Dataset Information

Recurrence of tuberculosis among newly diagnosed sputum positive pulmonary tuberculosis patients treated under the Revised National Tuberculosis Control Programme, India: A multi-centric prospective study.

ABSTRACT: 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.

SUBMITTER: Velayutham B

PROVIDER: S-EPMC6034867 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Recurrence of tuberculosis among newly diagnosed sputum positive pulmonary tuberculosis patients treated under the Revised National Tuberculosis Control Programme, India: A multi-centric prospective study.

Velayutham Banurekha B Chadha Vineet Kumar VK Singla Neeta N Narang Pratibha P Gangadhar Rao Vikas V Nair Sanjeev S Ramalingam Srinivasan S Narayanan Sivaramakrishnan Gomathi G Joseph Bency B Selvaraju Sriram S Shanmugam Shivakumar S Narang Rahul R Pachikkaran Praseeja P Bhat Jyothi J Ponnuraja Chinnaiyan C Bajaj Bhalla Bhoomika B Shivashankara Bhadravathi Amarnath BA Sebastian George G Yadav Rajiv R Kumar Sharma Ravendra R Sarin Rohit R Myneedu Vithal Prasad VP Singla Rupak R Khayyam Khalidumer K Mrithunjayan Sunil Kumar SK Jayasankar Subramonia Pillai SP Sanker Praveen P Viswanathan Krishnaveni K Viswambharan Rajeevan R Mathuria Kapil K Bhalla Manpreet M Singh Nitu N Tumane Kondeshvar Balaji KB Dawale Ajay A Tiwari Chandra Prakash CP Bansod Radhelal R Jayabal Lavanya L Murali Lakshmi L Khaparde Sunil D SD Rao Raghuram R Jawahar Mohideen S MS Natrajan Mohan M

PloS one 20180706 7

<h4>Introduction</h4>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.<h4>Objective</h4>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 unfavourab ...[more]

PMID: 29979738

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Project description:BackgroundTuberculosis is a major public health problem especially in developing countries, the comparative efficacy and safety of fluroquinolones (FQs) for adult patients with newly diagnosed, sputum-positive tuberculosis remains controversial. We aimed to investigate the benefits and risks of FQs-containing (addition/substitution) regimens in this population.MethodsA network meta-analysis was performed to compare FQs (C: ciprofloxacin; O: ofloxacin; Lo: levofloxacin; M: moxifloxacin; G: gatifloxacin) addition/substitution regimen with standard HRZE regimen (ie isoniazid, rifampicin, pyrazinamide and ethambutol) in newly diagnosed, sputum-positive tuberculosis. Medline, Embase and Cochrane Central Register of Controlled Trials were systematically searched, randomized trials with duration longer than 8 weeks were included. The primary outcome was week-8 sputum negativity, and secondary outcomes included treatment failure, serious adverse events and death from all cause.ResultsTwelve studies comprising 6465 participants were included in the network meta-analysis. Löwenstein-Jensen culture method showed that HRZEM (OR 4.96, 95% CI 2.83-8.67), MRZE (OR 1.48, 95% CI 1.19-1.84) and HRZM (OR 1.32, 95% CI 1.08-1.62) had more sputum conversion than HRZE by the eighth week, whereas HRC (OR 0.39, 95% CI 0.19-0.77) and HRZO (OR 0.47, 95% CI 0.24-0.92) were worse than HRZE. Moxifloxacin-containing regimens showed more conversion than HRZE by liquid method at the end of two months. But by the end of treatment, FQs-containing regimens didn't show superiority than HRZE on treatment failure. There were no significant differences between any regimens on other outcomes like serious adverse events and all-cause death.ConclusionThis comprehensive network meta-analysis showed that compared with HRZE, moxifloxacin-containing regimens could significantly increase sputum conversion by the eighth week for patients with newly diagnosed pulmonary tuberculosis while HRC and HRZO regimens were inferior. But all the FQs-containing regimens did not show superiority in other outcomes (such as treatment failure, serious adverse events and all-cause death). Thus, HRZE is still an effective regimen for this population. Although moxifloxacin-containing regimens have deomonstrated their potential, FQs-containing regimens should be used with great caution to avoid widespread FQs-resistance worldwide.

Project description:BACKGROUND:Emerging mutations in the ESR1 gene that encodes for the estrogen receptor (ER) are associated with resistance to endocrine therapy. ESR1 mutations rarely exist in primary tumors (~?1%) but are relatively common (10-50%) in metastatic, endocrine therapy-resistant cancers and are associated with a shorter progression-free survival. Little is known about the incidence and clinical implication of these mutations in early recurrence events, such as local recurrences or newly diagnosed metastatic disease. METHODS:We collected 130 archival tumor samples from 103 breast cancer patients treated with endocrine therapy prior to their local/metastatic recurrence. The cohort consisted of 41 patients having at least 1 sample from local/loco-regional recurrence and 62 patients with metastatic disease (of whom 41 newly diagnosed and 28 with advanced disease). The 5 most common ESR1 hotspot mutations (D538G, L536R, Y537S/N/C) were analyzed either by targeted sequencing or by droplet digital PCR. Progression-free survival (PFS), disease-free survival (DFS), and distant recurrence-free survival (DRFS) were statistically tested by Kaplan-Meier analysis. RESULTS:The prevalence of ESR1 mutations was 5/41 (12%) in newly diagnosed metastatic patients and 5/28 (18%) for advanced metastases, detected at allele frequency >?1%. All mutations in advanced metastases were detected in patients previously treated with both tamoxifen (TAM) and aromatase inhibitors (AI). However, in newly diagnosed metastatic patients, 4/5 mutations occurred in patients treated with TAM alone. PFS on AI treatment in metastatic patients was significantly shorter for ESR1 mutation carriers (p?=?0.017). In the local recurrence cohort, ESR1 mutations were identified in 15/41 (36%) patients but only 4/41 (10%) were detected at allele frequency >?1%. Again, most mutations (3/4) were detected under TAM monotherapy. Notably, 1 patient developed ESR1 mutation while on neoadjuvant endocrine therapy. DFS and DRFS were significantly shorter (p?=?0.04 and p?=?0.017, respectively) in patients that had ESR1 mutations (>?1%) in their loco-regional recurrence tumor. CONCLUSIONS:Clinically relevant ESR1 mutations are prevalent in newly diagnosed metastatic and local recurrence of endocrine-treated breast cancer. Since local recurrences are amenable to curative therapy, these mutations may inform the selection of subsequent endocrine therapies.

Project description:Objectives:This study aimed to assess the coverage and explore enablers and challenges in implementation of direct benefit transfer (DBT) cash incentive scheme for patients with tuberculosis (TB).Design:This is a mixed methods study comprising a quantitative cohort and descriptive qualitative study.Setting:The study was conducted in City TB Centre, Vadodara, Western India.Participants:We used routinely collected data under the National TB Programme (NTP) on patients with TB notified between April and September 2018 and initiated on first-line anti-tuberculosis treatment (ATT) to assess the coverage of DBT. We interviewed NTP staff and patients to understand their perceptions.Primary and secondary outcome measures:The study outcomes are receipt of DBT (primary), time to receipt of first instalment of DBT and treatment outcome.Results:Among 1826 patients, 771 (42.2%) had received at least one instalment. Significantly more patients from the public sector had received DBT (at least one instalment) compared with those from private sector (adjusted relative risk (adjRR)=16.3; 95% CI 11.6 to 23.0). Among public sector patients, 7.3% (49/671) had received first instalment within 2 months of treatment initiation. Median (IQR) time to receipt of first instalment was 5.2 (3.4, 7.4) months. Treatment in private sector, residing outside city limits and being HIV non-reactive were significantly (p<0.001) associated with longer time to receipt. Timely and sufficient fund release, adequate manpower and adequate logistics in TB centre were the enablers. Inability of patients to open bank accounts due to lack of identity/residence proof, their reluctance to share personal information and inadequate support from private providers were the challenges identified in implementation.Conclusion:During the early phase of DBT implementation, the coverage was low and there were delays in benefit transfer. Facilitating opening of bank accounts for patients by NTP staff and better support from private providers may improve DBT coverage. Repeat assessment of DBT coverage after streamlining of implementation is recommended.

Project description:ObjectivesTo assess the long term clinical and cost effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) intervention compared with usual care in people with newly diagnosed type 2 diabetes.DesignWe undertook a cost-utility analysis that used data from a 12 month, multicentre, cluster randomised controlled trial and, using the Sheffield type 2 diabetes model, modelled long term outcomes in terms of use of therapies, incidence of complications, mortality, and associated effect on costs and health related quality of life. A further cost-utility analysis was also conducted using current "real world" costs of delivering the intervention estimated for a hypothetical primary care trust.SettingPrimary care trusts in the United Kingdom.ParticipantsPatients with newly diagnosed type 2 diabetes.InterventionA six hour structured group education programme delivered in the community by two professional healthcare educators.Main outcome measuresIncremental costs and quality adjusted life years (QALYs) gained.ResultsOn the basis of the data in the trial, the estimated mean incremental lifetime cost per person receiving the DESMOND intervention is pound209 (95% confidence interval - pound704 to pound1137; euro251, -euro844 to euro1363; $326, -$1098 to $1773), the incremental gain in QALYs per person is 0.0392 (-0.0813 to 0.1786), and the mean incremental cost per QALY is pound5387. Using "real world" intervention costs, the lifetime incremental cost of the DESMOND intervention is pound82 (- pound831 to pound1010) and the mean incremental cost per QALY gained is pound2092. A probabilistic sensitivity analysis indicated that the likelihood that the DESMOND programme is cost effective at a threshold of pound20 000 per QALY is 66% using trial based intervention costs and 70% using "real world" costs. Results from a one way sensitivity analysis suggest that the DESMOND intervention is cost effective even under more modest assumptions that include the effects of the intervention being lost after one year.ConclusionOur results suggest that the DESMOND intervention is likely to be cost effective compared with usual care, especially with respect to the real world cost of the intervention to primary care trusts, with reductions in weight and smoking being the main benefits delivered.

Dataset Information

Recurrence of tuberculosis among newly diagnosed sputum positive pulmonary tuberculosis patients treated under the Revised National Tuberculosis Control Programme, India: A multi-centric prospective study.

Publications

Recurrence of tuberculosis among newly diagnosed sputum positive pulmonary tuberculosis patients treated under the Revised National Tuberculosis Control Programme, India: A multi-centric prospective study.

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