中医药研究人员对随机对照试验质量评价工具/报告规范认识现状的横断面调查

Recognition status of quality assessment and standards for reporting randomized controlled trials of traditional Chinese medicine researchers

目的:明确中医药研究人员对随机对照试验质量评价工具/报告规范的了解程度与重视程度,以了解其临床研究相关知识储备和科研素养现状,使科研人员更加有针对性地弥补可能缺失的临床研究知识,提高研究水平。方法:采用横断面调查研究的方法,对中医药研究人员进行问卷调查,共收集合格问卷180份。使用频数分布的描述性统计方法、非参数检验和Spearman相关分析对收集到的数据进行分析。结果:依据各个项目平均秩次的高低:(1)中医药研究人员对随机对照试验质量评价工具/报告规范的了解程度从高到低依次是:Cochrane风险偏倚评估工具>CONSORT声明>Jadad量表>改良Jadad量表>CONSORT声明扩展版(STRICTA)>CONSORT声明扩展版(for TCM)>CASP清单(for RCT)>其他CONSORT声明扩展版。(2)研究人员对RCT常用质量评价工具/报告规范的重视程度从高到低依次是:Cochrane风险偏倚评估工具>CONSORT声明>Jadad量表>改良Jadad量表>CONSORT声明扩展版(STRICTA)>CONSORT声明扩展版(for TCM)>CASP清单(for RCT)>其他CONSORT声明扩展版。研究者的年龄、工作年限、学历、职称和研究方向与其对RCT常用质量评价工具/报告规范的了解程度和重视程度相关的项目不多,相关程度不高。结论:现阶段我国中医药研究人员对随机对照试验常用质量评价工具/报告规范的了解程度有限,对不同的质量评价工具/报告规范了解程度差异较大。所以需针对各类研究者加强相应的宣教工作,多角度全方面地建立起研究者对随机对照研究的认识,从而提高我国中医药研究人员的临床研究水平。

Objective： To clarify the degree of the comprehension and attaching importance of traditional Chinese medicine（TCM） researchers. To attain the current status of knowledge and quality of the scientific research and cover the shortage of the missing clinical research knowledge, and improve the study level. Methods： A cross-sectional study was established and the questionnaire was filled out by TCM researchers. A total of 180 pieces were collected as the qualified one. The descriptive statistic method, nonparametric method and the Spearman relevant analysis were used to deal with the collected data. Results： According to the mean rank of each items,（1）the degree of the comprehension of TCM researchers from high to low： Cochrane risk of bias CONSORT statement Jadad scale modified Jadad scale CONSORT statement expand（STRICTA） CONSORT statement expand（for TCM） CASP list（for RCT） other CONSORT statement expand.（2）the degree of attaching importance of TCM researchers from high to low： Cochrane risk of bias CONSORT statement Jadad scale modified Jadad scale CONSORT statement expand（STRICTA） CONSORT statement expand（for TCM） CASP list（for RCT） other CONSORT statement expand. Conclusion： The degree of the comprehension and attaching importance of TCM researchers are limited. There are great variances between different assessment tools and report standards. It is necessary to enhance the education of different kinds of researchers and establish the understanding of the randomized controlled trial from multiple aspects, so as to improve the clinical research level of TCM researchers.