Nauer Selina, Porchet François, Kleinstueck Frank S, Haschtmann Daniel, Burgstaller Jakob M, Fekete Tamas F, Loibl Markus, Mannion Anne F
Department of Teaching, Research and Development, Schulthess Klinik, Zurich, Switzerland.
Department of Spine Surgery and Neurosurgery, Schulthess Klinik, Zurich, Switzerland.
Eur Spine J. 2025 May 17. doi: 10.1007/s00586-025-08894-x.
The reliability of patient-reported outcome measures is typically evaluated in patients with chronic or stable symptoms, pre-treatment. After treatment, symptoms may be less extreme and less variable within a group, which may influence indices of reliability. Further, few studies have examined the reliability of retrospective, single item global assessment scores after treatment, despite the latter often being used as the external criterion when determining an instrument's minimal clinically important change (MCIC) score. This study examined the stability of Core Outcome Measures Index (COMI) and Global Treatment Outcome (GTO) scores after spine surgery.
Data were extracted for patients with lumbar spinal stenosis who had completed the COMI and GTO twice at follow-up, for both an in-house outcomes database (ROUTINE) and as part of a separate prospective study (LSOS). To be included, the questionnaires had to have been completed within 3 months of each other for 1-year follow-up (FU), within 4 months for 2-year FU and within 5 months for 5-year FU. Repeated measures ANOVA, intraclass correlation coefficients (ICC; 2-way mixed, absolute agreement), and weighted Kappa values were calculated.
64 patients (72.9 ± 6.9 y; 48% female) had a COMI and GTO available from both ROUTINE and LSOS, completed on average 9.8 ± 6.2 weeks apart. There were no significant differences between test and retest scores for any of the COMI domains or for the COMI summary score (all p > 0.05), and ICCs/weighted Kappas were moderate to good (0.73-0.87). In the ROUTINE and LSOS datasets, 83% and 81% patients, respectively, reported a "good global outcome" on the GTO (i.e. treatment helped/helped a lot); the corresponding Kappa for agreement between the ratings on an individual basis was 0.74 ("good agreement").
Despite the more stringent nature of the evaluation given by this "real-life" analysis of the stability of outcome scores, the FU COMI scores showed moderate to good reliability comparable to that reported in previous studies with reliability assessed 1-2 weeks apart. The GTO was also confirmed as a reliable variable yielding stable values at mid to longer term follow-up.
患者报告结局测量的可靠性通常在治疗前患有慢性或稳定症状的患者中进行评估。治疗后，症状可能在一组内不那么极端且变化较小，这可能会影响可靠性指标。此外，尽管在确定工具的最小临床重要变化（MCIC）分数时，后者经常被用作外部标准，但很少有研究检查治疗后回顾性单项总体评估分数的可靠性。本研究检查了脊柱手术后核心结局测量指数（COMI）和总体治疗结局（GTO）分数的稳定性。
从腰椎管狭窄症患者中提取数据，这些患者在随访时两次完成了COMI和GTO，一次是在内部结局数据库（ROUTINE）中，另一次是作为一项单独的前瞻性研究（LSOS）的一部分。要纳入研究，问卷必须在1年随访（FU）的3个月内、2年FU的4个月内以及5年FU的5个月内彼此完成。计算重复测量方差分析、组内相关系数（ICC；双向混合，绝对一致性）和加权Kappa值。
64例患者（72.9±6.9岁；48%为女性）在ROUTINE和LSOS中均有COMI和GTO数据，平均间隔9.8±6.2周完成。COMI的任何领域或COMI汇总分数的测试和复测分数之间均无显著差异（所有p>0.05），ICC/加权Kappa值为中等至良好（0.73 - 0.87）。在ROUTINE和LSOS数据集中，分别有83%和81%的患者在GTO上报告了“良好的总体结局”（即治疗有帮助/帮助很大）；个体评分之间一致性的相应Kappa值为0.74（“良好一致性”）。
尽管对结局分数稳定性的这种“现实生活”分析给出的评估性质更为严格，但随访时的COMI分数显示出中等至良好的可靠性，与之前间隔1 - 2周评估可靠性的研究报告相当。GTO也被确认为一个可靠的变量，在中期至长期随访中产生稳定的值。
