Adverse events among persons with TB using in-person vs. electronic directly observed therapy

Details

• Alternative Title:
  Int J Tuberc Lung Dis
• Personal Author:
  Salerno, M. M. ; Burzynski, J. ; Mangan, J. M. ; Hill, A. ; Rey deCastro, B. ; Goswami, N. D. ; Lam, C. K. ; Macaraig, M. ; Schluger, N. W. ; Vernon, A. A.
• Description:
  BACKGROUND :
  
  We evaluated patient safety within a randomized crossover trial comparing electronic directly observed therapy (eDOT) to in-person DOT (ipDOT) in persons undergoing TB treatment in New York City, NY, USA.
  
  METHODS :
  
  Participant symptoms, symptom severity, and clinical management were documented. We assessed adverse event reports (AERs) by DOT method during the two-period crossover. Using Cox proportional-hazards mixed-effects models, we estimated the adjusted hazard ratio (aHR) of participants reporting an adverse event (AE) vs. not reporting an AE.
  
  RESULTS :
  
  Of 211 participants, 57 (27.0%) reported AEs during the two-period crossover; of these, 54.4% (31/57) were reported while using eDOT vs. 45.6% (26/57) while using ipDOT. Controlling for study group and period, the aHR for eDOT vs. ipDOT was 0.98 (95% CI 0.49–1.93). Although statistically not significant, the wide confidence intervals suggest that a significant association cannot be entirely ruled out. Gastrointestinal symptoms were most frequently reported (42.1%, 24/57). AER types and severity did not differ significantly by DOT method. Days from symptom onset to medical attention was similar across DOT methods (median: 1.0 day, IQR 0.0–2.0). No participants switched DOT methods due to AERs or monitoring concerns.
  
  CONCLUSION :
  
  Further evaluation to ascertain whether AERs differ when patients use eDOT vs. ipDOT is warranted.
  
  
• Subjects:
  Directly Observed Therapy Humans New York City Tuberculosis
• Keywords:
  Digital Health Medication Side Effects Patient Safety Randomized Controlled Trial Video DOT
• Source:
  Int J Tuberc Lung Dis. 27(11):833-840
• Pubmed ID:
  37880884
• Pubmed Central ID:
  PMC10794055
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/ ; CC/CDC HHSUnited States/
• Volume:
  27
• Issue:
  11
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:4b1ef713d36626e57a8f2f716c648a5abd99e9227933e076e55b6b32b8f6db706e373c5cd107fc51e688d66fdcfbb2a51f71033abba7b3c40ee7f12bc496b5ff
• Download URL:
  https://stacks.cdc.gov/view/cdc/142648/cdc_142648_DS1.pdf
• File Type:
  [PDF - 608.16 KB ]