Indian Setting Research Articles

Application of center for disease control and prevention standardized antimicrobial administration ratio to an Indian hospital.

Rigorous antibiotic stewardship is advised by international societies to combat rising antibiotic resistance. A major component of these programs is the metric used for antibiotic consumption measurement. A method for standardized antimicrobial administration ratio (SAAR) is suggested by the Centre for Disease Control & Prevention-National Healthcare Safety Network (NHSN). We applied the SAAR method to calculate antibiotic consumption in a tertiary care hospital in India. We also validated a limited sampling approach to calculate SAAR. The prospective study was conducted in three medical intensive care units over a period of 12 months. Monthly antibiotic consumption was measured by the hospital electronic records. Limited sampling was performed by weekly bedside review of the antibiotic orders. Formulae for SAAR calculation were derived from the NHSN guide. SAAR obtained by electronic records and limited sampling were compared to validate this approach. SAAR was calculated as >1 for an Indian hospital (1.49 by electronic records and 1.43 by limited sampling approach). The difference between the two ratios was not statistically significant (P = .47). SAAR in our setting is 1.49, which is slightly higher than the NHSN benchmark. Antibiotic usage (AU) risk adjustment based on data from the NHSN might not be adequate for calculating SAAR for Indian hospitals. There is a need to perform AU risk factor analysis for Indian settings for better defining SAAR in Indian context. The limited sampling approach can be adapted for calculation of SAAR in settings with limited resources.

Chapter 6: Risk Stratification and Surveillance in Differentiated Thyroid Cancers

ABSTRACT Surveillance strategies in differentiated thyroid cancers (DTCs) differ from other head-and-neck subsites by virtue of their excellent prognosis. Guidelines in this chapter are based on a comprehensive literature review, particularly in the Indian setting concurred upon by experts in the field. Key recommendations include serial measurement of thyroglobulin values, thyroglobulin antibodies, and risk-based suppression of thyroid-stimulating hormone during follow-up of treated DTCs, with radioactive iodine scan and structural imaging based on dynamic risk stratification. These recommendations take into consideration prevailing Indian scenario related to reliability of follow-up, insurance coverage, as well as burden on health-care systems.

Total risk approach for noncommunicable diseases: A review of cardiovascular disease risk prediction tools for Indian setting

Abstract Risk stratification approach considering total cardiovascular disease (CVD) risk and providing appropriate interventions is one of the WHO best-buys for tackling noncommunicable diseases (NCDs). Various risk prediction tools are available to assess total CVD risk and help identify high-risk individuals. Similarly, tools are available for the prediction of risk for specific NCDs such as diabetes and hypertension. Since these tools are context specific, we reviewed the CVD risk prediction tools and disease-specific risk scores relevant for Indian setting. A literature review was performed in PUBMED and Google Scholar using the keywords. A comparison of CVD risk prediction charts applicable for India has been carried out and includes WHO CVD risk charts, WHO/ISH risk charts, Globorisk, and INTERHEART modifiable risk charts. Among these, WHO CVD risk charts are highly recommended for use in India because of its robust methodology in development and have been externally validated. Disease-specific risk scores for Indian setting include Indian Diabetes Risk Score and Hypertension Risk Prediction Tool.

Expert Opinion on the Utilization of Proton Pump Inhibitors for the Treatment of Gastroesophageal Reflux Disease among Indian Patients

Several studies have demonstrated that esomeprazole enhances the management of gastroesophageal reflux disease (GERD) patients by reducing the incidence of heartburn and epigastric pain, as well as relapse rates. But, there was a dearth of data regarding the preference of esomeprazole. So, this study was conducted to gather expert opinions on the routine use of proton pump inhibitors (PPIs) in clinical practice with a focus on the utilization of esomeprazole as a maintenance therapy for GERD in Indian settings. A cross-sectional, questionnaire based study was conducted to collect opinion among physicians involved in managing GERD symptoms across India between June 2022 and December 2022. The study enrolled 972 participants, and 63% of them noted the frequent occurrence of both erosive and non-erosive reflux disease in GERD patients. Approximately 47% of the respondents identified obesity as a significant GERD risk factor, with 32% attributing it to irregular and unhealthy eating habits. The majority of the clinicians preferred PPIs for the treatment of GERD (90%), particularly esomeprazole (87%). The typical duration of PPIs for GERD patients was reported to be 2-4 weeks by approximately 57% of the experts. Most respondents recommended a combination of PPIs and prokinetic drugs for GERD treatment. When dealing with PPI-resistant patients, 56% of physicians preferred maintaining the same PPI therapy twice daily, while 32% advised switching to another PPI. The majority of the respondents (71.81%) recommended making dietary and lifestyle adjustments for managing GERD, including consuming smaller, more frequent meals, refraining from lying down for at least two hours after eating and addressing excess weight around the midsection. It was noted that clinicians recommended PPIs, especially esomeprazole, as the primary approach for GERD management. Experts advise a regimen of twice-daily PPIs for patients who exhibit resistance to the treatment. They also underscore the importance of dietary and lifestyle adjustments in GERD management.

Cost Variation Analysis of Branded Generics Used for Initial Treatment of Type 2 Diabetes, Hypertension and Dyslipidemia in India: A Pharmacoeconomic Perspective

Background: Branded generics are off-patent medications with proprietary names which are bioequivalent to the innovator medications. Cardiovascular diseases, driven by diabetes, hypertension, and dyslipidemia, are major health concerns, where patient compliance is crucial for long-term management. This analysis investigates cost variations of first-line branded generics for these conditions in Indian primary care settings.
 Methods: First-line medications preferred for type 2 diabetes, hypertension, and dyslipidemia were identified through an online survey of prescribers. Data from 1mg.com, an Indian online pharmacy, was used to compile a list of available brands for each medication. The study compared the prices of the five most prescribed brands, the three lowest-cost and one highest-cost brand per medication, and calculated the percentage cost difference.
 Results: First-line medications preferred for type 2 diabetes, hypertension, and dyslipidemia in India include Metformin 500mg, Enalapril 5mg, Telmisartan 40mg, Amlodipine 5 mg, and Atorvastatin 20mg. The analysis reveals significant cost disparities among commonly prescribed brands, with Metformin, Enalapril, Telmisartan, and Atorvastatin being notably more expensive (up to 1177%) than lower-cost alternatives, potentially placing a financial burden on patients. Amlodipine, however, exhibits modest cost variation (26-113%), with commonly prescribed brands leaning toward lower-cost options.
 Conclusion: Cost disparities among commonly prescribed brands could harm patient compliance and outcomes, emphasizing the need for cost-effective medication selection. This study offers crucial insights into cost variations in India's treatment of Type 2 Diabetes, Hypertension, and Dyslipidemia, underscoring the importance of cost awareness for improved patient compliance and healthcare system sustainability.

Understanding perspectives of asthma among pulmonologists in Indian settings: results from a questionnaire-based survey

Background: Asthma is associated with high morbidity and mortality in India. This survey was undertaken to explore the perspectives of pulmonologists towards in-clinic management of patients with asthma. Methods: It was a cross-sectional survey of pulmonologists conducted across India. It was formulated to provide unbiased observations of real-world clinical practice focusing on methods of diagnosis of asthma and its treatment preferences. Results: The participants included 805 pulmonologists, with the majority primarily treating patients with asthma (62%), chronic obstructive pulmonary disease (19%) and allergic rhinitis (19%). More than 86% of pulmonologists consider clinical symptoms, history of childhood asthma, family history, and chronic allergic rhinitis for initial diagnosis. About 19-23% prefer spirometry alone or in combination with family history for confirmation of asthma. The preferred inhaled corticosteroids-long-acting bronchodilator (ICS-LABA) combination was budesonide-formoterol amongst 83% of pulmonologists. For both dry powder inhaler (DPI) and metered dose inhaler (MDI) devices, fine particle fraction per cent and delivered dose were ranked as the two most important attributes. Conclusions: Asthma is the most prevalent diagnosis among patients treated by pulmonologists on the basis of clinical presentation and medical history. The most commonly used pharmacotherapy for the treatment of asthma comprises ICS-LABA, with budesonide-formoterol being the preferred combination. Fine particle fraction per cent and magnitude of delivered dose influence the choice of asthma inhaler prescriptions the most.

Feasibility of Hepatic Artery Infusion Chemotherapy for Colorectal Liver Metastasis in an Indian Setting.

Hepatic artery infusion chemotherapy (HAIC) is a popular treatment modality for the treatment of colorectal liver metastasis (CRLM). The aim of this study was to determine the feasibility of HAIC for high-risk resected CRLM delivered using repeated femoral puncture and delivering 5-fluorouracil infusional chemotherapy along with systemic adjuvant chemotherapy. The present study is a retrospective review of a prospectively maintained database. All patients who underwent HAIC for colorectal liver metastases between July 2022 and July 2023 were included. A total of 12 patients were included in the study of which 11 completed four sessions as planned. The median age was 47 (29-73) years with nine male (81%) and two female (18%) patients. Rectum (n = 7, 63%) was the most common primary location. All patients received systemic chemotherapy with 5-fluorouracil-based regimens prior to HAIC (median 12 cycles). The median number of metastasis was 2 (1-8). Eight patients had metastasis in unilobar distribution (73%). On completion of HAIC treatment, nine patients (64%) were completely disease free with a median follow-up of 8 months. None of the patients experienced any immediate adverse events during or after completion of the procedure. Conventional HAIC comes with various challenges such as unavailability of the agent floxuridine and the specialized HAIC pump. Percutaneous HAIC has a lower chance of infection. The delivery of HAIC using repeated femoral punctures and 5FU chemotherapy was successful in over 90% of the patients making it a feasible option in the treatment of CRLM.

Practice on Antibiotic Use: Analysis of Overall Practice Score in Indian Set-up

Antibiotic resistance poses a significant global health threat, necessitating a detailed analysis of antibiotic use practices in diverse healthcare environments. This study, situated in the Indian context, scrutinizes the overall practice scores associated with antibiotic utilization. In part VI of our research series, we explore intricate patterns and factors influencing antibiotic prescription, dispensation, and adherence to guidelines within Indian healthcare setups. The findings reveal multifaceted challenges faced by healthcare practitioners, encompassing issues of overprescription, inadequate awareness among patients, and varying adherence to established protocols. By employing a comprehensive approach, this study sheds light on the nuanced intricacies of antibiotic use practices, allowing for a nuanced understanding of the Indian healthcare landscape. The insights garnered in this research can inform targeted interventions, policy formulation, and educational initiatives, aiming to enhance antibiotic stewardship in Indian healthcare settings. As the world grapples with antibiotic resistance, this analysis provides valuable perspectives essential for effective and sustainable strategies in mitigating this pressing global health concern.

Risk Factors and Mental Health Issues in Adolescence: an Analysis of the Indian Setting

Adolescence in India is marked by heightened vulnerabilities to concerns related to mental health with depression playing an important role as a contributing factor. Recent years have seen an increase in the incidence of depression in Indian adolescents. Despite this the major causes of causes of depression still remain unidentified. The present article aims to provide a detailed examination of the possible risk factors that are becoming increasingly significant in the Indian setting. The primary purpose of the paper is to offer an in -depth understanding of the factors that commonly lead to mental health problems in contemporary Indian youth. It is believed that the article would help create an understanding and awareness among parents, teachers and policy makers about the pressures and challenges youth faces so that relevant interventions can be made at different levels.

Exclusive breastfeeding practices and its determinants in Indian infants: findings from the National Family Health Surveys-4 and 5

BackgroundThe World Health Organization (WHO) recommends exclusive breastfeeding (EBF) in infants for the first 6 months of life. This analysis aims to estimate the proportion of Indian infants exclusively breastfed for the first 6 months using the National Family Health Surveys (NFHS)-4 and 5, and further, determine factors associated with EBF practices.MethodsEBF for this analysis was defined as when infants received only breast milk and no complementary feeds (solid food, water, animal milk, baby formula, juice, and fortified food) in the last 24 h prior to the survey. The proportion of infants exclusively breastfed was plotted from birth to 6 months as per the age of children at the time of the survey, and this was computed for individual states, union territories, and overall, for India. Univariate and multivariable logistic regression analyses were performed to examine factors influencing EBF in Indian infants.ResultsThe proportion of Indian infants exclusively breastfed for 6 months was 31.3% (1280/4095; 95% CI 29.9, 32.7) and 43% (1657/3853; 95% CI 41.4, 44.6) as per the NFHS-4 and 5 surveys, respectively. In NFHS-5, infants of scheduled tribes (aOR 1.5; 95% CI 1.2, 1.9) and mothers who delivered at public health facilities (aOR 1.3; 95% CI 1.1, 1.5) showed an increased odds of being exclusively breastfed at 6 months of life compared to their counterparts. Further, infants of mothers aged < 20 years (aOR 0.5; 95% CI 0.4, 0.7), low birth weight infants (aOR 0.6; 95% CI 0.4, 0.8), and infants in whom breastfeeding was initiated one hour after birth (aOR 0.8; 95% CI 0.7, 0.9) showed a reduced odds of being exclusively breastfed at 6 months compared to their counterparts.ConclusionsThe overall EBF practice showed an increasing trend in the NFHS-5 compared to the NFHS-4 survey. However, a vast gap remains unaddressed in the Indian setting with > 50% of the population still not exclusively breastfeeding their infants for the WHO recommended duration of first 6 months. Behavioral studies dissecting the complex interplay of factors influencing EBF within the heterogenous Indian population can help plan interventions to promote and scale-up EBF in Indian infants.

Improving health outcomes among older adults in India: effectiveness and implementability of a novel comprehensive geriatric assessment based intervention

Background There is significant evidence on the benefits of comprehensive assessment in older adults. But this evidence is primarily from western countries and in secondary care settings. National policies in India recognize this need and envision community-based screening and facility-based assessment programs integrated into the care pathways for the elderly. However, this is yet to translate into specific interventions, primarily due to lack of complex interventions necessary and evidence of their effectiveness. This study aims to design and pilot an integrated (Community + Facility) Elderly Health Status Assessment and Screening (EHSAS) intervention to improve health outcomes of older adults and assess its feasibility for implementation in Indian rural settings. Methods We propose a hybrid design where we will build the complex intervention, develop and validate the tools needed, pilot it using an exploratory cluster randomized trial and evaluate its implementatbility using the Exploration-Preparation-Implementation-Sustainment (EPIS) framework. Conclusions This study will fill critical gaps in evidence regarding the effectiveness of geriatric screening and assessment in community and primary care settings in low-middle income countries and provide validated tools and implementation models for adoption into national programs. Registration CTRI/2023/07/055661

Evolutionary trends of carbapenem-resistant and susceptible Acinetobacter baumannii isolates in a major tertiary care setting from North India

Emergence of carbapenem-resistant A. baumannii (CRAB) is a global, ongoing healthcare concern. CRAB is among the topmost priority pathogens, with various studies focusing on its global population structure and resistant allelic profiles. However, carbapenem-susceptible A. baumannii (CSAB) isolates are often overlooked due to their sensitivity to beta-lactams, which can provide important insights into origin of CRAB lineages and isolates. In the present study, we report genomic investigation of CRAB and CSAB coexisting in Indian hospital setting. MLST based population structure and phylogenomics suggest they mainly follow distinct evolutionary routes forming two phylogroups. PG-I exclusively for a successful clone (ST2) of CRAB and PG-II comprises diversified CSAB isolates except PG3373, which is CRAB. Additionally, there are few CRAB isolates not belonging to PG-I and sharing clonal relationship with CSAB isolates indicating role of genome plasticity towards extensive drug resistance in the nosocomial environment. Further, genealogical analysis depicts prominent role of recombination in emergence and evolution of a major CRAB lineage. Further, CRAB isolates are enriched in resistomes as compared to CSAB isolates, which were encoded on the genomic island. Such comparative genomic insights will aid in our understanding and localized management of rapidly evolving pandrug resistant nosocomial pathogens.

Assessing feasibility of sewage sludge composting in rotary drum reactor

In a year-long study, the efficacy of a manually operated rotary drum prototype, jointly developed by CEIT Spain and IIM Mumbai, was examined for sanitized compost production in Indian conditions. The prototype, a 200-liter horizontal plastic drum made of high-density polyethylene, incorporated a perforated polypropylene pipe for passive aeration of the composting mixture. Focused on optimizing composting of sewage sludge from a Municipal MBBR, the research targeted key process variables in the rotary drum reactor to attain the thermophilic phase. Wood shavings emerged as the optimal bulking agent, with a mixing ratio of three parts dewatered sewage sludge to one-part bulking agent. A turning frequency of every 12 h proved optimal for achieving the desired temperature of around 60 °C. The study concluded that the final sludge quality met prescribed standards, showcasing the viability of the rotary drum system for efficient compost production in Indian settings.

Performance of the Heaviness of Smoking Index in Indian Settings.

Background and objective The heaviness of smoking index (HSI) is a popular tool to assess nicotine dependence in clinical and community settings. Low cigarette consumption and concurrent use of other tobacco products raise concerns about its validity in Indian settings. This study explores the performance of HSI in Indian settings. Methods This study analyzed daily manufactured cigarette smoker data from the cross-sectional Global Adult Tobacco Surveys (GATS) from its first (GAST-1, 2009) and second waves (GATS-2, 2016), both of which were available in the public domain. The HSI scores were calculated based on the number of cigarettes smoked per day (CPD) and time to first smoke (TTFS) after waking up among the current daily cigarette users. This study examined the utility of the HSI scale in Indian settings by estimating the predictability of low dependence on quit attemptsand quit intentions using the likelihood ratio parameter. Results About nine in 10 cigarette users in India consumed less than 10 cigarettes per day, yielding a low score on the HSI scale for most of the daily cigarette users. The majority of daily cigarette smokers scored ≤ 1 (low dependence) on the HSI scale both in GATS-1 and GATS-2, irrespective of their exclusive cigarette use status. The absolute value and the 95% confidence limit of positive likelihood ratios (falling below and above one) suggest that the predictability of low dependence on quit attempts and quit intention in the Indian setting is limited. Conclusions The utility of the HSI scale in assessing nicotine dependence among cigarette users in India is limited. This may be attributed to low average cigarette consumption, concurrent use of various tobacco products, and the sociocultural milieu of Indian smokers. This highlights the need for a new rapid nicotine dependence scale tailored to the specific patterns of tobacco use behavior prevalent in the Indian context.

Association of obstructive sleep apnea and sleep quality with cognitive function: a study of middle-aged and elderly persons in India.

Symptoms of obstructive sleep apnea (OSA) and poor sleep quality affect around one in ten people in India. We aimed to determine if OSA symptoms and poor sleep quality are independently associated with cognition in middle-aged and elderly urban Indian populations. We studied the cross-sectional association between OSA symptoms (by Berlin Questionnaire), poor sleep quality (by Pittsburgh Sleep Quality Index), and cognitive function in adults ≥ 50years. Using a standard neuropsychological battery for cognitive function, a G-factor was derived as the first rotated principal component assessing domains of information processing, memory, and executive function. The associations of exposures with cognitive measures were modeled using linear regression, adjusted for metabolic risk factors, lifestyle factors, and psychosocial problems, followed by stratified analysis by decadal age group. A total of 7505 adults were enrolled.Excluding those with MMSE < 26 (n 710), of 6795 individuals (49.2% women), mean (SD) age 64.2 (9.0) years, 38.3% had high risk of OSA symptoms, and 15.9% had poor sleep quality. OSA symptoms were negatively associated with cognitive domains of information processing (adjusted beta coefficient of z-score - 0.02, p-value 0.006), memory (- 0.03, 0.014), and G-factor (- 0.11, 0.014) in full-model. Stratified analysis by age group showed significant adverse effects of OSA symptoms on cognition for middle-aged people (50-60years) (- 0.26, 0.001), but not in later age groups. Poor sleep quality was also associated with lower cognitive scores for G-factor (- 0.48, < 0.001), memory (- 0.08, 0.005), and executive domains (- 0.12, < 0.001), but not with information domain. The findings suggest that both symptoms of OSA and poor sleep quality have a direct adverse impact on cognition in an Indian setting. A modest effect of age on the relationship of OSA and cognition was also observed.

Advancement of HIV and Co-infections: A Prospective Observational Study

Aim: To assess the incidence of comorbidities and opportunistic infections (OIs) in advanced HIV. Design: This is a prospective observational study conducted on people living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) (PLHA) with a laboratory-confirmed cluster of differentiation-4 (CD4) counts &lt;100/mm 3 . Recruitment of 102 PLHA patients was performed with no filtering criteria based on the duration of diagnosis, antiretroviral therapy (ART) naive, or ART failure. Data collection was initiated post-clearance by the Institutional Ethics Committee. Methods: The study was conducted at the tertiary care center. The prevalence of underlying comorbidities and the incidence of multiple OIs were assessed in 102 HIV patients with CD4 &lt;100/mm 3 . A detailed clinical examination was carried out, and all relevant investigations were digitally recorded. Results: The mean age of the participants among the 102 PLHA with a CD4 count of 100/mm 3 was 41.4 + 11.2 years, and their mean CD4 count was 62.3 + 20.5/mm 3 at the time of recruitment. A total of 62 (60.8%) patients were ART-naive. The two most prevalent comorbidities in the research population were anemia and renal failure. Fungal infections (66.6%) in the study cohort varied from the most frequent oral thrush (42.1%) to disseminated histoplasmosis (7.8%). Tuberculosis was the second most prevalent opportunistic illness (36.2%). Syphilis cases were prevalent (8.8%) among sexually transmitted illnesses linked to HIV, with most of the cases being latent syphilis; 3.9% of the patients were coinfected with chronic hepatitis B and HIV, and only one possessed chronic hepatitis C. Conclusion: Comorbidities and OIs are major public health concerns in Indian healthcare settings. Our findings show that the prevalence of comorbidities and OIs is high. Furthermore, late diagnosis with HIV, a CD4 count &lt;100/mm 3 , and poor adherence indicate an increased incidence and decreased survival time among PLHA with underlying comorbidities and OIs . Early care-seeking and the beginning of ART, as well as ongoing monitoring of patients to ensure they take their medication on schedule, are critical to reducing OIs and improving general health. Further research is highly recommended to gain deeper insights.

Cardiovascular Compatibility of Proton Pump Inhibitors: Practice Recommendations.

This manuscript aims to critically evaluate the current evidence regarding adverse cardiovascular effects associated with proton pump inhibitors (PPIs) in patients with coronary artery disease (CAD). It also provides guidance for the selection of the most appropriate PPI within the context of cardiovascular polypharmacy and emphasizes the importance of establishing consensus among clinicians on the need to prescribe PPIs with limited cytochrome P450 (CYP450) enzyme inhibition to reduce the risk of drug interactions. PPIs are among the most widely used drugs for the treatment of gastroesophageal reflux disease (GERD) and the prevention of gastrointestinal (GI) bleeding. The manuscript reports the proceedings from the first practice recommendations meeting on the cardiovascular compatibility of PPIs in an Indian setting. A panel of eight Indian experts in cardiology and gastroenterology reviewed 14 consensus statements. Available literature was searched and summarized, and after multiple rounds of review, consensus was achieved for these statements. Based on the available evidence, the consensus panel highlights that a PPI with minimal drug-drug interaction (DDI) is recommended, especially in patients requiring clopidogrel or polypharmacy. Rabeprazole appears to be a good option in cases where co-prescription is indicated, owing to its optimal acid suppression and minimal drug interaction profile.

Vestibular migraine and its management in Indian clinical setting: a narrative review

Vestibular migraine (VM) is a disorder connecting two clinical conditions, migraine and vertigo. A high prevalence of VM (~30%) is reported among Indians suffering from dizziness. Yet, there is no gold standard for diagnosis and treatment. Trials specifically for patients with VM are scarce. This review provides an overview on VM and its management in the Indian clinical setting. An evidence-based discussion and review of literature on VM was performed by expert panelists, and opinions were gathered. Experts opined that in vertigo clinics, around 50% of patients are diagnosed with VM, with a higher predominance in females aged 30-50 years, while in children, the age of manifestation is 12-14 years. The most common presenting symptoms of VM among adults are spontaneous vertigo, followed by positional vertigo with headache, nausea, vomiting, photophobia and phonophobia, while intolerance to loud sounds and sudden falls are common symptoms in children with VM. Common comorbidities associated with VM are benign paroxysmal positional vertigo (BPPV) and Meniere’s disease (MD). Experts opined that there are currently no approved standardized treatment protocols for VM. The steps in the management of VM include diet and lifestyle modification, along with medicines for symptomatic relief (abortive) and prophylaxis and vestibular rehabilitation. Globally, prochlorperazine, a vestibular suppressant, is widely used for the management of vertigo and its associated symptoms. According to experts, prochlorperazine 5 mg twice or thrice daily for 5-7 days can play a significant role as an abortive treatment in the management of various patient profiles of VM.

Mini-TAS as a confirmatory mapping tool for remapping areas with uncertain filarial endemicity to exclude/ include for mass drug administration: A report from field validation in India.

India has targeted elimination of lymphatic filariasis (LF) through mass drug administration (MDA) by 2027. Mapping of LF endemic areas is a priority for implementation of MDA. Current national LF remapping tool for unsurveyed/uncertain districts, have many limitations. The WHO has recommended a sensitive and rapid remapping protocol (Mini-TAS), that needs validation in Indian setting. Hence, in the present study a comparative assessment of these two protocols (national protocol vs Mini-TAS) was undertaken in two non-MDA districts of Odisha, with unknown filarial endemicity but reporting chronic cases. Purposive sampling was done in five top sites based on filarial case count as per the national protocol. Random 30 cluster survey was done by conducting school based Mini-TAS, Microfilariae (Mf) survey among adults (>10 years) in villages/wards with schools and Molecular Xenomonitoring (MX) of infection in vectors. Costing by activity and items of the surveys was acomplished using itemized cost menu. In Kalahandi, one of the five purposive sampling sites showed Mf prevalence above threshold (> 1%). But except Mini-TAS neither MX nor house-hold Mf survey among adults could detect the infection above the threshold. While in Balangir, Mf prevalence in all purposive sampling sites,Mini-TAS, Mf prevalence among adult and MX were above the respective thresholds confirming endemicity of LF in the district. The per sample cost of purposive sampling for Mf was the lowest INR 41, followed by adult Mf sampling INR 93. Mini-TAS and MX were expensive with INR 659 and 812 respectively. The study demonstrates that though all the sampling methods could detect filarial infection above the threshold in high-risk areas, Mini-TAS could only detect infection in low-risk areas. Therefore, in the national programme Mini-TAS can be used as a decision-making tool to determine whether to exclude/ include a district having uncertain endemicity for MDA.

Outcomes and Prognostic Factors in Patients with Primary Mediastinal B Cell Lymphoma: An Experience from Hematology Cancer Consortium

The treatment of Primary Mediastinal B Cell Lymphoma(PMBCL) has evolved from R-CHOP and V/MACOP-B chemotherapy to the use of dose-adjusted R-EPOCH(DA-R-EPOCH) after the pivotal NCI trial showed an improved 5 year EFS of 93% and 5 year OS of 97%. The former relied on consolidative RT, whereas the latter omitted RT for most of its patients. Being a rare disease, data from India is minimal. The need for inpatient care for continuous infusion and increased toxicity associated with DA-R-EPOCH, viz., neutropenic fever, mucositis, and neuropathy, makes it a resource-intense protocol. This retrospective multicentric study collected the data from seven- member centers of Hematology Cancer Consortium (www.hemecancer.org) using an electronic database, to analyze the clinical characteristics, treatment patterns, outcomes, and prognostic factors in newly diagnosed PMBCL diagnosed between 2015-2020. Patients who had received more than 2 weeks of chemotherapy or steroids prior to presentation were excluded. The data included demographic details, performance status (ECOG), CNS involvement, stage, treatment type, response to treatment, and treatment-related mortality as assessed by the investigator of the respective center. The primary objective was to evaluate event-free survival at 2 years. Secondary objectives were to evaluate the 2-year overall survival, the impact of age, Performance Status, stage, treatment regimen, and use of RT on the EFS and OS. Other endpoints included the evaluation of end of treatment response based on the protocol used and to assess the treatment-related toxicities. A total of 103 patients were included in this study. Of these, 95 patients received treatment and were analysed for outcomes and prognostic factors. There was no significant difference between the treated and untreated cohort. The baseline characteristics of the treated patients are summarized in Table 1. The median age of the patients was 28 years (IQR: 23 - 36). More than half the patients were men(male - 54.7%). B symptoms were present in 42 (44.7%) patients. Close to 60% of patients had baseline PS of 0 or 1 and 70% had only supradiaphragmatic disease. Bulky disease(&amp;gt;7 cm) at presentation was present in 60 patients(63%), &amp;gt;10 cm in 42 patients(44.2%), 21 patients (22.1%) had extra-nodal disease, and 40 patients(42%) had stage III/IV disease. The median LDH at presentation was 673 units/Litre(IQR: 405 - 1117.5). A total of 79 patients(83.2%) received DA-R-EPOCH as first-line chemotherapy, 9 patients(9.5%) received R-CHOP and the remaining patients received other regimens(COP, CHOP-E). Dose of chemotherapy was compromised in 23 patients (24.2%). Amongst the patient who received DA-R-EPOCH, maximum dose level of 3 or more was achieved in 51 patients(64.55%). Close to 90% of the patients received 6 or more cycles of chemotherapy. End-of-treatment response of CR/PR was achieved in 69 patients(72.7%). Radiation therapy was administered in 44 patients(46.3%) of which 38 (40%) received RT as consolidation after the first line chemotherapy. After a median follow-up of 35 months, 22 patients relapsed, and 8 patients died. 2 year EFS was 74% (95%CI: 69% - 79%) and 2 year OS was 92% (95%CI: 89% - 95%). On univariate analysis, achievement of CR at end of treatment(HR - 0.18; 95%CI- 0.06,0.56; P = 0.003) and receipt of 6 or more cycles of chemotherapy(HR - 0.17; 95%CI - 0.05 - 0.58; P = 0.005) positively impacted the EFS. On multivariate analysis, achievement of CR at the end of treatment (HR - 0.18; 95%CI - 0.06 - 0.56; P - 0.003) was the only factor which impacted the EFS. The treatment-related mortality was 8.4% (8/95). Febrile neutropenia was the most common toxicity seen in 48 patients (50.5%) followed by neuropathy in 10 patients (10.5%). Our data, one of the largest datasets of PMBCL, highlights the efficacy of DA-R-EPOCH in PMBCL in the Indian setting, albeit with survival lesser than the pivotal NCI trial and the North American retrospective data. The inferior outcomes could have been contributed by the heterogeneity in the first line chemotherapy (16 patients (16.8%) received non-DA-REPOCH regimen), dose compromise (seen in 23% of this cohort) and administration of DAREPOCH at lower dose levels (Dose level of less than 3 in 27%). In contrast to the previous DA-REPOCH trials, close to 40% of the patients received RT as consolidation. Being a retrospective study, selection bias remains a major limitation of this analysis.