Selective Outcome Reporting Bias in Randomized Controlled Trials on Dental Caries in Children and Adolescents: A Meta-Research Study.

IF 2.9 2区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Caries Research Pub Date : 2024-11-26 DOI:10.1159/000542108

Livia da Rosa Oliveira, Rokaia Ahmed Elagami, Thais Marchezini Reis, Tamara Kerber Tedesco, Fausto Medeiros Mendes, Mariana Minatel Braga, Claudio Mendes Pannuti, Daniela Prócida Raggio

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引用次数: 0

Abstract

Introduction: Selective outcome reporting (SOR) is a bias that can occur in randomized controlled trials (RCTs), defined as the alteration or omission of primary outcome in the publication compared to the original protocol. Researchers may modify outcomes to highlight statistically significant results. This study aimed to assess the prevalence of SOR in RCTs related to dental caries in children and adolescents.

Methods: We conducted a search on ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP), using a comprehensive search strategy with terms related to pediatric dentistry and dental caries, up to February 2023. Two independent reviewers included trials with two or more arms focusing on dental caries in pediatric dentistry. Registrations that did not result in at least one published article were excluded. Data on the characteristics and outcomes from the protocols and corresponding publications were extracted. The primary outcome was the prevalence of SOR in the included RCTs. A chi-square test, with a significance level of 5%, was used to assess the association between SOR and pre-specified variables, which was the secondary outcome.

Results: A total of 175 protocols and their corresponding publications were included. SOR was identified in 58.9% (n = 103) of the studies, with 41.1% (n = 72) showing discrepancies in the primary outcome's time frame. Retrospective registrations accounted for 73.7% of the studies. SOR was significantly associated with discrepancies in the follow-up period (p < 0.001) and with study design type (parallel assignment, split-mouth, cluster RCT, and no information) (p = 0.048).

Conclusions: The high prevalence of SOR in dental caries RCTs in pediatric dentistry highlights the need for attention to this issue. Ensuring transparency in the research process requires implementing an appropriate pre-registered protocol, disclosing deviations from it, and enabling stakeholders to compare the protocol with the published outcomes which can help reduce research waste.

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儿童和青少年龋齿随机对照试验中的选择性结果报告偏差：一项元研究。

导言：选择性结果报告（SOR）是随机对照试验（RCT）中可能出现的一种偏差，其定义是与方案相比，在发表的文章中改变或遗漏了主要结果。研究人员可能会改变结果，以强调具有统计学意义的结果。我们的目的是评估与儿童牙科龋齿相关的 RCT 中 SOR 的发生率：我们在 ClinicalTrials.gov 和国际临床试验注册平台 (ICTRP) 上进行了搜索，使用了一种全面的搜索策略，包括与儿童牙科和龋齿相关的术语，搜索时间截至 2023 年 2 月。两名独立审查员纳入了任何有两个或两个以上臂并侧重于儿童牙科龋齿的试验。我们排除了任何未发表至少一篇文章的注册。我们提取了研究特征和结果数据等数据。采用显著性水平为 5%的卡方检验来检测 SOR 与预先指定的变量之间的关联：结果：共纳入 144 项方案及其相应的出版物。58.9%的研究（n=103）观察到SOR，41.1%的研究（n=72）在主要结果随访方面存在差异。回顾性登记的研究占 73.7%。SOR 与随访期间的差异有明显关联（p结论：在儿童牙科的龋齿 RCT 中，SOR 的发生率很高，这证明这个问题值得关注。要实现这一过程的透明度，需要实施适当的预注册方案，披露偏离方案的情况，并允许利益相关者将既定方案与提交的文件进行比较。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Caries Research 医学-牙科与口腔外科

CiteScore

6.30

自引率

7.10%

发文量

审稿时长

6-12 weeks

期刊介绍： ''Caries Research'' publishes epidemiological, clinical and laboratory studies in dental caries, erosion and related dental diseases. Some studies build on the considerable advances already made in caries prevention, e.g. through fluoride application. Some aim to improve understanding of the increasingly important problem of dental erosion and the associated tooth wear process. Others monitor the changing pattern of caries in different populations, explore improved methods of diagnosis or evaluate methods of prevention or treatment. The broad coverage of current research has given the journal an international reputation as an indispensable source for both basic scientists and clinicians engaged in understanding, investigating and preventing dental disease.