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Tuberculosis, HIV disease, and directly observed therapy.

Directly observed therapy (DOT) to enable completion of antituberculous therapy works. DOT is largely responsible for the recent improvement in tuberculosis case rates in New York City. Despite this favorable trend, the factors of significant HIV disease rates and of multidrug resistant forms of tuberculosis bacteria in the population are of grave concern. Therefore, in addition to DOT other means of preventing tuberculosis spread should be encouraged. These include directly observed preventive therapy (DOPT) programs, use of masks, improved ventilation in crowded settings such as homeless shelters, and ultraviolet light germicidal irradiation of upper room air in such locations.

AIDS-Related Opportunistic Infections↗

Directly observed therapy for treating tuberculosis.

BACKGROUND: Up to half the people with tuberculosis do not complete their treatment. Strategies to improve adherence to diagnostic and treatment regimens are therefore important. OBJECTIVES: To assess the effects of directly observed therapy by an appointed agent (health worker, community volunteer, or family member) on cure and treatment completion in people on treatment for tuberculosis. SEARCH STRATEGY: We searched The Cochrane Controlled Trials Register, the Cochrane Infectious Diseases Group specialized trials register, MEDLINE, EMBASE, LILACS, and reference lists of articles. We also contacted experts in the field. SELECTION CRITERIA: Randomized and quasi-randomized trials of direct observation of tablet swallowing compared with self treatment for tuberculosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Four studies (n = 1603 participants) included. There was no difference detected between direct observation and self treatment for cure (Relative Risk [RR] 1.06, 95% confidence interval [CI] 0.98 to 1.14); and for cure plus treatment completion (RR 1.06, 95% CI 1.00 to 1.13). A stratified analysis by the appointed agent (health professional, lay health worker, or family/community member) did not reveal any important differences. One study conducted in an optimal setting in which patients were given a choice of supervisor did show modest benefit: cure (RR 1.13, 95% CI 1.04 to 1.24); cure plus treatment completion (RR 1.11, 95% CI 1.03 to 1.18). REVIEWER'S CONCLUSIONS: Randomized trials provide no evidence that directly observed therapy in low and middle income country settings improves cure or treatment completion rates in patients with tuberculosis.

Antitubercular Agents↗

Implementation of universal directly observed therapy at a New York City hospital and evaluation of an out-patient directly observed therapy program.

SETTING: Directly observed therapy (DOT) program for tuberculosis (TB) at a New York City hospital. OBJECTIVE: To describe a specific TB DOT program model utilizing active prospective identification of inpatients, and identify factors associated with patient acceptance of voluntary DOT and with their retention in therapy. METHODS: Recruitment for DOT by daily surveillance of in-patients. DOT was offered as the patient's choice together with concrete services and incentives. On-site DOT was offered in an out-patient clinic. Outreach efforts were initiated when a patient missed one or more DOT visit. RESULTS: During the study period, 95% of 176 in-patients with TB were evaluated for DOT. Of the 137 who were eligible for DOT, 85% (95% confidence interval [CI], 77.5% to 90%) elected to receive DOT. Illicit drug use was independently associated with a higher likelihood of acceptance of DOT (odds ratio[OR], 4.88; 95% CI, 1.5-15.7). Among the 101 patients who received onsite DOT, illicit drug use (OR, 0.21; 95% CI, 0.08-0.6) and previous TB therapy (OR, 0.27; 95% CI, 0.27-0.7) were both independently associated with lower retention in therapy. However, with intensive case management, only 1% of this cohort was lost to follow-up and the overall treatment completion index was 98%. CONCLUSION: In-patient surveillance is a highly effective DOT recruitment strategy. A DOT model which elicits patient participation in discharge plans and offers incentives can yield a high rate of voluntary acceptance. Outpatient case management is a highly effective means of ensuring treatment completion, especially in those at risk for poor retention.

Adult↗

Treatment costs of directly observed therapy and traditional therapy for Mycobacterium tuberculosis: a comparative analysis.

OBJECTIVE: Treatment of tuberculosis is a time-consuming and expensive process, often complicated by patient non-adherence. Directly observed therapy (DOT), an out-patient management strategy designed to ensure adherence, is not widely used because it is perceived to be too expensive. This study compared costs of tuberculosis treatment in DOT to the same factors in traditional therapy. DESIGN: A retrospective economic evaluation of 659 tuberculosis cases was reported to a major metropolitan county public health department between 1980 and 1994. Out-patient costs, in-patient costs and the cost impact of relapse and acquired resistance were estimated in 1995 dollars. RESULTS: Treatment costs were lower with DOT: $15,670 per case for in-patient care and $700 per case for out-patient care (P < 0.001). These cost differences resulted from shorter therapy duration (334 vs 550 days), fewer patient hospitalizations (58 vs 75%) and shorter hospital stays (26 vs 55 days per hospitalized patient). Relapse or acquired resistance occurred in 10.9% of patients and accounted for 35.7% of cost with traditional therapy, as compared to 1.2% of patients and 6.0% of cost with observed therapy. CONCLUSIONS: Directly observed therapy is less costly than traditional therapy.

Adolescent↗

Directly observed therapy and treatment adherence.

Direct observation of patients taking their medication is a strategy to improve completion rates for tuberculosis treatment, but the programmes to implement this approach consist of a complex array of inputs aimed at influencing adherence. Policy makers need a clear understanding of these inputs to succeed. We systematically identified and reviewed published reports of direct observation therapy (DOT) programmes and compared inputs with WHO's short-course DOT programme. DOT programmes frequently consist of more than the five elements of WHO's strategy, including incentives, tracing of defaulters, legal sanctions, patient-centred approaches, staff motivation, supervision, and additional external funds. Focusing on direct observation as a key factor in the promotion of adherence seems inappropriate. Multiple components might account for the success of DOT programmes, and WHO should make these explicit.

Antitubercular Agents↗

Medication monitors to treat tuberculosis. A supplement to directly observed therapy.

The use of directly observed therapy (DOT) for nearly all cases of pulmonary tuberculosis (TB) is being widely promoted by the Centers for Disease Control, but its implementation is being resisted by many health professionals. Consequently, less than half of the patients in major metropolitan health departments were given DOT in 1996. The usual justification for "universal" DOT instead of selective DOT is the well-known difficulty in differentiating between patients who are reliable in taking medication from those who are not. Devices called medication monitors, which record when medication is removed from a container, were shown to be effective in determining the reliability of TB patients in taking medication in the 1960s but were cumbersome to use. Since then several improved, convenient to use, electronic medication monitors have been introduced and further improvements can be anticipated. These increasingly practical medication monitors need to be studied as a supplement to DOT in order to make selective DOT an effective alternative to "universal" DOT in managing the medication compliance problem when treating TB.

Drug Monitoring↗

The use of directly observed therapy in TB: a brief pan-London survey.

AIM: The objective of this study was to investigate issues regarding adherence with tuberculosis therapy and the use of directly observed therapy. METHOD: A small-scale survey of TB nurse specialists at chest clinics in London was carried out to determine the current use of directly observed therapy for patients with tuberculosis in London. RESULTS: Responses to this survey indicate that directly observed therapy is currently used in less than half the available services in London. Many of the specialist TB nurses indicated that lack of resources and time were drawbacks to implementing directly observed therapy. CONCLUSION: Directly observed therapy was found to be a strategy that was infrequently used as a last measure for those people who were previous non-adherers.

Ambulatory Care↗

The influence of program acceptability on the effectiveness of public health policy: a study of directly observed therapy for tuberculosis.

OBJECTIVES: This study examined how patient acceptability influences the effectiveness of directly observed therapy for tuberculosis. METHODS: Decision and sensitivity analyses were used in assessing influences. RESULTS: If mandatory directly observed therapy discourages 6% of initial tuberculosis patients (range: 4% to 10%) from seeking care, then such therapy will be less effective than self-administered therapy. Directly observed therapy is more effective than repeated self-administered therapy for patients failing to complete initial treatment unless 32% (range: 27% to 38%) of patients avoid seeking care. CONCLUSIONS: Patient acceptability must be taken into consideration before selecting public health strategies.

AIDS-Related Opportunistic Infections↗

Eleven years of community-based directly observed therapy for tuberculosis.

OBJECTIVE: To evaluate community-based directly observed therapy (DOT) for tuberculosis (TB) control. DESIGN: Ecological study. METHODS: Three comparisons were made in this descriptive study. (1) An 11-year retrospective comparison of TB case rates, sputum conversion rates (SCRs), rates of therapy completion, and confounding factors (acquired immunodeficiency syndrome [AIDS], immigration, unemployment, and poverty) in Baltimore, Md, with those of the five major US cities having the highest TB incidence in 1981 but which did not have comprehensive DOT programs. (2) An 11-year trend of TB in Baltimore and the 19 major US cities with the highest TB incidence in 1981. (3) A 7-year trend in TB in both city groups between 1985 and 1992. SETTING: Twenty US metropolitan cities with more than 250,000 residents. RESULTS: Since 1981, Baltimore experienced the greatest decline in TB incidence (35.6 cases per 100,000 population, 1981; 17.2 cases per 100,000 population, 1992 [-51.7%]), and city rank for TB (sixth in 1981, 28th in 1992). Conversely, the average incidence of TB increased 2.1% in the five-city cohort and increased 1.8% in the 19-city cohort. Since 1985, TB incidence increased 35.3% in the five-city cohort and 28.5% in the 19-city cohort, but declined 29.5% in Baltimore. From 1986 through 1992, Baltimore's DOT-managed cases had the highest annual SCRs at 3 months (mean, 90.7%), and the highest completion rates for standard anti-TB therapy (mean, 90.1%) when compared with the five cities. These trends could not be attributed to differentials in AIDS, immigration, poverty, or unemployment. Increasingly, more Baltimore cases were treated under DOT (86.5%, 1993) over time. Disease relapse rates remained low, even among HIV-infected patients. Within Baltimore, the documented SCR was significantly higher among DOT-managed cases compared with non-DOT-managed cases (P < .05); multidrug resistance remains rare (0.57%). Within Maryland, Baltimore accounted for 44.4% of all TB cases in 1981, compared with 28.7% in 1992 (P < .001). CONCLUSIONS: In contrast to the national TB upswing during the 1980s, Baltimore experienced a substantial decline in TB following implementation of community-based DOT, despite highly prevalent medicosocial risk factors. Directly observed therapy facilitated high treatment completion rates and bacteriologic evidence of cure. Directly observed therapy could help reduce TB incidence in the United States, particularly in cities with high case rates.

Baltimore↗

Directly observed therapy and treatment completion for tuberculosis in the United States: is universal supervised therapy necessary?

OBJECTIVES: This study examined the relationship between directly observed therapy and treatment completion rates in the years before and after infusion of federal funding for tuberculosis (TB) control in 1993. METHODS: An ecological study of estimated directly observed therapy rates and 12-month treatment completion rates from 1990 through 1994 was undertaken for TB control programs in all 25 cities and counties across the nation with 100 or more incident TB cases in any year from 1990 to 1993. Three cohorts were formed: high treatment completion, intermediate completion, and low completion. RESULTS: In 1990, the median 12-month treatment completion rate was 80% for the entire study population, with a median estimated directly observed therapy rate of 16.8%. By 1994, those rates had increased to 87% and 49.4%, respectively, and increases were shown in all 3 cohorts. CONCLUSIONS: Directly observed therapy has had a marked impact on treatment completion rates in jurisdictions with historically low rates. But TB treatment completion rates of more than 90% can be attained with directly observed therapy rates far lower than those proposed by advocates of universal supervised therapy.

Algorithms↗

Enhancing adherence to HAART: a pilot program of modified directly observed therapy.

Based on the model of directly observed therapy (DOT) for tuberculosis, we implemented an uncontrolled pilot program of modified DOT to increase adherence to HAART. Participants met every weekday with an outreach worker who observed them taking the morning dose of HAART. Thirty-seven patients with a history of poor adherence were enrolled and followed for a mean duration of 10 months. The program was feasible and well accepted by the participants. Self-reported adherence to nonobserved doses improved, and those who remained in the program for a year (n = 18) demonstrated a mean 1.53-log decrease from baseline in plasma HIV RNA level.

Adult↗

Selective directly observed therapy: appraisement and perception of likely participants.

Directly observed therapy (DOT) has become a popular strategy in tuberculosis (TB) control. Limited resources to provide DOT makes selection of patients an issue. Studies were done in San Francisco to analyze the socioeconomic and behavioral characteristics of 1992 TB patients--and of those on DOT--and to determine attitudes of indigent San Franciscans toward TB and adherence to TB control measures. The studies show that (1) African American and Latino patients were more likely to be selected for DOT than Asian/Pacific Islanders and whites, regardless of factors associated with adherence behavior, and (2) DOT, delivered in a respectful manner and combined with incentives, was evaluated positively by those with risk factors.

Antitubercular Agents↗

Tuberculosis control and directly observed therapy from the public health/human rights perspective.

Directly observed therapy, short course (DOTS) is the current international strategy for controlling tuberculosis. Decisions have been taken internationally about the increasing tuberculosis epidemic-what to do and why to do it. But do we know bow the DOTS strategy can be implemented most appropriately and what changes need to be made to ensure that it is effective? This paper uses the Public Health/Human Rights framework to discuss TB control from a human rights rather than the biomedical perspective. The aim is to introduce different approaches to the current DOTS strategy in order to find more effective and appropriate ways to treat and care for people with tuberculosis. The paper argues that key dimensions of social, economic and physical access to TB services need to be assessed and accounted for in programme design. This will require that TB control adopt a wider interdisciplinary and multisectoral perspective to complement the current biomedical orientation.

Communicable Disease Control↗

Directly observed therapy (DOT) is not the entire answer: an operational cohort analysis.

SETTING: New Jersey Medical School National Tuberculosis Center-Lattimore Clinic, a TB Clinic for an inner city population of Newark, New Jersey, USA. OBJECTIVE: Directly observed therapy (DOT) is the recommended standard of TB care. Recent reports suggest that DOT may not be any better than self-administered therapy (SAT). To quantify the impact of different levels of SAT, DOT, and active case management on outcomes of TB treatment at our location, we reviewed the outcomes of six TB patient-cohorts from Newark between 1 January 1994 and 31 December 1996. STUDY DESIGN: A retrospective cohort study of the outcomes of 343 tuberculosis patients treated during the years 1994-1996. The three treatment strategies were 1) self-administered with occasional selective directly observed therapy, 2) universal directly observed therapy alone (universal DOT), and 3) universal DOT with nurse case management (NCM). RESULTS: The first two cohorts who began treatment during the transition may have received more than one treatment strategy. However, universal DOT did not significantly improve the TB treatment completion rates of Cohort 2 over SAT therapy with selective DOT given to Cohort 1. Universal DOT with NCM, Cohorts 3, 4, 5, and 6, significantly increased the TB treatment completion rates by three to six times. A cohort-specific step-wise reduction in duration of treatment from a median of 11.6-7.5 months and an increase in completion rates from 57-81% resulted. The most desirable and optimal (shortest) duration of treatment completion coincided with the application of universal DOT combined with NCM.

Adult↗

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↗

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↗

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↗