School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.
Department of Endodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.
J Dent. 2022 Aug;123:104183. doi: 10.1016/j.jdent.2022.104183. Epub 2022 Jun 9.
To record the proportion of Randomized Controlled Trials (RCTs) reporting significant (versus non- significant) primary outcomes, published across 12 high impact journals in Dentistry, covering 6 specialty domains. Associations with certain journal, publication and outcome characteristics were examined.
We identified and included all RCTs published from January 1st, 2017 to December 31st, 2021 in the two journals with the highest impact factors (Clarivate Analytics, 2020) from each of the following domains: Periodontology, Endodontics, Restorative Dentistry/ Prosthodontics, Orthodontics, Paediatric Dentistry, Oral and Maxillofacial Surgery. The primary outcome was the proportion of significant/ non- significant findings reported for the primary outcomes under study, while a range of characteristics such as: journal, year of publication, impact factor, funding, registration and others, were tested for associations.
A total of 474 RCTs were identified and included, with the majority reporting statistically significant outcomes (321/474; 67.7%). The multivariable model revealed significant effects of predictors related to specialty domain (p = 0.01), continent (p = 0.003) and registration (p = 0.004). Compared to Periodontology, RCTs published in Endodontics (OR= 0.40; 95%CIs: 0.22, 0.76) and Orthodontics (OR= 0.41; 95%CIs: 0.23, 0.74) were less likely to present statistically significant effects. There was strong evidence that registered trials presented lower odds of reporting statistically significant findings (OR= 0.52; 95%CIs: 0.34, 0.81).
The entirety of dentistry domains demonstrated preferential publication practices of outcomes considered as "successful" and statistically significant, with domains such as Orthodontics and Endodontics being more balanced. Trial non- registration is still prevalent and associated with reporting of statistically significant effects.
The findings of this empirical report bring attention to the interpretation of Systematic Reviews (SRs) conclusions. These largely depend on the availability and nature of outcomes of randomized controlled trials (RCTs) on a topic, which may impact on the synthesized estimate of a pooled effect and its direction.
记录在涵盖口腔医学 6 个专业领域的 12 种高影响力牙科期刊上发表的报告显著（与非显著）主要结局的随机对照试验（RCT）的比例。研究了某些期刊、出版和结局特征与报告显著结局之间的关系。
我们从以下领域中每一个领域的影响因子最高的两种期刊（Clarivate Analytics，2020）中确定并纳入了 2017 年 1 月 1 日至 2021 年 12 月 31 日期间发表的所有 RCT。主要结局是研究中主要结局报告的显著/非显著发现的比例，同时还测试了一系列特征，如：期刊、出版年份、影响因子、资助、注册等。
共确定并纳入了 474 项 RCT，其中大多数报告的结果具有统计学意义（321/474；67.7%）。多变量模型显示，与专业领域（p=0.01）、大陆（p=0.003）和注册（p=0.004）相关的预测因素存在显著影响。与牙周病学相比，发表于牙髓病学（OR=0.40；95%CI：0.22，0.76）和口腔正畸学（OR=0.41；95%CI：0.23，0.74）的 RCT 更不可能呈现统计学显著的效果。有强有力的证据表明，已注册的试验报告统计学显著结果的可能性较低（OR=0.52；95%CI：0.34，0.81）。
整个口腔医学领域都表现出对被认为“成功”和具有统计学意义的结局的优先发表倾向，而口腔正畸学和牙髓病学等领域则更为平衡。试验未注册仍然很普遍，并与统计学显著效果的报告有关。
本实证报告的结果引起了人们对系统综述（SR）结论解释的关注。这些结论在很大程度上取决于一个主题的随机对照试验（RCT）的结局的可获得性和性质，这可能会影响汇总效应的合成估计及其方向。
