School of Medicine, University of Split, Šoltanska 2, 21000, Split, Croatia.
Department of Psychiatry, Clinical Hospital Centre Split, Spinčićeva 1, 21000, Split, Croatia.
Eur Child Adolesc Psychiatry. 2022 May;31(5):757-769. doi: 10.1007/s00787-020-01710-5. Epub 2021 Jan 18.
Outcome reporting bias is one of the fundamental forms of publication bias. It implies publishing only outcomes that have positive results. The aim of this observational study was to explore primary outcome discrepancies between registry of clinical trials and their corresponding publications, since these can indicate outcome reporting bias in child mental health. Data were extracted from completed interventional clinical trials from ClinicalTrial.gov registry and its Archive site. Trials were registered under "Behaviours and Mental Disorders" category, and conducted on underage participants (0-17 years). Their primary outcomes were compared to those published in publication which had a corresponding NCT number stated in the text. Sixteen percent of trials did not have the minimum information on primary outcome stated in the registry-neither the measure used nor the measurement time points; 38.9% of trials had the minimum information stated to describe primary outcome, while only 3.3% of trials had all the necessary elements stated in the registry. Most of the publication in our sample had positive results (66.4%). Half of the trials registered before completion had non-matching primary outcomes in the registry and publication; 85.4% of trials with non-matching outcomes indicated possible outcome reporting bias for some of the primary outcome. Middle-sized trials and industry-funded trials were related with higher quality of primary outcome registration. Industry funding was related with positive findings in publication. Non-industry funding proved to be the only significant predictor of discrepancy between registered and published primary outcomes, and possible outcome reporting bias. Journal impact factor was not related with any of the outcome measures. The main limitation of the study is that it primarily offers an insight into discrepancy of registered and published outcomes. The methodology does not imply an access to results of unpublished outcomes - therefore, it was not possible to determine the presence of the bias with sufficient certainty in large number of trials. Further research should be done with improved methodology and additional data.
结局报告偏倚是发表偏倚的基本形式之一。它意味着只发表具有阳性结果的结局。本观察性研究的目的是探索临床试验注册与相应出版物之间主要结局的差异，因为这可能表明儿童心理健康结局报告偏倚。数据从 ClinicalTrial.gov 注册库及其存档网站中已完成的干预性临床试验中提取。试验按照“行为和精神障碍”类别注册，并在未成年参与者（0-17 岁）中进行。将其主要结局与在出版物中发表的结局进行比较，这些出版物在文本中都有相应的 NCT 编号。16%的试验在注册库中未报告主要结局的最小信息，既未报告使用的措施，也未报告测量时间点；38.9%的试验报告了描述主要结局的最小信息，而只有 3.3%的试验在注册库中报告了所有必要的信息。我们样本中的大多数出版物都有阳性结果（66.4%）。一半在完成前注册的试验在注册库和出版物中都有不匹配的主要结局；85.4%的不匹配结局试验表明，某些主要结局可能存在结局报告偏倚。中等规模的试验和行业资助的试验与主要结局注册的高质量有关。行业资助与出版物中的阳性发现有关。非行业资助被证明是注册和发表的主要结局之间差异以及可能的结局报告偏倚的唯一显著预测因子。期刊影响因子与任何结局指标都无关。该研究的主要局限性在于，它主要提供了对注册和发表结局差异的深入了解。该方法并不意味着可以获得未发表结局的结果，因此，在大量试验中，无法确定偏倚的存在。应使用改进的方法和其他数据进一步研究。
