York Trials Unit, Department of Health Sciences, University of York, York, UK.
J Eval Clin Pract. 2013 Aug;19(4):703-7. doi: 10.1111/jep.12031. Epub 2013 May 7.
RATIONALE, AIMS AND OBJECTIVES: Randomized controlled trials (RCTs) are powerful tools; it is essential that these trials are not only conducted rigorously, but reported accurately. The aim of this paper was to describe the reporting quality among a set of RCTs published in 2011 on methodological details essential to judging the adequacy of allocation concealment methods employed.
Medline was searched using the Ovid platform to identify all those RCTs published in January 2011 in core clinical journals. Methodological details in relation to allocation concealment were extracted from the identified RCTs to allow the reporting quality to be assessed. If the information was not available in the paper the corresponding author was contacted.
Eighty-five papers were identified, 74% (n = 63) endorsed the CONSORT statement. 73% (n = 62) required the author to be contacted for further information. Sequence generation methods were ascertained in 74% of trials, allocation concealment method in 41%, details of who recruited participants and who generated the randomization sequence in 38%.
There is evidence to suggest that in 2011 key methodological information relating to allocation concealment is still not reported well in RCTs. Authors and journal editors need to ensure explicit and clear methods are reported in RCTs published.
背景、目的和目标：随机对照试验（RCT）是强有力的工具；这些试验不仅要严格进行，而且要准确报告，这一点至关重要。本文的目的是描述一组 2011 年发表的 RCT 在判断所使用的分配隐藏方法是否充分方面的方法学细节的报告质量。
使用 Ovid 平台在核心临床期刊上搜索 2011 年 1 月发表的所有 RCT。从确定的 RCT 中提取与分配隐藏相关的方法学细节，以评估报告质量。如果论文中没有提供相关信息，则联系相应的作者。
确定了 85 篇论文，74%（n=63）支持 CONSORT 声明。73%（n=62）需要联系作者获取进一步信息。74%的试验确定了序列生成方法，41%的试验确定了分配隐藏方法，38%的试验确定了谁招募参与者和谁生成随机序列的细节。
有证据表明，2011 年，与分配隐藏相关的关键方法学信息在 RCT 中仍未得到很好的报告。作者和期刊编辑需要确保在发表的 RCT 中明确和清晰地报告方法。
