Department of Otorhinolaryngology and Head & Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Clinical and Experimental Neuroscience, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, The Netherlands.
PLoS One. 2019 Jul 10;14(7):e0219458. doi: 10.1371/journal.pone.0219458. eCollection 2019.
To examine 1) the publication rate of registered otology trials in ClinicalTrials.gov, 2) the public availability of the results, 3) the study characteristics associated with publication, and 4) the time to publication after trial completion.
Publication bias, the publication or non-publication of research findings, depending on the nature and direction of results, is accountable for wrong treatment decisions. The extent of publication bias in otology trials has not been evaluated.
All registered otology trials were extracted from ClinicalTrials.gov with completion date up to December 2015. A search strategy was used to identify corresponding publications up to June 2017, providing at least 18 months to publish the results after trial completion. Characteristics were obtained from ClinicalTrials.gov and corresponding publications. Regression models were used to examine study characteristics associated with publication or non-publication.
From the 419 trials identified on ClinicalTrials.gov, 225 (53.7%) corresponding publications were found in PubMed. Among these, 109 (48.4%) publications were cited on ClinicalTrials.gov and 124 (55.1%) articles reported the National Clinical Trial registry number. For 36 (8.6%) trials, results were only reported in ClinicalTrials.gov. Trials with a biological intervention were more likely to be published than studies involving drugs (odds ratio (OR) 10.41, 95% confidence interval (CI) 1.26-86.22, P = 0.030). Trials funded by industry were less likely to be published (OR 0.46, CI 0.25-0.84, P = 0.011). The median trial duration was 20 months (interquartile range (IQR) 26 months), and median time from trial completion to publication was 24 months (IQR 22 months).
In 37.7% of the registered otology trials the results remained unpublished, even several years after trial completion. With little citations on ClinicalTrials.gov and low reporting of the Clinical Trial registry number, the accessibility is limited. Our findings show that there is room for improvement in accuracy of trial registration and publication of results, in order to diminish publication bias in otology studies.
检查 1）ClinicalTrials.gov 注册的耳科学试验的发表率，2）结果的公开可用性，3）与发表相关的研究特征，以及 4）试验完成后发表的时间。
根据结果的性质和方向，出版偏倚，即研究结果的出版或不出版，可能导致错误的治疗决策。耳科学试验中的出版偏倚程度尚未得到评估。
从 ClinicalTrials.gov 中提取所有已完成的耳科学试验，截止日期为 2015 年 12 月。使用一种搜索策略来确定截至 2017 年 6 月的相应出版物，为试验完成后发表结果提供至少 18 个月的时间。从 ClinicalTrials.gov 和相应的出版物中获取特征。使用回归模型检查与发表或不发表相关的研究特征。
在 ClinicalTrials.gov 上确定的 419 项试验中，在 PubMed 上找到了 225 项（53.7%）对应的出版物。其中，109 项（48.4%）出版物在 ClinicalTrials.gov 上被引用，124 项（55.1%）文章报告了国家临床试验注册编号。对于 36 项（8.6%）试验，结果仅在 ClinicalTrials.gov 上报告。涉及生物干预的试验比涉及药物的试验更有可能发表（比值比（OR）10.41，95%置信区间（CI）1.26-86.22，P=0.030）。工业界资助的试验不太可能发表（OR 0.46，CI 0.25-0.84，P=0.011）。试验的中位数持续时间为 20 个月（四分位间距（IQR）为 26 个月），从试验完成到发表的中位数时间为 24 个月（IQR 为 22 个月）。
在已注册的耳科学试验中，有 37.7%的试验结果仍未发表，甚至在试验完成数年后也是如此。ClinicalTrials.gov 上的引用很少，临床试验注册编号的报告也很低，因此可及性有限。我们的发现表明，需要提高试验注册和结果发表的准确性，以减少耳科学研究中的出版偏倚。
