Douglas G. Altman1, Kenneth F. Schulz2, David Moher3, Matthias Egger4, Frank Davidoff5, Diana Elbourne6, Peter C. Gtzsch7, Thomas Lang8 for the CONSORT
<Title>COX-2 inhibitors, traditional NSAIDs, and the heart Adverse event data from clinical trials must inform decision making<Author>Peter Jüni, senior research fellow in clinical epidemiology Depart...<Title>COX-2 inhibitors, traditional NSAIDs, and the heart Adverse event data from clinical trials must inform decision making<Author>Peter Jüni, senior research fellow in clinical epidemiology Department of Social and Preventive Medicine, University of Berne, Finkenhubelweg 11, 3012 Berne, SwitzerlandStephan ReichenbachDepartment of Rheumatology, University Hospital Berne, 3010 Berne,SwitzerlandMatthias Egger,visiting professor ofclinical epidemiologyMRC Health Services Research Collaboration, Department of SocialMedicine, University of Bristol, Bristol BS8 2PR<Keywords>展开更多
基金United Kingdom National Institute for Health ResearchCanadian Institutes of Health Research+4 种基金Presidents FundCanadian Institutes of Health ResearchJohnson & JohnsonBMJthe American Society for Clinical Oncology
文摘大量证据显示随机对照临床试验(randomised controlled trial,RCT)的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即"CONSORT2010声明"。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。"CONSORT2010声明"、其说明与详述文件,以及相关网站(www.consort-statement.org),对于改进随机临床试验报告必将有所裨益。
文摘Douglas G. Altman1, Kenneth F. Schulz2, David Moher3, Matthias Egger4, Frank Davidoff5, Diana Elbourne6, Peter C. Gtzsch7, Thomas Lang8 for the CONSORT
文摘<Title>COX-2 inhibitors, traditional NSAIDs, and the heart Adverse event data from clinical trials must inform decision making<Author>Peter Jüni, senior research fellow in clinical epidemiology Department of Social and Preventive Medicine, University of Berne, Finkenhubelweg 11, 3012 Berne, SwitzerlandStephan ReichenbachDepartment of Rheumatology, University Hospital Berne, 3010 Berne,SwitzerlandMatthias Egger,visiting professor ofclinical epidemiologyMRC Health Services Research Collaboration, Department of SocialMedicine, University of Bristol, Bristol BS8 2PR<Keywords>
