临床随机对照研究注册内容与高影响因子杂志论文发表内容的比较
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重庆市高校期刊研究会“渝编〖DK〗·仁和基金”资助项目(CQYB20202);四川省科技厅面上项目(2017JY0116)


Comparison of clinical randomized controlled trials registration and high impact factor journal articles
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    摘要:

    【摘要】目的 比较临床随机对照研究进行注册内容及论文发表内容的差异性与纠正措施。 方法 将2017年1月~2018年12月发表在《Annals of internal medicine》上的临床随机对照研究方面的论文全部纳入。从题目、主要研究目的、次要研究目的、研究类型、纳入标准、排除标准、年龄组、随访、样本量、主要结果和次要结果等11个方面比较临床试验注册内容和最终发表论文内容之间的差异。如果试验注册内容和最终发表论文内容完全匹配计为2分,部分匹配计为1分,完全不匹配记为0分。每篇论文的最大可能得分为2×11,即22分。 结果 临床随机对照研究论文和试验注册内容匹配平均得分为1373分,无一篇论文得到22分。完全匹配比例较高的分别为次要研究目的、研究类型、年龄组、随访、样本量和主要结果。题目、主要研究目的和次要结果完全匹配比例分别只有1351%、1622%和2432%。 结论在高影响因子的期刊中,临床试验注册内容和论文发表内容之间也存在差异。因此论文作者和期刊编辑都应该遵守并严格执行CONSORT指南建议,确保所发表论文研究的透明性,临床随机对照研究注册制度将是必然的发展趋势,深刻了解,提高认识,制定适合国情的相关规则并组织实施,对国内规范开展临床研究及提高医学论文的学术水平与国际影响力,都具有重要的指导意义。

    Abstract:

    【Abstract】Objective To compare content of randomized controlled trials (RCTs) published within two years in Annals of Internal Medicine, with the information contained in trial registries and the corrective measures. Methods All the papers published in Annals of Internal Medicine from January 2017 to December 2018 were included. The differences between the contents of the trial registration and the final published papers were compared from 11 aspects: title, main research purpose, secondary research purpose, research type, inclusion criteria, exclusion criteria, age group, followup, sample size, main results and secondary results. If the registration content of the trial matches the content of the final published paper, 2 points will be counted, 1 point will be counted as part of the match, and 0 point will be recorded if there is no match at all. The maximum possible score of each paper is 2 × 11, that is 22 points.Results The mean value achieved by RCTs was 1373. No RCT achieved a perfect score of 22. The largest proportion of RCTs reported secondary objectives, study type, treatment age group, follow up, sample size and primary outcomes fully correctly. However, only 1351%, 1622% and 2432% of RCTs were perfect matches with registry entries in terms of title, primary objective and secondary outcomes respectively. Conclusion There exist discrepancies between trial registration and published paper even in a high impact factor journal. Both authors and editors should adhere to CONSORT guidelines to ensure transparency of published research.

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  • 在线发布日期: 2020-11-11
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