HomeSince publication of the 2013 TB standards, at least five systematic reviews have examined the effectiveness of DOT compared with self-administered therapy (SAT) in drug-susceptible TB treatment, although no new high-quality randomized controlled trials have been published.37,41–44 Four systematic reviews analyzed the same five or six studies that compared outcomes of DOT and SAT45–50, while 1 lower-quality systematic review included several additional studies that did not directly compare DOT to SAT.44 Overall, 3 of the 4 high-quality systematic reviews found no significant difference when comparing pooled outcomes of treatment success from randomized control trials comparing DOT to SAT.41–43 In these studies, DOT was usually clinic-based, while the SAT arms usually still received significant adherence support from providers in the form of frequent clinical follow-up and adherence monitoring. The fourth high-quality systematic review had somewhat inconsistent findings, demonstrating that SAT had lower rates of both adherence and cure, but no change in treatment completion, mortality, failure, loss to follow-up or acquired drug resistance.37
In addition, systematic reviews of observational studies have reported improved treatment outcomes with DOT in people living with HIV and people with multidrug-resistant TB, with limited data examining other populations at risk for adverse outcomes.37,51 Existing data highlight the need for DOT, at minimum, in populations at higher risk for adverse outcomes from TB therapy. People with risk factors for non-adherence, people with TB with significant morbidity and people with infectious drug-resistant disease should be considered for DOT. Individual risk factors for adverse outcomes may include: people with multidrug-resistant TB, people living with HIV, people experiencing TB treatment failure or relapse, people with substance use or mental health disorders, people experiencing homelessness or unstable housing and people with suspected or known non-adherence to TB therapy.
The decision to use DOT, and the type of DOT, should be made in collaboration with the patient to ensure that autonomy and trust are maintained. One approach to increase patient autonomy is community-based DOT, where DOT services are decentralized, and people can remain in their homes, schools or workplaces while receiving DOT rather than traveling to healthcare facilities. A recent systematic review of randomized controlled trials and observational studies comparing community-based DOT to clinic-based DOT demonstrated that community-based DOT increased the pooled odds of successful treatment outcome significantly in both randomized control trials and observational studies.52
Virtual DOT (VDOT) through video-enabled devices such as smartphones and computers has emerged as a cost-effective way to deliver DOT that may improve patient autonomy. VDOT has shown promise in randomized controlled trials of high-risk populations,40 and remains an active area of investigation. VDOT may be considered an acceptable alternative to DOT in some settings, and should be considered an option within the larger program of supportive care for people with TB disease. VDOT should be accompanied by in-person support and DOT when required, and within the framework of monitoring and evaluation.
Recommendations
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We strongly recommend that all jurisdictions provide the capacity to deliver daily, in-person, supportive care for people with TB disease. Daily support should be individualized, and may include directly observed therapy (good evidence).
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We strongly recommend that, if directly observed therapy (DOT) is used, community-based DOT be performed rather than clinic-based DOT (good evidence).
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