Bibawy Haidy, Cossu Anne, Cogan Sophia, Rosenfeld Richard
Department of Otolaryngology, SUNY Downstate Medical Center, Brooklyn, NY, USA.
Otolaryngol Head Neck Surg. 2009 Feb;140(2):241-4. doi: 10.1016/j.otohns.2008.11.015.
To identify the frequency and quality of harms and adverse events reporting in otolaryngology journals.
A literature review.
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.
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).
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.
确定耳鼻喉科期刊中危害及不良事件报告的频率和质量。
文献综述。
对1996年至2006年的四种主要耳鼻喉科期刊进行综述。对提供治疗建议的临床研究进行危害及不良事件报告频率和质量的评估。
在总共1835篇被综述的文章中，576篇（31%）提供了治疗建议。65%的文章提及了危害或不良事件，47%明确界定了这些事件，24%描述了收集危害数据的方法。报告的危害或不良事件中位数为3个。与得出无益处结论的研究相比，得出治疗有益结论的研究更有可能未提及不良事件（优势比2.99，P = 0.007）。手术治疗研究更有可能报告危害或不良事件（优势比1.46，P = 0.046）。
耳鼻喉科期刊中危害及不良事件报告不足且描述欠佳，约三分之一的临床研究根本未提及不良事件。大多数作者未明确描述危害或不良事件（53%）或收集不良事件数据背后的方法（76%）。当发现治疗效果有益时，报告不足的可能性更大。
