Directly observed therapy for treating tuberculosis

Abstract

Background Tuberculosis (TB) requires at least six months of treatment. If treatment is incomplete, patients may not be cured and drug resistance may develop. Directly Observed Therapy (DOT) is a specific strategy, endorsed by the World Health Organization, to improve adherence by requiring health workers, community volunteers or family members to observe and record patients taking each dose. Objectives To evaluate DOT compared to self‐administered therapy in people on treatment for active TB or on prophylaxis to prevent active disease. We also compared the effects of different forms of DOT. Search methods We searched the following databases up to 13 January 2015: the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; EMBASE; LILACS and m RCT. We also checked article reference lists and contacted relevant researchers and organizations. Selection criteria Randomized controlled trials (RCTs) and quasi‐RCTs comparing DOT with routine self‐administration of treatment or prophylaxis at home. Data collection and analysis Two review authors independently assessed risk of bias of each included trial and extracted data. We compared interventions using risk ratios (RR) with 95% confidence intervals (CI). We used a random‐effects model if meta‐analysis was appropriate but heterogeneity present (I 2 statistic > 50%). We assessed the quality of the evidence using the GRADE approach. Main results Eleven trials including 5662 participants met the inclusion criteria. DOT was performed by a range of people (nurses, community health workers, family members or former TB patients) in a variety of settings (clinic, the patient's home or the home of a community volunteer). DOT versus self‐administered Six trials from South Africa, Thailand, Taiwan, Pakistan and Australia compared DOT with self‐administered therapy for treatment. Trials included DOT at home by family members, community health workers (who were usually supervised); DOT at home by health staff; and DOT at health facilities. TB cure was low with self‐administration across all studies (range 41% to 67%), and direct observation did not substantially improve this (RR 1.08, 95% CI 0.91 to 1.27; five trials, 1645 participants, moderate quality evidence ). In a subgroup analysis stratified by the frequency of contact between health services in the self‐treatment arm, daily DOT may improve TB cure when compared to self‐administered treatment where patients in the self‐administered group only visited the clinic every month (RR 1.15, 95% CI 1.06 to 1.25; two trials, 900 participants); but with contact in the control becoming more frequent, this small effect was not apparent (every two...

The impact of the COVID-19 epidemic on tuberculosis control in China

“…However, there was no significant difference among the sputum conversion rate of smear positive patients after 2 months treatment in the three periods, as well as the cured rate. This is consistent with previous studies that DOT improves neither TB treatment completion and cured rate nor microbiologic failure and relapse, when it was compared to self-administered therapy [34][35][36] . Other studies, however, show a decline in relapse rates with DOT [37 , 38] .…”

The impact of the COVID-19 epidemic on tuberculosis control in China

“…However, there was no significant difference among the sputum conversion rate of smear positive patients after 2 months treatment in the three periods, as well as the cured rate. This is consistent with previous studies that DOT improves neither TB treatment completion and cured rate nor microbiologic failure and relapse, when it was compared to self-administered therapy [34][35][36] . Other studies, however, show a decline in relapse rates with DOT [37 , 38] .…”

Interventions to improve retention-in-care and treatment adherence among patients with drug-resistant tuberculosis: a systematic review

“…Furthermore, GELMANOVA et al [23] showed significant improvements in treatment adherence rates among MDR-TB patients when staff time allocated to each patient was increased. These findings are consistent with those reported in a recent Cochrane systematic review [38], which found that daily DOT did not improve TB cure rates, compared to self-administered therapy, when the frequency of contact with providers increased from monthly to every 2 weeks or more.…”

A scoping review of interventions in childhood tuberculosis prevention and treatment

“…Shorter regimens, such as a three-month course of isoniazid and rifapentine, achieved 100% completion, while six- and nine-month regimens showed more variable results. These findings are consistent with a systematic review reporting that shorter regimens demonstrated greater therapeutic efficacy and higher completion rates than longer, traditional treatments [ 77 ]. However, the referenced review focused exclusively on cohort studies and did not limit by age group.…”

The impact of the COVID-19 epidemic on tuberculosis control in China

“…However, there was no significant difference among the sputum conversion rate of smear positive patients after 2 months treatment in the three periods, as well as the cured rate. This is consistent with previous studies that DOT improves neither TB treatment completion and cured rate nor microbiologic failure and relapse, when it was compared to self-administered therapy [34][35][36] . Other studies, however, show a decline in relapse rates with DOT [37 , 38] .…”

Interventions to improve retention-in-care and treatment adherence among patients with drug-resistant tuberculosis: a systematic review

“…Furthermore, GELMANOVA et al [23] showed significant improvements in treatment adherence rates among MDR-TB patients when staff time allocated to each patient was increased. These findings are consistent with those reported in a recent Cochrane systematic review [38], which found that daily DOT did not improve TB cure rates, compared to self-administered therapy, when the frequency of contact with providers increased from monthly to every 2 weeks or more.…”

A scoping review of interventions in childhood tuberculosis prevention and treatment

“…Shorter regimens, such as a three-month course of isoniazid and rifapentine, achieved 100% completion, while six- and nine-month regimens showed more variable results. These findings are consistent with a systematic review reporting that shorter regimens demonstrated greater therapeutic efficacy and higher completion rates than longer, traditional treatments [ 77 ]. However, the referenced review focused exclusively on cohort studies and did not limit by age group.…”

The impact of the COVID-19 epidemic on tuberculosis control in China

“…However, there was no significant difference among the sputum conversion rate of smear positive patients after 2 months treatment in the three periods, as well as the cured rate. This is consistent with previous studies that DOT improves neither TB treatment completion and cured rate nor microbiologic failure and relapse, when it was compared to self-administered therapy [34][35][36] . Other studies, however, show a decline in relapse rates with DOT [37 , 38] .…”

Interventions to improve retention-in-care and treatment adherence among patients with drug-resistant tuberculosis: a systematic review

“…Furthermore, GELMANOVA et al [23] showed significant improvements in treatment adherence rates among MDR-TB patients when staff time allocated to each patient was increased. These findings are consistent with those reported in a recent Cochrane systematic review [38], which found that daily DOT did not improve TB cure rates, compared to self-administered therapy, when the frequency of contact with providers increased from monthly to every 2 weeks or more.…”

A scoping review of interventions in childhood tuberculosis prevention and treatment

“…Shorter regimens, such as a three-month course of isoniazid and rifapentine, achieved 100% completion, while six- and nine-month regimens showed more variable results. These findings are consistent with a systematic review reporting that shorter regimens demonstrated greater therapeutic efficacy and higher completion rates than longer, traditional treatments [ 77 ]. However, the referenced review focused exclusively on cohort studies and did not limit by age group.…”