Article(id=1241035552921808930, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241035543589483182, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202409141, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1725724800000, receivedDateStr=2024-09-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773815533142, onlineDateStr=2026-03-18, pubDate=1735056000000, pubDateStr=2024-12-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773815533142, onlineIssueDateStr=2026-03-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773815533142, creator=13701087609, updateTime=1773815533142, updator=13701087609, issue=Issue{id=1241035543589483182, tenantId=1146029695717560320, journalId=1227665162245664772, year='2024', volume='51', issue='24', pageStart='4417', pageEnd='4608', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773815530917, creator=13701087609, updateTime=1773815686426, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241036195896029478, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241035543589483182, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241036195896029479, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241035543589483182, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=4597, endPage=4602, ext={EN=ArticleExt(id=1241035553563537469, articleId=1241035552921808930, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Analysis of design flaws and statistical issues in manuscripts submitted to core medical journals, columnId=null, journalTitle=Modern Preventive Medicine, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective

To analyze the design flaws and statistical issues present in medical papers submitted to core domestic journals, and to explore strategies for improving the quality of medical papers and submission acceptance rates.

Methods

A questionnaire survey was conducted to collect data on submissions to domestic core medical journals between January 2021 and December 2023. Quantitative empirical and qualitative analyses were performed.

Results

A total of 306 clinical medicine research papers and 328 basic medicine research papers were included in the analysis. There was a statistically significant difference in the acceptance rates between these two categories (P<0.001), while no significant difference was found concerning the acceptance rates of papers supported by different levels of funding (P>0.05). Observational studies constituted 71.40% of all submissions; however, their acceptance rate was lower than that of experimental studies (43.75% vs. 53.66%, P<0.05). Various deficiencies were identified in the methodological design and statistical analysis reporting of the manuscripts. The main issues included unclear description of study design types, inadequate matching between groups, insufficient modeling and validation, neglect of sample size calculation, and errors in result reporting.

Conclusion

Significant flaws exist in the research design and statistical analysis reporting of medical manuscripts, with a considerable gap compared to internationally recognized medical reporting standards. Hospitals and medical schools should strengthen training in the latest medical research standards and statistical knowledge to improve the quality of academic papers and enhance research outcomes.

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目的

分析向国内核心期刊投稿的医学论文中存在的设计缺陷及统计学问题,探索提高医务人员和医学生论文质量和投稿命中率的策略。

方法

问卷调查收集2021年1月至2023年12月国内医学核心期刊稿件内容,进行定量实证和定性分析。

结果

纳入分析306篇临床医学研究论文和328篇基础医学研究论文,录用率差异有统计学意义(P<0.001),不同基金级别稿件的录用率差异无统计学意义(P>0.05)。观察性研究占全部稿件的71.40%,但其录用率低于实验性研究(43.75% vs. 53.66%,P<0.05)。稿件在方法学设计和统计学分析报告方面存在多种缺陷,主要问题包括:研究设计类型表述不清、组间匹配不严谨、建模和验证不足、忽略样本量计算、结果报告错误。

结论

医学稿件在研究设计和统计分析报告方面存在显著缺陷,与国际通用的医学报告规范存在较大差距。医院和医科院校应加强对最新医学研究规范和统计学知识培训,以提升学术论文质量,增加科研论文成果。

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孙昌朋,E-mail:
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余诗诗(1986—),女,硕士,编辑,研究方向:医学统计学,医学论文编辑

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Journal of Clinical Epidemiology, 2021, 137: 250-261., articleTitle=A cross-sectional literature survey showed the reporting quality of multicenter randomized controlled trials should be improved, refAbstract=null)], funds=[Fund(id=1241069987088093229, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, awardId=2024B1212110007, language=CN, fundingSource=广东省科学技术厅课题-广东省科技期刊优秀人才项目(2024B1212110007), fundOrder=null, country=null), Fund(id=1241069987234893877, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, awardId=卓越计划-C-081, language=CN, fundingSource=中国科技期刊卓越行动计划项目(卓越计划-C-081), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241069981148959562, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, xref=null, ext=[AuthorCompanyExt(id=1241069981157348171, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, companyId=1241069981148959562, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Editorial Department of the Journal of Southern Medical University, Guangzhou 510515, Guangdong, China), AuthorCompanyExt(id=1241069981165736780, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, companyId=1241069981148959562, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南方医科大学学报编辑部,广东 广州 510515)])], figs=[ArticleFig(id=1241069985481675722, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=EN, label=Fig.1, caption=Overall Acceptance and Rejection Status of Manuscripts Submitted to Core Journals (***P<0.001), figureFileSmall=q6ubHB+z9QsbUUsQy9NjJw==, figureFileBig=fYbPavaxjyeQ+dARpf8eVQ==, tableContent=null), ArticleFig(id=1241069985594921937, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=CN, label=图1, caption=向核心期刊投稿的稿件总体录用和退稿情况(***P<0.001), figureFileSmall=q6ubHB+z9QsbUUsQy9NjJw==, figureFileBig=fYbPavaxjyeQ+dARpf8eVQ==, tableContent=null), ArticleFig(id=1241069985733333976, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=EN, label=Fig.2, caption=Trends in the Number of Publications on Clinical Medical Research(A refers to literature indexed in CNKI, B refers to literature indexed in PubMed), figureFileSmall=AnyEM1xLcah/KQyRv5SxIA==, figureFileBig=P1wsP1SiiVB84ExFobD+mw==, tableContent=null), ArticleFig(id=1241069985825608671, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=CN, label=图2, caption=临床医学论著发文量变化趋势(注:A是CNKI收录文献,B是Pubmed收录文献), figureFileSmall=AnyEM1xLcah/KQyRv5SxIA==, figureFileBig=P1wsP1SiiVB84ExFobD+mw==, tableContent=null), ArticleFig(id=1241069985947243495, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=EN, label=Table 1, caption=

Acceptance Status of Different Types of Submissions to Core Journals

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研究类型稿件数退稿数录用率(%)
临床研究30619735.62
观察性临床预测模型372532.43
诊断试验452348.89
队列研究21957.14
病例对照研究723354.17
横断面研究965443.75
孟德尔随机化332718.18
实验性随机对照临床试验(RCT)271448.15
一般随机对照试验613542.62
基础研究32815253.66
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向核心期刊投稿的各类型接收情况

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研究类型稿件数退稿数录用率(%)
临床研究30619735.62
观察性临床预测模型372532.43
诊断试验452348.89
队列研究21957.14
病例对照研究723354.17
横断面研究965443.75
孟德尔随机化332718.18
实验性随机对照临床试验(RCT)271448.15
一般随机对照试验613542.62
基础研究32815253.66
), ArticleFig(id=1241069986245039103, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=EN, label=Table 2, caption=

Comparison of Acceptance Rates for Manuscripts Funded by Different Levels of Grants

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基金级别研究类型录用未录用总稿件录用率
(%)
P
各级基金中临床和基础研究临床研究中各级别基金稿件基础研究中各级别基金稿件
国家级临床615111254.460.6560.0090.268
基础836214557.24
省级临床588013842.030.143--
基础565310951.38
市级以下或无临床17395630.360.071--
基础34407445.95
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各级别基金资助稿件的录用率比较

, figureFileSmall=null, figureFileBig=null, tableContent=
基金级别研究类型录用未录用总稿件录用率
(%)
P
各级基金中临床和基础研究临床研究中各级别基金稿件基础研究中各级别基金稿件
国家级临床615111254.460.6560.0090.268
基础836214557.24
省级临床588013842.030.143--
基础565310951.38
市级以下或无临床17395630.360.071--
基础34407445.95
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Methodological Differences Between Clinical and Basic Medical Research

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项目临床医学研究基础医学研究
常用统计方法多重回归分析,生存分析(如Cox回归),逻辑回归,混合效应模型,方差分析,卡方检验,t检验,广义估计方程,贝叶斯分析,多水平模型,时间序列分析,结构方程模型t检验,方差分析(ANOVA),相关分析,主成分分析,聚类分析,卡方检验,线性回归
研究设计随机对照试验(RCT),队列研究,病例对照研究,横断面研究完全随机设计,随机区组设计,拉丁方设计,交叉设计,析因设计
样本选择严格的纳入和排除标准,随机分组随机选取实验样本,实验条件控制严格
数据类型连续变量(如血压、体温),分类变量(如性别、是否患病),生存时间数据连续变量(如酶活性、基因表达水平),分类变量(如基因型、实验组别)
数据处理处理缺失值,多重共线性处理,数据变换数据标准化,高维数据处理
数据异质性高度异质性数据相对单一的数据类型
), ArticleFig(id=1241069986593165328, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=CN, label=表3, caption=

临床医学研究与基础研究方法学区别

, figureFileSmall=null, figureFileBig=null, tableContent=
项目临床医学研究基础医学研究
常用统计方法多重回归分析,生存分析(如Cox回归),逻辑回归,混合效应模型,方差分析,卡方检验,t检验,广义估计方程,贝叶斯分析,多水平模型,时间序列分析,结构方程模型t检验,方差分析(ANOVA),相关分析,主成分分析,聚类分析,卡方检验,线性回归
研究设计随机对照试验(RCT),队列研究,病例对照研究,横断面研究完全随机设计,随机区组设计,拉丁方设计,交叉设计,析因设计
样本选择严格的纳入和排除标准,随机分组随机选取实验样本,实验条件控制严格
数据类型连续变量(如血压、体温),分类变量(如性别、是否患病),生存时间数据连续变量(如酶活性、基因表达水平),分类变量(如基因型、实验组别)
数据处理处理缺失值,多重共线性处理,数据变换数据标准化,高维数据处理
数据异质性高度异质性数据相对单一的数据类型
), ArticleFig(id=1241069986718994452, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=EN, label=Table 4, caption=

Summary of Issues in Research Papers

, figureFileSmall=null, figureFileBig=null, tableContent=
研究类型问题种类临床研究(n=306)基础研究(n=328)
篇数占比
(%)
已发表论文
中问题论文
构成比
n=120,%)
未发表论文
中问题论文
构成比
n=120,%)
篇数占比
(%)
已发表论文
中问题论文
构成比
n=120,%)
未发表论文
中问题论文
构成比
n=120,%)
普遍问题缺少样本量计算23978.1065.8382.5023170.4362.5074.17
统计推断方法描述不具体20566.9924.1765.8313741.775.0047.50
统计学结果报告不规范或有误7725.1615.8320.834313.116.6711.67
统计学描述与数据类型不符4916.016.6717.504112.501.6710.00
观察性研究设计类型不明确10333.6664.1780.83----
设计类型描述有误5618.307.5024.17----
病例与对照匹配不严谨4213.739.1715.83----
危险因素分析与建模相混淆3511.440.008.33----
模型验证不全面258.176.6710.00----
模型评价方法不规范206.545.837.50----
ROC曲线的比较未做假设检验196.210.835.00----
实验性研究实验设计不规范6220.260.8318.333911.890.009.17
统计报告不规范5417.653.3316.674614.024.1710.83
), ArticleFig(id=1241069986828046364, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241035552921808930, language=CN, label=表4, caption=

研究论文中的问题汇总

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研究类型问题种类临床研究(n=306)基础研究(n=328)
篇数占比
(%)
已发表论文
中问题论文
构成比
n=120,%)
未发表论文
中问题论文
构成比
n=120,%)
篇数占比
(%)
已发表论文
中问题论文
构成比
n=120,%)
未发表论文
中问题论文
构成比
n=120,%)
普遍问题缺少样本量计算23978.1065.8382.5023170.4362.5074.17
统计推断方法描述不具体20566.9924.1765.8313741.775.0047.50
统计学结果报告不规范或有误7725.1615.8320.834313.116.6711.67
统计学描述与数据类型不符4916.016.6717.504112.501.6710.00
观察性研究设计类型不明确10333.6664.1780.83----
设计类型描述有误5618.307.5024.17----
病例与对照匹配不严谨4213.739.1715.83----
危险因素分析与建模相混淆3511.440.008.33----
模型验证不全面258.176.6710.00----
模型评价方法不规范206.545.837.50----
ROC曲线的比较未做假设检验196.210.835.00----
实验性研究实验设计不规范6220.260.8318.333911.890.009.17
统计报告不规范5417.653.3316.674614.024.1710.83
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医学论文写作中的设计缺陷及统计学问题分析
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余诗诗 , 吴锦雅 , 经媛 , 陈望忠 , 孙昌朋
现代预防医学 | 人才培养 2024,51(24): 4597-4602
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现代预防医学 | 人才培养 2024, 51(24): 4597-4602
医学论文写作中的设计缺陷及统计学问题分析
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余诗诗, 吴锦雅, 经媛, 陈望忠, 孙昌朋
作者信息
  • 南方医科大学学报编辑部,广东 广州 510515
  • 余诗诗(1986—),女,硕士,编辑,研究方向:医学统计学,医学论文编辑

通讯作者:

孙昌朋,E-mail:
Analysis of design flaws and statistical issues in manuscripts submitted to core medical journals
Shi-shi YU, Jin-ya WU, Yuan JING, Wang-zhong CHEN, Chang-peng SUN
Affiliations
  • Editorial Department of the Journal of Southern Medical University, Guangzhou 510515, Guangdong, China
出版时间: 2024-12-25 doi: 10.20043/j.cnki.MPM.202409141
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目的

分析向国内核心期刊投稿的医学论文中存在的设计缺陷及统计学问题,探索提高医务人员和医学生论文质量和投稿命中率的策略。

方法

问卷调查收集2021年1月至2023年12月国内医学核心期刊稿件内容,进行定量实证和定性分析。

结果

纳入分析306篇临床医学研究论文和328篇基础医学研究论文,录用率差异有统计学意义(P<0.001),不同基金级别稿件的录用率差异无统计学意义(P>0.05)。观察性研究占全部稿件的71.40%,但其录用率低于实验性研究(43.75% vs. 53.66%,P<0.05)。稿件在方法学设计和统计学分析报告方面存在多种缺陷,主要问题包括:研究设计类型表述不清、组间匹配不严谨、建模和验证不足、忽略样本量计算、结果报告错误。

结论

医学稿件在研究设计和统计分析报告方面存在显著缺陷,与国际通用的医学报告规范存在较大差距。医院和医科院校应加强对最新医学研究规范和统计学知识培训,以提升学术论文质量,增加科研论文成果。

医学论文质量  /  研究设计缺陷  /  统计学问题  /  录用率  /  研究报告规范
Objective

To analyze the design flaws and statistical issues present in medical papers submitted to core domestic journals, and to explore strategies for improving the quality of medical papers and submission acceptance rates.

Methods

A questionnaire survey was conducted to collect data on submissions to domestic core medical journals between January 2021 and December 2023. Quantitative empirical and qualitative analyses were performed.

Results

A total of 306 clinical medicine research papers and 328 basic medicine research papers were included in the analysis. There was a statistically significant difference in the acceptance rates between these two categories (P<0.001), while no significant difference was found concerning the acceptance rates of papers supported by different levels of funding (P>0.05). Observational studies constituted 71.40% of all submissions; however, their acceptance rate was lower than that of experimental studies (43.75% vs. 53.66%, P<0.05). Various deficiencies were identified in the methodological design and statistical analysis reporting of the manuscripts. The main issues included unclear description of study design types, inadequate matching between groups, insufficient modeling and validation, neglect of sample size calculation, and errors in result reporting.

Conclusion

Significant flaws exist in the research design and statistical analysis reporting of medical manuscripts, with a considerable gap compared to internationally recognized medical reporting standards. Hospitals and medical schools should strengthen training in the latest medical research standards and statistical knowledge to improve the quality of academic papers and enhance research outcomes.

Quality of medical papers  /  Research design flaws  /  Statistical issues  /  Acceptance rate  /  Research reporting guidelines
余诗诗, 吴锦雅, 经媛, 陈望忠, 孙昌朋. 医学论文写作中的设计缺陷及统计学问题分析. 现代预防医学, 2024 , 51 (24) : 4597 -4602 . DOI: 10.20043/j.cnki.MPM.202409141
Shi-shi YU, Jin-ya WU, Yuan JING, Wang-zhong CHEN, Chang-peng SUN. Analysis of design flaws and statistical issues in manuscripts submitted to core medical journals[J]. Modern Preventive Medicine, 2024 , 51 (24) : 4597 -4602 . DOI: 10.20043/j.cnki.MPM.202409141
医学研究论文数量激增,但质量参差不齐[1],这与设计规范及统计方法运用的准确性相关。国外医学编辑协会重视这些问题[2-4],遵循规范有助于科研人员正确撰写研究方法和报告结果[5-7]。近年来,EQUATOR协作网已更新了多种研究报告规范,涵盖生物医学研究类型,如CONSORT 2010、STROBE、PRISMA 2020、STARD 2015等。截至2024年5月,已发布报告规范达622个[8]。《柳叶刀》指出我国生物医学论文统计报告错误率高达88%,基金赞助稿件中发生率为40%~80%[9]。尽管国内对统计审核的重视有所提升,但医务人员及医学生群体中,国际规范的知晓和应用率仍较低,医学论文质量偏低[10-12]
尽管已有多种指导意见[13-14],但应用中仍存诸多问题。既往研究多关注基础统计或案例,缺乏对系统性问题的揭示,未深入分析当前热门领域的方法缺陷[15-16]。此外,相关研究多为定性分析,忽视了大样本定量研究及临床和基础医学的差异,未能提供针对性建议。
本研究系统分析中文医学核心期刊稿件的设计及统计缺陷,旨在为医学科研论文作者提供具体改进建议,填补既往研究的不足,提升医务人员和医科院校学生论文的整体质量。
本研究采用线上问卷调查,于2021年1月至2023年12月期间收集向中文医学类核心期刊投稿的稿件信息。问卷的主要内容包括作者的基本信息、稿件类型、研究领域、投稿经历和稿件处理结果等。调查对象为在此期间向上述期刊投稿的作者。纳入标准:自愿参与本调研;向中文医学类核心期刊投稿的论文作者。排除标准:未完整填写问卷;重复提交问卷;非医学领域稿件作者。最终纳入分析的有效稿件共634篇,其中临床医学306篇,基础医学328篇。后续从临床医学和基础医学论文中随机抽取已发表和未发表论文各120篇进行对比分析。
逐篇分析问卷中反馈的稿件问题,记录并归纳所有问题为两大类:研究设计缺陷、统计方法缺陷。质量评价参考EQUATOR协作网(https://www.equator-network.org/about-us/what-is-a-reporting-guideline/)最新发布的指南。
根据统计学常规标准,样本量达到300以上通常能够提供足够的统计功效,本研究的样本量达到了这一标准,确保了统计分析的可靠性和结果的代表性。数据分析采用SPSS 26.0、StataMP 14和Excel 2021软件进行。计数资料以频数和构成比[n(%)]表示,组间比较采用卡方检验(Pearson χ2)和Wilcoxon秩和检验。统计检验的显著性水平设定为ɑ=0.05(双侧)。
本研究纳入向核心期刊投稿的临床研究和基础研究的录用率差异有统计学意义(P<0.001,图1),基础研究的录用率高于临床研究(53.66% vs. 35.62%)。临床研究中,队列研究和病例对照研究的接收率相对较高,而孟德尔随机化研究的接收率较低(表1)。在临床研究中,观察性研究占大多数,共218篇(71.24%),录用率低于实验性研究(43.75% vs. 53.66%, P<0.05)。对所有稿件类型的稿件接收率做卡方检验进行比较,差异有统计学意义(P<0.001)。
卡方检验分析不同基金级别的临床和基础研究稿件录用率差异(表2)。在国家级基金中,临床研究的录用率为54.46%,基础研究的录用率为57.24%,两者差异无统计学意义(P>0.05)。国家级基金支持下的临床研究稿件中,录用率差异有统计学意义(P<0.05),而基础研究稿件的录用率差异无统计学意义(P>0.05)。在省级基金中,临床研究的录用率为42.03%,基础研究的录用率为51.38%,两者差异无统计学意义(P>0.05)。在市级以下或无基金支持的情况下,临床研究的录用率为30.36%,基础研究的录用率为45.95%,差异也无统计学意义(P>0.05)。
由于临床医学研究涉及复杂的研究设计和多样的数据类型,统计方法和数据处理比基础医学研究的更复杂(表3)。实验设计和统计分析中的错误对临床研究结果的影响可能更为显著,直接关系到患者的治疗效果和安全性,而基础医学研究通常涉及更为简单的实验设计和数据处理,临床医学论文问题数量和种类均比基础医学论文多(P<0.05,表4)。
CNKI核心期刊和Pubmed数据库中,临床医学类论著中观察性研究的发文量呈持续上升趋势,数量超过了实验性研究(图2A、B)。观察性研究稿件在研究设计、数据质量、统计分析和结论可靠性等方面的问题突显,退稿率居高。孟德尔随机化研究和临床预测模型退稿率高达81.82%和67.57%。
对各类论文对比分析显示(表4),已发表论文在多个关键问题上优于未发表论文,尤其是在样本量计算、统计推断方法描述和统计学结果报告方面(P<0.05)。审稿人在研究设计、统计方法和结果报告中的严格审核显著提升了论文质量,有效纠正了部分问题。但在模型验证不全面等细节问题上,已发表论文中仍存在一定比例的问题稿件,该领域的审稿工作还有进一步改进的空间。
观察性研究设计类型不明确的问题最突出(占33.66%),主要原因是研究者在规划阶段缺乏清晰的研究理论框架,导致研究目的和方法不明确。此外,设计类型描述有误(18.30%)和病例对照匹配不严谨(13.73%)问题也较常见,这反映了研究者在定义和执行标准时的疏漏。实验性研究中,实验设计不规范的问题尤为显著(占20.26%),多因研究者未能严格控制实验条件或遵循标准化的实验流程,导致结果的重复性和可靠性降低。统计报告不规范的问题也较为严重(占17.65%),在数据呈现和解释上存在明显不足。
临床预测和诊断模型论文数量增多同时质量堪忧。TRIPOD声明中明确建议需报告建立模型时使用的所有统计方法,包括:1)模型类型,如logistic模型、Cox模型等;2)备选预测因素的选定:指在建模前所有潜在预测变量是通过什么方式选定的;3)模型内预测因素的筛选方法:指在建模中最终进入回归模型中的预测因素的筛选过程,如单因素分析、逐步回归等;4)交互项的处理;5)对于Cox模型是否满足比例风险假设;6)内部验证和外部验证方法。构建模型还需有足够的样本量,如果疾病发生率<20%,应根据每个变量对应的疾病发生例数(EPV,events per variable)>10的规则以增加样本量。纳入研究的预测模型类稿件中,绝大部分(>90%)都未写样本量确定方法。有些将本来就不多的样本数据划分为测试集(training data)和验证集(test data),更造成检验效能不足、模型过拟合等问题。主要问题还有:不报告模型性能评价指标、未做外部验证、把建模与危险因素分析相混淆。
本研究纳入的临床随机对照实验(RCT)稿件严重不符合规范,均未写清楚CONSORT声明的要素。多数稿件(占86.32%)在前言中只是引用了几篇文献说“研究很少或者未做相关研究”,引证力度不足。随机对照试验需要严格计算样本量,且应把计算的过程放在“方法”第1段。绝大部分稿件没有写样本量计算依据(占81.64%)。
许多稿件用而未采用规范的来进行统计描述,可能为掩盖其数据非正态分布的特点,或由于混淆了标准差和标准误的概念导致。在统计结果报告中还存在许多低级错误:相关系数正负号写错、统计学结果与实际数据不符、检验的统计量值与P值逻辑冲突、统计图所示与文字描述不相符等。
有些稿件内容突显了作者统计学概念未理解。例如:P>0.05实际上并不意味着两组相等。只有在等效性研究中,无统计显著性的P值才能得出两组指标相似的结论,而临床医学论文中常见非劣效性研究,差异没有统计学意义只能表明组间没有观察到差异。另外,当P<0.01时,并不能说结果具有极显著性差异。许多作者没有理解P值只是一个概率,代表差异出现的概率而不是差异的大小。
本研究纳入分析的稿件大部分有基金项目资助,不同基金级别稿件的录用率差异并不显著。虽然基金资助为研究者提供了更好的资源和条件,但缺乏严谨的科研态度和统计方法,难以产出高质量成果。由于基金论文比是许多期刊评价体系的重要指标,一些作者可能会在无关研究中标注基金资助、虚构基金资助信息以提高其稿件的评价和录用机会。这不仅破坏了学术诚信,也对期刊的评价体系造成了严重影响。基金论文比并不能准确反映文章的实际水平,真正的质量提升应基于研究方法和数据分析的改进。
大部分临床医学研究稿件设计不规范,导致结论存在逻辑性错误。根据流行病学研究方法理论[17],临床研究的设计类型可分为两大类:对研究对象人群进行被动观察的为观察性研究,进行主动干预的为实验性研究。观察性研究主要包括:队列研究、病例对照研究、横断面研究。近年来病例对照研究中根据研究目的不同发展出了许多新类型,如危险因素分析、临床预测和预后模型、临床疗效分析等等,横断面研究中较常见的是相关性分析和诊断试验[18]。实验性研究一般包括随机对照试验、没有随机分组或没有对照组的类实验。本研究分析的稿件包括上述类型,观察性研究的稿件数量远多于实验性研究。这可能是因为对于临床工作者来说,从医院平台获得观察性研究的资料途径较便捷,数据较齐全,开展研究的难度较小。但从退稿率来看,稿件的质量需要从多方面提高。观察性研究的稿件中,较常见的误区是在横断面数据中探索因果关系。例如作者收集病人入院时的临床资料,选取病例组和对照组,通过组间假设检验,发现某些指标在病例组和对照组间差异有统计学意义,然后纳入回归方程看其OR值及置信区间,结论得出某指标是疾病的独立危险因素。这样用入院时的横断面资料做危险因素分析不严谨,缺乏因果推断的内在逻辑。如果是回顾性的研究,目的是探索和验证疾病危险因素,一定要注意收集的病例资料是新发病例,其暴露因素的测量应发生在确诊疾病之前,否则会造成现患病例—新发病例偏倚。
近年来建立临床预测模型的文章增多,但许多设计不规范,导致结论缺乏意义,稿件质量差。合格的临床预测模型研究应包括模型构建、模型评价、模型验证(包括内部验证和外部验证)[19]。评价临床预测模型时,必须报告区分度和校准度,常用的区分度指标是ROC曲线和一致性统计量也被称为C统计量。ROC曲线的曲线下面积(AUC)在0.6以下是低区分度,在0.6~0.75之间是中区分度,高于0.75是高区分度,取值范围为0~1,越接近1表示模型区分度越好。C统计量等于0.5时表示模型没有预测能力,C统计量小于0.5表示模型预测与实际结果相反。若终点事件是二分类变量,C统计量与ROC曲线下面积(AUC)相同;若终点事件是事件-时间变量,最常用的是Harrell提出的Harrell’s C统计量。校准度可使用Hosmer-Lemeshow拟合优度检验、Calibration curve(Calibration plot) 图形化、Brier得分量化(取值范围为0~0.25),Brier得分越接近0表示模型校准度越好, Brier得分等于0.25时表示模型没有预测能力。也可增加R2、灵敏度、特异度、决策曲线等多维度反映模型性能,若要评价引入新预测因子后的预测效能增加值,也可使用综合区分改善度(IDI)及净重分类改善度(NRI)等指标。本研究纳入的建模类稿件中,模型评价往往几句话带过,没有做具体分析,图表及注解不清楚。稿件中普遍缺少对模型的验证,极少做外部验证。
在实验研究中,RCT通常被认为是临床证据中的金标准[5]。在循证医学中心制定的证据等级中位于证据强度最高的金字塔顶端,国际高水平期刊也倾向于刊登RCT的试验结果。设计有缺陷、报告质量低的临床试验无法为临床工作提供可靠有效的证据[20-21]。有研究评估了从1975年至2019年以英文发表的多中心RCTs论文质量,结果显示随着CONSORT2010发布,报告质量逐渐提高,但整体上还有较大提升空间[22]。从本研究分析的RCT论著来看,研究方法学存在严重问题,在研究设计和结果报告上,各种统计学概念混淆不清,许多作者甚至把“随机”和“随意”混为一谈,绝大多数都不报告样本量计算过程,忽略组间配比的科学性和规范性,导致文章结论缺乏临床指导意义。这样的结果显示,我国医疗工作者的临床研究规范理论及论文的统计学报告水平需进一步系统性加强。
本研究尚存在以下不足:研究对象仅局限于问卷调查收集的稿件,样本量有限,研究结果存在一定偏倚;国内医学期刊普遍未在稿约中对研究设计和统计分析内容做具体要求,而国外期刊相对在投稿指南上规定更详细,同一研究者投稿国内期刊和国外期刊,稿件质量表现可能不一样。
医学期刊应积极将最新的国际通行报告规范引入稿约,作者撰写、提交稿件时,应主动遵循相应稿约和报告规范,同时专家应积极推动报告规范在国内科技与出版领域的普及,建立中国医学报告规范体系,从而提升研究论文质量,促进研究论文的规范性。医院和医科院校应加强广泛的科研基础培训,加强医务人员和医学生对最新的国际通用医学研究规范学习认知和深入理解,加强其对统计学知识的学习和应用。
  • 广东省科学技术厅课题-广东省科技期刊优秀人才项目(2024B1212110007)
  • 中国科技期刊卓越行动计划项目(卓越计划-C-081)
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2024年第51卷第24期
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doi: 10.20043/j.cnki.MPM.202409141
  • 接收时间:2024-09-08
  • 首发时间:2026-03-18
  • 出版时间:2024-12-25
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  • 收稿日期:2024-09-08
基金
广东省科学技术厅课题-广东省科技期刊优秀人才项目(2024B1212110007)
中国科技期刊卓越行动计划项目(卓越计划-C-081)
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    南方医科大学学报编辑部,广东 广州 510515

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孙昌朋,E-mail:
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2种不同金属材料的力学参数

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占总种数比例
Percentage of
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Genus
种数
Number of
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Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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