Kaia Health announces results of a comprehensive safety study of its musculoskeletal (MSK) digital therapeutic.
In the study population, fewer than 1% of Kaia Health MSK solution users reported any adverse events (AEs). Additionally, no relationship between gender and the reporting of adverse events was found.
Published in the peer-reviewed JMIR Human Factors, the study evaluated the safety profile of the Kaia Health MSK solution by performing a comprehensive assessment of reported AEs by nearly 140,000 users. Study authors reported that AEs involving Kaia Health’s digital therapy were consistent with those reported for in-person therapies for low back pain.
“This study highlights the importance of, and historical lack of, adverse event reporting in digital therapeutics. The findings are encouraging, given that the overall rate of reported adverse events was very low and generally consistent with those described for in-person therapies for low back pain.”— Deeptee Jain, MD, orthopedic spine surgeon at Washington University in St. Louis and co-author of the study
Analyzed Users’ Messages
Using a standardized process for post-market surveillance of patient-reported outcomes, the observational study analyzed messages sent by users via the Kaia Health MSK app. These messages were then analyzed to determine if they described an AE. By integrating patient-reported outcomes into the assessment of digital rehabilitation apps, Kaia Health continues to demonstrate its dedication to providing safe, clinically validated, and equitable digital MSK care.
“This study provides the first and only comprehensive assessment of reported adverse events associated with real-world use of digital therapeutics for lower back pain. Investigating both the efficacy and safety of our MSK pain solution is hugely important. This latest study further demonstrates Kaia Health’s ability to make safe, high-quality care accessible to all patients—wherever they are in their journey—and deliver the best outcomes.”— Justin Yang, MD, Kaia Health Chief Medical Officer, US Commercial
Kaia Health is a clinically validated digital MSK pain solution. A recent clinical study suggests that its patented motion analysis technology is as accurate as a physical therapist in suggesting exercise corrections, while demonstrating consistent care across gender, age, body mass index (BMI), and location of pain. Pairing the accuracy of motion analysis technology with the safety profile of the Kaia Health MSK solution, patients are able to access safe, accurate, equitable therapy from the comfort of their homes.
[Source(s): Kaia Health, Business Wire]