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PubMed1996

Directly observed therapy for tuberculosis: the Harlem Hospital experience, 1993.

OBJECTIVES: A directly observed therapy program was established at Harlem Hospital, New York, NY, in 1993 to promote high tuberculosis treatment completion rates. METHODS: The Harlem program used an on-site surrogate family model. Treatment completion rate, visit adherence rate, human immuno-deficiency virus seroprevalence, and time to sputum culture conversion were assessed. RESULTS: Out of 145 enrolled patients with suspected and confirmed tuberculosis, 95 (92 confirmed and 3 suspected) continued treatment. The visit adherence rate was 91.1 +/- 7.9%, with one patient (1%) lost to follow-up. CONCLUSION: High rates of treatment completion and visit adherence were achieved because of unique program characteristics. Thus, directly observed therapy is advocated as a means of ensuring treatment completion.

AIDS-Related Opportunistic Infections↗
PubMed2006

Directly observed therapy for treating tuberculosis.

BACKGROUND: People with tuberculosis require treatment for at least six months. As many patients do not complete their treatment, policies have been introduced to encourage adherence to treatment regimens. One such policy is directly observed therapy, which involves people directly observing patients taking their antituberculous drugs. OBJECTIVES: To compare directly observed therapy (DOT) with self administration of treatment in people requiring treatment for clinically active tuberculosis or prevention of active disease. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (November 2005), CENTRAL (The Cochrane Library 2005, Issue 4), MEDLINE (1966 to November 2005), EMBASE (1974 to November 2005), LILACS (1982 to November 2005), and reference lists of articles. We also contacted researchers and organizations working in the field. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing a health worker, family member, or community volunteer routinely observing people taking antituberculous drugs compared with routine self administration of treatment at home. We include patients requiring treatment for clinically active tuberculosis or medication for preventing active disease. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial methodological quality and extracted data. Data were analysed using relative risks (RR) with 95% confidence intervals (CI) and the fixed-effect model when there was no statistically significant heterogeneity (chi square P > 0.1). Trials of drug users were analysed separately. MAIN RESULTS: Ten trials with 3985 participants met the inclusion criteria. There was no statistically significant difference between DOT and self administration of treatment for the number of people cured (RR 1.02, 95% CI 0.86 to 1.21, random-effects model; 1603 participants, 4 trials) or who were cured or completed treatment (RR 1.06, 95% CI 1.00 to 1.13; 1603 participants, 4 trials). Stratifying the location of the DOT by home or at a clinic suggests a possible small effect with home-based DOT (RR 1.10, 95% CI 1.02 to 1.18; 1365 participants, 3 trials). Two small trials of tuberculosis prophylaxis in intravenous drugs users found no statistically significant difference between DOT and self administration (199 participants, 1 trial), or a choice of location for DOT for completion of treatment (108 participants, 1 trial). AUTHORS' CONCLUSIONS: The results of randomized controlled trials conducted in low-, middle-, and high-income countries provide no assurance that directly observed therapy compared with self-administered treatment has any quantitatively important effect on cure or treatment completion in people receiving treatment for tuberculosis.

Antitubercular Agents↗
PubMed1996

Directly observed therapy for tuberculosis in rural South Africa, 1991 through 1994.

OBJECTIVES: This paper describes an audit of a community-based tuberculosis treatment program involving directly observed therapy in South Africa. METHODS: A program audit of 2473 consecutive tuberculosis patients in Hlabisa Health District, KwaZulu/Natal, South Africa, was conducted between 1991 and 1994. RESULTS: Monthly admissions increased from 34 per month in 1991 to 66 in 1994. Of 2186 patients managed in Hlabisa, 1903 (87%) received directly observed therapy. Of those receiving directly observed therapy, 1034 (55%) were supervised by volunteers; 743 (72%) of these were supervised by storekeepers. Among those patients managed locally, 1679 (85%) of 1967 surviving patients completed treatment. Completion rates for patients supervised by health workers and non-health workers were the same. Completion fell from a high of 90% in 1992 to 78% in 1994. Mortality increased from 5% in 1991 to 10% in 1994. CONCLUSIONS: Community-based directly observed therapy that uses an intermittent drug regime and volunteers as supervisors can achieve high treatment completion rates for tuberculosis, even in resource-poor settings.

Adult↗
PubMed1998

Directly observed therapy for treatment completion of pulmonary tuberculosis: Consensus Statement of the Public Health Tuberculosis Guidelines Panel.

OBJECTIVE: To evaluate evidence on the relative effectiveness of directly observed therapy in achieving treatment completion for pulmonary tuberculosis. PARTICIPANTS: A panel of 11 practitioners representing the public health, behavioral, and clinical management of tuberculosis was convened by the Council on Linkages Between Academia and Public Health Practice in 1995 to develop public health guidelines for tuberculosis treatment completion. EVIDENCE: English-language articles identified through MEDLINE (1966 to August 1, 1996) with original data on directly observed therapy, supervised therapy, compliance, treatment completion, case management, and treatment adherence for tuberculosis. CONSENSUS PROCESS: Each eligible article underwent structured review by at least 2 panel members for study design, sample size, evaluation methods, and treatment completion as the primary outcome. The full panel was convened twice, with intercurrent small group meetings, conference calls, and summary workshop to review findings. Recommendations made through this process were drafted by the panel chair and circulated twice for additional panel comments. CONCLUSIONS: Treatment completion rates for pulmonary tuberculosis are most likely to exceed 90%, as recommended by the Centers for Disease Control and Prevention, when treatment is based on a patient-centered approach using directly observed therapy with multiple enablers and enhancers. Other less intensive interventions, including nonsupervised strategies and modified approaches to directly observed therapy, are unlikely to achieve this recommended treatment completion goal. Directly observed therapy also appears to be cost-effective compared with self-administered therapy, although data on cost-effectiveness are limited.

Ambulatory Care↗
PubMed1998

Directly observed therapy in an inner city hospital.

SETTING: A directly observed therapy (DOT) tuberculosis (TB) program in a large urban teaching hospital in the East Harlem section of New York City. OBJECTIVE: In response to an emergent epidemic of TB, the State Department of Health mobilized a coalition of providers outside the public sector to provide DOT and medical care for people with TB, with the goal of treatment until cure. The results of the first 150 patients of one program are reviewed. DESIGN: A multidisciplinary DOT team coordinated treatment at several sites within and without the institution, according to established medical regimens. RESULTS: The program served a hard-to-reach population, 63% human immunodeficiency virus (HIV) positive, 64% substance users, 17% inadequately housed and 15% indigent. In the program's first three years there was 85% overall compliance with DOT visits. Using the completion of therapy index, 66% of patients completed therapy, 13% remained on treatment, 7% transferred to self medication and 1% were lost to follow up. No patient on DOT developed a drug resistant organism. There were no hospital readmissions for TB. CONCLUSION: The experience of this program demonstrates the efficacy of an intensive, personalized DOT program in ensuring treatment until cure.

AIDS-Related Opportunistic Infections↗
PubMed2004

Utility of tuberculosis directly observed therapy programs as sites for access to and provision of antiretroviral therapy in resource-limited countries.

The overwhelming share of the global human immunodeficiency virus (HIV) infection and disease burden is borne by resource-limited countries. The explosive spread of HIV infection and growing burden of disease in these countries has intensified the need to find solutions to improved access to treatment for HIV infection. The epidemic of HIV infection and acquired immune deficiency syndrome (AIDS) has been accompanied by a severe epidemic of tuberculosis. Tuberculosis has become the major cause of morbidity and mortality in patients with HIV disease worldwide. Among the various models of provision of HIV/AIDS care, one logical but unexplored strategy is to integrate HIV/AIDS and tuberculosis care and treatment, including highly active antiretroviral therapy, through existing tuberculosis directly observed therapy programs. This strategy could address the related issues of inadequate access and infrastructure and need for enhanced adherence to medication and thereby potentially improve the outcome for both diseases.

Anti-HIV Agents↗
PubMed2005

Use of community-based, directly observed therapy for HIV infection: lessons learned for treatment of hepatitis C virus infection.

Directly observed therapy (DOT) is an effective approach for the treatment of tuberculosis among substance users. We have adapted this model to treat human immunodeficiency virus infection. Our experience suggests that community-based, modified DOT should be explored further as a means to treat infectious diseases and chronic medical illnesses for persons with drug dependence; it may be especially pertinent for the treatment of hepatitis C virus infection. DOT can both optimize adherence and provide a way to offer psychosocial support and linkages to social, addiction, psychiatric, and other services, to help address many of the challenges faced by persons with substance abuse disorders.

Adult↗
PubMed2004

Effectiveness and tolerability of a once-daily amprenavir/ritonavir-containing highly active antiretroviral therapy regimen in antiretroviral-naïve patients at risk for nonadherence: 48-week results after 24 weeks of directly observed therapy.

OBJECTIVES: To determine the safety and effectiveness of a once-daily highly active antiretroviral therapy (HAART) regimen in patients at risk for poor adherence using directly observed therapy (DOT) for 24 weeks followed by weekly phone contact for another 24 weeks. METHODS: A prospective, open-label pilot study was carried out. Antiretroviral-naïve patients with advanced HIV disease were treated with once-daily amprenavir 1200 mg, ritonavir 200 mg, didanosine 400 mg and lamivudine 300 mg. After 24 weeks, DOT was substituted by weekly phone contact. Measurements of viral load and CD4 cell count, and safety laboratory measurements, were taken regularly for 48 weeks. RESULTS: Twenty-two patients were enrolled in the study, of whom 19 completed at least 4 weeks of treatment. Seventeen patients completed 24 weeks and 13 completed 48 weeks. None discontinued treatment as a result of adverse events. The median baseline HIV viral load was 5.29 log(10) HIV-1 RNA copies/mL and the median CD4 cell count was 20 cells/microL. At weeks 24 and 48, 74% of the patients had viral loads <400 copies/mL. At 48 weeks, the median decrease in viral load from baseline was 3.06 log(10) copies/mL, and the median increase in CD4 cell count was 118 cells/microL. The median trough plasma amprenavir concentrations at weeks 1 and 24 were 1.87 and 1.42 microg/mL, respectively. CONCLUSIONS: This study suggests that DOT followed by weekly patient contact results in good treatment outcome in this challenging population. The median trough plasma amprenavir concentrations were above the effective concentration of drug that resulted in 90% inhibition of viral load in vivo (EC(90)) for wild-type HIV.

Adult↗
PubMed2007

Directly observed therapy and tuberculosis: how can a systematic review of qualitative research contribute to improving services? A qualitative meta-synthesis.

AIM: This paper reports the findings from a qualitative meta-synthesis concerning people with, or at risk of, tuberculosis, service providers and policymakers and their experiences and perceptions of tuberculosis and treatment. BACKGROUND: Directly observed therapy is part of a package of interventions to improve tuberculosis treatment and adherence. A Cochrane systematic review of trials showed an absence of evidence for or against directly observed therapy compared with people treating themselves. METHOD: Qualitative systematic review methods were used to search, screen, appraise and extract data thematic analysis was used to synthesize data from 1990 to 2002, and an update of literature to December 2005. Two questions were addressed: 'What does qualitative research tell us about the facilitators and barriers to accessing and complying with tuberculosis treatment?' and 'What does qualitative research tell us about the diverse results and effect sizes of the randomized controlled trials included in the Cochrane review?' Findings help explain the diverse trial results in a Cochrane systematic review of directly observed therapy and tuberculosis and consider implications for research, policy and practice. FINDINGS: Five themes emerged from the 1990 to 2002 synthesis: socio-economic circumstances, material resources and individual agency; explanatory models and knowledge systems in relation to tuberculosis and its treatment; the experience of stigma and public discourses around tuberculosis; sanctions, incentives and support, and the social organization and social relationships of care. Two additional themes emerged from the 2005 update. CONCLUSION: The qualitative meta-synthesis improved the relevance and scope of the Cochrane review of trials. The findings make a major contribution to the development of theory concerning global WHO-branded disease control and the practicality of local delivery to people.

Directly Observed Therapy↗
PubMed2000

The effects of increasing incentives on adherence to tuberculosis directly observed therapy.

SETTING: Six New York State Department of Health tuberculosis (TB) directly observed therapy (DOT) programs in public, private and community facilities in New York City. OBJECTIVE: A key feature of the TB DOT program was provision of incentives to motivate patients and increase adherence to therapy. The study hypothesis was that adherence will improve as the value of incentives increases and bonuses are added in a schedule of increasing rewards. DESIGN: The study population consisted of 365 patients in six inner city TB DOT programs. Interviews, clinical data and attendance records for 3+ years were analyzed. RESULTS: Patients who adhered (attending 80% of prescribed DOT visits each month of treatment) and those who did not were similar on seven demographic factors (e.g., age and sex), but were significantly different on clinical and social variables. Previous TB, resistance to rifampin, human immunodeficiency virus infection, psychiatric illness, homelessness, smoking and drug use were related to non-adherence. High adherence was significantly associated with fewer months in treatment (P < 0.016). Logistic regression showed that the odds that a patient would adhere to therapy were greater with increased incentives. Odds of adherence were significantly lower with rifampin resistance and psychiatric illness. CONCLUSION: Increasing incentives is associated with improved adherence to therapy in inner city TB populations.

Adult↗
PubMed2002

Directly observed therapy for the treatment of people with human immunodeficiency virus infection: a work in progress.

The principle of directly observed therapy (DOT) has its roots in the treatment of tuberculosis (TB), for which DOT programs have improved cure rates in hard-to-reach populations. Human immunodeficiency virus (HIV) and TB affect similar populations, and there are concerns about both regarding the development of drug resistance associated with poor adherence to therapy. Accordingly, DOT may benefit certain HIV-infected people who have difficulty adhering to highly active antiretroviral therapy. However, important differences exist in the treatment of these diseases that raise questions about how DOT can be adapted to HIV therapy. DOT for management of HIV infection has been effective among prisoners and in pilot programs in Haiti, Rhode Island, and Florida. Although DOT can successfully treat HIV infection in marginalized populations in the short term, a multitude of questions remain. This review provides an account of the preliminary development of DOT programs for the treatment of HIV-infected individuals.

Antiretroviral Therapy, Highly Active↗
PubMedDate not supplied

The limits to patient compliance with directly observed therapy for tuberculosis: a socio-medical study in Pakistan.

Complying with the prescriptions of the directly observed therapy (DOT), one of the components of the Global Tuberculosis Programme of the WHO, is problematic for many patients. The factors leading to patient (non-) compliance with DOT are placed in a structural equation model. The study is based on a survey carried out in one general hospital in the Punjab province of Pakistan, amongst all sputum positive pulmonary TB patients (n = 621) who arrived at the TB unit from September 1997 to October 1998. The tested sequence of manifest variables and latent constructs shows that the social stratification perspective has to be extended by the stigmatization perspective. The advantages of universally applying DOT will increase even further when the latter perspective is involved in the analysis of non-compliance. There is a real danger that the patients reached by selective DOT will be stigmatized even more.

Adult↗
PubMed1998

Molecular and geographic patterns of tuberculosis transmission after 15 years of directly observed therapy.

CONTEXT: Recent studies suggest that one third of tuberculosis cases in urban areas result from recent transmission. Improved tuberculosis control measures such as uniform implementation of directly observed therapy might reduce the proportion of cases resulting from recent transmission. OBJECTIVE: To determine patterns of tuberculosis transmission in Baltimore, Md, after 15 years of community-based directly observed therapy. DESIGN: A 30-month (January 1994-June 1996), prospective, city-wide study of all cases of tuberculosis using traditional contact investigations, geographic information systems data, and molecular epidemiologic comparison of Mycobacterium tuberculosis isolates with 2 DNA probes. PATIENTS: One hundred eighty-two patients with culture-positive tuberculosis. MAIN OUTCOME MEASURES: Proportion of disease defined as recently transmitted based on epidemiologic linkage by traditional contact tracing and molecular linkage by DNA fingerprint analysis of isolates; geographic foci of transmission based on linkage of residences by geographic information systems data. RESULTS: Of the 182 patients who had isolates of M tuberculosis available, 84 (46%) showed molecular clustering with 58 (32%) defined as being recently transmitted. Only 20 (24%) of 84 cases with clustered DNA fingerprints had epidemiologic evidence of recent contact. Geographic analysis showed significant spatial aggregation of the 20 clustered cases with epidemiologic links (P<.001), occurring in areas of low socioeconomic status and high drug use. The 64 cases with clustered DNA fingerprints but without epidemiologic links shared common risk factors and demographic features with the 20 clustered patients who did have epidemiologic links. CONCLUSIONS: Recently transmitted tuberculosis accounts for a high proportion of tuberculosis cases in Baltimore. Recently transmitted cases occur in geographically distinct areas of Baltimore, and location-based control efforts may be more effective than contact tracing for the early identification of cases.

Adult↗
PubMedDate not supplied

Directly observed therapy for tuberculosis given twice weekly in the workplace in urban South Africa.

Effective models of delivery of directly observed therapy (DOT) for tuberculosis in resource-poor settings are needed. Intermittent chemotherapy may be an important component of DOT delivered in the community as it means fewer visits to supervisors. There is no published evidence on the efficacy of twice weekly therapy given from the start of treatment without an intensive daily phase. We analysed data from 3 large cohort studies in a migrant, urban workforce in South Africa between 1975 and 1983. All patients received 4 drugs (isoniazid, rifampicin, pyrazinamide and streptomycin) twice weekly under direct observation by a nurse in the workplace. Of 444 patients, 378 (85.1%) completed treatment. Cure could be assessed in 362, and 348 (96.1%, 95% confidence interval 93.7-97.8%) were bacteriologically cured. Sputum status was assessed at 2-3 months in 343 patients and 309 (90.1%) were sputum negative. Eighteen patients relapsed (5.7%; 2.9/100 patient-years of observation). DOT can be effectively delivered to a migrant, urban workforce, and 4-drug therapy given twice weekly under direct observation is efficacious.

Adult↗
PubMed2001

Utility of rifampin blood levels in the treatment and follow-up of active pulmonary tuberculosis in patients who were slow to respond to routine directly observed therapy.

STUDY OBJECTIVE: The standard daily dose of rifampin in directly observed treatment of Mycobacterium tuberculosis (TB) is 600 mg, taken orally. The purpose of this study was to assess the efficacy of standard dose rifampin therapy in patients who were slow to respond to routine directly observed therapy (DOT). METHODS: Patients with non-drug-resistant pulmonary TB who were receiving 600 mg of oral rifampin by DOT were eligible for inclusion. Patients were deemed slow to respond if their sputum smears and cultures remained positive for M tuberculosis and if the patient's condition did not improve clinically or radiographically after 3 months of treatment. Serum rifampin levels were ascertained to determine the adequacy of the standard rifampin dosing. Patients with subtherapeutic blood levels had their rifampin dose increased to 900 mg, and rifampin levels were repeated. Rifampin dosage was increased again if blood levels were still subtherapeutic. No antitubercular medications were added to the treatment regimen. The total weekly dose of the other standard treatment drugs was not increased. RESULTS: Of 124 new patients with active pulmonary TB, 6 patients were identified as slow to respond to the standard antitubercular DOT. All six patients had subtherapeutic serum rifampin levels. All six patients responded clinically, radiographically, and mycobacteriologically after an increase in rifampin dosage to reach target drug blood level. CONCLUSIONS: Standard dosing with rifampin resulted in a poor clinical response and subtherapeutic serum levels in six patients. Increasing the dosage of rifampin improved the outcome without additional side effects. In TB patients who are slow to respond to standard treatment, an inadequate dose of rifampin should be suspected. Current antituberculer drug administration does not include adjusted dosage for rifampin.

Administration, Oral↗
PubMed2006

Improvements in treatment success rates with directly observed therapy in Rio de Janeiro City.

SETTING: Rio de Janeiro City, Brazil. OBJECTIVE: To evaluate the effect of directly observed therapy (DOT) on treatment success, by comparing the treatment success rates between patients treated under DOT with those who received self-administered therapy (SAT). DESIGN: A longitudinal study in a cohort of tuberculosis (TB) patients. Of 9929 new pulmonary TB cases, 1190 (12%) were treated under DOT and 8739 (88%) under SAT. All patients received a three-drug regimen consisting of rifampicin (RMP), isoniazid (INH) and pyrazinamide for 2 months followed by 4 months of RMP and INH. RESULTS: Patients under DOT were more likely to convert to sputum-negative at the end of the second month than those treated under SAT (86.3% vs. 61.9%, P < 0.001). DOT alone was significantly associated with successful treatment (OR 1.6, 95%CI 1.37-1.86, P < 0.001), even when controlled by sex, age and positive smear or culture at enrollment (OR 1.56, 95%CI 1.33-1.82, P < 0.001). CONCLUSION: This pilot DOTS implementation phase showed that DOT is highly effective and feasible in a large urban centre of a developing country.

Adult↗