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MedDRA Adoption and Adverse Event Reporting Quality in Gastrointestinal and Abdominal Surgery Randomized Controlled Trials: A Cross-Sectional Analysis
2026-02-05
health systems and quality improvement
Title + abstract only
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IntroductionAdverse event (AE) reporting transparency is essential for evidence-based surgical practice, yet substantial reporting gaps persist despite Consolidated Standards for Reporting Trials (CONSORT) Harms guidance. The Medical Dictionary for Regulatory Activities (MedDRA) provides standardized terminology for AE classification, but its association with AE reporting quality remains unexplored. ObjectivesThe purpose of this study was to establish the frequency of Medical Dictionary for Reg...
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