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Meta-Analysis
. 2015 May 29;2015(5):CD003343.
doi: 10.1002/14651858.CD003343.pub4.

Directly observed therapy for treating tuberculosis

Jamlick Karumbi  1 , Paul Garner
Affiliations
Meta-Analysis

Directly observed therapy for treating tuberculosis

Jamlick Karumbi et al. Cochrane Database Syst Rev. .

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 mRCT. 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 weeks: RR 0.96, 95% CI 0.83 to 1.12; one trial, 497 participants; every week: RR 0.90, 95% CI 0.68 to 1.21; two trials, 248 participants).Treatment completion showed a similar pattern, ranging from 59% to 78% in the self-treatment groups, and direct observation did not improve this (RR 1.07, 95% CI 0.96 to 1.19; six trials, 1839 participants, moderate quality evidence). DOT at home versus DOT at health facility In four trials that compared DOT at home by family members, or community health workers, with DOT by health workers at a health facility there was little or no difference in cure or treatment completion (cure: 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). DOT by family member versus DOT by community health workerTwo trials compared DOT at home by family members with DOT at home by community health workers. There was also little or no difference in cure or treatment completion (cure: 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). Specific patient categoriesA trial of 300 intravenous drug users in the USA evaluated direct observation with no observation in TB prophylaxis to prevent active disease and showed little difference in treatment completion (RR 1.00, 95% CI 0.88 to 1.13; one trial, 300 participants, low quality evidence).

Authors' conclusions: From the existing trials, DOT did not provide a solution to poor adherence in TB treatment. Given the large resource and cost implications of DOT, policy makers might want to reconsider strategies that depend on direct observation. Other options might take into account financial and logistical barriers to care; approaches that motivate patients and staff; and defaulter follow-up.

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Conflict of interest statement

As a result of the earlier editions of this review from the mid 1990s, PG has become recognised and associated with the continued debate about whether DOT should be central to national programmes in low‐ and middle‐income countries.

Figures

1
1
Factors influencing adherence and possible intervention points.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials.
1.1
1.1. Analysis
Comparison 1 Directly observed versus self‐administered, Outcome 1 Cure (negative sputum smear in last month of Rx in patients +ve initially).
1.2
1.2. Analysis
Comparison 1 Directly observed versus self‐administered, Outcome 2 Cure (by intensity of monitoring in control group).
1.3
1.3. Analysis
Comparison 1 Directly observed versus self‐administered, Outcome 3 Treatment completion (both with smear sputum test at end and those without).
1.4
1.4. Analysis
Comparison 1 Directly observed versus self‐administered, Outcome 4 Treatment completion (grouped by frequency of monitoring in the self‐administered therapy group).
2.1
2.1. Analysis
Comparison 2 Home observed versus clinic observed, Outcome 1 Cure (having a negative sputum smear test in the last month of treatment having been smear‐positive initially).
2.2
2.2. Analysis
Comparison 2 Home observed versus clinic observed, Outcome 2 Treatment completion (both with smear sputum test at end and those without).
2.3
2.3. Analysis
Comparison 2 Home observed versus clinic observed, Outcome 3 Cure (stratified by intensity of observation).
3.1
3.1. Analysis
Comparison 3 Community observed vs family observed, Outcome 1 Cure (having a negative sputum smear test in the last month of treatment having been smear‐positive initially).
3.2
3.2. Analysis
Comparison 3 Community observed vs family observed, Outcome 2 Treatment completion (both with smear sputum test at end and those without).
4.1
4.1. Analysis
Comparison 4 Injecting drug users, Outcome 1 Treatment completion.
See this image and copyright information in PMC

Update of

Comment in

References

References to studies included in this review

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