BACKGROUND Randomised controlled trials (RCTs) provide the most reliable information to inform clinical practice and patient care. We aimed to map global clinical research publication activity through RCT-related articles in high-impact-factor medical journals over the past five decades. METHODS We conducted a cross-sectional analysis of articles published in the highest ranked medical journals with an impact factor > 10 (according to Journal Citation Reports published in 2017). We searched PubMed/MEDLINE (from inception to December 31, 2017) for all RCT-related articles (e.g. primary RCTs, secondary analyses and methodology papers) published in high-impact-factor medical journals. For each included article, raw metadata were abstracted from the Web of Science. A process of standardization was conducted to unify the different terms and grammatical variants and to remove typographical, transcription and/or indexing errors. Descriptive analyses were conducted (including the number of articles, citations, most prolific authors, countries, journals, funding sources and keywords). Network analyses of collaborations between countries and co-words are presented. RESULTS We included 39,305 articles (for the period 1965-2017) published in forty journals. The Lancet (n = 3593; 9.1%), the Journal of Clinical Oncology (n = 3343; 8.5%) and The New England Journal of Medicine (n = 3275 articles; 8.3%) published the largest number of RCTs. A total of 154 countries were involved in the production of articles. The global productivity ranking was led by the United States (n = 18,393 articles), followed by the United Kingdom (n = 8028 articles), Canada (n = 4548 articles) and Germany (n = 4415 articles). Seventeen authors who had published 100 or more articles were identified; the most prolific authors were affiliated with Duke University (United States), Harvard University (United States) and McMaster University (Canada). The main funding institutions were the National Institutes of Health (United States), Hoffmann-La Roche (Switzerland), Pfizer (United States), Merck Sharp & Dohme (United States) and Novartis (Switzerland). The 100 most cited RCTs were published in nine journals, led by The New England Journal of Medicine (n = 78 articles), The Lancet (n = 9 articles) and JAMA (n = 7 articles). These landmark contributions focused on novel methodological approaches (e.g. the "Bland-Altman method") and trials on the management of chronic conditions (e.g. diabetes control, hormone replacement therapy in postmenopausal women, multiple therapies for diverse cancers, cardiovascular therapies such as lipid-lowering statins, antihypertensive medications, and antiplatelet and antithrombotic therapy). CONCLUSIONS Our analysis identified authors, countries, funding institutions, landmark contributions and high-impact-factor medical journals publishing RCTs. Over the last 50 years, publication production in leading medical journals has increased, with Western countries leading in research but with low- and middle-income countries showing very limited representation.

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在高影响因子医学期刊上发表的随机试验相关文章的全球分布图：横断面分析。

背景技术随机对照试验（RCT）提供最可靠的信息来指导临床实践和患者护理。我们的目标是在过去的五十年中，通过高影响因子医学期刊中与RCT相关的文章来绘制全球临床研究的出版物活动。方法我们对影响因子> 10的排名最高的医学期刊的文章进行了横断面分析（根据2017年发表的期刊引文报告）。我们搜索PubMed / MEDLINE（从成立到2017年12月31日）以查找在高影响因子医学期刊上发表的所有与RCT相关的文章（例如主要RCT，二级分析和方法论论文）。对于每个收录的文章，原始元数据都是从Web of Science中提取的。进行了标准化过程，以统一不同的术语和语法变体，并消除印刷，转录和/或索引错误。进行了描述性分析（包括文章，引文，最多产的作者，国家，期刊，资金来源和关键字的数量）。介绍了国家和共同词之间合作的网络分析。结果我们收录了40份期刊上发表的39,305篇文章（1965年至2017年）。《柳叶刀》（n = 3593； 9.1％），《临床肿瘤学杂志》（n = 3343； 8.5％）和《新英格兰医学杂志》（n = 3275文章； 8.3％）的RCT数量最多。共有154个国家参与了商品的生产。全球生产力排名由美国领先（n = 18,393篇文章），其次是英国（n = 8028条），加拿大（n = 4548条）和德国（n = 4415条）。确定发表了100篇或更多文章的17位作者；最多产的作者是美国杜克大学，美国哈佛大学和加拿大麦克马斯特大学。主要的资助机构是美国国立卫生研究院，霍夫曼-拉罗什（瑞士），辉瑞（美国），默克·夏普和多姆（美国）和诺华（瑞士）。被引用最多的100个RCT在9份期刊上发表，其中以《新英格兰医学杂志》（n = 78篇），《柳叶刀》（n = 9篇）和《美国医学会杂志》（n = 7篇）为首。这些具有里程碑意义的贡献集中于新颖的方法论方法（例如“ Bland-Altman方法” ）以及关于慢性病管理的试验（例如糖尿病控制，绝经后妇女的激素替代疗法，多种癌症的多种疗法，降脂他汀类药物的心血管疗法，降压药以及抗血小板和抗血栓形成疗法）。结论我们的分析确定了发表RCT的作者，国家，资助机构，具有里程碑意义的贡献和影响较大的医学期刊。在过去的50年中，领先医学期刊的出版物产量有所增加，西方国家在研究方面处于领先地位，而中低收入国家的代表性却非常有限。心血管疗法，例如降脂他汀类药物，降压药以及抗血小板和抗血栓形成疗法）。结论我们的分析确定了发表RCT的作者，国家，资助机构，具有里程碑意义的贡献和影响较大的医学期刊。在过去的50年中，领先医学期刊的出版物产量有所增加，西方国家在研究方面处于领先地位，而中低收入国家的代表性却非常有限。心血管疗法，例如降脂他汀类药物，降压药以及抗血小板和抗血栓形成疗法）。结论我们的分析确定了发表RCT的作者，国家，资助机构，具有里程碑意义的贡献和影响较大的医学期刊。在过去的50年中，领先医学期刊的出版物产量有所增加，西方国家在研究方面处于领先地位，而中低收入国家的代表性却非常有限。