Urology studies increasingly likely to report treatment harms, researchers report

Randomized controlled trials (RCTs) in urology are more likely to publish data on the adverse effects (AEs) of urologic treatment than in previous years, according to a recent study published in The Journal of Urology.¹

"Our analysis finds a marked increase in reporting of potential harms in randomized treatment trials published in top-ranked urology journals," says Reece M. Anderson, MPH.

The findings provide updated data regarding harms reported in urologic research, which was studied in 2010 in a paper published in The Journal of Urology. The study found “significant deficiencies” in the reporting of AEs for urology treatments.²

For the current study, investigators analyzed 132 RCTs published in The Journal of Urology, Urology, European Urology, and BJU International from 2012 to 2020. The most common RCT topics were oncology (34.8%) and voiding dysfunction (27.5%). The studies were also most commonly investigating procedures/surgeries (38.4%) and drugs (37.7%).

Adherence to harms based on the Consolidated Standards of Reporting Trials (CONSORT) group guidelines on harms reporting, which were published in 2004, was assessed by 2 masked-duplicate authors.

Investigators found that the median number of harms criteria reported in RCTs increased from 5.3 (QR: 2.3-7.8) among papers in 2012 to 7.2 (IQR: 4.2-8.2) among papers in 2020 (P = .01).

Further, papers published in 2020 reported over three-fourths of the items included in the CONSORT harm reporting guidelines. This is an improvement over findings from the 2010 study, which showed that only one-third of items in CONSORT guidelines were addressed.² This also marks a nearly 40% increase since 2004, when the CONSORT guidelines were published.

Factors found to be associated with the median number of criteria reported were study topic (P = .038) and type of intervention (P = .015). There was no association observed with journal, sample size, funding source, or number of participating centers.

"Our analysis finds a marked increase in reporting of potential harms in randomized treatment trials published in top-ranked urology journals," commented lead author Reece M. Anderson, MPH, in a news release on the findings.³ Anderson is a medical student researcher at Oklahoma State University Center for Health Sciences in Tulsa. "This information will help to improve informed decision-making about urology treatments and contribute to improving the quality of urology research."

More detailed findings from the recent analysis showed that 66.7% of studies discussed harm in the abstract, and 64.5% discussed harm in the introduction. Regarding CONSORT guideline checklist items for the discussion section, 71% included an interpretation of harms, 67.4% included generalizability, and 82.2% included current evidence.

In comparing 2020 data with 2012 data, there were significant increases in reporting for several CONSORT criteria, including the plan to compare harms between groups (P = .017), denominators for harm outcomes (P < .005), stratified serious and minor harms (P = .008), and discussion of current evidence (P = .007).

However, the authors note that deficiencies still remain.

They concluded, “Despite the progress made, there is still a need for ongoing efforts to ensure that harms reporting meets the highest standards of transparency and accuracy.”¹

References

1. Anderson RM, Peña A, Magee T, Perkins D, Johnson BS, Breau RH, Vassar M. Reporting of harms in randomized controlled trials published in urology journals: An updated analysis. J Urol. Published online ahead of print December 8, 2023. Accessed December 12, 2023. doi:10.1097/JU.0000000000003740

2. Breau RH, Gaboury I, Scales CD, Fesperman SF, Watterson JD, Dahm P. Reporting of harm in randomized controlled trials published in urological literature. J Urol. 2010;183(5):1693-7. doi:10.1016/j.juro.2010.01.030

3. Urology treatment studies show increased reporting of harmful effects. News release. Wolters Kluwer Health: Lippincott. December 11, 2023. Accessed December 12, 2023. https://www.newswise.com/articles/urology-treatment-studies-show-increased-reporting-of-harmful-effects