Department of Gastroenterology, Shanghai Jiao-Tong University School of Medicine Ren-Ji Hospital, Shanghai Institute of Digestive Disease, 145 Middle Shandong Road, Shanghai, 200001, China.
BMC Med Res Methodol. 2011 Jul 30;11:110. doi: 10.1186/1471-2288-11-110.
It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001.
RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals.
A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time.
Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement.
2001 年 CONSORT 声明修订后，主要肝胆病学期刊中随机对照试验（RCT）的方法学报告质量是否有所提高仍不清楚。
通过高敏检索方法从 MEDLINE 中检索到 1998 年或 2008 年发表在 5 种主要肝胆病学期刊上的 RCT，并根据 CONSORT 声明和 Cochrane 干预系统评价手册评估其方法学细节的报告质量。通过风险比（95%置信区间）计算 2008 年与 1998 年之间方法学报告质量的变化。
共发现 2008 年发表的 107 项 RCT 和 1998 年发表的 99 项 RCT。与 1998 年相比，报告随机序列生成（RR，5.70；95%CI 3.11-10.42）、分配隐藏（RR，4.08；95%CI 2.25-7.39）、样本量计算（RR，3.83；95%CI 2.10-6.98）、未解决的不完整结局数据（RR，1.81；95%CI，1.03-3.17）、意向治疗分析（RR，3.04；95%CI 1.72-5.39）的 RCT 比例增加。多中心试验比单中心试验更能报告盲法和意向治疗分析。产业资助试验比公共资助试验更能报告分配隐藏和盲法。与历史研究相比，方法学报告质量随时间而提高。
尽管与 1998 年发表的文章相比，2008 年报告的一些重要方法学方面有所改善，这可能表明研究人员对修订后的 CONSORT 声明的认识和遵守有所提高，但仍有一些项目报告较差。未来仍有很大的改进空间。
