我国医学期刊临床研究论文质量控制策略

Quality control strategy of clinical research papers for medical journals in China

【目的】聚焦中文医学期刊编辑部工作流程和编辑行为,探讨中文临床研究论文整体质量控制策略。【方法】结合文献调研、专家访谈、会议讨论等方法,综合评价国内医学期刊发表的临床研究论文质量;从研究者、编辑部、编辑三方面分析其质量影响因素;探讨控制中文医学期刊临床研究论文质量的综合性策略。【结果】大量单中心、小样本、纯阳性的结果构成中文医学期刊临床研究论文的主体;研究规范性差、方法学缺失、报告质量低等情况普遍存在,导致国内临床研究论文的转化率低。影响我国临床研究质量的研究者层面分级因素有:大量基层医院医师缺乏基本的临床科研思维和研究方法学基础;教学科研型医院的规范化不足;顶级团队的研究缺乏原创性。医学期刊编辑部的构架不适、对临床研究注册和伦理审查要求的忽视、缺乏统一的发表准入条件;医学编辑相关知识储备不足、对国际规范与相关流程不熟等因素,限制了中文临床研究论文整体质量的提升。【结论】为把好中国临床研究论文质量"出口"关,国内医学期刊编辑部应统一认识:提高临床研究论文发表的"门槛";身体力行:严格实行临床研究注册制度,复核研究的伦理审查,加强临床研究国际规范、评价工具以及报告清单的认知普及,注明利益冲突以及允许发表阴性结果等。

[Purposes]Focusing on the workflowand editing behavior of the editorial offices of Chinese medical journals,this paper aims to explore the overall quality control strategy of Chinese clinical research papers.[Methods]Combining literature research,expert interviews,conference discussions,and other methods,we comprehensively evaluated the quality of clinical research papers published in domestic medical journals;analyzed the factors affecting the quality of Chinese clinical research papers from three aspects:researchers,editorial offices,and editors;and explored a comprehensive strategy to control the quality of Chinese clinical research papers.[Findings]A large number of single-center,small-sample,and pure-positive results constitute the main body of clinical research papers in China.The poor standardization,lack of methodology,and lowquality of reports in those papers lead to the research results that have not been well transformed.From the perspective of researchers,the factors influencing the quality of clinical research include a large number of primary hospital physicians lacking scientific research thoughts and research methodological basis,insufficient standardized management of clinical research in teaching and research hospitals,and the top team of domestic clinical research having insufficient originality.From the editor and editorial office,chaotic management of medical journal editorial office,out of sight clinical research registration and ethical reviewrules,ultra-lowstandard of the publication of clinical research papers,and limited knowledge reserve for medical editors reduce the overall quality of Chinese clinical research papers.[Conclusions]In order to improve the quality of the clinical research papers in China,we should strictly implement clinical research registration system,check the research of ethical review,step up the publicity of the clinical research to standardization,indicate the conflicts of interest,and allowissued negative results.