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Misreporting of Patient-Relevant and Study Design Elements in Anesthesiology Randomized Controlled Trials: An Observational Study.


ABSTRACT: Background/Objectives: The quality of trial data reporting within the field of anesthesiology has, to date, been insufficiently examined. This study aims to investigate the consistency of reporting for WHO Data Set Items, trial outcomes, and adverse events between the data reported in ClinicalTrials.gov and the corresponding peer-reviewed publications in a cohort of anesthetic-related randomized controlled trials (RCTs) subject to the FDAAA. Methods: In a cross-sectional study, we investigated RCTs performed on 29 drugs in anesthesiology. We examined data reporting for eight categories, including the results and outcome probability measures, adverse events, all-cause mortality, study size, study outcome, study arm, selection criteria, and date of enrollment. We also examined

SUBMITTER: Vukovic I 

PROVIDER: S-EPMC12735231 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature