Scientific Institute, IRCCS "E. Medea", Bioengineering Laboratory, Bosisio Parini, Lecco, Italy.
Bambino Gesù Children's Hospital, Neurosciences and Neurorehabilitation, Rome, Italy.
Biomed Res Int. 2020 May 15;2020:2794036. doi: 10.1155/2020/2794036. eCollection 2020.
The minimum clinically important difference (MCID) is a standard way of measuring clinical relevance. The objective of this work was to establish the MCID for the 6-minute walking test (6minWT) and the Gross Motor Function Measure (GMFM-88) in pediatric gait disorders.
A cohort, pretest-posttest study was conducted in a hospitalized care setting. A total of 182 patients with acquired brain injury (ABI) or cerebral palsy (CP) performed 20 robot-assisted gait training sessions complemented with 20 sessions of physical therapy over 4 weeks. Separate MCIDs were calculated using 5 distribution-based approaches, complemented with an anonymized survey completed by clinical professionals.
The MCID range for the 6minWT was 20-38 m in the ABI cohort, with subgroup ranges of 20-36 m for GMFCS I-II, 23-46 m for GMFCS III, and 24-46 m for GMFCS IV. MCIDs for the CP population were 6-23 m, with subgroup ranges of 4-28 m for GMFCS I-II, 9-19 m for GMFCS III, and 10-27 m for GMFCS IV. For GMFM-88 total score, MCID values were 1.1%-5.3% for the ABI cohort and 0.1%-3.0% for the CP population. For dimension "D" of the GMFM, MCID ranges were 2.3%-6.5% and 0.8%-5.2% for ABI and CP populations, respectively. For dimension "E," MCID ranges were 2.8%-6.5% and 0.3%-4.9% for ABI and CP cohorts, respectively. The survey showed a large interquartile range, but the results well mimicked the distribution-based methods.
This study identified for the first time MCID ranges for 6minWT and GMFM-88 in pediatric patients with neurological impairments, offering useful insights for clinicians to evaluate the impact of treatments. Distribution-based methods should be used with caution: methods based on pre-post correlation may underestimate MCID when applied to patients with small improvements over the treatment period. Our results should be complemented with estimates obtained using consensus- and anchor-based approaches.
最小临床重要差异（MCID）是衡量临床相关性的标准方法。本研究旨在确定儿科步态障碍患者 6 分钟步行测试（6minWT）和粗大运动功能测量（GMFM-88）的 MCID。
在住院治疗环境中进行了队列、预测试后测试研究。共有 182 名患有获得性脑损伤（ABI）或脑瘫（CP）的患者接受了 20 次机器人辅助步态训练，同时接受了 20 次物理治疗，为期 4 周。使用 5 种基于分布的方法计算了单独的 MCID，并补充了临床专业人员完成的匿名调查。
ABI 队列中 6minWT 的 MCID 范围为 20-38m，亚组范围为 GMFCS I-II 为 20-36m，GMFCS III 为 23-46m，GMFCS IV 为 24-46m。CP 人群的 MCID 为 6-23m，亚组范围为 GMFCS I-II 为 4-28m，GMFCS III 为 9-19m，GMFCS IV 为 10-27m。对于 GMFM-88 总分，ABI 队列的 MCID 值为 1.1%-5.3%，CP 人群为 0.1%-3.0%。对于 GMFM 的维度“D”，ABI 和 CP 人群的 MCID 范围分别为 2.3%-6.5%和 0.8%-5.2%。对于维度“E”，ABI 和 CP 队列的 MCID 范围分别为 2.8%-6.5%和 0.3%-4.9%。调查显示四分位间距较大，但结果很好地模拟了基于分布的方法。
本研究首次确定了患有神经损伤的儿科患者 6minWT 和 GMFM-88 的 MCID 范围，为临床医生评估治疗效果提供了有用的参考。应谨慎使用基于分布的方法：当应用于治疗期间改善较小的患者时，基于前后相关性的方法可能会低估 MCID。我们的结果应与使用共识和锚定方法获得的估计值相补充。
