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Patient-Centered TB Treatment Will Require Modernizing Directly-Observed Therapy

In the first of two linked posts, Mike Frick of Treatment Action Group (TAG) and Audrey Zhang of Harvard College argue that patient-centered approaches in treatment for drug-resistant and drug-sensitive tuberculosis are needed.

In “A Walk to Work with Dr. Vivan Cox,” the first short film in the series Tuberculosis: Behind the Numbers commissioned by TAG, director Jonathan Smith introduces an innovative approach to address multidrug-resistant tuberculosis (MDR-TB). In Khayelitsha, South Africa, Médecins Sans Frontières (MSF) is treating patients in community healthcare centers instead of confining them to hospitals. Vivian Cox, Deputy Medical Field Coordinator of Médecins Sans Frontières’ TB program in Khayelitsha, describes MDR-TB as “a community disease… that very often affects or infects whole families.” Dr. Cox describes how the dominant approach of confining MDR-TB patients to hospitals for up to two years can “tear families apart.”

Behind the Numbers: A Walk to Work with Dr. Vivian Cox from Visual Epidemiology on Vimeo.

Most TB treatment programs isolate MDR-TB patients in hospitals for a portion of their treatment and require that patients with drug-sensitive TB (DS-TB) take months of medication under the direct supervision of healthcare personnel in specialized TB clinics. MSF’s program has taken the social underpinnings of TB as a reason to decentralize treatment of MDR-TB to the primary healthcare centers where they are already receiving other health services, making it easier to diagnose people with TB, link them to care and support their treatment in a familiar environment. If this level of decentralization can be applied to MDR-TB care, which often requires treatment with highly toxic drugs that merit close clinical monitoring, TB programs should consider how to introduce similar patient-centered flexibilities into DS-TB treatment, where the drugs carry less risk of severe side effects.

The current approach to tuberculosis treatment, Directly Observed Therapy, Short-Course (DOTS), was adopted by the World Health Organization (WHO) in 1995 and consists of five elements. At the center of DOTS is DOT, or the direct observation of therapy by a healthcare worker or patient-appointed supporter. This observation often occurs at clinics, although some TB programs allow patients to take their medication in front of observers at home or in other settings. Proponents of DOT argue that it prevents acquired drug resistance by ensuring patient adherence to treatment. Critics of DOT have pointed out that the practice relies too heavily on a rigid, biomedical intervention that does not meet the needs of patients. Self-administered therapy (SAT) offers one alternative to swallowing pills under outside supervision. Despite continuing controversy, DOT remains a pillar of the WHO strategy and has emerged as the standard of care for DS-TB the world over.

Yet a new meta-analysis published in March 2013 in Clinical Infectious Diseases found no significant difference between DOT and SAT in terms of multiple microbiologic endpoints: treatment failure, acquired drug resistance or relapse. A 2007 Cochrane Review reached a similar conclusion when comparing DOT and SAT by programmatic outcomes such as “completion of treatment.” Given these results, why does DOT continue to operate as the global paradigm of DS-TB treatment?

The lack of change has a lot to do with inertia and an ingrained fear among TB programmers that overhauling DOT will lead to more drug resistance. Yet this fear also keeps DS-TB patients locked in a framework that falls far short of meeting their needs.

When thinking about patient needs, public health professionals should consider whether the mechanism of treatment delivery (DOT) accounts for how individuals are situated in and impacted by the larger socio-structural determinants of TB. These include crowded living and working conditions; food insecurity; migrant labor and schooling; poor access to healthcare; incarceration or punitive legal systems; and gender norms that differentially shape TB transmission risk among women, men and children.

Until recently, TB programs referred to patients thought to be non-compliant to medication as “suspects” and “defaulters.” The TB community has made admirable strides in replacing this stigmatizing terminology that evokes metaphors of punishment and discipline, but there remains a tendency to see patients as the root of the problem when the DOTS strategy fails.

The Patients’ Charter for Tuberculosis Care takes some steps toward promoting patient-centered care, but falls short by only discussing the responsibilities of patients without examining the corresponding obligations of their governments. This oversight is somewhat paradoxical considering that many of the documents referenced by the Patient Charter – such as the Convention on Economic, Social and Cultural Rights – are primarily concerned with outlining government obligations to respect, protect and fulfill the right to health. Just as human rights concern the relationship between individuals and their governments, patient-centered TB care must place reciprocal obligations on patients and their healthcare systems.

Decentralized treatment in community health centers, as practiced by MSF in Khayelitsha, offers one model for improving the patient-centeredness of DR-TB programs. Similarly, self-administered therapy with accompanying social support may improve patient experiences with DS-TB treatment. In moving toward patient-centered care, public health and medical professionals need to consult current and former TB patients. Members of Take-that-TB, a listserv of TB survivors, recently drafted a document outlining their suggestions for improving treatment for MDR-TB. Some of their top suggestions include: respecting the emotional conditions of patients in isolation; accompanying patients after discharge and through the end of treatment (including both physical and mental health support); making therapy compatible with obligations to work and family; and providing nutritional support.

Aligning DR- and DS-TB treatment with patient-centered approaches may not require complicated and potentially costly structural reforms. Programs that create supporting relationships between patients and healthcare providers can shift the tone of DR- and DS-TB treatment programs from supervision under suspected default to enabling patients to achieve cure. In a recent trip to Dharamsala, India, Treatment Action Group visited a TB program at Delek Hospital that has achieved good programmatic outcomes in part by fostering supportive relationships between patients, healthcare staff and the overall Tibetan community. The TB program at Delek Hospital uses DOT , but physicians said that their success stems from a philosophy of medicine that draws on the Buddhist concept of compassion. Doctors and nurses in Dharamsala offer patients much more than ‘supervised pill swallowing.’

Engaging patients and affected-communities is the norm in the HIV world, where concepts such as the Greater Involvement of People Living with HIV/AIDS underlie HIV programs. Similar concepts have not been fully mainstreamed into TB programs. Not only do too few TB programs meaningfully engage TB patients and survivors, but the core of the WHO strategy has barely changed for over a decade, even as the needs and identities of patient populations have evolved with the TB pathogen itself. It is time for the TB world to modernize our idea of DOT by drawing on successes from innovative TB programs, adapting models from other fields and, most importantly, listening to the voices and needs of TB patients and survivors.

Audrey Bio Pic

Audrey Zhang is a junior at Harvard College studying History and Science, focusing on global health and health policy.





MF bio picMike Frick is the TB/HIV project officer at Treatment Action Group, an independent AIDS research and policy think tank based in New York.




Twitter: @mwfrick

Email: mike.frick@treatmentactiongroup.org

Wesbite: http://www.treatmentactiongroup.org/

Mike Frick and Audrey Zhang declare no conflict of interests. The viewpoints expressed here are theirs and do not represent the position of the organizations with which they are affiliated.


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