摘要
目的通过对中医领域病例-对照研究进行系统检索和分析,了解其在方法学和报告质量方面可能存在的问题。方法检索PubMed、Embase、中国生物医学文献光盘数据库(CBM)、中国学术文献网络出版总库(CNKI)、中文科技期刊数据库(VIP)、万方数据库建库至2018年12月31日发表的中医药方面的病例-对照研究文献。采用Cochrane协作网推荐的方法学质量评价工具Newcastle-Ottawa Scale (NOS)和加强观察性流行病学研究报告的质量(STROBE声明)检查清单(引言和方法部分)对纳入文献分别进行评价。同时结合定性描述的方法对文献进行归纳分析,采用线性趋势检验、Spearman秩相关分析方法分析NOS质量等级与STROBE清单条目报告百分比的相关性。结果最终纳入文献289篇,中医证候、症状、体质是中医领域病例-对照研究的主要内容。文献的方法学评价发现,低质量文献(3~4分)占17. 0%(49篇)、中质量文献(5~6分)占59. 8%(173篇)、高质量文献(7~8分)占23. 2%(67篇)。报告质量评价结果发现,很多文献没有报告全面的信息,例如在配比的应用、偏倚控制和质量控制方面缺乏详细的报告,但在研究目的和统计分析方面报告较为详细。相关分析发现,文献的方法学质量和报告质量呈弱相关(r=0. 246,P <0. 001)。结论中医领域病例-对照研究文献整体质量尚可,但是高质量文献偏少,在配比、质量控制等方面尚存在报告不足的问题。
Objective To systematically retrieve and analyze case-control studies in traditional Chinese medicine(TCM) to understand possible problems in methodology quality and reporting quality. Methods PubMed,Embase,CBM,CNKI,VIP and Wanfang were systematically searched from database establishment to December 31,2018 for literatures on case-control study in TCM. The included literatures were evaluated by an assessment tool of methodology quality recommended by The Cochrane Collaboration,Newcastle Ottawa Scale(NOS),and Strengthening the Reporting of Observational Studies in Epidemiology(STROBE statement) checklist(introduction and methods sections),respectively. The literatures were summarized and analyzed by applying the method of qualitative description. Linear trend test and Spearman rank correlation analysis were used to analyze the correlation between NOS quality grades and reporting percentages of STROBE checklist items. Results A total of 289 literatures were finally included. TCM syndromes,symptoms and constitutions are core topics of case-control studies in TCM. Methodological evaluation on the literatures showed that low-quality literatures(3-4 points) accounted for 17. 0%(49 literatures),medium-quality literatures(5-6 points) accounted for 59. 8%(173 literatures),and high-quality literatures(7-8 points) accounted for 23. 2%(67 literatures). The results of reporting quality evaluation found that most of the literatures did not report complete information. Application of matching,bias control and quality control were short of necessary details,but the reporting on the purpose and statistical analysis of the study were explicit. The correlation analysis found that the methodology quality of the literatures was weakly correlated with the reporting quality(r = 0. 246,P < 0. 001). Conclusion The overall quality of the case-control studies in TCM was acceptable,but there were few high-quality literatures. There were problems of inadequate reporting of matching,quality control and other aspects.
作者
刘澳林
周莉
韩如雪
欧阳文伟
温泽淮
LIU Aolin;ZHOU Li;HAN Ruxue;OUYANG Wenwei;WEN Zehuai(The Second School of Clinical Medicine,Guangzhou University of Chinese Medicine,Guangzhou,510000;The Second Affiliated Hospital of Guangzhou University of Chinese Medicine;National Center for Design Measurement and Evaluation in Clinical Research,Guangzhou University of Chinese Medicine)
出处
《中医杂志》
CSCD
北大核心
2020年第7期594-600,共7页
Journal of Traditional Chinese Medicine
基金
国家自然科学基金(81703938)
广东省科学技术厅-广东省中医药科学院联合科研专项(2011B032200011)
广东省中医院中医药科学技术研究专项(YN2019QL14)。
关键词
中医药临床试验
病例-对照研究
方法学质量
报告质量
clinical trial of traditional Chinese medicine
case-control study
methodology quality
reporting quality
