Higher-Dose Primaquine to Prevent Relapse of Plasmodium vivax Malaria.

BACKGROUND: In most of the Americas, the recommended treatment to prevent relapse of Plasmodium vivax malaria is primaquine at a total dose of 3.5 mg per kilogram of body weight, despite evidence of only moderate efficacy. METHODS: In this trial conducted in Brazil, we evaluated three primaquine regimens to prevent relapse of P. vivax malaria in children at least 5 years of age and in adults with microscopy-confirmed P. vivax monoinfection. All the patients received directly observed chloroquine for 3 days (total dose, 25 mg per kilogram). Group 1 received a total primaquine dose of 3.5 mg per kilogram (0.5 mg per kilogram per day) over 7 days with unobserved administration; group 2 received the same regimen as group 1 but with observed administration; and group 3 received a total primaquine dose of 7.0 mg per kilogram over 14 days (also 0.5 mg per kilogram per day) with observed administration. We monitored the patients for 168 days. RESULTS: We enrolled 63 patients in group 1, 96 in group 2, and 95 in group 3. The median age of the patients was 22.4 years (range, 5.4 to 79.8). By day 28, three P. vivax recurrences were observed: 2 in group 1 and 1 in group 2. By day 168, a total of 70 recurrences had occurred: 24 in group 1, 34 in group 2, and 12 in group 3. No serious adverse events were noted. On day 168, the percentage of patients without recurrence was 58% (95% confidence interval [CI], 44 to 70) in group 1, 59% (95% CI, 47 to 69) in group 2, and 86% (95% CI, 76 to 92) in group 3. Survival analysis showed a difference in the day 168 recurrence-free percentage of 27 percentage points (97.5% CI, 10 to 44; P<0.001) between group 1 and group 3 and a difference of 27 percentage points (97.5% CI, 12 to 42; P<0.001) between group 2 and group 3. CONCLUSIONS: The administration of primaquine at a total dose of 7.0 mg per kilogram had higher efficacy in preventing relapse of P. vivax malaria than a total dose of 3.5 mg per kilogram through day 168. (Supported by the U.S. Agency for International Development; ClinicalTrials.gov number, NCT03610399.).

Randomized Controlled Trial of Automated Directly Observed Therapy for Measurement and Support of PrEP Adherence Among Young Men Who have Sex with Men.

Measurement of adherence to oral pre-exposure prophylaxis (PrEP) in real-time has been challenging. We developed DOT Diary, a smartphone application that combines automated directly observed therapy with a PrEP adherence visualization toolkit, and tested its ability to measure PrEP adherence and to increase adherence among a diverse cohort of young men who have sex with men (MSM). We enrolled 100 MSM in San Francisco and Atlanta and randomly assigned them 2:1 to DOT Diary versus standard of care. Concordance between DOT Diary measurement and drug levels in dried blood spots was substantial, with 91.0% and 85.3% concordance between DOT Diary and emtricitabine-triphosphate and tenofovir-diphosphate, respectively. There was no significant difference in the proportion of participants with detectable PrEP drug levels at 24 weeks between study arms. These results suggest DOT Diary is substantially better than self-reported measures of adherence, but additional interventions are needed to improve PrEP adherence over time.

RESUMEN: La medición de la adherencia a la profilaxis oral previa a la exposición (PrEP) en tiempo real ha constituido un desafío. Hemos desarrollado DOT Diary, una aplicación para teléfonos inteligentes que combina la terapia automatizada observada de forma directa con un kit de herramientas para visualizar la adherencia a la PrEP, y testeamos su capacidad para medir la adherencia a la PrEP, así como para aumentar la adherencia entre una cohorte variada de hombres jóvenes que tienen sexo con hombres (HSH). Reclutamos a 100 HSH en San Francisco y Atlanta y los asignamos aleatoriamente 2:1 a DOT Diary con respecto a la asistencia estándar. La concordancia entre la medición del DOT Diary y los niveles de fármacos en gotas de sangre seca fue sustancial, con un 91,0% y un 85,3% de concordancia entre el uso del DOT Diary y el de emtricitabina-trifosfato y tenofovir-difosfato, respectivamente. No hubo diferencias significativas en la proporción de participantes con niveles detectables del fármaco de la PrEP a las 24 semanas entre los brazos del estudio. Estos resultados sugieren que DOT Diary es sustancialmente superior a las medidas de adherencia que se notifican de forma personal, aunque hacen falta intervenciones adicionales para mejorar la adherencia a la PrEP a largo plazo.

Completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV: Interim analysis of a hybrid type 3 effectiveness-implementation randomized trial.

BACKGROUND: Scaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid-rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization's (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa. METHODS AND FINDINGS: The 3HP Options Trial is a pragmatic, parallel type 3 effectiveness-implementation randomized trial comparing 3 optimized strategies for delivering 3HP-facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid-to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (≥11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes. CONCLUSIONS: 3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934931.

People-centred care versus clinic-based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial.

BACKGROUND: WHO's directly observed therapy (DOT) strategy for tuberculosis (TB) treatment depends upon a well-organized healthcare system. This study sought to evaluate the effectiveness of self-administered drug intake supported by a family member versus in-clinic DOT. METHODS: This open-label, nationally-representative stratified cluster randomized controlled non-inferiority trial with two parallel equal arms involved drug-susceptible pulmonary TB patients in the continuation treatment phase. We randomly assigned outpatient-TB-centres (52 clusters) to intervention and control arms. The intervention included an educational/counseling session to enhance treatment adherence; weekly visits to outpatient-TB-centres to receive medication, and daily SMS medication reminders and phone calls to track adherence and record side effects. Controls followed clinical DOT at Outpatient-TB-centres. Both groups participated in baseline and 4-5 months follow-up surveys. The trial's non-inferiority comparisons include: treatment success as the clinical (primary) outcome and medication adherence (self-reported), knowledge, depressive symptoms, stigma, quality of life, and social support as non-clinical (secondary) outcomes. RESULTS: Per-protocol analysis showed that the intervention (n = 187) and control (n = 198) arms achieved successful treatment outcome of 92.0 and 92.9%, respectively, indicating that the treatment success in the intervention group was non-inferior to DOT. Knowledge, depression, stigma, quality of life, and social support also showed non-inferiority, demonstrating substantial improvement over time for knowledge (change in the intervention = 1.05: 95%CL (0.49, 1.60); change in the control = 1.09: 95%CL (0.56, 1.64)), depression score (change in the intervention = - 3.56: 95%CL (- 4.99, - 2.13); change in the control = - 1.88: 95% CL (- 3.26, - 0.49)) and quality of life (change in the intervention = 5.01: 95%CL (- 0.64, 10.66); change in the control = 7.29: 95%CL (1.77, 12.81)). The intervention resulted in improved treatment adherence. CONCLUSIONS: This socially empowering alternative strategy might be a preferable alternative to DOT available to patients in Armenia and in other countries. Further research evaluating cost effectiveness of the intervention and generalizability of the results is warranted. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02082340, March 10, 2014.

Directly observed therapy prior to ambulatory blood pressure measurement (DOT-HTN) in uncontrolled hypertensive patients - Effect on blood pressure, safety and patient perception.

Aims: Non-adherence to medication is a key challenge in treatment of hypertensive patients. Directly Observed Therapy prior to ambulatory blood pressure measurement (DOT-HTN) is relatively new in hypertension research and knowledge about its use and patients' perception of such control is warranted. We aimed to investigate DOT-HTN in relation to blood pressure control, procedural safety and patients' perception. Methods and results: Twenty patients with uncontrolled hypertension (daytime systolic ambulatory blood pressure measurement (ABPM) ≥135 mm Hg) were randomized to intervention with DOT-HTN and a visual analogue scale (VAS) assessment if they found DOT-HTN problematic (10 cm = very problematic), or to standard ABPM. They were followed for 2-4 weeks. There were no differences in baseline characteristics. Despite no difference in daytime systolic ABPM (p = 0.67) two patients were suggested to be non-adherent after DOT-HTN with reductions in daytime systolic ABPM of 18 and 22 mm Hg, respectively. No post DOT-HTN adverse reactions were reported. VAS assessment indicated that the patients had no problem being controlled (VAS median 0.30 cm (0.0-2.6)), however interesting comments and observed behaviour questioned the reliability of the patient-reported VAS in 38% of patients. Conclusions: Two of eight patients seemed to be non-adherent after DOT-HTN. Descriptive findings suggested reluctance towards control with DOT-HTN not captured by the VAS assessment. No DOT-related medical adverse-effects were reported.

Explaining the successes and failures of tuberculosis treatment programs; a tale of two regions in rural eastern Uganda.

BACKGROUND: Optimally performing tuberculosis (TB) programs are characterized by treatment success rate (TSR) of at least 90%. In rural eastern Uganda, and elsewhere in sub Saharan Africa, TSR varies considerably across district TB programs and the reasons for the differences are unclear. This study explored factors associated with the low and high TSR across four districts in rural eastern Uganda. METHODS: We interviewed District TB and Leprosy Supervisors, Laboratory focal persons, and health facility TB focal persons from four districts in eastern Uganda as key informants. Interviews were audio recorded, transcribed verbatim, and imported into ATLAs.ti where thematic content analysis was performed and results were summarized into themes. RESULTS: The emerging themes were categorized as either facilitators of or barriers to treatment success. The emerging facilitators prevailing in the districts with high rates of treatment success were using data to make decisions and design interventions, continuous quality improvement, capacity building, and prioritization of better management of people with TB. The barriers common in districts with low rates of treatment success included lack of motivated and dedicated TB focal persons, scarce or no funding for implementing TB activities, and a poor implementation of community-based directly observed therapy short course. CONCLUSION: This study shows that several factors are associated with the differing rates of treatment success in rural eastern Uganda. These factors should be the focus for TB control programs in Uganda and similar settings in order to improve rates of treatment success.

Evaluating the potential costs and impact of digital health technologies for tuberculosis treatment support.

Ensuring adherence and support during treatment of tuberculosis (TB) is a major public health challenge. Digital health technologies could help improve treatment outcomes. We considered their potential cost and impact on treatment for active or latent TB in Brazil.Decision analysis models simulated two adult cohorts with 1) drug-susceptible active TB, and 2) multidrug-resistant TB, and two cohorts treated with isoniazid for latent TB infection (LTBI): 1) close contacts of persons with active TB, and 2) others newly diagnosed with LTBI. We evaluated four digital support strategies: two different medication monitors, synchronous video-observed therapy (VOT), and two-way short message service (SMS). Comparators were standard directly observed treatment for active TB and self-administered treatment for LTBI. Projected outcomes included costs (2016 US dollars), plus active TB cases and disability-adjusted life years averted among persons with LTBI.For individuals with active TB, medication monitors and VOT are projected to lead to substantial (up to 58%) cost savings, in addition to alleviating inconvenience and cost to patients of supervised treatment visits. For LTBI treatment, SMS and medication monitors are projected to be the most cost-effective interventions. However, all projections are limited by the scarcity of published estimates of clinical effect for the digital technologies.

Patients' experiences and perceptions on associates of TB treatment adherence: a qualitative study on DOTS service in public health centers in Addis Ababa, Ethiopia.

BACKGROUND: Ethiopia is one of the countries with the highest TB burdens in the world. There are multitude of challenges related to the implementation of DOTS and adherence to treatment. This study aimed to assess patients' experiences and perceptions on associates of TB treatment adherence in Addis Ababa, Ethiopia. METHODS: A phenomenological approach was employed to generate qualitative data through the in-depth interview of TB patients attending DOTS in two public health centers. A total of ten participants, who were purposively selected till conceptual saturation was reached, were interviewed using topic guides prepared in line with the study objectives. Interviews were tape-recorded, transcribed verbatim, and translated to English. Open Code software was used to facilitate analysis. Themes pertaining to patient, health service, therapeutic, and socioeconomic factors were developed, and findings were presented accordingly. RESULTS: Experience of missing medications was reported by a single participant. Most informants pointed out that TB is transmitted through coughing and expectorate, and prevented by letting in open air in public gatherings. However, most of them stated cold air and few mentioned contaminated food as causes of TB. Perceived risk of non-adherence to medication was among recounted reasons behind treatment adherence. Some informants also recalled to have had the intention of withdrawing medication due to perceived wellness, which they actually did not change into action. Most of the participants generally had smooth relationships with their DOTS service providers. Even if more than half of the patients preferred follow-ups by the same professional, most received DOTS service by two or more service providers. CONCLUSIONS: TB treatment non-adherence was not found to be a major challenge among the study participants. Perceived risk and wellness were implied to be responsible factors for adherence. Albeit the fact that few informants encountered unethical behaviors by some health professionals, interviewed patients generally had positive evaluation of the patient-provider relationship and the DOTS service obtained. There is a need to train and monitor DOTS service providers and ensure the provision of DOTS service by the same provider throughout the treatment period of a given patient.

A New Method to Directly Observe Tuberculosis Treatment: Skype Observed Therapy, a Patient-Centered Approach.

CONTEXT: Tuberculosis (TB) treatment completion is in part determined by patient's adherence to long-term drug regimens. To best ensure compliance, directly observed therapy (DOT) is considered the standard of practice. Nassau County Department of Health TB Control is responsible for providing DOT to patients with TB. OBJECTIVE: Tuberculosis Control sought to use and evaluate Skype Observed Therapy (SOT) as an alternative to DOT for eligible patients. DESIGN: The evaluation included analysis of patient's acceptance and adherence to drug regimen using SOT. Tuberculosis Control assessed staff efficiency and cost savings for this program. MAIN OUTCOME MEASURES: Percentages of SOT of patients and successful SOT visits, mileage, and travel time savings. RESULTS: Twenty percent of the caseload used SOT and 100% of patients who were eligible opted in. Average SOT success was 79%. Total mileage savings and time saved were $9,929.07 and 614 hours. CONCLUSIONS: Because SOT saves cost and time and is a suitable alternative to DOT for patients, it should be considered as part of new policies and practices in TB control programs.

What would it take to eliminate tuberculosis in the Eastern Mediterranean Region? (Editorial).

Twenty-five years ago, tuberculosis (TB) was declared a global health emergency by the World Health Organization (WHO). However, TB still remained one of the top 10 causes of death worldwide in 2015. In 2014, the World Health Assembly (WHA) had approved a new global strategy to end TB that builds on successes achieved by the DOTS and the Stop TB Strategy. The End TB Strategy 2016-2035 envisions a world free of TB by pursuing policies that promote prevention and care, and encourage research and innovation, which is in line with the Sustainable Development Goals (SDGs) calling for the TB epidemic to end by 2030. In 2002, the Global Fund to fight AIDS, Tuberculosis and Malaria - a partnership between governments, civil society, private sector and patients - was launched to raise significant funds to support programmes in countries and communities most in need.

Directly observed iron supplementation for control of iron deficiency anemia.

Anemia is major public health problem affecting 1.6 billion people worldwide. The poor compliance of iron supplementation remains main contributor for high prevalence of anemia. The current paper reviewed the effectiveness of direct observation of oral iron supplementation on anemia. A systematic search was performed through electronic databases and local libraries. Search strategies used subject headings and key words "directly observed" and "iron supplementation." Searches were sought through April 2014. A total of 14 articles were included in the study. Findings were presented in three categories. First, all of those reported an improvement in compliance of iron supplementation. Second, reduction in the prevalence of anemia was reported by all and third, all except one reported increased blood hemoglobin level. Directly observed an iron supplementation is an effective approach for prevention and management of anemia in vulnerable groups. However, larger trials are needed before concluding that scaling up directly observed iron supplementation through community health volunteers would be beneficial.

Evaluation of the directly observed therapy for treating tuberculosis according to the dimensions of policy transfer. / Avaliação do tratamento diretamente observado da tuberculose segundo dimensões da transferência de políticas.

OBJECTIVE: To evaluate the directly observed therapy for treating tuberculosis in the Primary Health Care Service according to the dimensions of policy transfer. METHOD: Descriptive study, conducted with professionals from Basic Health Units in the city of São Paulo, SP state. The interviews were conducted from May to July/2016, using a validated, self-administered instrument with 39 items on a five-point Likert scale. The variables were organized in the dimensions: information, knowledge and innovation. The mean of the responses was calculated: the means between four and five were classified as adequate, between two and a half and three and a half as fair, and between one and two as inadequate. RESULTS: 112 health professionals participated in the study. In the dimension of information, participation of the community in the treatment was considered fair. In the dimension of knowledge, the treatment routine in the unit and the participation of the professionals in trainings were classified as fair. In the dimension of innovation, the unit infrastructure, the use of community resources and the creation of strategies to promote patient adherence were evaluated as fair. The other variables were adequate. CONCLUSION: The transfer of the directly observed therapy for treating tuberculosis in the Primary Health Care assessed has been occurring gradually and successfully.

Treatment for Tuberculosis Infection With 3 Months of Isoniazid and Rifapentine in New York City Health Department Clinics.

BACKGROUND: Completion of treatment for tuberculosis infection (TBI) with 9 months of self-administered daily isoniazid (9H) has historically been low (<50%) among New York City (NYC) Health Department tuberculosis clinic patients. Treatment of TBI with 3 months of once-weekly isoniazid and rifapentine (3HP) administered under directly observed therapy (DOT) might increase treatment acceptance and completion. METHODS: The study population included patients diagnosed with TBI at 2 NYC Health Department tuberculosis clinics from January 2013 through November 2013. Treatment acceptance and completion with 3HP were compared with historical estimates. Treatment outcomes, side effects, and reasons for refusing 3HP were described. RESULTS: Among 631 patients eligible for TBI treatment, 503 (80%) were offered 3HP; 302 (60%) accepted, 92 (18%) chose other treatment, and 109 (22%) refused treatment. The most common reason for refusing 3HP was the clinic-based DOT requirement. Forty (13%) patients treated with 3HP experienced side effects--9 were restarted on 3HP, 18 switched treatment regimens, and 13 discontinued. Although treatment acceptance did not differ from historical estimates (78% vs 79%, P = .75), treatment completion increased significantly (65% vs 34%, P < .01). CONCLUSIONS: Implementation of 3HP in 2 NYC Health Department tuberculosis clinics increased TBI treatment completion by 31 percentage points compared with historical estimates. More flexible DOT options may improve acceptance of 3HP. Wider use of 3HP may substantially improve TBI treatment completion in NYC and advance progress toward tuberculosis elimination.

Does directly observed therapy improve tuberculosis treatment? More evidence is needed to guide tuberculosis policy.

BACKGROUND: Tuberculosis (TB) now ranks alongside HIV as the leading infectious disease cause of death worldwide and incurs a global economic burden of over $12 billion annually. Directly observed therapy (DOT) recommends that TB patients complete the course of treatment under direct observation of a treatment supporter who is trained and overseen by health services to ensure that patients take their drugs as scheduled. Though the current WHO End TB Strategy does not mention DOT, only "supportive treatment supervision by treatment partners", many TB programs still use it despite the fact that the has not been demonstrated to be statistically significantly superior to self-administered treatment in ensuring treatment success or cure. DISCUSSION: DOT is designed to promote proper adherence to the full course of drug therapy in order to improve patient outcomes and prevent the development of drug resistance. Yet over 8 billion dollars is spent on TB treatment each year and thousands undergo DOT for all or part of their course of treatment, despite the absence of rigorous evidence supporting the superior effectiveness of DOT over self-administration for achieving drug susceptible TB (DS-TB) cure. Moreover, the DOT component burdens patients with financial and opportunity costs, and the potential for intensified stigma. To rigorously evaluate the effectiveness of DOT and identify the essential contributors to both successful treatment and minimized patient burden, we call for a pragmatic experimental trial conducted in real-world program settings, the gold standard for evidence-based health policy decisions. It is time to invest in the rigorous evaluation of DOT and reevaluate the DOT requirement for TB treatment worldwide. Rigorously evaluating the choice of treatment supporter, the frequency of health care worker contact and the development of new educational materials in a real-world setting would build the evidence base to inform the optimal design of TB treatment protocol. Implementing a more patient-centered approach may be a wise reallocation of resources to raise TB cure rates, prevent relapse, and minimize the emergence of drug resistance. Maintaining the status quo in the absence of rigorous supportive evidence may diminish the effectiveness of TB control policies in the long run.

CONFLICT IN EASTERN UKRAINE: STRATEGY FOR TUBERCULOSIS.

This root cause analysis concerns the conflict in the Eastern Ukraine and its impact on healthcare delivery in the context of treating internally displaced persons (IDPs). Inadequate treatment of tuberculosis (TB) was selected as a major topic for intervention planning in conflict areas in Ukraine. With respect to treating TB among IDPs, rapid diagnosis and adequate nutrition and shelter are important components of care and disease control. The DOT, supported by trained primary healthcare providers equipped with rapid MDR TB diagnostic capacities, need to provide appropriate shelter and nutrition to IDPs. In addition to active disease management, this paper discusses the important role of ongoing project monitoring and communicating evaluation findings with all the major stakeholders shaping the national TB strategy in Ukraine. A comprehensive strategy is essential for successful transitioning and re-structuring of TB healthcare delivery both during after conflict resolution.

Performance of Revised National Tuberculosis Control Programme (RNTCP) in tribal areas in India.

BACKGROUND & OBJECTIVES: The Revised National Tuberculosis Control Programme (RNTCP) provides free diagnostic and treatment services to all tuberculosis (TB) patients registered under it. Equitable access, implying a preference for the most hard-to-reach groups particularly for tribal areas, is a major concern for RNTCP. This study was conducted to assess the performance of RNTCP in terms of case detection and cure rates in areas dominated by tribal groups in India. METHODS: We used the RNTCP data collected by the Central TB Divison, Government of India. RNTCP has a systematic monitoring mechanism which tracks the outcome of every patient put on treatment. There is a standardized recording and reporting structure in place; indicators are monitored regularly at every level of the health system; and regular supervision ensures quality of the Programme. The main indicators include the number of cases diagnosed and the percentage of patients who are successfully treated. These indicators were used to assess the RNTCP performance in tribal areas. RESULTS: We observed a poor performance in terms of case detection rate (CDR) in tribal and backward districts as compared with other districts in India. Among tribal districts 53 per cent in 2010, 45 per cent in 2011 and 56 per cent in 2012 had CDR of new smear positive <70%. It was also observed that 26 per cent of tribal dominated districts had CDR of <51 per cent in 2012. More than 50 per cent of tribal districts were not able to achieve more than 85 per cent of cure rate. INTERPRETATION & CONCLUSIONS: The findings of this study suggested that the overall RNTCP performance in tribal areas was not optimal, and the target of >85 per cent of core rate was achieved by less than half of the tribal districts.

Legal briefing: coerced treatment and involuntary confinement for contagious disease.

This issue's "Legal Briefing" column covers recent legal developments involving coerced treatment and involuntary confinement for contagious disease. Recent high profile court cases involving measles, tuberculosis, human immunodeficiency virus, and especially Ebola, have thrust this topic back into the bioethics and public spotlights. This has reignited debates over how best to balance individual liberty and public health. For example, the Presidential Commission for the Study of Bioethical Issues has officially requested public comments, held open hearings, and published a 90-page report on "ethical considerations and implications" raised by "U.S. public policies that restrict association or movement (such as quarantine)." Broadly related articles have been published in previous issues of The Journal of Clinical Ethics. We categorize recent legal developments on coerced treatment and involuntary confinement into the following six categories: 1. Most Public Health Confinement Is Voluntary 2. Legal Requirements for Involuntary Confinement 3. New State Laws Authorizing Involuntary Confinement 4. Quarantine Must Be as Least Restrictive as Necessary 5. Isolation Is Justified Only as a Last Resort 6. Coerced Treatment after Persistent Noncompliance.

[RATES OF COMPLETION AND TREATMENT OUTCOMES FOR TYPE OF COMMUNITY DOTS].

AIM: To investigate the relationship between completion rates for community directly observed treatment short-course (DOTS) and treatment outcomes, according to implementation tactics, to improve the treatment outcomes. METHODS AND SUBJECTS: We evaluated 529 newly registered patients with smear-positive pulmonary tuberculosis who underwent community DOTS (checking medication at least once per week) during 2010 and 2011 in Osaka City. DOTS completion was defined as checking medication 3 times or more per month, with checking medication missed less than 3 consecutive times. DOTS was implemented using the following 4 tactics: healthcare staff visited the patients' home or workplace (visiting type), the patients visited a health and welfare center (HWC type), the patients visited a pharmacy (P type), or the patients visited an outpatient department at a medical center (MC type). Regarding treatment outcomes, resolution of the tuberculosis or treatment completion was defined as "successful treatment", and treatment failure or default was defined as "unsuccessful treatment". We then analyzed the DOTS completion rate for each DOTS implementation tactic. RESULTS: DOTS was completed in 417 (78.8%) of the 529 patients. The completion rates were 79.7%, 75.4%, 75.9%, and 81.3% for patients who underwent visiting (n= 394), HWC (n = 61), P (n = 58), and MC (n = 16) DOTS, respectively; no significant difference was observed. The mean ages for each group were 62.8 years, 53.6 years, 45.0 years, and 56.6 years for patients who underwent visiting, HWC, P, and MC DOTS, respectively; patients who underwent P DOTS were significantly younger (P < 0.001). Among the 4 groups, the visiting DOTS group had the lowest percentage of full-time employees (16.2%) and the highest percentage of unemployed individuals (67.3%). In contrast, the percentage of full-time employees was 63.8% and 50.0% in the P and MC DOTS groups, respectively. The P DOTS group had the lowest unemployment percentage (19.0%) among the 4 groups. Thus, a significant correlation existed between the DOTS implementation tactics and the presence/ absence of the patients' occupations (P < 0.001). Among the 417 patients who completed DOTS, 99.8% achieved successful treatment. Among the 112 patients who did not complete DOTS, 89.3% achieved successful treatment, and this success rate was significantly lower than that for the group who completed DOTS (P < 0.00 1). Among the visiting, HWC, and P DOTS groups, the completion of DOTS resulted in a high treatment success rate. DISCUSSION: Patients who completed DOTS achieved better treatment outcomes; therefore, it is important to provide patients with medication support until their tuberculosis is resolved. The P DOTS group contained a higher percentage of full-time employees and had a significantly lower mean age; this was likely because pharmacies are accessible at night and during the weekend. There was no significant difference in the DOTS completion rates according to implementation tactic, which suggests that it is important to assist patients with their medication according to their needs.

Tuberculosis treatment outcomes and interruption among patients assessing DOTS regimen in a tertiary hospital in semi-urban area of south-western Nigeria.

BACKGROUND: Tuberculosis remains one of the most infectious diseases worldwide especially with the HIV pandemic. It is a cause of high morbidity and mortality in developing countries including Nigeria. Reasons contributing to high morbidity and mortality include high defaulting rate and treatment interruption. Several studies had evaluated the treatment outcome of tuberculosis but there is paucity of published literature on the outcome of treatment interruption especially in this environment. This study thus assessed the outcome of treatments and interruption among patients assessing DOTS regimen in a tertiary hospital located in asemi urban area in south-western Nigeria. METHODOLOGY: The study was a review of TB register of the federal medical centre, Owo from its inception in 2008 to 2011. All the patients that have completed at least one course of chemotherapy (defined as 8 months of anti-tuberculosis treatment- 2 months intensive phase and 6 months continuation phase) were included. Treatment outcome and interruption were defined in accordance with World Health Organisation (WHO) recommendations. Data were analysed with SPSS version 17. RESULTS: A total of 400 patients were included. The mean age of patients was 36.8 +/- 16.8 years and 56.3% were male. Majority, (79.7%) were adults aged 19-64 years, 12.5% were in the paediatric age group and 7.8% were elderly. Less than half, 45.3% had TB/HIV co-infection. Regarding treatment outcome of tuberculosis, 75.5% were cured, 14.8% died, 4% relapsed and 3% defaulted. A little above one-fifth, 21 (5.3%) had treatment interruption among whom 9 (42.9%) were successfully traced and completed treatment. Significantly, higher proportion of those that had treatment interruption died, 54.1% compared with their counterpart, 14.9%, (p < 0.001) and had relapse. (14.3% versus 3.4%, p = 0.01). CONCLUSION: A high rate of tracking failure among patients with treatment interruption was found in the study. In addition, mortality and morbidity were higher among patients with treatment interruption. A more concerted effort is needed in tracking/tracing patients with treatment interruption in orderto reduce morbidity and mortality among TB patients assessing treatment.

Practical study concerning improvements in tuberculosis care practice.

With tuberculosis now relatively well contained in Japan, it is important to reconfigure treatment systems and structures to ensure the most appropriate treatments in the future. A survey of designated tuberculosis treatment facilities in Hiroshima Prefecture revealed declining standards of tuberculosis diagnosis and treatment as well as decreasing knowledge levels in regional areas, suggesting the need for improved collaboration between tuberculosis specialists and regional health care providers. A tuberculosis care pathway designed to promote improved collaboration between referring medical institutions and clinics, and the DOTS (directly observed treatment, short-course) Notebook for patient advice and assistance with compliance, were developed jointly by the Higashihiroshima Medical Center and the Onomichi Medical Association. Following the introduction of tuberculosis care pathway and the DOTS Notebook, we have seen a number of improvements, notably an increase in successful treatment outcomes in regional areas and fewer patients receiving treatment for more than 12 months. These results suggest that better liaison through the regional coordination pathway has led to improved tuberculosis treatment in regional areas. While further refinements and modifications are necessary, it is clear that this represents a step forward in tuberculosis care, and will provide the impetus to bring about meaningful changes to the system.