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评论:统计学显著性与临床显著性——呼吁考虑患者报告的结局指标、效应大小、置信区间和最小临床重要差异(MCID)。

Commentary: Statistical significance and clinical significance - A call to consider patient reported outcome measures, effect size, confidence interval and minimal clinically important difference (MCID).

作者信息

Fleischmann Michael, Vaughan Brett

机构信息

College of Health and Biomedicine, Victoria University, Melbourne, Australia.

Department of Medical Education, University of Melbourne, Melbourne, Australia.

出版信息

J Bodyw Mov Ther. 2019 Oct;23(4):690-694. doi: 10.1016/j.jbmt.2019.02.009. Epub 2019 Feb 10.

Abstract

In healthcare research an intervention may be statistically significant based on quantitative analysis; however, simultaneously it may be relatively insignificant to the health or quality of life of patients affected by a particular condition or disease being treated by the intervention - thus may be interpreted as having low clinical significance. An understanding of statistics is fundamental for evidence informed healthcare. Patient-reported outcome measures (PROMs) direct patients to evaluate aspects of their own health, including quality of life, disability and function. Data obtained from PROMs can be used to demonstrate the impact of healthcare interventions on these elements of a person's quality of life. To interpret outcome measure data for clinical decision making, a clinician must understand the concepts of statistical significance and clinical significance. This commentary explores the concepts of patient reported outcome measures (PROMs), their statistical and clinical significance, and explores their relationship with a practical example for the clinician. Limitations of research that only reports p-values and the need to consider effect size, confidence intervals, and minimal clinically important difference are also discussed. Together, these concepts can assist the clinician to evaluate whether an intervention may be suitable for their clinical practice.

摘要

在医疗保健研究中,基于定量分析,一种干预措施可能具有统计学意义;然而,与此同时,对于受该干预措施所治疗的特定病症或疾病影响的患者的健康或生活质量而言,它可能相对微不足道——因此可能被解释为临床意义较低。对统计学的理解是循证医疗保健的基础。患者报告结局测量(PROMs)引导患者评估自身健康的各个方面,包括生活质量、残疾状况和功能。从PROMs获得的数据可用于证明医疗保健干预措施对一个人生活质量这些要素的影响。为了在临床决策中解读结局测量数据,临床医生必须理解统计学意义和临床意义的概念。本评论探讨了患者报告结局测量(PROMs)的概念、它们的统计学和临床意义,并通过一个临床医生的实际例子探讨它们之间的关系。还讨论了仅报告p值的研究的局限性以及考虑效应大小、置信区间和最小临床重要差异的必要性。这些概念共同作用,可帮助临床医生评估一种干预措施是否适合其临床实践。

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