Harm and Adverse Events in Otolaryngology Journals

Objective To identify the frequency and quality of harm and adverse events reporting in otolaryngology journals. Methods Four major otolaryngology journals from 2006 and 1996 were reviewed. Clinical research studies offering therapeutic recommendations were evaluated for frequency and quality of harm and adverse events reporting. Results Of 1835 total articles reviewed, 576 (31%) offered therapeutic recommendations. Only 65% provided any mention of harm or adverse events; 47% explicitly defined the events and 24% described methodology for collecting harm data. The median number of harms or adverse events reported was 3. Studies concluding a beneficial effect of therapy were more likely to not mention adverse events (odds ratio 2.99, p= 0.007), compared to studies concluding no benefit. Studies of surgical therapy were more likely to report harm or adverse events (odds ratio 1.46, p= 0.046) than medical therapy. Conclusions Harm and adverse events are under-reported and poorly described in otolaryngology journals, with about 1/3 of clinical research not mentioning adverse events at all. Most authors do not explicitly describe harm or adverse events (53%), or the methodology behind collecting adverse events data (76%). Under-reporting is more likely when a therapeutic effect is found to be beneficial.