【目的】 通过调查、分类国内核心医学期刊临床研究论文方法学论述中存在的错误和偏倚,分析论文整体水平较低的原因,探讨提升国内临床研究论文质量的举措。【方法】 抽取国内2017年出版、具有代表性的高水平医学期刊13册,通过审读查找其所发129篇临床研究论文方法部分的错误,总结其突出问题并探索解决办法。【结果】 ①48.06%的论文对研究设计未提及,42.64%的论文对研究设计概念混淆,显示大部分论文对临床研究方法基本概念不甚清楚。②92.25%的论文未见病例确定过程,97.67%的论文未见样本量的估算方法,显示样本量确定的随意性是最突出的问题。③51.16%的论文存在明显的逻辑混乱,23.26%的论文未交待病例基线资料,41.09%的论文对纳入排除概念不清,表明国内临床研究论文整体质量不容乐观。【结论】 国内医学期刊编辑亟待提高业务水平,增加专业、方法学等知识;国内医学期刊应严格遵守国际标准,提高临床研究论文发表的门槛。以前瞻性和回顾性研究分类,提出临床研究论文方法部分撰写顺序的建议。
[Purposes] This paper aims to improve the quality of domestic clinical research papers on the basis of analysis of reasons for low-level papers in general situation by investigation and classification of errors occurring in methodology statement in clinical research papers from core medical journals in China. [Methods] Sampling survey of 13 domestic medical journals published in 2017 with featured representativeness was conducted. Errors occurring in methodology statement of 129 clinical research papers were collected and classified, major issues were summarized, and their solutions were discussed. [Findings] Firstly, confusion of basic concepts of clinical research methodologies is obvious. Study designs are not mentioned in 48.06% of researched papers. The concepts of study designs are confused in 42.64% of researched papers. Secondly, the prominent problem is declaring sampling randomly. 92.25% of researched papers lack of process to determine the case. Estimation methods are not mentioned in 97.67% of researched papers. Finally, the overall level of clinical research papers in China is not optimistic. 51.16% of the papers are logically confused, 23.26% do not set out baseline data of patients, and 41.09% are not clear about the inclusion/exclusion concept. [Conclusions] Editors of medical journals in China should improve their professional skills and acquire more knowledge in medical professions and methodologies. Medical journals in China should strictly abide by international standards and level up the threshold of publishing clinical research papers. Suggestions on writing order of methodology statement in clinical research papers are proposed in respect of prospective and retrospective studies.
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