Connecting the DOTS: Should we still be doing directly observed therapy?

Abstract

Since the 1960s, the primary approach to treating tuberculosis (TB) worldwide has been directly observed therapy (DOT) (taking medication under supervision). Drawing on ethnographic data from Romania, literature on DOT globally and a human rights-based analysis, I argue that in many places DOT is not occurring as intended, and that it is ineffective, onerous to the people being treated and in conflict with their human rights. Instead, DOT should be one of several types of adherence supports from which people can choose within a rights-based and person-centered treatment that serves their varied needs through their long and difficult TB treatment.

ABSTRACT (ROMANIAN)

Începând din anii 1960, metoda principală de tratare a tuberculozei (TBC) la nivel global a fost tratamentul direct observat (DOT) (administrarea medicamentelor sub supraveghere). Argumentul meu, bazat pe rezultatele cercetării mele etnografice din România, studii asupra DOT la nivel global și o analiză fundamentată pe drepturile omului, este că, în multe locuri de pe mapamond, DOT nu este implementat conform intenției inițiale, este ineficace, împovărează persoanele cu TBC și le încalcă drepturile umane. DOT ar trebui de fapt să fie o opțiune printre mai multe servicii de suport al aderenței la tratament oferite persoanelor cu TBC în cadrul unui model de îngrijire centrat pe persoană și fundamentat pe drepturile omului care răspunde diverselor nevoi pe care acestea le-ar avea în timpul lungului și dificilului lor tratament pentru TBC.

Implications

Directly observed therapy (DOT) is a cornerstone of TB treatment globally. However, clinic-based DOT has no medical benefit and, when used without socio-economic and psychological supports, is widely recognized as causing harm to people with TB. National TB programs should instead offer human rights-based and person-centered TB treatment and support options that best fit people’s needs, which may or may not include DOT. Donor, civil society and technical organizations should support these efforts.

Video Abstract

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©2024 The Author(s). Published with license by Taylor&Francis Group, LLC

Social Media Statement

Using ethnographic data from Romania, Jonathan Stillo argues that mandatory Directly Observed Therapy (DOT) causes harm to people with TB and that DOT should only exist as an option within rights-based, person-centered treatment.

Keywords:

• Romania
• DOT
• human rights
• person-centered
• tuberculosis

You need food for this treatment, you can’t take it on an empty stomach … If I take the treatment at home [DOT] and not go to work, I don’t have enough money to survive (Ion).

Despite the availability of effective medications and delivery strategies, Tuberculosis (TB) is responsible for a considerable portion of human suffering and deaths. In 2021, 1.6 million people died from and 10.6 million became ill with TB (WHO 2022, 2). Directly observed therapy (DOT) is at the heart of modern TB treatment: this requires people to take daily antibiotics while a health worker watches them do so. Based on fieldwork in Romania and critical analyses of policy and research literatures, I argue that, despite its centrality to TB care since the 1960s, DOT seldom occurs as intended, or at all, in many places. Further, most forms of DOT do not improve treatment outcomes, are onerous to many people being treated and conflict with human rights.

My findings exemplify the contrast between official guidelines for DOT and what happens on the ground. As a flexible localized strategy, DOT has the potential to alleviate the suffering caused by TB illness and treatment, but providers’ current application of DOT as a singular clinical regimen perpetuates this suffering by failing to consider community and individual life contexts and social forces. In this article, I draw attention to the ineffectiveness and direct and indirect costs of particularly clinic-based DOT. I am not suggesting that the absence of DOT would improve TB care, but investing in increased clinic-based DOT would be a poor use of funds. I argue that countries such as Romania can “leapfrog” directly to flexible, supportive forms of treatment which may or may not include DOT as part of a menu of options; and argue the value of more rights-based, person-centered approaches to care.

Ultimately, in this article I call for transparency and integrity at the global and local levels regarding the organization of treatment. I urge policymakers and clinicians to acknowledge that one-size-fits-all solutions do not serve all people equally well, and to prioritize flexible, rights-based approaches required by the expressed everyday needs of people with TB and their families.

Significance

Due to its many social dimensions (understood in the broadest sense, e.g., Koch 2016; Stillo 2020), TB has long been of interest to anthropologists, whose numerous contributions highlight issues such as: the problem of blaming people with TB for their inability to adhere to treatment, and the challenges of DR-TB (Das 2014; Farmer 2001, 2005); TB stigma and how a TB diagnosis can affect one’s sense of self (Villar and Carroll 2023); the introduction of DOT and its creation of “defaulters” (Seeberg 2014); the adoption of DOTS and modernization of diagnostic and treatment capacity (Koch 2013, 2016); challenges in accessing new diagnostics and medicines (Harper and Khatri 2020); and the interplay between TB and issues such as substance use, poverty, gendered violence and moral judgements about people with TB (Versfeld 2023).

Medical anthropologists provide technical advice to national programs and international organizations that ultimately influence major policy shifts, including the diagonal approach popularized by Partners in Health, whereby funding for one disease is also used to strengthen health services for adjacent conditions, such as HIV and TB, hepatitis, and so on (e.g., Mukherjee 2017). However, rights-based and less vertical approaches have not taken hold in much of Eastern Europe and Central Asia, where TB programs have long histories and aging infrastructures. For example, Romania’s infrastructure, which encompasses hospitals, sanatoria (special hospitals designed for long stays) and clinics, was created for largely inpatient treatment. For political reasons, as these are major employment sites and there are no mechanisms to fund community-based services, domestic funding continues to support hospital- and clinic-based approaches. In much of the WHO-EURO region, this is still based on per-bed calculations, in contrast to modern community-based approaches to TB care which elsewhere are replacing clinic-based DOT.

By relying on uniform case definitions and procedures, DOT promised comparability between vastly different settings (McMillen 2015) and aligned with post-World War Two one-size-fits-all vertical health interventions. The Directly Observed Therapy Short-course (DOTS) Strategy adopted by the World Health Organization (WHO) in 1994 consisted of five pillars: direct observation, political will, case detection using microscopy, an uninterrupted supply of anti-TB drugs and a standardized recording and reporting system (WHO 1994).

The practice of direct observation was criticized for being highly labor-intensive, requiring the creation of systems often far beyond local health programs’ capacity. These interventions also struggled due to their narrow focus on one specific disease, often in the context of weak, underfunded health systems (Basilico et al. 2013), and limited the spread of more sustainable community-based supports and synergies within other health programs.

Despite its claim of standardization, DOT varies greatly within and between countries, ranging from its absence or just periodic visits for additional medications, to bare-bones clinic-based DOT, to DOT without social and economic support but more flexible thanks to technologies such as phone applications and text reminders, to more supportive approaches that include socio-economic and psychological supports as well as the provision of medication under observation in places and by observers of a person’s choosing. Within this range of possibilities, the absence of DOT is notable given that DOT has been a cornerstone of TB treatment since the 1960s. Even in relatively well-resourced settings such as Mumbai (Benbaba et al. 2015), wide variations were documented between descriptions by providers and reports by people with drug-resistant TB (DR-TB) – a group for which DOT is especially advised – of what happened during DOT practices. Nevertheless, both providers and those being treated said that most people did not receive strict DOT. This poor implementation, particularly of community-based DOT, can also be observed elsewhere, including in China (Hu et al. 2008), Brazil (Rainho Brás, de Freitas, and Nunes 2020) and Moldova (WHO 2013).

DOT has also been criticized because of weak and inconsistent evidence for its effectiveness. Several systematic reviews have reported no apparent benefit from observation for treating either (active) TB disease or (latent) TB infection relative to self-administered treatment (SAT) (Karumbi and Garner 2015; Pasipanodya and Gumbo 2013). The one type of DOT that surpasses success rates of self-administration is community-based DOT, i.e., involving a trained supporter in one’s community (Zhang et al. 2016). However, community-based DOT did not improve the number of people lost to follow-up (Wright et al. 2015), i.e., people who stop coming for treatment (formerly known as “defaulters”). This finding contradicts most medical staff I interviewed, who argued that clinic-based DOT especially was critical to maintaining adherence—particularly for people deemed less cooperative.

Some community-based DOT programs also differ by offering economic and psychological support. These WHO-recommended interventions can reduce the severe burdens faced by people with TB and their families (WHO 2017), including treatment costs, and can improve outcomes for certain populations (Lutge et al. 2015; Wingfield et al. 2017). However, these supports are interventions in and of themselves and are frequently not part of DOT programs—particularly in Eastern Europe.

Further, although TB is one of many diseases with long or complex treatments, it is the only disease for which direct observation is nearly universally recommended. In contrast, diabetes treatment, for example, does not require observation, but rather a variety of approaches such as the 5Rs – right medicine, right dose, right route, right patient and right time (Wungrath and Autorn 2021). The justification for mandatory TB treatment observation is rooted in mistrust of the “types” of people perceived as at risk for TB, assumed to be unreliable and who will ignore doctors’ instructions, eschew the sick role or put other people at risk (Coker 2000; McMillen 2015; Rothman 1994). These ideas are incorrect since TB is an airborne disease that has always affected the totality of society. Further, this distrust and blaming of people with TB by medical staff and public health authorities have targeted marginalized populations, whose rights have been violated by compulsory practices such as DOT. While protecting the greater public from harm justifies limitations to the rights of people under the Siracusa Principles, the latter requires that restrictions be evidence-based and proportional to the potential risk (UNCHR 1984).

These concerns underscore the importance of person-centered and human rights-based TB care. Person-centered care places the person at the center of decisions about their care. Central to this approach is “respect for patients’ values, preferences, and expressed needs” (Gerteis, Edgman-Levitan, and Daley 1993, xxii). Human rights-based approaches move beyond biomedical or public health-based approaches as they are grounded in international and regional treaties and laws, such as the International Covenant on Economic, Social and Cultural Rights (UNHCHR 1966), and may be enshrined in national constitutions (Citro et al. 2016). Such documents create legally binding obligations on the part of states to observe people’s rights to nondiscrimination, dignity, autonomy, health and benefits of scientific advancement. Additionally, a rights-based approach analyzes and addresses problems which may be grounded in political and economic systems and unjust relations of power. For these reasons, we might think of a rights-based approach as including the characteristics of person-centered care, but revolving around the inherent rights of empowered individuals. This more comprehensive approach is seen as having created more effective and sustainable change, for example in HIV/AIDS care (Citro et al. 2016).

Person-centered, rights-based care should guide DOT. The consensus among most TB experts and technical/funding organizations is that DOT without socio-economic and psychological supports can do harm. Moreover, the WHO’s Ethical Guidance for the Implementation of the END TB Strategy makes it clear that, due to its burdens, DOT is “ethically justifiable only when done as part of a patient-centered approach to care” (WHO 2017,19). The long history of distrust and blaming of people with TB (Engel 2015; Farmer 2001) helps explain why, in the vast majority of instances, DOT does not meet these ethical standards.

If DOT is to adhere to WHO guidelines, its manner and the supports accompanying it should be tailored to meet each person’s needs. Eastern Europe and Central Asia favor medicalized approaches focusing on longer hospitalization followed by clinic-based DOT, to the detriment of more flexible and supportive forms of treatment. The historical specificities of TB care in the former Soviet Union and socialist countries (e.g., Koch 2013; Reichman and Hopkins Tanne 2003) are beyond the scope of this article, but even within these countries, one can find examples of person-centered, supportive DOTS programs—usually in collaboration with civil society organizations. The Sputnik project, which Partners in Health implemented in Russia, provided supportive services with DOT and targeted people who had difficulty adhering to standard treatment due to challenges such as substance use and being unhoused, by offering additional supports like clothing, assistance with documents, greater flexibility and access to nurses via provided cell phones (Gelmanova et al. 2011). Recently, a person-centered DOT trial in Armenia, which included greater flexibilities and supports than standard DOT, suggests that the former could be better for people with TB and be more cost effective (Khachadourian et al. 2020).

A variety of successful person-centered strategies, including counselling, text reminders, peer support via telephone and financial and in-kind incentives (Kanters et al. 2017), are used to improve adherence for HIV, diabetes and many mental health conditions, which require long-term (and even lifetime) treatment. Community-based supportive services for HIV/AIDS have been used successfully in countries like Haiti, South Africa, Rwanda and Lesotho. Some of these settings have integrated DOT for TB as part of a package of care (Fatti et al. 2012; Jerome and Ivers 2010; Joseph et al. 2012; Rich et al. 2012). Programs which provide supportive services for HIV, but not for TB, can create preferential adherence. People with HIV and TB in South Africa reported adhering to HIV but not to DR-TB treatment, due to the adverse reactions of TB medicines, feelings that their adherence to TB treatment was the responsibility of the observing nurse, TB stigma and the perception that TB treatment had worse outcomes because of the better education and counselling associated with HIV treatment (which is self-administered) (Daftary, Padayatchi, and O'Donnell 2014).

Rights-based, supportive and flexible approaches to treatment, which rely on community ownership rather than on surveillance, as common for HIV, emerged from activism and the demands of affected communities (e.g., Fassin 2007; Powers 2020; Susser 2009). These demands and activism now also come from the TB-affected community. One aim of the health system and TB treatment reforms proposed by the European Office of the WHO through the TB-REP projects is to guide countries in the region towards more supportive and flexible approaches to TB care, including socio-economic and psychological supports, community-based options and technology-assisted options (WHO 2023). Nevertheless, these projects do not broach the question of whether DOT should be required for everyone.

With United Nations high-level meetings occurring in 2018 and 2023, more attention is being dedicated to the disease through the leadership of TB survivors’ groups such as TB People, which authored the Declaration of the Rights of People Affected by TB (TBP and STBP 2019). However, it remains to be seen whether greater political will, new drugs and new diagnostic technologies will benefit everyone equally, and whether the health system and social welfare barriers to people’s treatment adherence can be overcome. Top down, one-size-fits-all approaches that are highly medicalized and increasingly reliant on technology will not address the problems I described below.

Methods

Romania’s TB rate in the mid-2000s was the second highest in Europe and Central Asia and unexpectedly high for a European Union (EU) member (WHO 2009). These statistics can be explained by Romania’s special placing at the convergence of forces characteristic of either more or less wealthy countries. Romania’s health and social welfare systems are well below European standards and have problems which can be found in poorer countries. At the same time, as an upper-middle income country and EU member, Romania is disqualified from receiving aid and benefits for which less wealthy countries with serious TB burdens (e.g., neighboring Moldova) are eligible, which might help stem its health and social welfare problems. Romania is eligible for some external funding, but this is not enough for the fundamental systemic changes necessary for implementing flexible, supportive TB care in line with international best practices.

This article is based on an extended ethnography of Romania’s TB epidemic conducted between 2009 and 2014. This timeframe facilitated long-term follow-up with participants as it ranged from their diagnosis and hospitalization to outpatient treatment, typically through clinic-based DOT, in their home communities. My research question ultimately developed into “Why are so many Romanians dying of an ostensibly curable disease?” My research captured the experiences of people treated in diverse settings, such as the National Pulmonology Institute and associated clinics in the capital city, Bucharest, a TB sanatorium high in the mountains and local hospitals and county-level clinics. Methods included participant observation with people treated for TB, medical staff and NGO workers, as well as 130 interviews, 5 focus groups and 230 surveys with people being treated. I used convenience sampling to provide all people over the age of 18 who were being treated at these research sites with the opportunity to be interviewed or surveyed. I conducted all surveys, interviews and focus groups in private settings, usually outdoors or on balconies, where masks were not medically required, with no medical staff or other people present. Interviews were semi-structured and aimed to trace each person’s illness and treatment narrative (Kleinman 1988). Policy makers, NGO staff and 25 medical workers including doctors, nurses and psychologists were also interviewed for a more nuanced understanding of TB care in Romania at the levels of policy and practice, in keeping with Ecks and Harper’s call to include in TB research constituencies beyond people being treated (2013). All discussions were conducted in Romanian unless the participant preferred English.

I collected data on DOT primarily from the perspective of people being treated, but I include provider perspectives in this article to showcase their positions, including the stigma and blame they may direct at people undergoing treatment. I was present for clinic-based and, to a lesser extent, community- or home-based DOT.

Themes were deductively developed based on prior research (in 2006 and 2008), the results of the 230-person survey and published research available at the time. Subsequent inductive coding ensured that nothing was missed (LeCompte and Schensul 2013). I developed codes in Atlas.ti. My research focus was broader than DOT. However, it came up frequently in survey and interview responses, typically in relation to the challenges of treatment during the continuation phase, which begins once people are discharged from the hospital. These challenges were especially felt by rural people, who had socio-economic difficulties.

Key themes included: barriers to accessing DOT services, reasons (including adverse reactions) why ambulatory TB treatment was onerous and discontinued, participants’ expressed needs for supportive and flexible treatment and ethical concerns. Additionally, DOT is incredibly disruptive to the care work that disproportionately falls on women, who often neglect their health to care for their children and older relatives.

The ethics of applied anthropology

While the ethnography formally concluded in 2014, I also rely on my policy work and advocacy in the region, including as a member of the TB Europe Coalition Board and of the Global TB Community Advisory Board. In collaboration with Romanian TB survivors and NGOs, I started STOP TB Romania, an affiliate of the STOP TB Partnership at the UN. I have also served as an International Expert and/or consultant for the WHO European Office, the European Centre for Disease Control and Prevention (ECDC) and the Global Fund, including as recently as 2019. I travel to Romania at least once a year and have worked closely with TB survivors there and in Moldova on research and advocacy.

As time passed, I realized that I was documenting a crisis. Most people with DR-TB were not receiving the treatment they needed due to diagnostic delays and drug stockouts. One by one, I watched them grow sicker and die. Simply documenting these suffering and deaths from a curable disease would have been unethical and a violation of their trust, especially as many asked me to help so that others might not suffer like they did. I was also inspired by Ida Susser, who writes: “It is equally untenable to conduct ethnography among people who are dying for lack of an available treatment without joining the struggle for treatment” (2009,15). I took a critical medical anthropology and biosocial approach to research, which builds upon the work of Paul Farmer (2001, 2006), Jeremy Greene (2004) and others, who have examined the range of factors preventing people from being cured. I particularly aimed to answer Farmer’s call to “name and rank the causes of suffering” (2001), i.e., to look at structural violence as an explanation for health systems not serving certain people, while at the same time considering the victim blaming inherent in invoking individual factors such as poverty, alcohol use and lack of education as reasons for treatment non-compliance. My critical medical anthropology approach also has a feminist dimension, in keeping with Susser’s analysis of the uneven burden of care work that falls on women and its impact on their ability to adhere to treatment (2009).

For me, the only way to ethically research TB in Romania was as an applied anthropologist working in collaboration with TB survivors and their allies. I feel that I have produced academically honest research, which, at the same time, has been successfully used by policy makers and advocates to obtain funding and to improve protections for people with TB. I have helped Romania’s National TB program and NGOs write funding applications, assisted with the 2018 passage of Romania’s TB law, helped author a US Government humanitarian aid grant to improve Romania’s TB diagnostic capacity and was involved in the planning of a Norwegian Development Programme project that provided access to DR-TB drugs that had previously been inaccessible to most people who needed them.

Because of this continued involvement, I am confident that, despite the time elapsed since the beginning of my research, the descriptions in this article of the challenges surrounding TB care and clinic-based DOT still reflect present-day reality in parts of the WHO European Region where the uptake of rights-based and person-centered approaches to treatment has been slow and uneven.

Findings

“The bag” - is DOT really practiced in Romania?

Romania exemplifies the inadequate implementation of DOT, as became evident in my observations, discussions with Romanians and an official monitoring visit conducted by the WHO and the European Centre for Disease Prevention and Control (ECDC). DOT was not occurring as prescribed by international and Romanian treatment guidelines for the majority of Romanians (WHO and ECDC 2015).

One pulmonologist in a rural county explained that the outpatient phase of treatment “must be strictly supervised, but generally it isn’t …. They give the patient one month’s medication, and that patient may take it or not.” Shaking his head disapprovingly, the doctor looked at me and said, “the bag.” I knew what he was describing. I saw people coming to TB hospitals and clinics around Romania, dusty from long walks or carriage rides from their villages, and leaving with plastic bags full of antibiotics and instructions to return several weeks later.

In multiple hospitals and sanatoria, it was hard to miss the TB drugs that were stuffed into holes in the walls or thrown out of windows, leaving me to question whether DOT was even happening in inpatient settings. However, even with the inconsistent use of DOT, Romania achieved the WHO benchmark of at least an 85 percent treatment success rate for drug-susceptible TB (DS-TB) (WHO and ECDC 2015).

DOT was not implemented in rural areas because the contract made by Romania’s National Insurance Program that paid family doctors for the diagnosis and treatment of people with TB had ended. Without compensation, most family doctors refuse to provide DOT to people with TB (WHO and ECDC 2015). People with serious challenges such as homelessness or previous unsuccessful treatment might be sent to one of a few TB sanatoria. However, in general, once a person completes the inpatient treatment phase, they begin outpatient treatment through the TB clinic closest to their home, which, for rural people, might be a distant hospital in the county seat. This, combined with family doctors refusing to provide DOT, resulted in most people periodically collecting drugs from the clinic and self-treating.

A lack of nurses to perform in-home DOT was another barrier. Even bare-bones clinic-based DOT is labor-intensive and costly because it draws medical staff away from other tasks. Medical staff, including nurses, explained that, due to budget and staffing shortages, even public health nurses, who are tasked with home visits and other work outside the hospital, actually worked inside the hospital as regular nurses.

Limited international funding aggravates these budget constraints. Outside funds have been aimed at addressing outdated medical practices in Eastern Europe and Central Asia, such as lengthy hospitalization, sometimes for the entire duration of treatment. The Global Fund to Fight AIDS, Tuberculosis and Malaria, a major international donor, funded multi-year regional grants (known as TB REP and TB REP 2) that focused on changing these models of care to better reflect current evidence and recent innovations in diagnosis and treatment (TB REP 2018). Internationally funded in-home or community-based treatment was carried out by NGOs outside of urban areas, such as Bucharest and Ilfov county, where the National TB Program organized in-home DOT. Problematically, donor programs are time-limited, subject to funding and restricted to specific localities and populations. For example, The Global Fund provided one car in the mid-2000s to each of Romania’s counties. However, a strict fuel limit imposed by the National Insurance Program of 100 liters per month per county was inadequate for home visits in rural areas where 45 percent of Romanians live. Doctors of the World administered a successful project in multiple Romanian counties funded by the United States Agency for International Development (USAID) and the Global Fund (DOW 2004). It provided, among other things, adherence supports such as food vouchers; this support stopped when the project finished.

In 2013, at a press conference discussing the findings of a WHO mission to Romania, the National TB Manager admitted that DOT was not possible in rural areas, which meant that about half of the country was not covered by DOT. It was the first time anyone from the National TB Program had publicly said what my research participants had been telling me for years.

O boală care nu iartă - a disease that does not forgive

Widely feared in Romania, TB was historically called “a disease that does not forgive” (o boală care nu iartă), because it was fatal and brought great stigma to affected individuals and families. This stigma was a source of shame for many people I interviewed, as disclosure of their illness could compromise their personal and professional relationships. Andrei said: “It is shameful because your friends and coworkers avoid you. Even some members of my family do.” One participant revealed that only his doctor knew he had TB. He had hidden this information even from his wife, whom he had told he had cancer. Stigma and mistrust drive the current system. Many medical staff and policymakers at least partially and sometimes quite explicitly blamed people with TB for their poor outcomes (Stillo 2016).

Distrust of the poor and vulnerable – “expecting better reasons, like missing a leg” for in-home DOT

Doctors’ divergent opinions about how funds should be spent complicates plans to provide DOT up to international and Romanian guidelines. Many did not consider the needs of people with TB, and some blamed the most vulnerable for not adhering to treatment. While doctors generally supported projects, some disagreed that they were needed or were good uses of scarce resources. Dr. Dascălu decried such projects and told me that, out of a list of twenty people receiving in-home DOT, only two could not travel to a clinic. “Uncooperative, alcoholic or Roma” is how he explained what he regarded as the spurious reasons for people receiving these services. He was “expecting better reasons, like missing a leg.” His response echoed the opinion of some policymakers and other medical staff—that, because the TB program was so poorly resourced, funds should only be used for the most crucial elements. These included TB diagnosis and treatment within clinical settings, not for community-based outpatient treatment and DOT; and not for socio-economic and psychological support or more recent innovations such as rapid diagnostics and new and repurposed drugs.

These attitudes may also showcase a power differential between doctors and the people they treat. Villar and Carroll (2023) note that medical staff’s preference for high-barrier forms of TB treatment in Ukraine is rooted in historical paternalism and their subjective assessments about people’s desire to get well. The same logic is likely present in Romania, given the preference here for inpatient and clinic-based DOT over community-based forms and an unofficial, though clear, strategy of housing people in sanatoria who were unable to adhere to clinic-based DOT because they lack socio-economic and psychological supports. Similarly, Versfeld (2023) draws attention to uneven power relations between people being treated and observers.

Regardless of priorities, Romania’s TB funding is inadequate to pay for even minimal necessities such as an uninterrupted supply of anti-TB drugs and guaranteed diagnosis meeting international standards. Yet, shifting blame and responsibility to people with TB for not complying with the inpatient and clinic-focused models of care is pervasive. This blame is assigned by labeling them as alcohol or drug users to separate them from deserving patients. Even people with TB invoked these stereotypes to mark themselves as “good” or “deserving” patients. Carroll (2019) notes similar behavior in Ukraine among people who inject drugs. However, there were doctors whose perspectives differed significantly from these conservative views. They tended to have greater familiarity with recent scientific literature, had more progressive positions and acted closer to current policy focusing on person-centered care and community-based care.

Many of the people labeled as non-compliant expressed a strong desire to get better in interviews. However, they often lacked the ability to adhere to strict clinic-based DOT due to their employment and family responsibilities. Furthermore, most “social cases” (cazuri sociale) – people that medical staff deem unable to care for themselves outside of institutional settings due to poverty, alcohol and drug use, psychological issues, advanced age or a lack of family support – were once middle- and working-class (Stillo 2015). Interviews revealed that, for some, it was not only their disease but the organization of treatment and lack of socio-economic and psychological support that led to their unfortunate situations. In line with Farmer’s findings (2001), it was not their unwillingness but their inability to adhere to treatment that worsened their disease and caused social and economic disasters that disrupted their lives.

Clinic-based DOT is onerous

Adverse reactions to TB medicines (especially for DR-TB) are common. Participants frequently reported hearing loss (due to the injectable antibiotics used at the time to treat DR-TB), headaches, nausea, exhaustion and a host of other physical and psychological issues, often providing these as reasons for interrupting treatment, especially for DR-TB. As Radu explained, “I didn’t complete it … I told [my doctor] I couldn’t anymore, that I was throwing up, that I couldn’t sleep.”

Clinic-based DOT amplifies the burden of these adverse reactions by further disrupting people’s lives. During my fieldwork, most people who received DOT got it on an inpatient basis or in a clinic, where they received their medication daily under the supervision of a nurse. In DOT clinics I found lines of people waiting to receive their pills grow long, snaking down hallways, sometimes including mothers with small children in tow. In Bucharest, people with DR-TB are scheduled to arrive later in the day to avoid exposing people with DS-TB, who are scheduled for mornings. This limits how people with DR-TB can spend their day during the continuation phase of their treatment, which, at the time, could last up to three years.

Travel to the clinic adds hurdles for both rural and urban people. Romanians in rural areas had to travel periodically to the city to collect their medicines for self-administration. City-dwellers who could not afford public transportation had to walk long distances for their treatment. This is reminiscent of Susser’s observation (2009) that AIDS and public infrastructure are rarely linked, given that people have to travel long distances for treatment and the costs for transportation are borne by families. A similar separation between TB and Romanian public infrastructure emerged in interviews. Mariana, a participant with DR-TB living in Bucharest, lamented how getting to and from the clinic drained all her strength: “I had to hurry so that it wouldn’t start working on the way, because I would have walked down my street leaning from one side to the other, the neighbors would look at me funny, seeing me leaving fine and coming back like that all dizzy.” Her only option for outpatient treatment took all morning, amplifying the fatigue caused by the drugs she was receiving and leaving her exhausted for housework or caring for her small child, with no help from her husband, who worked long hours.

The fixed schedule that clinic-based DOT required threatens employment—from office-work held by some middle- and upper-class people, to retail, security and food-service jobs with unpredictable schedules, to the manual day labor that some of the poorest people performed. The latter faced some of the most significant challenges in adhering to clinic-based DOT, as day labor is unpredictable, often physically exhausting and sometimes takes place far from workers’ homes, thus requiring them to spend nights at the job site.

People at the other end of the financial spectrum also face problems posed by clinic-based DOT. Nicolae, a man in his mid-20s, is a highly educated young entrepreneur. Near the end of his inpatient treatment, he was troubled about how his upcoming daily outpatient treatment would hinder his ability to support himself: “I can’t go back and forth to the clinic. I need to be at work. There you can’t say ‘I have to go take my medicine’ and then come back after.”

Those with stable jobs were also concerned about their employers finding out they had TB either by being seen going to a DOT clinic or by using sick pay entitlements while being treated. Alexandru, a man working in forestry, said that his boss found out about his illness because he recognized the code on the sick pay form for a condition that guaranteed 100 percent of his salary. Even though Alexandru was entitled to get his job back, his employer told him: “Oh, no, you had TB; I can’t hire you.” TB carries a weighty stigma in Romania and, because of such reactions, many people try to hide their illness from employers, friends and loved ones.

The burden of clinic-based DOT in Romania falls disproportionately on women by compounding the burdens which they already face on a daily basis and which recurred in their interviews. Most worked outside the home, as men did, yet they also shouldered cultural expectations of their caregiving and housework responsibilities as women. These burdens were not relieved by socio-economic support or societal validation of them in a sick role, but were further complicated by the draining illness and genuine labor of adhering to clinic-based DOT. I met several women who, against doctor’s orders (and, in several instances, by running away from the hospital at night), ended their hospitalization much earlier than recommended to return to their household responsibilities, sometimes at the demands of their partners.

Gilda, a tiny 34-year-old woman I met shortly before her death from DR-TB, described her challenges supporting her family over the nine years of TB treatment. Her voice was barely a whisper over the hum of her oxygen machine. Thinking about Constantin, her husband, she said: “He is alone, with two children. To wash, cook, find a job, let them by themselves, come back and cook for the next day, like a woman. You need someone, it does not matter if it is a woman or a man. You need help.”

Her family was poor, and neither she nor her husband had regular employment. They generated their income by selling things at a local outdoor market and received a small government allocation for their children of 80 lei per month (about $20 at the time). Gilda had also cared for her father-in-law, who had been sick with TB. Gilda followed a familiar pattern—interrupting her hospitalization to try to complete her treatment at home so she could be there for her family, only to grow much sicker and return to the hospital. This cycle repeated itself and, as time passed, she grew weaker and developed additional antibiotic resistance. The last time I saw Gilda, she had finally agreed to be hospitalized in Bucharest, where she had access to the best care in the country. It was a traumatic choice to separate from her family. Unfortunately, it was too late and she died shortly thereafter.

Gilda epitomized the taxing demands and path into death women face as a result of clinic-based DOT and the failure of the Romanian health and welfare systems to provide them with the necessary support to beat TB, an otherwise curable disease. The clinic-based DOT in Gilda’s town only offered surveillance, without the economic and caregiving support she needed to complete treatment. She was among the many Romanians I met labeled as “defaulters.” She was in this situation not because she was unwilling to be treated but because the only available form of treatment was not feasible for her, given her responsibilities. Gilda’s tragic case was not unique. Several women I interviewed contracted TB while caring for male relatives. Many experienced treatment interruptions resulting in additional drug resistance and worsening illness until their eventual deaths. Fundamentally, what links them all together is that they died of a curable disease because the available care did not fit their needs.

Are DOT practices in accordance with human rights?

Privacy and confidentiality are fundamental parts of the right to health. Sharing information about a person’s TB status is only permissible with their informed consent and for legitimate public health reasons (TBP and STBP 2019). Since TB is stigmatized, these rights to privacy and confidentiality gain heightened salience. Whether clinic-based, in-home or technology-assisted, DOT poses a severe risk to these rights. For instance, the cars provided to Romania by the Global Fund for in-home DOT were clearly labeled as belonging to the National TB Program.

Digital Adherence Technologies (DAT), a new frontier of supervised treatment, pose serious data privacy risks well beyond one’s community due to data sharing on a global and corporate scale. These increasingly varied and popular (among decision-makers) methods include video observed therapy, SMS reminders, smart pill bottles and even internal sensors that detect when a person has taken their medication. Human rights scholars Albrecht and Citro warn, “[DATs] purport to offer a new, more effective treatment paradigm, but they essentially dress up DOT in new digital clothes while producing enormous amounts of data on the people with TB who use them” (2020, 8).

Clinic and community DOT limit a person’s fundamental right to freedom of movement (TBP and STBP 2019) within their country or abroad, thus also potentially conflicting with their rights to work and education (TBP and STBP 2019). The set schedule of clinic-based DOT may interfere with people’s work hours and prevent students from attending university, as I observed multiple times.

The principle of reciprocity is critical to TB treatment. Simply put, people with TB endure a long and demanding treatment, which provides a public health benefit to society. In return, society is obligated to make this treatment as barrier-free as possible and to support people who endure it. DOT in general, and particularly as occurring in Romania, does not live up to this principle because it is arduous, expensive and often without appropriate support.

Discussion and policy implications

Because of the emphasis in Eastern Europe and Central Asia on inpatient treatment, discussions about reforming treatment have generally replicated outpatient models of care without attending to their impact on people with TB and their loved ones. However, DOT should be reconsidered as a cornerstone of TB treatment from a policy and health system investment perspective because there is clear evidence from many countries that providing DOT according to global TB guidelines, which promote a person-centered approach to care, is not feasible.

This person-centered approach must consider “the unanticipated messiness of the everyday”, which conflicts with the language and ideals of biomedical standardization (Abney 2020, 70). Viewed in their totality, the “lacks” of “staff, stuff, space, systems, and social support” (PIH 2021) are far less the exception than the rule—that is, global health in its entirety does not accurately reflect the dominant paradigms, the WHO-endorsed global standards or even national guidelines. The reality is messy, limited and improvised (Livingston 2012). This mismatch is perpetuated by funding mechanisms that support DOTS unquestioningly. According to an international aid NGO employee in Georgia, “no donors in the world will support treating TB any other way than DOTS” (Koch 2013, 19).

The case of Romania makes it clear that DOT must be implemented only within a rights-based, person-centered strategy that assesses its effectiveness within a specific context and removes onerous barriers to people with TB. When examining the impact of methods of care and making policy recommendations, it is essential to consider all treatment preferences and how they are informed by age and other traits. The idea of the patient as a consumer of health care or even as part of the care team (Mol 2008) is far off despite changing attitudes triggered by the increasing influence of NGOs, including patients’ organizations, and efforts to introduce person-centered care approaches, such as those described in the WHO’s End TB Strategy (2015) and Ethics Guidance (2017). If TB care is to be designed truly as person-centered and in accordance with international human rights law and ethical standards, then it must incorporate a broad range of care and support options. These might even include clinic-based DOT for people who feel it supports them best.

A rights-based, person-centered approach to care also requires implementing treatment monitoring and the mitigation of adverse reactions in a way that considers people’s best interests. Medical staff insisted that DOT was important also because it was an opportunity to monitor for progress and adverse reactions to medications and that, since some of this monitoring required laboratory tests and tools such as EKGs and audiometry equipment, it was easier to do DOT in the clinic. However, check-ins on people being treated can be done in many ways, including (as an innovative Romanian project recently showed) telephone calls from trained TB survivors (UNOPA 2020). Treatment monitoring by growing cultures from a person’s sputum only requires a monthly collection. That visit could be combined with other tests to ensure that the person is not experiencing adverse reactions such as heart, liver and kidney complications, none of which require daily or even weekly monitoring. Finally, hearing loss, a very common adverse reaction among people with DR-TB, was mostly self-diagnosed. Few people receiving injections that can cause hearing loss were receiving baseline audiometry and follow-up tests, even among the young, a gap in Romanian TB care that can be found in many countries (Almeida et al. 2021: Reuter et al. 2017). Thus, while treatment monitoring is vital, it does not need to be done at DOT clinics. In Romania, staff and equipment shortages prevented it from occurring routinely anyway.

The COVID-19 pandemic has forced many TB programs to change their approaches to DOT. Some have shifted to community, in-home or technology-assisted methods from clinic-based DOT, which became difficult or even impossible due to lockdowns, transportation and staffing challenges and people’s fears of contracting COVID-19 during visits. While no easy solutions to DOT have emerged from COVID-19, one potential benefit is that previously unquestioned practices, such as in-person observation of every dose, were forced to change and should now be reassessed in consultation with people affected by TB (Zimmer et al. 2021).

In much of the world, particularly in Eastern Europe and Central Asia, DOT exists but does not usually meet the person-centered and human rights standards established by the WHO (2017) and laid out in the Declaration of the Rights of People Affected by Tuberculosis (TBP and STBP 2019). I call not to simply meet those standards, but to reconsider the practice of universal DOT in the first place. The limited funds available would be better spent supporting people with TB and their families in the ways that they feel are most useful. Rather than a burden without clear clinical benefit, DOT (and DAT) would be voluntary and reimagined as one of many types of adherence support attuned to individual preferences.

Acknowledgements

The research was approved by the City University of New York Graduate Center IRB (08-05-1556, June 05, 2008). Local research permission was granted by the Romanian Ministry of Health and the Romanian National TB Control Program. Informed consent was obtained from all participants. All participant names are pseudonyms. Thanks to Ilinca Diaconu-Stillo for her editing assistance. I deeply thank the people with TB and the medical staff who made this work possible by sharing their lives with me. All opinions contained in this article are my own.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This research has been supported by the US National Science Foundation (#0921137), Fulbright-Hays, the Social Science Research Council, IREX, the Romanian Cultural Institute and New Europe College–Bucharest.

Notes on contributors

Jonathan Stillo

Jonathan Stillo is a medical anthropologist and assistant professor at Wayne State University. His research and advocacy focus on the socio-economic and political dimensions of the global tuberculosis crisis. He is the Chair-Elect of STOP TB USA, the Co-Chair of TB Europe Coalition and a member of the Global TB Community Advisory Board.