In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence

Details

• Alternative Title:
  JAMA Netw Open
• Personal Author:
  Burzynski, Joseph ; Mangan, Joan M. ; Lam, Chee Kin ; Macaraig, Michelle ; Salerno, Marco M. ; deCastro, B. Rey ; Goswami, Neela D. ; Lin, Carol Y. ; Schluger, Neil W. ; Vernon, Andrew
• Corporate Authors:
  eDOT Study Team
• Description:
  IMPORTANCE
  
  Electronic directly observed therapy (DOT) is used increasingly as an alternative to in-person DOT for monitoring tuberculosis treatment. Evidence supporting its efficacy is limited.
  
  OBJECTIVE
  
  To determine whether electronic DOT can attain a level of treatment observation as favorable as in-person DOT.
  
  DESIGN, SETTING, AND PARTICIPANTS
  
  This was a 2-period crossover, noninferiority trial with initial randomization to electronic or in-person DOT at the time outpatient tuberculosis treatment began. The trial enrolled 216 participants with physician-suspected or bacteriologically confirmed tuberculosis from July 2017 to October 2019 in 4 clinics operated by the New York City Health Department. Data analysis was conducted between March 2020 and April 2021.
  
  INTERVENTIONS
  
  Participants were asked to complete 20 medication doses using 1 DOT method, then switched methods for another 20 doses. With in-person therapy, participants chose clinic or community-based DOT; with electronic DOT, participants chose live video-conferencing or recorded videos.
  
  MAIN OUTCOMES AND MEASURES
  
  Difference between the percentage of medication doses participants were observed to completely ingest with in-person DOT and with electronic DOT. Noninferiority was demonstrated if the upper 95% confidence limit of the difference was 10% or less. We estimated the percentage of completed doses using a logistic mixed effects model, run in 4 modes: modified intention-to-treat, per-protocol, per-protocol with 85% or more of doses conforming to the randomization assignment, and empirical. Confidence intervals were estimated by bootstrapping (with 1000 replicates).
  
  RESULTS
  
  There were 173 participants in each crossover period (median age, 40 years [range, 16–86 years]; 140 [66%] men; 80 [37%] Asian and Pacific Islander, 43 [20%] Black, and 71 [33%] Hispanic individuals) evaluated with the model in the modified intention-to-treat analytic mode. The percentage of completed doses with in-person DOT was 87.2% (95% CI, 84.6%–89.9%) vs 89.8% (95% CI, 87.5%–92.1%) with electronic DOT. The percentage difference was −2.6% (95% CI, −4.8% to −0.3%), consistent with a conclusion of noninferiority. The 3 other analytic modes yielded equivalent conclusions, with percentage differences ranging from −4.9% to −1.9%.
  
  CONCLUSIONS AND RELEVANCE
  
  In this trial, the percentage of completed doses under electronic DOT was noninferior to that under in-person DOT. This trial provides evidence supporting the efficacy of this digital adherence technology, and for the inclusion of electronic DOT in the standard of care.
  
  TRIAL REGISTRATION
  
  ClinicalTrials.gov Identifier: NCT03266003
  
  
• Subjects:
  Antitubercular Agents Directly Observed Therapy Humans Telemedicine Treatment Adherence And Compliance Treatment Outcome Tuberculosis Tuberculosis, Pulmonary Videoconferencing
• Source:
  JAMA Netw Open. 5(1):e2144210
• Pubmed ID:
  35050357
• Pubmed Central ID:
  PMC8777548
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Place as Subject:
  New York City, NY
• Volume:
  5
• Issue:
  1
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:f2d8f910d2a0ac3df0671fc2c57c993f2ab4fbbad183cfefb6b76d1e29fc0afd
• Download URL:
  https://stacks.cdc.gov/view/cdc/114454/cdc_114454_DS1.pdf
• File Type:
  [PDF - 732.51 KB ]