8.4 Implementation considerations

Treatment adherence interventions. As treatment supervision alone is not likely to be sufficient to ensure good TB treatment outcomes, additional treatment adherence interventions need to be provided. Patient education should be provided to all patients on TB treatment. A package of the other treatment adherence interventions also needs to be offered to patients on TB treatment. The interventions should be selected on the basis of an assessment of the individual patient’s needs, provider ’s resources and conditions for implementation. With regard to telephone or video-assisted interventions, there may be reluctance to use new technology, making implementation more difficult. There may be privacy concerns surrounding security of telephone data, so encryption and other measures to safeguard privacy will need to be considered. The feasibility of implementing these types of interventions depends on telecommunication infrastructure, telephone availability and connection costs. Multiple organizations have initiated programmes such as these, so TB programmes may find it helpful to collaborate and communicate with other medical service delivery programmes that have already set up infrastructure. There may be reluctance on the part of implementers (e.g. national or local governments, health partners) to pay for incentives. Implementers may be more willing to pay for material support for smaller subgroups with particularly high risk (e.g. patients with MDR-TB). However, one of the components of the End TB Strategy (234) is to provide “social protection and poverty alleviation” for patients with TB. This publication specifically calls for measures to “alleviate the burden of income loss and non-medical costs of seeking and staying in care”. Included in these suggested protections are social welfare payments, vouchers and food packages. The benefit of material support found in this review supports these components of the End TB Strategy (234). In order to distribute the material support, government and/or nongovernment organization (NGO) infrastructure would need to be in place, including anti-fraud mechanisms (e.g. reliable unique personal identifiers) and appropriate accounting to ensure that incentives are distributed equitably and to the people who need them most. Countries should choose incentives that are the most appropriate for their situation.

Treatment administration. Community-based or home-based DOT has more advantages than health facility-based DOT, though family members should not be the first or only option for administering DOT. DOT is better provided at home or in the community and by trained lay providers or health care workers. There may be challenges in providing community- or home-based DOT by health care workers because of the increased number of health care workers required and the increased costs of staff time and daily travel to the community or patient’s home. DOT provision in the community or at home by trained local lay persons is more feasible. A combination of lay provider and health care worker for provision of community- or home-based DOT is also an option. Community-based or home-based DOT is more likely to be acceptable and accessible to patients than other forms of DOT. However, stigma may continue to be an issue with community- or home-based DOT. Having a health care worker coming regularly to a patient’s house may be stigmatizing and the feeling of being “watched over” may be disempowering for patients. Other forms of DOT (e.g. administered by an emotionally supportive relative or close friend) may be more acceptable but may still be stigmatizing. Given complex family social dynamics, family members may not always be the best people to supervise treatment, and the suitability of such treatment adherence supervisors needs to be carefully analysed in each national or local context. If family members are providing DOT, careful identification and training of those persons is required. Additional supervision of local supporters or health care workers is still needed, as family members cannot be depended on as the only option for care. Patients will continue to need social support, even if family members are providing DOT. Assessment of potential risk factors for poor adherence must be taken into account by health care workers at the start of treatment in order to decide which treatment administration option should be selected for the patient. Some groups of patients who are less likely to adhere to treatment may benefit more from DOT than others. Another factor to consider when selecting treatment administration options is that some patients with inflexible work or family responsibilities may not be able to do DOT. Any option of treatment administration offered to a patient must be provided in conjunction with proper medical care, including regular pick-up of TB drugs, consultations with a physician or other health care workers when necessary, TB treatment that is free of charge, and provision to the patient of essential information on TB treatment.

Ambulatory care. Cost varied widely across the modelled settings. The cost per disability adjusted life year (DALY) averted by an ambulatory model in one setting was sometimes higher than the cost per DALY averted by a hospitalization model in another setting. However, cost per DALY averted was lower under outpatient-based care than under inpatient-based care in the vast majority (at least 90%) of settings for which cost–effectiveness was modelled. The variation in cost–effectiveness among settings correlated most strongly with the variation in the cost of general health care services and other non-drug costs. Despite the limitations in the data available, there was no evidence that was in conflict with the recommendation and which indicated that treatment in a hospital-based model of care leads to a more favourable treatment outcome.

The overall cost–effectiveness of care for a patient receiving treatment for MDR-TB can be improved with an ambulatory model. The benefits include reduced resource use, and at least as many deaths avoided among primary and secondary cases compared with hospitalization models. This result is based on clinic-based ambulatory treatment (patients attend a health care facility); in some settings, home-based ambulatory treatment (provided by a worker in the community) might improve cost– effectiveness even further. The benefit of reduced transmission can be expected only if proper infection control measures are in place in both the home and the clinic. Potential exposure to people who are infectious can be minimized by reducing or avoiding hospitalization where possible, reducing the number of outpatient visits, avoiding overcrowding in wards and waiting areas, and prioritizing community-care approaches for TB management (214). The regimen used in one of the studies on ambulatory care was from a time when the combinations of medicines were not yet optimized, so outcomes achieved were probably inferior to those that can be obtained with the regimens in use today. Admission to hospitals for patients who do not warrant it may also have important social and psychological consequences that need to be taken into account.

There may be some important barriers to accessing clinic-based ambulatory care, including distance to travel and other costs to individual patients. Shifting costs from the service provider to the patient has to be avoided, and implementation may need to be accompanied by appropriate enablers. While placing patients on adequate therapy would be expected to decrease the bacterial load and transmission of DR-TB, infection control measures for home-based and clinic-based measures will need to be part of an ambulatory model of care to decrease the risk of transmission in households, the community and clinics. TB control programmes will have to consider whether they are capable of reallocating resources from hospital to ambulatory care support in order to undertake the necessary changes in patient management. The choice between these options will affect the feasibility of implementing the recommendation in a particular programme.

Decentralized care. NTPs should have standardized guidelines regarding which patients are eligible for decentralized care. Patient preference should be given a high value when choosing centralized or decentralized care.

Decentralized care for MDR-TB patients requires appropriate treatment supervision, patient education and social support, staff training, infection control practices and quality assurance. The optimal treatment supervision options and treatment adherence interventions recommended in this section should be considered for MDR-TB patients on decentralized care.

Several of the studies in the review addressed treatment costs. However, the cost estimates were found to vary widely and no concrete recommendations could be made on the basis of cost. Resource requirements are likely to vary because TB treatment programmes are highly variable, so costs for these programmes vary across different countries. The GDG raised several issues for TB programmes to consider. Although hospitalization is generally thought to be more expensive than outpatient care, the costs of good outpatient programmes can also be significant. Additionally, outpatient costs may vary significantly according to the services provided. A cost-saving measure to consider in decentralized care is that patients may be able to receive treatment faster. The financial benefits of decentralized care would include finding patients before they are very ill and require more medical care, while treating people before TB can be transmitted to contacts would be a public health benefit.

If a patient is living with a person from a high-risk group, such as a PLHIV or a young child, there may be complications in sending the patient home for treatment. However, the risk posed to these highrisk groups varies significantly, depending on whether the TB programme gives preventive treatment to high-risk persons. Studies involving preventive therapy for MDR-TB therapy are ongoing.

An additional implementation issue to consider is that it may be illegal in some settings to treat MDR-TB patients in a decentralized setting, especially when the treatment involves injections. Such legal concerns need to be addressed.  

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