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In March 2012, World Health Organization recommended that HIV testing should be offered to all patients with presumptive TB (previously called TB suspects). How this is best implemented and monitored in routine health care settings in India was not known. An operational research was conducted in Karnataka State (South India, population 64 million, accounts for 10% of India's HIV burden), to test processes and learn results and challenges of screening presumptive TB patients for HIV within routine health care settings. In this cross-sectional study conducted between January-March 2012, all presumptive TB patients attending public sector sputum microscopy centres state-wide were offered HIV testing by the laboratory technician, and referred to the nearest public sector HIV counselling and testing services, usually within the same facility. The HIV status of the patients was recorded in the routine TB laboratory form and TB laboratory register. The laboratory register was compiled to obtain the number of presumptive TB patients whose HIV status was ascertained, and the number found HIV positive. Aggregate data on reasons for non-testing were compiled at district level. Overall, 115,308 patients with presumptive TB were examined for sputum smear microscopy at 645 microscopy centres state-wide. Of these, HIV status was ascertained for 62,847(55%) among whom 7,559(12%) were HIV-positive, and of these, 3,034(40%) were newly diagnosed. Reasons for non-testing were reported for 37,700(72%) of the 52,461 patients without HIV testing; non-availability of testing services at site of sputum collection was cited by health staff in 54% of respondents. Only 4% of patients opted out of HIV testing. Offering HIV testing routinely to presumptive TB patients detected large numbers of previously-undetected instances of HIV infection. Several operational challenges were noted which provide useful lessons for improving uptake of HIV testing in this important group.

Background: In India, a new care package consisting of (i) daily regimen with fixed-dose combination drugs, collected once-a-month and self-administered by the patient, (ii) 'one stop service' at antiretroviral treatment (ART) centre for both HIV and tuberculosis (TB) treatment and (iii) technology-enabled adherence support (99DOTS, which required patients to give a missed phone call after consuming drugs) was piloted for treatment of TB among HIV-infected TB patients. Conventional care included intermittent regimen (drugs consumed thrice-weekly) delivered under direct observation of treatment supporter and the patients needing to visit TB and HIV care facilities, separately for treatment. Objective: To assess the effect of new care package on TB treatment outcomes among HIV-TB patients registered during January-December 2016, as compared to conventional care and explore the implementation challenges. Methods: A mixed-methods study was conducted in four districts of Karnataka, India where new care package was piloted in few ART centres while the rest provided conventional care. Quantitative component involved a secondary cohort analysis of routine programme data. Adjusted relative risk(aRR) was calculated using Poisson regression to measure association between new care package and unsuccessful treatment outcome. We conducted in-depth interviews with healthcare providers and patients to understand the challenges. Results: Unsuccessful TB treatment outcomes (death, loss to follow-up and failure) were higher in new care package (n = 871) compared to conventional care (n = 961) (30.5% vs 23.4%; P value<0.001) and aRR was 1.3(95% CI: 1.1-1.7). Key challenges included patients' inability to give missed call, increased work load for ART staff, reduced patient-provider interaction, deficiencies in training and lack of role clarity among providers and reduced involvement of TB program staff. Conclusion: With new care package, TB treatment outcomes did not improve as expected and conversely declined compared to conventional care. TB and HIV programs need to address the operational challenges to improve the outcomes.

Background Pre-diagnosis attrition needs to be addressed urgently if we are to make progress in improving MDR-TB case detection and achieve universal access to MDR-TB care. We report the pre-diagnosis attrition, along with factors associated, and turnaround times related to the diagnostic pathway among patient with presumptive MDR-TB in Bhopal district, central India (2014). Methods Study was conducted under the Revised National Tuberculosis Control Programme setting. It was a retrospective cohort study involving record review of all registered TB cases in Bhopal district that met the presumptive MDR-TB criteria (eligible for DST) in 2014. In quarter 1, Line Probe Assay (LPA) was used if sample was smear/culture positive. Quarter 2 onwards, LPA and Cartridge-based Nucleic Acid Amplification Test (CbNAAT) was used for smear positive and smear negative samples respectively. Pre-diagnosis attrition was defined as failure to undergo DST among patients with presumptive MDR-TB (as defined by the programme). Results Of 770 patients eligible for DST, 311 underwent DST and 20 patients were diagnosed as having MDR-TB. Pre-diagnosis attrition was 60% (459/770). Among those with pre-diagnosis attrition, 91% (417/459) were not identified as ‘presumptive MDR-TB’ by the programme. TAT [median (IQR)] to undergo DST after eligibility was 4 (0, 10) days. Attrition was more than 40% across all subgroups. Age more than 64 years; those from a medical college; those eligible in quarter 1; patients with presumptive criteria ‘previously treated – recurrent TB’, ‘treatment after loss-to-follow-up’ and ‘previously treated-others’; and patients with extra-pulmonary TB were independent risk factors for not undergoing DST. Conclusion High pre-diagnosis attrition was contributed by failure to identify and refer patients. Attrition reduced modestly with time and one factor that might have contributed to this was introduction of CbNAAT in quarter 2 of 2014. General health system strengthening which includes improvement in identification/referral and patient tracking with focus on those with higher risk for not undergoing DST is urgently required.

Background: The national tuberculosis (TB) programme in India recommends screening all pregnant women for TB, but this is rarely implemented. We carried out systematic TB screening among women attending the antenatal clinic of a tertiary care hospital in Puducherry, South India, during February to April 2018. Objective: To assess the number screened and number (proportion) with presumptive and active TB, and understand potential implementation from the healthcare providers' perspective. Methods: We conducted a mixed-methods study. The quantitative phase was a cross-sectional study including 4203 pregnant women. Data were captured using a structured proforma. Any of the following symptoms constituted 'presumptive TB': any cough, haemoptysis, fever, weight loss, night sweats, neck swellings, joint pains, neck stiffness and disorientation. Those screening positive were referred for investigations and evaluation by a chest physician. The qualitative phase involved seven one-to-one interviews with healthcare providers. Manual thematic analysis was performed to generate themes. Results: Among 4203 women (two HIV-positive) screened, 77 (1.8%) had presumptive TB. Cough was the predominant symptom (n = 75). Only 12 women could produce a sputum sample, of whom one (0.02%) was diagnosed with active TB by the Xpert MTB/RIF assay. Challenges cited by healthcare providers were lack of awareness among clients and providers, high case load, lack of dedicated staff, perception that TB screening is a low-yield, low-priority activity and losses in the referral process. Suggested solutions were providing dedicated staff and space for screening, educating women to self-report using posters and videos, and creating a one-stop care provision. Conclusions: The TB yield among pregnant women was very low, calling into question the value of systematic screening in a low-HIV setting. However, the findings may not be generalizable. Evidence is urgently needed from primary and secondary care facilities. The challenges and solutions identified may help in optimizing the screening process.

Background: The Structured Operational Research and Training Initiative (SORT IT) is a successful model of integrated operational research and capacity building with about 90% of participants completing the training and publishing in scientific journals. Objective: The study aims at assessing the influence of research papers from six SORT IT courses conducted between April 2014 and January 2015 on policy and/or practice. Methods: This was a cross-sectional mixed-method study involving e-mail based, self-administered questionnaires sent to course participants coupled with telephone/Skype/in-person responses from participants, senior facilitators and local co-authors of course papers. A descriptive content analysis was performed to generate themes. Results: Of 71 participants, 67 (94%) completed the course. A total of 67 papers (original research) were submitted for publication, of which 61 (91%) were published or were in press at the censor date (31 December 2016). Among the 67 eligible participants, 65 (97%) responded to the questionnaire. Of the latter, 43 (66%) research papers were self-reported to have contributed to a change in policy and/or practice by the course participants: 38 to a change in government policy or practice (26 at the national level, six at the subnational level and six at the local/hospital level); four to a change in organisational policy or practice; and one study fostered global policy development. Conclusion: Nearly two-thirds of SORT IT course papers contributed to a change in policy and/or practice as reported by the participants. Identifying the actual linkage of research to policy/practice change requires more robust methodology, in-depth assessment and independent validation of the reported change with all concerned stakeholders.

Background: In 2007, a field observation from India reported 11% misclassification among 'new' patients registered under the revised national tuberculosis (TB) control programme. Ten years down the line, it is important to know what proportion of newly registered patients has a past history of TB treatment for at least one month (henceforth called 'misclassification'). Methods: A study was conducted among new smear-positive pulmonary TB patients registered between March 2016 and February 2017 in 18 randomly selected districts to determine the effectiveness of an active case-finding strategy in marginalised and vulnerable populations. We included all patients detected through active case-finding. An equal number of randomly selected patients registered through passive case-finding from marginalised and vulnerable populations in the same districts were included. Before enrolment, we enquired about any history of previous TB treatment through interviews. Results: Of 629 patients, we interviewed 521, of whom, 11% (n=56) had past history of TB treatment (public or private) for at least a month: 13% (34/268) among the active case-finding group and 9% (22/253) among the passive case-finding group (p=0.18). No factors were found to be significantly associated with misclassification. Conclusion: Around one in every ten patients registered as 'new' had previous history of TB treatment. Corrective measures need to be implemented, followed by monitoring of any change in the proportion of 'previously treated' patients among all registered patients treated under the programme at national level.

Background There is an increasing trend of non-communicable diseases in Bhutan including Diabetes Mellitus (DM). To address this problem, a National Diabetes Control Programme was launched in 1996. There is anecdotal evidence that many patients do not visit the DM clinics regularly, but owing to lack of cohort monitoring, the magnitude of such attrition from care is unknown. Knowledge of the extent of this problem will provide a realistic assessment of the situation on the ground and would be helpful to initiate corrective actions. In this first country-wide audit, we thus aimed to determine among type 2 DM patients registered for care the i) pre-treatment attrition ii) one-year programme outcomes including retention in care, died and Lost–to-follow-up (LTFU, defined as not having visited the clinic at least once within a year of registration) iii) factors associated with attrition from care (death + LTFU) and iv) quality of follow-up care, measured by adherence to recommended patient-monitoring protocols including glycaemic control. Methods A retrospective cohort study involving a review of records routinely maintained under the National Diabetes Control Programme. All type 2 DM patients registered between 1st January and 31st December 2012 in 18 district hospitals of Bhutan were included. Glycaemic control was defined as glycosylated haemoglobin of <7 % or [Fasting Blood Sugar of <130 mg/dl and, Post-prandial Blood Sugar of <180 mg/dl]. Results Of 350 registered DM patients (52 % female, median age 55 years), 63(18 %) were LTFU before treatment initiation (pre-treatment attrition). Of the remaining 287 individuals who started treatment, 226(79 %) were retained in care while 61(21 %) either died or were LTFU. Glycaemic control was achieved in 85(38 %) patients retained in care. Between 7 and 98 % of monitoring parameters had missing data. Conclusion Nearly one-third of DM patients were LTFU and there were short comings in monitoring. Qualitative research is urgently needed to find out the reasons for high attrition. Given the high political commitment by the Royal Government of Bhutan, the findings provide ample grounds for instituting corrective measures and propelling DM care further. It is time to do better!

Management of multidrug-resistant TB (MDR-TB) patients co-infected with human immunodeficiency virus (HIV) is highly challenging. Such patients are subject to long and potentially toxic treatments and may develop a number of different psychiatric illnesses such as anxiety and depressive disorders. A mental health assessment before MDR-TB treatment initiation may assist in early diagnosis and better management of psychiatric illnesses in patients already having two stigmatising and debilitating diseases. To address limited evidence on the baseline psychiatric conditions of HIV-infected MDR-TB patients, we aimed to document the levels of depressive symptoms at baseline, and any alteration following individualized clinical and psychological support during MDR-TB therapy, using the Patient Health Questionnaire-9 (PHQ-9) tool, among HIV-infected patients. This was a retrospective review of the medical records of an adult (aged >15 years) HIV/MDR-TB cohort registered for care during the period of August 2012 through to March 2014. A total of 45 HIV/MDR-TB patients underwent baseline assessment using the PHQ-9 tool, and seven (16%) were found to have depressive symptoms. Of these, four patients had moderate to severe depressive symptoms. Individualized psychological and clinical support was administered to these patients. Reassessments were carried out for all patients after 3 months of follow-up, except one, who died during the period. Among these 44 patients, three with baseline depressive symptoms still had depressive symptoms. However, improvements were observed in all but one after 3 months of follow-up. Psychiatric illnesses, including depressive symptoms, during MDR-TB treatment demand attention. Routine administration of baseline mental health assessments by trained staff has the potential to assist in determining appropriate measures for the management of depressive symptoms during MDR-TB treatment, and help in improving overall treatment outcomes. We recommend regular monitoring of mental health status by trained counsellors or clinical staff, using simple, validated and cost-effective tools.

While HIV care among tuberculosis (TB) patients is successfully implemented and monitored, it is not routinely reported among \"presumptive TB patients without TB\". The present study describes the ascertainment of HIV status and receipt of antiretroviral therapy (ART) and the associated factors among presumptive TB patients (with and without TB) in 35 public health facilities of Masvingo district of Zimbabwe from January to June 2017. This was an analysis of secondary programme data. We performed log binomial regression to calculate adjusted relative risks (aRR) and 95% confidence intervals (CI). Of 1369 presumptive TB patients, 1181 (86%) were ascertained for HIV status (98% among those subsequently diagnosed with TB, 83% among non-TB). Of them, 748 (63%) were HIV positive, more among TB patients (69%) than those without TB (61%). Among HIV-positive patients, 475 (64%) received ART, significantly higher among TB patients (78%) compared to those without TB (57%). Patients without TB were significantly more likely to have non-ascertained for HIV status (aRR=2.4, 95% CI=1.4-5.0) and not receiving ART (aRR=1.8, 95% CI=1.6-2.0), compared to those with TB. We found high rates of HIV status ascertainment among presumptive TB patients. But, ART uptake was poor among \"presumptive TB patients without TB\", despite implementation of \"test and treat\" strategy in Zimbabwe. The programme should step up the monitoring of HIV status and ART receipt among presumptive TB patients, by introducing an indicator in the quarterly reports of the national TB programme.

Case finding and the diagnosis of tuberculosis (TB) are key activities to reach the World Health Organization’s End TB targets by 2030. This paper focuses on the diagnosis of pulmonary TB (PTB) in low- and middle-income countries. Sputum smear microscopy, despite its many limitations, remains the primary diagnostic tool in peripheral health facilities; however, this is being replaced by molecular diagnostic techniques, particularly Xpert MTB/RIF, which allows a bacteriologically confirmed diagnosis of TB along with information about whether or not the organism is resistant to rifampicin within two hours. Other useful diagnostic tools at peripheral facilities include chest radiography, urine lipoarabinomannan (TB-LAM) in HIV-infected patients with advanced immunodeficiency, and the loop-mediated isothermal amplification (TB-LAMP) test which may be superior to smear microscopy. National Reference Laboratories work at a higher level, largely performing culture and phenotypic drug susceptibility testing which is complemented by genotypic methods such as line probe assays for detecting resistance to isoniazid, rifampicin, and second-line drugs. Tuberculin skin testing, interferon gamma release assays, and commercial serological tests are not recommended for the diagnosis of active TB. Linking diagnosis to treatment and care is often poor, and this aspect of TB management needs far more attention than it currently receives.