Bai Yu, Gao Jun, Zou Duo-Wu, Li Zhao-Shen
Evidence-Based Medicine Group, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
Hepatology. 2009 Jun;49(6):2108-12. doi: 10.1002/hep.22861.
To determine the current quality of reporting of randomized clinical trials (RCTs) in the field of gastroenterology and hepatology, we evaluated the methodological reporting of RCTs in six major gastroenterology and hepatology journals. The methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, and sample size calculation; number of patients; disease area; and funding source was also retrieved from each trial, and the relevant trials were identified by searching MEDLINE in 2006 using a highly sensitive search strategy. The status of reporting the methodological quality of RCTs was descriptively reported. One hundred five trials were included in the final analysis; of these, 81% (85/105) reported adequate generation of the allocation sequence, 61% (64/105) reported adequate allocation concealment, 51% (54/105) were double-blind, and 75% (79/105) reported adequate sample size calculation. The reported methodological quality greatly improved when compared with historical cohorts.
This study shows that there was substantial improvement in the reported methodological quality in the major gastroenterology and hepatology journals, but this quality can be further improved.
为了确定胃肠病学和肝病学领域随机临床试验（RCT）报告的当前质量，我们评估了六种主要胃肠病学和肝病学杂志中RCT的方法学报告。还从每个试验中获取了方法学质量，包括分配序列的产生、分配隐藏、双盲和样本量计算；患者数量；疾病领域；以及资金来源，并在2006年使用高灵敏度检索策略通过检索MEDLINE识别相关试验。对RCT方法学质量的报告状况进行了描述性报告。最终分析纳入了105项试验；其中，81%（85/105）报告了分配序列的充分产生，61%（64/105）报告了充分的分配隐藏，51%（54/105）为双盲，75%（79/105）报告了充分的样本量计算。与历史队列相比，报告的方法学质量有了很大提高。
本研究表明，主要胃肠病学和肝病学杂志中报告的方法学质量有了显著提高，但该质量仍可进一步提高。
