基于CONSORT的心血管疾病临床随机对照试验报告质量评价

Quality review on clinical randomized controlled trials of cardiovascular diseases based on Consolidated Standards of Reporting Trials Statement

目的评价我国心血管疾病随机对照试验(RCT)报告质量。方法对照1996、2001、2010年三版CONSORT声明清单列表,依清单条目在各版次被纳入情况赋予各评价条目权重。计算机检索CNKI、万方医学网和Pub Med数据库,按纳入排除标准收集1997年以来国内的有关心血管疾病的RCT。分析和评价RCT报告质量。结果共纳入368篇报告,质量平均分41.02,随机方法部分各条目平均分1.07(10分制),且存在报告条目信息位置或内容不规范问题。在"是否被中华医学会期刊刊载"分层子集中RCT报告质量的平均加权分具有显著差异(P<0.000)。结论我国心血管疾病RCT报告质量处于中等或中下等水平,提升空间较大。

Objective To review the reporting quality of randomized controlled trials （RCT） of cardiovascular diseases.Methods Comparing the checklists of 3 versions of Consolidated Standards of Reporting Trials （CONSORT） Statement （1996, 2001 and 2010）, and all itmes were weighed according to these items enclosed status in all CONSORT versions. The databases of CNKI, WanFang Database and PubMed were retrieved with computer for collecting RCT of cardiovascular diseases from 1997 according to inclusion and exclusion criteria. The reporting quality of the RCT was analyzed and reviewed.Results There were totally 368 RCT enclosed and mean quality score was 41.02. The mean score of items in random method was only 1.07 （10 point system）, and some non-standard problems were found in item postions and content. There was significant difference in mean weighed score of RCT reporting quality at layed-subset-whether RCT reports published by journals of China Medicial Association （CMA） or not （P〈0.000）.Conclusion The reporting quality of RCT of cardiovascular diseases is at medium level or lower. There is a larger space of improving RCT reporting quality.