Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study.

BACKGROUND: Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. OBJECTIVE: To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. METHODS: Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. RESULTS: The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). CONCLUSIONS: The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis.

Performance and Stability of Pearl Millet Varieties for Grain Yield and Micronutrients in Arid and Semi-Arid Regions of India.

Pearl millet [Pennisetum glaucum (L.) R. Br.] is grown under both arid and semi-arid conditions in India, where other cereals are hard to grow. Pearl millet cultivars, hybrids, and OPVs (open pollinated varieties) are tested and released by the All India Coordinated Research Project on Pearl Millet (AICRP-PM) across three zones (A1, A, and B) that are classified based on rainfall pattern. Except in locations with extreme weather conditions, hybrids dominate pearl millet growing areas, which can be attributed to hybrid vigor and the active role of the private sector. The importance of OPVs cannot be ruled out, owing to wider adaptation, lower input cost, and timely seed availability to subsidiary farmers cultivating this crop. This study was conducted to scrutinize the presently used test locations for evaluation of pearl millet OPVs across India, identify the best OPVs across locations, and determine the variation in grain Fe and Zn contents across locations in these regions. Six varieties were evaluated across 20 locations in A1 and A (pooled as A) and B zones along with three common checks and additional three zonal adapted checks in the respective zones during the 2019 rainy season. Recorded data on yield and quality traits were analyzed using genotype main effects and genotype × environment interaction biplot method. The genotype × environment (G × E) interaction was found to be highly significant for all the grain yield and agronomic traits and for both micronutrients (iron and zinc). However, genotypic effect (G) was four (productive tillers) to 49 (grain Fe content) times that of G × E interaction effect for various traits across zones that show the flexibility of OPVs. Ananthapuramu is the ideal test site for selecting pearl millet cultivars effectively for adaptation across India, while Ananthapuramu, Perumallapalle, and Gurugram can also be used as initial testing locations. OPVs MP 599 and MP 600 are identified as ideal genotypes, because they showed higher grain and fodder yields and stability compared with other cultivars. Iron and zinc concentration showed highly significant positive correlation (across environment = 0.83; p < 0.01), indicating possibility of simultaneous effective selection for both traits. Three common checks were found to be significantly low yielders than the test entries or zonal checks in individual zones and across India, indicating the potential of genetic improvement through OPVs.

Factors associated with successful tobacco use cessation among teachers in Bihar state, India: a mixed-method study.

Although tobacco use is declining in several countries including India (dropping from 35% in 2009-10 to 29% 2016-17 among adults)-it still poses a huge burden on India, as the world's second largest consumer of tobacco products. In Bihar state, with a prevalence of 25%, the Bihar School Teachers Study (BSTS) successfully enlisted teachers as role models for encouraging quitting and changing social norms pertaining to tobacco. The study used a mixed-methods approach to identify factors associated with teachers' quitting. Qualitative data were collected through focus groups with teachers and school principals. Quantitative data were collected through a written survey administered to school personnel post-intervention. Key findings from focus groups were that teachers and principals quit using tobacco and promoted cessation because they wanted to model positive behaviors; specific information about tobacco's harms aided cessation; and the BSTS intervention facilitated a school environment that supported quitting. Survey results indicated teachers who reported knowing people who quit using tobacco in the prior year were far more likely to quit as were teachers who reported that their school's tobacco policy was completely enforced. The combination of qualitative and quantitative data yielded important insights with strong implications for future interventions.

Feedback from vendors on gutka ban in two States of India.

BACKGROUND & OBJECTIVES: Beginning in 2012, all States in India eventually banned the sale of gutka. This study was conducted to investigate gutka vendors' knowledge on gutka ban, products covered under ban, penalties for non-compliance and action for enforcement by government agencies. METHODS: Twenty vendors were interviewed, 10 each in Mumbai (Maharashtra) and Indore (Madhya Pradesh) during May - June, 2013, one year after ban was imposed. Interviewers used a standardized questionnaire to assess vendors' knowledge of gutka ban, their attitude towards it and compliance to it in practice. RESULTS: All 20 vendors were aware that gutka sale was banned. However, despite ban, eight of the 10 vendors in Mumbai perceived sale of pan masala as legal. In Indore, all 10 vendors perceived sale of Indori Tambakoo, a local gutka variant, as legal. No vendor was sure about the quantum of fine applicable on being caught selling the banned product. Two vendors in Mumbai and nine in Indore admitted selling gutka. Five vendors in Mumbai and four in Indore supported an existing ban on gutka. INTERPRETATION & CONCLUSIONS: All vendors were aware of the ban on gutka and reason for it. Many vendors supported the ban. However, awareness of other products covered under ban and on fines in case of non-compliance was low. Law enforcement system needs to be intensified to implement ban. Notification of ban needs to be further strengthened and made unambiguous to explicitly include all smokeless tobacco products.

Scaling up a tobacco control intervention in low resource settings: a case example for school teachers in India.

Research on processes of bringing effective tobacco control interventions to scale to increase quit rates among tobacco users is uncommon. This study examines processes to bring to scale one such intervention for school teachers, i.e. Tobacco Free Teacher-Tobacco Free Society (TFT-TFS). This intervention provides a foundation for an effective and low cost approach to promote cessation through schools. The present study was conducted in the states of Bihar and Maharashtra in 2014 using quantitative and qualitative methods. Focus group discussions (FGDs) were analysed using immersion crystallization method. The data presented are from a survey of 291 principals and seven FGDs. This study examined characteristics of principals and teachers, organizational environment, external environmental factors and program characteristics to determine facilitators and barriers for successful dissemination and implementation of the TFT-TFS program. Some facilitators were, incorporation of the program in existing channels like staff meetings and trainings, certification and recognition by the department of education; while some barriers were routine time bound duties (mainly teaching) of teachers and prevalence of tobacco use among teachers and administrators. Principals and teachers expressed a need and high level of interest in the adoption and implementation of the TFT-TFS program in their schools.

Consensus on Management of Deep Vein Thrombosis with Emphasis on NOACs (Non-Vitamin K Antagonist Oral Anticoagulants): Recommendations from Inter-Disciplinary Group of Indian Experts.

It is estimated that around 2.5 lac patients are identified as having an acute venous thrombo-embolic event in India annually. This includes patients with deep vein thrombosis and pulmonary embolism, and is estimated to result in more than 3.7 lacs deaths each year in European countries. The 'Consensus on Management of Deep Vein Thrombosis with Emphasis on NOACs (Non-Vitamin K Antagonist Oral Anticoagulants): Recommendations from Inter-Disciplinary Group of Indian Experts' position paper was developed to assist clinicians and institutions with an evidence-based approach to the diagnosis and treatment of acute deep vein thrombosis patients. Key to the evaluation of patients with suspected deep vein thrombosis is the use of the clinician's clinical evaluation with the help of pre-test probability tools as well as judicious use of objective diagnostic tests. Our hope is that we have supplemented clinicians' clinical acumen, and assisted them and their health systems in developing best practice approaches to this ever-interesting population of patients. The Deep Vein Thrombosis Consensus Working Group welcomes your inputs on how improvements might be made on this paper in the future.

Social impacts on adult use of tobacco: findings from the International Tobacco Control Project India, Wave 1 Survey.

BACKGROUND: Social impacts on tobacco use have been reported but not well quantified. This study investigated how strongly the use of smoked and smokeless tobacco may be influenced by other users who are close to the respondents. METHODS: The International Tobacco Control Project (TCP), India, used stratified multistage cluster sampling to survey individuals aged ≥15 years in four areas of India about their tobacco use and that of their close associates. The present study used logistic regression to calculate odds ratios (ORs) for tobacco use for each type of close associate. RESULTS: Among the 9780 respondents, tobacco use was significantly associated with their close associates' (father's, mother's, friends', spouse's) tobacco use in the same form. After adjusting for confounding variables, women smokers were nine times more likely to have a mother who ever smoked (OR: 9.0; 95% confidence interval [CI]: 3.3-24.7) and men smokers five times more likely (OR: 5.4; 95% CI: 2.1-14.1) than non-smokers. Men smokers were seven times more likely to have close friends who smoked (OR: 7.2; 95% CI: 5.6-9.3). Users of smokeless tobacco (SLT) were five times more likely to have friends who used SLT (OR: 5.3; 95% CI: 4.4-6.3 [men]; OR: 5.0; 95% CI: 4.3-5.9 [women]) and four times more likely to have a spouse who used SLT (OR: 4.1; 95% CI: 3.0-5.8 [men]; OR: 4.3; 95% CI: 3.6-5.3 [women]), than non-users. The ORs for the association of the individuals' tobacco use, whether smoked or smokeless, increased with the number of close friends using it in the same form. CONCLUSION: The influence of family members and friends on tobacco use needs to be appropriately addressed in tobacco-control interventions.

Tracking intervention delivery in the 'Tobacco-Free Teachers/Tobacco-Free Society' program, Bihar, India.

In health education and behavior change interventions, process tracking monitors the delivery of an intervention and its receipt to the intended audience. A randomized controlled trial in the state of Bihar, India was conducted to help school teachers become tobacco free through appropriately designed intervention program and delivery system. We describe the results from process tracking of this intervention delivery. The intervention program was centred on six topics delivered in each school through 12 sessions over 6 successive months. The program deliverers recorded the process measures as total number of sessions and program-components implemented (fidelity); time spent conducting sessions (dose) and proportion of teachers attending at least one session (reach). The outcome measures (teachers' exposure to intervention messages and tobacco policy adoption) were assessed post-intervention. All 12 sessions were delivered in 33 out of 36 schools. Thirty-one schools implemented all six program components. In 18 schools, ≥95% of the teachers participated in one or more sessions. Thirty-three schools received 12 or more hours of dose. In 29 schools, 100% teachers reported exposure to all program messages. Tobacco policy was adopted by all schools. Thus, the intervention was generally delivered as planned and it had a positive impact on teachers and schools.

Experiences recruiting Indian worksites for an integrated health protection and health promotion randomized control trial in Maharashtra, India.

This article provides an overview of the recruitment strategies utilized in the Mumbai Worksites Tobacco Control Study, a cluster randomized trial testing the effectiveness of an integrated tobacco control and occupational safety and health program in Indian manufacturing worksites. From June 2012 to June 2013, 20 companies were recruited. Companies were identified using association lists, referrals, internet searches and visits to industrial areas. Four hundred eighty companies were contacted to validate information, introduce the study and seek an in-person meeting with a company representative. Eighty-three company representatives agreed to meet. Of those 83 companies, 55 agreed to a formal 'pitch meeting' with key decision makers at the company. Seventy-seven recruitment 'pitches' were given, including multiple meetings in the same companies. If the company was interested, we obtained a letter of participation and employee roster. Based on this experience, recommendations are made that can help inform future researchers and practitioners wishing to recruit Indian worksites. When compared with recruitment of US manufacturing worksites, recruitment of Indian worksites lacked current industrial lists of companies to serve as a sampling frame, and required more in-person visits, incentives for control companies and more assurances around confidentiality to allow occupational safety and health experts into their worksite.

Influence of tobacco industry advertisements and promotions on tobacco use in India: findings from the Global Adult Tobacco Survey 2009-2010.

INTRODUCTION: The developing world, including countries like India, has become a major target for the tobacco industry to market its products. This study examines the influence of the marketing (advertising and promotion) of tobacco products on the use of tobacco by adults (ages 15 and over) in India. METHOD: Data from Global Adult Tobacco Survey 2009-2010 was analyzed using methods for complex (clustered) sample designs. Multivariate logistic regression was employed to predict the use of different tobacco products by level of exposure to tobacco marketing using adults who have never used tobacco as the reference category. Odds ratios (ORs) were adjusted for education, gender, age, state of residence, wealth index, and place of residence (urban/rural). RESULTS: Adults in India were almost twice as likely to be current smokers (versus never users) when they were exposed to a moderate level of bidi or cigarette marketing. For bidis, among adults with high exposure, the OR for current use was 4.57 (95% confidence interval [CI]: 1.6, 13.0). Adults were more likely to be current users of smokeless tobacco (SLT) with even a low level of exposure to SLT marketing (OR = 1.24 [95% CI: 1.1, 1.4]). For SLT, the ORs showed an increasing trend (P for trend < 0.001) with greater level of exposure (moderate, OR = 1.55 [95% CI: 1.1, 2.2]; high, OR = 2.05 [95% CI: 0.8, 5.1]). The risk of any current tobacco use rose with increasing level of exposure to any marketing (minimum, OR = 1.25 [1.1-1.4]; moderate, OR = 1.38 [1.1-1.8]; and high, OR = 2.73 [1.8-4.2]), with the trend highly significant (P < 0.001). CONCLUSION: Exposure to the marketing of tobacco products, which may take the form of advertising at the point of sale, sales or a discounted price, free coupons, free samples, surrogate advertisements, or any of several other modalities, increased prevalence of tobacco use among adults. An increasing level of exposure to direct and indirect advertisement and promotion is associated with an increased likelihood of tobacco use.

Improvement in prevalence of tobacco use among teachers in Bihar after COTPA.

CONTEXT: A high prevalence of tobacco use, even among educated professionals like teachers, has been reported from Bihar. After passing of the Cigarette and Other Tobacco Products Act (COTPA) in 2003, there have been major improvements in tobacco control nationwide. AIMS: To compare tobacco use prevalence among school teachers in Bihar reported in 2000 with a survey in 2008 and investigate correlates of current and past tobacco-use. METHODS: Data from the baseline survey of a cluster random sample of 72 government schools conducted during the beginning of two consecutive school years was analyzed. RESULTS: The prevalence of current tobacco use was 35.5% and past use, 11.3%. Likelihood of current use compared with no use increased with age (odds ratio [OR] =3.27 for > 50 years compared to < 30, 95% confidence interval [CI]: [1.50, 7.13]); whereas that of past use compared to current use decreased (OR = 0.25, 95% CI: [0.09-0.68] for age > 50 years compared to < 30 years). DISCUSSION: Compared to the tobacco use prevalence among Bihar school teachers reported from a survey in the year 2000 (77.4%), the prevalence in this survey in 2008 was much lower and past use, much higher. In the earlier survey, lal dantmajan was counted as a tobacco product. If we do the same in the current survey, and consider ever use, the prevalence even then was 53.9%, lower than the earlier figure. Although the tobacco use among teachers in Bihar is still high, it has decreased after the implementation of COTPA and the cessation has increased.

Quit history, intentions to quit, and reasons for considering quitting among tobacco users in India: findings from the Tobacco Control Policy Evaluation India Wave 1 Survey.

BACKGROUND: Global Adult Tobacco Survey India 2009-2010 revealed that more than one-third (35%) of adults in India use tobacco in some form: 21% use smokeless tobacco, 9% smoke, and 5% are mixed users (they smoke and use smokeless tobacco), and the quit rate is very low. In an effort to decrease prevalence of tobacco use, it is thus important to understand the factors that are related to intention to quit among Indian tobacco users. Research has shown consistently that intention to quit is a strong predictor of future quitting. The present study reports the factors encouraging quitting tobacco products in India. SUBJECTS AND METHODS: Cross-sectional data from Wave 1 of the International Tobacco Control Policy Evaluation India Survey conducted in four cities and surrounding rural areas (i.e. Mumbai [Maharashtra], Patna [Bihar], Indore [Madhya Pradesh], and Kolkata [West Bengal]) between August 2010 and December 2011 were analyzed. A total of 8051 tobacco users (15+ years) were randomly sampled from 8586 households: 1255 smokers, 5991 smokeless users, and 805 mixed (smoke and smokeless) users. Validated, standardized questions were asked about current tobacco use, intention to quit, and factors encouraging quitting. RESULTS: Overall, 19.6% of tobacco users intended to quit. Smokers had less intention to quit as compared to smokeless tobacco users whereas mixed users had more intention to quit (odds ratio [OR] =1.48, 95% confidence interval [CI] =1.12-1.97) compared to smokeless tobacco users. Highly educated people were more likely to report intention to quit (OR = 1.82, 95% CI = 1.09-3.02) compared to less educated. Advice by doctors to quit tobacco had a strong impact on intention to quit (OR = 1.68, CI = 1.29-2.15). Tobacco users who were exposed to antitobacco messages at work places (OR = 1.74, CI = 1.23-2.46), at restaurants (OR = 1.65, CI = 1.12-2.43), bars (OR = 1.81, CI = 1.07-3.06), on public transportation (OR = 2.14, CI = 1.49-3.08) and on tobacco packages (OR = 1.77, CI = 1.29-2.14) also expressed greater intention to quit tobacco use. CONCLUSION: Around one-fifth of tobacco users in India intended to quit tobacco use. Higher education, doctor's advice, and antitobacco messages were positively associated with users' intention to quit tobacco.