过去5年发表于牙髓病学杂志的随机临床试验中注册及选择性结果报告的依从性：一项元研究

Adherence to Registration and Selective Outcome Reporting in Randomized Clinical Trials Published in Endodontic Journals Over the Past 5 Years: A Meta-Research Study.

作者信息

Vitali Filipe Colombo, Santos Pablo Silveira, Rocha Aurélio de Oliveira, Maia Lucianne Cople, Garcia Lucas da Fonseca Roberti, Teixeira Cleonice da Silveira

机构信息

Department of Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.

出版信息

J Endod. 2025 Mar;51(3):258-267.e7. doi: 10.1016/j.joen.2024.12.001. Epub 2024 Dec 4.

DOI:10.1016/j.joen.2024.12.001

PMID:39643266

Abstract

INTRODUCTION

Prospective registration of randomized clinical trials (RCTs) is highly recommended to ensure research transparency and prevent selective outcome reporting (SOR). This study aimed to evaluate the adherence to registration and the presence of SOR in RCTs published in endodontic journals over the past 5 years.

METHODS

Electronic searches were conducted in PubMed and the libraries of the Journal of Endodontics, International Endodontic Journal, European Endodontic Journal, and Australian Endodontic Journal. Two reviewers were involved in the study selection and evaluation. Publications were assessed for key methodological aspects, including the presence and timing of trial registration. RCT registries were examined to identify discrepancies between publication and registered protocols and the presence of SOR. Logistic regression was used to explore the effect of study variables on registration practices and SOR.

RESULTS

Of the 144 RCTs included, 104 (72.2%) were registered. Among those registered, only 19 (18.3%) adhered to prospective registration. Registration practice increased by 53% per year (OR 1.53; 95% CI: 1.34-2.08; P < .01). Discrepancies between publication and protocol were identified in 55.8% of studies, primarily related to sample size (33.7%). SOR was identified in 41 trials (39.4%), mainly due to discrepancies in the outcome time frame (18.3%). Studies evaluating multiple outcomes had 4.95 times higher odds of exhibiting SOR (OR 4.95; 95% CI: 1.63-12.95; P < .01). Furthermore, studies that were registered retrospectively or exhibited discrepancies between publication and protocol accounted for 6.10 times (OR 6.10; 95% CI: 1.81-18.96; P = .03) and 5.61 times (OR 5.61; 95% CI: 2.93-16.58; P < .01) higher odds of exhibiting SOR, respectively.

CONCLUSIONS

RCTs published in endodontic journals over the past 5 years presented low adherence to prospective trial registration and a high prevalence of SOR.

摘要

引言

强烈建议对随机临床试验（RCT）进行前瞻性注册，以确保研究的透明度并防止选择性结果报告（SOR）。本研究旨在评估过去5年发表在牙髓病学杂志上的RCT对注册的依从性以及SOR的存在情况。

方法

在PubMed以及《牙髓病学杂志》《国际牙髓病学杂志》《欧洲牙髓病学杂志》和《澳大利亚牙髓病学杂志》的数据库中进行电子检索。两名评审员参与了研究的筛选和评估。对出版物的关键方法学方面进行评估，包括试验注册的存在情况和时间。检查RCT注册库，以确定出版物与注册方案之间的差异以及SOR的存在情况。使用逻辑回归来探讨研究变量对注册实践和SOR的影响。

结果

在纳入的144项RCT中，104项（72.2%）进行了注册。在那些已注册的研究中，只有19项（18.3%）坚持前瞻性注册。注册实践每年增加53%（比值比1.53；95%置信区间：1.34 - 2.08；P <.01）。在55.8%的研究中发现了出版物与方案之间的差异，主要与样本量有关（33.7%）。在41项试验（39.4%）中发现了SOR，主要是由于结果时间框架的差异（18.3%）。评估多个结果的研究出现SOR的几率高4.95倍（比值比4.95；95%置信区间：1.63 - 12.95；P <.01）。此外，回顾性注册的研究或在出版物与方案之间存在差异的研究出现SOR的几率分别高6.10倍（比值比6.10；95%置信区间：1.81 - 18.96；P =.03）和5.61倍（比值比5.61；95%置信区间：2.93 - 16.58；P <.01）。