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寻找不可预测性悖论的合理性依据。

In search of justification for the unpredictability paradox.

作者信息

Howick Jeremy, Mebius Alexander

机构信息

Department of Primary Care Health Sciences, University of Oxford, New Radcliffe House, 2nd floor, Oxford OX2 6NW, UK.

出版信息

Trials. 2014 Dec 10;15:480. doi: 10.1186/1745-6215-15-480.

Abstract

A 2011 Cochrane Review found that adequately randomized trials sometimes revealed larger, sometimes smaller, and often similar effect sizes to inadequately randomized trials. However, they found no average statistically significant difference in effect sizes between the two study types. Yet instead of concluding that adequate randomization had no effect the review authors postulated the "unpredictability paradox", which states that randomized and non-randomized studies differ, but in an unpredictable direction. However, stipulating the unpredictability paradox is problematic for several reasons: 1) it makes the authors' conclusion that adequate randomization makes a difference unfalsifiable—if it turned out that adequately randomized trials had significantly different average results from inadequately randomized trials the authors could have pooled the results and concluded that adequate randomization protected against bias; 2) it leaves other authors of reviews with similar results confused about whether or not to pool results (and hence which conclusions to draw); 3) it discourages researchers from investigating the conditions under which adequate randomization over- or under-exaggerates apparent treatment benefits; and 4) it could obscure the relative importance of allocation concealment and blinding which may be more important than adequate randomization.

摘要

2011年考科蓝系统评价发现,充分随机的试验有时显示出比随机不充分的试验更大的效应量,有时更小,且常常相近。然而,他们发现这两种研究类型在效应量上没有统计学意义上的平均显著差异。然而,综述作者并未得出充分随机化没有效果的结论,而是提出了“不可预测性悖论”,即随机和非随机研究存在差异,但方向不可预测。然而,提出不可预测性悖论存在几个问题:1)这使得作者关于充分随机化有作用的结论无法被证伪——如果充分随机的试验与随机不充分的试验平均结果有显著差异,作者本可以汇总结果并得出充分随机化可防止偏差的结论;2)它让其他得出类似结果的综述作者对于是否汇总结果(以及由此得出哪些结论)感到困惑;3)它阻碍研究人员去探究充分随机化夸大或低估明显治疗益处的条件;4)它可能掩盖分配隐藏和盲法的相对重要性,而这可能比充分随机化更重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b70b/4295227/dc3bdc963d31/13063_2014_2349_Fig1_HTML.jpg

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