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接受手术治疗的脊柱转移瘤患者的最小临床重要差异、显著临床获益及患者可接受症状状态:一项多中心前瞻性临床研究

Minimum clinically important difference, substantial clinical benefit, and patient acceptable symptomatic state for patients with spinal metastasis who underwent surgical treatment: a multicenter prospective clinical study.

作者信息

Yin Mengchen, Yang Xinghai, Zhou Haohan, Yu Wenlong, Zhang Fan, Zhou Zihuan, Chen Dingbang, Zhang Luosheng, Gao Xin, Wang Tao, Chu Peilin, Sun Yueli, Sun Zhengwang, Mo Wen, Ma Junming, Huang Quan, Xiao Jianru

机构信息

1Department of Orthopaedic Oncology, Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai.

2Department of Orthopaedics, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai.

出版信息

J Neurosurg Spine. 2025 Jun 13;43(3):283-293. doi: 10.3171/2025.3.SPINE241329. Print 2025 Sep 1.

DOI:10.3171/2025.3.SPINE241329
PMID:40513233
Abstract

OBJECTIVE

There is increasing emphasis on patient-reported outcomes (PROs) in assessing surgical efficacy, especially in patients with spinal metastasis (SM). The updated version of the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ 2.0) is a disease-specific tool, while the EQ-5D-5L is a general quality-of-life instrument. The aim of this study was to establish the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) thresholds for these tools in patients undergoing surgery for SM.

METHODS

A multicenter prospective observational study of patients with SM who underwent surgical treatment from January 2020 to December 2022 across 4 institutions was performed, and patients were followed for 6 months. Patients completed the SOSGOQ 2.0 and EQ-5D-5L at baseline and 1-, 3-, and 6-month follow-up assessments. Anchor- and distribution-based methods were used to calculate the MCID, SCB, and PASS. Clinical performance was compared between the two tools.

RESULTS

A total of 260 patients (138 males, mean age 62.4 years) who underwent surgery for SM were included. Surgery resulted in significant improvements in both PRO measures. The MCID was 19.4 for the SOSGOQ 2.0 total score and 19.6 for the visual analog scale of the EQ-5D-5L. A higher percentage of patients achieved clinically meaningful outcomes per the SOSGOQ 2.0, indicating superior sensitivity and clinical utility over the EQ-5D-5L.

CONCLUSIONS

Compared with the EQ-5D-5L, the SOSGOQ 2.0 demonstrated higher sensitivity in assessing functional improvements in patients with SM, making it the preferred tool in clinical settings. Further research is recommended for long-term validation.

摘要

目的

在评估手术疗效时,患者报告结局(PROs)受到越来越多的重视,尤其是在脊柱转移瘤(SM)患者中。脊柱肿瘤研究组结局问卷(SOSGOQ 2.0)的更新版本是一种针对特定疾病的工具,而EQ-5D-5L是一种通用的生活质量工具。本研究的目的是确定这些工具在接受SM手术患者中的最小临床重要差异(MCID)、显著临床获益(SCB)和患者可接受症状状态(PASS)阈值。

方法

对2020年1月至2022年12月期间在4家机构接受手术治疗的SM患者进行了一项多中心前瞻性观察研究,并对患者进行了6个月的随访。患者在基线以及1个月、3个月和6个月的随访评估时完成SOSGOQ 2.0和EQ-5D-5L。采用基于锚定和分布的方法计算MCID、SCB和PASS。比较了两种工具的临床性能。

结果

共纳入260例接受SM手术的患者(138例男性,平均年龄62.4岁)。手术使两种PRO测量指标均有显著改善。SOSGOQ 2.0总分的MCID为19.4,EQ-5D-5L视觉模拟量表的MCID为19.6。根据SOSGOQ 2.0,达到临床有意义结局的患者比例更高,表明其敏感性和临床效用优于EQ-5D-5L。

结论

与EQ-5D-5L相比,SOSGOQ 2.0在评估SM患者功能改善方面表现出更高的敏感性,使其成为临床环境中的首选工具。建议进一步开展长期验证研究。

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