Tsujimoto Yasushi, Tsutsumi Yusuke, Kataoka Yuki, Tsujimoto Hiraku, Yamamoto Yosuke, Papola Davide, Guyatt Gordon H, Fukuhara Shunichi, Furukawa Toshi A
Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Department of Nephrology and Dialysis, Kyoritsu Hospital, Kawanishi, Hyogo, Japan.
BMJ Open. 2017 Oct 22;7(10):e018856. doi: 10.1136/bmjopen-2017-018856.
Many studies have indicated the impact of bias in dissemination and publication in medical research. Existence of such bias among clinical trials has been repeatedly pointed out, but it has not been well studied in the field of systematic reviews (SRs). We therefore aim to investigate whether or not time lag bias and publication bias in SRs based on statistical significance in results exist. In addition, we will examine at what stage of paper publication process such bias, if any, creeps in.
The present study is a meta-epidemiological study. We will include all SRs of interventions registered in the international prospective register of SRs (PROSPERO) before December 2014 if the SR has completed its analysis irrespective of its publication status. All contact authors of eligible SRs will be asked to participate in a survey administered through the Internet. Our primary outcome is time from protocol registration to full publication of SR as a journal article, defined as time from the registration date to the acceptance date among all the relevant SRs. We will examine the impact of statistically significant findings on the primary outcomes through time to event analyses.
Ethics approval will be obtained from the Ethical Committee of the Kyoto University Graduate School of Medicine. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry. We will publish our findings in a peer-reviewed journal and also may present them at conferences.
UMIN000028325.
许多研究表明了医学研究中传播和发表偏倚的影响。临床试验中此类偏倚的存在已被反复指出，但在系统评价（SR）领域尚未得到充分研究。因此，我们旨在调查基于结果统计显著性的SR中是否存在时间滞后偏倚和发表偏倚。此外，我们将研究在论文发表过程的哪个阶段会出现此类偏倚（如果存在的话）。
本研究是一项元流行病学研究。如果SR已完成分析，无论其发表状态如何，我们将纳入2014年12月之前在国际系统评价前瞻性注册库（PROSPERO）中注册的所有干预措施的SR。将要求符合条件的SR的所有通讯作者参与通过互联网进行的调查。我们的主要结局是从方案注册到SR作为期刊文章完全发表的时间，定义为所有相关SR中从注册日期到接受日期的时间。我们将通过事件时间分析来研究具有统计学显著性的结果对主要结局的影响。
将获得京都大学医学研究生院伦理委员会的伦理批准。本方案已在大学医院医疗信息网络临床试验注册库中注册。我们将在同行评审期刊上发表我们的研究结果，也可能在会议上展示。
UMIN000028325。
