Adverse events among persons with TB using in-person vs. electronic directly observed therapy.
Int J Tuberc Lung Dis
; 27(11): 833-840, 2023 08 01.
Article
in En
| MEDLINE
| ID: mdl-37880884
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tuberculosis
/
Directly Observed Therapy
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Int J Tuberc Lung Dis
Year:
2023
Document type:
Article