肺癌临床随机对照试验文献的质量评价

Qualitative evaluation on literatures of clinical randomized controlled trials in lung cancer

目的分析国内肺癌治疗随机对照试验文献的质量。方法按照CONSORT声明的要求,对2013年1至3月国内肺癌治疗随机对照试验文献进行评价。结果共纳入分析文献81篇。描述试验设计方法的文献占8.6%;研究对象诊断标准、纳入标准、排除标准、签署知情同意书、医学伦理审查的报告率分别为85.2%、88.9%、38.3%、23.5%、2.5%;样本含量估计方法报告率为0%,样本量小于40例的文献占51.9%;随机分组样本数报告率为100.0%,描述随机分组方法占18.5%;详实描述试验组、对照组干预措施的比例占100.0%、92.6%;报告了两组人口学基线资料、临床特征基线资料的占75.3%和64.2%;报告两组人口学资料可比性、临床特征可比性的占91.4%和82.7%;报告按资料类型进行统计学分析的占93.8%,采用主要结局指标的占67.9%,具体描述各结局指标统计学分析方法的占6.2%,提及意向处理分析的占2.5%。除人口学资料描述与临床特征描述外,统计源论文与非统计源论文CONSORT声明要求内容符合情况比较无显著差异(P>0.05)。结论国内肺癌治疗随机对照试验文献的质量是较低的,尤其是试验设计、随机分组、知情同意、伦理审查、样本含量估计方法等方面需要进一步提高质量。

Objective To understand quality of literatures of clinical randomized controlled trials for lung cancer published in Chinese journals. Methods Literatures of clinical randomized controlled trials for lung cancer treatment published in Chinese journals from January to March in 2013 were enrolled. The quality of reporting was assessed according to consolidated standard of reporting trials statement in 2010. Results A total of 81 articles were analyzed. The experimental design method was described in 8.6% of literatures. The report rates of diagnostic criteria, included criteria, exclusion criteria, informed consent, ethical review, sample size estimated, randomized samples and randomization method were respectively 85.2%, 88.9%, 38.3%, 23.5% , 2.5% , 0% , 100.0% and 18.5%. The literatures that the sample size was less than 40 cases accounted for 51.9%. The interventions of experimental group and control group were described in 100% and 92.6%. The baseline data and comparability of demographic and clinical characteristics were described respectively in 75.3% , 91.4% , 64.2% and 82.7%. The statistical analysis according to the data type was described respectively in 93.8%. The proportion of main outcome indicators used was 67.9%, but the outcome indicators statistical analysis method and intention to treat analysis were deseripted respectively in 6.2% and 2.5%. In addition to the baseline data, the above indexes between statistical source journals and non statistical source journals were no significant difference （ P 〉 0.05 ）. Conclusions The quality of randomized controlled trials of lung cancer is low, which needs to be further improved, especially the experimental design,randomization method, informed consent, ethical review, intention to treat analysis and sample size calculation.