| 袁 欣,胡 丹,廖联明.CNKI数据库中肿瘤治疗的临床随机对照试验文献评价[J].肿瘤学杂志,2013,19(8):639-643. |
| CNKI数据库中肿瘤治疗的临床随机对照试验文献评价 |
| Evaluation of Randomized Controlled Trials Reports on the Treatment for Tumor in CNKI Database |
| 投稿时间：2013-05-29 |
| DOI：10.11735/j.issn.1671-170X.2013.08.B012 |
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| 中文关键词: 肿瘤 临床随机对照试验 CONSORT CNKI |
| 英文关键词:neoplasms randomized controlled trials CONSORT CNKI |
| 基金项目:福建省自然科学基金（2013J01379） |
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| 中文摘要: |
| 摘 要：［目的］ 评价CNKI数据库中肿瘤治疗的临床随机对照试验（RCT）文献的质量。［方法］ 检索2006~2011年CNKI数据库中发表的有关肿瘤治疗的临床随机对照试验的期刊文献，并参考2010年版报告随机临床试验的CONSORT声明，对文献质量进行评价。［结果］ 共纳入合格文献696篇。其中列举了具体纳入和排除标准的占82.04%；报告了随机分配方法的占14.37%；运用盲法的占0.43%；简单描述随机分配隐藏的占1.15%；具体描述基线资料的占1.87%；有受试者流程图的占0.72%；所有文献中，提及样本量计算的占0.29%；有试验注册的占0.14%；所有文献中均没有记载试验方案和商业资助的内容。［结论］ 目前肿瘤治疗的临床随机对照试验质量普遍较低，还有待进一步提高，尤其是盲法的使用和样本量的估算方面。 |
| 英文摘要: |
| Abstract：［Purpose］ To assess the quality of randomized controlled trials reports on the treatment for tumor in China. ［Methods］ All primary reports of randomized controlled trials for tumor treatment published in CNKI from 2006 to 2011 were enrolled. The quality of reporting was assessed according to consolidated standards of reporting trials statement in 2010.［Results］ A total of 696 articles which met the inclusion criteria were analyzed. Reports with inclusion and exclusion criteria accounted for 82.04%. Reports describing randomization allocation method，blinding methods，random allocation concealment，baseline data，flow figure，sample size evaluation and trial registration accounted for 14.37%，0.43%，1.15%，1.87%，0.72%，0.29% and 0.14% of all reports respectively. ［Conclusion］ The quality of randomized controlled trials of cancer treatment is generally low，which needs to be further improved，especially the use of blinding and sample size calculation. |
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