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
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摘要
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.
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.
引文
1 General Assembly of the World Medical Association.World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects.J Am Coll Dent,2014,81(3):14-18.
2 Tonks A.Registering clinical trials.BMJ,1999,319(7224):1565-1568.
3 International Committee of Medical Journal Editors.Uniform requirements for manuscripts submitted to biomedical journals:writing and editing for biomedical publication(2010-04).Available at:http://www.icmje.org/urm-full.pdf.
4 吴泰相,李幼平,刘关键,等.临床试验注册制度与循证医学.中国循证医学杂志,2007,7(4):239-243.
5 吴泰相,李幼平,刘关键,等.中国临床试验注册中心及中国循证医学中心提高我国临床试验质量的策略和措施.中国循证医学杂志,2010,10(11):1243-1248.
6 Logvinov I.Clinical trials transparency and the Trial and Experimental Studies Transparency(TEST)act.Contemp Clin Trials,2014,37(2):219-224.
7 Tharyan P,Ghersi D.Registering clinical trials in India:a scientific and ethical imperative.Natl Med J India,2008,21(1):31-34.
8 Huser V,Cimino JJ.Evaluating adherence to the international committee of medical journal editors'policy of mandatory,timely clinical trial registration.J Am Med Inform Assoc,2013,20(e1):e169-e174.
9 vande Wetering FT,Scholten RJ,Haring T,et al.Trial registration numbers are underreported in biomedical publications.PLoS One,2012,7(11):e49599.
10 Pinto RZ,Elkins MR,Moseley AM,et al.Many randomized trials of physical therapy interventions are not adequately registered:a survey of 200 published trials.Phys Ther,2013,93(3):299-309.
11 Hooft L,Korevaar DA,Molenaar N,et al.Endorsement of ICMJE's clinical trial registration policy:a survey among journal editors.Neth J Med,2014,72(7):349-355.
12 Mathieu S,Chan AW,Ravaud P.Use of trial register information during the peer review process.PLoS One,2013,8(4):e59910.
13 David Moher,Sally Hopewell,Kenneth F Schulz,等.CONSORT2010说明与详述:报告平行对照随机临床试验指南的更新.中西医结合学报,2010,8(8):701-741.
14 张明妍,杨丰文,李越,等.《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究.中国循证医学杂志,2017,17(3):357-363.
15 田冬霞,张金钟,侯军儒.中国伦理委员会运作现状的一个缩影-天津市三级医院伦理委员会的调查与分析.中国医学伦理学,2008,21(1):44-47.
16 吴晓瑞,李义庭,赵学志,等.北京地区机构伦理审查委员会现状的调查分析.医学与哲学,2010,31(5):11-13.
17 周吉银,邓璠,刘丹,等.我国医学伦理委员会存在的问题及建议.中国临床药理学杂志,2017,33(4):365-368.
2 Tonks A.Registering clinical trials.BMJ,1999,319(7224):1565-1568.
3 International Committee of Medical Journal Editors.Uniform requirements for manuscripts submitted to biomedical journals:writing and editing for biomedical publication(2010-04).Available at:http://www.icmje.org/urm-full.pdf.
4 吴泰相,李幼平,刘关键,等.临床试验注册制度与循证医学.中国循证医学杂志,2007,7(4):239-243.
5 吴泰相,李幼平,刘关键,等.中国临床试验注册中心及中国循证医学中心提高我国临床试验质量的策略和措施.中国循证医学杂志,2010,10(11):1243-1248.
6 Logvinov I.Clinical trials transparency and the Trial and Experimental Studies Transparency(TEST)act.Contemp Clin Trials,2014,37(2):219-224.
7 Tharyan P,Ghersi D.Registering clinical trials in India:a scientific and ethical imperative.Natl Med J India,2008,21(1):31-34.
8 Huser V,Cimino JJ.Evaluating adherence to the international committee of medical journal editors'policy of mandatory,timely clinical trial registration.J Am Med Inform Assoc,2013,20(e1):e169-e174.
9 vande Wetering FT,Scholten RJ,Haring T,et al.Trial registration numbers are underreported in biomedical publications.PLoS One,2012,7(11):e49599.
10 Pinto RZ,Elkins MR,Moseley AM,et al.Many randomized trials of physical therapy interventions are not adequately registered:a survey of 200 published trials.Phys Ther,2013,93(3):299-309.
11 Hooft L,Korevaar DA,Molenaar N,et al.Endorsement of ICMJE's clinical trial registration policy:a survey among journal editors.Neth J Med,2014,72(7):349-355.
12 Mathieu S,Chan AW,Ravaud P.Use of trial register information during the peer review process.PLoS One,2013,8(4):e59910.
13 David Moher,Sally Hopewell,Kenneth F Schulz,等.CONSORT2010说明与详述:报告平行对照随机临床试验指南的更新.中西医结合学报,2010,8(8):701-741.
14 张明妍,杨丰文,李越,等.《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究.中国循证医学杂志,2017,17(3):357-363.
15 田冬霞,张金钟,侯军儒.中国伦理委员会运作现状的一个缩影-天津市三级医院伦理委员会的调查与分析.中国医学伦理学,2008,21(1):44-47.
16 吴晓瑞,李义庭,赵学志,等.北京地区机构伦理审查委员会现状的调查分析.医学与哲学,2010,31(5):11-13.
17 周吉银,邓璠,刘丹,等.我国医学伦理委员会存在的问题及建议.中国临床药理学杂志,2017,33(4):365-368.