PURPOSE A statistically significant score change of a PROM (Patient-Reported Outcome Measure) can be questioned if it does not exceed the clinically Minimal Important Change (MIC) or the SDC (Smallest Detectable Change) of the particular measure. The aim of the study was to define the SDC of three common PROMs in degenerative lumbar spine surgery: Numeric Rating Scale (NRSBACK/LEG), Oswestry Disability Index (ODI) and Euroqol-5-Dimensions (EQ-5DINDEX) and to compare them to their MICs. The transition questions Global Assessment (GABACK/LEG) were also explored. METHODS Reliability analyses were performed on a test-retest population of 182 symptomatically stable patients, with similar characteristics as the Swespine registry population, who underwent surgery for degenerative lumbar spine conditions 2017-2018. The MIC values were based on the entire registry (n = 98,732) using the ROC curve method. The ICC for absolute agreement was calculated in a two-way random-effects single measures model. For categorical variables, weighted kappa and exact agreement were computed. RESULTS For the NRS, the SDC exceeded the MIC (NRSBACK:3.6 and 2.7; NRSLEG: 3.7 and 3.2, respectively), while they were of an equal size of 18 for the ODI. The gap between the two estimates was remarkable in the EQ-5DINDEX, where SDC was 0.49 and MIC was 0.10. The GABACK/LEG showed an excellent agreement between the test and the retest occasion. CONCLUSION For the tested PROM scores, the changes must be considerable in order to distinguish a true change from random error in degenerative lumbar spine surgery research. These slides can be retrieved under Electronic Supplementary Material.

中文翻译：

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2020 年 ISLS 临床科学奖：腰椎研究中评分变化的可靠性和可解释性。

目的 如果 PROM（患者报告的结果测量）的具有统计学意义的得分变化不超过特定测量的临床最小重要变化 (MIC) 或 SDC（最小可检测变化），则可以对其进行质疑。该研究的目的是定义退行性腰椎手术中三种常见 PROM 的 SDC：数字评定量表 (NRSBACK/LEG)、Oswestry 残疾指数 (ODI) 和 Euroqol-5-Dimensions (EQ-5DINDEX) 并比较它们到他们的 MIC。还探讨了过渡问题全球评估 (GABACK/LEG)。方法 对 182 名症状稳定患者的重新测试人群进行了可靠性分析，这些患者具有与 Swespine 登记人群相似的特征，他们在 2017-2018 年接受了退行性腰椎疾病手术。MIC 值基于使用 ROC 曲线方法的整个注册表 (n = 98,732)。绝对一致性的 ICC 是在双向随机效应单一测量模型中计算的。对于分类变量，计算了加权 kappa 和精确一致性。结果 对于 NRS，SDC 超过了 MIC（NRSBACK：3.6 和 2.7；NRSLEG：分别为 3.7 和 3.2），而 ODI 的大小相同，均为 18。在 EQ-5DINDEX 中，两个估计值之间的差距非常显着，其中 SDC 为 0.49，MIC 为 0.10。GABACK/LEG 在测试和重新测试场合之间表现出极好的一致性。结论 对于测试的 PROM 分数，变化必须相当大，以便在退行性腰椎手术研究中区分真正的变化和随机错误。这些幻灯片可以在电子补充材料下检索。