Department of Traditional Chinese Medicine, Second Military Medical University, Changhai Hospital, Shanghai, China.
PLoS One. 2012;7(2):e30683. doi: 10.1371/journal.pone.0030683. Epub 2012 Feb 13.
The CONSORT Statement is a reporting guideline for authors when reporting randomized controlled trials (RCTs). It offers a standard way for authors to prepare RCT reports. It has been endorsed by many high-impact medical journals and by international editorial groups. This study was conducted to assess the endorsement of the CONSORT Statement by high-impact medical journals in China by reviewing their instructions for authors.
METHODOLOGY/PRINCIPAL FINDINGS: A total of 200 medical journals were selected according to the Chinese Science and Technology Journal Citation Reports, 195 of which publish clinical research papers. Their instructions for authors were reviewed and all texts mentioning the CONSORT Statement or CONSORT extension papers were extracted. Any mention of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM) developed by the International Committee of Medical Journal Editors (ICMJE) or 'clinical trial registration' was also extracted. For journals endorsing the CONSORT Statement, their most recently published RCT reports were retrieved and evaluated to assess whether the journals have followed what the CONSORT Statement required. Out of the 195 medical journals publishing clinical research papers, only six (6/195, 3.08%) mentioned 'CONSORT' in their instructions for authors; out of the 200 medical journals surveyed, only 14 (14/200, 7.00%) mentioned 'ICMJE' or 'URM' in their instructions for authors, and another five journals stated in their instructions for authors that clinical trials should have trial registration numbers and that priority would be given to clinical trials which had been registered. Among the 62 RCT reports published in the six journals endorsing the CONSORT Statement, 20 (20/62, 32.26%) contained flow diagrams and only three (3/62, 4.84%) provided trial registration information.
CONCLUSIONS/SIGNIFICANCE: Medical journals in China endorsing either the CONSORT Statement or the ICMJE's URM constituted a small percentage of the total; all of these journals used ambiguous language regarding what was expected of authors.
CONSORT 声明是一份针对作者的报告指南,用于报告随机对照试验 (RCT)。它为作者准备 RCT 报告提供了一种标准方法。该声明已经得到许多高影响力医学期刊和国际编辑团体的认可。本研究通过回顾其作者指南,评估中国高影响力医学期刊对 CONSORT 声明的认可情况。
方法/主要发现:根据中国科技期刊引证报告,共选择了 200 种医学期刊,其中 195 种发表临床研究论文。对这些期刊的作者指南进行了回顾,并提取了所有提及 CONSORT 声明或 CONSORT 扩展文件的文本。还提取了国际医学期刊编辑委员会 (ICMJE) 制定的统一要求 (URM) 或“临床试验注册”的任何提及。对于认可 CONSORT 声明的期刊,检索并评估了其最近发表的 RCT 报告,以评估这些期刊是否遵循了 CONSORT 声明的要求。在发表临床研究论文的 195 种医学期刊中,只有 6 种(6/195,3.08%)在作者指南中提及“CONSORT”;在调查的 200 种医学期刊中,只有 14 种(14/200,7.00%)在作者指南中提及“ICMJE”或“URM”,另有 5 种期刊在作者指南中指出,临床试验应有试验注册号,并优先考虑已注册的临床试验。在认可 CONSORT 声明的 6 种期刊中发表的 62 篇 RCT 报告中,有 20 篇(20/62,32.26%)包含流程图,只有 3 篇(3/62,4.84%)提供了试验注册信息。
结论/意义:在中国,认可 CONSORT 声明或 ICMJE 的 URM 的医学期刊仅占总数的一小部分;所有这些期刊在作者期望方面使用的语言都含糊不清。