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脊柱肿瘤研究学会结局问卷(SOSGOQ)2.0 简体中文版的跨文化调适及验证,并在临床环境中进行评估。

Cross-cultural adaptation and validation of simplified Chinese version of the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) 2.0 with its assessment in clinical setting.

机构信息

Department of Orthopedics, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China; Department of Orthopedics Oncology, Changzheng Hospital, Second Affiliated Hospital of Naval Medical University, Shanghai, China.

Department of Musculoskeletal Surgery, Shanghai Cancer Center, Fudan University, Shanghai, China.

出版信息

Spine J. 2022 Dec;22(12):2024-2032. doi: 10.1016/j.spinee.2022.08.013. Epub 2022 Aug 26.

Abstract

BACKGROUND CONTEXT

The treatment of spinal metastases (SM) has been significantly improved in recent years, which gives health-related quality of life (HRQOL) further significance in management of SM. The Spine Oncology Study Group Outcomes Questionnaire version 2.0 (SOSGOQ 2.0) was a specific targeted SM HRQOL criterion that was previously reported to pose good reliability and validity. However, there is no culturally adapted, reliable, and validated version of SOSGOQ 2.0 in mainland China.

PURPOSE

The current study aimed to translate the SOSGOQ 2.0 in a cross-cultural fashion, before evaluating the reliability and validity of the adapted simplified Chinese version of (SC-SOSGOQ 2.0) for patients with spinal metastases (SM).

STUDY DESIGN/SETTING: Translation, cross-cultural adaptation, and validation were performed on the Chinese version of the SOSGOQ 2.0.

PATIENT SAMPLE

Patients who were diagnosed with metastatic spinal disease, posing at least 6-years experience of education and the ability to read and speak Chinese.

OUTCOME MEASURES

Reliability and Validity of the SC-SOSGOQ 2.0 were measured to assess HRQOL in patients with SM.

METHODS

The cross-cultural adaptation of the SOSGOQ 2.0 was conducted following international guidelines. The reliability and validity of the SC-SOSGOQ 2.0 was assessed in a multi-center, prospective observational study. The test-retest reliability was assessed by comparing the results of the first and final SC-SOSGOQ 2.0 scales, with 2 weeks apart. The discriminative, concurrent, and construct validity of the cross-culturally adapted questionnaire was individually evaluated. The relationship among the SC-SOSGOQ 2.0, SC-EQ-5D-5L and SC-SF-36 was assessed using the correlation coefficients.

RESULTS

One hundred and twenty patients were included in this study. No floor or ceiling effects were observed for the SC-SOSGOQ 2.0. The Cronbach's α for domains of neurological function, pain, mental health, social function, and post-therapy were 0.825, 0.876, 0.896, 0.897, 0.943, and 0.835, respectively. The value of inter-class correlation coefficient ranged from 0.55 to 0.83, which reflected a satisfactory test-retest reliability. Concurrent assessment of criterion validity demonstrated a moderate-to-strong correlation in all domains of SC-SOSGOQ 2.0 with the SC-EQ-5D-5L (0.34-0.74) and SC-SF-36 (0.33-0.76). The best-correlated domain was physical function (0.741 in the EQ-5D-5L and 0.722 in the SF-36).

CONCLUSIONS

The SC-SOSGOQ 2.0 demonstrated an excellent acceptability, score distribution, internal consistency, test-retest reliability and validity. It was therefore considered as a tool effective for evaluating HRQOL of Chinese patients with SM.

摘要

背景环境

近年来,脊柱转移瘤(SM)的治疗取得了显著进展,这使得健康相关生活质量(HRQOL)在 SM 的管理中具有更重要的意义。脊柱肿瘤研究组生存质量问卷 2.0 版(SOSGOQ 2.0)是一种专门针对 SM HRQOL 的特定标准,之前已经报道其具有良好的可靠性和有效性。然而,在中国内地还没有经过文化适应性、可靠性和验证的 SOSGOQ 2.0 版本。

目的

本研究旨在对 SOSGOQ 2.0 进行跨文化翻译,然后评估适用于脊柱转移瘤(SM)患者的简化中文版本(SC-SOSGOQ 2.0)的可靠性和有效性。

研究设计/地点:对 SOSGOQ 2.0 的中文版本进行翻译、跨文化适应性和验证。

患者样本

诊断为转移性脊柱疾病的患者,具有至少 6 年的教育经验,能够阅读和说中文。

结果测量

采用 SC-SOSGOQ 2.0 评估 SM 患者的 HRQOL,测量其可靠性和有效性。

方法

按照国际指南对 SOSGOQ 2.0 进行跨文化适应性改编。在一项多中心前瞻性观察研究中评估 SC-SOSGOQ 2.0 的可靠性和有效性。通过比较首次和末次 SC-SOSGOQ 2.0 量表的结果,间隔 2 周,评估测试-重测信度。分别评估经文化调适问卷的鉴别、同期和结构效度。使用相关系数评估 SC-SOSGOQ 2.0、SC-EQ-5D-5L 和 SC-SF-36 之间的关系。

结果

本研究共纳入 120 例患者。SC-SOSGOQ 2.0 无地板或天花板效应。神经功能、疼痛、心理健康、社会功能和治疗后域的 Cronbach's α 值分别为 0.825、0.876、0.896、0.897、0.943 和 0.835。类内相关系数的范围为 0.55 至 0.83,表明测试-重测信度良好。同时进行的标准效度评估表明,SC-SOSGOQ 2.0 的所有领域与 SC-EQ-5D-5L(0.34-0.74)和 SC-SF-36(0.33-0.76)之间存在中度至高度相关性。相关性最好的领域是身体功能(EQ-5D-5L 为 0.741,SF-36 为 0.722)。

结论

SC-SOSGOQ 2.0 具有极好的可接受性、评分分布、内部一致性、测试-重测信度和有效性。因此,它被认为是一种有效的评估中国 SM 患者 HRQOL 的工具。

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