我国高影响因子中文医学期刊发表随机对照试验注册、伦理、知情同意报告现状及质量评价分析

The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals

目的搜集中国科学引文数据库(CSCD)收录的影响因子排名前20位医学期刊发表的临床随机对照试验(RCT),分析其方案注册、伦理审查和知情同意现状,并评价其方法学质量。方法计算机检索CSCD收录的影响因子排名前20位的医学期刊,搜集2016和2017年发表的所有RCT。对RCT的方案注册、伦理审查和知情同意的相关因素进行统计分析。结果共纳入395个RCT。19个(4.8%)RCT报告了方案注册信息。4本中医药期刊发表的207个RCT中仅有4个报告了注册信息,占1.9%;16本西医期刊发表的188个RCT中有15个报告了注册信息,占8.0%。报告伦理审查的RCT为185个,占46.8%,其中中医药期刊发表的RCT有66个报告了伦理审查,占31.9%;西医期刊发表的RCT有119个报告了伦理审查,占63.3%。报告知情同意的RCT为253个,占64.1%,其中中医药期刊发表的RCT有154个报告了知情同意,占74.4%;西医期刊发表的RCT有99个报告了知情同意,占52.7%。在RCT的方法学质量报告方面:报告随机序列产生的研究299个,占75.7%;报告分配隐藏的研究38个,占9.6%;报告盲法实施的研究60个,占15.2%。结论我国高影响因子中文医学期刊发表RCT的方案注册比例、伦理审查和知情同意的执行率仍较低,其方法学质量的报告有待提高。应加强临床试验方法学的培训。

Objectives To investigate the status of clinical trial registrations（CTRs）, ethical reviews（ERs） and informed consent forms（ICFs） of randomized controlled trials（RCTs）, which were published in the top 20 journals included by Chinese Science Citation Database（CSCD）, and evaluate the methodological quality of RCTs. Methods We selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed. Results A total of 395 RCTs were included for data analysis. Nineteen RCTs（4.8%） reported the information of registration. For the 4 traditional Chinese medicine journals, only 4（1.9%） of 207 RCTs reported the registered information. For the 16 western medical journals, only 15（8%）of 188 RCTs reported the registered information. There were 185 RCTs（46.8%） which reported the information of ethical review. Among them, 66 RCTs（31.9%） were published in traditional Chinese medical journals and 119 RCTs（63.3%）were published in western medical journals. There were 253 RCTs（64.1%） which reported the information of informed consent. Among them, 154 RCTs（74.4%） were published in Chinese medical journals and 199 RCTs（52.7%） were in western medical journals. In terms of methodology, approximately 299 RCTs（75.7%） reported the type of randomization where 60 RCTs（15.2%） reported the information of allocation concealment and 38 RCTs（59.6%） reported blinding.Conclusions The proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.