Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and Pain Scales
Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and Pain Scales
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DOI：
10.1016/j.spinee.2007.11.006
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发表时间：
2008-11-01
期刊：
影响因子：
4.5
通讯作者：
Carreon, Leah Y.
中科院分区：
文献类型：
--
作者：
Copay, Anne G.;Glassman, Steven D.;Carreon, Leah Y.
背景：腰椎手术的影响通常通过三种患者报告的结果指标进行评估：Oswestry 残疾指数 (ODI)、医疗结果研究简表 (SF-36) 的身体成分摘要 (PC) 和疼痛量表。最小临床重要性：差异（MCID）是用于衡量临床治疗效果的阈值。尽管对于最佳 MCID 计算方法缺乏一致意见，但仍建议将可变阈值作为这些仪器的 MCID。 目的：本研究有三个目的。首先，说明常见的基于锚点和基于分布的MCID计算方法所得到的值范围。其次，为腰椎手术患者的 ODI、PC、背痛量表和腿痛量表确定统计上合理且有临床意义的 MCID。第三，比较两个锚点的辨别能力：整体健康评估和对手术结果的满意度评级。研究设计：本研究是对前瞻性收集的患者报告结果数据的回顾。患者样本：研究中纳入了腰椎研究组进行的大型手术数据库中总共 454 名患者，并对 ODI 或 PC 进行了 1 年随访。结果指标：术前和术后 1 年的 ODI、PC、背痛量表、腿痛量表、SF-36 健康过渡项目 (HTI) 和结果满意度量表评分。 方法：在脊柱手术前和术后 1 年进行 ODI、SF-36 和疼痛量表评分。对数据应用了几种候选 MCID 计算方法，并对结果值进行了比较。 SF-36 的 HTI 用作锚点，并与第二个锚点进行比较（结果满意度量表）。 结果：潜在 MCID 计算得出一系列值：ODI、PCS 和腿痛为 5 倍，背痛为 10 倍。使用两个锚点获得的阈值非常相似。结论：最小可检测变化 (MDC) 显示为统计上和临床上合适的 MCID 值。该样本中的 MCID 值：ODI 为 12.8 分，PC 为 4.9 分，背痛为 1.2 分，腿痛为 1.6 分。 (C) 2008 Elsevier Inc. 保留所有权利。
BACKGROUND CONTEXT: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCs) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important: difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method.PURPOSE: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCs, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery.STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data.PATIENT SAMPLE: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCs were included in the study.OUTCOME MEASURES: Preoperative and 1-year postoperative scores for ODI, PCs, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales.METHODS: ODI, SF-36, and pain scales were administered before and I year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale).RESULTS: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar.CONCLUSIONS: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCs, 1.2 points for back pain, and 1.6 points for leg pain. (C) 2008 Elsevier Inc. All rights reserved.