Department of Health Sciences, University of Genoa, Genoa, Italy.
Mult Scler. 2012 Jun;18(6):776-81. doi: 10.1177/1352458512444327. Epub 2012 Apr 11.
Randomized clinical trials (RCT) in multiple sclerosis (MS) have a recent tradition, but their number has been exponentially increasing since the first study detecting the efficacy of a disease modifying drug in MS. To examine the methodological details of reports of RCT in MS, we extracted from five leading journals all the reports of RCT published between 1993 and 2010. Trial reports were compared for different periods (1993-2001, 2002-2006, 2007-2010) for a set of indicator variables reflecting methodological quality (including details about randomization and blinding, statistical methods, results reporting, subgroup analyses). Fifty-three reports were included in the analysis. All of the methodological items indicated an improvement over time in the quality of reporting, the main weaknesses being frequent and inappropriate use of significance testing for assessing baseline imbalances and the statistical approach to subgroup analysis. A complete and transparent reporting of trial methodology is becoming even more important in an era when new design strategies are required for the feasibility of future trials in MS.
随机对照临床试验（RCT）在多发性硬化症（MS）中具有近期传统，但自第一项检测疾病修饰药物对 MS 疗效的研究以来，其数量呈指数级增长。为了检查 MS 中 RCT 报告的方法学细节，我们从五个主要期刊中提取了 1993 年至 2010 年期间发表的所有 RCT 报告。对于反映方法学质量的一组指标变量（包括关于随机化和盲法、统计方法、结果报告、亚组分析的详细信息），比较了不同时期（1993-2001 年、2002-2006 年、2007-2010 年）的试验报告。共有 53 份报告纳入分析。所有方法学项目都表明报告质量随着时间的推移而有所提高，主要的弱点是频繁且不恰当地使用显著性检验来评估基线不平衡和亚组分析的统计方法。在需要新的设计策略来提高未来 MS 试验可行性的时代，试验方法的完整和透明报告变得更加重要。
