Shamseer Larissa, Hopewell Sally, Altman Douglas G, Moher David, Schulz Kenneth F
Centre for Practice-Changing Research, Ottawa Hospital Research Institute, Ottawa, ON, K1H 8L6, Canada.
School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, ON, K1H 8M5, Canada.
Trials. 2016 Jun 24;17(1):301. doi: 10.1186/s13063-016-1408-z.
The CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomedical publishing community. This research aims to provide an update on the endorsement of CONSORT by high impact medical journals.
We performed a cross-sectional examination of the online "Instructions to Authors" of 168 high impact factor (2012) biomedical journals between July and December 2014. We assessed whether the text of the "Instructions to Authors" mentioned the CONSORT Statement and any CONSORT extensions, and we quantified the extent and nature of the journals' endorsements of these. These data were described by frequencies. We also determined whether journals mentioned trial registration and the International Committee of Medical Journal Editors (ICMJE; other than in regards to trial registration) and whether either of these was associated with CONSORT endorsement (relative risk and 95 % confidence interval). We compared our findings to the two previous iterations of this survey (in 2003 and 2007). We also identified the publishers of the included journals.
Sixty-three percent (106/168) of the included journals mentioned CONSORT in their "Instructions to Authors." Forty-four endorsers (42 %) explicitly stated that authors "must" use CONSORT to prepare their trial manuscript, 38 % required an accompanying completed CONSORT checklist as a condition of submission, and 39 % explicitly requested the inclusion of a flow diagram with the submission. CONSORT extensions were endorsed by very few journals. One hundred and thirty journals (77 %) mentioned ICMJE, and 106 (63 %) mentioned trial registration.
The endorsement of CONSORT by high impact journals has increased over time; however, specific instructions on how CONSORT should be used by authors are inconsistent across journals and publishers. Publishers and journals should encourage authors to use CONSORT and set clear expectations for authors about compliance with CONSORT.
《试验报告统一标准》(CONSORT)声明提供了已发表临床试验中应报告的一组最低标准项目;它在生物医学出版界得到了广泛认可。本研究旨在提供关于高影响力医学期刊对CONSORT认可情况的最新信息。
我们在2014年7月至12月期间对168种高影响因子(2012年)生物医学期刊的在线“作者须知”进行了横断面调查。我们评估了“作者须知”文本是否提及CONSORT声明及任何CONSORT扩展内容,并对期刊对这些内容的认可程度和性质进行了量化。这些数据以频率描述。我们还确定期刊是否提及试验注册和国际医学期刊编辑委员会(ICMJE;除试验注册外),以及这两者是否与CONSORT认可相关(相对风险和95%置信区间)。我们将研究结果与该调查的前两轮(2003年和2007年)进行了比较。我们还确定了所纳入期刊的出版商。
63%(106/168)的纳入期刊在其“作者须知”中提及了CONSORT。44个认可期刊(42%)明确表示作者“必须”使用CONSORT来撰写试验稿件,38%要求提交一份完整的CONSORT清单作为投稿条件,39%明确要求投稿时附上流程图。很少有期刊认可CONSORT扩展内容。130种期刊(77%)提及了ICMJE,106种(63%)提及了试验注册。
随着时间的推移,高影响力期刊对CONSORT的认可有所增加;然而,各期刊和出版商对于作者应如何使用CONSORT的具体说明并不一致。出版商和期刊应鼓励作者使用CONSORT,并对作者遵守CONSORT的情况设定明确期望。