Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Aug 1;27(11):833-840.
doi: 10.5588/ijtld.22.0594.

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

M M Salerno  1 , J Burzynski  2 , J M Mangan  3 , A Hill  3 , B Rey deCastro  3 , N D Goswami  3 , C K Lam  3 , M Macaraig  2 , N W Schluger  4 , A A Vernon  5
Affiliations
Randomized Controlled Trial

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

M M Salerno et al. Int J Tuberc Lung Dis. .

Abstract
in English, French

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.

CONTEXTE :: Nous avons évalué la sécurité des patients dans le cadre d’un essai croisé randomisé comparant la thérapie électronique sous observation directe (eDOT) à la thérapie en personne (ipDOT) chez des personnes suivant un traitement contre la TB dans la ville de New York, NY, États-Unis.

MÉTHODES :: Les symptôms des participants, leur gravité et la prise en charge clinique ont été documentés. Nous avons évalué les rapports d’événements indésirables (AERs) en fonction de la méthode DOT pendant la période croisée de 2 ans. À l’aide de modèles d’effets mixtes à hasards proportionnels de Cox, nous avons estimé le rapport de risque ajusté (aHR) entre les participants ayant signalé un événement indésirable (AE) et ceux n’ayant pas signalé d’AE.

RÉSULTATS :: Sur 211 participants, 57 (27,0%) ont signalé des AE au cours de la période croisée de 2 ans; parmi ceux-ci, 54,4% (31/57) ont été signalés lors de l’utilisation de l’eDOT contre 45,6% (26/57) lors de l’utilisation de l’ipDOT. En tenant compte du groupe d’ étude et de la période, le aHR pour l’eDOT par rapport à l’ipDOT était de 0,98 (IC 95% 0,49–1,93). Bien que statistiquement non significatif, les larges intervalles de confiance suggérent qu’une association significative ne peut pas être totalement exclue. Les symptômes gastro-intestinaux ont été les plus frequémment signalés (24/57; 42,1%). Les types de AER et leur gravité ne differaiént pas significativement en fonction de la méthode DOT. Le délai entre l’apparition des symptômes et l’obtention d’un avis médical était similaire pour toutes les méthodes DOT (médiane : 1,0 jour; intervalle interquartile 0,0–2,0). Aucun participant n’a changé de méthode DOT enraison d’effets indésirables ou de problèmes de surveillance.

CONCLUSION :: Une évaluation plus poussée est justifiée pour déterminer si les AERs diffèrent lorsque les patients utilisent l’eDOT par rapport à l’ipDOT.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study timeline of participants with AERs during the two-period crossover. Only patients who reported an AE during the crossover phase were included (n = 57). Patients’ first reported AE is used for DOT data. AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events. Scheduled doses excluded weekend and holidays. Study Group 1 entailed a DOT plan of 20 scheduled doses with ipDOT, followed by 20 scheduled doses with eDOT. Study Group 2 entailed a schedule of 20 planned doses of eDOT, followed by 20 planned doses of ipDOT. Among participants with multiple AERs (n = 16), 7 reported subsequent AERs while using the opposite DOT method, 5 reported subsequent AERs with ipDOT only, and 4 reported subsequent AERs with eDOT only, later in treatment. Analysis of the subsequently reported AERs yielded results similar to the analysis of first AERs. AE = adverse event; DOT = directly observed therapy; ipDOT = in-person DOT; eDOT = electronic DOT; AER = AE reports.
Figure 2
Figure 2
Forest plot of hazard ratios from Cox proportional hazards mixed effects model. Study Group 1 entailed a DOT plan of 20 scheduled doses with ipDOT, followed by 20 scheduled doses with eDOT. Study Group 2 entailed a schedule of 20 planned doses of eDOT, followed by 20 planned doses of ipDOT. Crossover Period I included the first 20 scheduled doses with the assigned DOT method. Crossover Period II included an additional 20 scheduled doses with the alternate, assigned DOT method. All participants (n = 211) who did not withdraw before the start of the crossover period were included as intention-to-treat. Hazard ratio estimates are presented on the logarithmic scale. aHR = adjusted hazard ratio; CI = confidence interval; DOT = directly observed therapy; ipDOT = in-person DOT; eDOT = electronic DOT.
See this image and copyright information in PMC

References

    1. World Health Organization. Global diffusion of eHealth: making universal health coverage achievable. Report of the third global survey on eHealth. Geneva, Switzerland: WHO, 2016.
    1. Kadakia K, Patel B, Shah A. Advancing digital health: FDA innovation during COVID-19. NPJ Digit Med 2020;3(1):161. - PMC - PubMed
    1. World Health Organization. WHO guideline recommendations on digital interventions for health system strengthening. Geneva, Switzerland: WHO, 2019. - PubMed
    1. Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities; Board on Population Health and Public Health Practice; Health and Medicine Division; National Academies of Sciences, Engineering, and Medicine. The promises and perils of digital strategies in achieving health equity: workshop summary. Washington, DC, USA: National Academies Press, 2016. - PubMed
    1. Brewer LC, et al. Back to the future: achieving health equity through health informatics and digital health. JMIR Mhealth Uhealth 2020;8(1):e14512. - PMC - PubMed

Publication types

LinkOut - more resources