State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, PR China.
State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, PR China; Center for Evidence-Based Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, PR China; Hubei Provincial Clinical Research Center for Dentofacial Deformities in Children, School & Hospital of Stomatology, Wuhan University, Wuhan, PR China.
J Dent. 2024 Dec;151:105448. doi: 10.1016/j.jdent.2024.105448. Epub 2024 Nov 1.
To study the prevalence and manifestation of selective outcome reporting (SOR) among randomized controlled trials (RCTs) published in leading dental journals, and to explore the association between SOR and potentially related factors.
We hand-searched RCTs published in the leading dental journals between 2018 and 2023. RCTs with registrations and defined primary outcomes were included, and their relevant characteristics were extracted for analysis. Discrepancies between publication and corresponding registration were compared regarding primary outcome and other study characteristics. The generalized estimating equation model was applied to identify factors associated with SOR.
Two hundred and seventy trials were included. SOR was identified in 51.5% (n = 139) of the included RCTs with the discrepancy in the assessment timing of the primary outcome as the most common manifestation (n = 86, 31.9%). Substantial discrepancies were observed regarding sample size (n = 148, 54.8%) and source of funding (n = 105, 38.9%). Sample size [odds ratio (OR) 0.61, 95% confidence interval (CI) 0.40 to 0.92], timing of registration (OR 2.10, 95% CI 1.03 to 4.31), and discrepancy in follow-up length (OR 32.01, 95% CI 11.80 to 86.83) were identified as statistically significant factors associated with SOR.
SOR was prevalent among RCTs in leading dental journals. Researchers and other stakeholders should be aware of this reporting issue and make joint efforts to improve the outcome reporting quality.
The findings of this research-on-research study indicate a substantial presence of SOR in the field of dentistry. Such bias can potentially mislead readers and distort the pooled effect estimates in evidence synthesis, ultimately influencing clinical decision-making.
研究发表在主要牙科期刊上的随机对照试验（RCT）中选择性结果报告（SOR）的流行情况和表现，并探讨 SOR 与潜在相关因素之间的关系。
我们手动搜索了 2018 年至 2023 年发表在主要牙科期刊上的 RCT。纳入了有注册和明确主要结局的 RCT，并提取了其相关特征进行分析。比较了出版物和相应注册之间在主要结局和其他研究特征方面的差异。应用广义估计方程模型确定与 SOR 相关的因素。
共纳入 27 项试验。在纳入的 RCT 中，有 51.5%（n=139）存在 SOR，最常见的表现是主要结局评估时间的差异（n=86，31.9%）。在样本量（n=148，54.8%）和资金来源（n=105，38.9%）方面存在显著差异。样本量（比值比 [OR]0.61，95%置信区间 [CI]0.40 至 0.92）、注册时间（OR 2.10，95%CI1.03 至 4.31）和随访时间差异（OR 32.01，95%CI11.80 至 86.83）被确定为与 SOR 相关的统计学显著因素。
主要牙科期刊上的 RCT 中存在 SOR 现象。研究人员和其他利益相关者应该意识到这一报告问题，并共同努力提高结局报告质量。
这项关于研究的研究结果表明，在牙科领域存在大量的 SOR。这种偏倚可能会误导读者，并扭曲证据综合中的汇总效应估计，最终影响临床决策。
