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一项旨在减少随机试验中发表偏倚的活动的范围综述。

A scoping review of activities intended to reduce publication bias in randomised trials.

作者信息

Hohlfeld Ameer, Kredo Tamara, Clarke Michael

机构信息

Division of Epidemiology and Biostatistics, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.

Health Systems Research Unit, South African Medical Research Council, Cape Town, 7501, South Africa.

出版信息

Syst Rev. 2024 Dec 20;13(1):310. doi: 10.1186/s13643-024-02728-5.

Abstract

BACKGROUND

The World Health Organization recommends that a randomised controlled trial (RCT) publishes its results in a peer-reviewed journal within 24 months of study completion. When RCTs are not published or publication is delayed, this can contribute to publication bias, which is the tendency for studies with positive or significant results to be published more frequently than studies with nonsignificant or negative results. This bias skews the available evidence, creating a distorted view of the research landscape. There is uncertainty about which activities best mitigate publication bias. This review systematically synthesises literature on activities that targeted researchers with the intention of reducing publication bias among health science researchers.

METHODS

We conducted a comprehensive search in PubMed and Scopus and forward and backward citation searches. There were no restrictions on language, time or publication status. We included studies of any design that tested an activity to reduce publication bias in health research. Ideally, participants had to be investigators or researchers who had conducted, led or been involved in RCTs. The context was any research institution that conducts research. Two reviewers independently assessed titles and abstracts for eligibility, followed by duplicate full-text screening and data extraction. One reviewer collated and summarised the extracted data and arranged these using an analytical framework to describe the findings thematically. For quality assurance, a second reviewer checked the data analysis.

RESULTS

Our database search yielded 14,185 records, with 11,754 after de-duplication. Of these, we excluded 11,728 records after title and abstract screening. We assessed 26 full texts for eligibility. One of these met the eligibility criteria. Forward and backward citation searches yielded 57 records, and 43 were eligible. We included 44 studies published between 1995 and 2022 that described activities promoting the publication of health-related research. We identified 10 broad activities that were often used in combination and concentrated on writing manuscripts.

DISCUSSION

This review describes several strategies that have been used to assist health researchers in publishing their findings. However, our search was unable to find studies that tested activities specifically geared toward researchers conducting RCTs. Rigorous research is needed to determine effective strategies for reducing publication bias among trialists.

摘要

背景

世界卫生组织建议随机对照试验(RCT)在研究完成后的24个月内在同行评审期刊上发表其结果。当随机对照试验未发表或发表延迟时,这可能会导致发表偏倚,即具有阳性或显著结果的研究比具有非显著或阴性结果的研究更频繁地发表的趋势。这种偏倚会扭曲现有证据,造成对研究领域的扭曲看法。关于哪些活动能最有效地减轻发表偏倚尚不确定。本综述系统地综合了针对研究人员旨在减少健康科学研究人员发表偏倚的活动的文献。

方法

我们在PubMed和Scopus中进行了全面检索,并进行了向前和向后的引文检索。对语言、时间或发表状态没有限制。我们纳入了任何测试旨在减少健康研究中发表偏倚活动的设计的研究。理想情况下,参与者必须是进行、领导或参与过随机对照试验的研究者或研究人员。背景是任何进行研究的研究机构。两名评审员独立评估标题和摘要的合格性,随后进行重复的全文筛选和数据提取。一名评审员整理并总结提取的数据,并使用分析框架将其进行整理,以便按主题描述研究结果。为确保质量,另一名评审员检查数据分析。

结果

我们的数据库检索产生了14,185条记录,去重后有11,754条。其中,在标题和摘要筛选后,我们排除了11,728条记录。我们评估了26篇全文的合格性。其中一篇符合合格标准。向前和向后的引文检索产生了57条记录,43条符合条件。我们纳入了1995年至2022年间发表的44项描述促进健康相关研究发表活动的研究。我们确定了10种广泛使用且经常结合使用并集中于撰写手稿的活动。

讨论

本综述描述了几种用于协助健康研究人员发表其研究结果的策略。然而,我们的检索未能找到测试专门针对进行随机对照试验的研究人员的活动的研究。需要进行严谨的研究以确定减少试验者发表偏倚的有效策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5785/11660680/3c4b6a522961/13643_2024_2728_Fig1_HTML.jpg

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