Background

Tuberculosis (TB) requires at least six months of treatment. If treatment is incomplete, patients may not be cured and drug resistance may develop. Directly Observed Therapy (DOT) is a specific strategy, endorsed by the World Health Organization, to improve adherence by requiring health workers, community volunteers or family members to observe and record patients taking each dose.


Objectives

To evaluate DOT compared to self-administered therapy in people on treatment for active TB or on prophylaxis to prevent active disease. We also compared the effects of different forms of DOT.


Search methods

We searched the following databases up to 13 January 2015: the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; EMBASE; LILACS and mRCT. We also checked article reference lists and contacted relevant researchers and organizations.


Selection criteria

Randomized controlled trials (RCTs) and quasi-RCTs comparing DOT with routine self-administration of treatment or prophylaxis at home.


Data collection and analysis

Two review authors independently assessed risk of bias of each included trial and extracted data. We compared interventions using risk ratios (RR) with 95% confidence intervals (CI). We used a random-effects model if meta-analysis was appropriate but heterogeneity present (I2 statistic > 50%). We assessed the quality of the evidence using the GRADE approach.


Main results

Eleven trials including 5662 participants met the inclusion criteria. DOT was performed by a range of people (nurses, community health workers, family members or former TB patients) in a variety of settings (clinic, the patient's home or the home of a community volunteer).

DOT versus self-administered 

Six trials from South Africa, Thailand, Taiwan, Pakistan and Australia compared DOT with self-administered therapy for treatment. Trials included DOT at home by family members, community health workers (who were usually supervised); DOT at home by health staff; and DOT at health facilities. TB cure was low with self-administration across all studies (range 41% to 67%), and direct observation did not substantially improve this (RR 1.08, 95% CI 0.91 to 1.27; five trials, 1645 participants, moderate quality evidence). In a subgroup analysis stratified by the frequency of contact between health services in the self-treatment arm, daily DOT may improve TB cure when compared to self-administered treatment where patients in the self-administered group only visited the clinic every month (RR 1.15, 95% CI 1.06 to 1.25; two trials, 900 participants); but with contact in the control becoming more frequent, this small effect was not apparent (every two weeks: RR 0.96, 95% CI 0.83 to 1.12; one trial, 497 participants; every week: RR 0.90, 95% CI 0.68 to 1.21; two trials, 248 participants).

Treatment completion showed a similar pattern, ranging from 59% to 78% in the self-treatment groups, and direct observation did not improve this (RR 1.07, 95% CI 0.96 to 1.19; six trials, 1839 participants, moderate quality evidence).

DOT at home versus DOT at health facility 

In four trials that compared DOT at home by family members, or community health workers, with DOT by health workers at a health facility there was little or no difference in cure or treatment completion (cure: RR 1.02, 95% CI 0.88 to 1.18, four trials, 1556 participants, moderate quality evidence; treatment completion: RR 1.04, 95% CI 0.91 to 1.17, three trials, 1029 participants, moderate quality evidence).

DOT by family member versus DOT by community health worker

Two trials compared DOT at home by family members with DOT at home by community health workers. There was also little or no difference in cure or treatment completion (cure: RR 1.02, 95% CI 0.86 to 1.21; two trials, 1493 participants, moderate quality evidence; completion: RR 1.05, 95% CI 0.90 to 1.22; two trials, 1493 participants, low quality evidence).

Specific patient categories

A trial of 300 intravenous drug users in the USA evaluated direct observation with no observation in TB prophylaxis to prevent active disease and showed little difference in treatment completion (RR 1.00, 95% CI 0.88 to 1.13; one trial, 300 participants, low quality evidence).


Authors' conclusions

From the existing trials, DOT did not provide a solution to poor adherence in TB treatment. Given the large resource and cost implications of DOT, policy makers might want to reconsider strategies that depend on direct observation. Other options might take into account financial and logistical barriers to care; approaches that motivate patients and staff; and defaulter follow-up.

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Directly observed therapy for treating tuberculosis

Author(s): Alipanah, Narges; Jarlsberg, Leah; Miller, Cecily; Linh, Nguyen Nhat; Falzon, Dennis; Jaramillo, Ernesto; Nahid, Payam | Abstract: BackgroundIncomplete adherence to tuberculosis (TB) treatment increases the risk of delayed culture conversion with continued transmission in the community, as well as treatment failure, relapse, and development or amplification of drug resistance. We conducted a systematic review and meta-analysis of adherence interventions, including directly observed therapy (DOT), to determine which approaches lead to improved TB treatment outcomes.Methods and findingsWe systematically reviewed Medline as well as the references of published review articles for relevant studies of adherence to multidrug treatment of both drug-susceptible and drug-resistant TB through February 3, 2018. We included randomized controlled trials (RCTs) as well as prospective and retrospective cohort studies (CSs) with an internal or external control group that evaluated any adherence intervention and conducted a meta-analysis of their impact on TB treatment outcomes. Our search identified 7,729 articles, of which 129 met the inclusion criteria for quantitative analysis. Seven adherence categories were identified, including DOT offered by different providers and at various locations, reminders and tracers, incentives and enablers, patient education, digital technologies (short message services [SMSs] via mobile phones and video-observed therapy [VOT]), staff education, and combinations of these interventions. When compared with DOT alone, self-administered therapy (SAT) was associated with lower rates of treatment success (CS: risk ratio [RR] 0.81, 95% CI 0.73-0.89; RCT: RR 0.94, 95% CI 0.89-0.98), adherence (CS: RR 0.83, 95% CI 0.75-0.93), and sputum smear conversion (RCT: RR 0.92, 95% CI 0.87-0.98) as well as higher rates of development of drug resistance (CS: RR 4.19, 95% CI 2.34-7.49). When compared to DOT provided by healthcare providers, DOT provided by family members was associated with a lower rate of adherence (CS: RR 0.86, 95% CI 0.79-0.94). DOT delivery in the community versus at the clinic was associated with a higher rate of treatment success (CS: RR 1.08, 95% CI 1.01-1.15) and sputum conversion at the end of two months (CS: RR 1.05, 95% CI 1.02-1.08) as well as lower rates of treatment failure (CS: RR 0.56, 95% CI 0.33-0.95) and loss to follow-up (CS: RR 0.63, 95% CI 0.40-0.98). Medication monitors improved adherence and treatment success and VOT was comparable with DOT. SMS reminders led to a higher treatment completion rate in one RCT and were associated with higher rates of cure and sputum conversion when used in combination with medication monitors. TB treatment outcomes improved when patient education, healthcare provider education, incentives and enablers, psychological interventions, reminders and tracers, or mobile digital technologies were employed. Our findings are limited by the heterogeneity of the included studies and lack of standardized research methodology on adherence interventions.ConclusionTB treatment outcomes are improved with the use of adherence interventions, such as patient education and counseling, incentives and enablers, psychological interventions, reminders and tracers, and digital health technologies. Trained healthcare providers as well as community delivery provides patient-centered DOT options that both enhance adherence and improve treatment outcomes as compared to unsupervised, SAT alone.

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Adherence interventions and outcomes of tuberculosis treatment: A systematic review and meta-analysis of trials and observational studies.

Background 
Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB) treatment adherence based on Health Belief Model (HBM).


Methodology 
A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs) (14 HCs intervention and 16 HCs control groups). A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence.


Results 
At enrollment, the level of non-adherence among intervention (19.4%) and control (19.6%) groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline) to 9.5% (at endpoint), while it increased among control group from 19.4% (baseline) to 25.4% (endpoint). Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI) (0.18–0.53), p < 0.001)).


Conclusion 
Psychological counseling and educational interventions, which were guided by HBM, significantly decreased treatment non-adherence level among intervention group. Provision of psychological counseling and health education to TB patients who are on regular treatment is recommended. This could be best achieved if these interventions are guided by behavioral theories and incorporated into the routine TB treatment strategy.


Trial Registration 
Pan African Clinical Trials Registry PACTR201506001175423

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Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial

Background: Multidrug resistant tuberculosis(MDR-TB) is becoming a major threat to tuberculosis control programs in Ethiopia. Objectives: To determine risk factors of MDR-TB patients in Amhara National Regional State, Ethiopia. Methods: Case-control study was conducted from May 2013 to January 2014. Resistance to rifampicin and isoniazid were done molecularly using line probe assay. TB patients infected with MDR-M.tuberculosis and non MDR-M.tuberculosis strain were considered as cases and controls, respectively. Data was collected using structured questionnaire with face to face interview. Patients’ clinical record review was also done.Multivariate analysis was computed to determine the risk factors of MDR-TB. Results: A total of 153 MDR-TB and equal number of non MDR-TB patients’ participated in the study. Patients who had TB treatment failure (AOR=13.5,CI=2.69-70), cavitations on chest x-ray (AOR=1.9,CI=1.1-3.38) and contact with MDR-TB patients (AOR=1.4,CI=0.19-0.39) were more likely to be MDR-TB patients. Low monthly income (AOR=1.1,CI=0.34-0.47),alcohol consumption (AOR=1.5,CI=0.2-0.98) and young age (AOR=2.9,CI=1.07-7.68) were the other risk factors of MDR-TB. Conclusions: TB treatment failure, cavitation on chest X-ray, contact with MDR-TB patients and low socioeconomic status were important risk factors for development of MDR-TB. Therefore, strict adherence to directly observed therapy, appropriate management of TB patients and advice on the value of nutrients are helpful to control the spreading of MDR-TB.

/pdf/risk-factors-for-multidrug-resistant-tuberculosis-patients-1w4xb1a3ip.pdf

Risk factors for multidrug resistant tuberculosis patients in Amhara National Regional State.

Multi drug resistant tuberculosis (MDR-TB) is an emerging challenge for TB control programs globally. According to World health organization, 2012 report Ethiopia stands 15th out of the 27 high priority countries in the world and 3rd in Africa. Updated knowledge of the magnitude of MDR-TB is so substantial to allocate resources, and to address prevention and control measures. Therefore, the aim of this study was to assess the prevalence of MDR-TB and associated risk factors in West Armachiho and Metema districts of North Gondar. A cross-sectional study was conducted in West Armachiho and Metema districts between February 01 and June 25, 2014. A total of 124 consecutive smear positive pulmonary tuberculosis patients were included in the study. Socio-demographic and possible risk factor data were collected using a semi-structured questionnaire. Drug susceptibility testing was first performed for rifampicin using GeneXpert MTB/RIF. For those rifampicin resistant strains, drug susceptibility testing was performed for both isoniazid and rifampicin to identify MDR-TB using the proportional method on LJ media. Data were analyzed using statistical Package SPSS version 20; binary logistic regression was used to assess the association. P-values < 0.05 were considered as statistically significant. Of 124 smear-positive pulmonary TB patients, 117 (94.4 %) were susceptible to Rifampicin, while 7 (5.7 %) were confirmed to be resistant to Rifampicin and Isoniazid. The overall prevalence of MDR-TB was 5.7 % (2.3 % among new cases and 13.9 % among previously treated cases). History of previous treatment (OR = 7, P = 0.025) was significantly associated risk factor for MDR-TB. The overall prevalence of MDR-TB was 5.7 % among cases at five health centers and a history of previous treatment was found to be a risk factor for being infected by an MDR-TB strain. Therefore, maximizing early case detection and treatment, strengthening TB infection control activities and proper implementation of DOTS are recommended to reduce the burden of MDR-TB.

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Multidrug resistant tuberculosis: prevalence and risk factors in districts of metema and west armachiho, Northwest Ethiopia

Background
Worldwide, there were 650,000 multidrug-resistant tuberculosis (MDR-TB) cases in 2010, and in 2008 the World Health Organization estimated that 150,000 deaths occurred annually due to MDR-TB. Ethiopia is 15th among the 27 MDR-TB high-burden countries. This study identifies factors associated with the occurrence of MDR-TB in patients who underwent first-line TB treatment in Addis Ababa City.

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Alemayehu Mekonen

Papers

Determinants of multidrug-resistant tuberculosis in patients who underwent first-line treatment in Addis Ababa: a case control study