Journal of clinical epidemiology
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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.
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To analyze data sharing practices among authors of randomized controlled trials (RCTs) published in seven high-ranking anesthesiology journals from 2014 to 2016. ⋯ Willingness to share data among anesthesiology RCTs is very low. To achieve widespread availability of de-identified trial data, journals should request their publication, as opposed to only encouraging authors to do so.
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This article presents official guidance from the Grading of Recommendations Assessments, Development, and Evaluation (GRADE) working group on how to address incoherence when assessing the certainty in the evidence from network meta-analysis. Incoherence represents important differences between direct and indirect estimates that contribute to a network estimate. ⋯ Reviewers need to be alert to the possibility of misguidedly arriving at excessively low ratings of certainty by rating down for both incoherence and other closely related GRADE domains. This article describes and illustrates each of these issues and provides explicit guidance on how to deal with them.
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The aim of the article was to assess the appropriateness and rationales of subgroup analyses planned in protocols of randomized controlled trials and reported in subsequent corresponding trial publications. ⋯ Inappropriate specification and reporting of subgroup analyses remain problematic in protocols and reports of randomized controlled trials. Justifications or rationales for subgroup analyses were only rarely provided in trial protocols and reports.
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To determine how often stepped-wedge cluster randomized controlled trials reach their planned sample size, and what reasons are reported for choosing a stepped-wedge trial design. ⋯ About half of recently published stepped-wedge trials reached their planned sample size indicating that recruitment is also a major problem in these trials. Still, the stepped-wedge trial design can yield practical, ethical, and methodological advantages.