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1999-2017 年新西兰一项回顾性队列研究中,公基金资助的随机对照试验的注册和发表时间。

Trial registration and time to publication in a retrospective cohort of publicly funded randomised controlled trials in New Zealand 1999-2017.

机构信息

School of Nursing, The University of Auckland, Auckland, New Zealand

National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.

出版信息

BMJ Open. 2022 Oct 6;12(10):e065050. doi: 10.1136/bmjopen-2022-065050.

Abstract

OBJECTIVES

To determine how quickly randomised controlled trials funded by the Health Research Council of New Zealand (HRC) were registered and published, and whether time to publication differed by trial result.

DESIGN

We created a retrospective cohort of trials offered funding from 1999 to 2017 by seeking lists of candidate studies using the Official Information Act 1982. These lists were supplemented by searching the HRC's online research repository and an open-access database on Figshare. One investigator searched for trial registrations and for dissemination using electronic databases, university websites and ResearchGate. One investigator extracted data from the obtained studies and a second investigator independently corroborated the data entry from a 10% random sample.

RESULTS

We identified 258 trials that were offered funding, 252 trials were conducted and 229 (90.9%) were registered, 179 prospectively by the date of the final search (24 March 2022). Overall, 236 trials were completed by the date of the last search and in 209 (88.6%) trials the results had been disseminated, 200 (84.7%) of which were by journal publication. We obtained the results for 214 trials, 91 (42.5%) of which were positive, 120 (56.1%) of which were null and 3 (1.4%) of which were negative. Median time to publication was 22.7 months for positive trials and 21.5 months for combined null or negative trials (log rank test p=0.83). Median time since trial completion in the trials that had not been published was 43.6 months (IQR 17.1-108.2 months).

CONCLUSIONS

Between 1999 and 2017, almost 9 out of every 10 HRC-funded trials had been registered and a similar proportion of completed trials had been published with no difference in time to publication based on type of result. However, only a slim majority of trials had published within the 2-year time frame set by the WHO.

摘要

目的

确定新西兰健康研究委员会(HRC)资助的随机对照试验的注册和发表速度,以及发表时间是否因试验结果而异。

设计

我们通过使用 1982 年《官方信息法》寻求候选研究的清单,创建了一个 1999 年至 2017 年期间接受资助的试验的回顾性队列。这些清单通过搜索 HRC 的在线研究存储库和 Figshare 上的一个开放获取数据库进行了补充。一名调查员使用电子数据库、大学网站和 ResearchGate 搜索试验注册和传播情况。一名调查员从获得的研究中提取数据,第二名调查员独立核实从 10%随机样本中输入的数据。

结果

我们确定了 258 项获得资助的试验,其中 252 项进行了试验,229 项(90.9%)进行了注册,179 项是在最后一次搜索(2022 年 3 月 24 日)日期前进行的前瞻性注册。总体而言,在最后一次搜索日期之前,236 项试验已经完成,在 209 项(88.6%)试验中已经传播了结果,其中 200 项(84.7%)通过期刊发表。我们获得了 214 项试验的结果,其中 91 项(42.5%)为阳性,120 项(56.1%)为阴性,3 项(1.4%)为阴性。阳性试验的发表中位时间为 22.7 个月,阴性或阴性试验的中位时间为 21.5 个月(对数秩检验 p=0.83)。未发表的试验中,自试验完成以来的中位时间为 43.6 个月(IQR 17.1-108.2 个月)。

结论

在 1999 年至 2017 年期间,HRC 资助的近 10 项试验中,有近 9 项进行了注册,并且已发表的完成试验中有类似比例的试验发表,基于结果类型,发表时间没有差异。然而,只有略超过一半的试验在世界卫生组织设定的 2 年时间框架内发表了论文。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3993/9540847/ad4f2ae6a1be/bmjopen-2022-065050f01.jpg

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