Kaleth Anthony S, Slaven James E, Ang Dennis C
From the Department of Kinesiology, Indiana University-Purdue University, Indianapolis (ASK); Department of Biostatistics, Indiana University, Indianapolis (JES); and Division of Rheumatology, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina (DCA).
Am J Phys Med Rehabil. 2016 Oct;95(10):738-45. doi: 10.1097/PHM.0000000000000485.
The aim of this study was to estimate the minimal clinically important difference (MCID) for 6-min walk distance (6MWD) in patients with fibromyalgia.
Data from a recently completed trial that included 187 patients who completed the 6-min walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 wks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain as clinical anchors.
The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (P < 0.001). The anchor-based MCIDs for the 6MWD were 156 and 167 m for the FIQ and SF36-physical function domain, respectively. These MCIDs correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-physical function domain (10-point increase).
The MCID for 6MWD in patients with fibromyalgia was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with fibromyalgia.
本研究旨在评估纤维肌痛患者6分钟步行距离（6MWD）的最小临床重要差异（MCID）。
使用来自最近完成的一项试验的数据，该试验纳入了187例患者，这些患者在12周和36周时完成了6分钟步行试验、纤维肌痛影响问卷（FIQ）和简短健康调查问卷36项（SF36），以检查6MWD的纵向变化。采用基于锚定的方法，通过线性回归分析来确定6MWD的MCID，将FIQ总分（FIQ-Total）和SF36身体功能领域作为临床锚定指标。
从基线到第36周，6MWD的平均（标准差）变化为34.4（65.2）米（P<0.001）。对于FIQ和SF36身体功能领域，6MWD基于锚定的MCID分别为156米和167米。这些MCID分别对应于FIQ（降低14%）和SF36身体功能领域（提高10分）的临床意义上的改善。
纤维肌痛患者6MWD的MCID为156至167米。这些发现首次证明了患者认为具有临床意义的6MWD的变化。需要使用其他MCID计算方法进行进一步研究，以完善对纤维肌痛患者6MWD的MCID的估计。
