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社论评论:揭示运动医学中非显著试验的脆弱性。

Editorial Commentary: Illuminating the Fragility of Nonsignificant Trials in Sports Medicine.

出版信息

Arthroscopy. 2023 Sep;39(9):2084-2085. doi: 10.1016/j.arthro.2023.03.014.

DOI:10.1016/j.arthro.2023.03.014
PMID:37543391
Abstract

Orthopaedic clinical research findings can be prone to β error (false negative), owing to small sample sizes. Such trials show no difference between groups when, in fact, a difference may exist. The reverse fragility index is defined as the number of "events" that would cause an individual research study's findings to flip from nonsignificant to statistically significant, and this index can help determine the clinical relevance and validity of clinical trials reporting nonsignificant results. Orthopaedic surgeons should critically evaluate clinical research that shows no statistically significant difference between groups to rule out a β error, given that underpowered studies are particularly prone to fragility. If an orthopaedic trial reports statistically insignificant results, this does not mean the results are clinically insignificant.

摘要

骨科临床研究结果可能容易出现β错误(假阴性),这是由于样本量小所致。此类试验显示组间无差异,但实际上可能存在差异。相反的易碎指数定义为会导致个体研究结果从无统计学意义变为有统计学意义的“事件”数量,该指数可帮助确定无统计学意义结果的临床试验的临床相关性和有效性。鉴于研究力量不足的研究特别容易出现脆弱性,骨科医生应仔细评估显示组间无统计学差异的临床研究,以排除β错误。如果骨科试验报告统计学上无显著结果,并不意味着结果在临床上无意义。

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