DOTS & DOTS-Plus
In 1994 the World Health Organisation (WHO) announced a new strategy, called DOTS, for the worldwide control of TB. DOTS was the Directly Observed Treatment Short course strategy. All countries with a TB problem were to provide standardized short course drug treatment to, at least, all sputum smear positive TB patients. Until 2006 DOTS was to be the internationally recommended approach to global TB control.
DOTS had five components which were initially as follows.1"What is DOTS?", https://www.who.int/tb/publications/dots-who-guide/en
- Sustained political and financial commitment.
- Diagnosis of TB by quality ensured sputum smear microscopy.
- Standardized short course anti TB treatment (SCC) given under direct and supportive observation (DOTS).
- A regular uninterrupted supply of high quality anti TB drugs.
- Standardized recording and reporting.
DOTS involved treatment with a four drug regimen. These were isoniazid (INH), Rifampicin (Rif), Prazinamide (PZA) and Ethambutol (EMB) for 6-9 months.
In 1996 the WHO claimed that “where the health system is working even moderately well, the DOTS strategy is extraordinarily effective achieving cure rates over 90%.” But where in sub-Saharan Africa were there TB programs reliably implementing all five parts of DOTS? There were certainly some places where DOTS was remarkably effective. For example, with the control of TB in China where the country achieved cure rates of more than 85% although case detection barely climbed above 50%.2C McMillen, “Discovering Tuberculosis”, Yale University Press, 2015
DOTS was not however the “magic bullet” it was thought to be, and a universal solution had not been found. However, the World Bank made support of TB programs contingent on the adoption of DOTS, and the “gospel” of DOTS spread far and wide. Five years after its emergence 120 countries had at least nominally adopted DOTS.
When it was first introduced DOTS did not take any account of HIV. In a 2006 interview Arata Kochi the former director of TB programs at the WHO said:
One thing that I didn’t do well is develop an additional strategy in addition to DOTS for HIV/TB. That is my regret.
Direct & supportive observation
An important part of DOTS is that the patient has to take their TB treatment in front of a DOTS agent. The DOTS agent is often a volunteer from the patient's community and may be a family member. But when a volunteer is not available the patient may need to go to a health clinic every day.
Multi drug resistant TB
DOTS also did not take any account of drug resistant TB. Where resistance already exists to first line drugs such as isoniazid and rifampin, the DOTS program reverted to a short course of pyrazinamide and ethambutol. These were at doses insufficient to treat active TB, but in doses large enough to boost resistance. Further, if a patient’s TB was not cured, DOTS also called for retreatment with rifampin and isoniazid. So in these circumstances the DOTS programme could actually cause a worsening of the MDR TB situation.
In 1999 WHO and their partners launched DOTS-Plus. DOTS-Plus was to be developed as a comprehensive initiative that was to build upon the five elements of DOTS. However it would take into account specific issues such as the use of second line anti TB drugs, that needed to be used in resource limited settings where there were significant levels of MDR TB.
This new approach of DOTS Plus needed rapid assessment of its feasibility and effectiveness under programme conditions. So in 2000 the first DOTS-Plus pilot projects were launched and the Stop TB Working Group on DOTS-Plus for MDR-TB was also set up. One of the difficulties with the implementation of some of the DOTS-Plus pilot projects, was the need for quality second line anti TB drugs. These were normally very expensive and difficult to obtain. WHO and their partners made an arrangement with the pharmaceutical industry for preferential prices for the second line drugs used for the pilot projects.
However, it was considered important that these beneficial prices were only used in projects that were organised according to certain standards. So the Green Light Committee was established to review project applications.They had to decide whether the applications were sufficiently in accordance with the guidelines that had been established for the pilot projects.3“DOTS-Plus & the Green Light Committee”,
www.who.int/tb/publications/2000/en/index.html If programs were approved the drug purchasing took place through the Global Drug Facility.4“What is the GDF?”,
www.stoptb.org/gdf/ By July 2005 36 DOTS-Plus pilot projects had been established in 27 countries for the treatment of more than 10,000 MDR-TB patients.
With the ending of the piloting phase of DOTS-Plus it was believed that there was evidence that MDR-TB management was both feasible and effective in resource limited settings. With additional resources being available for MRD-TB control, there was then a rapid increase in the number of countries implementing DOTS-Plus.
The Global Plan to Stop TB 2001-2005
By the year 2000 some global TB targets set in 1991 had still not been met. So further international meetings were held, and a new declaration was the Amsterdam Declaration to Stop TB. The same goals were once again set, but this time to be achieved by 2005.5“Amsterdam Declaration to Stop TB”, Amsterdam, The Netherlands, 24th March 2000
The Stop TB Partnership was set up in 2001 following the Amsterdam Conference in 2000. Initially the partnership comprised just six organisations. Three of its working groups were:
- DOTS Expansion
By the time the first Stop TB Partners’ Forum took place in October 2001 the partnership had grown from six to over 120 organisations. At the Forum the launch took place of the Global Plan to Stop TB 2001-2005. Its aim was to provide a “roadmap” towards a TB free world, and it was considered that the 2005 TB control targets were realistic.6“First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6
The Global Plan to Stop TB 2001-2005 made a number of commitments including that:7“First Stop TB Partners’ Forum”, Washington, 22 October 2001, 6
- Within the next 50 months - by the end of 2005:
- A global DOTS case detection rate of at least 70% would have been achieved, while maintaining a treatment success rate of at least 85%
- Effective responses to TB/HIV and MDR TB would have been developed and scaled up
- A Global Plan to Stop TB for the period 2006-2010 would have been developed.
The ending of DOTS Plus
In 2006 WHO decided on an expansion of DOTS. This was not though a geographical expansion. This was effectively a redefinition of DOTS. In future DOTS would be about the provision of diagnosis, treatment and care for all patients. This would include those with drug resistant TB, and also patients co-infected with TB and HIV. Effectively DOTS Plus would no longer exist, as its various parts for drug resistant TB, and for TB/HIV co-infection were included in a redefined DOTS program.
The Global Plan to Stop TB 2006-2015
Once again the targets set in a Global Plan to Stop TB had not been reached. This time it was the targets in the Global Plan to Stop TB 2001-2005. These targets had been considered realistic back when they were set in 2001.
In the new global plan for 2006-2015, the targets were no longer set in terms of the percentage of people reached in case detection rates, or a treatment success rate of at least 85%. Instead there were a range of targets covering specific areas such as the development of improved diagnostics and drugs, and the targets set in the Millenium Development Goals.
The Global Plan to Stop TB 2011-2015
In 2009 the Stop TB Partnership produced a report on the progress that had been made in global TB control between 2006 and 2008.8“The Global Plan to Stop TB 2006-2015: Progress Report 2006-2008”, WHO, 2009 www.stoptb.org/resources/publications/plans_strategies'Many different areas were highlighted and in some, significant progress had been made, whereas in others, such as screening HIV positive people for TB, it was noted that much less progress had been made. It was particularly noted that the provision of funding for TB was an area of particular difficulty with a funding gap still existing of over US$1 billion per year.
Is DOT still needed?
DOT is the direct observation of treatment and it has continued to be an important part of DOTS overall. But is it still useful and indeed necessary?
The authors of a 2015 Cochrane review concluded that:
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, policymakers might want to reconsider strategies that depend on direct observation
But nothing appears to have been done. Also in some countries such as South Africa it is now considered to be an invasion of personal freedom and it adds to the stigma of TB.10Elri Voigt, Some TB patients still required to take pills in front of witnesses, September 2020, https://www.dailymaverick.co.za/article/2020-09-18-some-tb-patients-still-required-to-take-pills-in-front-of-witnesses
After 2015 - Another Global Plan
This time the plan was to end TB, with the WHO End TB Strategy, and the Global Plan to End TB 2016 - 2020. Meetings were held, documents were written and targets set. It was said that there needed to be a paradigm shift, that there needed to be a radical change in how TB was viewed. A belief that this time it was different. The WHO End TB Strategy and the Global Plan to End TB 2016 - 2020 set out as other plans had before the resources needed and how the targets could be met.
Why is it going to be different?
However, what they did not explain was why this time it would be different. Except that at some point those people who can implement these changes might decide that they care. They care about the 1.5 million people who die each year from a curable disease. Resources were made available for Ebola, and how many people died? The answer is a fraction of the people who died in the same period from TB. This time lets all show that we care.
This page was last updated in September 2020.
Author Annabel Kanabus
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