Disconnected DOTS: Tackling Tuberculosis Is More Than Just Therapy – Sumit Raybardhan

Introduction
Tuberculosis (TB) was believed to be relatively well-controlled public health disease, till its’ re-emergence in the mid-1980s. Several factors, including the HIV/AIDS epidemic, rising poverty rates, and demographic pressures lead to this re-emergence (1). It was in this context that the World Health Organization (WHO) declared TB to be a public health emergency and developed a global public health framework to combat this disease. The directly observed therapy short-course (DOTS) strategy was launched in 1993 providing a ‘blueprint’ for TB control (1). The strategy centred around the concept of directly observing a patient taking their TB medication by a health care professional and involved government commitment to TB control, passive TB case detection, secure and regular supply of essential TB drugs, and a monitoring and evaluation system for the TB program (1). The WHO’s recommended strategy of DOTS has been a cornerstone of global public health programs in tackling tuberculosis. However, the strategy’s focus on direct observation of TB treatment is of particular concern and will be the focus of this paper.

TB is a chronic infectious disease that requires the administration of complex medication regimens. TB primarily affects the respiratory system and requires taking three to four medications daily for at least 4 to 6 months (2). Furthermore, these medications can have significant side effects, including gastrointestinal disturbances, peripheral nerve damage, and liver and kidney effects. Consequently, many patients are deterred from initiating and maintaining taking TB medications during the treatment period. Therefore, an important component of any TB control strategy is to ensure patients are taking their medication properly and consistently. This requires careful monitoring and proper patient education. Poor adherence to TB treatment regimens remains a major barrier to TB control (2, 3), as such behaviour reduces treatment efficacy, causes drug resistance, and increases morbidity and mortality (2).
Although DOTS has provided a framework to try and control TB, it does not take into account the importance of adherent behaviour to TB treatment success. This strategy fails to address the social elements of non-adherent behaviour that is driving this epidemic. The DOTS strategy focuses on the treatment aspect of TB, without effectively illuminating the social and behavioural dimensions of this disease. India, an important testing ground for many of the principles of DOTS, fully adopted this strategy into its national TB control initiative in 1992. However, despite a national TB program that is based on the DOTS strategy, India continues to have nearly 25% of new TB cases in the world and accounts for 30% of the tuberculosis disease burden (4). In this paper, I will draw on the Indian experience to illustrate the social and behavioural vacuum in which the DOTS strategy is operating in. However, given the global utility of this public health strategy, the experiences in other countries that have implemented DOTS will also illuminate the appropriateness of this strategy.

DOT fails to encourage self-efficacy
WHO recognized that treatment adherence was key for successful TB control and grounded DOTS around the concept of directly observed therapy (DOT), whereby a health care provider observes a patient take the TB medication for at least 2 months of treatment (1). In of itself DOT is not based on any social theory, even though it aims to address the issue of medication adherence, which has many social and behavioural facets (1,2). Fundamentally, DOT breaches patient autonomy and self-care, thereby directly interfering with the concept of self-efficacy posited by social cognitive theory. Empowering patients is important to establish and maintain medication adherent behaviour, by observing a patient take a TB medication, it removes any sense of confidence or autonomy the patient might have in pursuing adherent behaviour (1,2). The WHO has advocated for the use of DOTS without taking into account that it promotes a very paternalistic model of health care, and creates an imbalance of power and capacity between the public health professional and infected patient (5).

The importance of patient autonomy as a predictor for TB treatment adherence has been recognized in many settings (1), and in fact there has been a growing trend to implement DOTS as a patient-centred strategy (6). However, this is still not the norm. Many countries are still implementing DOTS using health care providers as the only source for observing patients taking their medications.

In an international survey looking at DOTS implementation, the ramifications of such an approach, was seen in India and other countries, where patients perceive that utilizing health care workers in observing them taking TB medications is constrictive and indicates mistrust, which subsequently decreased self-care (1). A separate Indian survey evaluating the impact of the revised national TB strategy, found a majority of patients did not participate in DOT programs because of the logistical issues of attending a clinic where the TB medication could be observed being taken (7). A notable finding from this survey, also found that providers (i.e. health care workers) of DOT would selectively screen only those patients who were deemed to comply with the DOT program. Furthermore, the research found that those that were most likely to be refused DOT treatment were “in absolute poverty, socially marginalized, and itinerant labourers” (7). The authors concluded that in an attempt to meet TB control targets, the DOT program was failing to provide TB care to the potentially most vulnerable patients (7).

DOT provides the wrong focus
The study findings that I have mentioned earlier point to the problem of depending on DOT for dealing with TB medication adherence. It removes patient autonomy and impinges on self-efficacy, creating a constrictive and non-empowering environment where the patient cannot pursue medication adherent behaviour. Furthermore, by moving the focus onto the patient, DOT programs, detract the responsibilities that health care providers and health care systems have in providing the necessary elements whereby patients can engage in medication adherent behaviour (5). Rather, as in the case of India, health care providers are focused on achieving TB control targets.

There are considerable consequences of ensuring TB medication adherence through a process such as DOT. By removing patient autonomy and not taking into account the social dimension of medication adherence, DOT provides a narrow context in which to understand these issues. Primarily, DOT is an individual level intervention that constrains the view of medication adherence into a bio-medical context, forcing a proximate understanding of why patients do not adhere to their TB medications. It fails to contextualize the risk factors for medication non-adherence.

Contextualizing risk factors has been argued as an important element in disease modification (8), which holds even more significance with a disease that spreads through social means, such as TB does. Indeed stigmatization of TB is an important barrier to accessing and completing TB treatment found globally (9) and in South East Asian countries (10,11). However, understanding these important social links can be restricted by DOT, as it provides a bio-medical perspective. These links are not just superficial in terms of determining risk factors for contracting and spreading TB, but also filter down to treatment issues. The implementation of DOT as a public health strategy implicitly has driven research into identifying patient-related factors for understanding when such programs fail and how to improve implementation of DOT (12). However, since the early 1990s it has been recognized that patient adherence to TB medication is multifaceted, and not only requires an understanding of patient related factors but the social and economic context in which they operate (13).

Unfortunately in India, this limited view of medication adherence as promoted by the DOT strategy, has been the primary driver for research in India. An Indian study conducted in 1992 to understand why patients were not adhering to medications identified health beliefs, education, and socioeconomic factors as strong predictors for not adhering to medications (14), however, remarkably the authors conclude that educational interventions (patient-related factors) are key to improving medication adherence (12). More recently in 2006, a study conducted in south India, where authors identified education and access as key reasons for not being able to comply with DOT programs, still primarily concluded of the importance of developing TB educational materials for improving adherence (15).

Contextualizing medication non-adherence is needed
The spread of TB is heavily influenced by social determinants (12). One of the primary determinants is poverty and the associated issue of health care access (9,12,13). Non-adherence to TB medication needs to be understood in this context. Simply using DOT as a tool for TB control does not address the issues of poverty and access, since the strategy can only be implemented when the patient accesses the health care system. There is no active provision to seek out patients who are suffering from TB and cannot access the health care system. In order to be an effective and sustainable public health intervention that ensures TB medication adherence, DOT must make these social realities explicit. Evidence both in India and it’s neighbour, Pakistan, point to the issues of poverty and health care access as barriers to TB medication adherence (7,10,15), however little has been done to incorporate these issues into the DOT strategy.

Indeed, the global experience from implementing DOT, has been varied. In most settings there is great variation between and within countries regarding observation of a patient taking the medication (16). Some programs, such as the one in Gambia, provide medications on a weekly or biweekly basis to the patients to take home for administration, which ultimately is self-administration (1). Countries such as South Africa, Malawi, Colombia, have adopted a patient-centred approach. These strategies include patients choosing who will be their supervisor and a decentralization of supervisory responsibilities by allowing community lay-workers supervise administration of TB medication (1, 17). Initial assessments of these programs have shown that these methods provide more efficient TB control (1), compared to the biomedical-centred approach of a health care provider initiated observation of TB treatment.

Patient centred modifications made to DOTS are essential to understand treatment adherence of a disease that is spread socially. Allowing patients to choose their own medication administration supervisor or decreasing the number of supervisory visits, increases patient autonomy and self-efficacy. In addition, decentralizing supervisory responsibilities to the community can increase access.

Implications
The WHO as the global public health agency that developed the DOT strategy, should make these issues explicit in the strategy, so as to provide guidance to governments on how to properly tackle medication adherence issues around TB. Medication non-adherence is a critical component in TB treatment failure, the rise of resistant TB strains, and the spread of this disease. It is even more significant with the advent of the HIV and TB co-epidemics. This was not more evident than the recent outbreak of the highly drug-resistant strain of TB in South Africa. Not only was the strain resistant to first-line TB medications, but also several second-line TB medications as well. Even though the majority of infected individuals also tested positive for HIV, it also infected health care personnel, with a case fatality rate of 98% (18).

Conclusions
The DOT component of the DOTS strategy proposed by the WHO is a misspent opportunity to tackle a complex issue that is integral to properly control TB. It aims to tackle an issue heavily steeped in social and economic factors, without any grounding in social theory. Consequently it shifts focus to patient related issues both in regard to research and implementation, ultimately failing to recognize the broad social constructs impeding TB medication adherence. Given the importance of medication adherence to TB control and the urgent need for an effective public health strategy that tackles this issue, the DOT component should be revised to reflect the intricate social, behavioural and economic realities of TB medication adherence.


References
Lienhardt C, Ogden JA. Tuberculosis control in resource-poor countries: have we reached the limits of the universal paradigm. Tropical Medicine and International Health 2004; 9(7):833-841.


Munro SA, Lewin SA, Swart T, Volmink J. A review of health behaviour theories: how useful are these for developing interventions to promote long-term medication adherence to TB and HIV/AIDS? BMC Public Health 2007; 7(4):1-16.


Dick J, Ernesto J, Dermot M, Volmink J. Tuberculosis (pp 123-133). In: Adherence to long-term therapies: evidence for action. Geneva, Switzerland: World Health Organization, 2003.


Khatri GR, Frieden TR. The status and prospects of tuberculosis control in India. International Journal of Tuberculosis and Lung Disease 2000; 4(3):193-200.


Hurtig AK, Porter JDH, Ogden JA. Tuberculosis control and directly observed therapy from the public health/human rights perspective. International Journal of Tuberculosis and Lung Disease 1999; 3(7):553-560.


Volmink J, Matchaba P, Garner P. Directly observed therapy and treatment adherence. Lancet 2000; 355:1345-1350.


Singh V, Jaiswal A, Porter JD, Ogden JA, Sarin R, Sharma PP, et al. TB control, poverty, and vulnerability in Delhi, India. Tropical medicine & International Health 2002; 7:693-700.


Link BG, Phelan J. Social conditions as fundamental causes of disease. Journal of Health and Social Behaviour 1995; Extra issue:80-94.


Bates I, Fenton C, Gruber J, Lalloo D, Lara AM, Squire SB, et al. Vulnerability to malaria, tuberculosis, and HIV/AIDS infection and disease. Part II: Determinants operating at environmental and institutional level. The Lancet infectious diseases. 2004; 4:368-375.


Khan MA, Walley J, Witter SN, Shah SK, Javeed S. Tuberculosis patient adherence to direct observation: results of a social study in Pakistan. Health Policy and Planning 2005; 20(6): 354-365.


Meulemans H, Mortelmans D, Liefooghe R. The limits to patient compliance with directly observed therapy for tuberculosis: a socio-medical in Pakistan. International Journal of Health

Planning and Management 2002; 17:249-267.


Farmer P. Social scientists and the new tuberculosis. Social Science and Medicine 1997; 44(3):347-358.


Sumartojo E. When tuberculosis treatment fails: a social behavioral account of patient adherence. American Review of Respiratory Disease 1993; 147(5):1311-20.


Barnhoorn F, Adriaanse H. In search of factors responsible for noncompliance among tuberculosis patients in Wardha District, India. Social Science and Medicine 1992; 34(3):291-306.


Gopi PG, Vasantha M, Muniyandi M, Chandrasekaran V, Balasubramanian R, Narayanan PR. Risk factors for non-adherence to directly observed treatment (DOT) in a rural tuberculosis unit, South India. Indian Journal of Tuberculosis 2007; 54:66-70.


De Cock KM & Chaisson RE. Will DOTS do it? A reappraisal of tuberculosis control in countries with high rates of HIV infection. International Journal of Tuberculosis and Lung Diseases 1999; 3:457–465.


Macq JC, Theobald S, Dick J, Dembele M. An exploration of the concept of directly observed treatment (DOT) for tuberculosis patients: from a uniform to a customised approach.


International Journal of Tuberculosis and Lung Disease 2003; 7(2):103-9.
Singh JA, Upshur R, Padayatchi N. XDR-TB in South Africa: no time for denial or complacency. PLoS Medicine 2007; 4(1):e50.