观察性研究使用倾向评分分析低估了重症医学中的效应大小。
Observational studies using propensity score analysis underestimated the effect sizes in critical care medicine.
机构信息
Department of Critical Care Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, No. 351, Mingyue Street, Jinhua, Zhejiang, 321000, P.R. China.
Department of Critical Care Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, No. 351, Mingyue Street, Jinhua, Zhejiang, 321000, P.R. China.
出版信息
J Clin Epidemiol. 2014 Aug;67(8):932-9. doi: 10.1016/j.jclinepi.2014.02.018. Epub 2014 Apr 26.
BACKGROUND AND OBJECTIVE
Propensity score (PS) analysis has been increasingly used in critical care medicine; however, its validation has not been systematically investigated. The present study aimed to compare effect sizes in PS-based observational studies vs. randomized controlled trials (RCTs) (or meta-analysis of RCTs).
METHODS
Critical care observational studies using PS were systematically searched in PubMed from inception to April 2013. Identified PS-based studies were matched to one or more RCTs in terms of population, intervention, comparison, and outcome. The effect sizes of experimental treatments were compared for PS-based studies vs. RCTs (or meta-analysis of RCTs) with sign test. Furthermore, ratio of odds ratio (ROR) was calculated from the interaction term of treatment × study type in a logistic regression model. A ROR < 1 indicates greater benefit for experimental treatment in RCTs compared with PS-based studies. RORs of each comparison were pooled by using meta-analytic approach with random-effects model.
RESULTS
A total of 20 PS-based studies were identified and matched to RCTs. Twelve of the 20 comparisons showed greater beneficial effect for experimental treatment in RCTs than that in PS-based studies (sign test P = 0.503). The difference was statistically significant in four comparisons. ROR can be calculated from 13 comparisons, of which four showed significantly greater beneficial effect for experimental treatment in RCTs. The pooled ROR was 0.71 (95% CI: 0.63, 0.79; P = 0.002), suggesting that RCTs (or meta-analysis of RCTs) were more likely to report beneficial effect for the experimental treatment than PS-based studies. The result remained unchanged in sensitivity analysis and meta-regression.
CONCLUSION
In critical care literature, PS-based observational study is likely to report less beneficial effect of experimental treatment compared with RCTs (or meta-analysis of RCTs).
背景与目的
倾向评分（PS）分析已在重症医学中得到越来越多的应用；然而，其验证尚未得到系统的研究。本研究旨在比较基于 PS 的观察性研究与随机对照试验（RCT）（或 RCT 的荟萃分析）的效应大小。
方法
系统地检索了从成立到 2013 年 4 月在 PubMed 中发表的使用 PS 的重症监护观察性研究。根据人群、干预、比较和结局，将基于 PS 的研究与一个或多个 RCT 相匹配。使用符号检验比较基于 PS 的研究与 RCT（或 RCT 的荟萃分析）中实验治疗的效应大小。此外，在 logistic 回归模型中，从治疗与研究类型的交互项计算比值比（ROR）。ROR<1 表示 RCT 中实验治疗的获益大于基于 PS 的研究。使用随机效应模型的荟萃分析方法对每个比较的 ROR 进行汇总。
结果
共确定了 20 项基于 PS 的研究，并与 RCT 相匹配。20 项比较中有 12 项显示 RCT 中实验治疗的获益大于基于 PS 的研究（符号检验 P=0.503）。其中四项比较有统计学意义。可从 13 项比较中计算 ROR，其中四项显示 RCT 中实验治疗的获益明显更大。汇总的 ROR 为 0.71（95%CI：0.63，0.79；P=0.002），表明 RCT（或 RCT 的荟萃分析）更有可能报告实验治疗的获益。敏感性分析和荟萃回归结果不变。
结论
在重症监护文献中，基于 PS 的观察性研究可能报告实验治疗的获益小于 RCT（或 RCT 的荟萃分析）。
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