Directly observed therapy (DOT) with antituberculous drugs appears not to improve cure rates compared with self administration of treatment. However, it may be possible to achieve treatment completion rates exceeding 90% by patient centred approach using DOT with multiple enablers and enhancers.
A Cochrane review [Abstract] 1 included 11 trials with a total of 5 662 subjects. No statistically significant difference was detected between DOT and self administration in terms of cure (RR 1.08, 95% CI 0.91 to 1.27), with similar results for cure plus completion of treatment. When stratified by location, DOT provided at home compared with DOT provided at clinic suggests a possible small advantage with home-based DOT for cure (RR 1.15, 95% CI 1.06 to 1.25). There was no significant difference detected in clinical outcomes between DOT at a clinic versus by a family member or community health worker (RR 1.02, 95% CI 0.88 to 1.18, four trials, 1556 participants, moderate quality evidence; treatment completion: RR 1.04, 95% CI 0.91 to 1.17, three trials, 1029 participants, moderate quality evidence), or for DOT provided by a family member versus a community health worker (RR 1.02, 95% CI 0.86 to 1.21; two trials, 1493 participants, moderate quality evidence; completion: RR 1.05, 95% CI 0.90 to 1.22; two trials, 1493 participants, low quality evidence). Two small trials of tuberculosis prophylaxis in intravenous drugs users found no statistically significant difference between DOT and self administration (RR 1.00, 95% CI 0.88 to 1.13; one trial) or a choice of location for DOT for completion of treatment (1 trial, n=108).
A systematic review 3 on the long-term efficacy of standard directly observed treatment, short-course (DOTS) regimens in preventing the recurrence of tuberculosis (TB), including 16 studies with a total of at least 4 246 participants was abstracted in DARE. There was a high level of clinical and methodological heterogeneity across a range of variables. Rates of TB recurrence in the included studies ranged from 0 to 14%.
Another systematic review 2 including 27 studies with a total of 274 683 subjects (including 5 randomized or semi-randomized trials) was abstracted in DARE. Directly Observed Therapy (DOT) using multiple incentives and enablers reported the highest treatment completion rates ranging from 86% to 96.5% (median 91%), with tuberculosis relapse rates ranging from 0 to 11.5% (12 studies). The 4 studies of DOT without incentives and enablers reported treatment completion rates ranging from 85% to 87.6% (median 86.3%), with relapse rates ranging from 0.8 to 4.9%. The 9 studies with non-supervised strategies reported treatment completion rates ranging from 41.9 to 82% (median 61.4%), and relapse rates ranging from 2.1 to 4.5%. Two studies concluded that DOT was more cost-effective than self-administered therapy (SAT). In one study the cost per case cured for DOT was 13 925 dollars compared to 15 003 dollars for SAT. In the other study cost per case using DOT was 3 999 dollars compared to 12 167 dollars using SAT.
Comment: The quality of evidence is downgraded by inconsistency (heterogeneity in results in different populations).
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