Department of Gastroenterology, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai, China.
Surg Endosc. 2010 May;24(5):1158-63. doi: 10.1007/s00464-009-0743-5. Epub 2009 Nov 14.
Assessment of the reported methodology for randomized controlled trials (RCTs) in the major gastrointestinal and surgical endoscopy journals has never been reported.
Generation of the allocation sequence, allocation concealment, double blinding, sample size calculation, number of patients, and funding source included in methodologic quality were retrieved from each trial, and all the relevant trials were identified by a search of all clinical trials published in 2008 in four major gastrointestinal and surgical endoscopy journals.
A total of 64 trials were included in the final analysis, which found that 50% (32/64) of all trials reported adequate generation of the allocation sequence, 58% (37/64) reported adequate allocation concealment, 47% (30/64) reported adequate blinding, 47% (30/64) reported adequate sample size calculation, and 67% (43/64) failed to disclose the funding source.
The study showed that the quality of the reported methodology in the major gastrointestinal and surgical endoscopy journals needs great improvement.
对主要胃肠和外科内镜杂志中报告的随机对照试验（RCT）的方法学评估从未有过报道。
从每个试验中检索了分配序列的产生、分配隐藏、双盲、样本量计算、患者数量和资金来源等方法学质量，并通过检索 2008 年在四个主要胃肠和外科内镜杂志上发表的所有临床试验，确定了所有相关的试验。
共有 64 项试验被纳入最终分析，发现所有试验中仅有 50%（32/64）报告了充分的分配序列产生，58%（37/64）报告了充分的分配隐藏，47%（30/64）报告了充分的盲法，47%（30/64）报告了充分的样本量计算，67%（43/64）未能披露资金来源。
该研究表明，主要胃肠和外科内镜杂志中报告的方法学质量需要极大的改进。
