Suliman Sharain, van den Heuvel Leigh, Suryapranata Alexandra, Bisson Jonathan I, Seedat Soraya
1Department of Psychiatry, Faculty of Medicine and Health Sciences, Stellenbosch University, PO Box 19063, Cape Town, Tygerberg 7505 South Africa.
2Division of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Cardiff, UK.
Res Integr Peer Rev. 2019 Jul 25;4:15. doi: 10.1186/s41073-019-0074-6. eCollection 2019.
Although a large number of clinical trials on interventions demonstrating efficacy (or lack thereof) are conducted annually, much of this evidence is not accessible to scientists and clinicians.
We aimed to determine the publication rate of posttraumatic stress disorder (PTSD) trials that have been registered in clinical trial registries, and the factors associated with publication.
Trials, completed on January 15, 2015, were identified via the US National Institutes of Health clinical trials registry, the European Union Clinical Trials Register and the WHO International Clinical Trials Registry Platform. A systematic search for publications (published by the end of March 2018) related to each of the registered trials were then performed.
Four hundred and thirty-eight of 1982 potentially eligible trials were included. Only 34% of interventional trials were registered prior to initiation, 9% were registered within 2 months of starting and 20% after trial completion. Of the 438 included trials, 72% had generated peer-reviewed publications, while an additional 7% had disseminated results in some other form (such as on the trial database), 26 months after trial completion. Randomisation of a trial was the only factor individually associated with publication, in logistic regression analysis ( < 0.001). Intervention type, university as sponsor and study registration prior to completion were factors that influenced the time to publication, using Cox regression ( < 0.001).
This study underscores the importance of timely and accurate publication and dissemination of trial results, in order to avoid the potential waste of resources and to ensure research integrity and patient safety. We suggest that authors and journal editors adhere to conditions set out by the International Committee of Medical Journal Editors and that more diligent data sharing is encouraged through prospective trial registration and trial reporting websites.
尽管每年都会进行大量关于干预措施有效性（或无效性）的临床试验，但科学家和临床医生无法获取其中的许多证据。
我们旨在确定已在临床试验注册机构注册的创伤后应激障碍（PTSD）试验的发表率，以及与发表相关的因素。
通过美国国立卫生研究院临床试验注册机构、欧盟临床试验注册机构和世界卫生组织国际临床试验注册平台，识别出截至2015年1月15日完成的试验。然后对与每项注册试验相关的出版物（截至2018年3月底发表）进行系统检索。
1982项潜在合格试验中有438项被纳入。只有34%的干预性试验在启动前注册，9%在开始后2个月内注册，20%在试验完成后注册。在纳入的438项试验中，72%产生了经同行评审的出版物，另有7%以其他形式（如在试验数据库上）在试验完成26个月后传播了结果。在逻辑回归分析中，试验随机分组是与发表单独相关的唯一因素（<0.001）。使用Cox回归分析，干预类型、大学作为资助方以及在完成前进行研究注册是影响发表时间的因素（<0.001）。
本研究强调了及时、准确地发表和传播试验结果的重要性，以避免潜在的资源浪费，并确保研究的完整性和患者安全。我们建议作者和期刊编辑遵守医学期刊编辑国际委员会规定的条件，并通过前瞻性试验注册和试验报告网站鼓励更积极的数据共享。
