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Adverse events among persons with TB using in-person vs. electronic directly observed therapy
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8 01 2023
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Source: Int J Tuberc Lung Dis. 27(11):833-840
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Alternative Title:Int J Tuberc Lung Dis
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Personal Author:
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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.
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Pubmed ID:37880884
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Pubmed Central ID:PMC10794055
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Volume:27
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Issue:11
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