Revicki Dennis, Hays Ron D, Cella David, Sloan Jeff
Center for Health Outcomes Research, United Biosource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA.
J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3.
The objective of this review is to summarize recommendations on methods for evaluating responsiveness and minimal important difference (MID) for patient-reported outcome (PRO) measures.
We review, summarize, and integrate information on issues and methods for evaluating responsiveness and determining MID estimates for PRO measures. Recommendations are made on best-practice methods for evaluating responsiveness and MID.
The MID for a PRO instrument is not an immutable characteristic, but may vary by population and context, and no one MID may be valid for all study applications. MID estimates should be based on multiple approaches and triangulation of methods. Anchor-based methods applying various relevant patient-rated, clinician-rated, and disease-specific variables provide primary and meaningful estimates of an instrument's MID. Results for the PRO measures from clinical trials can also provide insight into observed effects based on treatment comparisons and should be used to help determine MID. Distribution-based methods can support estimates from anchor-based approaches and can be used in situations where anchor-based estimates are unavailable.
We recommend that the MID is based primarily on relevant patient-based and clinical anchors, with clinical trial experience used to further inform understanding of MID.
本综述的目的是总结关于评估患者报告结局（PRO）指标反应度和最小重要差异（MID）方法的建议。
我们回顾、总结并整合了有关评估反应度及确定PRO指标MID估计值的问题和方法的信息。针对评估反应度和MID的最佳实践方法提出了建议。
PRO工具的MID并非一成不变的特征，而是可能因人群和背景而异，不存在适用于所有研究应用的单一MID。MID估计值应基于多种方法及方法的三角互证。应用各种相关的患者自评、临床医生评分和疾病特异性变量的基于锚定的方法可提供工具MID的主要且有意义的估计值。来自临床试验的PRO指标结果也可基于治疗比较提供对观察到的效应的见解，应用于帮助确定MID。基于分布的方法可支持基于锚定方法的估计值，且可用于无法获得基于锚定估计值的情况。
我们建议MID主要基于相关的患者本位和临床锚定，利用临床试验经验进一步加深对MID的理解。
