Assessment of consistency in the risk of bias in medical randomized controlled trials in China

Corresponding author: LOU Wen, wlou@infor.ecnu.edu.cn

DOI: 10.12201/bmr.202505.00027

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  Abstract: Objective/Significance The explosive growth of medical literature has made clinical decision-making reliant on high-quality evidence, and the consistency of this evidence has become an urgent issue to be addressed. Inconsistent interpretations of various bias assessment tools can lead to a reduction in the reliability of meta-analysis results and may mislead clinical decisions. This study aims to provide more scientific and unified evaluation standards for clinical research and meta-analysis, thus promoting the improvement of medical evidence quality. Methods/Process 390 duplicate risk bias assessment records were retrieved from the CNKI database. These records were analyzed from three perspectives: overall result consistency, thematic and content consistency, and indicator consistency. Results Over 80% of the groups exhibited inconsistent risk assessments for the same randomized controlled trial. In terms of thematic content, the consistency of research in Traditional Chinese Medicine was found to be relatively low, with poor consistency in assessing treatment efficacy and safety. Significant differences were found in the indicators of selective reporting, completeness of outcome data, and other biases.

  Key words: Bias Risk; Consistency; RCT; Meta-Analysis

  Submit time: 21 May 2025

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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