PMID- 34751664
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220125
IS  - 2292-9495 (Electronic)
IS  - 2292-9495 (Linking)
VI  - 8
IP  - 4
DP  - 2021 Nov 9
TI  - Using Postmarket Surveillance to Assess Safety-Related Events in a Digital 
      Rehabilitation App (Kaia App): Observational Study.
PG  - e25453
LID - 10.2196/25453 [doi]
LID - e25453
AB  - 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>.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.
CI  - (c)Deeptee Jain, Kevin Norman, Zachary Werner, Bar Makovoz, Turner Baker, Stephan 
      Huber. Originally published in JMIR Human Factors 
      (https://humanfactors.jmir.org), 09.11.2021.
FAU - Jain, Deeptee
AU  - Jain D
AUID- ORCID: 0000-0002-9576-9722
AD  - Department of Orthopaedic Surgery, Washington University in St. Louis, St. Louis, 
      MO, United States.
FAU - Norman, Kevin
AU  - Norman K
AUID- ORCID: 0000-0002-2587-5159
AD  - Neoteric Consulting, New York, NY, United States.
FAU - Werner, Zachary
AU  - Werner Z
AUID- ORCID: 0000-0001-7350-737X
AD  - Neoteric Consulting, New York, NY, United States.
FAU - Makovoz, Bar
AU  - Makovoz B
AUID- ORCID: 0000-0002-8344-4285
AD  - Neoteric Consulting, New York, NY, United States.
FAU - Baker, Turner
AU  - Baker T
AUID- ORCID: 0000-0002-3440-9563
AD  - Neoteric Consulting, New York, NY, United States.
FAU - Huber, Stephan
AU  - Huber S
AUID- ORCID: 0000-0002-6332-688X
AD  - Kaia Health GmbH, Munich, Germany.
LA  - eng
PT  - Journal Article
DEP - 20211109
PL  - Canada
TA  - JMIR Hum Factors
JT  - JMIR human factors
JID - 101666561
PMC - PMC8663617
OTO - NOTNLM
OT  - adverse event
OT  - digital health
OT  - digital therapeutics
OT  - lower back pain
OT  - multidisciplinary pain treatment
OT  - pain
OT  - safety
COIS- Conflicts of Interest: This study was funded by Kaia Health. DJ and TB receive 
      compensation for advisory services. KN, ZW, and BM receive compensation for 
      advisory services through Neoteric Consulting Group. SH is an employee of Kaia 
      Health and receives stock options and salary.
EDAT- 2021/11/10 06:00
MHDA- 2021/11/10 06:01
PMCR- 2021/11/09
CRDT- 2021/11/09 12:18
PHST- 2020/11/05 00:00 [received]
PHST- 2021/07/23 00:00 [accepted]
PHST- 2021/02/11 00:00 [revised]
PHST- 2021/11/09 12:18 [entrez]
PHST- 2021/11/10 06:00 [pubmed]
PHST- 2021/11/10 06:01 [medline]
PHST- 2021/11/09 00:00 [pmc-release]
AID - v8i4e25453 [pii]
AID - 10.2196/25453 [doi]
PST - epublish
SO  - JMIR Hum Factors. 2021 Nov 9;8(4):e25453. doi: 10.2196/25453.