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A fifteen-month survey of directly observed therapy--short course and antibiotic drug resistance in the region of Plovdiv.

OBJECTIVE: This study addresses the issue of antituberculosis drug resistance in a cohort of 213 patients from Plovdiv included in the pilot phase of a DOTS based project for a 15-month period. Between July 1. 1998 and September 30, 1999, ninety three culture-positive patients participated in the study. 89 of them were tested for drug susceptibility to rifampicin, izoniazid, etambutol, and streptomycin. RESULTS: Resistance to at least one antituberculosis drug was established in 24.7% of the patients. Monoresistance was found in 13.5% of the cases. The median prevalence of combined resistance to rifampicin and isoniazid was 6.7%. The prevalence of resistance to rifampicin or isoniazid was 21.4%. Drug susceptibility testing results were obtained within 67 days. In 33% of the patients continuation treatment phase was initiated before drug susceptibility data were available. CONCLUSIONS: During the observed period a considerably high rate of drug resistant tuberculosis was registered among the patients included in the pilot phase of the program based on Directly Observed Therapy--Short Course. The percentage of resistance to R and/or I gives better information about the risk of inadequate treatment during the continuation treatment phase. The high percentage of this pattern of resistance in our region requires the continued use of four first-line drugs for therapy until the results of drug-susceptibility testing are received.

Adult↗

A controlled comparison of directly observed therapy vs self-administered therapy for active tuberculosis in the urban United States.

STUDY OBJECTIVES: To compare treatment completion rates at 8 and 12 months after treatment initiation for patients with active TB treated with either directly observed therapy (DOT) or self-administered therapy (SAT). DESIGN: Retrospective comparison study of DOT and SAT concurrent patient cohorts. SETTING: Urban Tuberculosis Control Program within a Department of Public Health. PATIENTS: Three hundred nineteen patients confirmed to have active TB between July 1, 1994, and June 30, 1995, who began outpatient drug therapy. INTERVENTIONS: Patients and/or their physicians chose to receive their anti-TB drug therapy by DOT (n=113) or SAT (n=206) and were assessed for treatment completion at prospectively determined times, 8 and 12 months. MEASUREMENTS AND RESULTS: Proportions of patients who completed treatment at 8 and 12 months without crossing over to the other group were compared. At 8 months, 52% of DOT and 35% of SAT patients had completed treatment (relative superiority of DOT, 49%; p=0.003). At 12 months, completion rates were 70% for DOT patients and 53% for SAT patients (relative superiority of DOT, 30%; p=0.006). CONCLUSIONS: In our setting, patients receiving DOT were much more likely to complete treatment earlier than those receiving SAT. Even with DOT, only 52% of patients had completed treatment by 8 months.

Adolescent↗

Unpaid community volunteers--effective providers of directly observed therapy (DOT) in rural South Africa.

OBJECTIVE: To illustrate successes and difficulties for the South African National Tuberculosis Programme in a rural area. DESIGN: Prospective cohort study. SETTING: Sekhukhuneland, Provincial Health Service Southern Region, Northern Province, South Africa. SUBJECTS: All patients diagnosed with tuberculosis (TB) in the catchment area of four rural hospitals between January 1997 and June 1999. MAIN OUTCOME MEASURES: Standard outcomes for TB treatment as defined by the World Health Organisation. Treatment failure, treatment interruption and death were grouped as poor outcomes. RESULTS: One thousand four hundred and seventy-six people were diagnosed with TB. The majority (76%) had smear-positive pulmonary disease. Treatment was given by directly observed therapy (DOT) throughout in all but 15 instances. Excluding 10 subjects with known multidrug-resistant TB (MDRTB), 723 (66%) were cured, 68 (6%) completed treatment, 73 (7%) interrupted treatment, 37 (3%) failed treatment, 66 (6%) transferred out, and 134 (12%) died. Of the 920 initially smear-positive patients who survived the first 2 months to receive DOT in the community, 693 (75%) were supervised by unpaid community volunteers. Poor outcomes were no more common among patients supervised by these volunteers than among patients supervised by professional health care workers. Male gender (odds ratio 1.38, 95% confidence interval 1.02, 1.87) was significantly associated with a poor outcome. CONCLUSION: Although there were difficulties, the national programme was successfully applied with no additional funds or facilities. Explanations for the high death rate and poor outcomes for men need to be found. Great efforts will be required to preserve the quality of the TB programme if it is devolved to primary care level.

Adolescent↗

Tuberculosis in the 21st century: DOTS and SPOTS. Plenary lecture given at the 29th World Conference of the International Union Against Tuberculosis and Lung Disease, Bangkok, Thailand, 23-26 November 1998. Directly observed therapy.

Surveys of the global burden of disease have established that formidable health problems loom as the new millennium approaches. In both industrialized and developing countries lung disease is particularly problematic. Tuberculosis provides a concrete example of the ability of existing interventions such as directly observed therapy (DOT) to save millions of lives in the immediate future and the potential for new knowledge and tools to eventually eliminate the disease. Molecular epidemiology shows the potential of new technology to supplement established approaches in answering questions central to public health. Our knowledge of the complete genomic sequence of Mycobacterium tuberculosis now has us poised on the brink of a new era. Emerging technologies such as microscopic arrays comprised of thousands of spots of DNA will provide knowledge that will fundamentally alter our approach to disease control. The synergy of a balanced portfolio incorporating a globalized public health commitment and creative basic research will provide us with the infrastructure and tools needed to eliminate tuberculosis before the close of the 21st century.

Communicable Disease Control↗

Who fails to complete tuberculosis treatment? Temporal trends and risk factors for treatment interruption in a community-based directly observed therapy programme in a rural district of South Africa.

SETTING: Hlabisa Tuberculosis Programme, Hlabisa, South Africa. OBJECTIVE: To determine trends in and risk factors for interruption of tuberculosis treatment. METHODS: Data were extracted from the control programme database starting in 1991. Temporal trends in treatment interruption are described; independent risk factors for treatment interruption were determined with a multiple logistic regression model, and Kaplan-Meier survival curves for treatment interruption were constructed for patients treated in 1994-1995. RESULTS: Overall 629 of 3,610 surviving patients (17%) failed to complete treatment; this proportion increased from 11% (n = 79) in 1991/1992 to 22% (n = 201) in 1996. Independent risk factors for treatment interruption were diagnosis between 1994-1996 compared with 1991-1993 (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.6-2.4); human immunodeficiency virus (HIV) positivity compared with HIV negativity (OR 1.8, 95%CI 1.4-2.4); supervised by village clinic compared with community health worker (OR 1.9, 95%CI 1.4-2.6); and male versus female sex (OR 1.3, 95%CI 1.1-1.6). Few patients interrupted treatment during the first 2 weeks, and the treatment interruption rate thereafter was constant at 1% per 14 days. CONCLUSIONS: Frequency of treatment interruption from this programme has increased recently. The strongest risk factor was year of diagnosis, perhaps reflecting the impact of an increased caseload on programme performance. Ensuring adherence to therapy in communities with a high level of migration remains a challenge even within community-based directly observed therapy programmes.

Adolescent↗

Implications of directly observed therapy in tuberculosis control measures among IDUs.

Tuberculosis (TB) is a rapidly growing problem among injecting drug users (IDU), especially those infected with human immunodeficiency virus. The authors review IDUs' responses to current TB control strategies and discuss the implications of their findings for the proposed implementation of directly observed therapy (DOT), a method for ensuring that patients take prescribed medication. Field workers carried out 210 ethnographic interviews with 68 IDUs in a Brooklyn, NY, community during 1990-93. Case studies suggested that many IDUs are uninformed about TB and often misinformed about their personal TB status. Ethnographic interviews and observations indicated that the threat of TB-related involuntary detainment may lead IDUs to avoid TB diagnostic procedures, treatment for TB, or drug abuse treatment, and to avoid AIDS outreach workers and other health-related services. IDUs who tested positive for the purified protein derivative (PPD) of TB sometimes have left hospitals before definitive diagnoses were made, because of a perceived lack of respectful treatment, fear of detention, or lack of adequate methadone therapy to relieve the symptoms of withdrawal from drugs. Current TB diagnosis and treatment systems are, at best, inadequate. The threat of TB-related detention discourages some IDUs from seeking any type of health care. There is an urgent need to educate IDUs about TB and to educate and sensitize health care providers about the lifestyles of IDUs. DOT may help in servicing this difficult-to-serve population, particularly if techniques are incorporated that have been developed for other successful public health interventions for IDUs.

Adult↗

Geographic diversity in tuberculosis trends and directly observed therapy, New York City, 1991 to 1994.

The New York City tuberculosis (TB) case rate declined from 1991 to 1994 following more than a decade of increases. The present study investigated TB trends in New York City neighborhoods and their association with neighborhood-specific rates of application of directly observed therapy (DOT). Using Poisson regression models, TB trends in each of New York City's 30 health districts were classified as increasing, decreasing, or stable, as indicated respectively by significant positive, negative, or nonsignificant regression coefficient. Case counts increased in four health districts, decreased in 10, and were stable in 16. Decreasing TB was associated with a higher rate of application of DOT. TB cases among foreign-born persons increased in 12 health districts and were stable in 18, whereas cases among persons born in the United States decreased in 19 and were stable in 11 districts. Among the foreign-born, increasing TB was not associated with a lesser rate of application of DOT. These data provide some support for the role of DOT in containing TB, but also suggest that the application of DOT among foreign-born residents is less effective than among United States-born residents. This may be due to a greater proportion of TB cases among the foreign-born being due to reactivation of TB rather than new infection.

Antitubercular Agents↗

The effect of directly observed therapy on the rates of drug resistance and relapse in tuberculosis.

BACKGROUND: Tuberculosis has reemerged as an important public health problem, and the frequency of drug resistance is increasing. A major reason for the development of resistant infections and relapse is poor compliance with medical regimens. In Tarrant County, Texas, we initiated a program of universal directly observed treatment for tuberculosis. We report the effect of the program on the rates of primary and acquired drug resistance and relapse among patients with tuberculosis. METHODS: We collected information on all patients with positive cultures for Mycobacterium tuberculosis in Tarrant County from January 1, 1980, through December 31, 1992. Through October 1986, patients received a traditional, unsupervised drug regimen. Beginning in November 1986, nearly all patients received therapy under direct observation by health care personnel. RESULTS: A total of 407 episodes in which patients received traditional treatment for tuberculosis (January 1980 through October 1986) were compared with 581 episodes in which therapy was directly observed (November 1986 through December 1992). Despite higher rates of intravenous drug use and homelessness and an increasing rate of tuberculosis during this 13-year period, the frequency of primary drug resistance decreased from 13.0 percent to 6.7 percent (P < 0.001) after the institution of direct observation of therapy, and the frequency of acquired resistance declined from 14.0 percent to 2.1 percent (P < 0.001). The relapse rate decreased from 20.9 percent to 5.5 percent (P < 0.001), and the number of relapses with multidrug-resistant organisms decreased from 25 to 5 (P < 0.001). CONCLUSIONS: The administration of therapy for M. tuberculosis infection under direct observation leads to significant reductions in the frequency of primary drug resistance, acquired drug resistance, and relapse.

Adolescent↗

Coping with Africa's increasing tuberculosis burden: are community supervisors an essential component of the DOT strategy? Directly observed therapy.

Tuberculosis incidence in Africa is increasing dramatically and fragile health systems are struggling to cope. Potential coping capacity may lie within affected communities but this capacity needs to be harnessed if tuberculosis is to be controlled. Since 1991 all patients with tuberculosis in Hlabisa health district, South Africa have been eligible for community-based directly observed therapy (DOT). Patients are supervised either by a health worker (HW) in a village clinic, or in the community by a community health worker (CHW) or a volunteer lay person (VLP). Tuberculosis incidence increased from 312 cases in 1991 to 1250 cases in 1996. By December 1995, 2622 (87%) of 3006 patients had received DOT, supervised mainly by VLP (56%) but also by HW (28%) and CHW (16%). The proportion supervised by HW fell from 46% in 1991 to 26% in 1995 (P < 0.0001). More patients supervised by VLP (85%) and CHW (88%) than by HW (79%, P = 0.0008) completed treatment. Case-holding by HW declined more between 1991 and 1995 (84% to 71%, P = 0.02) than did case-holding by both CHW (95% to 90%. P = 0.7) and VLP (88% to 84%, P = 0.4). Mortality was similar (4-6%) and stable over time, irrespective of the supervisor. High tuberculosis treatment completion rates are achievable and sustainable for several years in resource-poor settings despite a massively increased case load if community resources are harnessed. Patients may be more effectively supervised by voluntary lay people than by health workers under these circumstances, without being placed at increased risk. These findings suggest that community supervisors may be an essential component of any DOT strategy.

Antitubercular Agents↗

Tuberculosis treatment through directly observed therapy in a large multisite methadone maintenance treatment program: addressing the public health needs of a high-risk population.

The rate of tuberculosis in patients receiving methadone treatment is significantly greater than the general population. The stabilization of former injection drug users occurs within methadone maintenance treatment programs, indicating the suitability of these sites for directly observed therapy (DOT). There are formidable barriers to the success of DOT, some are institutional, others patient-related. Strategies to address these obstacles need to be implemented. The integration of DOT into existing programs required support from the New York State Department of Health, institutional commitment, as well as continued staff and patient education and training.

Adult↗

Evaluation of the effectiveness of a directly observed therapy program with Vietnamese tuberculosis patients.

Tuberculosis (TB) has long been recognized as major public health problem. The rate of TB is high in immigrants, and the frequency of drug resistance is increasing. A major reason for the development of resistant infections as well as relapse is poor adherence to TB treatment. In response to thi problem, directly observed therapy (DOT) was introduced to thi TB program in Santa Clara county in 1993. The purpose of thi study is to compare the completion rates, relapse rates, and sputum conversion rates between a DOT group and a non-DOT group of Vietnamese TB patients. A chart review was completed with a convenience sample of 25 records of DOT patients ani 25 records of non-DOT patients. Frequencies and percentage were used to analyze the completion rates and the relapse rates The results show that the completion of therapy rate was 16% higher in the DOT group and the relapse rate was 8% lower. A t-test indicated that the sputum conversion rate was significantly more rapid in the DOT group than in the non-DOT group (p< 0.05). Vietnamese TB patients appear to benefit from the DOT program.

Adult↗

Creation of a tuberculosis directly observed therapy provider network in New York City: a new model of public health.

A 1990-1991 New York State Department of Health (NYSDOH) assessment of the ongoing tuberculosis (TB) epidemic in New York City (NYC) led to legislative enactment of policy recommendations to help stem the epidemic. The principal strategy entailed mobilization of community resources for TB directly observed therapy (DOT) to supplement the DOT available from the NYC Department of Health (NYCDOH). For implementation, the NYSDOH engaged a coalition of public and private health care providers in a TB DOT Provider Network. Network participants include freestanding facilities, many of which already have preexisting affiliative relationships through which DOT can be extended. The number of individuals receiving DOT in NYC has increased more than 10-fold in two years. Over 1,000 individuals have completed their anti-TB treatment while enrolled in the network.

Antitubercular Agents↗

Modeling the epidemiology and economics of directly observed therapy in Baltimore.

SETTING: From 1958 to 1978, Baltimore maintained one of the highest pulmonary tuberculosis (TB) rates in the US. But, from 1978 to 1992 its TB rate declined by 64.3% and its ranking for TB fell from second highest among large US cites to twenty-eighth. This TB trend coincided with the implementation of an aggressive directly observed therapy (DOT) program by Baltimore's Health Department. OBJECTIVES: We used modeling to estimate the range of TB cases prevented in Baltimore under DOT. Case estimates equal the difference between the observed number of TB cases in Baltimore versus the expected number if Baltimore's TB trend was replaced by the TB trend for the US (low estimate) or the TB trend for all US cities with over 250,000 residents (high estimate). Economic savings are estimated. RESULTS: Without DOT we estimate there would have been between 1,577 (53.6%) and 2,233 (75.9%) more TB cases in Baltimore, costing $18.8 million to $27.1 million. Cases prevented and expenditures saved increased with increased DOT participation. CONCLUSION: Our model predicts that Baltimore's TB decline accompanying DOT resulted in health care savings equal to twice the city's total TB control budget for this period. These results are most plausibly due to DOT, since it was the only major change in Baltimore's TB control program, and rising TB risk factors-AIDS, injection drug use, poverty-in a city where TB had been epidemic should have triggered a TB increase as in comparable US cities, rather than the observed decline. As national TB rates continue to decline it will be important to identify ways to capture and reinvest these savings to support effective TB control programs.

Antitubercular Agents↗

Influenza A in a basic training population: implications for directly observed therapy.

PURPOSE: To describe our evaluation of basic trainees exposed to influenza A and our experience with mass prophylaxis. METHODS: Using a structured interview, 101 individuals were evaluated for symptoms of influenza A. Nasopharyngeal wash specimens were obtained from symptomatic troops; amantadine prophylaxis was prescribed for all. Diagnosis was confirmed using a rapid influenza assay or shell vial culture. After completing prophylaxis, the group was reevaluated to determine medication compliance and perceived side effects. RESULTS: At baseline, 80 trainees reported symptoms. Three additional cases of influenza were identified, two using the rapid assay. Reported compliance with amantadine prophylaxis was 46.5%. CONCLUSIONS: Nonspecific complaints that could be consistent with viral infection were numerous in this basic trainee cohort. The rapid assay allowed us to expediently identify additional patients, who were then removed from the cohort to limit further transmission. Compliance with prophylaxis was poor; thus, directly observed therapy is recommended.

Aerospace Medicine↗