TBEC Board Co-Chair Dr Jonathan Stillo recently gave a presentation at the MSF Regional Tuberculosis Symposium in Kyiv, Ukraine on March 5^th 2020 on the pros and cons of DOT. He has generously agreed to share a summary of this presentation here below.

Directly observed therapy is when a person is watched by someone (or some device) while they take their treatment. This can take place in a hospital or medical centre, supervised by medical professionals; it can take place at home, supervised by medical professionals, civil society organisations, or trained family members; it can even take place digitally, with patients sending videos of their compliance to treatment (this is often referred to as Video Supported Therapy (VST) or Video Observed Therapy (VOT)). The World Health Organisation (WHO) DOTS Strategy (2014) and Ethical Guidance (2017), recommend a patient-centred approach with multiple options for treatment including but not limited to observed treatment. Any treatment scheme, the WHO states, should include economic, social and psychological support. If DOT is included, it should be available at a location of one’s choice, provided by a supporter of one’s choice and the cost associated with treatment (e.g. transport) should not be borne by the patient.

Many studies and reviews of the WHO programme and Green Light Committee reports show that DOT schemes very rarely meet these criteria, especially in rural areas (e.g. Benbaba et al 2015 and de Colombani et al 2013). In the case of Mumbai, there were wide differences between reports on the delivery and efficacy of DOT coming from providers versus what patients were reporting. This is also the case in Romania, which has reported that there is 100% “DOTS coverage” since 2006, however, in 2013, it was announced that in rural areas (covering 45% of the population) even dispensary or family doctor-based DOT was not possible due to health system limitations. But Romania is not alone. These same challenges are faced in many parts of the WHO European region.

Is DOT a burden or even harmful?

• Generally direct and indirect economic costs are paid by the patient and their family. For example, when DOT does not occur at home, patients and their families have to cover costs such as transport, time off work (especially for people involved in agriculture and other work that has seasonal requirements), the time needed to care for small children or other dependents. This can be especially burdensome to women.
• DOT is expensive for health systems and is often weak or non-existent in rural areas.
• DOT can cause patients to be stigmatised against if they are seen going to TB treatment centres or having DOT staff (especially if staff use identifiable vehicles) visit one’s home.

There is very little decisive evidence as regards the efficacy and use of DOT and what there is often contradictory.

Multiple systematic reviews and meta-analyses show that there is no clear benefit from DOT versus self-administered treatment (SAT) for active and latent TB treatment (most recently Karumbi and Garner 2015).

However, a systematic review of community-based DOT did show a benefit versus SAT (Zhang et al 2016). However, much of the DOT that happens in our region is hospital or clinic-based, not community-based.

There is strong data showing that economic, social and psychological support increase adherence. Sometimes these are delivered as part of DOT, but often they are separate. The WHO recommendations prioritise community-based DOT over health facility DOT and observation by trained workers is preferred over family observation or SAT. However, the quality of the evidence this is based on is low.

Human rights and ethical concerns connected to DOT

• Privacy – as stated, DOT can make patients’ conditions public and cause them to face stigmatisation.
• Dignity of people with TB and their families must be respected
• Health accessibility (especially economic) services should be accessible to everyone?
• The principle of reciprocity- people with TB endure a long and difficult treatment which provides a public health benefit to society. In return, society has an obligation to provide social and economic support
• The right to work—TB treatment should not interfere with one’s ability to work.
• The right to education—TB treatment should not interfere with one’s access to education.
• The right to participate in cultural life

In summary, the evidence base for direct observation therapy is weak and recent research suggests that it provides no adherence or outcome benefit. DOT is based on a historical mistrust of people with TB, who are not considered able or likely to adhere to treatment. The clinic or hospital-based DOT that most people receive is not patient-centred and may cause an economic burden due to the associated costs. If TB treatment is truly to be patient-centred and based in human rights, it must offer flexibility for people with TB and their families to determine, in consultation with medical staff what the most supportive and least disruptive approach would be. Adherence technologies like VOT/VST are tools, which may help some people adhere to treatment, but they are not a “magical bullet” or a “one-size fits all” solution. They can also introduce additional human rights concerns. This is the time to talk about what does work and to promote strategies that are patient-centred, evidence-based, and which respect human rights. For more information please click here.