STANDARD 9.

To foster and assess adherence, a patient-centered approach to administration
of drug treatment, based on the patient’s needs and mutual respect between the
patient and the provider, should be developed for all patients. Supervision and
support should be gender-sensitive and age-specifi c and should draw on the
full range of recommended interventions and available support services,
including patient counseling and education. A central element of the patient-
centered strategy is the use of measures to assess and promote adherence
to the treatment regimen and to address poor adherence when
it occurs. These measures should be tailored to the individual patient’s
circumstances and be mutually acceptable to the patient and the provider.
Such measures may include direct observation of medication ingestion
(directly observed therapy—DOT) by a treatment supporter who
is acceptable and accountable to the patient and to the health system.

Rationale and Evidence Summary

The approach described is designed to encourage and facilitate a positive partnership
between providers and patients, working together to improve adherence. Adherence to
treatment is the critical factor in determining treatment success.87 The success of treatment
for tuberculosis, assuming an appropriate drug regimen is prescribed, depends
largely on patient adherence to the regimen. Achieving adherence is not an easy task,
either for the patient or the provider. Antituberculosis drug regimens, as described previously,
consist of multiple drugs given for a minimum of six months, often when the patient
feels well (except, perhaps, for adverse effects of the medications). Commonly, treatments
of this sort are inconsistent with the patient’s cultural milieu, belief system, and
living circumstances. Consequently, it is not surprising that, without appropriate treatment
support, a signifi cant proportion of patients with tuberculosis discontinue treatment
before completion of the planned duration or are erratic in drug taking. Yet, failure to
complete treatment for tuberculosis leads to prolonged infectivity, poor outcomes, and
drug resistance.88

Adherence is a multi-dimensional phenomenon determined by the interplay of fi ve sets of
factors (dimensions), as illustrated in Figure 2 and Table 4.⁸⁷

FIGURE 2: The five dimensions of adherence⁸⁷

Source: WHO, 2003⁸⁷

TABLE 4: Factors affecting adherence⁸⁷

Despite evidence to the contrary, there is a widespread tendency to focus on patientrelated
factors as the main cause of poor adherence.87 Sociological and behavioral research
during the past 40 years has shown that patients need to be supported, not blamed.87
Less attention is paid to provider and health system-related factors. Several studies have
evaluated various interventions to improve adherence to tuberculosis therapy. (These interventions
are listed in Table 4.) There are a number of reviews that examine the evidence
on the effectiveness of these interventions.69, 87, 89, 90–95

Among the interventions evaluated, DOT has generated the most debate and controversy.(There is an important distinction between directly observed treatment (DOT) and the DOTS strategy for tuberculosis control: DOT is
one of a range of measures used to promote and assess adherence to tuberculosis treatment, whereas the DOTS strategy consists five
components and forms the platform on which tuberculosis control programs are built.⁹⁶)

The third component of the global DOTS strategy, now widely recommended as
the most effective strategy for controlling tuberculosis worldwide, is the administration of a
standardized, rifampicin-based regimen using case management interventions that are appropriate
to the individual and the circumstances.23,24,69,97 These interventions may include
DOT as one of a range of measures to promote and assess adherence to treatment.
The main advantage of DOT is that treatment is carried out entirely under close, direct
supervision.92 This provides both an accurate assessment of the degree of adherence
and greater assurance that the medications have actually been ingested. When a second
individual directly observes a patient swallowing medications, there is greater certainty
that the patient is actually receiving the prescribed medications. This approach, therefore,
results in a high cure rate and a reduction in the risk of drug resistance. Also, because
there is a close contact between the patient and the treatment supporter, adverse drug
effects and other complications can be identifi ed quickly and managed appropriately.92

Moreover, such case management can also serve to identify and assist in addressing the
myriad other problems experienced by patients with tuberculosis, such as undernutrition,
poor housing, and loss of income, to name a few.

The exclusive use of health facility-based DOT may be associated with disadvantages
that must be taken into account in designing a patient-centered approach. For example,
these disadvantages may include loss of income, stigma, and physical hardship, all factors
that can have an important effect on adherence.87 Ideally, a fl exible mix of health
facility-based and community-based DOT should be available.

In a Cochrane systematic review that synthesized the evidence from six controlled trials
comparing DOT with self-administered therapy,89,90 the authors found that patients allocated
to DOT and those allocated to self-administered therapy had similar cure rates (Risk
Ratio [RR] 1.06, 95% Confi dence Interval [CI] 0.98, 1.14); and rates of cure plus treatment
completion (RR 1.06, 95% CI 1.00, 1.13). They concluded that direct observation of
medication ingestion did not improve outcomes.89,90

In contrast, other reviews have found DOT to be associated with high cure and treatment
completion rates.24,69,91,92,98 Also, programmatic studies on the effectiveness of the DOTS
strategy have shown high rates of treatment success in several countries.87 It is likely that
these inconsistencies across reviews are due to the fact that primary studies are often
unable to separate the effect of DOT alone from the overall DOTS strategy.87,94 In a retrospective
review of programmatic results, the highest rates of success were achieved with “enhanced DOT,” which consisted of “supervised swallowing” plus social supports, incentives,
and enablers as part of a larger program to encourage adherence to treatment.91
Such complex interventions are not easily evaluated within the conventional randomized
controlled trial framework.87

Interventions other than DOT have also shown promise.87, 95 For example, interventions that
used incentives, peer assistance, repeated motivation of patients, and staff training and
motivation all have been shown to improve adherence signifi cantly.95 In addition, adherence
may be enhanced by provision of more comprehensive primary care, as described
in the Integrated Management of Adolescent and Adult Illness (IMAAI),99-101 as well as by
provision of specialized services such as opiate substitution for injection drug users.
Systematic reviews and extensive programmatic experience demonstrate that there is
no single approach to case management that is effective for all patients, conditions, and
settings. Consequently, interventions that target adherence must be tailored or customized
to the particular situation and cultural context of a given patient.87 Such an approach
must be developed in concert with the patient to achieve optimum adherence. This
patient-centered, individualized approach to treatment support is now a core element
of all tuberculosis care and control efforts. It is important to note that treatment support
measures, and not the treatment regimen itself, must be individualized to suit the unique
needs of the patient.

In addition to one-on-one support for patients being treated for tuberculosis, community
support is also of importance in creating a therapeutic milieu and reducing stigma.3 Not
only should the community expect that optimum treatment for tuberculosis is provided,
but it also should expect and play a role in promoting conditions that facilitate and assist
in ensuring that the patient will adhere to the prescribed regimen.