
of the examiners filled the medical reports for each patient, drawing an
individual map of auscultation landmarks and specifying any additional
respiratory (vesicular murmur, crackle, rhonchus, wheeze, pleural rub or
stridor) or sonographic findings.
The landmarks identified by the multidisciplinary team were compared to
the standard auscultation landmarks, four on the back and four on the
front, provided by the device for patients with typical configuration of
chest and trunk in the absence of spinal deformities.
Fig. 2 Identification of optimal chest auscultation
landmarks
2. Training sessions and application of the new device by carers
The medical part of the “remote” team gave a 30 minutes in-person
practical training. The carers were shown how to place the device
following the map of optimal landmarks identified for each child and to
perform lung auscultation while an ICT expert offered technical support
for the whole team. After training, as soon as they felt confident, they
autonomously placed the Tytocare digital stethoscope at the
corresponding landmarks, perform the entire respiratory evaluation back
and front on their own, made sure each lung recording was as clear as
possible without background noise (the device provide such features) and
forward the files. In case of poor quality recording sessions the device
displays on its screen several alert messages inviting the examiner to
repeat the step until acceptable quality is obtained before moving
forward. At the end of the session parents alone or with their children,
recorded one or more free short videos to describe their experiences,
ease-of -use, difficulties, expectations and so on.
3. Assessment of accuracy and sensitivity of the device in our
cohort of SMA children.
Data obtained by the carers were reviewed by an independent pediatric
team who blindly accessed the encrypted patient’s charts. The blinded
team examined the lung sounds from each recorded station (landmarks)
using high quality headset in a quiet room and filled a report assigning
an overall quality value, from 1 (very poor) to 5 (very good), identify
and report possible interfering/background noise (mechanical
ventilation, heart sounds, voices, rustle, TV/music) for each of the
auscultation landmark
The blinded team also compared the recordings of respiratory findings
obtained using the device by the carers with the reports of the bedside
team who used conventional auscultation techniques.