Telehealth company TytoCare has produced peer-reviewed data showing that its remote examination technology can produce outcomes essentially as good as in-person exams.
In a study conducted at a pediatric emergency department, a review of exams of the ears, heart, lungs and throat in patients aged 2-18 found an average rating of 4.4 on a scale of 5 for remote encounters. That compares to a 4.5 rating for in-person exams using standard otoscopes and stethoscopes, according to TytoCare, a statistically insignificant difference.
The ratings were based on data quality and user experience, the company said.
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TytoCare, which has dual headquarters in New York City and Netanya, Israel, conducted the study in conjunction with researchers at Schneider Children’s Medical Center of Israel and the Sackler Faculty of Medicine at Tel Aviv University. They reported no adverse events related to TytoCare’s hardware, which has Food and Drug Administration clearance in the U.S.
“The results are clear — examination findings achieved with TytoCare are on par with those reached by conventional examination tools,” co-lead researcher Dr. Yehezkel Waisman, director of emergency medicine at Schneider, said in a TytoCare press release. “Beyond that, the quality of the readings as well as the overall user experience received positive ratings from physicians, a great testament to the solution’s promise to provide accurate and confident diagnoses via telehealth technology.”
TytoCare CEO Dedi Gilad said that the study “shows the effectiveness of our product in terms of [collecting] the right data.”
Gilad told MedCity News that the data will be presented at the American Telemedicine Association’s annual meeting in April in Orlando, Florida. The researchers also are preparing a paper for publication in an unspecified medical journal, he added.
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“We’re taking very seriously as a company the importance of having clinical evidence,” Gilad said. Other studies of the technology are under way in both the U.S. and Israel.
Last fall, the 4½-year-old telemedicine vendor received FDA 510(k) clearance for its digital stethoscope, allowing the company to package an entire telehealth kit for remote examinations and diagnoses.
CLARIFICATION: After this story initially ran, TytoCare provided the following information, but did not offer any data on exam findings:
In a study conducted at a pediatric emergency department, patients’ ears, heart, lungs and throat were examined and assessed by one physician using conventional exam tools in the ER, and again by a second physician in a remote location using exam data captured using TytoCare. Both the TytoCare results and the conventional examination results were compared and analyzed using standard statistical tests for agreement. The results showed good to excellent agreement in exam findings conducted using conventional tools when compared to those conducted using TytoCare, thus showing parity between the two.
In addition, the quality of the data retrieved and the user experience of TytoCare was evaluated on a spectrum from 1 (poor) to 5 (excellent). The quality of the data across all exams averaged 4.4, and user experience averaged 4.5.
Photo: TytoCare