3 research outputs found

    A review on generation of real-world evidence

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    Real-world evidence can generate credible evidence to inform treatment decisions. Real-world evidence is in developmental stage and is fast evolving yet there are many unexplained attributes of real-world evidence. Real-world evidence informs benefit-risk decisions and is increasingly being used to support regulatory decision making. Potential benefits of real-world data include determination of extended outcomes including long-term outcomes, opportunities to partner with patients in innovative ways, and reduction in time and cost to generate dependable evidence. Limitations of real-world evidence include uncertainty in the quality of datasets and lack methodologic rigor in real-world studies. Use of real-world evidence for healthcare practices and policies is limited. Ensuring completeness, homogeneity, and linkage of datasets can enhance utility for epidemiological investigations and improvement in health outcomes. Research should be strengthened for real-world studies and technical standards should be reinforced. Collaborations of stakeholders is key to formulation and adoption of guidance for real-world evidence. Real-world data cannot be a substitute to randomized clinical studies but can possibly augment the generated evidence

    Management of anemia in patients with diabetic kidney disease: A consensus statement

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    This consensus statement focuses on the window of opportunity, which exists while treating patients with diabetic kidney disease and anemia

    Consensus dietary guidelines for healthy living and prevention of obesity, the Metabolic syndrome, Diabetes, and related disorders in Asian Indians

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    India is undergoing rapid nutritional transition, resulting in excess consumption of calories, saturated fats, trans fatty acids, simple sugars, salt and low intake of fiber. Such dietary transition and a sedentary lifestyle have led to an increase in obesity and diet-related non-communicable diseases (type 2 diabetes mellitus [T2DM], cardiovascular disease [CVD], etc.) predominantly in urban, but also in rural areas. In comparison with the previous guidelines, these consensus dietary guidelines include reduction in the intake of carbohydrates, preferential intake of complex carbohydrates and low glycemic index foods, higher intake of fiber, lower intake of saturated fats, optimal ratio of essential fatty acids, reduction in trans fatty acids, slightly higher protein intake, lower intake of salt, and restricted intake of sugar. While these guidelines are applicable to Asian Indians in any geographical setting, they are particularly applicable to those residing in urban and in semi-urban areas. Proper application of these guidelines will help curb the rising "epidemics" of obesity, the metabolic syndrome, hypertension, T2DM, and CVD in Asian Indians
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