JIACM 2004; 5(2): 109-13

EDITOR’S CHOICE

Directly Observed Treatment, Short-Course (DOTS)

SK Sharma*, A Mohan**

Abstract
Directly observed treatment, short-course (DOTS), is recommended by the World Health Organisation (WHO) globally, for control
of tuberculosis (TB). DOTS strategy which aims at detecting at least 70% of the existing cases of sputum smear-positive cases and
curing at least 85% of these newly detected cases, has been observed not only to ensure cure but also reduce the number of deaths
due to TB. DOTS also results in the reduction of the prevalence of TB by reducing the pool of infectious cases and curtailing the
disease transmission. The short-course anti-tuberculosis treatment regimens employed in the DOTS strategy are effective and the
supply of drugs is uninterrupted. As regular drug intake is ensured with DOTS strategy by direct observation, drug resistance and
relapses develop less frequently. The revised national tuberculosis control programme (RNTCP) of India has adopted the DOTS
strategy for the control of TB and has expanded rapidly during the last five years. From a coverage of 18 million in mid-1998, as of
June 30, 2003, DOTS coverage has expanded to 712 million of India’s population. India’s DOTS programme is the second largest in
the world. The current expansion is rapidly progressing and the entire country is expected to be covered by 2005. The initial
experience with DOTS suggests that, in areas of the world where the prevalence of drug-resistant TB is high, modifications such as
“DOTS-Plus” strategy may be required to achieve the desired results. From a public health point of view, the DOTS strategy is
indeed one of the most cost-effective health interventions ever conceived.

Key words : DOTS, Tuberculosis, Control, DOTS-Plus.

Introduction short-course treatment (n = 2,306) and 35% of those

Tuberculosis (TB) has been a major cause of death and
suffering since ancient times1. M.tuberculosis is most often
transmitted by the inhalation route as droplet infection.
Therefore, interrupting the transmission of TB at the source
is of considerable importance in the control of TB. Till the
discovery of streptomycin, isoniazid and para-
aminosalicylic acid (PAS) in the mid-1940s, it was not
possible to cure TB. Subsequently, “short-course
chemotherapy (SCC)” became available with the
introduction of rifampicin, pyrazinamide, and ethambutol2.
Even though predictable, curative drug therapy is
available, TB continues to plague mankind. Worldwide, TB
remains a serious cause of illness and death; so serious as
to have been declared a “global emergency” in 1993 by
the World Health Organization (WHO)3. Thus, it becomes
evident that mere availability of anti-tuberculosis drugs
is not enough to control TB4. From a public health point of
view, irregular, incomplete treatment of TB is more
dangerous than no treatment at all. When patients fail to
complete standard treatment regimens, or receive the
wrong treatment, they continue to remain infectious, may
harbour drug resistant strains that may be passed on to
others. For example, in a study conducted in south India5,
it was observed that only 43% of the patients receiving
receiving standard chemotherapy (n = 1051) completed
80% or more of their treatment5. Poorly functioning
control programmes, use of non-standard treatment
regimens with varying drug combinations of doubtful
bioavailability for variable periods of time have all been
implicated as important causes for the emergence of
multidrug-resistant tuberculosis (MDR-TB, defined as
M.tuberculosis resistant to rifampicin and isoniazid). As
MDR-TB is very difficult to treat, prevention of
development of MDR-TB by ensuring “cure” of new smear-
positive patients is a much higher public health priority
than its treatment.
Directly observed treatment, short-course (DOTS) is an
interventional strategy developed by Dr. Karel Styblo and
is recommended by the WHO as the strategy that ensures
cure of TB6. Several key concepts underlying the DOTS
strategy are :
i. domiciliary treatment;
ii. need for supervised treatment – now called directly
observed treatment (DOT);
iii. effectiveness of intermittent treatment with the
medications administered two or three times a week
was effective; and

* Department of Medicine, All India Institute of Medical Sciences, New Delhi-110 029.
** Department of Emergency Medicine, Sri Venkateswara Institute of Medical Sciences, Tirupati-517 507, A.P.
iv. the crucial contribution of sputum microscopy which
is very effective as a case finding tool have their roots
in the monumental research work carried out in India7.
DOTS strategy
The fundamental principles of the DOTS strategy2 are
listed in Table I.
Table I : Fundamental principles of the DOTS strategy.

Political will

Case-finding – primarily by sputum smear microscopy,
among patients presenting to health facilities

Standardised short-course chemotherapy with first-
line anti-tuberculosis drugs given under direct
observation

Adequate uninterrupted drug supply, and

Systematic monitoring and accountability for every
patient diagnosed.
Political will
In many countries, efforts to control TB are poorly funded
and supported. Strong political will and government
commitment are essential for ensuring communication
and collaboration between local health authorities, the
primary health care system, hospitals, medical schools,
private practitioners, non-governmental organisations
(NGOs), and others.
Diagnosis by sputum microscopy
In the DOTS strategy, diagnosis of TB is based primarily on
microscopy rather than clinical examination, chest
radiograph or culture, primarily among patients attending
health facilities and not by active case-finding in the
community. Sputum microscopy is a highly specific test –
a low-cost, appropriate technology which can be reliably
and reproducibly performed even in remote areas7. It is
also useful to monitor the outcome and confirm that a
patient with TB is cured.
Directly observed standardised short-course
treatment
Short-course chemotherapy refers to a treatment regimen
that uses a combination of anti-tuberculosis drugs and
110 Journal, Indian Academy of Clinical Medicine
lasts six to eight months. Anti-tuberculosis drugs can only
be effective if they are taken7. Directly observed therapy
(DOT) is essential to ensure that the drugs are taken in
the right combinations and for the appropriate duration.
However, ensuring regular intake of drugs during
unsupervised self-administration for prolonged periods
is very difficult and may lead to the emergence of MDR-
TB. Depending on the local requirements, observation
must be done by a person who is accessible and
acceptable to the patient and who is accountable to the
health system8,9. There is a chance for TB control only when
all patients diagnosed to have TB get treated properly.
Thus, there is a need for universal implementation of DOTS
strategy.
Adequate supply of good quality drugs
Ensuring adequate supply of good quality anti-
tuberculosis drugs is essential for TB control. In the DOTS
strategy, an accurate recording and reporting system
provides the information needed to plan and maintain
adequate drug stocks.
Systematic monitoring and accountability
Good record-keeping facilitates easy review and audit. This
system not only allows effective programme
management but also operational research.
DOTS and TB control
The revised national tuberculosis control programme
(RNTCP) of the Government of India has adopted the DOTS
strategy and aims at detecting at least 70% of the existing
cases of sputum smear-positive TB and curing at least 85%
of these newly detected cases. DOTS strategy has
beneficial effects much beyond simply curing the patients
with TB (Table II). It reduces the number of deaths due to
TB. It also reduces the prevalence of TB by reducing the
pool of infectious cases and the disease transmission.
Since the treatment regimens are effective, drug supplies
are not interrupted and regular drug intake is ensured by
direct observation, relapses and drug resistance develop
less frequently5.
The DOTS strategy has been implemented successfully
world over. The RNTCP of India has expanded rapidly
during the last five years10,11. From a coverage of 18 million

Vol. 5, No. 2
April-June, 2004
in mid-1998, as of June 30, 2003, DOTS coverage has
expanded to 712 million of India’s population12. India’s
DOTS programme is the second largest in the world. The
current expansion is rapidly progressing and the entire
country is expected to be covered by 2005. Since its
inception, the programme has initiated over 2.5 million
patients on treatment, and cure rates are around 85%,
while case detection for 2002 was 59% and is moving
towards the 70% target13.
Table II : Advantages of DOTS strategy in the control
of TB : The Indian experience.
DOTS strategy:

More than doubles the accuracy of TB diagnosis

results in success rates of up to 95%

cuts down TB deaths by seven fold

doubles the cure rate

reduces the incidence and prevalence of TB

helps in alleviating poverty by saving lives, reducing the
duration of illness and preventing new infectious cases

improves the quality of care and overcomes stigma

prevents treatment failure and the emergence of MDR-
TB.
The future
Although the DOTS strategy has been widely accepted,
many developing countries have been unable to expand
coverage as rapidly as required and have failed to achieve
the global targets of 70% case detection and 85% cure by
the year 2000. In March 2000, the Amsterdam Declaration
to Stop TB called for increased political commitment and
financial resources to reach the targets for global TB
control by 2005. In May 2000, this call was restated by a
resolution of the world health assembly (WHA). In
response to these efforts, national tuberculosis
programme (NTP) managers of the 22 high-burden
countries, technical partners, financial partners, and the
global TB network of WHO agreed to develop a global
DOTS expansion plan (GDEP) 14. With the aim of
development of national DOTS expansion plans and
partnership-building to control TB.
DOTS-Plus
It has been observed that in areas of minimal or no
Journal, Indian Academy of Clinical Medicine
Vol. 5, No. 2
MDR-TB, DOTS achieves cure rates of up to 95%; results
in a dramatic reduction in the TB burden and will be
able to prevent the emergence of drug-resistant TB15-18.
However, standard short-course chemotherapy has
been found to be inadequate treatment for some
patients with drug-resistant TB19. These observations
suggest that although the DOTS strategy is good for
TB control, it requires to be modified in some settings.
In 1998, WHO and several partners around the world
conceived DOTS-Plus strategy for the management of
MDR-TB 20-22. This strategy is under continuous
development and testing and is considered to be a
supplement to the DOTS strategy. The green light
committee, a sub-group of the working group, has
been established for this purpose. WHO is a permanent
member of the green light committee and houses the
Secretariat. The green light committee approves,
oversees, and conducts pilot projects for the
management of MDR-TB and aims to improve access
to second-line anti-TB drugs for DOTS-Plus21.
In the “DOTS-Plus“ strategy20,21, which has been conceived
to work as a supplement to the standard DOTS strategy,
certain modifications have been suggested for all five
elements of the DOTS strategy such as providing
individualised treatment; provision of on-site laboratory
facilities for culture and sensitivity testing, reliable supply
of second line drugs among others (Table III). In a
recently published decision analysis23, it was observed
that fewer TB deaths would occur under DOTS-Plus
than under DOTS under conditions of optimal
implementation. If, however, implementation of DOTS-
Plus were associated with even minimal decreases in
the effectiveness of treatment, considerably larger
number of patients would die than under DOTS23. These
aspects merit further evaluation.
A co-ordinated effort by all concerned is required to
ensure that majority of the patients with TB get treated
through the RNTCP-DOTS strategy, for this appears to
be the only way to control TB. Conservative estimates
are that nationwide effective DOTS implementation by
2005 would result in cumulative savings of more than
US$ 27 billion through the year 2020. Thus, DOTS is
indeed one of the most cost-effective health
interventions ever conceived24!

April-June, 2004 111
Table III : DOTS-Plus strategy.
DOTS strategy

Standardised treatment throughout
the duration of treatment

Diagnosis by microscopy

Reliable supply of a limited number
of reliable first-line drugs

Continuous evaluation of patient notifications,
smear results, and outcomes

Commitment from the local government
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DOTS-Plus strategy

Individualised treatment regimens when mycobacterial culture
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Local facilities for mycobacterial culture and anti-tuberculosis
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antituberculosis drug sensitivity testing.

Provision of a wide-range of second-line anti-tuberculosis
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Additional support from external governments and agencies.
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A N N O U N C E M E N T
XII Annual Conference of Indian Association of Clinical Medicine

Dr. Nitya Nand 3/7J, Medical Enclave,

Professor of Medicine, PGIMS, Rohtak Rohtak-124001
President-Elect, IACM Phone 01262 213626
Chairman, Scientific Committee E-mail : nitya_49@yahoo.com

Dear Colleague,

I would like to express my gratitude to you for resposing your faith and confidence in electing me for the post of
President-Elect of IACM. I hope to live up to your expectations and assure you of my relentless and untiring efforts in
achieving the highest standard of academic activities.

As President-Elect, I have the important responsibility of preparing the Scientific Programme and Clinical Medicine
Update 2004 for our next annual conference, being held on 24-26 September 2004, in the city of The Taj – Agra (UP).
There has been tremendous explosion of knowledge in the field of Medicine during the last 2 decades directed towards
providing better health care. The primary aim of any scientific meet is to share this expanding knowledge. Your feedback
and suggestions will be of immense importance in preparing the scientific programme, and in the update book.

I would therefore, like to take this opportunity to request you to send me your suggestions regarding :
1. The topics for inclusion in the symposia, plenary sessions, workshops, clinical case presentation, CPC, etc.
2. Topics to be covered in the Clinical Update 2004.
3. Any other suggestion, which may improve the quality of contents and interaction amongst the members of the
association.

The important dates for the scientific programmes are :

1. Last date for the suggestions on scientific programme : 16-5-04
2. Last date for receiving free papers : 30-6-04
3. Last date for sending case presentation summary : 30-7-04

There would be prizes for the two best papers. I would request the fellows/members to encourage the PG students to
actively participate in the conference. The abstract for the Free Papers should not exceed 250 words.

The scientific committee is hopeful that scientific programme during the IACMCON-2004 will enable us to enrich
ourselves in the field of clinical medicine.

I look forward to your early response.

Yours sincerely,

(Nitya Nand)

Journal, Indian Academy of Clinical Medicine
Vol. 5, No. 2
April-June, 2004 113