Directly Observed Treatment Short Course Therapy Research Articles

Tuberculosis (TB) treatment challenges in TB-diabetes comorbid patients: a systematic review and meta-analysis

Background The Directly Observed Treatment-Short Course (DOTS) Programme was implemented by WHO and includes a combination of four anti-tuberculosis (TB) drugs (isoniazid, pyrazinamide, ethambutol and rifampicin) for a period of six months to eradicate the TB infection completely. Diabetes mellitus (DM) is recognized as one of a strong contributor of TB according to World Health Organization (WHO). The presence of diabetes mellitus type 2 (DM type 2) makes TB treatment complicated. Thus, the objective of the current meta-analysis was to identify and quantify the impact of type 2 DM on treatment outcomes of TB patients treated under the DOTS Programme. Methods This meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Through a systematic review of relevant literature, we focused on studies investigating treatment outcomes including extended treatment duration and recurrence for individuals with both TB and DM undergoing DOTS therapy. The extracted information included study designs, sample sizes, patient characteristics and reported treatment results. Results In 44 studies from different parts of the world, the pooled HR for the impact of DM on extended treatment duration and reoccurrence were HR 0.72, 95% CI 0.56–0.83, p < .01 and HR 0.93, 95% CI 0.70–1.04, p = .08, respectively. The pooled HR for impact of DM on composite TB treatment outcomes was calculated as 0.76 (95% CI 0.60–0.87), p < .01 with an effect size of 41.18. The heterogeneity observed among the included studies was moderate (I 2 = 55.79%). Conclusions A negative impact of DM was found on recurrence and extended treatment duration in TB patients treated with DOTS therapy. DM type 2 is responsible for the TB treatment prolongation and TB recurrence rates. By implementing effective management strategies and advancing research, the challenges can be mitigated, arising due to the complex interaction between DM and TB.

Tuberculosis Elimination in India: Where the Country Stands

Tuberculosis (TB) remains a significant public health challenge in India, with the country bearing the highest burden of TB cases globally. This article provides an overview of India's ongoing efforts towards TB elimination, highlighting both progress and persistent challenges. India's Revised National Tuberculosis Control Program (RNTCP), launched in 1997, has made remarkable strides in TB control. The introduction of the RNTCP and later its expansion as the National Tuberculosis Elimination Program (NTEP) in 2017, aimed to strengthen diagnostic and treatment services, with a focus on achieving universal access to TB care. DOTS (Directly Observed Treatment, Short-course) therapy has been a cornerstone of treatment, contributing to significant reductions in TB mortality. In recent years, India has made strides in adopting new technologies, including molecular diagnostics and telemedicine, to enhance TB case detection and patient care. The introduction of Bedaquiline and Delamanid, novel drugs for drug-resistant TB, has offered hope for patients with more resistant forms of the disease. However, the road to TB elimination in India is not without challenges. There is a pressing need for improved healthcare infrastructure, reduced stigma, and increased awareness among both the public and healthcare providers. The emergence of drug-resistant TB and the impact of the COVID-19 pandemic on TB services have posed additional hurdles. India's journey toward TB elimination is marked by significant progress and continued challenges. To achieve the ambitious goal of eliminating TB by 2025, concerted efforts are required to strengthen healthcare systems, improve diagnostic capabilities, and address social determinants of the disease.

Pre-Post Assessment of Serum Zinc and Copper Status in Uncomplicated Pulmonary Tuberculosis Patients Receiving Directly Observed Treatment Short Course

Mycobacterium tuberculosis causing the infectious disease tuberculosis has a predilection for the lungs although it is common to see other organs involved. India has adopted the TB-DOTS program for the treatment of the same. Undernutrition and tuberculosis are mutually inclusive. Micronutrients like zinc and copper play a key role in cytokine kinetics and immunity and thus are important in an individual’s response to infectious disease. Serum copper and zinc levels in patients with pulmonary tuberculosis (pTB) before and after two months of directly observed treatment short course (DOTS) were assessed in this study. The serum samples of 39 pTB patients were collected before the commencement of anti-tubercular therapy (ATT) and tested for copper and zinc levels. At the end of the intensive phase of treatment, blood samples of 31 out of the 39 pTB patients were again collected and tested for the same trace elements. In the pre-post comparison of 31 patients who could be followed up, an increase in serum zinc levels [101 (74.9) μg/ dl vs 112(155.5) μg/dl)] after the treatment was not statistically significant (p=0.15). The serum copper levels [184(105.7) μg/dl vs 247(80.8) μg/dl)] were significantly (p&lt;0.01) increased after two months of DOTS therapy. Sputum negativity was close to 81%.Serum copper, as well as zinc levels, were increased after DOTS therapy for two months. Since the response to therapy was 69%, supplementation of copper and zinc may benefit the pTB patients in achieving sputum negativity sooner and completely.

The study of adverse drug reactions in indoor patients of tuberculosis taking standardized antitubercular therapy (directly observed treatment short-course and programmatic management of drug resistant tuberculosis) in a tertiary care hospital at Surat

Background: Tuberculosis is a serious public health issue in India. The treatment regimen followed is Directly observed treatment short-course (DOTS) and Programmatic Management of Drug resistant Tuberculosis (PMDT) approach. In a long period of treatment adverse drug reactions (ADRs) can be an important programmatic issue. Thus, study was undertaken to assess the ADRs caused by antitubercular therapy in indoor patients in a tertiary care hospital at Surat.Methods: The Observational, prospective study was carried out for one year period. The causality was determined by WHO UMC scale and severity was determined by Modified Hartwig and Siegel scale. Chi square test was applied for statistical analysis.Results: Among 255 tuberculosis patients, 85 (33.3%) patients developed ADRs. Occurrence of ADRs was more among females (46.6%). The commonly involved systems are gastrointestinal (40.6%) followed by haematological (17.9%). The most common ADRs observed were nausea and vomiting (21.7%). High percentage of ADRs causing drugs were isoniazid (30.6%) followed by rifampicin (26.1%). Causality assessment showed 60.4% ADRs were possible, 37.7% ADRs were probable and 1.9% ADRs was certain. Severity assessment scale showed 81.1% of moderate, 12.3% of mild and 6.6% of severe grading. Occurrence of ADRs was more among PMDT (60%) in comparison to DOTS therapy (31.06%) [p value = 0.0084 (significant p value &lt; 0.05)].Conclusions: Antitubercular treatment is safer but early detection, management and reporting of ADRs is required to prevent it at initial stage and helps to decrease default rate.

The possible impact of socioeconomic, income, and educational status on adverse effects of drug and their therapeutic episodes in patients targeted with a combination of tuberculosis interventions.

First-line antituberculosis (anti-TB) compounds have been considered as proven components of the Directly Observed Treatment-Short course (DOTS). Drug therapy against tuberculosis has been categorized as I, II, or III following the Revised National Tuberculosis Control Program guidelines. Anti-TB are drugs are quite common and show limited adverse effects. However, first-line anti-TB compounds mediated DOTS therapy and were found with several complications. Thus, those drugs have been discontinued. Therefore, the present study was designed to find out the possible impact of socioeconomic, income, and educational status on the adverse effects of drugs and their therapeutic episodes in patients targeted with a combination of tuberculosis intervention. This study found that an increased incidence of tuberculosis was found in patients who have finished high school, contributing to a high percentage of adverse effects. Notably, adverse events were shown maximally in poor patients compared with rich- or high-income patients. On the contrary, a high prevalence of adverse events was shown to be increased in partially skilled workers compared with full-skilled workers. Consequently, adversely considerable events were implicated to be raised in patients associated with minimal socioeconomic class. Such interesting factors would help in monitoring such events in experimental patients.

Dynamic mucus penetrating microspheres for efficient pulmonary delivery and enhanced efficacy of host defence peptide (HDP) in experimental tuberculosis

Pulmonary drug delivery system is increasingly gaining popularity for several lung diseases including tuberculosis(TB) due to its ability to attain high drug concentrations at the site of infection and to minimize systemic toxicity. In TB therapy, the efficacy of the antibiotics decreases and bacteria becomes resistant in course of time due to the formation of several barriers like lung-mucus and biofilms around the microorganism. The conventional inhalable microparticles(MP) are majorly trapped in dense mucin mess network and quickly cleared by mucocilliary clearance. In this study, we determined whether the anti-TB activity of drug-loaded inhalable polymeric microparticles could be synergized with the mucus-penetrating and biofilm disrupting properties. Mucus-penetrating-microparticles(NAC/PLGA-MPP) were developed combining the benefits of anti-TB drug with host defence peptides(HDP). IDR-1018 peptide was encapsulated with/without an anti-TB drug in N-acetyl cysteine(NAC) decorated porous PLGA microspheres. Aerodynamic parameters(MMAD-3.79 ± 1.04 μm, FPF-52.9 ± 5.11%) were optimized for the finest deposition and targeting inside the lungs. The multiple-tracking-technique(MPT) results indicate that the coating of NAC on porous PLGA-MS dramatically increased (4.1fold) the particle transit through the mucus barrier. Designed inhalable NAC/PLGA-MPP do not adhere to lung mucus, disrupt the bacterial biofilm and provide uniform drug delivery to lungs after pulmonary delivery. The formulation was evaluated for activity against M.tb in macrophage cultures and in mice model infected with a low-dose bacterial (~100 CFU) aerosol. The inhalation of NAC/PLGA-MPP encapsulated with IDR-1018 significantly reduced (p < .05) bacterial load (up to ~3.02LogCFU/ml) and inflammation in lungs in a mouse model of TB compared to untreated and blank treated animals in 6 weeks of daily dose. The histopathological results validate the compelling chemotherapeutic outcome of inhaled formulations. This data supports the harnessing potential of mucus penetrating inhalable drug delivery systems as a vehicle for targeted lung delivery. This “value-added” inhalable formulation could be beneficial for resistant TB therapeutics when used as an “adjunct” to existing DOTS (Directly observed treatment, short-course) therapy.

Compliance to Directly Observed Treatment Short Course (DOTS) Chemotherapy among the Patient of Pulmonary Tuberculosis in Banke District of Nepal

Tubercular infection is still a pervasive public health problem in Nepal despite the massive efforts of National Health Service stakeholders. High bacterial infectivity, transmissibility, increasing drug resistance and non compliance to the therapy have been adding up challenges to prevention and control of tuberculosis. This study was conducted to observe the treatment compliance pattern among new pulmonary sputum smear positive cases of tuberculosis. A cross sectional study was carried out in the year 2009. The 114 new smear positive pulmonary tuberculosis patients registered in the six selected DOTS centres of the Banke Disrtict were randomly selected. Participants were selected from each DOTS centre by probability proportionate sampling methods. Data were analyzed by SPSS (11.0 Version) and P&lt; 0.05 was considered as significant. Overall compliance to DOTS was 86.80 percent; of these, 57.00 percent showed excellent and regular compliance followed by nearly 30 percent good compliance. And 13.20 percent participants were non complaint to DOTS therapy. Positive Family behaviors were positively associated with compliance while alcohol consumption was found to be negatively associated with compliance however; age, sex and income were found to be non significant factors for compliance. Feeling of getting cure even before the course of DOTS therapy (feeling better after 2-3 months regular treatment) and drinking habits were found to be the major causes of non compliance. Supportive family behaviors and avoidance of alcohol consumption may promote the compliance. Excellent treatment compliance in the face of many odds is highly encouraging and the pattern can be useful in treatment despite little non compliances; furthermore compliance can be enhanced by acting on these causes of non compliances.&#x0D; Key words: Pulmonary, Tuberculosis, DOTS, Banke, Nepal

Evaluation of revised national tuberculosis control programme in rural Puducherry

Background: WHO estimates that annually 3 million deaths occurs due to tuberculosis and will reach to more than one billion in 2020. In India, more than 40% of population is infected. The revised national tuberculosis control programme (RNTCP) uses directly observed treatment, short-course (DOTS) therapy strategy to reduce mortality and morbidity, reduce transmission. Compliance to DOTS therapy is one of the important factors that affect the treatment outcome. Hence this study was done to assess the drug compliance rate of adults registered under RNTCP in the past one year and first three months after starting the study and to explore the factors associated with drug compliance.Methods: A longitudinal study was done in Bahour Commune Panchayat with subjects registered under RNTCP from January 2011 to March 2012. They were followed-up by house visit, interviewed using a semi-structured questionnaire.Results: The mean age was 44±13 years, 35 (68.6%) males were illiterate. About 60 (85.7%) belong to Class IV socio-economic status; 15 (29.4%) and 33 (64.7%) of adults had smoking and alcohol intake respectively; 03 (04.3) were diabetic. The treatment compliance rates were cured 64.3% (45/70), completed 27.1% (19/70), default 2.9% (02/70), failure 5.7% (04/70).Conclusions: Male being diseased in the productive age-group, will not only affect the health of the patient but also affect the family’s economic status. Most of the males gave history of alcohol intake, for which they require constant motivation for compliance to the treatment.

Tuberculosis related stigma attached to the adherence of Directly Observed Treatment Short Course (DOTS) in West Bengal, India

BackgroundStigma is a major barrier to the successful completion of the Directly Observed Treatment Short Course (DOTS). People put on DOTS have to face repeated exposure to stigma as per the requirement of the treatment. Thus stigma can shape the extent of access and adherence to treatment. But there is very little information available in Indian context explaining the extent of association between the stigma perceived among the patients and adherence to their DOTS therapy. AimTo explore the level of stigma perceived by the persons with TB and its influence on the adherence to DOTS treatment. MethodsA cross sectional epidemiological study was conducted among 145 DOTS defaulters from three randomly selected districts in West Bengal. Respondents were approached at their households. Information was collected using a pretested questionnaire. Adherence to DOTS was grouped as early default (continued DOTS from 0 to 30 days) and late default (continued DOTS > 30). Stigma score was assessed using 11 item questions. Stigma score was grouped as low level (0–23) and high level (24–44). Analysis was done using Chi-square and multivariate logistic regression models to identify factors to influence adherence to DOTS. SPSS 23.0 version statistical software was used for analysis. ResultsMean stigma score for the state was 23.0. Total 51 (40.69%) persons were within the low stigma group and 94 persons (59.31%) were within high stigma score group. District wise mean score was 19.8, 22.8 and 24.5 respectively for Birbhum, Jalpaiguri and North 24 Parganas. In North 24 Parganas, the high stigma score group accounted for 85.5% compared to 35.9% in Birbhum. Among the low stigma group, late default was 52.1% compared to 66.7% in high stigma group (p = 0.054). People with lower stigma level were 8.59 times more likely to have late default than the people with higher stigma level (p = 0.001). ConclusionPerceived stigma among the patients was identified as an important predictor for the adherence to DOTS therapy. Stigma reduction strategy should be designed to improve adherence to DOTS therapy. Present study recommends in-depth qualitative research to get more insight on the extent and shape of stigma and the way it influences the adherence. Apart from the stigma of the patients, influence of community stigma is a gray area for further research.

Factors influencing compliance to directly observed treatment, short course therapy and effectiveness of awareness program on knowledge and compliance

Background: Tuberculosis (TB) is one of the most infectious diseases if not treated properly it may lead to mortality. The directly observed treatment, short course (DOTS) therapy is the choice of the treatment of TB. Objectives: The objectives of the study were (1) to determine the factors influencing compliance of persons with TB to DOTS, (2) to evaluate the effectiveness of an awareness program on knowledge and compliance to DOTS among persons with TB, (3) to find the association between pre-test level of knowledge with selected sociodemographic variables, and (4) to find the association between pre-test level of compliance to DOTS with selected sociodemographic variables. Materials and Methods: An evaluative approach with one group pre-test and post-test design was used as a research design in the study. 50 participants were selected as a sample using purposive sampling technique. The data were collected using structured knowledge questionnaire and compliance checklist through interview schedule Results: The study result showed that the mean post-test knowledge score (17.32 ± 1.58) was higher than the mean pre-test knowledge score (10.80 ± 2.05) and “t” value is 27.22 at P < 0.05. Similarly, the mean post-test compliance score (8.92 + 0.72) was higher than the mean pre-test compliance score (6.00 ± 1.05) and “t” value is 9.369 at P < 0.05. The sociodemographic variable such as age and educational status was significantly associated with pre-test knowledge score (χ² = 5.993, P < 0.05, and χ² = 11.49, P < 0.05), respectively, and gender was significantly associated with pre-test compliance score (χ² = 4.482, P < 0.05). The main reason for noncompliance to DOTS therapy was difficult to take multiple drugs for a long period and data showed that family support (29.55%) was highly influencing to comply with DOTS therapy. Conclusion: The awareness program was highly effective in increasing knowledge among TB person and compliance to DOTS therapy. Therefore, the knowledge and compliance of the TB person to DOTS therapy can be further improved by providing on-going awareness programs.

Assessment of Microbiological Status after Successful Completion of Intermittent Revised National Tuberculosis Control Programme Directly Observed Treatment, Short Course Regimen for Microbiologically Confirmed Pulmonary Tuberculosis Cases: While New Daily Regimen Going to be Implemented in India

Purpose: The Revised National Tuberculosis Control Programme (RNTCP) is now introducing daily fixed-dose regimen instead of Directly Observed Treatment, Short Course (DOTS) regimen for treatment of drug-sensitive tuberculosis (TB) in India. It would be beneficial to understand the drawbacks, barriers and advantages of the existing system for better implementation of new policy. Our study was aimed to evaluate the current microbiological status of new microbiologically confirmed pulmonary TB patients who have successfully completed intermittent DOTS regimen within last 2 years and also to find the economic barriers faced by beneficiaries to avail DOTS treatment. Materials and Methods: We included patients who had completed CAT 1 DOTS regimen within the last 2 years. The patients were interviewed. Sputum sample was collected for microscopy and cartridge-based nucleic acid amplification test. Results: All patients were adhered to intermittent DOTS therapy, and sputum conversion rate was 83%. Minor gastrointestinal side effects were experienced by 60% of cases and 87% consumed drugs under supervision. On microbiological examination, 10% of the study population was found to be positive for TB and they all were rifampicin sensitive. Those who had completed treatment within 1 year with no clinical symptoms re-appeared after treatment. Conclusion: Till date, RNTCP does not follow up the patients for any period of time after successful completion of treatment. Through the present study, we could find relapse cases in 10% of the previously treated non-symptomatic patients. These unnoticed relapse cases have potential to spread TB and increase disease burden of country. Thus, we can conclude that RNTCP has to follow up the patients after successful treatment to determine whether they relapse. It is needed for the success of programme and control of the disease in the country.

Health-related quality of life among tuberculosis patients under Revised National Tuberculosis Control Programme in rural and urban Puducherry

BackgroundGlobally, tuberculosis (TB) continues to be the major public health problem. Limited research is carried out on the impact of the disease on health-related quality of life (HR-QoL). The study aims to assess the HR-QoL among TB patients during and after Directly Observed Treatment Short-course (DOTS) therapy and to compare the HR-QoL of these patients with matched neighbourhood controls. MethodologyA community-based longitudinal study was conducted in Ariyankuppam and Bahour communes of Puducherry from January 2014 to April 2015. 92 TB patients registered for DOTS therapy during January–June 2014 were interviewed in their DOTS centres during first visit using the SF-36 questionnaire to assess their HR-QoL. During the second visit, 9 TB patients were lost to follow-up; therefore, a total of 83 patients were interviewed in their houses and, simultaneously, 83 matched neighbourhood controls were interviewed. Non-parametric tests were used to compare the HR-QoL scores. p value <0.05 was considered as statistically significant. ResultsThe mean HR-QoL scores had improved among TB patients upon completion of DOTS (80.8±20.3), when compared to HR-QoL scores (48.3±30) during treatment with significant difference. The HR-QoL scores of TB patients after DOTS completion (80.8±20.3) had improved to levels comparable to that of non-TB controls (77.5±29.1) without significant difference. ConclusionHR-QoL of patients suffering from TB was low. However, the study provides evidence that DOTS treatment offers a demonstrable improvement of HR-QoL among TB patients almost to the level of general population. The findings can be used in advocating the effectiveness of DOTS in TB control efforts.

Coping with tuberculosis and directly observed treatment: a qualitative study among patients from South India.

BackgroundIn India, the Revised National TB control programme (RNTCP) offers free diagnosis and treatment for tuberculosis (TB), based on the Directly Observed Treatment Short course (DOTS) strategy. We conducted a qualitative study to explore the experience and consequences of having TB on patients enrolled in DOTS and their caretakers in Tumkur district, located in a southern state of India, Karnataka.MethodsWe conducted 33 in-depth interviews on a purposive sample of TB patients from three groups: (1) patients who reached RNTCP directly on their own and took DOTS at RNTCP; (2) patients who were referred by private practitioners (PPs) to RNTCP and took DOTS at RNTCP; and (3) patients diagnosed by RNTCP and took DOTS from PPs. Data was analyzed using a thematic approach with the support of NVivo9.ResultsThe study revealed that TB and DOTS have a large impact on patient’s lives, which is often extended to the family and caretakers. The most vulnerable patients faced the most difficulty in accessing and completing DOTS. The family was the main source of support during patient’s recovery. Patients residing in rural areas and, taking DOTS from the government facilities had to overcome many barriers to adhere to the DOTS therapy, such as long travelling distance to DOTS centers, inconvenient timings and unfavorable attitude of the RNTCP staff, when compared to patients who took DOTS from PPs. Advantages of taking DOTS from PPs cited by the patients were privacy, flexibility in timings, proximity and more immediate access to care. Patients and their family had to cope with stigmatization and fear and financial hardships that surfaced from TB and DOTS. Young patients living in urban areas were more worried about stigmatisation, than elderly patients living in rural areas. Patients who were referred by PPs experienced more financial problems compared to those who reached RNTCP services directly.ConclusionOur study provided useful information about patient’s needs and expectations while taking DOTS. The development of mechanisms within RNTCP towards patient centered care is needed to enable patients and caretakers cope with disease condition and adhere to DOTS.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1545-9) contains supplementary material, which is available to authorized users.

A Study on Incidence of Adverse Drug Reaction of Anti-Tubercular Drugs in New Cases of Pulmonary Tuberculosis in a Tertiary Care Teaching Hospital

Objective: A study on incidence of adverse drug reaction of anti-tubercular drugs in new cases of pulmonary tuberculosis. Method: It was prospective observational study conducted on Positive pulmonary tuberculosis patients admitted in the ward of T.B and chest and enrolled on the directly observed treatment short course (DOTS) and monitored for ADRs. The causality and severity of adverse drug reaction carried out as per Naranjo scale and modified Hartwig and Siegel scale respectively. Result: In this study, Out of 263 patient enrolled on DOTS therapy, n= 74(28.14%) patients developed ADRs in which male patient were n= 48 (27.58%) and female patient were n= 26 (29.21%). Total no. of ADRs reported in n=74 patients were n=212. The severity of ADRs were from mild group with n= 161(75.94%) followed by moderate with n= 38(17.92%) and severe n= 13(6.14%). The causality of ADRs reported were probable with n= 158(74.52%) of cases, followed by possible n= 42(19.81%) and definite n=12(5.67%). The most commonly reported ADR was hyperacidity n= 34 (16.03%). Conclusion: This prospective study conclude that the majority of adverse drug reaction found during the treatment of pulmonary tuberculosis were mild with 75.94% and did not need modification of treatment or administration of specific antidotes followed by moderate with 17.92%, which required discontinuation or change of treatment and antidotes also required and Severe ADRs constituted 6.14% patients which requires intensive medical care.

A study to assess the stigma related to tuberculosis among directly observed treatment short-course (DOTS) providers and patients on DOTS therapy attending DOTS centres of Mandya City, Karnataka, India

Background: Stigma is defined as a powerful and tainting social label that radically changes the way individuals view themselves and are viewed by others. Tuberculosis is the second leading cause of death from an infectious disease. In India, social stigma attached to tuberculosis hinders patients from seeking adequate treatment interventions thus adding to the burden of disease. Methods: All the patients receiving DOTS therapy for pulmonary and or extra pulmonary tuberculosis at DOTS Centres at Mandya Institute of Medical Sciences (MIMS), primary health care centres (PHCs) Guthalu and Kyathamgere were interviewed using Explanatory Model Interview Catalogue (EMIC) stigma scale. During the study period there were 33, 17 and 11 patients receiving DOTS therapy at MIMS, PHC Guthalu and PHC Kyathamgere respectively. A total of 18 DOT providers were interviewed using Social Distance Scale (SDS). Results: 21(34.43%) of the 61 DOTS patients were found to be stigmatised and 40(65.57%) were not stigmatised. 10 (47.62%) females and 11 (27.5%) males were found to be stigmatised. 43 (70.49%) patients preferred to keep other people from knowing that they were suffering from tuberculosis. 27(44.26%) patients had decided to stay away from work/social groups and 26(42.62%) felt that others give them less respect. 14(77.78%) of the 18 DOT providers were definitely unwilling to have someone with tuberculosis as a caretaker of their children for a couple of hours. Conclusions: One-third of the patients on DOTS therapy were stigmatised and three-fourth of the DOT providers reported stigma.

Treatment outcome of new smear positive patients of pulmonary tuberculosis treated under directly observed treatment, short-course in a rural tertiary care hospital of a hilly area

Background: Tuberculosis is one of the world’s most common causes of morbidity and mortality. The directly observed treatment, short-course (DOTS) Strategy aims to improve patient adherence to treatment and thereby prevents development of drug resistance. Aims and Objectives: To study the treatment outcome in new smear positive patients of pulmonary tuberculosis treated under DOTS at DR. RPGMC Kangra at Tanda, H.P. Methods: A prospective observational study was conducted over duration of seven months in Dr. RPGMC Kangra at Tanda, Himachal Pradesh, India. A total of 130 new smear positive (NSP) patients of pulmonary tuberculosis (PTB) were enrolled during study period after taking informed consent. Patients were started on category I and were followed till the completion of DOTS. Treatment outcomes were recorded as per RNTCP guidelines. Results: Out of total 130 patients, 109 (83.8%) patients were cured, 14(10.7%) patients died, 2 (1.6%) patients treatment completed, 2(1.6%) patients defaulted, 2 (1.6%) patients were treatment failure and in 1(0.7%) patient treatment regime was modified due to severe hypersensitivity reaction with HRZE. He was put on HES for one year. The mean weight ±SD was 44.5±3.53 kg at the time of start of treatment which increased to mean of 50.6±2.97 kg at the end of treatment. There was an average increase of 6.08±1.12 kg weight at the end of treatment. This was statistically significant and was evenly distributed in all age groups. Conclusions: The high cure rate and less default rate ensures that the DOTS therapy is highly effective and safe and also the DOTS program is running successfully in this rural hilly area. The increase in weight at the end of treatment was found to be strongly associated with favourable treatment outcome (p<0.05). And also furthermore it may be concluded that increased weight can also be included as one of the criteria for the favourable treatment outcome.

Awareness and knowledge about tuberculosis in patient of tuberculosis at GMERS Medical College and Hospital Dharpur, Patan, Gujarat

Background: India has the highest burden of tuberculosis (TB) accounting for one-fifth of the global incidence and is 17th among 22 high-TB burden countries in terms of incidence rate of TB. Objective: To know the sociodemographic profile of patients with TB and to assess knowledge and awareness regarding TB among patients with TB. Materials and Methods: A cross-sectional study was carried out including all TB treatment units of GMERS Medical College and Hospital Dharpur, Patan, Gujarat, India, for 3 months from June to August 2014. Total 151 registered patients of all age groups during June to August 2014 were selected by purposive sampling. After taking verbal consent, all patients were interviewed on the basis of predesigned, pretested pro forma. Information was collected regarding their health status, DOTS (directly observed treatment short course) therapy, and their awareness regarding TB. The data were statistically analyzed using SPSS software. Result: Of 151 patients, 104 (68.8%) were male aged from 14 to 80 years; 147 (97.3%) were from rural area, 63 (41.7%) were illiterate, 130 (86%) belonged to joint family, and 118 (78.1%) had less than Rs. 500 per capita income. More than 50% patients with TB were aware of person-to-person transmission of TB. About 62 (41.05%) patients of TB knew mode of spread of TB and 95 (62.91%) correctly answered that cough was the most common symptom. About 91 (60.26%) patients said that TB can be prevented by BCG vaccine, 99 (65.56%) knew about DOTS clinic, 40 (26.9%) knew about TB from doctor, and only 90 (59.6%) believed that TB was curable. Conclusion: Apart from pharmacological treatment, poor knowledge regarding TB among patients of TB also needs great attention.

Adverse effects of first line antitubercular medicines on patients taking directly observed treatment short course: A hospital based study

Introduction: Tuberculosis (TB) continues to remain one of the most pressing health problems, with India being the highest TB burden country. India has adopted and enforced Directly Observed Treatment Short course (DOTS) strategy to combat TB. The first line medicines in DOTS are known to cause adverse effects like gastritis, hepatotoxicity and skin allergies. This study was done to determine the occurrence of such adverse effects in patients under DOTS therapy and to assess their impact if any on patient compliance. Methods: A hospital based cross-sectional observational study was carried out on all newly diagnosed cases of TB as well as those registered in DOTS centre in Chest and TB department of a tertiary care hospital. A structured proforma was used to collect information regarding adverse effects of medicines under DOTS. Biochemical tests were done after voluntary consent. Results: A total of 168 patients (132 male, 36 female) were interviewed for the study. Patients reported adverse drug effects which mainly involved Gastro-intestinal system (39%), Genito-urinary system (32%), Musculo-skeletal system (13%), Central Nervous System (7%), Dermatological (6%), Vestibulo-ocular system (3%). 68.5% of the patients gave consent for biochemical investigations out of which Serum bilirubin (direct) was raised in 52%, Serum albumin was below normal limit in 59% and ESR was raised in 59%. Conclusion: Majority of adverse effects were mild. Most commonly encountered symptoms were abdominal. Most patients reported adverse drug effects to be the most likely cause to stop the treatment. Special interventions to cure these mild adverse effects can lead to increased patient compliance and hence a better cure rate. Results also showed that family plays the most important role as a support to combat the illness.

Revised National Tuberculosis Control Program regimens with and without directly observed treatment, short-course: A comparative study of therapeutic cure rate and adverse reactions

Objective:To compare the therapeutic cure rate and adverse reactions in the regimens of the Revised National Tuberculosis Control Program (RNTCP) with directly observed treatment, short-course (DOTS) and without DOTS.Materials and Methods:Fifty patients in the DOTS regimen and 50 patients in the non-DOTS regimen were enrolled in the study. All the participants were asked to come regularly for 3 consecutive days for sputum collection, and the sputum samples were examined for acid-fast bacilli. If tuberculosis (TB) was confirmed, the disease status was confirmed through a chest X-ray (PA view). The participants were monitored for adverse events arising from the use of anti-TB drugs for the next 6 months.Results:The TB cure rates for RNTCP with DOTS and RNTCP with non-DOTS were 80% and 66%, respectively. The DOTS therapy had a better cure rate for radiologically positive, sputum-positive cases compared with the non-DOTS regimen group. The non-DOTS treatment regimen had significantly increased numbers of adverse events in the hepatic and hematinic systems.Conclusion:The DOTS regimen has higher cure rates and a lower incidence of adverse reactions compared with the non-DOTS regimen.

Safety evaluation of Directly Observed Treatment Short course (DOTS) regimen in a tertiary care hospital, Pune.

Background: Directly observed treatment short course (DOTS) is a cornerstone of Revised National Tuberculosis Control Program of India. Adverse drug reactions (ADRs) induced by this therapy is common and it causes significant morbidity and mortality. Hence, the present study was undertaken to determine the incidence and pattern of ADRs and to assess causality and severity. Methods: We conducted prospective, observational study at DOTS center of tertiary care hospital, Pune. 150 pulmonary tuberculosis patients undergoing DOTS therapy were enrolled. They were monitored weekly in an intensive phase and monthly in the continuation phase. The suspected ADRs were recorded and assessed for causality and severity by standard algorithms. Results: Incidence of ADRs due to DOTS was 19.33% &amp; total 35 ADRs had occurred in our study. Gastrointestinal intolerance, arthralgia &amp; itching with or without rashes were most common ADRs (incidence rates: 12.67%, 2.67% and 2.67%, respectively). On evaluation of causality by Naranjo algorithm, majority of ADRs 91.43% were “possible.” As per WHO- Uppsala Monitoring Center scale, majority of ADRs 91.43% were “possible.” As per Modified Hartwig and Siegel scale, majority of ADRs were “moderate” (48.57%) but 8.57% were “severe.” Female gender was found to be a significant risk factor for developing ADRs (odds ratio: 3.08, 95% confidence interval: 1.33-7.12. 3.33%). ADRs &amp; hepatotoxicity was major reason for defaulting from DOTS (60%). Conclusion: ADRs induced by DOTS are common and there is need of incorporating pharmacovigilance system for this vital public health program. Counseling of patients for timely prevention, detection, and management of ADRs will help in minimizing the further occurrence of ADRs.