Challenges associated with electronic and in-person directly observed therapy during a randomized trial

Details

• Alternative Title:
  Int J Tuberc Lung Dis
• Personal Author:
  Mangan, J. M. ; Burzynski, J. ; Rey deCastro, B. ; Salerno, M. M. ; Lam, C. K. ; Macaraig, M. ; Reaves, M. ; Kiskadden-Bechtel, S. ; Bowers, S. ; Sathi, C. ; Dias, M. P. ; Goswami, N. D. ; Vernon, A.
• Corporate Authors:
  eDOT Study Team
• Description:
  BACKGROUND:
  
  Electronic directly observed therapy (eDOT) has been proposed as an alternative to traditional in-person DOT (ipDOT) for monitoring TB treatment adherence. Information about the comparative performance and implementation of eDOT is limited.
  
  METHODS:
  
  The frequency of challenges during DOT, challenge type, and effect on medication observation were documented by DOT method during a crossover, noninferiority randomized controlled trial. A logistic mixed-effects model that adjusted for the study design was used to estimate the percentage of successfully observed doses when challenges occurred.
  
  RESULTS:
  
  A total of 20,097 medication doses were scheduled for observation with either eDOT (15,405/20,097; 76.7%) or ipDOT (4,692/20,097; 23.3%) for 213 study participants. In total, one or more challenges occurred during 17.3% (2,672/15,405) of eDOT sessions and 15.6% (730/4,692) of ipDOT sessions. Among 4,374 documented challenges, 27.3% (n = 1,192) were characterized as technical, 65.9% (n = 2,881) were patient-related, and 6.9% (n = 301) were program-related. Estimated from the logistic model (n = 6,782 doses, 173 participants), the adjusted percentage of doses successfully observed during problematic sessions was 21.7% (95% CI 11.2–37.8) for eDOT and 4.2% (95% CI 1.1–14.7) for ipDOT.
  
  CONCLUSION:
  
  Compared to ipDOT, challenges were encountered in a slightly higher percentage of eDOT sessions but were more often resolved to enable successful dose observation during problematic sessions.
  
  
• Subjects:
  Directly Observed Therapy Humans Medication Adherence Research Design Tuberculosis
• Keywords:
  EDOT IpDOT Tuberculosis VDOT Video-observed Therapy Video DOT VOT
• Source:
  Int J Tuberc Lung Dis. 27(4):298-307
• Pubmed ID:
  37035970
• Pubmed Central ID:
  PMC10807436
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  27
• Issue:
  4
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:88727a3cffe754e2356f4080b34a124816e29e311e8efeb0ea10568e0ecb27cb1c05e7b1042fdca68cd148e9f3e7e0f647fd4237225c85f2f752e8b611cc1429
• Download URL:
  https://stacks.cdc.gov/view/cdc/147641/cdc_147641_DS1.pdf
• File Type:
  [PDF - 563.98 KB ]