Directly observed therapy for treating tuberculosis

  • Review
  • Intervention

Authors


Abstract

Background

Using a pilot system we have categorised this review as: Current question - no update intended (Results conclusive) Please see "Published notes" section of the review for more details.

For tuberculosis treatment, policies have been introduced to encourage adherence to treatment regimens. One such policy is directly observed therapy (DOT), which involves people directly observing patients taking their antituberculous drugs.

Objectives

To compare DOT with self administration of treatment or different DOT options for people requiring treatment for clinically active tuberculosis or prevention of active disease.

Search methods

In May 2007, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2007, Issue 2), MEDLINE, EMBASE, LILACS, and mRCT. We also checked article reference lists and contacted relevant researchers and organizations.

Selection criteria

Randomized and quasi-randomized controlled trials comparing a health worker, family member, or community volunteer routinely observing people taking antituberculous drugs compared with routine self administration of treatment at home. We include people requiring treatment for clinically active tuberculosis or medication for preventing active disease.

Data collection and analysis

Both authors independently assessed trial methodological quality and extracted data. Data were analysed using relative risks (RR) with 95% confidence intervals (CI) and the fixed-effect model when there was no statistically significant heterogeneity (chi square P > 0.1). Trials of drug users were analysed separately.

Main results

Eleven trials with 5609 participants met the inclusion criteria. No statistically significant difference was detected between DOT and self administration in terms of cure (RR 1.02, 95% CI 0.86 to 1.21, random-effects model; 1603 participants, 4 trials), 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 1.10, 95% CI 1.02 to 1.18; 1365 participants, 3 trials). There was no significant difference detected in clinical outcomes between DOT at a clinic versus by a family member or community health worker (2 trials), or for DOT provided by a family member versus a community health worker (1326 participants, 1 trial). Two small trials of tuberculosis prophylaxis in intravenous drugs users found no statistically significant difference between DOT and self administration (199 participants, 1 trial) or a choice of location for DOT for completion of treatment (108 participants, 1 trial).

Authors' conclusions

The results of randomized controlled trials conducted in low-, middle-, and high-income countries provide no assurance that DOT compared with self administration of treatment has any quantitatively important effect on cure or treatment completion in people receiving treatment for tuberculosis.

Plain language summary

Directly observing people taking their tuberculosis drugs did not improve the cure rate compared with people without direct monitoring of treatment

Using a pilot system we have categorised this review as: Current question - no update intended (Results conclusive). Please see "Published notes" section of the review for more details.

Tuberculosis is a very serious health problem with two million people dying each year, mostly in low-income countries. Effective drugs for tuberculosis have been available since the 1940s, but the problem still abounds. People with tuberculosis need to take the drugs for at least six months, but many do not complete their course of treatment. For this reason, services for people with tuberculosis often use different approaches to encourage people to complete their course of treatment. This review found no evidence that direct observation by health workers, family members, or community members of people taking their medication showed better cure rates that people having self administered treatment. The intervention is expensive to implement, and there appears to be no sound reason to advocate its routine use until we better understand the situations in which it may be beneficial.

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