Xiao Lu, Hu Jing, Zhang Li, Shang Hong-cai
Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.
Chin J Integr Med. 2014 Jul;20(7):510-5. doi: 10.1007/s11655-014-1865-8. Epub 2014 Jun 28.
To determine the extent to which Chinese medical (CM) journals incorporate Consolidated Standards for Reporting of Trials (CONSORT) into their "instruction to authors".
We reviewed the latest "instruction to authors" of the CM journals in China which indexed by MEDLINE in 2010 or Excerpta Medica Database (EMBASE) in 2012 and extracted all information of CONSORT, International Committee of Medical Journal Editors (ICMJE), other reporting guidelines or clinical trial registration. By reading the instructions to authors and reviewing recent studies published in those journals, those that do not publish clinical trials were excluded. We also contacted each of journals by telephone on contributor's status to ask them whether mentioned CONSORT in their instructions and incorporated it into their editorial and peer-review process. Full-text papers of randomized controlled trials (RCTs, from January 2011 to March 2012) published in the journals which mentioned "CONSORT" in their instructions for authors were downloaded.
Seven CM journals were included. Three of these journals mentioned CONSORT in its instructions. By telephone survey, all journals gave responses and all respondents knew CONSORT statement. Three of 7 journals required authors to comply with the CONSORT statement and provide the CONSORT checklist and a flow chart of the trial. The rest 4 journals recommended authors of RCTs to refer to the CONSORT statement. From January 2011 to March 2012, a total of 50 RCTs were obtained from the 3 journals endorsing the CONSORT statement; 17 (17/50, 34%) contained a flow diagram in their manuscript, and none of those RCTs had mentioned the trial registration information.
The endorsement of CONSORT by CM journals' "instruction to authors" was not satisfactory. The spread of CONSORT endorsement should be wider in instructing the performance of CM clinical trials in the future. Chinese journals should introduce CONSORT to their authors and require authors to comply with CONSORT when they submit their research.
确定中国医学期刊在其“作者须知”中纳入试验报告统一标准(CONSORT)的程度。
我们查阅了2010年被MEDLINE收录或2012年被荷兰医学文摘数据库(EMBASE)收录的中国医学期刊的最新“作者须知”,提取了所有关于CONSORT、国际医学期刊编辑委员会(ICMJE)、其他报告指南或临床试验注册的信息。通过阅读作者须知并查阅这些期刊近期发表的研究,排除那些不发表临床试验的期刊。我们还通过电话联系每本期刊,询问其对投稿者的要求,以了解它们在作者须知中是否提及CONSORT,并是否将其纳入编辑和同行评审过程。下载了在作者须知中提及“CONSORT”的期刊发表的随机对照试验(RCT,2011年1月至2012年3月)的全文论文。
纳入了7本中国医学期刊。其中3本期刊在其作者须知中提及了CONSORT。通过电话调查,所有期刊都给予了回复,所有受访者都知道CONSORT声明。7本期刊中有3本要求作者遵守CONSORT声明,并提供CONSORT清单和试验流程图。其余4本期刊建议RCT的作者参考CONSORT声明。2011年1月至2012年3月,从3本认可CONSORT声明的期刊中总共获得了50项RCT;其中17项(17/50,34%)在其手稿中包含流程图,且这些RCT均未提及试验注册信息。
中国医学期刊“作者须知”对CONSORT的认可情况并不理想。未来在指导中国医学临床试验的实施方面,CONSORT认可的推广应更加广泛。中文期刊应向作者介绍CONSORT,并要求作者在提交研究时遵守CONSORT。