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Promoting adherence to treatment for tuberculosis: Four of the major elements of the strategy, which came to be known as DOTS, were political commitment by governments, improved laboratory services, a continuous supply of good-quality drugs, and a reporting system to document the progress and failure of treatment for individual patients and of the programme.
The fifth element, effective case management via direct observation of treatment by an independent and trained third party, was a response to decades of reports documenting the failure of patients to complete treatment. We challenge the validity of these assertions. What is the validity of trials reported to support self-administration of treatment?
The random controlled trial is the gold standard to identify the effect of a single variable on patient treatment. To our knowledge, only three such trials have compared self-administered i.
However, these three trials do confirm that direct observation of treatment can, as with any health initiative relying on human effort, be implemented ineffectively.
To our knowledge, post-treatment relapse rates have not been analysed in any study used to support the elimination of direct observation.
In public health practice, failure to ensure treatment observation has been associated with a significantly increased risk of relapse, 7 often compounded by the emergence of drug resistance; treatment observation has been shown to reduce both relapse and drug resistance.
If direct observation is to be replaced with administration of treatment by the patient or by the family, the potential community impact of patient non-adherence must be considered. Direct observation of treatment is only one part of the comprehensive case management of each patient with TB.
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|Directly Observed Therapy (DOT) for the Treatment of Tuberculosis - Minnesota Dept. of Health||This is an open access article distributed under the Creative Commons Attribution Licensewhich permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract The risk of progression from exposure to the tuberculosis bacilli to the development of active disease is a two-stage process governed by both exogenous and endogenous risk factors.|
Rigorous monitoring of all patients who have started treatment and a rapid response to ensure that patients who interrupt their treatment are returned to care are also essential components of effective case management and community-wide TB control. Because these activities cannot be accomplished effectively in a setting of treatment by self-administration, the full spectrum of TB control services, including direct observation of treatment, must be provided and monitored if public health authorities are to meet their basic and primary responsibility to protect the public by ensuring patient cure.
After all, who cares more about sick patients than their immediate relatives? Is not family observation more patient-friendly?
It is true that some small pilot projects none of which have monitored relapse or development of drug resistance using family observation, combined with intensive supervision and home visits, have achieved high cure rates. In cultures with strong matriarchal or patriarchal structures, it is not realistic to believe that any member of the family can insist on any behaviour by the dominant family head.
In our experience, people outside the family structure, who are subject to greater supervision by TB control programmes, are more likely to report valid information to programme managers and take appropriate action when patients decline or forget treatment.
Family members may not understand the need to ensure treatment; despite the best educational efforts of health-care staff, there may be limited understanding of, or confidence in, the efficacy of prescribed medicines.
And if adherence to treatment creates tension in the family, the simplest way to eliminate the source of that tension is to discontinue treatment observation. Trials that have investigated the effect of treatment observation by family members are small, non-blinded, usually with enhanced supervision and monitoring, confounded by limited patient selection, have not evaluated relapse or drug resistance and are of questionable generalizability.
A recent report from Senegal 17 is an example of this. Such programme conditions are difficult to duplicate and sustain on a large scale, and the study did not evaluate drug resistance or relapse.
Is there a place for family observation? In the Senegal study, 17 direct observation of treatment was delivered by a person selected by the patient. Self-administration was not an option.
This study, more comprehensive than its predecessors, suggests that family members can potentially be effective treatment observers — but only within the restrictions imposed by the study design, which required close monitoring of all aspects of the treatment delivery system.
Treatment observation must be performed by a person who is accessible and acceptable to the patient, but who is also accountable to the health system.
In the Senegal study, the family member was clearly accountable to the system. Public health personnel were responsible for closely monitoring treatment, identifying and responding to patients thought to be in danger of defaulting, and for finding patients who had abandoned treatment.
If family members can be transformed into reliable members of the health-care team through careful programme design combined with intensive supervision and monitoring including accurate, honest and ongoing cohort analysis measuring real outcomesthen any system of treatment observation, including by family members, might be able to achieve acceptable results.
However, the lack of monitoring of relapse and drug resistance in published studies of family observation makes this a theoretical rather than an evidence-based possibility.
We have reviewed several large programmes, one published, 16 in which small pilot projects achieved acceptable results with family observation, after which a policy decision was made to implement DOTS using family observation on a large scale.
Each culture, each society and each community is unique. Each has particular strengths, and the challenge in implementing direct observation of treatment is to identify and enlist the support of these strengths.
About one-third of patients do not take medications regularly as prescribed, and it is not possible to predict accurately which patients will not adhere to treatment.
To address this consistent non-adherence, direct observation of treatment has been given by various members of the community, including health staff, community workers or volunteers, members of nongovernmental organizations and religious leaders.
Self-administration should never be an option. It also confirms the responsibility of the programme and the community to ensure successful treatment through respect for the patient by providing treatment at convenient times and in appropriate facilities.
Before WHO endorses the inclusion of family members as treatment observers, it must ensure that the programme setting will provide the required system support and close supervision, and will not increase rates of relapse and the acquisition of drug resistance.
No large-scale programme without direct observation of treatment has achieved global targets, while most programmes using direct observation of treatment achieve or nearly achieve these targets.Dec 04, · Introduction.
Tuberculosis (TB) control has been accorded a high priority within the health sector as it is a major public health problem. The Revised National Tuberculosis Control Programme (RNTCP) with Directly Observed Treatment Short Course .
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