Department of Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
Leibniz Institute for Resilience Research (LIR), Mainz, Germany.
BMC Med Res Methodol. 2023 Jul 29;23(1):173. doi: 10.1186/s12874-023-01991-9.
The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources.
This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs.
We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%).
In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries.
COVID-19 大流行期间，快速发表的科学研究数量急剧增加，尤其是在大流行早期。有人认为 COVID-19 试验报告的质量低于典型报告，但就主要结局报告而言，这方面的证据有限。本研究的目的是评估注册、预印本和期刊文章中报告的完全定义主要结局的发生率，并评估这些来源之间主要结局报告的一致性。
这是一项针对 COVID-19 治疗和预防的注册干预临床试验队列的描述性研究，该队列来自于 DIssemination of REgistered COVID-19 Clinical Trials（DIRECCt）研究数据集。主要结局是：1）完全报告主要结局的发生率；2）注册条目与预印本以及注册条目与期刊文章对之间主要结局报告的一致性发生率。
我们分析了 87 项试验，共 116 篇相关出版物（87 个注册条目、53 个预印本和 63 篇期刊文章）。所有主要结局在 47/87（54%）的注册条目中、31/53（58%）的预印本中和 44/63（70%）的期刊文章中都完全定义。在 13/53（25%）的注册-预印本对和 27/63（43%）的注册-期刊文章对中，所有主要结局都一致报告。在 13/53（25%）的预印本和 8/63（13%）的期刊文章中没有指定主要结局。在这个样本中，与没有制药公司参与的试验相比，有制药公司参与的试验中更频繁地出现完全定义的主要结局（76% 比 45%），与其他研究设计相比，随机对照试验（RCTs）中更频繁地出现完全定义的主要结局（68% 比 49%）。一致的主要结局报告模式也观察到了（制药公司：56% 比 12%，RCT：43% 比 22%）。
在大流行早期的 COVID-19 试验中，注册条目、预印本和期刊文章中分别有 54%、58%和 70%的完全定义了所有主要结局。只有 25%的预印本和 43%的期刊文章报告了与注册条目一致的主要结局。
