Using postmarket surveillance to assess safety-related events in a digital rehabilitation app (Kaia App): Observational study

BACKGROUND: Low back pain (LBP) affects nearly 4 out of 5 individuals during their lifetime and is the leading cause of disability globally. Digital therapeutics are emerging as effective treatment options for individuals experiencing LBP. Despite the growth of evidence demonstrating the benefits of these therapeutics in reducing LBP and improving functional outcomes, little data has been systematically collected on their safety profiles. OBJECTIVE: This study aims to evaluate the safety profile of a multidisciplinary digital therapeutic for LBP, the Kaia App, by performing a comprehensive assessment of reported adverse events (AEs) by users as captured by a standardized process for postmarket surveillance. METHODS: All users of a multidisciplinary digital app that includes physiotherapy, mindfulness techniques, and education for LBP (Kaia App) from 2018 to 2019 were included. Relevant messages sent by users via the app were collected according to a standard operating procedure regulating postmarket surveillance of the device. These messages were then analyzed to determine if they described an adverse event (AE). Messages describing an AE were then categorized based on the type of AE, its seriousness, and its relatedness to the app, and they were described by numerical counts. User demographics, including age and gender, and data on app use were collected and evaluated to determine if they were risk factors for increased AE reporting. RESULTS: Of the 138,337 active users of the Kaia App, 125 (0.09%) reported at least one AE. Users reported 0.00014 AEs per active day on the app. The most common nonserious AE reported was increased pain. Other nonserious AEs reported included muscle issues, unpleasant sensations, headache, dizziness, and sleep disturbances. One serious AE, a surgery, was reported. Details of the event and its connection to the intervention were not obtainable, as the user did not provide more information when asked to do so; therefore, it was considered to be possibly related to the intervention. There was no relationship between gender and AE reporting (P\u3e.99). Users aged 25 to 34 years had reduced odds (odds ratio [OR] 0.31, 95% CI 0.08-0.95; P=.03) of reporting AEs, while users aged 55 to 65 years (OR 2.53, 95% CI 1.36-4.84, P=.002) and ≥75 years (OR 4.36, 95% CI 1.07-13.26; P=.02) had increased odds. AEs were most frequently reported by users who had 0 to 99 active days on the app, and less frequently reported by users with more active days on the app. CONCLUSIONS: This study on the Kaia App provides the first comprehensive assessment of reported AEs associated with real-world use of digital therapeutics for lower back pain. The overall rate of reported AEs was very low, but significant reporting bias is likely to be present. The AEs reported were generally consistent with those described for in-person therapies for LBP

Explosion of Comet 17P/Holmes as revealed by the Spitzer Space Telescope

An explosion on comet 17P/Holmes occurred on 2007 Oct 23, projecting particulate debris of a wide range of sizes into the interplanetary medium. We observed the comet using the Spitzer spectrograph on 2007 Nov 10 and 2008 Feb 27, and the photometer, on 2008 Mar 13. The fresh ejecta have detailed mineralogical features from small crystalline silicate grains. The 2008 Feb 27 spectra, and the central core of the 2007 Nov 10 spectral map, reveal nearly featureless spectra, due to much larger grains that were ejected from the nucleus more slowly. We break the infrared image into three components (size, speed) that also explain the temporal evolution of the mm-wave flux. Optical images were obtained on multiple dates spanning 2007 Oct 27 to 2008 Mar 10 at the Holloway Comet Observatory and 1.5-m telescope at Palomar Observatory. The orientation of the leading edge of the ejecta shell and the ejecta blob, relative to the nucleus, do not change as the orientation of the Sun changes; instead, the configuration was imprinted by the orientation of the initial explosion. The kinetic energy of the ejecta >1e21 erg is greater than the gravitational binding energy of the nucleus. We model the explosion as being due to crystallization and release of volatiles from interior amorphous ice within a subsurface cavity; once the pressure in the cavity exceeded the surface strength, the material above the cavity was propelled from the comet. The size of the cavity and the tensile strength of the upper layer of the nucleus are constrained by the observed properties of the ejecta; tensile strengths on >10 m scale must be greater than 10 kPa. The appearance of the 2007 outburst is similar to that witnessed in 1892, but the 1892 explosion was less energetic by a factor of about 20.Comment: 51 pages. Some figures compressed (see real journal for full quality). accepted by Icaru

Multi-species single-cell transcriptomic analysis of ocular compartment regulons

10.1038/s41467-021-25968-8Nature Communications121567