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...