Terwee Caroline B, Peipert John Devin, Chapman Robert, Lai Jin-Shei, Terluin Berend, Cella David, Griffiths Pip, Mokkink Lidwine B
Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, P.O. box 7057, 1007, Amsterdam, MB, The Netherlands.
Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Qual Life Res. 2021 Oct;30(10):2729-2754. doi: 10.1007/s11136-021-02925-y. Epub 2021 Jul 10.
We define the minimal important change (MIC) as a threshold for a minimal within-person change over time above which patients perceive themselves importantly changed. There is a lot of confusion about the concept of MIC, particularly about the concepts of minimal important change and minimal detectable change, which questions the validity of published MIC values. The aims of this study were: (1) to clarify the concept of MIC and how to use it; (2) to provide practical guidance for estimating methodologically sound MIC values; and (3) to improve the applicability of PROMIS by summarizing the available evidence on plausible PROMIS MIC values. We discuss the concept of MIC and how to use it and provide practical guidance for estimating MIC values. In addition, we performed a systematic review in PubMed on MIC values of any PROMIS measure from studies using recommended approaches. A total of 50 studies estimated the MIC of a PROMIS measure, of which 19 studies used less appropriate methods. MIC values of the remaining 31 studies ranged from 0.1 to 12.7 T-score points. We recommend to use the predictive modeling method, possibly supplemented with the vignette-based method, in future MIC studies. We consider a MIC value of 2-6 T-score points for PROMIS measures reasonable to assume at this point. For surgical interventions a higher MIC value might be appropriate. We recommend more high-quality studies estimating MIC values for PROMIS.
我们将最小重要变化(MIC)定义为个体随时间发生的最小变化阈值,超过该阈值患者会认为自身有显著变化。关于MIC的概念存在很多混淆,尤其是最小重要变化和最小可检测变化的概念,这对已发表的MIC值的有效性提出了质疑。本研究的目的是:(1)阐明MIC的概念及其使用方法;(2)为估计方法合理的MIC值提供实用指导;(3)通过总结关于合理的PROMIS MIC值的现有证据,提高PROMIS的适用性。我们讨论了MIC的概念及其使用方法,并为估计MIC值提供了实用指导。此外,我们在PubMed上对使用推荐方法的研究中任何PROMIS测量指标的MIC值进行了系统综述。共有50项研究估计了PROMIS测量指标的MIC,其中19项研究使用的方法不太合适。其余31项研究的MIC值范围为0.1至12.7个T分数点。我们建议在未来的MIC研究中使用预测建模方法,可能辅以基于 vignette 的方法。目前,我们认为PROMIS测量指标的MIC值为2至6个T分数点是合理的假设。对于手术干预,可能需要更高的MIC值。我们建议开展更多高质量研究来估计PROMIS的MIC值。
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