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骨科对照试验中混杂因素的管理:一项横断面研究。

Management of confounding in controlled orthopaedic trials: a cross-sectional study.

作者信息

Vavken Patrick, Culen Georg, Dorotka Ronald

机构信息

Department of Orthopedic Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.

出版信息

Clin Orthop Relat Res. 2008 Apr;466(4):985-9. doi: 10.1007/s11999-007-0098-y. Epub 2008 Feb 21.

Abstract

Confounding occurs when the effect of an exposure on an outcome is distorted by a confounding factor and will lead to spurious effect estimates in clinical studies. Although confounding can be minimized at the design stage, residual confounding may remain. An argument therefore can be made for controlling for confounding during data analysis in all studies. We asked whether confounding is considered in controlled trials in orthopaedic research and hypothesized the likelihood of doing so is affected by participation of a scientifically trained individual and associated with the magnitude of the impact factor. We performed a cross-sectional study of all controlled trials published in 2006 in eight orthopaedic journals with a high impact factor. In 126 controlled studies, 20 (15.9%; 95% confidence interval, 9.5%-22.3%) studies discussed confounding without adjusting in the analysis. Thirty-eight (30.2%; 95% confidence interval, 22.2%-38.2%) controlled for confounding, although we suspect the true proportion might be somewhat higher. Participation of a methodologically trained researcher was associated with (odds ratio, 3.85) controlling for confounding, although there was no association between impact factor and controlling for confounding. The question remains to what extent the validity of published findings is affected by failure to control for confounding.

摘要

当暴露因素对结果的影响被一个混杂因素扭曲时,就会出现混杂情况,这将导致临床研究中出现虚假的效应估计。尽管在设计阶段可以将混杂因素降至最低,但可能仍会存在残余混杂。因此,可以认为在所有研究的数据分析过程中都应对混杂因素进行控制。我们探讨了骨科研究中的对照试验是否考虑了混杂因素,并假设这样做的可能性受具有科学专业训练背景人员参与情况的影响,且与影响因子的大小相关。我们对2006年在8种高影响因子骨科期刊上发表的所有对照试验进行了一项横断面研究。在126项对照研究中,有20项(15.9%;95%置信区间为9.5%-22.3%)研究讨论了混杂因素,但在分析中未进行调整。38项(30.2%;95%置信区间为22.2%-38.2%)研究对混杂因素进行了控制,不过我们怀疑实际比例可能会略高一些。有经过方法学培训的研究人员参与与对混杂因素进行控制相关(比值比为3.85),尽管影响因子与对混杂因素的控制之间没有关联。未控制混杂因素对已发表研究结果有效性的影响程度仍是一个问题。

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