Department of Orthodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.
School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.
J Dent. 2024 Oct;149:105263. doi: 10.1016/j.jdent.2024.105263. Epub 2024 Jul 22.
To record the proportion of data sharing reporting in terms of primary data and/or statistical code of Randomized Controlled Trials (RCTs), published across 12 high impact journals in Dentistry, covering 6 specialty domains. Associations with certain journal, publication and outcome characteristics were examined. Transparency indicators such as registration or funding statements were assessed.
We identified and included all RCTs published from January 1st, 2017 to December 31st, 2023 in journals of high impact of the following domains: Periodontology, Endodontics, Restorative Dentistry/Prosthodontics, Orthodontics, Pediatric Dentistry, Oral/Maxillofacial Surgery. The primary outcome was the proportion of RCTs reporting their intent to share or openly shared primary data and we tested for associations with potential predictors. Funding, registration, and statistical code/script sharing practices were also examined.
A total of 752 RCTs were included, of which only 119 (15.8%) either openly provided their data or included a statement of intention to share upon request. Only one study openly provided the statistical code underlying the analysis used. RCTs in periodontology more frequently included statements about positive intent to share (57/210;27.1%), followed by Orthodontics (35/157;22.3%). Significant effects of year, dentistry domain and continent of authorship on data sharing practices were identified (p < 0.001 in all cases). There was evidence that registered RCTs had 2.04 times higher odds for intention to share data (95%confidence interval: 1.06, 3.92;p = 0.03).
Overall, in oral health RCTs, empirical evidence suggested very low prevalence of positive data sharing practices. Enhancing transparency is pivotal in promoting reproducibility and credibility of research findings.
The findings of this empirical report bring attention to key transparency indicators in randomized controlled trials. These largely impact on the credibility and reproducibility of the evidence base for clinical decision making.
记录在 12 种高影响力的牙科学期刊上发表的涵盖 6 个专业领域的随机对照试验（RCT）中，主要数据和/或统计代码的报告比例。研究了与某些期刊、出版和结果特征的关联。评估了透明度指标，如注册或资助声明。
我们确定并纳入了 2017 年 1 月 1 日至 2023 年 12 月 31 日在以下领域高影响力期刊上发表的所有 RCT：牙周病学、牙髓学、修复牙科/修复学、正畸学、儿科牙科、口腔/颌面外科。主要结果是报告其意图共享或公开共享主要数据的 RCT 的比例，并对其与潜在预测因素的关联进行了测试。还检查了资助、注册和统计代码/脚本共享实践。
共纳入 752 项 RCT，其中只有 119 项（15.8%）公开提供了数据或在请求时包含了共享意图的声明。只有一项研究公开提供了用于分析的统计代码。牙周病学 RCT 更频繁地包含关于积极共享意图的声明（210 项中的 57 项；27.1%），其次是正畸学（157 项中的 35 项；22.3%）。研究发现，年份、牙科学领域和作者所在大陆对数据共享实践有显著影响（在所有情况下 p < 0.001）。有证据表明，已注册的 RCT 有 2.04 倍的可能性有共享数据的意图（95%置信区间：1.06，3.92；p = 0.03）。
总体而言，在口腔健康 RCT 中，实证证据表明积极的数据共享实践的流行率非常低。提高透明度对于促进研究结果的可重复性和可信度至关重要。
本实证报告的结果引起了对随机对照试验中关键透明度指标的关注。这些指标主要影响临床决策证据基础的可信度和可重复性。
