Reporting of Harms in Randomized Controlled Trials Published in Urology Journals: An Updated Analysis

Research output: Contribution to journalArticlepeer-review


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 languageEnglish
Pages (from-to)48-54
Number of pages7
JournalJournal of Urology
Issue number1
StatePublished - 1 Jan 2024


  • adverse effects
  • checklist
  • evidence-based medicine
  • randomized controlled trials as topic
  • urology


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