Accuracy of cobas MTB and MTB-RIF/INH for Detection of Mycobacterium tuberculosis and Drug Resistance.

This study evaluated the performance of cobas MTB and cobas MTB-RIF/INH for the diagnosis of tuberculosis and detection of rifampicin (RIF) and isoniazid (INH) resistance. Adults presenting with pulmonary tuberculosis symptoms were recruited in South Africa, Moldova, and India. Performance of cobas MTB was assessed against culture, whereas cobas MTB-RIF/INH was assessed using phenotypic drug susceptibility testing and whole-genome sequencing as composite reference standards. Xpert MTB/RIF (Xpert) or Xpert MTB/RIF Ultra (Ultra) was used as a comparator. The overall sensitivity and specificity of cobas MTB were 95% (95% CI, 93%-96%) and 96% (95% CI, 95%-97%). Among smear-negatives, the sensitivity of cobas MTB was 75% (95% CI, 66%-83%). Among participants tested with both cobas MTB and Xpert, sensitivity was 96% (95% CI, 94%-97%) for cobas MTB and 95% (95% CI, 93%-97%) for Xpert. Among participants tested with both cobas MTB and Ultra, sensitivity was 88% (95% CI, 81%-92%) for cobas MTB and 89% (95% CI, 83%-93%) for Ultra. Sensitivity and specificity of cobas MTB-RIF/INH for RIF and INH detection were 90% (95% CI, 84%-94%) and 100% (95% CI, 99%-100%), and 89% (95% CI, 84%-93%) and 99.5% (95% CI, 98%-100%), respectively. The cobas MTB and cobas MTB-RIF/INH assays exhibited high performance in a diverse population and present a suitable option for molecular detection of tuberculosis and RIF and INH resistance.

Empowering Health Workers to Build Public Trust in Vaccination: Experience from the International Pediatric Association's Online Vaccine Trust Course, 2020-2021.

BACKGROUND: The quality of interactions between health workers (HWs) and caregivers is key in vaccine acceptance. To optimize this, HWs need knowledge about best vaccine communication practices in person and on social media. Most pre-service curricula do not include such approaches. COVID-19 necessitated the International Pediatric Association (IPA) to shift from in-person train the trainer workshops to developing an online Vaccine Trust Course to address these gaps. METHOD: The seven-module, 8-hour Vaccine Trust Course was offered online in seven languages and promoted globally. Course outcomes for participants between September 1, 2020 and September 30, 2021 were assessed using enrollment, participation, and completion data; pre-and post-training surveys of attitudes, knowledge, and practice skills; and follow-up practice surveys 3 months post course completion. RESULTS: Of the 4,926 participants across 137 countries who registered; 2,381 (48.3 %) started the course, with 1,217 (51.1 %) completing. The majority were 25 - 39 years (57 %), female (57 %), and in pediatrics (70 %); 31 % came from India. 62 % of completers rated course structure/design as excellent, 36 % as good. Over 80 % rated the content as the most valuable aspect. Three months post training, 61 % HWs reported increased empathy towards caregivers, confidence while counseling and increased vaccine acceptance amongst their patients. 21 % identified the course as the only factor in these positive changes. CONCLUSION: Shifting from face-to-face to online training due to the COVID-19 pandemic helped increase the global reach of HWs course engagement and uptake. Trained HWs reported increased empathy towards caregivers and confidence while counseling and increased patient vaccine acceptance.

Strengthening resistance testing for tuberculosis in India - Investment cost, throughput, and efficiency of new laboratories.

A lack of laboratory capacity for drug-resistant tuberculosis (DR-TB) testing is a major barrier to DR-TB control. To overcome this barrier, the Central Tuberculosis Division (CTD), Ministry of Health and Family Welfare (MoHFW), Government of India (GoI), and FIND India established a partnership under the National Tuberculosis Elimination Program (NTEP) to strengthen and expand tuberculosis (TB) laboratory diagnostic capabilities. This partnership has led to the establishment of 61 culture & DST laboratories, increasing the testing capacity to a capability of performing over 200,000 liquid cultures and over 170,000 molecular drug sensitivity tests annually. In this study, we assess the data on throughput, efficiency, investment cost, and the capacity of the laboratory services supported by this partnership to understand impact and inform future resource allocation. We estimated the technical efficiency using Stochastic Frontier Analysis (SFA). Our results show that the established laboratory network is operating at 69% efficiency, with the capacity to perform an additional 450,000 cultures and 180,000 first-line molecular drug-susceptibility tests by 2025. This additional capacity, together with current efforts to enhance the laboratory network, has the potential to make a significant contribution to NTEP's TB elimination target by 2025.

Impact of active tuberculosis on treatment decisions in cancer.

Background Tuberculosis (TB) and cancer can coexist in some patients especially from low- and middle-income countries. Impact of active TB on treatment decisions in cancer is less well studied. Methods A retrospective case record review of all cases of cancer diagnosed and or treated between January 2012 and December 2019 who were also diagnosed to have active TB (pulmonary or extrapulmonary) was done. Results Any delay or change in standard treatment of cancer because of active TB or its treatment was noted. Among a total of 32,509 cancer cases, 56 (0.17%) patients were diagnosed to have active TB. Twenty six patients (46%) had delay in starting treatment or delay during cancer treatment. Six (11%) patients were changed from curative treatment option to palliative intent (either best supportive care or palliative Radiation) or no further treatment. Three (5%) patients required change from one type of curative treatment modality to another curative option. Conclusion Eleven percent of patients had to be changed from curative intent to palliative treatment or no further treatment, TB being either the direct or indirect cause in all of them. A nationwide data registry of cancer patients with TB, involving multiple centers, should be considered so that specific problems in this context can be identified and addressed in larger details.

Clinical Outcomes of Head and Neck Cancer Patients Treated with Palliative Oral Metronomic Chemotherapy at a Tertiary Cancer Center in Kerala, India.

BACKGROUND: Cetuximab-based chemotherapy is the standard palliative chemotherapy in head and neck cancers, but there is a limitation due to financial and logistic reasons, and where oral metronomic chemotherapy can be a successful alternate. Oral metronomic chemotherapy (MCT) can either be with Methotrexate alone or a combination of Methotrexate and Erlotinib. The study was aimed to assess the clinical outcome of oral MCT in head and neck cancer patients. MATERIALS AND METHODS: This was a retrospective review done at a tertiary cancer centre in India. The clinical outcomes of head and neck cancers patients started on palliative oral MCT from 1st August 2016 to 31st December 2017 were analyzed. The demographic details, toxicity profiles, response to MCT, disease progression status were analyzed. Univariate analysis was done to assess the factors associated with disease progression. Kaplan Meier curve was used for estimating progression free survival (PFS). RESULTS: Of the total 104 patients, the most common primary site of head and neck cancer was oral cavity (52%). MCT scheduled with Methotrexate and Erlotinib in 80 patients. Toxicity rate was 61%, with Grade 3-4 toxicity in 21%. Response rate was 56% and clinically meaningful response rate was 69%. Disease progression was observed in 55% patients. Median PFS rate was 134 Days. Oral MCT was permanently stopped in 73%, the most common reason being disease progression. DISCUSSION: Patients who underwent palliative oral MCT had a median PFS of 134 days which is considered as promising treatment method. Results confirmed more than 50% response rate with lower Grade 3-4 toxicities. CONCLUSION: Palliative oral MCT either with Methotrexate and Erlotinib or Methotrexate alone will be a feasible treatment option in patients with head and neck cancers treated with palliative intent.

Pain Management in Children With Cancer Using World Health Organization Guidelines at a Tertiary Cancer Center in Rural India.

Management of cancer pain among children is a difficult process due to the way they perceive pain, their dependence on parents, complexity of assessment, and limited availability of safe analgesics. Pain among children with cancer is still a less explored problem in India. This descriptive study was carried out in a tertiary cancer center to explore the characteristics of pain and its management among the children with cancer. We analyzed children diagnosed with hematologic malignancies, aged 4-18 years, admitted between January 2013 and December 2017. This retrospective cohort study involved the review of patient records available at the medical records department. During the study period, there were 290 admission episodes, of which 93 (32.1%) episodes were associated with pain. Of these 93 episodes, 14 (15%) were primarily for pain management. Step I analgesic was utilized in the majority (83%) of the admission episodes involving younger age group (4-9 years) children, whereas for the older age group (10-18 years) Step 2 analgesic (tramadol) was utilized in 29 (58%) episodes, and this was found to be statistically significant (P < .001). Only in 9 (9.7%) episodes Step 3 analgesic was utilized. A significant proportion of children with hematologic malignancies had pain episodes, and these episodes in older age group children were managed with weak opioids.

Community engaged breast cancer screening program in Kannur District, Kerala, India: A ray of hope for early diagnosis and treatment.

INTRODUCTION: Community based programs can assist in early detection and improved survival of breast cancer. AIMS: To assess the feasibility and explore challenges of a district-wide door-to-door breast cancer screening program "ASWAS" conducted in Kannur district, Kerala, India from 2011 to 2014. METHODS: Aggregate data from survey records were collected in terms of the population screened, referred, diagnosed, and treated. Case records of breast cancer patients who were identified were reviewed and updated. In-depth interviews were conducted with program stakeholders. The contents of the interview were organized into a strength, weakness, opportunity and threat (SWOT) matrix to describe the screening program. RESULTS: A total of 1,049,410 eligible women above 30 years residing in 81 panchayats were visited door-to-door by 8,200 community volunteers; of them, 93% were screened using a symptom-risk factor checklist. Of those referred with symptoms (n = 5353), 81% attended the cancer camp. In total, 23 breast cancer cases were confirmed. 14 (61%) were in early stages, treated, and are disease free at 3-year follow-up. Those in the advanced stage and old age had poor outcomes. SWOT analysis identified political support, female volunteers, community engagement, dedicated fund for treatment, and teamwork as strengths. Weaknesses included poor healthcare access, maintaining volunteer motivation, and issues around sustainability. CONCLUSION: Community participation with the engagement of the health system and local self-government are required for implementing a comprehensive cancer screening strategy. Breast-cancer screening program using local volunteers for early detection is feasible in low-income settings, thereby improving survival.

Limiting factors for autologous transplantation among transplant-eligible multiple myeloma patients: Lesson from a Tertiary Cancer Centre in rural India.

There is limited data from low and middle income countries on the exact proportion of Myeloma patients undergoing transplant even if they are eligible for the same. In this retrospective analysis of all newly diagnosed transplant eligible Myeloma treated between January 2011 to June 2017, number of patients undergoing transplant were recorded and among those not opting for transplant, reasons for the same were noted. Among 89 eligible patients, 23 (26%) patients could undergo transplantation. Most common reasons for not undergoing transplant were fear of the complications in 42 (47%) and financial reasons in 41 (46%) of patients. The transplanted group had better progression free survival when compared against the non-transplanted group (3 year PFS of 80% versus 36%, HR = 0.09, 95%CI 0.02-0.4, p = 0.001). Future studies may be conducted to arrive at measures, for correcting the transplant related concerns and fears, through psycho-social interventions.

Prognostic efficiency of clinicopathologic scoring to predict cervical lymph node metastasis in oral squamous cell carcinoma.

BACKGROUND: The extent of involvement of cervical lymph nodes is known to be the most important prognosticator in oral squamous cell carcinoma (SCC) that significantly affects the survival rate of patients. The clinical, radiological and pathological factors that can predict cervical lymph node metastasis are yet to be ascertained clearly, which poses a challenge for the surgeon to determine the extent of neck dissection. AIM: This study aims to identify the clinical and histopathologic predictors of lymph node metastasis among patients with oral SCC and to devise a scoring system based on those predictors to aid in better clinical decision-making regarding the extent of neck dissection. SETTING: Malabar Cancer Centre, a specialized tertiary cancer care center in Kerala, India. METHODS: A retrospective review of 160 patient records and biopsy slides collected and preserved between June 2014 and May 2016. CONCLUSION: The clinicopathologic parameters such as site of cancer (P = 0.03), histologic differentiation (P = 0.03), shape of rete pegs (P = 0.002), pattern of invasion (P = 0.0001) and depth of invasion >3 mm (P = 0.016) were significantly associated with the risk of lymph node metastasis. The risk score devised based on these predictors serves as an efficient tool in aiding clinical decision-making regarding the extent of neck dissection.

Improved survival among oral cancer patients: findings from a retrospective study at a tertiary care cancer centre in rural Kerala, India.

BACKGROUND: Oral cancer is very common in India. The reported 5-year survival of such patients is around 50% after treatment with surgery and radiotherapy, much lower than most of the developed countries. METHODS: A retrospective study of a prospective database of oral cancer patients undergoing surgery from June 2009 to June 2013 was conducted. Follow-up details were updated from case records and by phone calls. Data were double entered in EpiData Entry version 3.1 and were analysed using EpiData Analysis software 2.1.0.73. RESULTS: Two-hundred and twenty patients were analysed (136 males); 85% were consuming tobacco, mainly in chewable form. The majority (51.1%) had tongue cancer, of whom 75 patients (34.1%) had T4 tumours. Postoperative radiotherapy was given to 108 patients (49.1%). Forty had recurrence, of which 23 were in early stage. Of these, 19 showed node positivity (p < 0.01). Node-negative patients had 79% 5-year survival while node positive had 59% which is comparable to that reported in developed countries. Median disease-free survival duration was 48.2 months. CONCLUSIONS: Node positivity is the single factor affecting recurrence and survival. The overall survival and disease-free survival is better in patients without lymph node involvement and in patients with early stage of cancer as compared to the patients with node involvement and in advanced stages.

Population-based cancer screening through community participation: Outcome of a district wide oral cancer screening program from rural Kannur, Kerala, India.

BACKGROUND: Oral cancer is a major public health challenge, and about one-fifth of all oral cancer cases reported globally are from India. In spite of the potential for early detection by simple visual examination, the majority of patients report in later stages of the disease, especially in low and middle-income countries. We report the results from a district level population-based oral cancer screening program. METHODS: A cross-sectional survey was carried out among people aged >15 years in 48 panchayats of Kannur district in Kerala, India. This comprehensive multi-stakeholder district-wide screening was carried out in six stages including planning, sensitization, recruiting of community volunteers and training, survey, organization of specialist camps and referring to cases to cancer center. The descriptive statistical analysis was performed using EpiData analysis software (Version 2.2.2.180). RESULTS: Among the 1,061,088 people in 265,272 houses surveyed, 2507 of them attended the screening camps, and 13 oral cancers and 174 oral precancers were detected. Majority of the oral cancer patients were male (69%), with primary education or illiterate (62%) and low socioeconomic status (61%). Five of the patients diagnosed with early-stage cancer are alive and have good oral health-related quality of life. CONCLUSION: Detection of precancerous and early-stage cancers should be a priority of oral cancer screening programs. The possible key for addressing cancer screening needs of the rural population is to equip the primary health centers in cancer screening activities with available human resources while adapting to local context.

Does Alcohol consumption during multidrug-resistant tuberculosis treatment affect outcome?. A population-based study in Kerala, India.

RATIONALE: India reports the largest number of multidrug-resistant tuberculosis cases in the world; yet, no longitudinal study has assessed factors related to treatment outcomes under programmatic conditions in the public sector. OBJECTIVES: To describe demographic, clinical, and risk characteristics associated with treatment outcomes for all patients with multidrug-resistant tuberculosis registered in the Revised National Tuberculosis Control Programme, Kerala State, India from January 1, 2009 to June 30, 2010. METHODS: Cox regression methods were used to calculate adjusted hazard ratios with 95% confidence intervals (CIs) to assess factors associated with an unsuccessful treatment outcome. MEASUREMENTS AND MAIN RESULTS: Of 179 patients with multidrug-resistant tuberculosis registered, 112 (63%) had successful treatment outcomes (77 bacteriologically cured, 35 treatment completed) and 67 (37%) had unsuccessful treatment outcomes (30 died, 26 defaulted, 9 failed treatment, 1 stopped treatment because of drug-related adverse events, and 1 developed extensively drug-resistant tuberculosis). The hazard for unsuccessful outcome was significantly higher among patients who consumed alcohol during treatment (adjusted hazard ratio, 4.3; 95% CI, 1.1-17.6) than those who did not. Persons who consumed alcohol during treatment, on average, missed 18 more intensive-phase doses (95% CI, 13-22) than those who did not. Although many patients had diabetes (33%), were ever smokers (39%), or had low body mass index (47%), these factors were not associated with outcome. CONCLUSION: Overall treatment success was greater than global and national averages; however, outcomes among patients consuming alcohol remained poor. Integration of care for multidrug-resistant tuberculosis and alcoholism should be considered to improve treatment adherence and outcomes.

Outcome of tuberculosis treatment in patients with diabetes mellitus treated in the revised national tuberculosis control programme in Malappuram District, Kerala, India.

SETTINGS: Kerala State, India has reported the greatest dual burden of Tuberculosis (TB) and Diabetes Mellitus (DM). Malappuram district in Kerala has monitored and recorded DM status and its control from 2010 under Revised National Tuberculosis Control Program (RNTCP). OBJECTIVES: To assess, under programme conditions, comprehensiveness of recording DM status among TB cases and the TB treatment outcomes among DM patients (disaggregated by glycemic control) and compare with-non DM patients. DESIGN: This retrospective record review included 3,116TB patients from April 2010 to September 2011.DM was defined as per international guidelines and TB treatment outcomes were categorized as favourable(cured and treatment completed) and unfavourable(death, default, failure and transfer out). Relative Risk (RR) and 95% confidence intervals(CI) were calculated to assess the risk of unfavourable outcomes. RESULTS: DM status was recorded in 90% of TB cases and 667 (24%) had DM. 17% of DM patients and 23% of patients with unknown DM status had unfavourable outcomes but this difference was not statistically significant. Unadjusted RR for poor glycemic control or unknown control status for unfavourable outcome were (2.00; 95% CI 0.97-4.13) and (2.14; 95% CI 1.11-4.13). CONCLUSION: This study could not confirm an adverse association between DM or its control during treatment and the course of response to TB treatment.DM screening in TB cases and recording of DM care needs to be improved to enable more conclusive evidence.