Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
Research Institute of St. Joe's Hamilton, Hamilton, ON, Canada.
Trials. 2019 May 27;20(1):288. doi: 10.1186/s13063-019-3412-6.
There is an increasing number of interventions aimed at reducing the incidence and improving the identification and management of intimate partner violence (IPV), which are being tested in randomized clinical trials. Publication bias, improper reporting, and selective reporting in clinical trials have led to widespread adoption of pre-registration of clinical trials. Non-publication of study results leads to inefficiency, ethical issues, and scientific issues with the IPV literature. When study results and methodology are not made available through publication or other public means, the results cannot be used to their full potential. The objective of this study was to determine the publication rates of IPV trials registered in a large clinical trial registry.
We conducted a systematic review of all IPV-related clinicaltrials.gov records and determined whether the studies that had been completed for ≥ 18 months have been published in a peer-reviewed journal or in the clinicaltrials.gov registry. Two authors extensively searched the literature and contacted study investigators to locate full-text publications for each included study.
Of 83 completed IPV-related trials registered on clinicaltrials.gov, 64 (77.1%, 95% CI: 66.6-85.6) were subsequently published in full-text form. Of the 19 unpublished studies, authors confirmed that there was no publication for 11 studies; we were unable to contact the investigator or locate a publication for the remaining eight studies. Only four studies (all published) posted their results on clinicaltrials.gov upon completion.
Approximately one in four IPV trials are not published 18 months after completion, indicating that clinicians, researchers, and other evidence users should consider whether publication bias might affect their interpretation of the IPV literature. Further research is warranted to understand reasons for non-publication of IPV research and methods to improve publication rates.
越来越多的干预措施旨在降低亲密伴侣暴力（IPV）的发生率，并提高其识别和管理水平，这些措施正在随机临床试验中进行测试。临床试验中的发表偏倚、不当报告和选择性报告导致了临床试验的预先注册广泛采用。研究结果未发表导致了效率低下、伦理问题以及 IPV 文献的科学问题。当研究结果和方法无法通过发表或其他公开方式获得时，这些结果就无法充分发挥其潜力。本研究的目的是确定在大型临床试验注册中心注册的 IPV 试验的发表率。
我们对所有与 IPV 相关的 clinicaltrials.gov 记录进行了系统回顾，并确定了已完成 ≥18 个月的研究是否已在同行评议期刊或 clinicaltrials.gov 注册处发表。两位作者广泛搜索文献，并联系研究调查人员，以查找每个纳入研究的全文出版物。
在 clinicaltrials.gov 上注册的 83 项已完成的 IPV 相关试验中，有 64 项（77.1%，95%CI：66.6-85.6）随后以全文形式发表。在 19 项未发表的研究中，作者确认有 11 项研究没有发表；我们无法联系到研究者或找到其余 8 项研究的出版物。只有 4 项研究（全部发表）在完成后在 clinicaltrials.gov 上公布了其结果。
大约四分之一的 IPV 试验在完成后 18 个月未发表，这表明临床医生、研究人员和其他证据使用者应考虑发表偏倚是否可能影响他们对 IPV 文献的解释。需要进一步研究以了解 IPV 研究未发表的原因和提高发表率的方法。
