In:
The International Journal of Tuberculosis and Lung Disease, International Union Against Tuberculosis and Lung Disease, Vol. 27, No. 11 ( 2023-08-01), p. 833-840
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1027-3719
DOI:
10.5588/ijtld.22.0594
Language:
English
Publisher:
International Union Against Tuberculosis and Lung Disease
Publication Date:
2023
detail.hit.zdb_id:
1385624-8
