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

目的 从方法学和伦理学视角,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 计算机检索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,并分别根据Jadad量表和Berdeu量表,评价所纳入RCTs的方法学和伦理学报告质量。 结果 检索获得10 421条记录,最终纳入3 065个RCTs进行分析。评价结果显示,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%,均低于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”(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。

Methodological and ethical quality report on randomized controlled trials of non-small cell cancer in China

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.