Quality Assessment of Reports of Randomized Controlled Trials Published in Chinese in Field of Non-small Cell Lung Cancer in China
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摘要:目的
采用CONSORT声明对非小细胞肺癌（NSCLC）领域发表的中文随机对照试验（RCT）报告质量进行客观评估，分析其报告情况及存在的问题。
方法计算机检索中国生物医学文献数据库（CBM, 1978—2013.6）、中国知网（CNKI, 1979—2013.6）、维普数据库（VIP, 1989—2013.6）、万方数据库( WF, 1982—2013.6)，纳入中文发表的NSCLC的RCT，采用CONSORT清单（2010版）进行质量评价，并分析纳入RCT报告质量的影响因素，所有数据录入Excel 2007软件，采用SPSS19.0软件进行统计分析。
结果检索获得10 421条记录，最终纳入2 752篇RCT，评价结果显示NSCLC RCT报告质量存在缺陷，40.54%的条目完整报告率在30%及以下。分层分析结果显示，发表年代（2010年之前 vs. 2010年及之后）、单位数量（1个 vs. ≥2个）、杂志级别（CSCD vs. 非CSCD)、论文页数（<中位数 vs. ≥中位数）和基金资助（有基金 vs. 无基金）5个分层因素对50%及以上的CONSORT条目的报告有影响（P<0.05），其中以论文页数对条目报告的影响最大。
结论目前发表的中文NSCLC RCT整体报告质量不高，主要体现在对于方法学的描述和对结果的分析呈现都很不规范。作者单位数、CONSORT（2010版）的发布、论文页数、资金支持等均对文献报告质量有影响，在以后的研究中应该遵循CONSORT规范，提升NSCLC RCT的报告质量。
Abstract:ObjectiveTo explore the reporting quality and potential problems of randomized controlledtrials(RCT) published in Chinese in the field of non-small cell lung cancer(NSCLC) by CONSORTStatement.
MethodsCBM, CNKI, VIP, Wanfang database were systematically searched to identify RCTsof NSCLC. The deadline of the searching was June 2013. Date extraction table was designed according toCONSORT-2010 Statement, and the data were input into Excel 2007. Statistical analysis was performedusing SPSS19.0.
ResultsA total of 10421 references were identified, and 2752 RCTs were includedaccording to the inclusion and exclusion criteria. The assessment results showed that the reporting qualityof included studies had some problems. 40.54% items had a full report rate at ≤30%. Stratified analysisshowed that more than 50% items of CONSORT were associated with the year of publication (<2010 vs. ≥2010), the number of affiliations (1 vs. ≥2), journals indexed (CSCD vs. non CSCD), the median numberof paper page (<2 vs. ≥2), and fund (fund vs. non-funded) (P<0.05), moreover, the effect of paper page wasthe most obvious(P<0.00001).
ConclusionThe NSCLC RCT published in Chinese academic journals areinadequately reported, especially in the description of methods and presentation of results. The number ofunits, CONSORT (2010) published, the paper pages and financial support affect the quality of the reports. TheCONSORT statement should be complied in future studies to enhance the quality of NSCLC RCT.
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Key words:
- CONSORT /
- Randomized controlled trials /
- Non-small cell lung cancer /
- Reporting quality
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表 1 纳入2752篇RCT的CONSORT评价结果及不同分层因素报告质量比较
Table 1 Comparison of CONSORT evaluation results and different factors of report quality in 2752 randomized controlled trial(RCTs)
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