{'fraction_non_alphanumeric': 0.037742382271468145, 'fraction_numerical': 0.031163434903047092, 'mean_word_length': 4.754980079681275, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Using Post-market Surveillance to Assess Safety-relevant Events in a Digital Rehabilitation Application: Results From an Observational Study (Preprint)


 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 suffering from LBP. Despite the growth of evidence demonstrating their benefits in reducing LBP and improving functional outcomes, there is little systematically collected data on their safety profile.
 
 
 OBJECTIVE
 This study aims to evaluate the safety profile of a multidisciplinary digital therapeutic for LBP by performing a comprehensive assessment of reported adverse events (AEs) by users as captured by a standardized process for post-market surveillance.
 
 
 METHODS
 All subjects using a digital multidisciplinary digital application that includes physiotherapy, mindfulness techniques, and education for LBP (Kaia App) from 2018-2019 were included. Relevant messages sent by users via the app were collected according to a Standard Operating Procedure regulating post-market 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: type of AE, seriousness, and relatedness to the app, and they were described by numerical counts. Users demographics, including age and gender, and app usage were collected and evaluated to determine if they were risk factors for increased AE reporting.
 
 
 RESULTS
 Of the 138,337 active users of the multidisciplinary digital therapeutic, 125 (0.09%) users reported at least one AE. 0.00014 AEs per active day on the app were reported. The most common non-serious AE reported was increased pain. Other non-serious AEs reported included muscle issues, unpleasant sensations, headache, dizziness, and sleep disturbances. One serious AE was reported, a surgery. It was determined to be unlikely related to the digital intervention. There was no relationship between gender and AE reporting (P=1.000). Users ages 25-34 had reduced odds (0.31, 95% confidence interval (CI): 0.08-0.95, P=0.029) of reporting AEs while users ages 55-65 (2.53, 95% CI: 1.36-4.84, P=0.002) and 75+ (4.36, 95% CI: 1.07-13.26, P=0.02) had increased odds. AEs were most frequently reported by users that had 0-99 active days on the app, and less frequently reported by users with more active days on the app.
 
 
 CONCLUSIONS
 This study 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.
