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

Autor: J. M. Mangan, J. Burzynski, B. Rey deCastro, M. M. Salerno, C. K. Lam, M. Macaraig, M. Reaves, S. Kiskadden-Bechtel, S. Bowers, C. Sathi, M. P. Dias, N. D. Goswami, A. Vernon, null for the eDOT Study Team
Rok vydání: 2023
Předmět:
Zdroj: The International Journal of Tuberculosis and Lung Disease. 27:298-307
ISSN: 1027-3719
DOI: 10.5588/ijtld.22.0583
Popis: 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.
Databáze: OpenAIRE