1. 广东省中医院
2. 广州中医药大学第二临床医学院
纸质出版:2015
移动端阅览
[1]温万鑫,卢静敏,陆丽明,郭新峰.国内应用CONSORT及STRICTA评价RCT的现状分析[J].中医杂志,2015,56(18):1559-1563.
WEN Wanxin, LU Jingmin, LU Liming, et al. Analysis of the Current Status of RCTs Evaluation with CONSORT Statement and STRICTA in China[J]. Journal of Traditional Chinese Medicine2015, 56(18): 1559-1563.
[1]温万鑫,卢静敏,陆丽明,郭新峰.国内应用CONSORT及STRICTA评价RCT的现状分析[J].中医杂志,2015,56(18):1559-1563. DOI: 10.13288/j.11-2166/r.2015.18.009.
WEN Wanxin, LU Jingmin, LU Liming, et al. Analysis of the Current Status of RCTs Evaluation with CONSORT Statement and STRICTA in China[J]. Journal of Traditional Chinese Medicine2015, 56(18): 1559-1563. DOI: 10.13288/j.11-2166/r.2015.18.009.
目的对国内应用临床试验报告的统一标准(CONSORT)及其扩展版针刺临床试验干预措施报告标准(STRICTA)评价随机对照临床试验(RCT)的现状与问题进行系统总结。方法计算机检索中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普网(VIP)、万方数据(Wanfang)数据库中应用CONSORT及STRICTA评价RCT的研究
对其应用情况进行分析
并对评价方法、报道方式、结果表示方法进行分析与总结。结果共纳入109篇文献
其中应用2001版CONSORT的75篇(68.8%)
应用2010最新修订版的31篇(28.4%);评价中医药或中西医结合疗法RCT的研究有74篇(67.9%);由两位研究者独立进行评价
如遇分歧通过协商或第三位研究者解决的占81.7%(89篇);评价时采用二级评价(报道
未报道)的有72篇(66.1%)
采用三级评价(充分报道
部分报道
未报道)的有6篇(5.5%);使用列表方式或同时结合文字描述表示结果的有75篇(68.8%)。结论应用CONSORT声明及STRICTA评价RCT的研究越来越受关注
临床研究报告质量呈上升趋势
评价方法仍亟需提高与规范。
Objective To make systemic summary on the status and problems of randomized controlled trials( RCTs) evaluation with Consolidated Standards of Reporting Trials( CONSORT) statement
which is the unified standard of clinical trial reports
and Standards for Reporting Interventions in Clinical Trials of Acupuncture( STRICTA)
which is expanded standards for reporting interventions in controlled trials of acupuncture interiorly
in China.Methods Studies on RCTs evaluated with CONSORT and STRICTA were searched in China Biomedical Bibliographic Database( CBM)
China National Knowledge Infrastructure( CNKI)
VIP Database
and Wanfang Database. The application of CONSORT and STRICTA was analyzed
and the evaluation methods
reporting styles
and ways of showing results were summarized. Results 109 papers were included in. Among them
CONSORT of 2001 edition was applied in 75 papers( 68. 8%)
CONSORT of 2010( latest revised) edition was applied in 31 papers( 28. 4%); 74 papers( 67. 9%) were about evaluation on Chinese Medicine RCTs or integrated Chinese Medicine and Western Medicine treatments RCTs; 81. 7% of evaluations( 89 papers) were made by two researchers independently
and different opinions were solved by consultation or a third researcher; two-level evaluation( reported
unreported) was adopted in 72 papers( 66. 1%)
and three-level evaluation( fully reported
partly reported
unreported)was used in 6 papers( 5. 5%); and 75 papers( 68. 8%) showed results by list or list combined with text description.Conclusion Researches on RCT evaluation by CONSORT and STRICTA have attracted more and more attention.The quality of clinical research reports is getting better
but the evaluation methods need to be improved and regulated urgently.
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