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PubMed2000

Factors influencing compliance in patients with tuberculosis on directly observed therapy at Ile-Ife, Nigeria.

BACKGROUND: Increased morbidity and mortality of tuberculosis have been blamed on neglect of the human dimension of tuberculosis control. One of such factors included in human dimension is non-compliance, a behavioural parameter, which has led to the emergence of multi-drug resistant tuberculosis, and poor treatment outcome. OBJECTIVE: To explore the impact of directly observed therapy (DOT) on compliance and the factors influencing it. DESIGN: A retrospective study. SETTING: Chest clinic of Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria. METHODS: Directly observed therapy (DOT) was employed. Records of the socio-demographic characteristics, treatment categories, complications developed, results of investigations, level of compliance and treatment outcome for the patients were kept. The data for the patients seen between May 1996 and April 1997 were retrieved and analysed. Those that complied were compared with those that did not comply. RESULTS: One hundred and ninety nine patients comprising ninety one males and 108 females, were seen during the period. They were mostly between the ages of 16 years and 45 years (mean +/- SD = 31.7+/-14.98). One hundred and fifty eight (73%) complied and all of them were cured. The only factor that significantly influenced rate of compliance was proximity to the chest clinic. CONCLUSION: DOT improves the rate of compliance. No socio-demographic factors considered significantly influenced the rate of compliance under DOT, and as such they are not reliable predictive factors. Locating chest units in the existing primary health care facilities will improve the rate of compliance with antituberculosis therapy. More attention should be paid to behavioural aspect of tuberculosis control.

Adolescent↗
PubMed2004

Directly observed therapy for tuberculosis in New York City: factors associated with refusal.

OBJECTIVES: To describe patients who utilize hospital-based directly observed therapy (DOT) programs and to describe factors that influence refusal of DOT. METHODS: Retrospective analysis of patients diagnosed with tuberculosis through hospital admission in 1997 at 12 hospital sites with out-patient DOT programs. Data were obtained from hospital patient records and from the New York City Tuberculosis Case Registry. RESULTS: Of 443 patients diagnosed with tuberculosis in 1997 at the 12 hospital sites and available and/or eligible for DOT, 52 (12%) refused DOT. The two main reasons for DOT refusal were that the patients felt they could self-medicate (21%) and that their work schedule interfered with a DOT program (19%). White non-Hispanic race/ethnicity was associated with refusal of DOT (P = 0.001). Conversely, interview for DOT while in the hospital (P < 0.001) and enrollment in drug treatment were associated with acceptance of DOT (P = 0.05). The five hospitals with tuberculosis clinics on site had the lowest percentages (0-9%) of patients refusing DOT. CONCLUSION: To increase patient acceptance of DOT, programs need flexible hours that accommodate patients in the workforce. Patient education should focus on the difficulty of completing tuberculosis treatment on a self-administered regimen and the importance of the support offered through DOT.

Adolescent↗
PubMed2003

Directly observed therapy (DOT) for individuals with HIV: successes and challenges.

Many HIV-infected individuals have not reaped the benefits of combination antiretroviral therapy due to inability either to adhere to medications or to access care. It is now recognized that innovative approaches are needed to increase access and adherence to highly active antiretroviral therapy (HAART), especially among these hard-to-reach populations. Due to the success of directly observed therapy (DOT) for the treatment of Mycobacterium tuberculosis (TB), our group and others have questioned whether DOT can be adapted to deliver HAART to hard-to-reach communities. In this review, we discuss the results of pilot programs that have utilized DOT in multiple different settings and use case studies to explore the diverse issues that can arise when implementing these programs. As we continue to gain more experience with observed therapy, we will be able to better identify the key components for a successful intervention.

Adult↗
PubMed1997

A cost-effectiveness analysis of directly observed therapy vs self-administered therapy for treatment of tuberculosis.

STUDY OBJECTIVES: To compare the costs and effectiveness of directly observed therapy (DOT) vs self-administered therapy (SAT) for the treatment of active tuberculosis. DESIGN: Decision analysis. SETTING: We used published rates for failure of therapy, relapse, and acquired multidrug resistance during the initial treatment of drug-susceptible tuberculosis cases using DOT or SAT. We estimated costs of tuberculosis treatment at an urban tuberculosis control program, a municipal hospital, and a hospital specializing in treating drug-resistant tuberculosis. OUTCOME MEASURES: The average cost per patient to cure drug-susceptible tuberculosis, including the cost of treating failures of initial treatment. RESULTS: The direct costs of initial therapy with DOT and SAT were similar ($1,206 vs $1,221 per patient, respectively), although DOT was more expensive when patient time costs were included. When the costs of relapse and failure were included in the model, DOT was less expensive than SAT, whether considering outpatient costs only ($1,405 vs $2,314 per patient treated), outpatient plus inpatient costs ($2,785 vs $10,529 per patient treated), or outpatient, inpatient, and patients' time costs ($3,999 vs $12,167 per patient treated). Threshold analysis demonstrated that DOT was less expensive than SAT through a wide range of cost estimates and clinical event rates. CONCLUSION: Despite its greater initial cost, DOT is a more cost-effective strategy than SAT because it achieves a higher cure rate after initial therapy, and thereby decreases treatment costs associated with failure of therapy and acquired drug resistance. This cost-effectiveness analysis supports the widespread implementation of DOT.

Antitubercular Agents↗
PubMed1998

Pulmonary tuberculosis treated with directly observed therapy: serial changes in lung structure and function.

OBJECTIVES: (1) To correlate structure (CT) with function in pulmonary tuberculosis (TB), and (2) to describe the evolution of structural and functional abnormalities when pulmonary TB is treated with directly observed therapy. SUBJECTS AND METHODS: Twenty-five patients with drug-susceptible pulmonary TB, 15 cavitary and 10 noncavitary, were studied prospectively. Conventional CT and pulmonary function testing (spirometry, diffusing capacity, and arterial blood gases) were performed at baseline, and after 1 and 6 months of directly observed therapy. RESULTS: All but one patient with noncavitary miliary TB had CT evidence of endobronchial disease, and all patients with cavitary disease had coexistent reduced lung attenuation, the latter presumably a result of gas trapping, hypoxic vasoconstriction, and vascular injury. Functional impairment was minimal and in proportion to the number of diseased segments and cavitary volume. Bronchiectasis was significantly more likely to complicate cavitary than noncavitary disease (64 vs 11%; p<0.05). CONCLUSIONS: CT findings correlate well with function in pulmonary TB. Physiologic data were consistent with the concept that pulmonary TB is an endobronchial disease that causes parallel reductions in ventilation and perfusion. This concurrent involvement of both airways and contiguous pulmonary blood supply offers an explanation for the minimal respiratory limitation experienced by these patients despite often extensive lung disease. Supervised therapy of drug-susceptible disease results in minimal structural and functional residua.

Adult↗
PubMed2002

Temporal trends in tuberculosis hospitalization rates before and after implementation of directly observed therapy: New York City, 1988-1995.

New York City hospitalization rates were analyzed to investigate whether tuberculosis (TB) hospitalizations declined after implementation of directly observed therapy (DOT) for TB. TB hospitalization rates mirrored incidence rates in pattern but not in magnitude. Rates have declined significantly following widespread implementation of DOT in 1993.

Antitubercular Agents↗
PubMed2004

Directly observed therapy for tuberculosis in a low prevalence region: first experience at the Tuberculosis Dispensary in Lausanne.

AIM: Evaluation of first experience of the directly observed therapy (DOT) programme for tuberculosis introduced in the Canton of Vaud in 1997. METHOD: Retrospective analysis of tuberculosis patients included in a DOT programme from October 1997 to March 2000 under the supervision of the TB Dispensary in Lausanne. RESULTS: 54 patients were included, 49 of whom were new cases and 5 relapses. 70% were asylum seekers and illegal immigrants. The indications for DOT were immigrant status, social problems, and physical or psychiatric comorbidities. Treatment was fully supervised in 67% and partially in 33%. The outcome was favourable (cure or treatment completion) in 88.9% and unfavourable in 11.1%. A similar success rate was observed in full and partial DOT and there was no difference in success rates between the various structures where DOT was administered. By comparison, the success rate in a historical group from the same institution was 70% in 1990. The biggest problem was communication with the patients and within the team. CONCLUSION: Treatment of tuberculosis under DOT in the Canton of Vaud resulted in improvement of the treatment success rate.

Adolescent↗
PubMed2001

The application of telemedicine technology to a directly observed therapy program for tuberculosis: a pilot project.

We evaluated the use of videophone technology to provide directly observed therapy (DOT) to patients with active tuberculosis. During 304 treatment doses, adherence on videophone DOT was 95%, and patient acceptance of the technology was excellent. In selected cases, the use of videophone technology can maintain a high level of adherence to DOT in a cost-effective manner.

Centers for Disease Control and Prevention, U.S.↗
PubMed1999

Directly observed therapy, short-course: the best way to prevent multidrug-resistant tuberculosis.

Adherence to therapy in patients with tuberculosis (TB) is a major determinant of their outcomes. Unfortunately, there are no currently known predictors of adherence, given that this phenomenon represents a complex, task-specific behavior. Notwithstanding criticisms from civil liberty advocates, directly observed therapy (DOT), facilitated by education, holistic care, enablers and incentives, is still the best strategy to ensure patient adherence to treatment. To enhance delivery of DOT, short-course chemotherapy (SCC) must be strongly advocated. Monitoring of patient progress, dependable drug supply, and adequate programme funding are other important elements of the entire strategy. Indeed, since the global resurgence of TB and associated rampant drug resistance in the 1990s, directly observed therapy, short-course (DOTS) has now become the WHO strategy for effective TB control. Data obtained so far in different continents worldwide have underscored the unrivalled efficacy of DOTS in ensuring treatment success and preventing development of acquired drug resistance. The recent WHO/International Union against Tuberculosis and Lung Disease (IUATLD) global project on anti-TB drug resistance surveillance has also revealed that countries in which >33-90% of the population has access to the WHO DOTS strategy have, as a group, lower levels of drug resistance: primary multidrug-resistant (MDR) (1.4%; median) and acquired MDR index (0. 6; median). The use of SCC was also inversely associated with the prevalence of combined resistance to any drug. Countries with MDR rates >2% reported using SCC in a median of 70% of their patients, compared with 100% in countries with MDR rates <2% (WHO/TB/97.229). Despite greater initial cost, DOTS is a more cost-effective strategy than self-administered therapy because it decreases the re-treatment costs associated with therapy failure and acquired drug resistance. Finally, in addition to harnessing the complementary roles of a national tuberculosis programme and community participation, DOTS might be further enhanced by the use of newly developed drugs with a long duration of action or more potent bactericidal and sterilizing activities.

Antitubercular Agents↗
PubMed2001

Short course directly observed therapy to monitor compliance with antiretroviral therapy in human immunodeficiency virus-infected children.

We report our experience with short course directly observed therapy (DOT) in six human immunodeficiency virus-infected children who had a poor response to their prescribed therapy. Four to 8 days of DOT resulted in a significant drop in the viral load of all six children, demonstrating that short course DOT is an effective way to document poor compliance with antiretroviral therapy.

Administration, Oral↗
PubMed1999

Cost-effectiveness analysis of directly observed therapy for patients with tuberculosis at low risk for treatment default.

To determine the incremental cost of directly observed therapy (DOT) for patients with tuberculosis at low risk for treatment default, we applied a model of DOT effectiveness to 1,377 low-risk patients in California during 1995. The default rate for this cohort, which consisted of those with no recent history of substance abuse, homelessness, or incarceration, was 1.7%. The model predicted that DOT and self-administered therapy (SAT) cured 93.1 and 90.8% of these patients, respectively. DOT would initially cost $1.83 million more than SAT, but avert $569,191 in treatment cost for relapse cases and their contacts, for a net incremental cost of $1.27 million ($919 per patient treated), or $40,620 per additional case cured. The cost-effectiveness of DOT was sensitive to the default rate and relapse rate after completing SAT. DOT would generate cost savings only when the default and relapse rates were more than 32.2 and 9.2%, respectively. Given the low default rate and resulting high incremental cost of DOT, provision of DOT to low-risk patients in California should be evaluated in the context of resource availability, competing program priorities, and program success in completing self-administered therapy with a low relapse rate.

Adult↗
PubMed1995

Implementing a directly observed therapy program in an urban community hospital.

St. Clare's Health and Hospital Center has implemented a directly observed therapy (DOT) program for a challenging urban population of largely HIV+ patients in response to a need for the prevention of the spread of multidrug-resistant tuberculosis in the population. Identified treatment barriers are needs of patient subgroups within the population. Issues in the implementation include: patient compliance, effectiveness of patient identification and follow-up, and continuity of care. Challenges to continuity of care include patients signing out of the hospital against medical advice and missed clinic appointments. Patient identification and follow-up is enhanced by coordinating DOT treatment with the methadone maintenance treatment program.

AIDS-Related Opportunistic Infections↗
PubMed2006

Modified directly observed therapy to facilitate highly active antiretroviral therapy adherence in Beira, Mozambique. Development and implementation.

As resource-limited countries expand access to highly active antiretroviral therapy (HAART) treatment, innovative programs are needed to support adherence in the context of significant health system barriers. Modified directly observed therapy (mDOT) is one such strategy, but little is known about the process of designing and implementing mDOT programs for HAART in resource-limited settings. In this descriptive study, we used a mixed-methods approach to describe the process of implementing mDOT for an ongoing randomized control trial (RCT) in Beira, Mozambique. Interviews with clinic staff, mDOT peers, and participants provided information on design elements, problems with implementation, satisfaction, and benefits. Acceptability and feasibility measures were obtained from the RCT. Most (81%, N = 350) eligible persons agreed to participate, and of those randomized to mDOT (n = 174), 95% reported that their time with peers was beneficial. On average, participants kept 93% of the 30 required daily mDOT visits. Key components of the intervention's success included using peers who were well accepted by clinic staff, adequate training and retention of peers, adapting daily visit requirements to participants' work schedules and physical conditions, and reimbursing costs of transportation. This study identified aspects of mDOT that are effective and can be adopted by other clinics treating HIV patients.

Adult↗
PubMed2005

Patients perceived stigma associated with community-based directly observed therapy of tuberculosis in Uganda.

OBJECTIVE: To assess whether linkage of tuberculosis (TB) and HIV/AIDS increases the perception of stigma among TB patients on Community-Based Directly Observed Therapy (CB-DOT) compared to similar TB patients on self-administered therapy (SAT). DESIGN: A Cross-sectional study. SETTING: Kiboga (CB-DOT) and Mubende (SAT) districts, Uganda in 2000. SUBJECTS: One hundred and five tuberculosis patients on CB-DOT and 202 patients on SAT. One hundred and twenty one (39%) of these patients agreed to be tested for HIV. RESULTS: Patients on CB-DOT and patients on SAT were similar on most of the domains used to assess stigma associated with a TB diagnosis, except for the domain of TB diagnosis and general belief that TB and HIV/AIDS are linked. Patients on CB-DOT were more likely to believe that neighbours knew they had TB compared to patients on SAT (91% vs. 62%, p < 0.001), but the groups did not differ in their perception that neighbours thought they have HIV because of TB (46% vs. 46%, p = 0.954). HIV prevalence was similar in both groups. CONCLUSION: The study demonstrates that TB patients on CB-DOT did not differ from SAT patients in their perception of stigma as a result of TB. Therefore, HIV-related stigma may not limit wide implementation of CB-DOT in countries like Uganda.

Adolescent↗
PubMed2004

Modified directly observed therapy for the treatment of HIV-seropositive substance users: lessons learned from a pilot study.

Highly active antiretroviral therapy (HAART) can dramatically decrease human immunodeficiency virus (HIV) load in plasma, increase CD4+ cell counts, and prolong life for HIV-seropositive persons. However, the need for optimal adherence has been recognized. We implemented a pilot community-based program of directly observed therapy (DOT) with HAART among persons with substance use disorders and a history of failure of HAART. A near-peer outreach worker initially delivered and observed once-daily HAART doses on up to 7 days per week. Many participants tapered the frequency of visits. Participants were assessed by a brief questionnaire and determination of their CD4+ cell count and plasma HIV load. Twenty-five HIV-seropositive persons were enrolled and followed-up for a mean of 6.6 months (standard deviation, 3.9 months). We found that once-daily dosing of HAART by DOT is feasible in this population; in addition to observation of the majority of doses, most participants achieved virus suppression and felt favorably about the intervention. Tapering the intensity of visits with maximum flexibility was necessary to enhance the acceptability of the program to participants.

Adult↗
PubMed2001

A novel approach to directly observed therapy for tuberculosis in an HIV-endemic area.

OBJECTIVES: This study evaluated a novel approach to the delivery of directly observed therapy (DOT) for tuberculosis in Haiti. METHODS: A total of 194 patients (152 HIV seropositive, 42 HIV seronegative) received daily unsupervised triple-drug therapy for 4 to 8 weeks, followed by twice-weekly 2-drug therapy for the remainder of the 6-month period. DOT was deferred until initiation of the twice-weekly phase. RESULTS: A total of 169 of 194 patients (87.1%) completed the 6-month course. The program of deferred DOT had an effectiveness of 85%. Overall cost was reduced by approximately 40%. CONCLUSIONS: Flexible approaches to DOT, integrating behavioral knowledge, cost considerations, and practicality may improve completion rates and program effectiveness.

Adult↗
PubMed2004

Directly observed therapy for the management of HIV-infected patients in a methadone program.

The objective of this prospective, observational clinical study was to evaluate the safety and efficacy of once-daily and twice-daily directly observed therapy (DOT) in human immunodeficiency virus (HIV)-infected patients undergoing methadone treatment. Methadone and highly active antiretroviral therapy (HAART) were dispensed daily as DOT, with patients in the twice-daily HAART group self-administering the second dose. Clinical and laboratory end points were monitored, along with the impact of ongoing cocaine use. We studied 54 patients coinfected with HIV and hepatitis C virus. At baseline, the median virus load was 111,000 copies/mL, and the median CD4+ cell count was 165 cells/mm3. After a median of 24 months, 17 of 29 patients in the once-daily HAART group and 18 of 25 in the twice-daily HAART group had virus loads of <400 copies/mL, regardless of ongoing cocaine use. Thirty-two patients required methadone dose adjustment, which was managed without modification of HAART. Treatment-limiting hepatic toxicity was rare. A DOT program of coadministered methadone and HAART can be implemented with good results, even for patients who continue to use cocaine.

Anti-HIV Agents↗