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Randomized Controlled Trial
. 2023 Apr 1;27(4):298-307.
doi: 10.5588/ijtld.22.0583.

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

J M Mangan  1 , J Burzynski  2 , B Rey deCastro  1 , M M Salerno  3 , C K Lam  4 , M Macaraig  2 , M Reaves  3 , S Kiskadden-Bechtel  3 , S Bowers  4 , C Sathi  3 , M P Dias  3 , N D Goswami  1 , A Vernon  5
Affiliations
Randomized Controlled Trial

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

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

Abstract
in English, French

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.

CONTEXTE:: Une forme électronique de traitement sous observation directe (eDOT) a été proposée comme alternative à la traditionnelle DOT en personne (ipDOT) pour le suivi de l’observance du traitement antituberculeux. Les données relatives aux performances comparatives et à la mise en place de l’eDOT sont limitées.

MÉTHODES:: La fréquence des problèmes rencontrés pendant la DOT, le type de problèmes et l’effet sur l’observation de la prise du traitement ont été documentés en utilisant la stratégie DOT pendant un essai controˆlé randomisé croisé de non-infériorité. Un modèle logistique à effets mixtes ajusté au schéma de l’étude a été utilisé pour estimer le pourcentage de doses dont la prise a été observée avec succès en cas de problèmes.

RÉSULTATS:: Au total, 20 097 doses de médicaments ont été programmées pour observation de la prise soit par eDOT (15 405/20 097 ; 76,7%) soit par ipDOT (4 692/20 097 ; 23,3%) pour 213 participants à l’étude. Un ou plusieurs problèmes ont été rencontrés dans 17,3% (2 672/15 405) des sessions eDOT et dans 15,6% (730/4 692) des sessions ipDOT. Parmi les 4 374 problèmes documentés, 27,3% (n = 1 192) ont été qualifiés de techniques, 65,9% (n = 2 881) étaient liés au patient et 6,9% (n= 301) étaient liés au programme. Estimé à partir du modèle logistique (n = 6 782 doses, 173 participants), le pourcentage ajusté de doses dont la prise a été observée avec succès pendant les sessions problématiques était de 21,7% (IC 95% 11,2–37,8) pour l’eDOT et de 4,2% (IC 95% 1,1–14,7) pour l’ipDOT.

CONCLUSION:: Par rapport à l’ipDOT, des problems ont été rencontrés dans un pourcentage légèrement plus élevé de sessions eDOT, mais ils ont été plus souvent résolus afin de permettre une observation réussie de la prise des doses pendant les sessions problématiques.

Trial registration: ClinicalTrials.gov NCT03266003.

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Conflict of interest statement

Conflicts of interest: none declared.

Figures

Figure
Figure
Technical, patient-, and program-related problems by DOT method and observation outcome. LVDOT = live video directly observed therapy; RVDOT =recorded video DOT; ipDOT = in-person DOT; CDOT =clinic DOT; FDOT = field DOT.
See this image and copyright information in PMC

Comment in

References

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