Abstract
Purpose: Harms are often overlooked, but important, outcomes of randomized controlled trial reporting. Our goal was to determine if harms reporting has improved in high-impact urology journals.
Materials and Methods: Randomized controlled trials published in The Journal of UrologyÒ, Urology, European Urology, and BJU International in 2012 and 2020 were analyzed. Each randomized controlled trial was evaluated by 2 authors in a masked-duplicate fashion to evaluate for adherence to harms reporting guidelines recommended by the Consolidated Standards of Reporting Trials (CONSORT) group.
Results: One hundred and thirty-two published studies met inclusion criteria. Between 2012 and 2020, there was a statistically significant increase in the median number of harms criteria reported between 2012 and 2020 (5.3 vs 7.2; P [ .01). Methods criteria demonstrating the greatest improvements included item #3 “which harms were assessed,” item #4a “when harm information was collected,” and item #4b “methods to attribute harm to intervention.” Results sections with the most improvement in reporting include item #6 “reasons for patient withdrawal,” item #8a “effect size for harms,” and item #8b “stratified serious D minor harms.”
Conclusions: Reporting of adverse events in randomized trials published in several top urology journals has demonstrated marked improvement. Studies published in 2020 reported approximately 70% of CONSORT-Harms criteriadan increase of nearly 40% since 2004. While these improvements mark significant change, deficits remain present and should be addressed to provide clinicians with the most complete perspective possible.
Original language | English |
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Pages (from-to) | 48-54 |
Number of pages | 7 |
Journal | Journal of Urology |
Volume | 211 |
Issue number | 1 |
DOIs | |
State | Published - 1 Jan 2024 |
Keywords
- adverse effects
- checklist
- evidence-based medicine
- randomized controlled trials as topic
- urology