Chen Xiao, Zhai Xiao, Wang Xue, Su Jiacan, Li Ming
Graduate Administrative Unit, Shanghai Changhai Hospital, Shanghai, People's Republic of China,
Eur Spine J. 2014 Aug;23(8):1606-11. doi: 10.1007/s00586-014-3283-1. Epub 2014 Apr 20.
To elucidate the methodological reporting quality of randomized controlled trials (RCTs) in three spine journals from 2010 to 2012.
In this study, we summarized the methodological report of RCTs in three major spine journals, including the Spine Journal, Spine and the European Spine Journal from 2010 to 2012. The methodological reporting quality, including the allocation sequence generation, allocation concealment, blinding and sample size calculation, was revealed. Number of patients, funding source, type of intervention and country were also retrieved from each trial. The methodological reporting quality was descriptively reported.
Ninety trials were involved and 57.8% (52/90) reported adequate allocation sequence generation, 46.7% (42/90) reported adequate allocation concealment, 34.4% (31/90) reported adequate blinding and 37.8% (34/90) reported adequate sample size calculation.
This study shows that the methodological reporting quality of RCTs in the spine field needs further improvement.
阐明2010年至2012年三本脊柱期刊中随机对照试验（RCT）的方法学报告质量。
在本研究中，我们总结了2010年至2012年三本主要脊柱期刊（包括《脊柱杂志》《脊柱》和《欧洲脊柱杂志》）中RCT的方法学报告。揭示了方法学报告质量，包括分配序列产生、分配隐藏、盲法和样本量计算。还从每个试验中获取了患者数量、资金来源、干预类型和国家。对方法学报告质量进行了描述性报告。
共纳入90项试验，57.8%（52/90）报告了充分的分配序列产生，46.7%（42/90）报告了充分的分配隐藏，34.4%（31/90）报告了充分的盲法，37.8%（34/90）报告了充分的样本量计算。
本研究表明脊柱领域RCT的方法学报告质量需要进一步提高。
