Journal of clinical epidemiology
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The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group defines patient values and preferences as the relative importance patients place on the main health outcomes. We provide GRADE guidance for assessing the risk of bias and indirectness domains for certainty of evidence about the relative importance of outcomes. ⋯ This article provides guidance and examples for rating the risk of bias and indirectness for a body of evidence summarizing the importance of outcomes.
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Evidence-based medicine (EBM) has experienced numerous advances since its inception over 2 decades ago. Yet a persistent gulf remains between how medicine is actually practiced and the goal of providing care based on best available research evidence integrated with patient perspective and clinical expertise. A primary source of challenge for EBM is induced by inefficiencies in the generation, synthesis, and translation of evidence. ⋯ Based on the features of a natural ecosystem, the ecosystem of evidence is influenced by living organisms: stakeholders replete with competition and collaboration among and between them, as well as their conflicts of interest; the environment: social, cultural, economic, and/or political contexts; and nonliving components: scientific evidence, influenced by the rules, standards, and frameworks associated with evidence generation, synthesis, and translation. This article provides an analysis of the strengths and weaknesses of this ecosystem with a focus on nonliving components, specifically evidence generation, synthesis, and translation. Specific suggestions are outlined for building a stable and resilient ecosystem of evidence.
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To determine which systematic review characteristics are needed to estimate the risk of conclusion change in systematic review updates. ⋯ When estimating the risk of conclusion change in systematic review updates, information about the sizes of trials that will be added in an update are most useful. Future tools aimed at signaling conclusion change risks would benefit from complementary tools that automate screening of relevant trials.
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To investigate whether comparing observed with expected P-value distributions for baseline continuous variables in randomized controlled trials (RCTs) might be limited by randomization methods, normality and correlation of variables, or calculation of P-values from rounded summary statistics. ⋯ Randomization methods, non-normality, and strength of correlation of baseline variables did not have important effects on baseline P-value distribution or AUC-CDF, but baseline P-values calculated from rounded summary statistics are non-uniformly distributed.
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Review
Most noninferiority trials were not designed to preserve active comparator treatment effects.
To evaluate whether noninferiority trials are designed to adequately preserve the historical treatment effect of their active comparators. ⋯ Most noninferiority trials published in major medical journals could allow erroneous declarations of noninferiority.