BMJ Open. 2023 Oct 4;13(10):e076264. doi: 10.1136/bmjopen-2023-076264.
Prospectively registering study plans in a permanent time-stamped and publicly accessible document is becoming more common across disciplines and aims to reduce risk of bias and make risk of bias transparent. Selective reporting persists, however, when researchers deviate from their registered plans without disclosure. This systematic review aimed to estimate the prevalence of undisclosed discrepancies between prospectively registered study plans and their associated publication. We further aimed to identify the research disciplines where these discrepancies have been observed, whether interventions to reduce discrepancies have been conducted, and gaps in the literature.
Systematic review and meta-analyses.
Scopus and Web of Knowledge, published up to 15 December 2019.
Articles that included quantitative data about discrepancies between registrations or study protocols and their associated publications.
Each included article was independently coded by two reviewers using a coding form designed for this review (osf.io/728ys). We used random-effects meta-analyses to synthesise the results.
We reviewed k=89 articles, which included k=70 that reported on primary outcome discrepancies from n=6314 studies and, k=22 that reported on secondary outcome discrepancies from n=1436 studies. Meta-analyses indicated that between 29% and 37% (95% CI) of studies contained at least one primary outcome discrepancy and between 50% and 75% (95% CI) contained at least one secondary outcome discrepancy. Almost all articles assessed clinical literature, and there was considerable heterogeneity. We identified only one article that attempted to correct discrepancies.
Many articles did not include information on whether discrepancies were disclosed, which version of a registration they compared publications to and whether the registration was prospective. Thus, our estimates represent discrepancies broadly, rather than our target of discrepancies between registered study plans and their associated publications. Discrepancies are common and reduce the trustworthiness of medical research. Interventions to reduce discrepancies could prove valuable.
osf.io/ktmdg. Protocol amendments are listed in online supplemental material A.
在一个永久性的、时间戳和公开可访问的文档中预先注册研究计划在各个学科中变得越来越普遍，旨在降低偏倚风险并使偏倚风险透明。然而，当研究人员在不披露的情况下偏离预先注册的计划时，选择性报告仍然存在。本系统评价旨在估计预先注册的研究计划与其相关出版物之间未公开差异的发生率。我们还旨在确定观察到这些差异的研究学科，是否已经进行了减少差异的干预措施，以及文献中的差距。
系统评价和荟萃分析。
Scopus 和 Web of Knowledge，截至 2019 年 12 月 15 日发布。
包括注册或研究方案与相关出版物之间差异的定量数据的文章。
每个入选的文章都由两位评审员使用为此审查设计的编码表进行独立编码(osf.io/728ys)。我们使用随机效应荟萃分析来综合结果。
我们审查了 k=89 篇文章，其中 k=70 篇报告了 n=6314 项研究的主要结局差异，k=22 篇报告了 n=1436 项研究的次要结局差异。荟萃分析表明，至少有 29%至 37%（95%CI）的研究包含至少一个主要结局差异，至少有 50%至 75%（95%CI）包含至少一个次要结局差异。几乎所有的文章都评估了临床文献，并且存在很大的异质性。我们只发现了一篇试图纠正差异的文章。
许多文章没有说明差异是否披露、他们将出版物与哪一个注册版本进行比较以及注册是否前瞻性。因此，我们的估计代表了广泛的差异，而不是我们的目标，即预先注册的研究计划与其相关出版物之间的差异。差异很常见，降低了医学研究的可信度。减少差异的干预措施可能是有价值的。
osf.io/ktmdg。在线补充材料 A 中列出了方案修订。
