van Beurden Isabeau, van de Beek Megan J, van Heteren Jan A A, Smit Adriana L, Stegeman Inge
Department of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
Department of Clinical and Experimental Neuroscience, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, Netherlands.
Front Neurol. 2021 Jun 10;12:669501. doi: 10.3389/fneur.2021.669501. eCollection 2021.
We aimed to study the prevalence of selective reporting of primary and secondary outcomes in tinnitus trials and to examine if selective reporting of outcome measures is influenced by the nature and direction of its results. Selective reporting of outcome measures has been reported in several biomedical fields and can influence the clinical usefulness and implementation of outcomes of clinical trials. It is reported as one of the obstacles in finding an effective intervention for tinnitus. ClinicalTrials.gov (CT.gov) was used to identify all registered interventional tinnitus trials up to December 2015. A standardized search was used to find corresponding publications up to March 2018. The prespecified outcomes in CT.gov were compared with the outcomes reported in corresponding publication(s). The effects of the (lack of) statistical significance of trial results and the effects of funding source on record adherence were evaluated. Changes in registration elements were assessed with the Archive site of CT.gov. We found corresponding publications for 60 (64.5%) of 93 eligible tinnitus trials registered in CT.gov. Of all the publications, five (7.5%) fully reported outcome measures entirely in line with the prespecified outcome measures. Discrepancies between the prespecified and reported outcomes were found in a total of 51 (76.1%) of the studies for primary outcomes, whereas 62 (92.5%) of the studies had discrepancies in secondary outcomes. In secondary outcomes, statistical significance of trial results influenced CT.gov record adherence. In addition, there was a statistically significant difference in the rate of discrepancy in industry-funded [ = 98 (87.5%) discrepant outcomes] and non-industry funded trials [ = 172 (74.5%) discrepant outcomes] ( = 0.01). Finally, 15 (25.9%) trialists made modifications in registered outcome measures during or after the trial period. Tinnitus trials suffer from substantial outcome reporting bias. Awareness of its presence must be raised to limit the obstacles of finding an effective intervention for tinnitus.
我们旨在研究耳鸣试验中主要和次要结局的选择性报告的患病率，并探讨结局指标的选择性报告是否受其结果的性质和方向的影响。在几个生物医学领域都有关于结局指标选择性报告的报道，它会影响临床试验结果的临床实用性和应用。据报道，这是寻找耳鸣有效干预措施的障碍之一。我们使用ClinicalTrials.gov（CT.gov）来识别截至2015年12月所有注册的介入性耳鸣试验。采用标准化搜索来查找截至2018年3月的相应出版物。将CT.gov中预先指定的结局与相应出版物中报告的结局进行比较。评估试验结果（缺乏）统计学显著性的影响以及资金来源对记录依从性的影响。使用CT.gov的存档网站评估注册要素的变化。我们在CT.gov注册的93项符合条件的耳鸣试验中找到了60项（64.5%）的相应出版物。在所有出版物中，有五项（7.5%）完全按照预先指定的结局指标完整报告了结局指标。在总共51项（76.1%）的主要结局研究中发现了预先指定结局与报告结局之间的差异，而在62项（92.5%）的次要结局研究中存在差异。在次要结局中，试验结果的统计学显著性影响了CT.gov记录的依从性。此外，行业资助试验[ = 98项（87.5%）有差异的结局]和非行业资助试验[ = 172项（74.5%）有差异的结局]的差异率存在统计学显著性差异（ = 0.01）。最后，15名（25.9%）试验者在试验期间或试验期后对注册的结局指标进行了修改。耳鸣试验存在严重的结局报告偏倚。必须提高对其存在的认识，以限制寻找耳鸣有效干预措施的障碍。
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