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| 2009 - 2011年国内主要期刊关于骨质疏松随机对照试验文献报告质量分析 |
| Quality assessment of the reports of randomized controlled trials of osteoporosis published in China from 2009 to 2011 |
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| DOI：10.3969/j.issn.1006.7108.2013.11.009 |
| 中文关键词: 随机对照试验 骨质疏松 CONSORT声明 |
| 英文关键词:Randomized controlled teals Osteoporosis CONSORT statement |
| 基金项目:国家自然科学基金(81001573) |
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| 中文摘要: |
| 目的 运用临床试验报告的统一标准(CONSORT 2010)声明评价2009-2011年国内主要期刊发表的关于骨质疏松方面随机对照试验(RCT)文献的方法学质量。方法 以“随机、骨质疏松”为检索词，搜索万方数据库中可以获得全文的RCT期刊文献，依据CONSORT 2010声明，对文献质量进行综合评价。结果共纳入RCT文献 388篇，其中2009年83篇，2010年129篇，2011年176篇。3年文献在文题和摘要、引言、方法、结果、结论、其他信息等6大方面各个小方面差异均无统计学意义(P>0.05)。388篇文献中，384篇(99. 0 %)有结构式摘要，363篇(93. 6%)阐述背景，386篇(99. 5 %)描述试验设计，267篇(68. 8%)有受试者合格标准，387篇(99. 7%)描述干预措施，7篇((1. 8%)预先设定主要和次要结局指标，67篇(17. 3%)阐述产生随机序列方法，4篇((1.0%)描述分配隐藏，29篇((7.5%)实施盲法，42篇(10. 8%)用表格描述基线资料，153篇(39. 4% )描述危害和意外效应，50篇(12. 9%)描述局限性，381篇(98. 2%)解释结果。结论2009-2011年国内发表的关于骨质疏松方面RCT文献报告质量与CONSORT 2010声明标准差距较大，还需在相关期刊推广并采用CONSORT声明。 |
| 英文摘要: |
| Objective To evaluate the quality of methodology about the reports of randomized controlled teals of osteoporosis published in China from 2009 to 2011 according to CONSORT statement.Methods Using the search terms“random,osteoporosis”，the literatures of randomized controlled teals related to osteoporosis in Chinese academic journals were searched in Wanfang full text database. The quality of randomized controlled teals was evaluated according to the CONSORT 2010 statement. Results A total of 388 literatures about RCTs were included，including 83 in 2009，129 in 2010，and 176 in 2011.No significant difference about aspects of title and abstract，introduction，methods，results，conclusions，and other information of all the literatures in 3 years was observed. In all 388 literatures，384 ( 99.0%)RCTs had structured abstract，363(93.6%)RCTs described the background，386 ( 99.5 %)RCTs described the experimental design，267 ( 68.8 %)RCTs described subject eligibility criteria，387 (99.7%)RCTs described intervention, 7(1. 8%)RCTs preset the primary and secondary outcome measures，67(17.3 %)RCTs elaborated generated a random sequence，4(1. 0%)RCTs described allocation concealment，29 (7.5%)RCTs implemented blind method，42 (10.8%)described the baseline information in a table，153(39.4%)RCTs described the hazards and accidental effects，50 (12.9%)RCTs described limitations，and 381 ( 98.2%)interpreted the results. Conclusion The quality of the reports of RCTs in academic journals of osteoporosis from 2009 to 2011 in China is still far from the standard of CONSORT 2010 statement. The CONSORT statement should he widely popularized and adopted in related journals. |
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