Comparison of a Novel Handheld Telehealth Device with Stand-Alone Examination Tools in a Clinic Setting

 Research demonstrates that telemedicine is effective in pediatric settings but little is published to validate the quality of the data acquired by remote peripheral examination devices to accurately inform clinical decision-making. The primary aim was to compare a novel Food and Drug Administration (FDA)-cleared multifunctional remote examination device (Tyto) with other stand-alone digital examination devices. The secondary aim was to ascertain whether either device produced images or sounds better able to provide clinical information to clinicians caring for children. Otoscopic images and heart and lung sounds from 50 patients of ages 2-18 years were acquired using the novel device and a stand-alone digital otoscope and stethoscope. Data were stored on a secure server for review by physicians (two pulmonary faculty, two general faculty, two cardiology faculty, and two cardiology fellows). Reviewers were blinded and they reviewed images and audio files in a randomized manner. Images and sounds were scored in terms of quality using a Likert scale. Means and standard deviations (and t-tests to compare those means) were calculated. Individual (heart sounds, lung sounds, and otoscopic images) and aggregate scores were compared. The novel device provided higher sound and image quality with less chance of an inability to make a diagnosis than the stand-alone devices. The novel device had a superior mean comparative diagnostic score with a high intra- and inter-reliability of cardiac, pulmonary, and otoscopic diagnosis. The novel device outperformed the stand-alone digital stethoscope and otoscope and was better able to provide usable data to support a clinical encounter.