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PubMed2004

Pharmaceutical care for HIV patients on directly observed therapy.

BACKGROUND: Inner-city patients infected with HIV can be a challenging group to treat. Homelessness, mental illness, substance abuse, and hepatitis C infection may serve as barriers to effective treatment. A multidisciplinary team including the pharmacist can impact upon the delivery of care to the inner-city HIV patient population. OBJECTIVE: To describe the implementation and provision of pharmaceutical care to inner-city patients taking directly observed therapy (DOT), as well as drug-related problems (DRPs) and their respective outcomes. METHODS: Pharmaceutical care, including the prospective identification and management of DRPs, was provided by a clinical pharmacist. RESULTS: Fifty-seven patients were followed over a 14-month period. Overall, 149 DRPs were identified and >95% were resolved. Those included (1) adverse effects (n = 56; gastrointestinal, central nervous system effects, allergies, laboratory abnormalities), (2) drug interactions (n = 32), (3) drugs indicated for comorbidities (n = 24; safety in pregnancy, tuberculosis, Pneumocystis carinii pneumonia prophylaxis, oral candidiasis, herpes zoster, nutritional supplements), (4) adherence issues (n = 20; altering timing of medication, changing formulation, decreasing pill burden), (5) drugs no longer indicated (n = 10; opportunistic infection prophylaxis, treatment of primary infection), and (6) dosage adjustment (n = 7) for weight and renal insufficiency. CONCLUSIONS: In the provision of pharmaceutical care to HIV-infected patients on DOT, an HIV pharmacist significantly contributed to antiretroviral selection, monitoring of drug therapy, and managing DRPs. An HIV pharmacist can assist in promoting patient adherence and improved outcomes in this setting.

Anti-HIV Agents↗
PubMed1999

Patient satisfaction with care at directly observed therapy programs for tuberculosis in New York City.

OBJECTIVES: This study examined patients' satisfaction with New York State's tuberculosis (TB) directly observed therapy (DOT) programs in New York City. METHODS: A survey was conducted of 435 patients at 19 public, private, and community-based TB DOT clinics about their satisfaction with various aspects of the programs. RESULTS: Patients identified the opportunity to receive good medical care as the most important aspect of TB DOT. Also significant was the supportiveness of DOT staff. Receiving incentives to encourage participation was statistically less important. Half of the patients reported being better off with DOT than with self-supervised care. CONCLUSIONS: This study confirms the value of patient-focused care among inner-city TB patients.

Adult↗
PubMed2004

Health-seeking patterns among Chinese immigrant patients enrolled in the directly observed therapy program in New York City.

SETTING: Outreach services and chest clinics of the Department of Health in New York City. OBJECTIVE: To investigate the health-seeking behavior patterns of Chinese immigrant patients enrolled in the directly observed therapy (DOT) program in New York City, and to suggest service provision strategies. DESIGN: Data were collected by means of participant observation, semi-structured interviews, and patient narratives. These data were then analyzed statistically as well as qualitatively, based on grounded theory. RESULTS: Of 60 patient informants, 38 had sought treatment for the relief of symptoms, and 22 were diagnosed by physical examination. Among 125 consultations made by 38 symptomatic patients during the period of their illness, there were more Chinatown physicians, including traditional Chinese practitioners, than other types of health providers, but they proportionally made the fewest referrals to the DOT program. CONCLUSIONS: Chinatown physicians are the main health providers to whom Chinese immigrants with tuberculosis resort. Education and collaboration with Chinese doctors, practitioners of both biomedical and traditional Chinese medicine, in New York City's Chinatown, are essential to reduce enrolment delays in the DOT program. The free services of the DOT program should be made more widely known to the Chinese immigrant population.

Adult↗
PubMed2006

Multidisciplinary, inpatient directly observed therapy for HIV-1-infected children and adolescents failing HAART: A retrospective study.

Children and adolescents with HIV-1 infection and elevated viral loads are at risk for disease progression. When outpatient adherence efforts fail to reduce viral loads, we have chosen to hospitalize patients for directly observed antiretroviral therapy. A retrospective chart review was performed for patients who were admitted for adherence concerns to a rehabilitation facility from December 1, 2000 to December 1, 2003. Differences in CD4 count and viral load at admission, prior to discharge and 6 months after discharge were evaluated using the Wilcoxon signed-ranks test. Nineteen admissions were included in the analysis. Compared to the mean CD4 count at admission (262), the mean CD4 counts at discharge (492) and 6 months after discharge (429) were significantly higher (p < 0.001 and p = 0.01, respectively). Similar results were observed for change in CD4 percentage. Compared to the mean viral load at admission (log 5.7), the mean viral loads at discharge (log 4.7) and 6 months after discharge (log 5) were significantly lower (p < 0.001 and p < 0.004). The majority of admissions (74%) involved a change in highly active antiretroviral therapy (HAART) regimen. In conclusion, hospitalization for directly observed therapy of HIV-1-infected children and adolescents with elevated viral loads and nonadherence resulted in an immediate and sustained (up to 6 months) reduction in viral load and increase in CD4 count.

Adolescent↗
PubMed2006

Failure of modified directly observed therapy combined with therapeutic drug monitoring to enhance antiretroviral adherence in a patient with major depression.

Improving medication nonadherence in HIV-infected patients with concomitant psychiatric issues remains a challenging therapeutic dilemma. One strategy may be to use a short course of modified directly observed therapy combined with therapeutic drug monitoring as an adherence intervention. Individual drug pharmacokinetics could be evaluated while the increased visit frequency is an opportunity to provide additional patient training and psychosocial support. We report our experience with a 43-year-old woman with severe depressive symptoms and persistent virologic failure despite appropriate therapy. Although the intervention was well-received by the patient, improvements in medication adherence behaviors waned over time. It should be recognized that not all patients are capable of achieving lifelong medication adherence and may benefit from continued supervised therapy.

Anti-HIV Agents↗
PubMed1997

Universal directly observed therapy. A treatment strategy for tuberculosis.

Patient adherence to prescribed tuberculosis regimens must be assured to prevent relapse, acquired resistance, and transmission. Directly observed therapy (DOT), an outpatient management strategy designed to ensure adherence, is not widely used because it is perceived to be inordinately expensive. The primary focus of this article is on using universal, as opposed to selective, DOT in the treatment of tuberculosis patients. Universal DOT is a policy where it is intended that observed therapy be used for all patients. Selective DOT is a policy where patients are observed taking medications only if certain selection criteria are satisfied. Topics addressed include cost, efficacy, nonadherence, and implementation guidelines.

Ambulatory Care↗
PubMed1995

A simple methodology to finance public health initiatives: reimbursement for tuberculosis directly observed therapy services in New York State.

New York State (NYS) used Medicaid reimbursement to create incentives for health care providers to offer directly observed therapy (DOT) services for active tuberculosis (TB) disease. This resulted in proliferation of 26 new TB DOT providers and expanded capacity for the New York City (NYC). Department of Health. As a result, over 1,200 individuals now receive DOT in NYC. The reimbursement methodology was also used for other NYS public health initiatives. It is applicable for public health initiatives elsewhere.

Ambulatory Care↗
PubMed1998

Pediatric tuberculosis in rural South Africa--value of directly observed therapy.

Tuberculosis is a major cause of mortality and morbidity among children in resource-poor settings. A strategy of community-based, directly observed therapy employed in a rural health district in South Africa since 1991 is described. Most children (75 per cent) diagnosed with tuberculosis were treated in the community and most of them (85 per cent) completed treatment. Supervision was either by clinic-based health workers (26 per cent), community health workers (20 per cent), or volunteer lay people (46 per cent). Among children diagnosed with tuberculosis who were also HIV infected, the case-fatality rate was higher than among the HIV uninfected, and a larger proportion of the HIV infected failed to complete treatment.

Adolescent↗
PubMed1997

Noncompliance with directly observed therapy for tuberculosis. Epidemiology and effect on the outcome of treatment.

STUDY OBJECTIVES: To describe the epidemiology and clinical consequences of noncompliance with directly observed therapy (DOT) for treatment of tuberculosis. DESIGN: Retrospective review. SETTING: An urban tuberculosis control program that emphasizes DOT. PATIENTS: All patients treated with outpatient DOT from 1984 to 1994. MEASUREMENTS AND RESULTS: We defined noncompliance as follows: (1) missing > or = 2 consecutive weeks of DOT; (2) prolongation of treatment > 30 days due to sporadic missed doses; or (3) incarceration for presenting a threat to public health. Poor outcomes of therapy were defined as a microbiologic or clinical failure of initial therapy, relapse, or death due to tuberculosis. Fifty-two of 294 patients (18%) who received outpatient DOT fulfilled one or more criteria for noncompliance. Using multivariate logistic regression, risk factors for noncompliance were alcohol abuse (odds ratio, 3.0; 95% confidence interval, 1.2 to 7.5; p = 0.02) and homelessness (odds ratio, 3.2; 95% confidence interval, 1.5 to 7.2; p = 0.004). Noncompliant patients had poor outcomes from the initial course of therapy more often than compliant patients: 17 of 52 (32.7%) vs 8 of 242 (3.3%); relative risk was 9.9; 95% confidence interval was 4.5 to 21.7 (p < 0.001). CONCLUSIONS: In an urban tuberculosis control program, noncompliance with DOT was common and was closely associated with alcoholism and homelessness. Noncompliance was associated with a 10-fold increase in the occurrence of poor outcomes from treatment and accounted for most treatment failures. Innovative programs are needed to deal with alcoholism and homelessness in patients with tuberculosis.

Adult↗
PubMed1995

Hospital care of tuberculosis patients referred for directly observed therapy in New York City: identifying factors in prolonged stays.

Individuals hospitalized and treated for tuberculosis (TB) who were then enrolled into TB directly observed therapy at four study hospitals in New York City (NYC) were identified. Review of hospital medical records determined whether the hospitalizations were warranted and whether lengths of stay were prolonged. Most hospitalizations were appropriate but over 70 percent of cases analyzed had prolonged stays. Of these, almost half were to document bacteriologic response to anti-TB treatment. Some were prolonged due to misunderstanding of state recommendations. Focused educational efforts could significantly reduce lengths of stay and save up to $9.7 million annually in NYC hospitalization costs.

AIDS-Related Opportunistic Infections↗
PubMed2006

[Systematic review of directly observed therapy on tuberculosis control in China].

OBJECTIVE: To evaluate the effectiveness of directly observed treatment (DOT) implementation in tuberculosis (TB) control in China. METHODS: Systematic literature review was carried out for published and unpublished articles regarding DOT, and meta analysis was used to compile results from selected papers. Also, sensitive analysis was carried out to explore the potential factors influencing the effectiveness of DOT. RESULTS: Two hundred and four articles were identified from China National Knowledge Infrastructure, Wanfang and Medline databases during 1994 - 2004 in which 120 articles were eligible according to our selection criteria. (1) Regarding TB case management: TB patients managed under DOT was compared to cases managed under the whole course treatment management (WCM). The combined RD of cure rate was 0.14 (95% CI: 0.06 - 0.22) and the two case management methods were significantly different (P < 0.00001). Data from stratified analysis showed that strict implementation of WMC had similar effectiveness with DOT (P = 0.06), and with RD 0.02 (95% CI: 0.00 - 0.03). However, the cure rate of DOT management was significantly better than that under un-strict WCM management (P < 0.05) with RD 0.16 (95% CI: 0.07 - 0.24). The cure rate of DOT was significantly better than those patients under self-administration (RD was 0.24 with 95% CI: 0.10 - 0.38 and P = 0.002). (2) Chemotherapeutics: when short-course and long course-treatments were compared, the combined RD became 0.04 (95% CI: 0.01 - 0.07) and P = 0.003. CONCLUSIONS: If the implementation was under strict management, the different models of patient management showed similar adherence rates. However, the effect of adherence would depend on the regimen, pattern of intake of the drugs and the methods of supervision being used.

China↗
PubMed2004

From directly observed therapy to accompagnateurs: enhancing AIDS treatment outcomes in Haiti and in Boston.

Like tuberculosis, human immunodeficiency virus (HIV) disease is associated with poverty and social inequalities, conditions that hamper the delivery of care. Like tuberculosis, treatment of HIV infection requires multidrug regimens, and the causative agent acquires drug resistance, which can be transmitted to others. A pilot project in rural Haiti introduced DOT-HAART (directly observed therapy with highly active antiretroviral therapy) for the care of patients with advanced acquired immune deficiency syndrome. A similar DOT-HAART effort was launched in Boston for patients with drug-resistant HIV disease who had experienced failure of unsupervised therapy. In both settings, community health promoters or accompagnateurs provide more than DOT: they offer psychosocial support and link patients to clinical staff and available resources. DOT-HAART in these 2 settings presents both challenges and opportunities. These models of care can be applied to other poverty-stricken populations in resource-poor settings.

Anti-HIV Agents↗
PubMed1997

Directly observed therapy in New York City. History, implementation, results, and challenges.

The history of the New York City Department of Health Bureau of Tuberculosis Control Program, and the events leading to the adoption of wide-scale directly observed therapy (DOT) in 1992 are described. The organization and role of Department of Health and non-Department of Health directly observed programs are discussed. Details are provided regarding the Department of Health's program: the use of standard treatment and program protocols, the use of incentives and enablers, a profile of the successful DOT worker, the detention program, and other issues. Program data and outcomes from 1992 through 1995 are presented, along with some of the challenges and questions for the future.

Communicable Disease Control↗
PubMed1999

Directly observed therapy for the treatment of tuberculosis--evidence based dosage guidelines.

Tuberculosis is a communicable disease with public health implications and effective treatment is essential for control of the disease and prevention of the emergence of drug resistant strains. Drug therapy for this disease is well established and discussion now surrounds frequency of administration, duration of treatment and methods of improving compliance. Directly observed intermittent therapy of tuberculosis is supported by the World Health Authority and has become the standard of care in the U.S.A. Available dosage guidelines for directly observed therapy are only supported by limited data. A literature review of recent studies with clinical outcome measures was conducted. Following this review evidence based guidelines have been produced.

Antitubercular Agents↗
PubMed2002

Modified directly observed therapy (MDOT) for injection drug users with HIV disease.

Injection drug use is an important factor in the spread of HIV infection, and strategies to enhance adherence to HIV therapeutics are critically important to controlling viral transmission and improving clinical outcomes. To this end, the authors sought (1) to enhance adherence to highly active antiretroviral therapy (HAART) among methadone-maintained injection drug users (IDUs) using modified directly observed therapy (MDOT), and (2) to define interactions between methadone and HAART and the potential contribution of drug interactions to adherence and HIV outcomes in this population. Adherence was explored here through a pilot, unblinded, 24-week study in a methadone maintenance program in which simplified HAART (efavirenz and didanosine [one daily] and a second nucleoside [twice daily]) was administered 6 days/week by clinic staff to HIV-infected IDUs (n = 5) with their methadone. Evening doses of riboflavin-tagged nucleoside and one full day of medication weekly were given as take home doses. As a result of HAART administration, four of five participants with mean viral load at baseline of 10(5) copies/ml had undetectable viral load by 8 weeks of treatment (p = .043). Methadone area under the curve (AUC) decreased by 55% (p = .007) within 2 weeks of initiating this HAART regimen, and a mean methadone dose increase of 52% was required. The authors conclude that MDOT is a promising intervention for the treatment of IDUs with HIV disease, though significant drug interactions must be monitored for carefully and rapidly addressed.

Adult↗
PubMed1997

The Baltimore City Health Department program of directly observed therapy for tuberculosis.

To address the vexing problem of treatment completion for tuberculosis patients, the Baltimore City Health Department (BCHD) in 1981 implemented a community outreach strategy employing directly observed therapy (DOT). By 1995, the incidence of tuberculosis in Baltimore had declined 61.7%. This BCHD program has reduced the need for patient incentives by providing nearly 90% of all DOT at either the patient's home, workplace or school; or drug treatment facility, city jail, or nursing home. Today, the proportion of all TB cases in Baltimore receiving DOT through the program approaches 90%, treatment completion rates exceed 90%, sputum-conversion rates among DOT-managed cases are nearly double the rates of privately treated cases, and drug resistant organisms remain rare (0.57% of all isolates, 1989-1993). This article describes the interworkings of this community-based program.

Baltimore↗
PubMed2001

Community-based treatment of advanced HIV disease: introducing DOT-HAART (directly observed therapy with highly active antiretroviral therapy).

In 2000, acquired immunodeficiency syndrome (AIDS) overtook tuberculosis (TB) as the world's leading infectious cause of adult deaths. In affluent countries, however, AIDS mortality has dropped sharply, largely because of the use of highly active antiretroviral therapy (HAART). Antiretroviral agents are not yet considered essential medications by international public health experts and are not widely used in the poor countries where human immunodeficiency virus (HIV) takes its greatest toll. Arguments against the use of HAART have mainly been based on the high cost of medications and the lack of the infrastructure necessary for using them wisely. We re- examine these arguments in the setting of rising AIDS mortality in developing countries and falling drug prices, and describe a small community-based treatment programme based on lessons gained in TB control. With the collaboration of Haitian community health workers experienced in the delivery of home-based and directly observed treatment for TB, an AIDS-prevention project was expanded to deliver HAART to a subset of HIV patients deemed most likely to benefit. The inclusion criteria and preliminary results are presented. We conclude that directly observed therapy (DOT) with HAART, "DOT-HAART", can be delivered effectively in poor settings if there is an uninterrupted supply of high-quality drugs.

Acquired Immunodeficiency Syndrome↗
PubMed2003

Outcome of directly observed therapy for tuberculosis in Yokohama City, Japan.

BACKGROUND: Yokohama City is currently developing directly observed treatment (DOT) in its programme, and requires guidance on types of DOT appropriate for local conditions. OBJECTIVE: To assess the effectiveness of DOT for tuberculosis treatment in a retrospective study under operational conditions in Yokohama City. METHODS: We included 80 patients with sputum-positive tuberculosis, 39 enrolled in DOT and 41 self-administered patients. The study was done at the National Hospital for Chest Diseases and the Community Clinic, which provide tuberculosis services with a standard daily short-course regimen. The main outcome measures were cure and treatment completion. RESULTS: The cure or treatment completion rate for the DOT and self-administered groups were respectively 87.2% and 68.3%. In a multivariate logistic regression model, cure or treatment completion was significantly associated with out-patient DOT (OR 4.04, 95%CI 1.22-13.33, P = 0.022). CONCLUSION: DOT was shown to be significantly superior to the self-administered regimen. However, our results were from an impoverished population with city-sponsored apartments and supplementary benefits. Further research will be needed to know the effectiveness of DOT in the general population.

Antitubercular Agents↗