Assessment of Directly Observed Treatment in Revised National Tuberculosis Control Programme: A Study from North India.
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ABSTRACT:
SUBMITTER: Kanungo S
PROVIDER: S-EPMC5523523 | biostudies-other | 2017 Jul-Dec
REPOSITORIES: biostudies-other
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Project description:In this study, we investigate differences in tuberculosis (TB) treatment outcomes between urban and rural India and estimate their impact on epidemiological outcomes such as TB incidence, prevalence and mortality using a mathematical model of TB transmission dynamics. Publicly available district-level treatment outcomes data for new and previously treated TB cases was analyzed in conjunction with census data providing the proportion of urban population in each district to determine the effect of urbanity/rurality on treatment outcomes. Districts were grouped in clusters based on the proportion of urban population in each district, wherein the clusters were identified by applying machine learning methods. Regression analyses revealed that average treatment success rates among both new and previously treated cases decline with increase in the proportion of urban population in a district cluster, with substantially sharper declines in treatment success rates with degree of urbanity observed for previously treated cases. The impact of differences in treatment outcomes on epidemiological outcomes was estimated using a dynamic transmission model developed for this purpose. For example, the cluster with highest treatment success rates is projected to have an average of 3.2% fewer deaths per 100,000 population in comparison with the national average across 2019-24, and the cluster with the lowest treatment success rates has an average of 4.5% more deaths per 100,000 in comparison with the national average. We anticipate that these disparities in TB treatment outcomes and epidemiology between urban and rural India may motivate investigations into the associated causes and their redressal.
| S-EPMC7021308 | biostudies-literature
Project description:INTRODUCTION:There is lack of information on the proportion of new smear-positive pulmonary tuberculosis (PTB) patients treated with a 6-month thrice-weekly regimen under Revised National Tuberculosis Control Programme (RNTCP) who develop recurrent TB after successful treatment outcome. OBJECTIVE:To estimate TB recurrence among newly diagnosed PTB patients who have successfully completed treatment and to document endogenous reactivation or re-infection. Risk factors for unfavourable outcomes to treatment and TB recurrence were determined. METHODOLOGY:Adult (aged ? 18 yrs) new smear positive PTB patients initiated on treatment under RNTCP were enrolled from sites in Tamil Nadu, Karnataka, Delhi, Maharashtra, Madhya Pradesh and Kerala. Those declared "treatment success" at the end of treatment were followed up with 2 sputum examinations each at 3, 6 and 12 months after treatment completion. MIRU-VNTR genotyping was done to identify endogenous re-activation or exogenous re-infection at TB recurrence. TB recurrence was expressed as rate per 100 person-years (with 95% confidence interval [95%CI]). Regression models were used to identify the risk factors for unfavourable response to treatment and TB recurrence. RESULTS:Of the1577 new smear positive PTB patients enrolled, 1565 were analysed. The overall cure rate was 77% (1207/1565) and treatment success was 77% (1210 /1565). The cure rate varied from 65% to 86%. There were 158 of 1210 patients who had TB recurrence after treatment success. The pooled TB recurrence estimate was 10.9% [95%CI: 0.2-21.6] and TB recurrence rate per 100 person-years was 12.7 [95% CI: 0.4-25]. TB recurrence per 100 person-years varied from 5.4 to 30.5. Endogenous reactivation was observed in 56 (93%) of 60 patients for whom genotyping was done. Male gender was associated with TB recurrence. CONCLUSION:A substantial proportion of new smear positive PTB patients successfully treated with 6 -month thrice-weekly regimen have TB recurrence under program settings.
| S-EPMC6034867 | biostudies-literature
Project description:Isoniazid is the most commonly used drug for treatment of tuberculosis, and is administered individually or in combination with other drugs as standard first line therapy. Offsetting its efficacy, severe adverse effects, especially peripheral neuropathy and hepatotoxicity, are associated with isoniazid therapy, limiting its use in tuberculosis. Isoniazid is acetylated in vivo producing hydrazine and acetyl hydrazine, which are responsible for hepatotoxicity. Marked pharmacogenetic differences in acetylation have been reported among different population across the globe. This study evaluates isoniazid acetylation patterns in tuberculosis patients receiving DOT therapy under the Revised National Tuberculosis Control Program (RNTCP) in a specialized tuberculosis hospital in north India. Of 351 patients from whom samples were taken for biochemical analysis of adverse events, 36 were assessed for acetylation patterns. Blood samples were taken 1 h after administration of a 600 mg dose of isoniazid, and plasma concentrations of isoniazid were determined using a validated HPLC method. Of these 36 patients, 20 (55.56%) were slow acetylators and 16 (44.44%) were fast acetylators. Our results are consistent with those of an earlier study conducted in a different region of India. Most biochemical changes produced during long-term isoniazid therapy resolve after therapy is terminated.
| S-EPMC7292862 | biostudies-literature
Project description:BACKGROUND: India accounts for one-fifth of the global incident cases of tuberculosis(TB). The country presently has the world's largest directly observed treatment, short course (DOTS) programme, that has shown impressive results and covers almost 100% of the billion-plus Indian population. Despite such a successful programme, the majority of Indian patients with tuberculosis prefer private healthcare, although repeated audits of this sector have shown the quality to be poor. We aimed to ascertain the level of awareness and knowledge of private patients with tuberculosis attending our clinic at a tertiary private healthcare institute with regards to the DOTS programme, understanding the reasons behind their preference for private healthcare, and evaluating their perceptions and reasons for accepting or failing to accept directly observed therapy as a treatment option. METHODS: A structured interview schedule was administered to private patients with tuberculosis at the P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India between January 2006 to November 2007. RESULTS: Only 30 of 200 patients (15%) were aware of the DOTS programme. After being explained what directly observed therapy was, 136 patients (68%) found this form of treatment unacceptable.183 patients (91.5%) preferred buying the drugs themselves to visiting a DOTS centre. 90 patients (45%) were not prepared to be observed while swallowing their TB drugs, finding it an intrusion of privacy. CONCLUSIONS: Our study reveals a poor knowledge and awareness of the DOTS programme among the cohort of TB patients that we interviewed. The control of TB in India will undoubtedly benefit from more patients being attracted to and treated by the existing DOTS programmes. However, directly observed treatment, in its present form, is considered too rigid and intrusive and is unlikely to be accepted by a majority of patients seeking private healthcare. Novel strategies and more flexible options will have to be devised to ensure higher cure rates without compromising patient choice.
| S-EPMC2903519 | biostudies-other
Project description:India launched a national community-based active TB case finding (ACF) campaign in 2017 as part of the strategic plan of the National Tuberculosis Elimination Programme (NTEP). This review evaluated the outcomes for the components of the ACF campaign against the NTEP's minimum indicators and elicited the challenges faced in implementation. We supplemented data from completed pretested data proformas returned by ACF programme managers from nine states and two union territories (for 2017-2019) and five implementing partner agencies (2013-2020), with summary national data on the state-wise ACF outcomes for 2018-2020 published in annual reports by the NTEP. The data revealed variations in the strategies used to map and screen vulnerable populations and the diagnostic algorithms used across the states and union territories. National data were unavailable to assess whether the NTEP indicators for the minimum proportions identified with presumptive TB among those screened (5%), those with presumptive TB undergoing diagnostic tests (>95%), the minimum sputum smear positivity rate (2% to 3%), those with negative sputum smears tested with chest X-rays or CBNAAT (>95%) and those diagnosed through ACF initiated on anti-TB treatment (>95%) were fulfilled. Only 30% (10/33) of the states in 2018, 23% (7/31) in 2019 and 21% (7/34) in 2020 met the NTEP expectation that 5% of those tested through ACF would be diagnosed with TB (all forms). The number needed to screen to diagnose one person with TB (NNS) was not included among the NTEP's programme indicators. This rough indicator of the efficiency of ACF varied considerably across the states and union territories. The median NNS in 2018 was 2080 (interquartile range or IQR 517-4068). In 2019, the NNS was 2468 (IQR 1050-7924), and in 2020, the NNS was 906 (IQR 108-6550). The data consistently revealed that the states that tested a greater proportion of those screened during ACF and used chest X-rays or CBNAAT (or both) to diagnose TB had a higher diagnostic yield with a lower NNS. Many implementation challenges, related to health systems, healthcare provision and difficulties experienced by patients, were elicited. We suggest a series of strategic interventions addressing the implementation challenges and the six gaps identified in ACF outcomes and the expected indicators that could potentially improve the efficacy and effectiveness of community-based ACF in India.
| S-EPMC8705069 | biostudies-literature
Project description:Researchers and policy-makers have identified loss to follow-up as a major programmatic problem. Therefore, the objective of this study is to quantify TB related pre-treatment loss to follow up and treatment delay in private sector health care facilities in Pakistan.This was a retrospective, descriptive cohort study using routinely collected programmatic data from TB referral, diagnosis and treatment registers. Data from 48 private healthcare facilities were collected using an online questionnaire prepared in ODK Collect, for the period October 2015 to March 2016. Data were analysed using SPSS. We calculated the: (1) number and proportion of patients who were lost to follow-up during the diagnostic period, (2) number and proportion of patients with pre-treatment loss to follow-up, and (3) the number of days between diagnosis and initiation of treatment.One thousand five hundred ninety-six persons with presumptive TB were referred to the laboratory. Of these, 96% (n?=?1538) submitted an on-the-spot sputum sample. Of the 1538 people, 1462 (95%) people subsequently visited the laboratory to submit the early morning (i.e. the second) sample. Hence, loss to follow-up during the diagnostic process was 8% overall (n?=?134). Of the 1462 people who submitted both sputum samples, 243 (17%) were diagnosed with sputum smear-positive pulmonary TB and 231 were registered for anti-TB treatment, hence, loss in the pre-treatment phase was 4.9% (n?=?12). 152 persons with TB (66%) initiated TB treatment either on the day of TB diagnosis or the next day. A further 79 persons with TB (34%) commenced TB treatment within a mean time of 7 days (range 2 to 64 days).Concentrated efforts should be made by the National TB Control Programme to retain TB patients and innovative methods such as text reminders and behavior change communication may need to be used and tested.
| S-EPMC5845151 | biostudies-literature
Project description:BackgroundThe National Tuberculosis Elimination Programme (NTEP) of India is aiming to eliminate TB by 2025. The programme has increased its services and resources to strengthen the accurate and early detection of TB. It is important to estimate the cost of TB diagnosis in India considering the advancement and implementation of new diagnostic tools under the NTEP. The objective of this study was to estimate the unit costs of providing TB diagnostic services at different levels of public health facilities with different algorithms implemented under the NTEP in Chennai, Tamil Nadu, South India.MethodsThis costing study was conducted from the perspective of the health system. This study used only secondary data and information that were available in the public domain. Data were collected with the approval of health authorities. The patient's diagnostic path from the point of registration until the final diagnosis was considered in the costing exercise. The unit costs of different diagnostic tools used in the NTEP implemented by Chennai Corporation were calculated.ResultsWe estimated the unit cost of the eight laboratory tests (Ziehl-Neelsen [ZN], fluorescence microscopy [FM], x-ray, digital x-ray, gene Xpert MTB/RIF (cartridge-based nucleic acid amplification test [NAAT] that identifies rifampicin resistant Mycobacterium Tuberculosis) Mycobacterium Tuberculosis/Rifampicin [MTB/RIF], mycobacteria growth indicator tube [MGIT], line probe assay [LPA] and Lowenstein Jensen [LJ] culture) for diagnosis of drug-sensitive and drug-resistant TB. The unit costs included fixed and variable costs for smear examination by ZN microscopy (₹ [Indian Rupee] 326 [US${\$}$4.72], FM (₹104 [US${\$}$1.5]), x-ray (₹218 [US${\$}$3.15]), digital X-ray (₹281 [US${\$}$4.07]), gene Xpert MTB/RIF (₹1137 [US${\$}$16.47]), MGIT (₹7038 [US${\$}$102]), LPA (₹6448 [US${\$}$93.44]) and LJ culture (₹4850 [US${\$}$70.28]). Out of 10 diagnostic algorithms used for TB diagnosis, algorithms using only smear microscopy had the lowest cost, followed by smear microscopy with x-ray for drug-sensitive TB (₹104 [US${\$}$1.5] to ₹544 [US${\$}$7.88]). Diagnostic algorithms for drug-resistant TB involving LPA and gene Xpert MTB/RIF were the most expensive.ConclusionsUnderstanding the various costs contributing to TB diagnosis in India provides crucial evidence for policymakers, programme managers and researchers to optimise programme spending and efficiently use resources.
| S-EPMC8643484 | biostudies-literature
Project description:AimThis study aimed to evaluate the feasibility of implementing community pharmacy-based tuberculosis-directly observed treatment (TB-DOT) in Malaysia.BackgroundTuberculosis (TB) eradication is one of the top priorities in the public health agenda in Malaysia. While public-private mix (PPM) initiatives have been launched, community pharmacists remain undervalued assets in TB management.MethodsA two-phase mixed-methods study targeting community pharmacists was conducted in Malaysia between March and October 2021. The first phase was an online self-administered survey developed according to the Consolidated Framework for Implementation Research (CFIR). The second phase was a semi-structured interview to allow deeper understanding on the quantitative results. Quantitative data were analysed using descriptive analysis while qualitative data were analysed using thematic analysis with a semi-inductive approach. The data were triangulated to enhance comprehensiveness and credibility of the findings.FindingsThe survey was completed by 388 community pharmacists, and 23 pharmacists participated in the interview. Most community pharmacists indicated their willingness to serve as TB-DOT supervisors (70.1%). Qualitative results supported the findings. Community pharmacy-based TB-DOT service was perceived as an avenue to improve TB management and outcomes and to enhance the professional role of pharmacists in TB service at primary care settings. This was also perceived as a feasible intervention with the potential to strengthen the National TB Control programme. This initiative needs be reinforced with adequate support from the public healthcare sector for a strong partnership in ensuring success.
| S-EPMC10050952 | biostudies-literature
Project description:IntroductionTuberculosis is a public health problem in Nigeria. One of the most effective ways of controlling tuberculosis is the directly observed treatment short-course. However, some factors influence tuberculosis patients' treatment nonadherence via directly observed treatment short-course. The study objective was to assess medication nonadherence and associated factors among tuberculosis patients in north-west Nigeria.MethodsA cross-sectional study enrolled tuberculosis patients using directly observed treatment short-course in public health facilities in Kano and Kaduna States from January 2015 to June 2016. The sample selection was conducted via a multistage sampling procedure. Data were collected using tuberculosis patients' demographic and clinical characteristics forms, well-validated structured instruments, and medical records. SPSS version 20 was used for data analysis. Logistic and multivariable logistic regression analyses to determine factors of medication nonadherence (P < 0.05).ResultsComplete responses from 390 patients out of the 460 patients recruited for the study were used for data analyses. The mean age was 51.5 (standard deviation = ±13.8) years. The mean tuberculosis medication adherence questionnaire score was 4.35 ± 1.12. The prevalence of nonadherence to tuberculosis medication was 30.5%. Multivariable logistic regression analysis showed that having a monthly income between #100,000 and #199, 000 (adjusted odds ratio = 0.01; 95% confidence interval: 0.00-0.13), being widowed (adjusted odds ratio = 26.74, 95% confidence interval: 2.92-232.9), being married (adjusted odds ratio = 120.49, 95% confidence interval: 5.38-271.1), having a distance <5 km to directly observed treatment short-course center from home (adjusted odds ratio = 0.06, 95% confidence interval: 0.00-0.01), having a tuberculosis/HIV co-infection (adjusted odds ratio = 0.01, 95% confidence interval: 0.12-0.35), use of antiretroviral treatment and cotrimoxazole prophylaxis therapy medications (adjusted odds ratio = 24.9, 95% confidence interval: 19.6-304.3) were associated with tuberculosis medication nonadherence.ConclusionTuberculosis medication nonadherence was high among the patients. Thus, patient-specific adherence education, attenuation of potential factors for tuberculosis medication nonadherence, and continual resource support for tuberculosis patients are needed to improve treatment outcomes.
| S-EPMC7871291 | biostudies-literature
Project description:BACKGROUND:Globally, India has the world's highest burden of multidrug-resistant tuberculosis (MDR-TB). Programmatic Management of Drug Resistant TB (PMDT) in India began in 2007 and nationwide coverage was achieved in early 2013. Poor initial microbiological outcomes under the Revised National Tuberculosis Control Programme (RNTCP) prompted detailed analysis. This is the first study on factors significantly associated with poor outcomes in MDR-TB patients treated under the RNTCP. OBJECTIVE:To evaluate initial sputum culture conversion, culture reversion and final treatment outcomes among MDR-TB patients registered in India from 2007 to early 2011 who were treated with a standard 24-month regimen under daily-observed treatment. METHODS:This is a retrospective cohort study. Clinical and microbiological data were abstracted from PMDT records. Initial sputum culture conversion, culture reversion and treatment outcomes were defined by country adaptation of the standard WHO definitions (2008). Cox proportional hazards modeling with logistic regression, multinomial logistic regression and adjusted odds ratio was used to evaluate factors associated with interim and final outcomes respectively, controlling for demographic and clinical characteristics. RESULTS:In the cohort of 3712 MDR-TB patients, 2735 (73.6%) had initial sputum culture conversion at 100 median days (IQR 92-125), of which 506 (18.5%) had culture reversion at 279 median days (IQR 202-381). Treatment outcomes were available for 2264 (60.9%) patients while 1448 (39.0%) patients were still on treatment or yet to have a definite outcome at the time of analysis. Of 2264 patients, 781 (34.5%) had treatment success, 644 (28.4%) died, 670 (29.6%) were lost to follow up, 169 (7.5%) experienced treatment failure or were changed to XDR-TB treatment. Factors significantly associated with either culture non-conversion, culture reversion and/or unfavorable treatment outcomes were baseline BMI < 18; ? seven missed doses in intensive phase (IP) and continuation phase (CP); cavitary disease; prior treatment episodes characterized by re-treatment regimen taken twice, longer duration and more episodes of treatment; any weight loss during treatment; males and additional resistance to first line drugs (Ethambutol, Streptomycin). In a subgroup of 104 MDR-TB patients, 62 (59.6%) had Ofloxacin resistance among whom only 25.8% had treatment success, half of the success (54.8%) seen in Ofloxacin sensitive patients. Baseline susceptibility to Ofloxacin (HR 2.04) and Kanamycin (HR 4.55) significantly doubled and quadrupled the chances for culture conversion respectively while baseline susceptibility to Ofloxacin (AOR 0.37) also significantly reduced the odds of unfavorable treatment outcomes (p value ?0.05) in multinomial logistic regression model. CONCLUSION:India's initial MDR-TB patients' cohort treated under the RNTCP experienced poor treatment outcomes. To address the factors associated with poor treatment outcomes revealed in our study, a systematic multi-pronged approach would be needed. A series of policies and interventions have been developed to address these factors to improve DR-TB treatment outcomes and are being scaled-up in India.
| S-EPMC5894982 | biostudies-literature