[procaare] Summary: Effectiveness of the direct observation component of DOTS

[Albert Shaw <procaare@usa.healthnet.org>]

Effectiveness of the direct observation component of DOTS for tuberculosis:
a randomised controlled trial in Pakistan.

Summary by Dr. Albert Shaw

AU Walley, J.D. et al.
SO Lancet 2001; 357: 664-669.

This trial enrolled 497 patients at three centers in Pakistan (Rawalpindi,
Gujranwala, and Sahiwal) with sputum-positive pulmonary
tuberculosis. Participants were randomized to one of three arms: directly
observed treatment, short-course (DOTS) with direct observation by health
care workers, direct observation of treatment by family members, or
self-administered treatment. All received a regimen consisting of 2 months
of isoniazid, rifampin, pyrazinamide, and ethambutol, followed by 6 months
of isoniazid and ethambutol. Intention to treat analysis was utilized.

No significant difference was observed among the three arms of the
trial. The cure rates for health care worker DOTS, family member DOTS, and
self-administered treatment were 64%, 55%, and 62%, respectively. The
respective rates of cure or completion of treatment regimen were 67%, 62%,
and 65%. Notably, women had significantly higher rates of cure overall
than men (21% difference, 95% confidence interval 13-30, p<0.0001).

The overall cure rate for tuberculosis was only 60% in this study; the
authors speculate that this may reflect a number of factors, including
health care infrastructure and national health care policy, as well as poor
expectations regarding the health care system and a general perception in
the population that tuberculosis is incurable.

Potential areas of bias that may have influenced these results, such as patients
crossing over among different categories (e.g. a health care DOTS participant
who asks a family member to assist in administering therapy).

While it is unclear if these results can be generalized beyond Pakistan, this
study suggests that the assumption of the superiority of DOTS, which places
substantial burdens on both patients and health care systems,
must be directly tested to determine efficacy in a particular setting in the developing
world.

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Moderator note:

We thank Dr. Shaw for this summary and we take up the challenge in his concluding
statement by inviting forum members to contribute their experiences with implementing DOTS
in different contexts. It is also an important issue to consider in looking at home-based
care where, more and more, volunteers and family members are involved in administering and
monitoring DOTS.

We look forward to your participation in this discussion

- HDN Moderator
****


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