Journal of clinical epidemiology
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Comparing observed and expected distributions of baseline variables in randomized controlled trials (RCTs) has been used to investigate possible research misconduct, although the validity of this approach has been questioned. We explored this technique and introduced a novel metric to compare P values from baseline variables between treatment arms. ⋯ Assessing baseline P values in groups of RCTs can identify highly unusual distributions that might raise or reinforce concerns about randomization and data integrity.
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Meta-analyses inform clinical practice by summarizing treatment effect estimates based on results from several trials. However, the statistical significance of a meta-analysis (i.e., whether the pooled treatment effect is statistically significant or not) may rely on the outcome of only a few patients from specific trials in the meta-analysis. We aimed to evaluate the extent to which the statistical significance of meta-analyses can be changed (from statistically significant to nonsignificant, or vice versa) after modifying the event status of patients in specific arms of specific trials. ⋯ The statistical significance of meta-analyses often depends on the outcome of a few patients. The fragility index of meta-analyses may help in interpreting the conclusions of meta-analyses.
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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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Practice Guideline
GRADE guidelines: 22. The GRADE approach for tests and strategies-from test accuracy to patient-important outcomes and recommendations.
This article describes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group's framework of moving from test accuracy to patient or population-important outcomes. We focus on the common scenario when studies directly evaluating the effect of diagnostic and other tests or strategies on health outcomes are not available or are not providing the best available evidence. ⋯ Overall certainty may be expressed by the weakest critical step in the linked evidence. The linked approach to addressing optimal testing will often require the use of decision analytic approaches. We present an example that involves decision modeling in a GRADE Evidence to Decision framework for cervical cancer screening. However, because resources and time of guideline developers may be limited, we describe alternative, pragmatic strategies for developing recommendations addressing test use.
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To provide Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidance for assessing inconsistency, imprecision, and other domains for the certainty of evidence about the relative importance of outcomes. ⋯ We provide guidance and examples for rating inconsistency, imprecision, and other domains for a body of evidence describing the relative importance of outcomes.