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"Kaul, Sanjay"
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An alternative development agenda for India
\"This book provides a revamped, transformative, and fiscally sustainable developmental agenda for India to radically improve the well-being and livelihoods of its citizens. Grounded in a 'people first' approach, this alternative agenda focuses on seven vital development and inter-connected areas, including health, education, food and nutrition, child development, gender, livelihood and jobs, and urbanization. The volume highlights the systemic issues plaguing these sectors and offers pragmatic and implementable solutions to address them. The author takes cognizance of the COVID-19 pandemic and draws attention to the limitations of the current public policies and suggests cost-effective interventions and strategies that focus on the poor. The volume discusses crucial themes of universalizing healthcare, battling malnutrition and food insecurity, ensuring quality schooling, unshackling gendered mindsets, enhancing livelihoods and improving the urban quality of life to spell out a pragmatic and workable development agenda for India. Accessible and reader-friendly, the book will be an essential read for scholars and researchers of development studies, economics, public policy, governance, development policy, public administration, political studies, South Asia studies. It will also be of interest to professionals in the development sector\"-- Provided by publisher.
Book
The Cardiovascular Safety of Diabetes Drugs — Insights from the Rosiglitazone Experience
A signal of cardiovascular harm with rosiglitazone led to a new FDA policy on diabetes-drug approval. As that signal has faded in recent analyses, should FDA policy change?
The management of type 2 diabetes has been challenged by uncertainty about possible cardiovascular effects related to treatment intensity and choice of drug. Although the Food and Drug Administration (FDA) considers a decrease in glycated hemoglobin an approvable end point, very intensive glycemic control is associated with increased cardiovascular and all-cause mortality.
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The safety of specific drugs for type 2 diabetes — particularly the thiazolidinediones — has also been questioned. After rosiglitazone had been approved in the United States in 1999 and in Europe in 2000, a highly publicized meta-analysis in 2007 reported a 43% increase in myocardial infarction (P=0.03) . . .
Journal Article
Dietary Intervention for Overweight and Obese Adults: Comparison of Low-Carbohydrate and Low-Fat Diets. A Meta-Analysis
Reduced calorie, low fat diet is currently recommended diet for overweight and obese adults. Prior data suggest that low carbohydrate diets may also be a viable option for those who are overweight and obese.
Compare the effects of low carbohydrate versus low fats diet on weight and atherosclerotic cardiovascular disease risk in overweight and obese patients.
Systematic literature review via PubMed (1966-2014).
Randomized controlled trials with ≥8 weeks follow up, comparing low carbohydrate (≤120gm carbohydrates/day) and low fat diet (≤30% energy from fat/day).
Data were extracted and prepared for analysis using double data entry. Prior to identification of candidate publications, the outcomes of change in weight and metabolic factors were selected as defined by Cochrane Collaboration. Assessment of the effects of diets on predicted risk of atherosclerotic cardiovascular disease risk was added during the data collection phase.
1797 patients were included from 17 trials with <1 year follow up in 12. Compared with low fat diet, low carbohydrate was associated with significantly greater reduction in weight (Δ = -2.0 kg, 95% CI: -3.1, -0.9) and significantly lower predicted risk of atherosclerotic cardiovascular disease events (p<0.03). Frequentist and Bayesian results were concordant. The probability of greater weight loss associated with low carbohydrate was >99% while the reduction in predicted risk favoring low carbohydrate was >98%.
Lack of patient-level data and heterogeneity in dropout rates and outcomes reported.
This trial-level meta-analysis of randomized controlled trials comparing LoCHO diets with LoFAT diets in strictly adherent populations demonstrates that each diet was associated with significant weight loss and reduction in predicted risk of ASCVD events. However, LoCHO diet was associated with modest but significantly greater improvements in weight loss and predicted ASCVD risk in studies from 8 weeks to 24 months in duration. These results suggest that future evaluations of dietary guidelines should consider low carbohydrate diets as effective and safe intervention for weight management in the overweight and obese, although long-term effects require further investigation.
Journal Article
Fibrates in the Treatment of Dyslipidemias — Time for a Reassessment
No clinical benefit from modulating high triglyceride levels and low high-density–lipoprotein cholesterol levels with fibrates has been firmly established, though benefit for patients with diabetes and mixed dyslipidemia remains possible.
Lowering the concentration of low-density lipoprotein (LDL) cholesterol with statins substantially reduces the rate of cardiovascular events among patients with underlying cardiovascular disease or other risk factors. Yet a substantial risk persists, suggesting that additional lipid-modifying interventions may be needed. High triglyceride levels and low levels of high-density lipoprotein (HDL) cholesterol independently correlate with increased cardiovascular risk, and data from the National Health and Nutrition Examination Survey show that approximately 7% of the U.S. population has combined dyslipidemia of high triglycerides (≥200 mg per deciliter) and low HDL cholesterol (<40 mg per deciliter in men, <50 mg per deciliter in . . .
Journal Article
Risk and the Physics of Clinical Prediction
The current paradigm of primary prevention in cardiology uses traditional risk factors to estimate future cardiovascular risk. These risk estimates are based on prediction models derived from prospective cohort studies and are incorporated into guideline-based initiation algorithms for commonly used preventive pharmacologic treatments, such as aspirin and statins. However, risk estimates are more accurate for populations of similar patients than they are for any individual patient. It may be hazardous to presume that the point estimate of risk derived from a population model represents the most accurate estimate for a given patient. In this review, we exploit principles derived from physics as a metaphor for the distinction between predictions regarding populations versus patients. We identify the following: (1) predictions of risk are accurate at the level of populations but do not translate directly to patients, (2) perfect accuracy of individual risk estimation is unobtainable even with the addition of multiple novel risk factors, and (3) direct measurement of subclinical disease (screening) affords far greater certainty regarding the personalized treatment of patients, whereas risk estimates often remain uncertain for patients. In conclusion, shifting our focus from prediction of events to detection of disease could improve personalized decision-making and outcomes. We also discuss innovative future strategies for risk estimation and treatment allocation in preventive cardiology.
Journal Article
On Reporting of Effect Size in Randomized Clinical Trials
Published reports of randomized clinical trials tend to emphasize the statistical significance of the treatment effect (p values) rather than its magnitude (effect size), although the clinical importance of the evidence depends more on the latter than on the former. We, therefore, compared the standard measures of effect size (relative and absolute risk reduction) and nonstandard composites of these measures (the product of the relative and absolute risk reductions and information content) with conventional assessments of statistical significance for 100 trials published in The New England Journal of Medicine. The p values were reported for 100% of the trials, relative risk reductions for 89%, and absolute risk reductions for 39%. Only 35% of trials reported both standard measures, and none reported either of the nonstandard measures. The standard measures correlated weakly (unexplained variance 77%). In contrast, the nonstandard measures correlated highly (unexplained variance 1.3%) but correlated weakly with statistical significance (unexplained variance 83%). Consequently, 25% of the trial results were adjudged “clinically unimportant” despite being “statistically significant.” In conclusion, our results have shown that composite measures of effect size communicate the clinical importance of trial results better than do conventional assessments of risk reduction and statistical significance.
Journal Article
Forbidden Fruit: On the Analysis of Recurrent Events in Randomized Clinical Trials
The conventional analysis of a typical clinical trial focuses on the time to occurrence of the first among a composite set of alternative events such as death or nonfatal myocardial infarction. Subsequent recurrent events are thereby excluded from consideration to ensure that all the observations were mutually exclusive of each other. Thus, not all events occurring during follow-up will be analyzed. Consequently, some investigators are now reporting additional analyses of previously published trials based on a naive comparison of the total number of events—first events plus recurrent events—and are recommending that these additional analyses be routinely conducted in future trials. We have summarized the potential limitations of this proposal and suggest other methods to analyze recurrent events, with a particular focus on kinetic modeling. The application of this approach to several previously published trials illustrates its facility to help elucidate the causal mechanisms underlying empirical demonstrations of safety and efficacy.
Journal Article
Analysis of the Bypass Angioplasty Revascularization Investigation Trial Using a Multistate Model of Clinical Outcomes
Current cardiovascular randomized trials typically use composite outcomes. We hypothesized that the Bypass Angioplasty Revascularization Investigation (BARI) outcomes and conclusions would differ using a multistate model relative to the intervention for the composite outcome of death (D) and nonfatal Q-wave myocardial infarction (MI). We used a multistate model which uses transition paths to simultaneously assess multiple end points. Using the 10-year follow-up BARI data, we post hoc analyzed outcomes according to 3 transition paths: (1) from intervention to MI; (2) from intervention to death; and (3) from MI to death. Of 1,829 patients randomized to the intervention of percutaneous transluminal coronary angioplasty or coronary artery bypass grafting (CABG), 700 (38%) experienced the composite event D/MI which included 230 (13%) nonfatal MI and 470 (26%) death without antecedent nonfatal MI, whereas 79 of 230 (34%) experienced death after nonfatal MI. Outcomes of the 3 individual transition paths were analyzed by a multistate model. In contrast to standard survival analyses, after adjustment for baseline clinical covariates, outcomes after percutaneous transluminal coronary angioplasty or CABG were not significantly different for intervention to MI (p = 0.33) or intervention to death (p = 0.23), but MI to death favored CABG (p = 0.02). Deconstruction of the BARI data using a multistate model identifies a significant difference in individual transition-stage outcomes and therefore trial conclusions in contrast to the standard methods of survival analysis. These observations suggest multistate models should be considered in the design and analysis of randomized cardiovascular trials which use composite outcomes.
Journal Article