Comparative Effectiveness of an Integrated, Multi-functional Telehealth Examination Device to Standard of Care Digital Devices in a Pediatric Setting
Health services research has shown that telemedicine is effective in a diverse number of pediatric settings, but little has been published in the peer reviewed literature regarding the evaluation of digital health tools to validate the quality of the data acquired from such devices to accurately inform clinical decision making.
The primary aim of the study was to evaluate a novel multifunctional remote examination device (TytoCare) in comparison to other FDA approved stand-alone digital examination devices currently available to clinicians. The secondary aim was to evaluate which device produced images or sounds that were better able to provide diagnostic information to clinicians caring for children.
Otoscopic images and heart and lung sounds from 50 pediatric patients ages 2-18 were acquired by a nurse in the outpatient cardiology clinic using the Tyto examination device and a standard of care digital otoscope and stethoscope. The clinic visit was routine and scheduled. In each examination the following information was recorded:
- 4 heart sounds from Tyto device and 4 from standard of care stethoscope
- 6 lung sounds from Tyto device (front/back of body) and 6 from standard of care stethoscope
- 2 ear images from Tyto device (left/right) and 2 from standard of care otoscope
The data was loaded onto a secure server for review by 8 physicians (2 fellows in cardiology, 2 pulmonary faculty, 2 general pediatric faculty and 2 pediatric cardiology faculty). All reviewers were blinded to where the data originated from and were exposed to it in a randomized manner. Images and heart sounds were scored on a scale of 1 (very good) to 5 (very poor) in terms of quality by the blinded reviewers using a Likert scale. Means and standard deviations (and t-tests to compare those means) were then calculated. A higher mean indicates worse images or sounds in terms of quality. Individual (heart sounds, lung sounds and otoscopic images) and aggregate scores were compared.
Analysis of the data demonstrated that the images and sounds acquired through the use of the Tyto device were of higher quality, sufficient for diagnosis, and superior to those acquired through the stand alone standard of care devices.
Mean quality score (higher is worse):
- Tyto device = 2.80 (SD = 05)
- Standard of care devices = 3.39 (SD = 94)
- Tyto device had significantly better quality overall (p = 0.000) Device vs. Diagnosis
- Standard of care otoscope and stethoscope devices were significantly more likely to lead to “can’t diagnose” (p = 0.001) compared to the Tyto device
Aim 1: the Tyto device performed as well as the standard of care digital devices. Aim 2: the Tyto device was better able to provide usable data to support a diagnosis.
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