Psychological changes and associated factors among patients with tuberculosis who received directly observed treatment short-course in metropolitan areas of Japan: quantitative and qualitative perspectives.

BACKGROUND: The directly observed treatment short-course (DOTS) is one of the most effective tuberculosis (TB) control measures worldwide. However, despite its aim of providing comprehensive and humanistic care, few studies have examined its psychological effects from the patient's perspective. Thus, this study aimed to evaluate the psychological changes and identify associated factors among patients with TB undergoing the DOTS program in Japan. METHODS: This cross-sectional study recruited patients with TB receiving the DOTS program via 32 public health centers in four metropolitan cities in Japan. Surveys were administered to the patients and their attending public health or clinical nurses, who were responsible for their care and the DOTS program. Data were collected regarding the patients' demographic and clinical characteristics, post-traumatic growth (using the Post-Traumatic Growth Inventory-Short Form [PTGI-SF]), and medication adherence, alongside open-ended questions, from 2014 to 2015. Additionally, the patients' appraisal of the DOTS program's efficacy and nurses' assessment of the program's practices were measured using two original questionnaires. Factors associated with post-traumatic growth were analyzed using variable estimation, correlation analysis, and logistic regression. Thematic analysis was conducted on the open-ended responses. RESULTS: Questionnaires were returned by 127 patients (125 valid answers); 98 (78.4%) of the respondents were men. Their mean age was 63.3 (standard deviation: 15.8) years. The mean PTGI-SF score was 21.7 (standard deviation: 11.1). The logistic regression analysis found that post-traumatic growth was significantly associated with the patients' appraisal of the program's efficacy (odds ratio [OR] = 1.157, 95% confidence interval [CI] = 1.026-1.304) and nurses' assessment of the practices (OR = 1.307, 95% CI = 1.065-1.603). In the qualitative analysis, "Non-acceptance," "Frustration," and "Anxiety" were extracted as barriers to treatment; "Fear," "Acquiring a partner," "Relief," and "Belief" were extracted as treatment drivers; and "Life changes" and "Rebuilding oneself" were extracted as treatment outcomes. CONCLUSIONS: The DOTS program in Japan improves patients' treatment adherence and leads to recovery and psychological growth. Even in other regions, it may be effective to incorporate this program's practices that place importance on partnerships with patients. It is also necessary to continue refined quantitative and qualitative evaluations.

Thai district Leaders' perceptions of managing the direct observation treatment program in Trang Province, Thailand.

BACKGROUND: Thailand is 18th out of the 22 countries with the highest tuberculosis (TB) burden. It will be a challenge for Thailand to achieve the UN Millennium Development target for TB, as well as the new WHO targets for eliminating TB by 2035. More knowledge and a new approach are needed to tackle the complex challenges of managing the DOT program in Thailand. Contextual factors strongly influence the local implementation of evidence in practice. Using the PARIHS model, the aim has been to explore district leaders' perceptions of the management of the DOT program in Trang province, Thailand. METHODS: A phenomenographic approach was used to explore the perceptions among district DOT program leaders in Trang province. We conducted semi-structured interviews with district leaders responsible for managing the DOT program in five districts. The analysis of the data transcriptions was done by grouping similarities and differences of perceptions, which were constructed in a hierarchical outcome space that shows a set of descriptive categories. RESULTS: The first descriptive category revealed a common perception of the leaders' duty and wish to comply with the NTP guidelines when managing and implementing the DOT program in their districts. More varied perceptions among the leaders concerned how to achieve successful treatment. Other perceptions concerned practical dilemmas, which included fear of infection, mutual distrust, and inadequate knowledge about TB. Further, the leaders perceived a need for improved management practices in implementing the TB guidelines. CONCLUSION: Using the PARIHS framework to gain a retrospective perspective on the district-level policy implementation of the DOT program and studying the leadership's perceptions about applying the guidelines to practice, has brought new knowledge about management practices. Additional support and resources from the regional level are needed to manage the challenges.

A randomized controlled trial examining the efficacy of motivational counseling with observed therapy for antiretroviral therapy adherence.

This study determined whether motivational interviewing-based cognitive behavioral therapy (MI-CBT) adherence counseling combined with modified directly observed therapy (MI-CBT/mDOT) is more effective than MI-CBT counseling alone or standard care (SC) in increasing adherence over time. A three-armed randomized controlled 48-week trial with continuous electronic drug monitored adherence was conducted by randomly assigning 204 HIV-positive participants to either 10 sessions of MI-CBT counseling with mDOT for 24 weeks, 10 sessions of MI-CBT counseling alone, or SC. Poisson mixed effects regression models revealed significant interaction effects of intervention over time on non-adherence defined as percent of doses not-taken (IRR = 1.011, CI = 1.000-1.018) and percent of doses not-taken on time (IRR = 1.006, CI = 1.001-1.011) in the 30 days preceding each assessment. There were no significant differences between groups, but trends were observed for the MI-CBT/mDOT group to have greater 12 week on-time and worse 48 week adherence than the SC group. Findings of modest to null impact on adherence despite intensive interventions highlights the need for more effective interventions to maintain high adherence over time.

[On-the-street DOTS for a homeless tuberculosis patient--case report of a patient who had difficulties with TB treatment adherence].

PURPOSE: A homeless patient with tuberculosis (TB), who had often quit his TB treatment in mid-course and then gone homeless again, succeeded in completing his treatment for over 10 months through on-the-street DOTS ("Bluesky DOTS" is another expression). Based on the analysis of this case, we have discussed how to provide effective countermeasures to non-compliant TB patients. METHOD: An episode of a successful on-the-street DOTS for a 70-year-old homeless man with sputum smear positive pulmonary TB was qualitatively analyzed, with a view toward patient's empowerment. RESULT: The patient had had human-relations problems in his life, and trouble with medical and welfare service staff. During his hospital admissions, he repeatedly self-discharged or was forced to discharge due to violent behavior against staff. Public health nurses at Shinjuku public health center visited the patient frequently at the hospital, and tried to build a good relationship with the patient from the beginning of the treatment. Following a two and half month interruption of the TB treatment after he disappeared from the hospital, he was discovered staying outside at a canal side in the area, and on-the-street TB treatment was carried out, with good cooperation with the hospital and social welfare office. Directly observed TB medication was given to him by a public health nurse and another health center staff member for 293 days, at the park near his living place. The patient often rejected the medication, particularly when he was hungry, but offering lunch to him was a very effective incentive. Through comprehensive supports to the patient, he gradually changed his attitude, and on his own came to consider his health and his future. DISCUSSION: We have analyzed a successfully treated case of a homeless TB patient who had difficulties in maintaining a social life and had not been cooperative in complying with the medication. The level of independence improved during the course of on-the-street DOTS with incentive and other supports. He became receptive to TB treatment and became self-supportive during the course of DOTS, with food as an incentive. This indicates that on-the-street DOTS was successful not only for the treatment completion but also contributed to empowering the TB patient. This approach of adjusting the service to the patient's needs fostered a positive relationship with all stakeholders.

Directly observed versus self-administered antiretroviral therapies: preference of HIV-positive jailed inmates in San Francisco.

Directly observed therapy (DOT) of antiretroviral (ARV) medications has beneficial effects on HIV treatment for incarcerated inmates but has been associated with limited continuation after release and inadvertent disclosure of HIV status. Guided self-administered therapy (g-SAT) may be a preferred method of ARV delivery and may encourage medication-taking behavior. We surveyed the preference of 102 HIV-positive jailed inmates at the San Francisco City and County Jails regarding receiving ARVs via DOT versus g-SAT while incarcerated. Participants overwhelmingly preferred g-SAT over DOT.

Developing a modified directly observed therapy intervention for hepatitis C treatment in a methadone maintenance program: implications for program replication.

BACKGROUND: Hepatitis C virus (HCV) is a prevalent chronic blood-borne infection among opioid-dependent patients on methadone maintenance treatment (MMT). Despite case reports and case-control studies, a randomized controlled trial (RCT) examining HCV treatment adherence in methadone-maintained patients is lacking and was the impetus for this ongoing RCT examining modified directly administered therapy for HCV treatment integrated within a MMT. METHODS: Subjects were randomized 1:1 to receive HCV treatment as modified directly observed therapy (mDOT) into the MMT program or at a liver specialty clinic as self-administered therapy (SAT). Randomization was stratified based on HIV status and HCV genotype. RESULTS: Twenty-one subjects to date have enrolled in this pilot study. The mDOT subjects have had greater success in starting treatment and 10 of the 12 mDOT subjects achieved early virologic response (EVR) at week 12 and 6 of those 10 achieved sustained virologic response (SVR). Of the nine SAT subjects, only three achieved EVR at week 12 and only one achieved SVR despite not completing the treatment. CONCLUSIONS: Hepatitis C treatment can be successfully integrated into a methadone maintenance clinic, and mDOT can be implemented with a methadone clinic's existing nursing and medical staff. Patients struggling with concurrent substance use and mental illness comorbidity may be successfully addressed in such settings and facilitate access to and completion of treatment through the utilization of on-site clinical services for HCV treatment and adherence support with mDOT. The exact importance of site of services and adherence support remains a significant area for future investigation.

A woman's lived experience with directly observed therapy for tuberculosis-a case study.

This is a case study to investigate the lived experience of tuberculosis (TB) treatment for a Hispanic female. The theme was accumulating aggravation. Her daily life was interrupted with appointments and negative side effects. She had to wear a mask that made her feel isolated. She felt ignored by her doctors. Although she experienced the opposite feeling of being overly observed, the informant began to feel like she was always being watched. The participant described herself as paranoid due to the threat of imprisonment for nonadherence. The accumulating aggravation made the directly observed therapy short-course (DOTS) experience a difficulty and stressful experience.

Stigma related to tuberculosis among patients attending DOTS clinics of Dharan municipality.

BACKGROUND: The patients suffering from tuberculosis are receiving shame and unfair treatment from the people living around them within their own society attending DOTS clinic of Dharan municipality. OBJECTIVE: To assess the stigma experienced by tuberculosis patients and to find out the association between stigma experienced by Tuberculosis patient and the selected variables (socio-demographic characteristics, clinical profile and illness experience). METHODS: Descriptive Cross Sectional study was done among sixty tuberculosis patients. Stratified random sampling was used to select the main center and sub center of Tuberculosis treatment and population proportionate simple random sampling using lottery method was done. Data was collected using predesigned, pretested performa from Explanatory Model Interview Catalogue developed by World Health Organization. RESULTS: The study revealed that 63.3% of the subjects were stigmatized. There was association between stigma and variables such as occupation, monthly family income and past history of Tuberculosis. There was also association of stigma with treatment phase, category of the patient and past outcome of illness. CONCLUSION: Due to lack of knowledge and awareness about Tuberculosis, many patients were stigmatized. Efforts should be made to educate the public about Tuberculosis to reduce stigma experienced by Tuberculosis patients and improve the compliance of the patient.

Improving tuberculosis care in low income countries - a qualitative study of patients' understanding of "patient support" in Nepal.

BACKGROUND: In the new Stop TB Strategy for Tuberculosis (TB) Care, direct observation of treatment has been replaced by "supervision and patient support". However, it is still unclear what patient support means and how it is to be best implemented. The objective of this study was to accurately document patients' support needs during TB treatment from their own perspectives, to inform development of appropriate support and supervision strategies that meet patients' needs. METHODS: In-depth individual interviews and focus group discussions were conducted in three districts in Nepal. Analysis took place concurrently with data collection to allow emerging issues to guide selection of subsequent interviewees. In total 23 patients, 15 male and 8 female, were interviewed and six focus group discussions were held. Issues from these interviews were grouped into emergent themes. RESULTS: Respondents reported that the burden of treatment for TB was high, particularly in terms of difficulties with social and psychological aspects of undergoing treatment. They saw three main areas for support during their treatment: relevant information for them and their families about their disease, its treatment, potential side-effects and what they should do if side-effects arise; approachable and supportive healthcare staff with whom patients feel comfortable discussing (often non-medical) problems that arise during treatment; and some flexibility in treatment to allow essential elements of patients' lives (such as income generation, food-growing and childcare) to continue. They were anxious to ensure that family support did not absolve healthcare workers from their own support responsibilities. CONCLUSION: In order to support people with TB more during their treatment, health policy and practice must appreciate that TB affects all aspects of TB patients' lives. A focus on caring for each patient as an individual should underlie all aspects of treatment. Improved communication between healthcare providers and patients and increased patient knowledge and understanding of the treatment programme would give those receiving treatment a sense of individual empowerment and raise their confidence in treatment.

A prospective study on quality of life in patients with pulmonary tuberculosis at a tertiary care hospital in Kashmir, Northern India.

BACKGROUND: Pulmonary Tuberculosis (PTB) is a contagious, airborne infection that destroys when M. tuberculosis primarily attacks the lungs. PTB is curable with an early diagnosis and antibiotic treatment. Stigmatization and negative emotions resulting from the illness could result in long term impairment of patients psychological well being which may result in work absenteeism resulting in loss of productivity and reduced monthly income. METHODS: This was a prospective study which was conducted over a period of one and half year. A total of 198 patients were recruited for the study. Quality Of Life (QOL) was assessed at baseline and at the end of intensive phase. For QOL WHO based QOLBREF was used. RESULTS: In the present study patients scored lowest in the baseline physical (8.36 ± 1.60) followed by the psychological domain (10.40 ± 1.72) however at the end of intensive phase both physical (11.98 ± 1.70) and psychological (12.75 ± 1.) domains improved very much and the difference was statistically significant. CONCLUSION: We conclude that HRQOL is significantly reduced in patients with PTB, and that it improves rapidly and significantly with DOTS-based intensive phase of treatment. Special focus on reduction of stigmatization should be given in the management of TB to reduce the psychological distress.

Optimising the benefits of unobserved dose administration for stable opioid maintenance patients: follow-up of a randomised trial.

BACKGROUND: The registration of combination buprenorphine/naloxone, a formulation designed to reduce risk of diversion, has led some Australian jurisdictional authorities to allow treatment without direct observation of dosing for stable, opioid-dependent patients. AIM: To compare two approaches (1) initiating treatment with observed dosing, then allowing patients who demonstrate stability to change to unobserved dosing; or (2) initiating patients with unobserved dosing, subsequently requiring those who fail to stabilize to change to observed treatment. METHODS: This study builds on an RCT comparing efficacy of observed and unobserved treatment at 3 months. At the conclusion of the RCT, clinically "stable" subjects were allocated to continue without observed dosing, while those who did not demonstrate stability were allocated to observed dosing. Subjects were followed for a further 3 months. Primary end-point was retention in treatment. RESULTS: Of 119 subjects randomised, 70 were retained in treatment to 3 months. Forty-five stable subjects were allocated to unobserved dosing, 25 to observation. Unstable subjects allocated to observed treatment were more likely to drop out thereafter (OR 2.14, 95% CI 1.09-4.19). There was a non-significant trend for people initiated with observed dosing to be better retained during the allocation phase; at 6 months, 13 subjects (22%) from the original unobserved group, and 22 (34%) from the observed group, were retained in treatment (chi2=2.10, 1 df, p=0.15). CONCLUSIONS: Withdrawal of unobserved doses led to marked attrition from treatment. If access to unobserved dosing is to be restricted to stable patients, it appears preferable to initiate dosing with observation and allow unobserved doses for people who successfully stabilize, than to initiate with unobserved doses and transfer unstable patients to observation.

Virologic response using directly observed therapy in adolescents with HIV: an adherence tool.

Virologic response to highly active antiretroviral therapy (HAART) treatment of HIV infection depends on viral sensitivity to antiretrovirals and excellent medication adherence. Adolescents with vertically acquired HIV may require complicated regimens because of significant treatment experience and often have poor medication adherence. A retrospective chart review identified five adolescents with vertically acquired HIV and plasma HIV viral load rebound or nonresponse on a stable HAART regimen followed by a period of directly observed therapy (DOT) in a clinic or hospital setting with serial viral load measurements. Four subjects had a virologic response (mean decline, 1.15 log10) after DOT. A response to HAART can be seen despite antiretrovirals resistance using DOT and treatment-experienced patients seemingly unresponsive to HAART may be nonadherent even with reassuring adherence measures. A period of clinic-monitored DOT may allow diagnosis of nonadherence, discussion of medication barriers, and avoidance of unnecessary medication changes.

Patient attitudes towards community-based tuberculosis DOT and adherence to treatment in an urban setting; Kampala, Uganda.

INTRODUCTION: High Tuberculosis treatment default rate (17%) and sub-optimal treatment completion rates (45%) has burdened Kampala. Nevertheless, there are observable increase in the number of patients on TB DOT; from 6% to 29% in two consecutive annual reports. The main objective was to determine the association of TB patient attitudes towards community-based observers on the TB drug adherence on directly observed treatment for TB in Kampala. METHODS: A cross-sectional study was carried out in Lubaga division, Kampala. A total of 201 patients in continuation phase of treatment for Pulmonary TB (i.e. 8 to 20 weeks of TB treatment) were included in the study. Patient attitudes were measured using a 4-point Likert scale aggregated into a binary outcome with ''agree'' and ''disagree'' responses. Poisson regression model using a forward fitting approach in STATA v12 was used to determine the association between patient attitude towards CB-DOTs observers and adherence to TB treatment. RESULTS: Among the 201 patients, 66% reported their treatment was being observed by someone. Relatives were the commonest (82%) treatment observers, 26% were non adherent to their TB treatment. Perceiving ''no need for a treatment observer'' and ''people rejecting TB patients'' were predictors of non-adherence to TB treatment (IRR=1.6,95%CI 1.00-2.57;p=0.048) and (IRR=0.6, 95%CI 0.35-0.95; p=0.019) respectively. CONCLUSION: Patient's perceived attitude and stigma towards treatment observers contribute to non-adherence on TB treatment. For improved local TB control, more emphasis is needed to build a friendly environment between treatment supporters and patients during the course of TB treatment.

Depressive symptoms and adherence to asthma therapy after hospital discharge.

STUDY OBJECTIVES: To evaluate the effect of depressive symptoms on adherence to therapy after discharge in patients hospitalized for asthma exacerbations. DESIGN: Prospective cohort study in which depressive symptoms were assessed during hospitalization and use of asthma medications was electronically monitored for 2 weeks after discharge. SETTING: Inner-city academic hospital in Baltimore, MD. PATIENTS: Patients were 59 adults with a mean age of 43.2 +/- 10.9 years (+/- SD), who were mostly female (64%), African American (80%), and were hospitalized for an asthma exacerbation. MEASUREMENT AND RESULTS: Depressive symptoms were assessed with the Center for Epidemiological Studies-Depression scale. Electronic monitors were used to evaluate inhaled corticosteroid and oral corticosteroid use for up to 2 weeks after discharge. Forty-one percent of patients had high levels of depressive symptoms. Mean adherence to therapy was significantly lower in patients with (vs without) high levels of depressive symptoms (60 +/- 26% vs 74 +/- 21%, p + 0.02). Even after controlling for age, gender, and education, depressive symptoms were a significant and independent predictor of poorer adherence. High levels of depressive symptoms were associated with a 11.4-fold increase (95% confidence interval, 2.2 to 58.2) in the odds of poor adherence to therapy after adjustment for potential confounders. CONCLUSIONS: Depressive symptoms are common in inner-city adults hospitalized for asthma exacerbations and identify a subset of patients at high risk for poor adherence to asthma therapy after discharge. Further research is needed to determine if screening for and treating depression improves adherence and asthma outcomes in this population.

Adherence is associated with the quality of professional-patient interaction in Directly Observed Treatment Short-course, DOTS.

OBJECTIVE: To investigate the association between the behaviour of health professionals as reported by patients, the quality of communication, patients' communication about their disease, and non-adherence to Directly Observed Tuberculosis Treatment Short-course, DOTS. METHODS: This study was designed as a case-control study based on 50 cases (non-adherents) and 100 controls (adherents), conducted in a hilly western district in Nepal. The participation rate was 80% for 50 cases and 95% for 100 controls. All covariates with p-value

Frontal assault on tuberculosis. Interview by Eileen Fursland.

Nurses working with people who have TB in London battle to reduce the stigma attached to the disease. For many patients, TB is just one of many problems they have to contend with. People living in shared accommodation can face homelessness as a result of their infection. In some countries TB is associated with HIV, increasing the stigma patients face. Some patients are given incentives to encourage concordance with treatment.

Experiences of patients having tuberculosis (TB) regarding the use of Directly Observed Treatment Short-Course (DOTS) in the North West Province, South Africa.

BACKGROUND: Tuberculosis (TB) management remains a major challenge despite the implementation of Directly Observed Treatment Short-Course (DOTS). Some of the challenges include defaulting treatment, low TB cure rates and relapse after patients had been treated under DOTS. OBJECTIVES: This study explored and described experiences of patients having TB regarding the use of DOTS in Doctor Ruth Segomotsi Mompati District of North West Province, South Africa. The study describes and recommends support required by patients having TB who are using DOTS. METHODS: A qualitative, exploratory, descriptive and contextual design was used. The population consisted of all patients having TB under DOTS who had taken treatment for 2 months and more in one of the community health centres in Doctor Ruth Segomotsi Mompati District. Purposive sampling technique was applied to select participants receiving DOTS service. In-depth unstructured individual interviews were conducted, and data saturation occurred after having interviewed 15 participants. Ethical considerations were ensured throughout the study, and data were analysed using Tesch's method of coding and analysis. RESULTS: Two themes emerged from data and these are discussed as concerns related to ineffective use of DOTS and lack of resources as contributory factor to ineffective use of DOTS. Among other categories, poor nurse-patient relationships and difficulties in accessing the community health centre emerged as consistent themes related to default and inconsistent use of DOTS. CONCLUSION: Ineffective use of DOTS contributed to TB treatment default and low cure rate. Therefore, recommendations focused on strengthening effective use of DOTS for the management of TB.

Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India.

BACKGROUND: The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to the patient and accountable to the health system, except a family member. This poses challenges among children with TB who may be more comfortable receiving medicines from their parents or family members than from unfamiliar DOT providers. We conducted a non-inferiority trial to assess the effect of family DOT on treatment success rates among children with newly diagnosed TB registered for treatment during June-September 2012. METHODS: We randomly assigned all districts (n = 30) in Gujarat to the intervention (n = 15) or usual-practice group (n = 15). Adult family members in the intervention districts were given the choice to become their child's DOT provider. DOT was provided by a non-family member in the usual-practice districts. Using routinely collected clinic-based TB treatment cards, we compared treatment success rates (cured and treatment completed) between the two groups and the non-inferiority limit was kept at 5%. RESULTS: Of 624 children with newly diagnosed TB, 359 (58%) were from intervention districts and 265 (42%) were from usual-practice districts. The two groups were similar with respect to baseline characteristics including age, sex, type of TB, and initial body weight. The treatment success rates were 344 (95.8%) and 247 (93.2%) (p = 0.11) among the intervention and usual-practice groups respectively. CONCLUSION: DOT provided by a family member is not inferior to DOT provided by a non-family member among new TB cases in children and can attain international targets for treatment success. TRIAL REGISTRATION: Clinical Trials Registry-India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2015/09/006229.

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.