Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database
Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database
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DOI：
10.3171/2017.10.focus17554
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发表时间：
2018-01-01
影响因子：
4.1
通讯作者：
Bydon, Mohamad
中科院分区：
文献类型：
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作者：
Asher, Anthony L.;Kerezoudis, Panagiotis;Bydon, Mohamad
目的：患者报告的结果（PRO）在确定脊柱疾病手术干预的价值方面起着关键作用。最小临床重要差异（MCID）的概念被认为是确定给定治疗有效性和描述患者对该治疗的满意度的新标准。本研究的目的是确定与手术治疗退行性腰椎滑脱症相关的MCID。方法作者查询了2014年7月至2015年12月期间接受后路腰椎手术治疗I级退行性腰椎滑脱症的患者的质量结局数据库注册表。记录的PRO包括奥斯韦斯特里功能障碍指数（ODI）、EQ-5D和数字评定量表（NRS）的腿部疼痛（NRS-LP）和背部疼痛（NRS-BP）评分。效标（使用北美脊柱协会满意度量表）和基于分布的（半个标准差，小科恩效应量，测量标准误差，结果441例患者中，所有患者的MCID均为阴性，而所有患者的MCID均为阴性来自11个参与研究中心的患者（80例仅接受椎板切除术，361例接受融合术）被纳入分析。基线与术后1年评价之间的功能结局评分变化如下：ODI为23.5 +/- 17.4分，EQ-5D为0.24 +/- 0.23分，NRS-LP为4.1 +/- 3.5分，NRS-BP为3.7 +/- 3.2分。不同的计算方法生成了每个PRO的MCID值范围：ODI为3.3-26.5分，EQ-5D为0.04-0.3分，NRS-LP为0.6-4.5分，NRS-BP为0.5-4.2分。MDC方法似乎最适合计算MCID，因为它提供的阈值大于测量误差，并且最接近满意和不满意患者之间的平均变化差异。在亚组分析中，仅接受椎板切除术的患者的MCID阈值与接受关节融合术的患者以及整个队列的MCID阈值相当。结论PRO的MCID差异很大，具体取决于计算技术。MDC似乎是一种统计学和临床上合理的方法，用于定义I级退行性腰椎滑脱患者的适当MCID值。基于该方法，ODI的MCID值为14.3分，EQ-5D为0.2分，NRS-LP为1.7分，NRS-BP为1.6分。
OBJECTIVE Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis.METHODS The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen's effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO.RESULTS A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 +/- 17.4 points for ODI, 0.24 +/- 0.23 for EQ-5D, 4.1 +/- 3.5 for NRS-LP, and 3.7 +/- 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3-26.5 points for ODI, 0.04-0.3 points for EQ-5D, 0.6-4.5 points for NRS-LP, and 0.5-4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort.CONCLUSIONS The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.