Reporting of harms and adverse events in otolaryngology journals

Abstract

Objective: To identify the frequency and quality of harms and adverse events reporting in otolaryngology journals. Study Design: A literature review. Methods: Four major otolaryngology journals from 2006 and 1996 were reviewed. Clinical research studies offering therapeutic recommendations were evaluated for frequency and quality of harms and adverse events reporting. Results: Of 1,835 total articles reviewed, 576 (31%) offered therapeutic recommendations. Sixty-five percent provided any mention of harms or adverse events, 47 percent explicitly defined the events, and 24 percent described methodology for collecting harms data. The median number of harms or adverse events reported was three. Studies concluding a beneficial effect of therapy were more likely to not mention adverse events (odds ratio 2.99, P = .007) compared with studies concluding no benefit. Studies of surgical therapy were more likely to report harms or adverse events (odds ratio 1.46, P = .046). Conclusions: Harms and adverse events are underreported and poorly described in otolaryngology journals with about one third of clinical research not mentioning adverse events at all. Most authors do not explicitly describe harms or adverse events (53%) or the methodology behind collecting adverse events data (76%). Underreporting is more likely when a therapeutic effect is found to be beneficial.