Ending tuberculosis in a post-COVID-19 world: a person-centred, equity-oriented approach.

The COVID-19 pandemic has disrupted systems of care for infectious diseases-including tuberculosis-and has exposed pervasive inequities that have long marred efforts to combat these diseases. The resulting health disparities often intersect at the individual and community levels in ways that heighten vulnerability to tuberculosis. Effective responses to tuberculosis (and other infectious diseases) must respond to these realities. Unfortunately, current tuberculosis programmes are generally not designed from the perspectives of affected individuals and fail to address structural determinants of health disparities. We describe a person-centred, equity-oriented response that would identify and focus on communities affected by disparities, tailor interventions to the mechanisms by which disparities worsen tuberculosis, and address upstream determinants of those disparities. We detail four key elements of the approach (data collection, programme design, implementation, and sustainability). We then illustrate how organisations at multiple levels might partner and adapt current practices to incorporate these elements. Such an approach could generate more substantial, sustainable, and equitable reductions in tuberculosis burden at the community level, highlighting the urgency of restructuring post-COVID-19 health systems in a more person-centred, equity-oriented way.

Measuring tuberculosis patient perceived quality of care in public and public-private mix settings in India: an instrument development and validation study.

BACKGROUND: At present, there are no validated quantitative scales available to measure patient-centred quality of care in health facilities providing services for tuberculosis (TB) patients in India and low-income and middle-income countries. METHODS: Initial themes and items reflective of TB patient's perceived quality of care were developed using qualitative interviews. Content adequacy of the items were ascertained through Content validity Index (CVI) and content validity ratio (CVR). Pilot testing of the questionnaire for assessing validity and reliability was undertaken among 714 patients with TB. Sampling adequacy and sphericity were tested by Kaiser-Meyer-Olkin and Bartlett's test, respectively. Exploratory and confirmatory factor analysis was undertaken to test validity. Cronbach's α and test-retest scores were used to test reliability. RESULTS: A 32-item tool measuring patient-perceived quality of TB distributed across five domains was developed initially based on a CVI and CVR cut-off score of 0.78 and cognitive interviews with patients with TB. Bartlett's test results showed a strong significance f (χ2=3756 and p<0.001) and Kaiser-Meyer-Olkin was measured to be 0.698 highlighting data adequacy and correlation between the variables. Exploratory factor analysis with varimax rotation extracted 4 factors related to 14 items with Eigen values >1 which accounted for 60.9% of the total variance of items. Correlation (z-value >1.96) between items and factors was highly significant and Cronbach's α was acceptable for the global scale (0.76) for the four factors. Intraclass correlation coefficient and the test retest scores for four factors were (<0.001) significant. CONCLUSION: We validated a measurement tool for patient-perceived quality of care for TB (PPQCTB) which measured the patient's satisfaction with healthcare provider and services. PPQCTB tool could enrich quality of care evaluation frameworks for TB health services in India.

How to work with intangible software in public health systems: some experiences from India.

This commentary focuses on "intangible software", defined as the range of ideas, norms, values and issues of power or trust that affect the performance of health systems. While the need to work with intangible software within health systems is increasingly being recognized, the practical hows of doing so have been given less attention. In this commentary, we, a team of researchers and implementers from India, have tried to deliberate on these hows through a practice lens. We engage with four questions of current relevance to intangible software in the field of health policy and systems research (HPSR): (1) Is it possible to rewire intangible software in health systems? (2) What approaches have been attempted in the Indian public health system to rewire intangibles? (3) Have such approaches been evaluated? (4) What practical lessons can we offer from our experience on rewiring intangibles? From our perspective, approaches to rewiring intangible software recognize that people in health systems are capable of visioning, thinking, adapting to and leading change. These approaches attempt to challenge the often-unchallenged power hierarchies in health systems by allowing people to engage deeply with widely accepted norms and routinized actions. In this commentary, we have reported on such approaches from India under six categories: approaches intended to enable visioning and leading; approaches targeted at engaging with evidence better; approaches intended to help health workers navigate contextual complexities; approaches intended to build the cultural competence; approaches that recognize and reward performance; and approaches targeted at enabling collaborative work and breaking power hierarchies. Our collective experiences suggest that intangible software interventions work best when they are codesigned with various stakeholders, are contextually adapted in an iterative manner and are implemented in conjunction with structural improvements. Also, such interventions require long-term investments. Based on our experiences, we highlight the need for the following: (1) fostering more dialogue on this category of interventions among all stakeholders for cross-learning; (2) evaluating and publishing evidence on such interventions in nonconventional ways, with a focus on participatory learning; and (3) building ecosystems that allow experiential learnings on such interventions to be shared.

The clinical utility and safety of short-course immune checkpoint inhibitors in multiple tumours-A real-world multicentric study from India.

The real-world data on short course of immune checkpoint inhibitor (ICI) use are sparse and merit exploration. A multicentric observational study on the safety and efficacy of ICI in oncology patients between August 2014 and October 2020 involves 1011 patients across 13 centers in India. The median age was 59 (min 16-max 98) years with male preponderance (77.9%). The predominant cohort received short-course ICI therapy; the median number of cycles was 5 (95% confidence interval [CI] 1-27), and the median duration of therapy was 3 (95% CI 0.5-13) months. ICIs were used commonly in the second and third line setting in our study (66.4%, n = 671). Objective response rate (complete or partial response) was documented in 254 (25.1%) of the patients, 202 (20.0%) had stable disease, and 374 (37.0%) had progressive disease. The clinical benefit rate was present in 456 (45.1%). Among the patients whom ICI was stopped (n = 906), the most common reason for cessation of ICI was disease progression (616, 68.0%) followed by logistic reasons like financial constraints (234, 25.82%). With a median follow-up of 14.1 (95% CI 12.9-15.3) months, there were 616 events of progression and 443 events of death, and the median progression free survival and overall survival were 6.4 (95% CI 5.5-7.3) and 13.6 (95% CI 11.6-15.7) months, respectively, in the overall cohort. Among the immune-related adverse events, autoimmune pneumonitis (29, 3.8%) and thyroiditis (24, 2.4%) were common. Real-world multicentric Indian data predominantly with short-course ICI therapy have comparable efficacy/safety to international literature with standard ICI therapy.

One year of COVID-19 and its impact on private provider engagement for TB: A rapid assessment of intermediary NGOs in seven high TB burden countries.

The COVID-19 pandemic has impacted health systems and health programs across the world. For tuberculosis (TB), it is predicted to set back progress by at least twelve years. Public private mix (PPM)has made a vital contribution to reach End TB targets with a ten-fold rise in TB notifications from private providers between 2012 and 2019. This is due in large part to the efforts of intermediary agencies, which aggregate demand from private providers. The COVID-19 pandemic has put these gains at risk over the past year. In this rapid assessment, representatives of 15 intermediary agencies from seven countries that are considered the highest priority for PPM in TB care (the Big Seven) share their views on the impact of COVID-19 on their programs, the private providers operating under their PPM schemes, and their private TB clients. All intermediaries reported a drop in TB testing and notifications, and the closure of some private practices. While travel restrictions and the fear of contracting COVID-19 were the main contributing factors, there were also unanticipated expenses for private providers, which were transferred to patients via increased prices. Intermediaries also had their routine activities disrupted and had to shift tasks and budgets to meet the new needs. However, the intermediaries and their partners rapidly adapted, including an increased use of digital tools, patient-centric services, and ancillary support for private providers. Despite many setbacks, the COVID-19 pandemic has underlined the importance of effective private sector engagement. The robust approach to fight COVID-19 has shown the possibilities for ending TB with a similar approach, augmented by the digital revolution around treatment and diagnostics and the push to decentralize health services.

The impact of chest radiography and Xpert MTB/RIF testing among household contacts in Chennai, India.

Tuberculosis prevalence surveys have demonstrated the benefit of screening with chest x-ray (CXR) and sensitive diagnostic tests compared to symptoms and smear microscopy. However, in programmatic practice there is little evidence on the yield of different algorithms. We implemented contact tracing in Chennai, India for adult sputum-positive TB patients registered from January 2015 to March 2016. Patients with symptoms or abnormal X-ray findings further underwent testing using Xpert MTB/RIF (Xpert) and smear microscopy. A retrospective cohort study was done to summarize the key findings. We verbally screened 5553 contacts for symptoms, CXR through private sector collaboration, Xpert, and smear microscopy. Overall, 1312 (23.6%) contacts screened positive. CXR alone identified 531 (40.5%) of them, 679 (51.8%) were symptom-positive only, while 102 (7.8%) were positive on both the symptom and CXR screen. Overall, 35 bacteriologically positive cases were identified (0.7%). A standard approach of symptoms screening followed by microscopy identified only 9 (25.7%) of the total number of bacteriologically positive cases, whereas the combination of a CRX screening followed by microscopy identified 13 (37.1%) of the cases. The algorithm of symptoms screening followed by Xpert testing, detected 20 cases, whereas the combination of symptoms and CXR followed by Xpert increased this number to 35 (75% increase compared to symptoms and Xpert). Optimal use of more sensitive screening tests, better diagnostic tests, and novel private sector engagement can improve diagnostic yield in a programmatic setting.

Successfully Engaging Private Providers to Improve Diagnosis, Notification, and Treatment of TB and Drug-Resistant TB: The EQUIP Public-Private Model in Chennai, India.

BACKGROUND: Private physicians in India see and treat more than half of all people with tuberculosis (TB) each year and thus have potential to make significant contributions to TB control. The EQUIP project was designed as a prospective cohort study to assess the potential of private providers to diagnose and appropriately treat drug-resistant TB (DR-TB) in the Central and South districts of Chennai, India. METHODS: The private-sector engagement model consisted of free access to rapid diagnostics; choice of free daily or thrice-weekly treatment regimens; support for notification of patients; and patient support including directly observed therapy through EQUIP centers staffed by a community-based interface agency. Data were collected on provider participation; referral results; treatment regimens prescribed; and treatment outcomes. RESULTS: From October 2015 through June 2017, 227 of the 466 (48.7%) private providers approached referred at least 1 patient to an EQUIP center for evaluation. A total of 2,621 patients received testing and 1,232 (47.0%) were diagnosed with TB. Of those, 727 (59.0%) were bacteriologically confirmed, including 694 (56.3%) using GeneXpert and 33 (2.7%) using smear microscopy. A total of 26 (3.7% of GeneXpert diagnosed) patients were confirmed as rifampicin-resistant cases. EQUIP-related notifications comprised approximately 10% of TB and DR-TB notifications in Chennai during the project period. The project initiated 1,167 (96.8%) drug-sensitive TB patients on treatment. Of those, 691 (59.2%) received standard daily regimens with EQUIP support and 288 (24.7%) received standard intermittent regimens. At the time of writing, 89.4% of 868 drug-susceptible TB patients receiving EQUIP support had treatment success. Of the 26 rifampicin-resistant TB cases notified, 20 (77%) started and continued on second-line treatment; 2 died and 4 were lost to follow-up prior to treatment initiation. CONCLUSION: Private providers can make a substantial contribution to detection and appropriate treatment of patients with TB and DR-TB in India when provided with access to rapid diagnostics, support for notification and patient treatment through interface agencies, and free, quality anti-TB drugs.

Glycemic control monitoring in patients with tuberculosis and diabetes: a descriptive study from programmatic setting in Tamil Nadu, India.

Background: India's national tuberculosis (TB) programme recommends that among patients with diabetes mellitus and TB, fasting blood glucose (FBG) be recorded at baseline, the end of intensive phase and the end of continuation phase of TB treatment. We conducted this operational research in select districts of Tamil Nadu, India, in 2016 to determine the availability of blood glucose records and glycemic control status during TB treatment. Methods: This was a descriptive study involving secondary programme data. Glycemic control during TB treatment was 'optimal' if both baseline and end of intensive phase FBG (during TB treatment) were <130 mg/dl. In the absence of FBG, we used random blood glucose (RBG), with <180 mg/dl as the cut off. Results: Of 438 patients, FBG at baseline, the end of intensive phase and the end of continuation phase were each available in <20%. Glycemic control status was known for 94% (412/438) patients at baseline and for 91% (400/438) during TB treatment. Among those with known glycemic status, glycemic control was not optimal in 77% of patients (316/412) at baseline and in 84% (337/400) during TB treatment. The proportion of patients with unfavourable TB treatment outcomes at the end of intensive phase was 11% (46/438) and at the end of continuation phase was 5% (21/438). We decided against assessing factors associated with glycemic control during TB treatment and association between glycemic control and TB treatment outcomes because glycemic control assessment, if any, was based mostly on RBG values. Conclusion: Among patients with diabetes and tuberculosis, recording of FBG during tuberculosis treatment requires urgent attention.

Use of Rapid, Point-of-Care Assays by Private Practitioners in Chennai, India: Priorities for Tuberculosis Diagnostic Testing.

SETTING: Private practitioners are frequently the first point of healthcare contact for patients with tuberculosis (TB) in India. As new molecular tests are developed for point-of-care (POC) diagnosis of TB, it is imperative to understand these individuals' practices and preferences for POC testing. OBJECTIVE: To evaluate rapid testing practices and identify priorities for novel POC TB tests among private practitioners in Chennai. DESIGN: We conducted a cross-sectional survey of 228 practitioners practicing in the private sector from January 2014 to February 2015 who saw at least one TB patient in the previous year. Practitioners were randomly selected from both the general community and a list of practitioners who referred patients to a public-private mix program for TB treatment. We used standardized questionnaires to collect data on current practices related to point-of-care diagnosis and interest in hypothetical POC tests. We used multivariable Poisson regression with robust estimates of standard error to calculate measures of association. RESULTS: Among 228 private practitioners, about half (48%) utilized any rapid testing in their current practice, most commonly for glucose (43%), pregnancy (21%), and malaria (5%). Providers using POC tests were more likely to work in hospitals (56% vs. 43%, P = 0.05) and less likely to be chest specialists (21% vs. 54%, P<0.001). Only half (51%) of providers would use a hypothetical POC test for TB that was accurate, equipment-free, and took 20 minutes to complete. Chest specialists were half as likely to express interest in performing the hypothetical POC TB test in-house as other practitioners (aPR 0.5, 95%CI: 0.2-0.9). Key challenges to performing POC testing for TB in this study included time constraints, easy access to local private labs and lack of an attached lab facility. CONCLUSION: As novel POC tests for TB are developed and scaled up, attention must be paid to integrating these diagnostics into healthcare providers' routine practice and addressing barriers for POC testing.

How Do Urban Indian Private Practitioners Diagnose and Treat Tuberculosis? A Cross-Sectional Study in Chennai.

SETTING: Private practitioners are frequently the first point of healthcare contact for patients with tuberculosis (TB) in India. Inappropriate TB management practices among private practitioners may contribute to delayed TB diagnosis and generate drug resistance. However, these practices are not well understood. We evaluated diagnostic and treatment practices for active TB and benchmarked practices against International Standards for TB Care (ISTC) among private medical practitioners in Chennai. DESIGN: A cross-sectional survey of 228 practitioners practicing in the private sector from January 2014 to February 2015 in Chennai city who saw at least one TB patient in the previous year. Practitioners were randomly selected from both the general community and a list of practitioners who referred patients to a public-private mix program for TB treatment in Chennai. Practitioners were interviewed using standardized questionnaires. RESULTS: Among 228 private practitioners, a median of 12 (IQR 4-28) patients with TB were seen per year. Of 10 ISTC standards evaluated, the median of standards adhered to was 4.0 (IQR 3.0-6.0). Chest physicians reported greater median ISTC adherence than other MD and MS practitioners (score 7.0 vs. 4.0, P<0.001), or MBBS practitioners (score 7.0 vs. 4.0, P<0.001). Only 52% of all practitioners sent >5% of patients with cough for TB testing, 83% used smear microscopy for diagnosis, 33% monitored treatment response, and 22% notified TB cases to authorities. Of 228 practitioners, 68 reported referring all patients with new pulmonary TB for treatment, while 160 listed 27 different regimens; 78% (125/160) prescribed a regimen classified as consistent with ISTC. Appropriate treatment practices differed significantly between chest physicians and other MD and MS practitioners (54% vs. 87%, P<0.001). CONCLUSION: TB management practices in India's urban private sector are heterogeneous and often suboptimal. Private providers must be better engaged to improve diagnostic capacity and decrease TB transmission in the community.

TB Treatment Delays in Odisha, India: Is It Expected Even after These Many Years of RNTCP Implementation?

BACKGROUND: In India, the Revised National TB Control Programme (RNTCP) envisages initiation of TB treatment within seven days of diagnosis among smear-positive patients. After nearly two decades of RNTCP implementation, treatment delays are usually not expected. OBJECTIVES: To determine the proportion of sputum smear-positive TB patients who were initiated on treatment after seven days and their associated risk factors. METHODS: The study was conducted in Cuttack and Rayagada districts of Odisha. It was a retrospective cohort study that involves review of TB treatment registers and laboratory registers for 2013. RESULTS: Among 1,800 pulmonary TB (PTB) patients, 1,074 (60%) had been initiated on treatment within seven days of diagnosis, 721 (40%) had been initiated on treatment more than seven days, and 354 (20%) had delays of more than 15 days. The mean duration between TB diagnosis and treatment initiation was 21 days with a range of 8-207 days (median = 14 days). Odds of treatment delay of more than seven days were 4.9 times (95% confidence interval [CI] 3.3-6.6) among those who had been previously treated, 6.2 times (95% CI 1.3-29.7) among those infected with HIV, and 1.8 times (95% CI 1.1-2.9) among those diagnosed outside district DMC. CONCLUSION: Delay in initiation of TB treatment occurred in majority of the smear-positive patients. The RNTCP should focus on core areas of providing quality TB services with time-tested strategies. To have real-time monitoring mechanisms for diagnosed smear-positive TB patients is expected to be the way forward.

The profile and treatment outcomes of the older (aged 60 years and above) tuberculosis patients in Tamilnadu, South India.

BACKGROUND: With changing demographic patterns in the context of a high tuberculosis (TB) burden country, like India, there is very little information on the clinical and demographic factors associated with poor treatment outcome in the sub-group of older TB patients. The study aimed to assess the proportion of older TB patients (60 years of age and more), to compare the type of TB and treatment outcomes between older TB patients and other TB patients (less than 60 years of age) and to describe the demographic and clinical characteristics of older TB patients and assess any associations with TB treatment outcomes. METHODS: A retrospective cohort study involving a review of records from April to June 2011 in the 12 selected districts of Tamilnadu, India. Demographic, clinical and WHO defined disease classifications and treatment outcomes of all TB patients aged 60 years and above were extracted from TB registers maintained routinely by Revised National TB Control Program (RNTCP). RESULTS: Older TB patients accounted for 14% of all TB patients, of whom 47% were new sputum positive. They had 38% higher risk of unfavourable treatment outcomes as compared to all other TB patients (Relative risk (RR)-1.4, 95% CI 1.2-1.6). Among older TB patients, the risk for unfavourable treatment outcomes was higher for those aged 70 years and more (RR 1.5, 95% CI 1.2-1.9), males (RR 1.5, 95% CI 1.0-2.1), re-treatment patients (RR 2.5, 95% CI 1.9-3.2) and those who received community-based Direct Observed Treatment (RR 1.4, 95% CI 1.1-1.9). CONCLUSION: Treatment outcomes were poor in older TB patients warranting special attention to this group - including routine assessment and recording of co-morbidities, a dedicated recording, reporting and monitoring of outcomes for this age-group and collaboration with National programme of non-communicable diseases for comprehensive management of co-morbidities.

Expenditure Pattern for TB Treatment among Patients Registered in an Urban Government DOTS Program in Chennai City, South India.

Background. Tuberculosis (TB) patients registered in the government clinics under the DOTS (Directly Observed Treatment, Short Course) program in Chennai city catering to about 4.3 million population. Objective. To estimate the pattern and overall costs incurred by the new patients (who have never had treatment for tuberculosis or have taken antituberculosis drugs for less than one month) registered under DOTS program in the treatment of tuberculosis in Chennai city. Methodology. A cross-sectional survey among new TB patients, who had completed intensive phase of antituberculosis treatment, was done using a precoded semi-structured questionnaire between March and June 2007. Information was collected on demographic, socioeconomic characteristics and expenditure for before and during treatment. Mean costs were used for comparison. Results. Among the 300 TB patients, most economically productive age group and 186 (62%) were males. The overall estimated total costs incurred right from the onset of symptoms until treatment completion was found to be Rs. 3211 (3.8% of annual family income) under DOTS program, which is less compared to previous studies. The overall mean total cost was significantly high among male (Rs. 3270; P < 0.01), employed (Rs. 3945; P < 0.01), and extrapulmonary patients (Rs. 3915; P < 0.01). Conclusion. The study has reiterated the fact that DOTS helps in reducing out-of-pocket expenses to patients with tuberculosis and hence is a cost-effective health intervention. This cost reduction may help to increase the access to the poor people which would help in achieving universal access to TB care services.

Socioeconomic impact of TB on patients registered within RNTCP and their families in the year 2007 in Chennai, India.

BACKGROUND: Tuberculosis patients are registered in government clinics under Directly Observed Treatment Short-course (DOTS) program in Chennai city catering to 4.34 million population. With the entire country geographically covered under the DOTS program, research into socioeconomic impact of TB on patients and their households is crucial for providing comprehensive patient-friendly TB services and to document the benefits of DOTS. OBJECTIVE: To assess the social and economic impact of TB on patients registered under DOTS program and their families. MATERIALS AND METHODS: A cross-sectional study of 300 TB patients was done using a pre-coded semi-quantitative questionnaire between March and June 2007 in all the Tuberculosis Units (TUs) of Chennai city. RESULTS: Social and economic impact was perceived by 69.0% and 30.3% patients, respectively. About 24.3% suffered from both social and economic impact, while 75% patients suffered from any one form of impact. Social impact was perceived by more female patients as compared to males (80.7% vs. 62%; P < 0.001). More patients with extra-pulmonary disease (44.4%) and patients belonging to joint families (40.7%) perceived economic impact (P < 0.05). CONCLUSION: After 8 years of DOTS implementation, the present study has shown that with the availability of DOTS, percentage of patients who mortgaged assets or took loans has reduced. Social impact of TB is still perceived by two-thirds of the patients (69%). Elimination or reduction of social stressors with specific, focused, and intense social support services, awareness generation, and counseling to patients and families need to be built into the program.