Adverse Event Reporting in Dermatology RCTs Falls Short of CONSORT Harms Guidelines: Analysis

A new review assessing adverse event (AE) reporting in dermatology randomized controlled trials (RCTs) has significant gaps in adherence to the Consolidated Standards of Reporting Trials (CONSORT) Harms guidelines.

The systematic review included 125 RCTs published in dermatology journals in 2022. The median number of CONSORT Harms items reported per trial was 5 out of 13. Just 2% of trials demonstrated full adherence and 14% reported none of the items. Although basic AE data presentation was common, details like severity grading (27%) and attribution methods (2%) were rarely reported.

Among the factors the study identified as influencing AE reporting quality:

• Trials published in higher-impact journals (impact factor > 5) had significantly better adherence to CONSORT Harms guidelines
• Trials funded by industry showed better adherence to CONSORT Harms guidelines.
• Behavioral intervention trials reported significantly fewer CONSORT Harms items than pharmacologic trials.

Dermatology journals showed an average adherence rate of 39%, which was lower than rates reported in other specialties (41% to 67%). The findings echo prior reviews, indicating frequent omission of AE definitions, data collection methods, and statistical comparisons.

"In conclusion, we found poor quality of AE reporting in trials published in dermatology-specific journals, particularly regarding AE definitions, severity grading and analysis methods," the authors wrote. "Our findings underscore the need for better implementation of the CONSORT Harms guidance."

Some limitations were also included in the research letter. 

Source: Song Z, et al. Journal of Investigative Dermatology. 2025. Doi:10.1016/j.jid.2025.02.144