Department of Epidemiology and Biostatistics, VU University Medical Center, The EMGO Institute for Health and Care Research, van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands.
J Clin Epidemiol. 2010 May;63(5):524-34. doi: 10.1016/j.jclinepi.2009.08.010. Epub 2009 Nov 18.
There is no consensus on the best method to determine the minimal important change (MIC) of patient-reported outcomes. Recent publications recommend the use of multiple methods. Our aim was to assess whether different methods lead to consistent values for the MIC.
We used two commonly used anchor-based methods and three commonly used distribution-based methods to determine the MIC of the subscales: pain and physical functioning of the Western Ontario and McMaster University Osteoarthritis Index questionnaire in five different studies involving patients with hip or knee complaints. We repeated the anchor-based methods using relative change scores, to adjust for baseline scores.
We found large variation in MIC values by the same method across studies and across different methods within studies. We consider it unlikely that this variation can be explained by differences between disease groups, disease severity, or lengths of follow-up. The variation persisted when using relative change scores. It was not possible to conclude whether this variation is because of true differences in MIC values between populations or to conceptual and methodological problems of the MIC methods.
To better disentangle these two possible explanations, the MIC methodology should be improved and standardized. In the meantime, caution is needed when interpreting and using published MIC values.
目前对于患者报告结局最小重要变化(MIC)的最佳测定方法尚未达成共识。最近的文献建议使用多种方法。我们旨在评估不同方法是否会得出 MIC 的一致值。
我们使用两种常用的基于锚定的方法和三种常用的基于分布的方法,在涉及髋或膝部疾病患者的五项不同研究中,确定 Western Ontario 和 McMaster 大学骨关节炎指数问卷的子量表(疼痛和身体功能)的 MIC。我们使用相对变化分数重复了基于锚定的方法,以调整基线分数。
我们发现,同一种方法在不同研究和同一研究中的不同方法之间 MIC 值存在很大差异。我们认为,这种差异不太可能是由于疾病组、疾病严重程度或随访时间的不同所导致。当使用相对变化分数时,这种差异仍然存在。无法确定这种差异是由于人群之间 MIC 值的真实差异,还是 MIC 方法的概念和方法问题。
为了更好地区分这两种可能的解释,MIC 方法学应得到改进和标准化。同时,在解释和使用已发表的 MIC 值时需谨慎。