随机对照试验中的亚组分析似乎取决于使用相对还是绝对效应测量。
Subgroup analysis in randomized controlled trials appeared to be dependent on whether relative or absolute effect measures were used.
机构信息
Department of Otorhinolaryngology, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands; Department of Health Evidence, Radboud University Medical Center Nijmegen, PO Box 9101, 6500 HB Nijmegen, The Netherlands; Department of Operating Rooms, Radboud University Medical Center Nijmegen, PO Box 9101, 6500 HB Nijmegen, The Netherlands.
出版信息
J Clin Epidemiol. 2014 Apr;67(4):410-5. doi: 10.1016/j.jclinepi.2013.11.003. Epub 2014 Feb 5.
OBJECTIVES
To assess whether relative or absolute effect measures were used in subgroup analyses of randomized controlled trials (RCTs) and study whether conclusions would change if subgroup effects were calculated on a different scale than reported.
STUDY DESIGN AND SETTING
We studied all 327 RCTs published in 2010 in five major medical journals. For trials with a dichotomous primary outcome, we extracted reported main and subgroup effect measures. If crude subgrouping data were reported, we calculated the subgroup effects on both relative and absolute scales.
RESULTS
Of the 229 RCTs with a dichotomous primary outcome, 120 (52%) performed subgroup analyses. In 106 of these 120 (88%) RCTs, relative effect measures were used for subgroup analyses, whereas an absolute scale was used in 9 (8%) trials. Two (2%) RCTs reported both relative and absolute subgroup effects. Crude data of the subgroups could be extracted in 41 of the 120 (34%) RCTs. Calculating subgroup effects on a different scale than reported lead to a change in conclusion in 17% of the 41 trials.
CONCLUSION
Almost all RCTs used relative effect measures for subgroup analyses. Interpretation of subgroup effects, however, appeared to be dependent on whether relative or absolute effect measures were used.
目的
评估随机对照试验（RCT）的亚组分析中使用的是相对还是绝对效应量，并研究如果以与报告不同的尺度计算亚组效应，结论是否会发生变化。
研究设计和地点
我们研究了 2010 年在五家主要医学期刊上发表的所有 327 项 RCT。对于具有二分类主要结局的试验，我们提取了报告的主要和亚组效应量。如果报告了原始的亚组分组数据，则我们在相对和绝对尺度上计算了亚组效应。
结果
在 229 项具有二分类主要结局的 RCT 中，有 120 项（52%）进行了亚组分析。在这 120 项中的 106 项（88%）RCT 中，亚组分析使用了相对效应量，而在 9 项（8%）试验中使用了绝对尺度。有 2 项（2%）RCT 报告了相对和绝对亚组效应。在 120 项中的 41 项（34%）RCT 中可以提取亚组的原始数据。在这 41 项试验中，以与报告不同的尺度计算亚组效应导致 17%的结论发生变化。
结论
几乎所有 RCT 都使用相对效应量进行亚组分析。然而，亚组效应的解释似乎取决于使用的是相对还是绝对效应量。
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