Center for Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
J Invest Dermatol. 2012 Dec;132(12):2727-34. doi: 10.1038/jid.2012.231. Epub 2012 Jul 26.
We assessed completeness of trial registration and the extent of outcome-reporting bias in published randomized controlled trials (RCTs) of eczema (atopic dermatitis) treatments by surveying all relevant RCTs published from January 2007 to July 2011 located in a database called the Global Resource of Eczema Trials (GREAT). The GREAT database is compiled by searching six bibliographic databases, including EMBASE and MEDLINE. Out of 109 identified RCTs, only 37 (34%) had been registered on an approved trial register. Only 18 out of 109 trials (17%) had been registered "properly" in terms of submitting the registration before the trial end date and nominating a primary outcome. The proportion of "any registered" and "properly registered" RCTs increased from 19% and 10% in 2007 to 57% and 36% in 2011, respectively. Assessment of selective outcome-reporting bias was difficult even among the properly registered trials owing to unclear primary outcome description especially with regard to timing. Only 5 out of the 109 trials (5%) provided enough information for us to be confident that the outcomes reported in the published trial were consistent with the original registration. Adequate trial registration and description of primary outcomes for eczema RCTs is currently poor.
我们通过调查全球湿疹试验资源数据库(GREAT)中 2007 年 1 月至 2011 年 7 月期间发表的所有相关随机对照试验(RCT),评估了湿疹(特应性皮炎)治疗的试验注册完整性和结局报告偏倚程度。GREAT 数据库通过搜索包括 EMBASE 和 MEDLINE 在内的六个书目数据库编制而成。在确定的 109 项 RCT 中,只有 37 项(34%)在已批准的试验注册处进行了注册。只有 18 项(17%)的试验按照在试验结束日期前提交注册并指定主要结局的规定“正确”地进行了注册。“任何已注册”和“正确注册”RCT 的比例从 2007 年的 19%和 10%分别增加到 2011 年的 57%和 36%。即使是在那些已正确注册的试验中,评估选择性结局报告偏倚也很困难,因为主要结局的描述不清楚,尤其是在时间方面。在 109 项试验中,只有 5 项(5%)提供了足够的信息,使我们有信心报告的试验结果与原始注册一致。目前,湿疹 RCT 的试验注册和主要结局描述都很差。