我国非小细胞肺癌随机对照试验方法学与伦理学报告质量评价

摘要

Objective To assess the methodological and ethical quality of randomized controlled trials (RCT) of non-small cell lung cancer ( NSCLC ) in China. Methods The methodological and ethical quality on RCT of NSCLC, covered in CBM, CNKI, VIP and Wanfang was assessed according to the Jadad Scale and Berdeu Scale respectively. Results The average methodological and ethical quality was 62. 24% according to the Jadad Scale and was 18. 79% according to the Berdeu Scale. Correlation analysis showed that the methodological quality was closely correlated with the ethical quality, except that of "curative effect of invasive therapy" (OR=1. 064, 95%CI:0. 832-1. 361, P>0. 05). Conclusion The methodological and ethical quality of RCT of NSCLC in China is low. The methodological quality is positively correlated with the ethical quality.%目的：评价我国已发表非小细胞肺癌( NSCLC)随机对照试验( RCT)的方法学和伦理学报告质量,并分析两者之间的关联性。方法：根据Jadad量表和Berdeu量表,评价中国生物医学文献数据库( CBM)、中国知网( CNKI)、维普数据库( VIP)和万方数据库收录的RCTs的方法学和伦理学报告质量。结果：Jadad量表各条目平均完整报告率为62.24%,Berdeu量表各条目平均完整报告率为18.79%,低于50%。方法学报告质量和伦理学报告质量相关性分析表明,除“是否有侵入性的疗效评估冶(OR=1.064,95%CI：0.832~1.361,P>0.05)条目外,其余方法学条目的报告质量与伦理学质量具有较强关联性。结论：我国已发表非小细胞肺癌的RCTs方法学和伦理学的报告质量普遍偏低,方法学报告质量与伦理学的报告质量呈正相关。